Designing a sustainable transition in the MedTech industry

Mas e ’s hesis
Designing a sus ainable ansi ion in
he MedTech indus y
s uden numbe : 4541294
e-mail: d dolde [email p o ec ed]
Phone numbe : +31 623052024
Do ien an Dolde en
Thesis de ense: 02-03-2023
In eg a ed P oduc Design
Facul y o Indus ial Design Enginee ing
TU Del
An analysis o he cu en challenges o he
implemen a ion o he ci cula economy on
su gical de ices like he single-use endocu e
Abs ac
This g adua ion p ojec explo ed how he ci cula economy could be implemen ed o single-use su gical de ices like he endocu e .
Design o ep ocessing appea s o be he bes s a egy, bu modula solu ions should be conside ed when ep ocessing he en i e
de ice is no easible. The p ojec ollowed a ansi ion managemen app oach; a sus ainable u u e is en isioned o he indus y, and
h ough backcas ing a adical bu sho - e m easible solu ion is designed which could help us mo e owa ds his u u e. Concep ual
se ice design “MedFlo” helps heal hca e acili ies o e come ba ie s in he implemen a ion o modula de ices in o hei wo k low
and logis ics, by p o iding access o a sa e and comple e in en o y o de ices. MedFlo can help dec ease he en i onmen al and was e
oo p in o medical de ices, c ea e mo e esilien supply chains, s imula e ci cula design ini ia i es and se es as an example o how
he ci cula economy can be implemen ed in he MedTech indus y.
| 3
Mas e ’s hesis - Do ien an Dolde en
Designing a sus ainable ansi ion in he MedTech indus y
An analysis o he cu en challenges o he implemen a ion
o he ci cula economy on su gical de ices like he single-use
endocu e
Mas e hesis
In eg a ed P oduc Design
Facul y o Indus ial Design Enginee ing
Del Uni e si y o Technology
The Ne he lands
Au ho
Do ien an Dolde en
S uden numbe : 4541294
G adua ion Commi ee
Chai
P o . d . i . Conny Bakke
Facul y o Indus ial Design Enginee ing
Depa men o Sus ainable Design Enginee ing
Men o
D . i . Jan Ca el Diehl
Facul y o Indus ial Design Enginee ing
Depa men o Sus ainable Design Enginee ing
Design case
Kenne h Robe shaw
O ice o Sus ainabili y | Johnson & Johnson
Design o Sus ainabili y Lead | E hicon F on End Inno a ion
pa o he DiCE p ojec
Ma ch, 2023
P e ace
Acknowledgemen sThis is a mas e ’s hesis is w i en o ul il he g adua ion equi emen s
o he Mas e ’s deg ee In eg a ed P oduc Design o he Indus ial
Design acul y a he Del Uni e si y o Technology in he Ne he lands.
I wo ked on his g adua ion p ojec ull- ime om Sep embe 2022 o
Feb ua y 2023.
When I was looking o a hesis subjec , I knew I wan ed o wo k on a
combina ion o sus ainable design and design o heal hca e. O en he
bes cou se o ac ion when designing ci cula solu ions is simply inding
ways a p oduc is no longe needed a all. In heal hca e, phasing ou
p oduc s no so s aigh o wa d. Medical p oduc s can ha e c ucial
unc ions in sa ing human li es, and we canno simply choose no o
use hem. The cons ain s and complica ions o ci cula ini ia i es ha
exis in he heal hca e sec o in igued me and seemed like a sou ce o
g ea design challenges. A e all, a en’ limi a ions an impo an d i e
o c ea i i y?
This epo will gi e you a comple e insigh in o my jou ney om an
unknowing s uden o a (by he ime you ead his) g adua ed design
enginee wi h insigh in o he MedTech indus y, he ci cula economy
and he complexi y o medical de ices. I will show you my ision o
a sus ainable u u e, how I hink we can ge he e and wha you as a
eade , depending o cou se on you backg ound and unc ion, can do
o help us along he way.
Please enjoy,
Do ien an Dolde en
I wan o hank my supe iso s Conny and JC, as well as PhD candida e
Tama a, o all he excellen guidance and suppo du ing my p ojec
and o challenging me whene e I ended o s ay in my com o zone.
I could always each ou o eedback o ques ions, and ou mee ings
ga e me g ea new insigh s and di ec ion. I also wan o hank Kenne h
o a ending so many mee ings, ge ing me in o con ac wi h expe s
om Johnson & Johnson and b inging g ea new pe spec i es and
ideas o he able.
On op o ha , I wan o hank Associa e p o esso And és Felipe
Valde ama Pineda o Aalbo g Uni e si y Copenhagen o eaching a
g ea cou se on ansi ion heo y and aking he ime o p oo ead pa s
o my hesis, and P o esso Paul Hekke o helping me unde s and he
VIP me hod and o mula e a clea ision. I also wan o hank all he
expe s om Johnson & Johnson, Philips, AMDR, P eze o, LUMC and
Claa o allowing me o in e iew hem and o gi ing me new insigh s
and g ea eedback.
I wan o hank my amily o he s eady suppo and g ea ques ions,
and my 15 housema es o p o iding dis ac ions and en e ainmen
a imes whene e I needed a b eak, and o gi ing me an audience
when I needed o p ac ice a p esen a ion. Finally, I wan o hank all he
s uden s who wo k in he silen oom on he second loo o he Echo
building on he TU Del campus e e y single day. I ha e no idea who
you a e and wha you a e wo king on, bu i ’s g ea no o wo k alone
and I app ecia e he silen pee p essu e. E en hough I was e y happy
wi h you company, I hope I will no see you he e again.
Mas e ’s hesis - Do ien an Dolde en
| 4
Table o con en s
P ojec in oduc ion
Theo e ical amewo k: T ansi ion heo y
Me hodology
1. Me hod
2. The assignmen
3. The s a e o heal hca e
4. The ci cula economy
5. The ci cula economy in heal hca e
6. The possible Ci cula Reco e y Flows o lapa oscopic
ins umen s
7. The MedTech indus y om a mul i-le el pe spec i e
8. Conclusion
1. Me hod
2. Design sp in ep ocessing
3. Design sp in emanu ac u ing
4. Design sp in ecycling
5. Design sp in bioma e ials
6. Conclusion
1. Me hod
2. Designing he con ex
3. T ansla ion o in e ac ion and p oduc quali ies
4. Conclusion
1. Me hod
2. How- o’s
3. Mo phological cha
4. Idea selec ion
6. Conclusion
1. Me hod
2. Design p ocess
3. MedFlo - he inal design
4. Ba ie s o he implemen a ion o MedFlo
5. Conclusion
Discussion
Recommenda ions
Conclusion
Pe sonal e lec ion
Re e ences
p. 7
p. 10
p. 13
p. 16
p. 17
p. 18
p. 21
p. 23
p. 25
p. 27
p. 29
p. 31
p. 32
p. 40
p. 45
p. 52
p. 57
p. 60
p. 61
p. 63
p. 63
p. 65
p. 66
p. 68
p. 74
p. 76
p.78
p. 80
p. 84
p. 90
p. 96
p. 98
p. 102
p. 104
p. 105
p. 106
Pa 1: P ojec backg ound Pa 2: Design sp in s Pa 3: En isioning a ansi ion in MedTech
Pa 4. Idea gene a ion and selec ion Pa 5: Designing o a sus ainable ansi ion Pa 6: Conclusions
| 5
Mas e ’s hesis - Do ien an Dolde en
Glossa y
A business model a che ype whe e ins ead o a
physical p oduc , access o ha p oduc is sold o
a consume [1].
Plas ics ha (1) a e biodeg adable, o (2) may o
may no be deg adable bu a e p oduced om
biological ma e ials o enewable eeds ock [2].
A business model ha is closing, na owing,
slowing, in ensi ying, and dema e ializing loops,
o minimize he esou ce inpu s in o and he was e
and emission leakage ou o he o ganiza ional
sys em [3].
An economic sys em ha eplaces he ‘end-o -
li e’ concep wi h educing, al e na i ely eusing,
ecycling and eco e ing ma e ials in p oduc ion/
dis ibu ion and consump ion p ocesses [4].
A cleaning me hod which des oys mos bac e ia
[5].
A cleaning me hod which des oys all mic o-
o ganisms excep high numbe s o bac e ial
spo es [5].
Cos ad an ages expe ienced by companies
as hey g ow and become mo e e icien . An
economy o scale is ealised as a company
inc eases in size and can sp ead ou he cos o
p oduc ion o e a la ge numbe o uni s o a
good [6].
The li e cycle s age when a p oduc eaches he
s a e o obsolescence and he e o e, eaches
he end o a unc ional li e. The p oduc hen
becomes was e in a linea economy, bu his
p ocess can be e e ed in a ci cula economy [7].
An en i onmen al policy app oach in which a
p oduce ’s esponsibili y is ex ended o he pos -
consume s age o a p oduc ’s li ecycle [8].
A business model a che ype whe e he le o e
alue o li espan o an exis ing p oduc is
exploi ed [1].
A ype o su ge y o which ins ead o a la ge
open wound, one o mo e small incisions a e
made h ough which ce ain ins umen s and a
lapa oscope (came a) can access in e nal issue
[9].
A me hodology o assessing en i onmen al
impac s associa ed wi h all he s ages o he li e
cycle o a comme cial p oduc , p ocess, o se ice
(also known as Li e Cycle Analysis) [10].
Changing pa s, cleaning and checking he de ice
a egula in e als [11].
Applica ion o o ganised knowledge and skills
in he o m o de ices, medicines, accines,
p ocedu es, and sys ems de eloped o sol e a
heal h p oblem and imp o e he quali y o li es
[12].
A p oduc becomes obsole e when i is no longe
conside ed use ul o signi ican by i s use [13].
The du a ion o he pe iod ha s a s a he
momen a p oduc is eleased o use a e
manu ac u e o eco e y and ends a he momen
a p oduc becomes obsole e [14].
The du a ion o he pe iod ha s a s a he
momen a p oduc is eleased o use a e
manu ac u e and ends a he momen a p oduc
becomes obsole e beyond eco e y a he
p oduc le el [14].
A alue p oposi ion o ien ed o p o ide
sa is ac ion o cus ome s/use s h ough he
deli e y o an in eg a ed sys em o p oduc s and
se ices [15].
Any ope a ion wi h he p ima y aim o e e sing
obsolescence [14].
In ecycling he iden i y and unc ionali y o he
p oduc and i s componen s a e los , he pu pose
is o euse ma e ials ins ead o pa s om used
p oduc s and componen s [16].
A econ igu a ion o eplacemen o pa s o
es o e a p oduc om unc ional obsolescence
caused by a speci ic aul [11].
A p ocess ca ied ou on a used de ice o allow
i s sa e euse including cleaning, disin ec ion,
s e ilisa ion and ela ed p ocedu es, as well as
es ing and es o ing he echnical and unc ional
sa e y o he used de ice [17].
Access model:
Bioplas ics:
Ci cula business
model:
Ci cula Economy:
Decon amina ion:
Disin ec ion:
Economies o
Scale:
End o Li e:
Ex ended
P oduce
Responsibili y:
Gap exploi e
model:
Lapa oscopy:
Li e Cycle
Assessmen :
Main enance:
Medical
Technology:
Obsolescence:
P oduc (li e)cycle
/Loop:
P oduc li e ime:
P oduc Se ice
Sys em:
Reco e y:
Recycling:
Repai :
Rep ocessing:

| 6
Mas e ’s hesis - Do ien an Dolde en
Abb e ia ions
CBM
CE
DiCE p ojec
EoL
EPR
EU
J&J
LCA
MedTech
MDR
MLP
OEM
OR
PSS
CRF
SD
SUD
VIP me hod
Ci cula Business Model
Ci cula Economy /
Con o mi é Eu opéenne
(EU p oduc ce i ica e)
DiCE p ojec = Digi al heal h in
Ci cula Economy p ojec
End o Li e
Ex ended P oduce Responsibili y
Eu opean Union
Johnson & Johnson
Li e Cycle Assessmen
Medical Technology
Medical De ice Regula ions
Mul i Le el Pe spec i e
O iginal Equipmen Manu ac u e
Ope a ing Room
P oduc Se ice Sys em
Ci cula Reco e y Flow
S e ilisa ion Depa men
Single-Use De ice
Vision in Design me hod
The comple e ebuilding o a de ice al eady
placed on he ma ke o pu in o se ice, o
he making o a new de ice om used de ices,
o b ing i in o con o mi y wi h egula ion,
combined wi h he assignmen o a new li e o
he emanu ac u ed de ice [17].
A dominan and s able con igu a ion in a socie al
(sub)sys em a he meso le el. A egime p o ides
o ien a ion and coo dina ion o he ac i i ies
o g oups and accoun s o he s abili y o he
exis ing socio- echnical sys ems [18].
Ma e ial and imma e ial elemen s a he mac o
le el beyond he di ec in luence o ac o s [18],
[19].
A cleaning me hod which des oys all
mic oo ganisms [5].
Indi idual ac o s and echnologies and local
p ac ices a he mic o le el [19].
A non-linea shi om one dynamic equilib ium
o ano he h ough a se o connec ed changes
[19], [20].
Any subs ance o objec ha he holde disca ds
o in ends o is equi ed o disca d [14].
Remanu ac u ing:
Socie al egime:
Socio- echnical
landscape:
S e ilisa ion:
Technological
niche:
T ansi ion:
Was e:
Su gical s eel
- high alue ma e ial
ha is cu en ly los
Hollow pa s
- ha d o clean
Replaceable ba e y
- canno be cha ged
De ice canno be disassembled
wi hou damage
Liquids can en e he
de ice h ough c e ices
2K injec ion moulding
- ma e ials canno be p ope ly
sepa a ed o ecycling
Kni e becomes blun
a e 12 i es
Elec onics
- aluable ma e ial ha
is cu en ly los and canno
easily be s e ilised
High g ade plas ics
- semi- aluable ma e ial
ha is cu en ly los and
is no sui able o high-
empe a u e s e ilisa ion
| 7
Mas e ’s hesis - Do ien an Dolde en
P ojec in oduc ion
Scope
This g adua ion p ojec is pa o he EU- unded DiCE (Digi al heal h
in Ci cula Economy) p ojec ; a p ojec o inno a e on he ci cula i y
o digi al heal h de ices as a way o enable a sus ainable ansi ion.
Wi hin he DiCE p ojec , ou digi al heal h de ices will be edesigned
o imp o ed ci cula i y and will se e as an example o he medical
echnology indus y. One o hese de ices, he endocu e , is he ocus
o his g adua ion p ojec . Endocu e s a e su gical ins umen s used
in lapa oscopy, a ype o minimally in asi e su ge y. This de ice can
be used o cu issue and seal i wi h he use o ows o iny s aples,
all h ough a small incision. Cu en ly, mos endocu e s ollow a
linea ( ake-make-was e) pa e n and a e only used once be o e hey
a e disca ded o he sake o pa ien sa e y. Figu e FIXME shows he
ba ie s o he ci cula i y o a cu en (linea ) endocu e design.
igu e 1. E hicon’s Echelon Flex 60 and cu en ba ie s o ci cula i y
The main s akeholde s in his p ojec a e Johnson & Johnson and
hei subsidia y E hicon, bu he p ojec is aimed owa ds p o iding an
example o he whole medical de ice indus y and se ing in mo ion
a sys emic change. E hicon’s ECHELON™+ S aple ( igu e 1) is he
endocu e analysed as he ounda ion o his p ojec . Howe e , he
aim is no o p o ide guidelines o a ci cula edesign o his speci ic
de ice, bu ins ead o explo e possibili ies o imp o emen s o a whole
ca ego y o aluable bu c i ical de ices; cos ly de ices which come
in o close con ac wi h pa ien s and pose a high isk o in ec ion. The
hope is ha his p ojec helps se in mo ion o ad ance a sus ainable
ansi ion in he MedTech indus y.
| 8
P oblem de ini ion Aim and esea ch ques ions
1.
2.
3.
T ansi ion pe spec i e
Mos endocu e s a e cu en ly designed o be incine a ed a e a single
su ge y. Mo ing away om his linea model is complica ed because o
sa e y isks, as eusing po en ially con amina ed de ices could cause
in ec ions and endange pa ien s. I is also egula o y e y complex
because o o example he medical de ice egula ions [17], was e
( anspo ) egula ions [21]–[24], and hospi al policies and logis ics. On
op o ha , manu ac u e s depend on he con inuous sales o single-
use de ices in hei cu en business models and canno easily adap o
mo e sus ainable p ac ices.
I is a challenge o iden i y he bes and mos impac ul measu es o
ake when he aim is o edesign o ci cula i y. Measu es can equi e
End-o -Li e (EoL) p ocesses wi h a high en i onmen al impac , complex
P oduc Se ice Sys ems (PSSs) ha can es ic heal hca e ac i i ies,
o d as ic p oduc edesigns which could limi he unc ionali y o he
de ice. Addi ionally, sa e y is c ucial and he de ice canno pose an
in ec ion isk o anyone in ol ed.
Cu en ly, he e is no clea o e iew o he possible ways he li e o he
endocu e can shi om linea o ci cula , as well as hei espec i e
bene i s and d awbacks. Mo e knowledge on his subjec could help us
mo e owa ds a mo e sus ainable model, and educe he en i onmen al
and was e oo p in o su ge ies. This p ojec will co e a design
explo a ion o di e en possible ci cula eco e y lows o he de ice in
o de o ad ance owa ds a sus ainable u u e o he MedTech indus y.
Wi hin his p ojec , di e en End-o -Li e oppo uni ies o he
endocu e ¬which could educe i s en i onmen al impac will be
iden i ied and explo ed h ough bo h quali a i e esea ch and
explo a i e design. The di e en possibili ies a e hen placed in he
pe spec i e o an en isioned sus ainable ansi ion in he indus y,
owa ds a u u e in which de ices like he endocu e mo e away
om hei linea and pollu ing model. Th ough backcas ing om he
en isioned u u e, a se ice design is concep ualised which is bo h
easible on he sho e m and helps he indus y mo e o wa d in
he igh di ec ion. This p ojec can se e as an example o a ange
o medical de ices wi h simila ba ie s o ci cula design o ci cula
business models, and can hope ully be used as a s epping s one o
u u e design s udies and p ojec s in his ield.
This hesis is guided by he ollowing esea ch ques ions:
This p ojec looks a he p oblems and de elopmen s in he MedTech
indus y om he pe spec i e o ansi ion heo y because his
app oach can gi e g ea insigh in o he complexi y o a p oblem as big
as his one, and wha i will ake o sol e i . A combina ion o esea ch
and design is used as a means o de e mine how we can shi om an
indus y dependen on single-use de ices o a sys em based on ci cula
design al e na i es. The nex chap e will explain ansi ion heo y in
mo e de ail, and he me hodology chap e will elabo a e on how i is
used o guide his p ojec . Figu es 2 and 3 explain how he di e en
sec ions o his epo ame he di e en phases o a sus ainable
ansi ion in he MedTech indus y.
igu e 2. The ocus o epo sec ions on di e en elemen s o a ansi ion.
Wha a e he di e en ci cula pa hs (Ci cula Reco e y Flows)
a medical de ice like he endocu e could ollow ins ead
o i s cu en linea model? And wha a e hei bene i s and
d awbacks?
Wha could a sus ainable ansi ion in he MedTech indus y
look like? How do I en ision he u u e?
How can he di e en Ci cula Reco e y Flows (CRFs) o he
endocu e be used o design an inc emen al bu adical s ep
in he en isioned di ec ion?
The i s esea ch ques ions will be answe ed h ough a li e a u e
e iew, expe in e iews and design sp in s on each possible CRF. The
second ques ion will be answe ed h ough a isioning p ocess using he
Vision in Design (VIP) me hod [25]. The inal ques ion will be add essed
h ough a design p ocess and guided expe in e iews.
Pa 1
P ojec backg ound
Pa 2
Design sp in s
Pa 3
En isioning a
ansi ion in MedTech
Pa 4
Idea gene a ion
and selec ion
Pa 5
Designing o a
sus ainable ansi ion
Explo e he sys em in which he endocu e exis s.
Wha a e he ba ie s and oppo uni ies o he
implemen a ion o he ci cula economy?
Whe e a e we now?
Wha a e he di e en ou es we can ollow
owa ds mo e ci cula designs?
Wha a e hei bene i s and d awbacks?
Wha could a sus ainable u u e look like o his
sys em?
Wha should be he end goal o a ansi ion?
Wha kind o solu ions can help us ge o his
sus ainable u u e?
Which should we choose?
Wha is a conc e e example o a solu ion ha
b ings us close o a sus ainable u u e and
helps us ad ance in a ansi ion?
| 9
Mas e ’s hesis - Do ien an Dolde en
Reading guide
Pa 1: P ojec backg ound Pa 2: Design sp in s Pa 3: En isioning a ansi ion in
MedTech
Pa 4. Idea gene a ion and
selec ion
Pa 5: Designing o a
sus ainable ansi ion
igu e 3. Reading guide - he implemen a ion o ansi ion heo y on he planning o his g adua ion p ojec
T
h
e p esen
?
Whe e a e we now?
wha does he p esen look like?
T
h
e p esen
Wha a e he di e en
ou es we can ake om he e?
Which should we choose?
T
h
e p esen
A sus aina
bl
e
u u
e
?
Wha could a sus ainable
u u e look like?
T
h
e p esen
A sus aina
bl
e
u u
e
Wha s eps could ge us o
ha sus ainble u u e?
Which should we choose?
T
h
e
p
esen
A sus aina
bl
e
u u
e
T
T
T
a
n
s
i
i
o
n
i
m
e
l
i
n
e
Wha is he
missing link
be ween wha is
possible and
wha helps us
ge o a
sus ainable
u u e?
Mas e ’s hesis - Do ien an Dolde en
| 16
Mas e ’s hesis - Do ien an Dolde en
1. Me hod
ABS ( ( ci cula OR ci cula i y ) AND (
su ge y OR su gical OR “ope a ing
oom” OR medical ) AND ( de ice*
OR ins umen ) AND NOT adius
AND NOT diame e AND NOT
implan * AND NOT ci cula ly )
Wi hin he subjec a eas o
enginee ing, ma e ials science,
business and en i onmen al science.
1.1. Collec ing da a 1.2. Sea ch s a egy
1.3. S uc u ing da a
Fo he ini ial li e a u e e iew, I used he academic pla o m ‘Scopus’. This pla o m
allows p ecise c i e ia and bounda ies such as keywo ds, publica ion yea s and subjec
a ea o be included in he li e a u e sea ch. The sea ch was ocused on he oppo uni ies
and ba ie s in he implemen a ion o ci cula business models on su gical de ices. I
also included was e managemen o su gical was e, ma e ial choices in su gical de ices,
egula ion in he ield and hospi al policies a ound he ope a ing oom in my sea ch
s a egy. The comple e s a egy is s a ed on he igh .
This s a egy p o ided 216 pape s. The esul s ha only men ioned heal hca e as an
example, as well as sou ces using he wo d “ci cula ” in a way ha did no e e o
he ci cula economy, we e excluded. A e checking he i les o ele ance, only 9
p omising a icles emained. These a icles o med he base o he p ojec backg ound
along wi h ele an mas e heses om he TU Del eposi o y. These heses co e ed
design s udies ocused on mo ing away om single-use de ices in a s e ile hospi al
en i onmen .
F om his ini ial sea ch, mo e speci ic esea ch ques ions eme ged and gaps in
knowledge became e iden . To ill hose gaps I did some mo e speci ic sea ches and
also looked in o sou ces such as books, legisla ion, he DiCE p ojec b ie , and company
websi es.
The da a om he li e a u e a e
summa ised and s uc u ed in o
chap e s 2-5:
2. The assignmen
3. The s a e o heal hca e
4. The ci cula economy
5. The ci cula economy in heal hca e
Based on he indings om he
li e a u e, I could decide on he
possible ci cula eco e y lows (CRFs)
o lapa oscopic ins umen s like he
endocu e . These CRFs a e desc ibed
in chap e 6. Chap e 7 ames he
indings in o a possible sus ainable
ansi ion as seen om a mul i-le el
pe spec i e. This chap e se s he
di ec ion o he es o he p ojec .

| 17
Mas e ’s hesis - Do ien an Dolde en
2. The assignmen
2.1. The DiCE p ojec
2.2. Lapa oscopy and endocu e s
2.3. E hicon and Johnson & Johnson
This g adua ion p ojec is a pa o he EU- unded DiCE (Digi al heal h in
Ci cula Economy) p ojec ; a p ojec o which nume ous o ganiza ions,
companies and uni e si ies h oughou Eu ope collabo a e o inno a e
on he ci cula i y o digi al heal h de ices as a way o enable a ci cula
ansi ion. The DiCE p ojec aims o mi iga e he globally expanding
heal h was e p oblem and c i ical ma e ial sho ages while p o ec ing
global heal h and sa e y.
Wi hin he p ojec , ou digi al heal h de ices will be edesigned o
imp o ed ci cula i y and will se e as an example o he indus y. One
o hese de ices is an endocu e designed by E hicon, a company
unde nea h he Johnson & Johnson umb ella, which is he ocus o his
g adua ion p ojec .
Johnson & Johnson is cu en ly he wo ld’s la ges and mos b oadly
based heal hca e company. The company was ounded in 1886 in he
US and de elops medical de ices, consume packaged goods and
pha maceu icals [34]. E hicon is a subsidia y o Johnson & Johnson wi h
a ocus on su gical and in e en ional solu ions ac oss di e en su gical
app oaches including lapa oscopy [35].
Lapa oscopic su ge y is a ype o su ge y in which ins ead o a la ge
open wound, one o mo e small incisions a e made h ough which
ce ain ins umen s and a lapa oscope (came a) can access in e nal
issue. This ype o su ge y is a p ecise and e ec i e way o pe o m
a ious su ge ies. Because he cu s a e smalle , he e is less blood loss,
a lowe chance o complica ions and a gene ally sho e eco e y ime
a e su ge y. Depending on he p ocedu e, lapa oscopic su ge y can
also be signi ican ly mo e cos -e ec i e compa ed o open-wound
su ge y [9].
Wo king inside small spaces poses challenges; ins umen s can only
ha e ou deg ees o eedom ins ead o he egula six. The ocus o
lapa oscopic ins umen design has been mos ly on he s ee abili y
o he ins umen ’s so-called “end-e ec o ”, which is he pa o he
ins umen ha in e ac s wi h issue. This has made many lapa oscopic
ins umen s oo complex o cleaning and main enance, which is why
hey a e o en labelled as single-use [9].
An endocu e (a ype o su gical s aple ) is one o hese lapa oscopic
ins umen s. I can be used o cu issue and su u e i wi h he use
o ows o iny s aples, all h ough a small incision. Cu en ly, mos
endocu e s a e only used once be o e hey a e disca ded o he sake
o pa ien sa e y. Wi h hei cu en ma ke p ice o a ound 400 eu os,
hey a e some o he mos expensi e ins umen s used in lapa oscopic
su ge y [32]. The e is one example o a semi- eusable endocu e
cu en ly on he ma ke . The handle is encased in a disposable plas ic
slee e and does no need o be cleaned, he sha can be s e ilised
up o 50 imes and he end e ec o is disposable[33]. E en hough he
main de ice only needs o be pu chased once, he disposable modules
s ill con ibu e o a cos pe su ge y ha is e y simila o ha o he
disposable endocu e . The modula de ice is also qui e complex o
p epa e, use and ep ocess (appendix 5.3).
igu e 9. E hicon’s Echelon Flex 60, 45 and 35
| 18
Mas e ’s hesis - Do ien an Dolde en
“... I will do no ha m ...”
Image om whi e coa ce emony 2018 o Washing on
Uni e si y School o Medicine in S . Louis
“… I will do no ha m…” is a key pa o he Hippoc a ic oa h. This ex is a his o ical
exp ession o medical e hics and is o en eci ed by medicinal g adua es in he so-
called whi e coa ce emony. Why is i ha , in ying o p o ec he heal h o socie y, he
heal hca e sec o con ibu es so much o ha ming i ?
The medical indus y is one o he mos pollu ing indus ies in he wo ld, wi h he
clima e oo p in o he heal hca e sec o being equi alen o 4.4% o global ne
emissions [36], and e en 7.3% o emissions in he Ne he lands [37]. De elopmen in his
ield has been mos ly aimed owa ds pa ien and pe sonnel sa e y and imp o ing he
quali y o ca e. These alues ha e such a high p io i y in he sec o , ha e o s owa ds
mo e sus ainable p ac ices and minimizing en i onmen al impac a e pu on he back
bu ne . This has caused he heal hca e indus y o lag behind o he indus ies when i
comes o educing he en i onmen al impac o hei p ac ices [38].
The heal hca e sec o gene a es la ge amoun s o was e e e y yea due o ac o s like
apid popula ion g ow h, an inc ease in he numbe and size o heal hca e acili ies, and
he sys ema ic use o single-use de ices (SUDs) [39]. Nex o he p opo ion o his was e
s eam, especially he composi ion is a challenge. The e is a complica ed combina ion
o non-haza dous was e and di e en ypes o haza dous was e, including medicine
esidues, sha p ins umen s, biological ma e ial and elec onics [40], [41]. Because o
a sa e y- i s mindse , p oduc s ha a e uncon amina ed some imes s ill end up in he
in ec ious was e s eam. I sepa a ed co ec ly hey could ha e been disposed o in an
al e na i e way o could ha e been ecycled [42].
The ecen Co id-19 pandemic has also exposed p oblems in he sys em. One impo an
weakness o he cu en MedTech indus y is ha o i s supply chains. Closing bo de s
led o sho ages o ce ain medical de ices, and especially he p oduc ion o powe ed
de ices su e ed because o a global sho age o semiconduc o chips [43], [44].
3. The s a e o heal hca e
| 19
Mas e ’s hesis - Do ien an Dolde en
An ope a ing oom (OR) mus gua an ee as much s e ili y as possible o he sa e y o
pa ien s. App oxima ely 20 o 30 pe cen o was e om hospi als o igina es in he OR
[45], [46]. To main ain he necessa y le el o s e ili y in he ope a ing oom, he whole
oom is ea ed as a con amina ion haza d a e su ge y. Fo medical de ices his means
all he ins umen s aken ou o hei s e ile packaging, bo h used on pa ien s and no
used a all, ei he need o be s e ilised o disca ded as haza dous ma e ial [42], [47].
On op o indi idual disposables, some imes disposable cus om packs a e used o
su gical p ocedu es. These packs a e p e-so ed su ge y ki s wi h di e en disposables
packaged oge he o educe c oss-con amina ion, ime and human mis akes. This
p ac ice leads o e en mo e unused p oduc s being disposed o a e su ge y [48].
Du ch spa ial a is Ma ia Koijck unde wen a 10-hou su ge y o ea b eas cance . She
collec ed all he was e and ans o med i in o a s a emen a ilm o c ea e awa eness
o he impac o heal hca e ( igu e 10) [49].
3.1. The impac o he OR
20-30% o o al was e olume om
hospi als o igina e in he OR
[45], [46]
igu e 10. The was e om one single mas ec omy (b eas cance su ge y), an a wo k by Ma ia Koijck i led “This is he was e o one ope a ion
,….my ope a ion!” [49]
3.2. Single-use de ices
Single-use de ices (SUDs) a e disposable p oduc s used in heal hca e as an al e na i e
o eusable de ices ha can be cleaned, disin ec ed, s e ilised and some imes epai ed
a e use [48]. Lowe pu chase cos s, pe cei ed in ec ion isks and po en ial o human
e o s in ep ocessing ha e led o a su ge in disposable p oduc s. O e he las ew
decades, medical de ices ha we e adi ionally eusable ha e now been edesigned
o one single use [39], [50]. The e a e, howe e , signi ican d awbacks o he use o
SUDs:
E en hough pu chasing p ices a e gene ally much lowe , ecen esea ch sugges s ha
SUDs a e no ac ually cheape compa ed o eusables in he long un [32], [39]. One
s udy compa ed disposable e sus eusable cos s o lapa oscopic cholecys ec omy and
ound disposable se cos s o be o e 6 imes g ea e compa ed o eusable se cos s
pe su ge y [51]. Also, a signi ican cos educ ion in lapa oscopic ba ia ic su ge y and
appendicec omy has been ound [52], [53]. In gene al, e idence sugges s ha he use
o SUDs is mo e expensi e compa ed o he use o eusables, bu he e a e excep ions
and u he esea ch is needed o de e mine i his is he case o he endocu e as
well. The e is also a la ge a ia ion in esul s be ween cases depending o example on
he geog aphical loca ions o hospi als and e en he le el o expe ience o indi idual
su geons [32].
| 20
3.3. A need o change
SUDs a e an example o p oduc s
ollowing a linea ( ake-make-was e)
economy. This economy is o en
an unsus ainable model which can
con ibu e o global ecological
des uc ion by deple ing esou ces
and gene a ing immense amoun s
o was e and ha m ul emissions. A
linea economy is no only ha m ul
o he plane bu also o human
heal h h ough ai pollu ion, wa e
con amina ion, biodi e si y loss and
apid clima e change [55]. This leads
o a icious cycle; he heal hca e sec o
con ibu es o clima e change, which
in i s u n pu s mo e p essu e on he
heal hca e sec o ( igu e 13).
he manu ac u e needs o p o e ha a de ice can be ep ocessed sa ely o be able
o ma ke i as eusable, bu he e a e no such equi emen s o ma ke ing a de ice as
single-use. This ex a s ep o alida e a eusable p oduc leads many manu ac u e s o
sa e ime and esou ces by simply labelling a de ice as single-use [55].
One dimension missing om he li e a u e al oge he is ha o he di e ences
in con enience and ease o use be ween single-use de ices and eusables. The
ep ocessing o de ices equi es hospi als o in es in o ou sou ce specialised acili ies,
ained pe sonnel, cleaning supplies, epai , acking and accoun ing. Meanwhile, he
use o SUDs only equi es an in ec ious was e s eam o hei EoL, which is eadily
a ailable in all heal hca e acili ies.
Figu e 12 p o ides a summa y o he compa ison be ween SUDs and eusable de ices
and shows whe e e idence is s ill lacking.
P essu e on heal hca e
Inc eased en i onmen al
impac
igu e 11. Con ibu ion medical elec onics o en i onmen al impac Du ch heal hca e [37] igu e 12. A summa ising able compa ing SUDs wi h eusable medical de ices
igu e 13. The icious cycle o clima e
change and heal hca e
The en i onmen al impac o eusables and disposables can a y signi ican ly
depending on ma e ials, ene gy ype and ene gy quan i ies consumed in o example
ep ocessing ac i i ies. Some cleaning agen s used in disin ec ion and s e ilisa ion
also g ea ly con ibu e o was e pollu ion [32]. In a s udy compa ing he en i onmen al
impac o SUDs and eusables used o lapa oscopic cholecys ec omy [54], e idence
was ound ha disposable ins umen s impose a g ea e load on he en i onmen .
The impac o was e om disposable ins umen s con as s wi h ha o ep ocessing
eusable ins umen s, and in he case o eusables, he impac o he de ice’s p oduc ion
is sp ead o e many li ecycles. A li e-cycle assessmen (LCA) is necessa y o de e mine
he di e ence in impac pe case, bu gene ally, e idence sugges s ha limi ing he use
o SUDs holds en i onmen al ad an ages [32].
E en hough in ec ion isk is pe cei ed o be lowe o SUDs compa ed o eusable
de ices, he e is no compelling e idence ha he use o SUDs educes heal h-ca e
acqui ed in ec ions [55]. This is because cases a e so a e ha sample sizes needed
o compa e in ec ion a es om single-use and disposable de ices a e oo la ge o a
s udy o be easible [56].
Big co po a ions depend on economies o scale o keep p oduc p ices low [50]. This
is why he income o manu ac u e s pa ly depends on con inuous sales o SUDs, which
makes a possible ansi ion back o eusables slow. Howe e , heal hca e acili ies aim o
become mo e sus ainable and cu cos s as sa ely as possible. Sol ing his con lic will
be a challenge since mos solu ions in ol e he design o a complex p oduc -se ice
sys em in which many mo e ac o s han jus he manu ac u e ake pa [42]. Cu en ly,
7,6%
4,2%
3,0%
2,6%
7,9%
En i onmen al
impac
(pe cei ed)
sa e y
Business case
Ease o use
Cos High
High
High
P ofi able
Easy
Less
p ofi able
Requi es
mo e ime
and esou ces
Lowe
Compa ison depends on use cycles,
geog aphical loca ion, indi idual su geons and
cleaning p ocesses. Needs mo e e idence
because o hidden cos s.
Depends on ma e ials, ene gy ype and ene gy
consumed by o example cleaning p ocesses.
Needs mo e e idence and LCAs.
Ac ual sa e y is impossible o p o e because o
la ge sample sizes. SUDs a e howe e pe cei ed
o be sa e compa ed o eusables.
The con inuous sales o SUDs is e y p o i able
o OEMs. On op o ha he design and
app o al o eusables is mo e expensi e because
o egula ion.
Reusables equi e cleaning in as uc u e.
Howe e , e idence on his subjec is lacking.
Lowe
Lowe
SUDs Reusables
| 21
Mas e ’s hesis - Do ien an Dolde en
4. The Ci cula economy
In a linea economy, aw ma e ials a e ex ac ed and hen o med in o p oduc s. These
p oduc s a some poin each he end o hei unc ional li es and a e disposed o as
“was e” [11]. The ci cula economy is an answe o his inhe en ly des uc i e model.
The ci cula economy is desc ibed as “An indus ial economy ha is es o a i e by
in en ion and design” [57] o mo e speci ically as “an economic sys em ha eplaces
he ‘end-o -li e’ concep wi h educing, al e na i ely eusing, ecycling and eco e ing
ma e ials in p oduc ion/dis ibu ion and consump ion p ocesses” [4]. The ci cula
economy aims o elimina e was e by leng hening p oduc li e – slowing loops – o
ein oducing he p oduc , pa s, o ma e ials back in o he sys em o euse – closing
loops [11], [55] ( igu e 14).
The Ellen MacA hu ounda ion isualized he ci cula economy as his bu e ly
diag am ( igu e 15), which shows he con inuous low o ma e ials. They di ided he
diag am in o wo ypes o cycles; echnical cycles and biological cycles. Th ough
echnical cycles, p oduc s and ma e ials a e kep in ci cula ion h ough p ocesses such
as euse, epai , emanu ac u e and ecycling. Th ough biological cycles, he nu ien s
om biodeg adable ma e ials a e e u ned o he Ea h o egene a e na u e [57].
Linea economy
Na u al esou ces
Renewable
esou ces
Renewable
esou ces
Non- enewable
esou ces
Non- enewable
esou ces
Use Use
Land ill and incine a e Land ill and incine a e
Na u al esou ces
T ansi ion owa ds a ci cula economy
Ci cula economy
igu e 14. The ansi ion o a ci cula economy, adap ed om Po ing e al. [58] igu e 15. The bu e ly diag am [57]
A ansi ion om a linea o a ci cula economy

| 22
Mas e ’s hesis - Do ien an Dolde en
4.1. P ese ing p oduc in eg i y
The e is an o de o p io i y o he cycles o “loops” a p oduc can go
h ough h oughou i s li e ime called he was e hie a chy. This is a
p io i y o de o managing was e, wi h he p e en ion o was e as he
highes p io i y and he disposal o was e as he lowes p io i y [12].
The was e hie a chy ies oge he closely wi h he ine ia p inciple: “Do
no epai wha is no b oken, do no emanu ac u e some hing ha
can be epai ed, do no ecycle a p oduc ha can be emanu ac u ed.
Replace o ea only he smalles possible pa o main ain he exis ing
economic alue o he echnical sys em” [42]. P oduc in eg i y is he
ex en o which a p oduc s ays in i s o iginal s a e, o as close o ha
s a e as possible, o e ime. Re aining p oduc in eg i y minimizes
en i onmen al impac om in e en ions o p ese e o es o e he
alue o a p oduc o e ime [12].
Ci cula i y s a egies wi hin he p oduc ion chain, in o de o p io i y
Ci cula
economy
Inc easing
di icul y
Rule o humb:
Highe le el o
ci cula i y =
ewe na u al
esou ces
and less
en i onmen al
p essu e
Linea
economy
R0
Re use
R1
Re hink
R2
Reduce
R3
Re-use
R4
Repai
R5
Re u bish
R6
Remanu ac u e
R7
Repu pose
R8
Recycle
R9
Reco e
Sma e
p oduc
use and
manu ac u e
Ex end
li espan o
p oduc and
i s pa s
Use ul
applica ion
o ma e ials
Make a p oduc edundan by
abandoning i s unc ion o by o e ing
he same unc ion wi h a adically
di e en p oduc
Make a p oduc ’s use mo e in ensi e
(e.g. h ough sha ing p oduc s, o by
pu ing mul i- unc ional p oduc s on he
ma ke )
Inc ease e iciency in a p oduc ’s
manu ac u e o use by consuming
ewe na u al esou ces and ma e ials
Re-use by ano he consume o a
disca ded p oduc which is s ill in good
condi ion and ul ills i s o iginal unc ion
Repai and main enance o a de ec i e
p oduc so i can be used wi h i s
o iginal unc ion
Res o e an old p oduc and b ing i up
o da e
Use pa s o disca ded p oduc in a new
p oduc wi h he same unc ion
Use disca ded p oduc o i s pa s in a
new p oduc wi h a di e en unc ion
P ocess ma e ials o ob ain he same
(high g ade) o lowe (low g ade) quali y
Incine a ion o ma e ials wi h ene gy
eco e y
igu e 16. The 9R amewo k, adap ed om Po ing e al. [58] igu e 17. The alue hill, adap ed om B owne-Wilkinson e al. [59]
Re use
Heal hca e
wo ke
P ocu emen
Assembly
Manu ac u ing
Resou ces
Redesign
Re hink
Re hinkReduce
Re u bish/
emanu ac u e
Repu pose/
e alo ise
Recycle
Reco e
Inc easing alue
As a ule o humb; mo e ci cula i y can be assumed o equal mo e
en i onmen al bene i s. This is because a highe le el o ci cula i y
means ha he ma e ials emain inside he sys em o longe , alue is
main ained, and he p oduc e ains a highe le el o in eg i y ( igu e
17). As a esul , ewe new ma e ials a e needed o he p oduc ion o
new p oduc s, and ewe ma e ials lea e he sys em as was e. The e a e
howe e excep ions o his ule. Some s a egies can equi e a lo o
ene gy o o example dange ous chemicals o execu e [43].
The o de o p io i y o he di e en ci cula i y s a egies is isualized in
he so-called 9R amewo k [43] ( igu e 16). The lowe he R numbe , he
highe he le el o ci cula i y. The R amewo k goes in o a highe le el
o ci cula i y compa ed o he bu e ly diag am, because i also akes
he beginning o cycles in o accoun wi h i s i s h ee s a egies.
| 23
5. The Ci cula economy in heal hca e
5.1. Oppo uni ies and challenges
5.1.1. Hygienic c i icali y
5.1.2. P oduc alue
Ci cula design in heal hca e is pa icula ly in e es ing. The impac o
he sec o is huge and he e a e a lo o design cons ain s due o he
high le el and complexi y o egula ions. Fo he edesign o medical
p oduc s, you canno simply ake he same app oach as o household
appliances since he e is way mo e isk in ol ed. E e y hing ha
has a isk o con amina ion needs o be ea ed wi h ex a ca e. This
ea men includes ex ensi e cleaning, disin ec ion and s e ilisa ion
p ocesses and special handling in anspo and s o age, o he sa e y
o e e yone in ol ed.
I a po en ial edesign nega i ely in luences he unc ionali y o he
de ice o poses an inc eased isk, he p oduc could endange pa ien s’
heal h o e en li es. Whe e no mally he choice be ween eusable
and single-use p oduc s is mos ly based on cos and ease o use, in
he medical indus y he de e mining ac o is o en ha o (pe cei ed)
in ec ion isk [11].
Cu en ly, he e is al eady some le el o ci cula ion o p oduc s and
ma e ials in he sec o . Remanu ac u ing o complex equipmen is
al eady qui e ad anced and widesp ead, bu hygienic eco e y o
ools like he endocu e (medium/high alue, high c i icali y) is o en
execu ed poo ly and agains manu ac u e s’ in en ions and designs,
when i is done a all. Recycling is also a p ocess ha needs mo e
esea ch and explo a ion in he medical ield [11].
Kane e al. [11] ound ha eco e y oppo uni ies o he medical
sec o p ima ily depend on hygienic c i icali y, p oduc alue and he
en i onmen al suppo s uc u e. They mapped di e en p oduc s
acco ding o hei p oduc alue and hygienic c i icali y and ad ised
ce ain design s a egies o eco e y acco dingly. Guzzo e al. [40] used
he same axes o p o ide ad ice on possible ci cula business models
(CBMs) a ound hese medical de ices.
Hygienic c i icali y is de ined by he Spaulding scale. Nonc i ical
i ems only come in o con ac wi h in ac skin and only need o be
decon amina ed be o e use. Semi-c i ical i ems come in o con ac
wi h mucous memb anes o non-in ac skin and equi e a high le el o
disin ec ion be o e use. C i ical i ems ha e a high isk o con amina ion,
hese a e objec s ha en e human issue o he ascula sys em.
This ca ego y includes su gical ins umen s like he endocu e , which
should be s e ile be o e use [5]. Decon amina ion is a cleaning me hod
which des oys mos bac e ia, disin ec ion des oys all mic o-o ganisms
excep high numbe s o bac e ial spo es, and s e ilisa ion des oys all
mic oo ganisms [60].
Whe he o no i is iable o eco e a medical de ice la gely depends
on i s economic alue, and how much i would cos o disca d he
p oduc compa ed o eco e ing i . I he cos o eco e y is g ea e han
he alue o he de ice i sel he i em will p obably emain disposable.
Howe e , he e could s ill be alue in ma e ial eco e y h ough
ecycling [11]. The cos o eco e y pa ly depends on economies o
scale [61].
5.1.3. En i onmen al suppo s uc u e
The oppo uni ies o eco e y o a medical de ice also depend on
he in as uc u e in he hospi al i is used. Fo example; some de ices
need specialized s e ilisa ion me hods which migh no be a ailable
in smalle hospi als, o equi e biomedical enginee s o epai o
emanu ac u e s uc u es [11].
igu e 18. Specialized hyd ogen pe oxide s e ilisa ion machine o
he moplas ics a LUMC
| 24
5.1.4. Oppo uni ies o he endocu e
Design s a egies Hygienic c i icali y
P oduc design
Regula ion
Ci cula Business Models
igu e 19. adap ed om Kane e al. [11] and Guzzo e al. [40]
Reco e y oppo uni ies by Kane e al. [11]
Ci cula business model ypes by Guzzo e al. [40]
C i icali y
Non-c i ical
Low Medium Hgih
Semi-c i ical C i ical
P oduc alue (economic)
The endocu e
Reco e y oppo uni ies:
- Op imize o hygienic eco e y
- Design he de ice o a ixed
amoun o eco e y cycles,
o lowe cos s o ci cula i y
- Design a hyb id de ice ha is
no en i ely c i ical o non-
c i ical, bu a hyb id o he
wo.
- Design o us in eusables
Possible CBMs
- Suppo o hospi al based
ep ocessing (in hospi al
ep ocessing)
- Full p o ision o
ep ocessed de ices
(manu ac u e o hi d pa y
ep ocessing)
Map o ci cula medical p oduc s and business modelsThe endocu e is a medium-high- alue, high-c i icali y de ice [11]. Fo
his ca ego y o de ices, he ollowing oppo uni ies show om he
p oduc map ( igu e 20).
Kane e al. [11] ad ise op imising de ices like he endocu e o
hygienic eco e y as much as possible. This means choosing ma e ials
ha can wi hs and high-g ade s e ilisa ion, and minimizing co ne s,
sha p edges and mo ing pa s in he design. This kind o edesign
o epea ed ep ocessing can make de ices mo e expensi e. An
al e na i e is o design o a ixed numbe o eco e y cycles ins ead
o an in ini e numbe o cycles, o main ain a ela i ely low p oduc ion
cos . A way a ound some o he issues wi h ep ocessing highly
complex de ices is o look in o hyb id p oduc s in which some pa s a e
ep ocessable and o he s a e no . This s a egy also allows o di e en
pa s o be ea ed acco ding o di e en le els o c i icali y, since
hey migh no ge in o con ac wi h he pa ien o he same ex en .
Las ly, because o a lack o us , some imes SUDs which could ha e
been eused a e disca ded anyways. Designing o us in he sa e y o
he ep ocessed o e u bished de ice could be a g ea oppo uni y o
imp o e he ci cula i y o he endocu e .
Guzzo e al. [40] ad ise p o iding a suppo sys em o in-hospi al
ep ocessing o de ices like he endocu e . Ano he op ion is o
p o ide ep ocessed de ices and ake away some o he isks and
esponsibili ies om indi idual hospi als. Rep ocessing acili ies can
e i y, so , ep ocess, inspec and epackage de ices all acco ding
o egula ions. This sys em also c ea es a g ea business model
oppo uni y and inc eases he chances o ecycling a he p oduc ’s
EoL.
5.1.5. Challenges o he endocu e
Pe cei ed isk and cos o designing mo e sus ainable de ices and
implemen ing hem in hospi al en i onmen s pose a oadblock o he
implemen a ion o ci cula s a egies [42].
The high c i icali y o he endocu e means hey ha e o wi hs and
mo e ha m ul s e ilisa ion p ocesses i hey we e o be ep ocessed.
The con amina ion haza d o a used endocu e also makes i subjec
o s ic anspo and was e egula ions which limi ex e nal EoL
oppo uni ies like emanu ac u ing and ecycling.
The endocu e has pa s made om bo h me als and plas ics and
includes elec ical componen s as well, which makes ecycling a
challenge. On op o ha , he de ice’s a chi ec u e is complex which
poses p oblems o a ious cleaning p ocesses and disassembly. The
de ice cu en ly canno be disassembled wi hou damaging o b eaking
ce ain componen s.
Regula ion in he medical de ice indus y occu s ia a complex ne wo k
o o ganiza ions in which he di ision o esponsibili ies and oles is
somewha unclea . Op ing o disposable de ices helps hospi als a oid
po en ial mis akes and liabili y [55]. Howe e , s udy shows ha good
egula ion could be he mos impac ul d i e in he design o mo e
en i onmen ally conscious medical de ices [42]. Cu en ly, egula ion
ocuses mos ly on independen pa ien sa e y bu ails o ake in o
accoun he consequences o he en i onmen al impac o he medical
indus y on popula ion heal h [55]. In conclusion; egula ion can be
seen as a oadblock o he ci cula de elopmen o endocu e s bu
could become a d i e wi h he igh al e a ions.
| 25
6. The possible Ci cula Reco e y Flows o lapa oscopic ins umen s
Kane e al. [11] did an ex ensi e li e a u e e iew on he exis ing
Ci cula Reco e y Flows ia echnical cycles wi hin he medical de ice
indus y. As a esul , hey ound he ollowing o ms o eco e y: Repai ,
ecycling, e u bishmen / emanu ac u ing and ep ocessing. These
CRFs we e also men ioned in o he sou ces. A o m o eco e y ia
biological cycles is an addi ion o hese ou lows. This s a egy was
men ioned by F eund e al. [62] and Guzzo e al. [40].
6.1. Inconsis ency in e ms and de ini ions
6.2. De ining he Ci cula Reco e y Flows
6.1.1. Rep ocessing
6.1.3. Repai and main enance
6.1.2. Re u bishing and emanu ac u ing
A challenge in de ining he Ci cula Reco e y Flows is he inconsis ency
in he use o di e en e ms and de ini ions. The e is qui e a lo o
o e lap and con usion be ween ep ocessing, main enance, epai ,
e u bishmen and emanu ac u ing. To be able o p ope ly de ine and
ame he di e en CRFs, hese inconsis encies need o be add essed
i s .
Rep ocessing is de ined by he EU Medical De ice Regula ions as “a
p ocess ca ied ou on a used de ice o allow i s sa e euse including
cleaning, disin ec ion, s e ilisa ion and ela ed p ocedu es, as well as
es ing and es o ing he echnical and unc ional sa e y o he used
de ice” [17]. This e m is howe e used o e u bishmen ac i i ies
in some coun ies as well, like he “ ep ocessing” se ice o ce ain
companies in he US. No he n Ame ican ep ocesso s eco e
de ices om hygienic obsolescence bu also go h ough a p ocess o
emanu ac u ing. They es o e de ices o be “Subs an ially equi alen
o he FDA-clea ed OEM de ice”, and sell he de ices as new a e he
eco e y p ocess [63].
The EU MDR de ines e u bishing as “ he comple e ebuilding o a
de ice al eady placed on he ma ke o pu in o se ice, o he making
o a new de ice om used de ices, o b ing i in o con o mi y wi h
his Regula ion, combined wi h he assignmen o a new li e o he
e u bished de ice”[17]. This de ini ion is howe e inconsis en wi h he
gene al de ini ion o e u bishing; “Re u bishing b ings used p oduc s
up o speci ied quali y, usually lowe han new p oduc s. P oduc s
a e disassembled in o modules, which a e inspec ed, es ed, and
some imes ixed o eplaced [16]. The EU MDR seems o discuss he
p ocess o emanu ac u ing ins ead; “Remanu ac u ing b ings used
p oduc s up o he same s anda d as newly p oduced p oduc s. Used
p oduc s a e comple ely disassembled and all pa s a e in ensi ely
es ed. App o ed pa s a e eassembled in o new p oduc s” [16].
To mee he high p oduc s anda ds se by egula ion, he concep
o emanu ac u ing seems mo e ele an o high- isk de ices like he
endocu e compa ed o he concep o e u bishing.
Repai in ol es a econ igu a ion o eplacemen o pa s o es o e a
p oduc om unc ional obsolescence caused by a speci ic aul , and
main enance includes changing pa s, cleaning and checking he
de ice a egula in e als [11]. Di e en componen s could be epai ed
as a pa o a emanu ac u ing p ocess. E en when de ices a e cleaned
in he in e nal s e ilisa ion depa men o a hospi al, hey a e checked
and main ained and some imes se aside o epai [64]. The e can be
no epai and main enance o he endocu e wi hou i s pe o ming
di e en cleaning s eps o comba in ec ion isks. Because epai and
main enance ac i i ies a e included in bo h ep ocessing as well as
emanu ac u ing p ocesses, and a e ne e s and-alone ac i i ies, I will
no ea hem as a sepa a e CRF.
I will de ine he CRF o ep ocessing acco ding o he EU MDR: “a
p ocess ca ied ou on a used de ice o allow i s sa e euse including
cleaning, disin ec ion, s e ilisa ion and ela ed p ocedu es, as well
as es ing and es o ing he echnical and unc ional sa e y o he
used de ice” [17] Rep ocessing ocuses on eco e y om hygienic
obsolescence, he main o m o obsolescence ha SUDs like he
endocu e expe ience [11], bu can include epai and main enance
ac i i ies as well.
Remanu ac u ing is he comple e ebuilding o a de ice al eady placed
on he ma ke o pu in o se ice, o he making o a new de ice om
used de ices, o b ing i in o con o mi y wi h egula ion, combined
wi h he assignmen o a new li e o he emanu ac u ed de ice. This is
an adap a ion o he de ini ion o e u bishing om he EU MDR [17].
Remanu ac u ing will also include cleaning, epai and main enance
p ocesses.
In ecycling he iden i y and unc ionali y o he p oduc and i s
componen s a e los , he pu pose is o euse ma e ials ins ead o pa s
om used p oduc s and componen s [16].
The CRF o bioma e ials explains eco e y ia he biological cycles
ins ead o he echnical cycles o he bu e ly diag am [57]. Bioma e ials
a e ma e ials ha (1) a e biodeg adable, o (2) may o may no be
deg adable bu a e p oduced om biological ma e ials o enewable
eeds ock (adap ed om A iwesh e al. [2]).
These CRFs will be used as a basis o ou design sp in s, and a e
isualized in igu e 22 on he nex page.
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Mas e ’s hesis - Do ien an Dolde en
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Mas e ’s hesis - Do ien an Dolde en
2. Design sp in ep ocessing
Rep ocessing is a p ocess ca ied ou on a used de ice
o allow i s sa e euse including cleaning, disin ec ion,
s e ilisa ion and ela ed p ocedu es, as well as es ing and
es o ing he echnical and unc ional sa e y o he used
de ice [17].
This design sp in explo es he di e en equi emen s
and p ocesses needed o p ope ly clean and main ain he
endocu e o ano he li ecycle. Rep ocessing a LUMC is also
desc ibed, as well as necessa y p oduc design al e a ions o
adap p oduc s o di e en cleaning p ocesses. Nex design
oppo uni ies and concep s o bo h in-hospi al and ex e nal
ep ocessing a e p oposed and e alua ed.
2.1. Resea ch
2.1.1. The Spaulding Scale
C i ical i ems
Semi-c i ical i ems
Nonc i ical i ems
In a compa ison s udy be ween a single-use and eusable su gical
s aple , depending on he ype o su ge y, he was e om a de ice could
be educed by up o 70% jus by swi ching o a eusable al e na i e.
This s a egy could also educe he o al ma e ial equi emen by o e
90% [67]. Howe e , his s udy compa ed wo e y speci ic de ices and
was highly impac ed by he numbe o cycles he eusable de ice was
able o wi hs and. Also, he s e ilisa ion p ocess i sel has a no able
en i onmen al impac bu was excluded om he analysis [55]. The
s e ilisa ion p ocess can ac ually make he en i onmen al impac o
eusables la ge han ha o a single-use e sion o he same p oduc ,
so he bes cou se o ac ion needs o be de e mined pe indi idual
case [68]. Howe e , ypically he use o single-use disposables esul s in
highe pe oleum use and highe g eenhouse gas emissions compa ed
o ha o eusables [55].
The Spaulding scale is a guideline o he disin ec ion and s e ilisa ion
o heal hca e equipmen . This scheme di ides medical de ices in o
h ee ca ego ies – c i ical, semi-c i ical and nonc i ical – based on he
isk o in ec ions om he use o he de ice [5].
The e is a high isk o in ec ion i c i ical i ems a e con amina ed. These
a e objec s ha en e s e ile issue o he ascula sys em, and ha
mus be s e ile be o e use. Su gical ins umen s like he endocu e a e
examples o i ems ha a e labelled as ‘c i ical’.
Semi-c i ical i ems come in o con ac wi h mucous memb anes – like
he inside o he mou h o he geni al a eas – o nonin ac skin. These
objec s equi e high-le el disin ec ion, which is gene ally de ined as
he comple e elimina ion o all mic oo ganisms in o on an ins umen ,
excep o small numbe s o bac e ial spo es.
Nonc i ical i ems only come in o con ac wi h in ac skin, which is an
e ec i e ba ie o mos mic o-o ganisms. Mos o hese objec s may
be decon amina ed, e en ou side o he cen al ep ocessing a ea and
pose li le isk o in ec ion o pa ien s.
igu e 24. An au ocla e mean o s eam s e ilisa ion
o c i ical medical de ices a LUMC
Al hough a SUD is usually cheape compa ed o a eusable de ice,
euse dis ibu es he cos o e many cycles which ypically makes he
li e ime cos o a eusable de ice lowe . SUDs a e also pe cei ed o be
sa e compa ed o eusables, he e is howe e no compelling e idence
ha hey ac ually educe he isk o in ec ion om medical de ices [55].

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Mas e ’s hesis - Do ien an Dolde en
2.1.2. S e ilisa ion echniques
S eam s e ilisa ion
E hylene Oxide (ETO) s e ilisa ion
Hyd ogen pe oxide gas plasma s e ilisa ion
C i ical i ems like he endocu e unde go a p ocess o decon amina ion,
disin ec ion and s e ilisa ion as desc ibed by he RIVM [69]. The e a e
howe e many di e en ways o s e ilise medical de ices, each wi h
i s bene i s and d awbacks. The ull o e iew o di e en echniques
is shown in igu e 26, bu some o he mos ele an and widesp ead
echniques a e:
S eam s e ilisa ion using sa u a ed s eam unde p essu e o s e ilisa ion
is he mos widely used and mos dependable p ocess. I is also he
p e e ed me hod o c i ical i ems, bu no e e y de ice can wi hs and
his p ocess because o he hea and mois u e in ol ed. The use o
s eam is non oxic, ela i ely inexpensi e and as [5].
This me hod is widely used as a low- empe a u e s e ilisa ion
echnique. De ices ha canno wi hs and he hea o mois u e om
s eam s e ilisa ion a e o en ea ed using ETO. ETO s e ilisa ion is
a om ideal. The p ocess akes a lo o ime, is cos ly, and had been
p o en o be oxic and ca cinogenic, wi h heal h haza ds o s a and
pa ien s as a esul . Because o his, ETO s e ilisa ion is being phased
ou and should be a oided [5].
The use o hyd ogen pe oxide gas plasma is ano he way o s e ilize
ins umen s ha a e sensi i e o high empe a u es o mois u e. The by-
p oduc s o his p ocess a e non- oxic, which makes i sa e o handle
s e ilised de ices [5].
igu e 25. Di e en me hods o s e ilisa ion, adap ed om Medical Plas ics News [70]
Asbes oses
Memb ane
Sin e ed
glass
D y hea Mois hea
Fil a ion Hea Radia ion Ul asonic/
ib a ion Gas Liquid
ChemicalPhysical
Me hods o s e ilisa ion
Ionizing Non-ionizing Fo maldehyde Alcohols
Halogens
Hea y me als
Phenols
Alkyla ing
agen s
(aldehydes)
Su ac an s
Oxidan s
(pe oxigens)
E hylene
Oxide (E O
Plasma
Ni ogen
cioxide
Ozo e
In a ed
Ul a iole
wa es
X- ays
Y- ays
Gamma ays
Cosmic ays
Ca hode ays
(E-beam)
Below 100C
Boiling
S eaming
Tyndalisa ion
Pas eu iza ion
Wa e ba hs
Inspissa ion
A 100 C Abo e 100C
Au ocla e
Di ec
laming
Incine a ion
Ho ai
o en
Ea henwa e
| 34
Mas e ’s hesis - Do ien an Dolde en
Mas e ’s hesis - Do ien an Dolde en
2.1.3. Rep ocessing a LUMC
I had he oppo uni y o ge a ou o he ¬S e ilisa ion
Depa men (SD) and OR o Leiden UMC, which ga e me a
good unde s anding o he p ac ice o ep ocessing in la ge
Du ch hospi als.
Di e en ypes o su ge ies equi e di e en combina ions
o ools. All he ools a e p e-so ed in so-called ‘ne s’;
labelled me al baske s used o anspo and s o age. A e
su ge y, he ne s wi h con amina ed equipmen a e b ough
o a designa ed con amina ed oom in he hospi al, whe e
e e y hing is ea ed wi h ex a ca e and employees a e well
p o ec ed. He e e e y hing is i s decon amina ed by hand
wi h wa e , specialised soaps and alcohol solu ions.
Nex , he ne s a e pu in o he disin ec ion machines in he
con amina ed oom, and a e he disin ec ion p ocess aken
ou o he machines in he clean oom on he o he side. In
his oom, he ne s a e checked and e-so ed. De ices can be
main ained, o example by lub ica ing hinges o mo ing pa s,
and b oken i ems a e se aside o epai . When e e y hing is
in o de , he ne s a e packed in blue polyp opylene (PP) w ap
and s acked in o ca s, eady o he s e ilisa ion p ocess.
A LUMC, mos ins umen s a e s e ilized by s eam s e ilisa ion.
A ca wi h mul iple ne s is d i en in o an au ocla e in he
clean oom, and aken ou on he o he side, whe e he s e ile
i ems a e s o ed. LUMC also has a hyd ogen pe oxide gas
plasma s e ilise , which is used o s e ilize he moplas ics.
The ca idges used o his p ocess make i e y expensi e in
compa ison, so his machine is used as li le as possible. These
machines a e usually ound in bigge hospi als wi h mo e
esou ces, and which make use o mo e specialized ools ha
equi e di e en ypes o s e ilisa ion.
Be o e su ge y, he blue w ap is emo ed om he ne s in a
p epa a ion oom and e e y hing is sp ead on o su ge y ca s,
eady o be mo ed in o he OR. The blue PP w ap is ea ed as
gene al was e and sepa a ed o ecycling.
igu e 26. The clean oom a LUMC
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Mas e ’s hesis - Do ien an Dolde en
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Mas e ’s hesis - Do ien an Dolde en
2.2. Design oppo uni ies
2.2.1. In e nal ep ocessing
2.2.3. Ex e nal ep ocessing
The e a e wo main di ec ions o ep ocessing; in e nal, in-hospi al
ep ocessing and ex e nal ep ocessing. In-hospi al ep ocessing can
be done by he SD o he hospi al, whe e owne ship o he de ices
emains wi h he hospi al, o by a hi d pa y loca ed inside he hospi al.
In his case owne ship shi s o he hi d pa y which ep ocesses he
de ices and hen esells hem o he hospi al. This shi in owne ship
can be done ex e nally as well. The p oduc can be owned by he
hospi al and only be cleaned by a hi d pa y, bu i can also be sold
o his hi d pa y. This las op ion would mean any de ice esold o
a hospi al could be a di e en one om he de ice he hospi al sold
o he ep ocesso o cleaning. These di e en ou es a e isualised in
igu e 35 on page 39.
2.2.2. P oduc design o ep ocessing
Choice o ma e ials
Elec onics
One impo an ac o in he possibili y o eco e ing a medical de ice
om hygienic obsolescence is he abili y o he de ice o su i e he
disin ec ion and s e ilisa ion p ocesses. On one hand, he e is he isk
o incomple e s e ilisa ion, on he o he , he e is he isk o ma e ial
damage [11]. The p oduc needs he mal s abili y, i mus be possible
o epea he ep ocessing cycle mul iple imes, and i he p oduc is
complex i mus be possible o easily disassemble and eassemble he
de ice du ing each cycle [71]. Cu en ly, he elec onics and complex
componen s and design o he endocu e pose a ba ie o s eam
s e ilisa ion o he de ice.
Depending on he ype and p ocess o s e ilisa ion, he e a e di e en
sui able ma e ials o medical de ice design. Me als can wi hs and
s eam s e ilisa ion, which is as men ioned be o e he p e e ed me hod
o s e ilisa ion. Howe e , no all ypes o plas ic a e compa ible wi h
au ocla ing. A use ul esou ce o de e mine possible ma e ial choices
is he book S e ilisa ion echniques o polyme s by Wayne Roge s [72].
Elec onics can wi hs and s eam s e ilisa ion as long as hey a e
encapsula ed o be p o ec ed agains mois u e. Howe e , high
empe a u es hu he li espan o ba e ies [73]. ETO s e ilisa ion is
be e sui ed o elec onic de ices; only he acuum could pose a isk
o ba e ies. Hyd ogen pe oxide plasma s e ilisa ion is no sui able o
embedded elec onics, especially o semiconduc o s [74].
In e nal ep ocessing is al eady common p ac ice o many su gical
ins umen s, which means ha s e ilizing he endocu e in e nally
could i well wi hin he cu en logis ics and in as uc u e o hospi als.
The e is less anspo in ol ed compa ed o ex e nal ep ocessing so
he p ocess is mo e e icien and he loop is smalle . Howe e , only a
limi ed a ie y o s e ilisa ion p ocesses is a ailable, which could mean
ha ei he he endocu e canno be s e ilized in e nally in many smalle
hospi als a all, o ha i needs a d as ic edesign, possibly a ec ing
he unc ionali y o he de ice.
Wi h ex e nal ep ocessing, a bigge change in logis ics and
in as uc u e is necessa y compa ed o in e nal ep ocessing. I equi es
a sepa a e collec ion o ce ain de ices and a new o m o in ec ious
anspo a ion. I he ep ocessing is handled by he OEM ha does
mean hey ha e ull con ol o e he quali y and sa e y o ep ocessed
de ices. When p ocessing SUDs, aking in o accoun liabili y is c ucial
[71]. Rep ocessing wi h a shi in owne ship could also se e as an ex a
e enue s eam o he company since hey ha e he chance o esell
he same de ices [40]. The e a e examples o ex e nal ep ocessing
se ices in he Ne he lands [75]. igu e 27. Idea ion on he CRF o ep ocessing
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Mas e ’s hesis - Do ien an Dolde en
2.3. Concep ing
2.3.1. Op imise o in-hospi al s e ilisa ion
2.3.2. Modula design
Design o ixed cycles
Hyb id design
Compa ibili y wi h o he s aple s
I came up wi h he ollowing concep s du ing my design sp in .
Since s eam s e ilisa ion is possible in many di e en hospi als and is
he p e e ed me hod o s e ilisa ion because o he cos and sa e y
o he echnique, i makes sense o y o edesign he endocu e
o his p ocess. This means ha i mus be possible o hospi al s a
o pa ly disassemble he p oduc so ha e e y hing is accessible o
disin ec ion. Also, elec onics mus be ei he encapsula ed o p o ec
hem om s eam o emo able be o e s e ilisa ion and es ed o
esis ance agains high empe a u es. Ma e ials mus be chosen o be
s eam esis an acco ding o Roge s [72].
S eam s e ilisa ion migh no be he only means o s e ilisa ion ha
hospi als ha e, especially when looking in o he u he u u e o
solu ions. Mo e specialised hospi als ha pe o m mo e lapa oscopic
p ocedu es migh also ha e mo e ad anced s e ilisa ion echniques a
hei disposal, which allow o less d as ic edesigns.
I making he p oduc en i ely eusable (∞ cycles) makes i oo
expensi e o impai s he unc ion o he endocu e , i migh be an
op ion o design he p oduc o a p ede e mined, limi ed numbe o
cycles ins ead [11]. A way o make he sa e y o he de ice isual o he
use is o include a so o coa ing ha dissol es a e he maximum
numbe o ep ocessing cycles ( igu e 29).
Ano he op ion is o design he de ice o be modula . This has bene i s
o disassembly, emanu ac u e and ecycling as well.
igu e 28. A isual cue o limi ed ep ocessing cycles
igu e 29. An example o a hyb id edesign o he endocu e
igu e 30. One mul i-pu pose handle o di e en s aple s
igu e 31. A compa ison o use ac ions o di e en E hicon s aple s
I ce ain pa s o he endocu e a e especially ha d o ep ocess,
o oo complex o disassemble, i could be an op ion o dispose o
some pa s o he de ice while ep ocessing o he s ( igu e 30). The e
is al eady an example o his hyb id design on he ma ke ; he Signia
s aple om Med onic [33]. This s aple has a eusable handle and a
disposable sha and shell.
E hicon manu ac u es di e en kinds o su gical s aple s wi h di e en
applica ions. I he handle we e o be eusable, maybe i could be used
in combina ion wi h o he s aple end e ec o s. This could educe he
aw ma e ial needed o each su ge y e en u he compa ed o he
hyb id design ( igu e 31).
To quickly es his heo y I documen ed he ac ions necessa y o
ope a e he de ice o he echelon lex endocu e as well as wo o he
ypes o s aple s om E hicon based on hei use guides ( igu e 32) [76].
Since he e is qui e a la ge a ia ion be ween he ope a ion ac ions
necessa y o con ol each de ice, and p ecision and e iciency a e
c ucial in he ope a ing oom, he concep o a mul i-pu pose s aple
handle does no seem easible a his ime.
Endocu e
Ac ua o / e aining pin
Close
Open
A icula ion
Unlock
Fi e
Kni e e u n
Manual kni e e u n
Adjus able o issue
Type o s aple
Ac ion on handle
Cu ed
cu e
Ci cula
s aple
Speed
no
cons an
| 37
Mas e ’s hesis - Do ien an Dolde en
Mas e ’s hesis - Do ien an Dolde en
| 37
Sepa a e classi ica ion
2.3.3. Design o ex e nal ep ocessing
Cu en ly, he endocu e is a class 3 medical de ice acco ding o he EU Medical
De ice Regula ions [17]. Could i be possible o egis e he handle and he sha as
wo di e en medical de ices ha a e used oge he ? This would mean he handle
could be classi ied as 2b, and i would no be c i ical, bu ins ead semi-c i ical on he
Spaulding scale since i does no en e s e ile issue o he ascula sys em [5]. I his
eclassi ica ion would be possible i would no be necessa y o en i ely s e ilise he
handle; high-le el disin ec ion would be su icien . I would also open doo s o he
edesign o many o he lapa oscopic de ices o which he handle is ope a ed ou side
o he pa ien ’s body.
I i would be possible o include endocu e s in an exis ing ex e nal ep ocessing
se ice, i could be possible o design o many mo e s e ilisa ion echniques compa ed
o in-hospi al s e ilisa ion. The e is al eady a CBM in place and he collec ion s a egies
ha e been p o en. I is, howe e , unclea which de ices a e cu en ly included in exis ing
Du ch se ices, and i hey a e e ie ed om he OR o jus om mo e accessible pa s
o he hospi al.
Fo a ake-back sys em like his o wo k, enough de ices need o be ep ocessed
o economic easibili y. The numbe o de ices would inc ease i he se ice would
collabo a e wi h mo e hospi als, bu i would also inc ease he dis ance o de ice
anspo a ion. Whe e lies he igh balance be ween scale and dis ance?
igu e 32. So ing and checking o disin ec ed de ices

| 38
Mas e ’s hesis - Do ien an Dolde en
2.4. E alua ion and e lec ion
Fo he CRF o ep ocessing,
he e a e wo main di ec ions;
in e nal ep ocessing and ex e nal
ep ocessing. The possibili y o in e nal
ep ocessing mainly depends on he
de ice i sel , so an in-dep h analysis
o he di e en pa s and ma e ials
is necessa y o mo e o wa d. Fo
ex e nal ep ocessing, his p oduc
analysis helps as well, bu he e also
needs o be a lo o a en ion on he
p oduc se ice sys em (PSS) and he
business model a ound he endocu e ,
as well as in-hospi al logis ics. To gain
a mo e in-dep h unde s anding o
he cu en ep ocessing o medical
de ices and he in as uc u e a ound
hem, I need o ge in con ac wi h a
ep ocessing se ice. Depending on
he ou come o he p oduc analysis
and ep ocessing se ice in e iews,
he ep ocessing low could be e y
ealis ic.
I g aded each concep on he
equi emen s and c i e ia de e mined
be o e he design sp in s ( igu e 34).
This g ading is an ini ial e alua ion, bu
will no be used o de ini i ely choose
o exclude ideas. Mo e esea ch
in o he ideas is needed han can be
co e ed in a one-day design sp in .
igu e 33. Ini ial compa ison o ep ocessing concep s
The only concep ha does no mee a equi emen is he concep o s aple
compa ibili y. The e would be such a d as ic edesign necessa y o make a handle
compa ible wi h mul iple ypes o s aple s, ha he unc ionali y o he endocu e will
change. I would be ha d o gua an ee he same le el o p ecision and ease o use as
ha o he o iginal de ice. Also, he concep o sepa a e classi ica ion is a isk, because
making medical de ice classi ica ion ules mo e lenien could inc ease con amina ion
isks om medical de ices.
The ep ocessing concep s o in-hospi al s e ilisa ion and ixed cycles sco e bes on
hese c i e ia. This is because he ull endocu e can be ep ocessed ia a s anda d
hospi al ep ocessing p ocedu e. The hyb id design, sepa a e classi ica ion and ex e nal
ep ocessing sco e well as well, bu ei he main ain a lowe le el o p oduc in eg i y o
do no cu en ly i in o hospi al logis ics.
To al sco e concep : 6 7 4 2 5 4
Concep s:
In-hospi al
s e ilisa ion Fixed cycles Hyb id
design
S aple
compa ibili y
Sepa a e
classi ica ion
Ex e nal
ep ocessing
Requi emen s and c i e ia:
Rq1 +
+
+
++
++
+-
++ = de ini ely (Rq) o 2 (C ) + = p obably (Rq) o 1 (C ) +- = maybe (Rq) o 0 (C ) - = maybe no (Rq) o -1 (C ) -- = de ini ely no (Rq) o -2 (C )
++
++
+
++
++
+
++
++
+
+
+
+
--
++
+
+
+-
+
++
++
+-
+
+
++
++
++
+
++
-
+
The endocu e main ains i s unc ionali y a e edesign
The endocu e is sa e o use on pa ien s (i.e. biocompa ibili y)
The endocu e does no pose a con amina ion isk o anyone
A high le el o p oduc in eg i y is main ained ( his c i e ium weighs double)
The endocu e i s wi hin he cu en logis ics and in as uc u e o he hospi al
and he OR
The edesign concep is applicable o mo e han jus he E hicon endocu e
and se s an example o he medical de ice indus y
Rq2
Rq3
C 1
C 2
C 3
Rep ocessing
Possible u he esea ch in o he opic o ep ocessing includes an in-dep h p oduc
analysis o he cu en design o he endocu e o explo e p oblema ic a eas o
di e en cleaning p ocesses, as well as esea ch in o logis ics and in as uc u e a ound
cu en ep ocessing p ac ices. I would also be use ul o look in o he app o al o
di e en pa s o he endocu e as di e en medical de ices, each wi h i s c i icali y and
cleaning guidelines. This possibili y would open doo s o di e en modula edesigns
o he de ice.
| 39
Mas e ’s hesis - Do ien an Dolde en
P epa e use o
endocu e
Decon amina e
by hand
Decon amina e
by hand
Disassemble Disassemble
Some (b oken)
pa s o de ices
could be
disposed o
o ecycled
In ec ious
non-In ec ious
In ec ious
anspo a ion
S e ile packaging
is disposed o
(no o in e nal
ep ocessing)
P oduc ion
o endocu e s
T anspo a ion
o ep ocessed
endocu e s
In he case o
a hyb id de ice
some pa s could
be disca ded as
in ec ious was e
In he case o
a hyb id de ice
some pa s could
be disca ded as
in ec ious was e
Disin ec
Disin ec
Reassemble
Reassemble
S e ilise
S e ilise
Package
Use
Check
Repai
M
a
y
b
e
a
i
x
e
d
n
u
m
b
e
o
c
y
c
l
e
s
E
x
e
n
a
l
e
p
o
c
e
s
s
e
o
O
E
M
I
n
s
i
d
e
h
e
h
o
s
p
i
a
l
2.5. The ep ocessing lows
igu e 34. A schema ic o e iew o di e en ep ocessing lows
| 40
Mas e ’s hesis - Do ien an Dolde en
3. Design sp in emanu ac u ing
Remanu ac u ing is he comple e ebuilding o a de ice
al eady placed on he ma ke o pu in o se ice, o he making
o a new de ice om used de ices, o b ing i in o con o mi y
wi h egula ion, combined wi h he assignmen o a new li e
o he emanu ac u ed de ice [17].
This design sp in goes in o p oduc design o
emanu ac u ing as well as examples om he medical
indus y. Oppo uni ies and one concep o emanu ac u ing
endocu e s a e p oposed.
3.1. Resea ch
3.1.1. How o emanu ac u e
Because emanu ac u e and e u bishmen a e some imes used
in e changeably, in o ma ion on bo h has been ga he ed. Also, an
den Be g & Bakke [77] p opose he e m “ emaking” as an umb ella
e m o e u bishing and emanu ac u ing. Remaking consis s o all
ac ions pe o med when a p oduc e u ns om he cus ome . They
also p o ide a ci cula economy amewo k ha se es as a ool o
designe s o applying ci cula p oduc design in p ac ice. Fo he
emanu ac u e (he e emaking) o p oduc s, he p oduc disassembly
needs o be non-des uc i e o p ese e pa s and ma e ials. Van den
Be g & Bakke [77] also ecommend s a egies wi hin he ca ego ies o
Modula i y, Reliabili y Assessmen and ( e e se) logis ics ( igu e 36).
In heo y, e e y hing ha is manu ac u ed can also be emanu ac u ed,
bu he easibili y o emanu ac u ing depends on he business case.
I is easie o emanu ac u e mass-p oduced i ems since p oduc co es
and spa e pa s a e mo e eadily a ailable [78].
igu e 35. Pa o he ci cul economy amewo k adap ed om an den Be g &
Bakke [77]
igu e 36. The wo in e - ela ed le els o design o emanu ac u e, adap ed
om G ay & Cha e [79]
Reliabili y assessmen
Modula i y
Li e ime p ognos ics
Main enance
P oduc a chi ec u e
Connec ions
Quick and easy disconnec
Limi use and di e si y o as ene s
Limi use and di e si y ools
Simpli y p oduc a chi ec u e
Allow ease o access o componen s
Cla i y o disassembly sequence
Ease o cleaning
Ease o epai /upg ade
Allow onsi e epai and upg ade
Use modula componen s
S anda dize in e aces
Back- and o wa ds compa ibili y
P oduc can easily be e u ned
Spa e pa ha es ing
Local p oduc ion
Online moni o ing o quali y, es ing, main enance
and billing
Allow o easy ead ou o componen s
Only non-des uc i e
(Re e se) logis ics
Remake
Reuse o pa s
Disassembly
allow o se ice,
emake and ecycle
Main enance
Reuse o p oduc s
Business
model &
p oduc
s a egy
design
De ailed
p oduc
design
Design o emanu ac u e in ol es bo h he business model and he
p oduc design ( igu e 37). P oduc s a egy includes sales, ma ke ing,
se ice and e e se logis ics, while p oduc design includes design o
co e collec ion, as well as unc ional design [79].
I is impo an o design o g ea e p oduc du abili y, bu he e needs
o be a ocus on some pa s o he p oduc . Designing en i e p oduc s
o a long li e could esul in unnecessa ily high p oduc ion cos s and a
was e o esou ces [78]. E ec i e p oduc design o emanu ac u ing
can imp o e e iciency in disassembly, eassembly and inspec ion,
which educes cos s.
In some cases, he s a egies a ound he emanu ac u ing p ocess
migh ha e a g ea e impac on emanu ac u ing possibili ies han
de ailed p oduc design [79]. Howe e , he p oduc design and ci cula
business model need o be de eloped concu en ly [80].
A limi ing ac o o emanu ac u ing is e ie ing he p oduc “co e” in
good condi ion and o a low enough p ice. The e also needs o be
a good ela ionship be ween possible 3 d pa y emanu ac u e s and
OEMs o a oid compe i ion. Fo he whole p ocess o be iable, he
cos o he p ocess o emanu ac u ing should be less han ha o he
o iginal manu ac u e, unless he disposal o he p oduc is so expensi e
ha a highe emanu ac u ing cos is jus i ied [78].
Some imes only some pa s o he p oduc can be eused. When ‘pa
ha es ing’, he goal is o eco e a limi ed se o eusable pa s om a
p oduc , which in u n can be used o emanu ac u e o he p oduc s o
componen s [80].
| 41
Mas e ’s hesis - Do ien an Dolde en
Mas e ’s hesis - Do ien an Dolde en
| 41
Design o disassembly
Since disassembly is cen al o he
ex ending o enewing o li ecycles,
design o disassembly is an
impo an s a egy. Disassembly can
be subdi ided in o connec ions and
p oduc a chi ec u e [77].
The e iciency o a p oduc ’s
disassembly is mos ly de e mined
du ing he design phase [77]. The
cos o disassembly is de e mined by
he EoL des ina ions o he ma e ials
eco e ed om he disassembly
p ocess, and he ime and esou ces i
akes o execu e disassembly [81].
3.1.2. Remanu ac u ing o medical de ices
3.1.3. Design oppo uni ies
Bo h p oduc edesign and CBM design a e c ucial o he CRF o emanu ac u ing.
A his poin , I ha e no ye analysed he endocu e a a p oduc le el, so concep ing
on design s a egies like modula i y, in e aces and compa ibili y is ine icien . Mo e
in o ma ion on he connec ions wi hin he endocu e and i s p oduc a chi ec u e is
needed i s .
Fo he CBM i is necessa y o look in o he collec ion sys em, as i should i in as
seamlessly as possible in he cu en logis ics a ound he OR.
Remanu ac u ing is al eady widesp ead in he medical indus y bu mos ly happens
wi h high- alue, low-c i icali y p oduc s like MRI machines. The p ocess o en in ol es
ake-back schemes om OEMs and leads o a educed cos o use s [11]. I is possible
o emanu ac u e ins umen s o su ge y as well [47].
Va ious companies assis no he n Ame ican hospi als in he “ ep ocessing” (bu
ac ually emanu ac u ing) o medical de ices [40]. Some a e subsidia ies o OEMs and
only handle de ices o a speci ic b and, o he s emanu ac u e a a ie y o b ands. These
companies p o ide dedica ed bins o sa e anspo and ain hospi al s a on how
and wha o collec a e p ocedu es. Cu en ly, used endocu e s a e no eco e ed
h ough emanu ac u ing [63].
Fo he emanu ac u e o su gical ins umen s, de ices i s need o be disin ec ed
and so ed be o e anspo by hospi al s a [40], o hey need o be anspo ed
as in ec ious was e. De ices need o be so ed acco ding o hei manu ac u e and
des ina ion, which is a p ocess ha does no cu en ly i in o hospi al logis ics. A
LUMC (appendix 1.1) hey men ioned ha he hospi al pu chases medical de ices om
many di e en OEMs so i would be a logis ic nigh ma e o collec de ices om each
manu ac u e sepa a ely. I emanu ac u e we e o be implemen ed, good collabo a ion
be ween OEMs – o be ween OEMs and a hi d pa y – would be essen ial. I he e was
a collabo a ion be ween many di e en manu ac u e s, he emanu ac u ing o medical
de ices would be easie o implemen .
igu e 37. Idea ion on he CRF o emanu ac u e
| 48
Mas e ’s hesis - Do ien an Dolde en
| 48
Mas e ’s hesis - Do ien an Dolde en
4.2. Design oppo uni ies
Fo simplici y, I di ided he endocu e in o ou main pa s; he handle,
he sha , he elec onics and he eloads. Each pa has di e en
oppo uni ies wi hin his eco e y low. The numbe o di e en
ma e ials used should be minimised and he ma e ials and connec ions
be ween hese ma e ials mus be sui able o ecycling.
The handle
The handle is made om a ype o plas ic ha could be ecycled. I
migh e en be possible o include ecycled ma e ial in his pa o he
de ice since i does no come in o di ec con ac wi h human issue.
I would be p e e ed o manu ac u e he whole handle om a single
ype o plas ic o be e ma e ial sepa a ion.
The sha
The sha is made om su gical s eel which is a high- alue ma e ial ha
can be ecycled (i he e is no need o a non-complian coa ing). Since
he sha is hollow i could be a challenge o disin ec i wi hou he
need o sh edding. This needs u he esea ch.
Since his pa o he endocu e en e s human issue, i is subjec o
igh e egula ion. S ainless s eel usually pa ly consis s o ecycled
ma e ial, how pu e should he ma e ial be in his kind o applica ion?
The elec onics
The elec onics inside he handle a e ea ed as e-was e and should be
ecycled as long as hey a e no in ec ious. The ba e y needs o be
sepa a ed om o he ma e ials as well.
The eload
The eloads a e small, complex uni s wi h mul iple di e en ma e ials.
They could be ecycled bu because o he small amoun s o di e en
ma e ials, i would p obably be less p o i able compa ed o he o he
pa s o he endocu e .
igu e 45. An example o he di e en pa s o an endocu e (E hicon Echelon Flex 60 s aple ) by Cen al In usion Alliance (CIA) [91] igu e 46. Idea ion on he CRF o ecycling

| 49
Mas e ’s hesis - Do ien an Dolde en
4.3. Concep ing
4.3.1. Inclusion o ecycled ma e ial 4.3.2. Design o ecycling
igu e 47. Concep inclusion o ecycled ma e ial
igu e 48. Concep Design o ecycling
Designing o ecyclabili y can be achie ed acco ding o di e en
s a egies, acco ding o an den Be g & Bakke [77]. The ma e ials
included in he design need o be e alua ed and may need o be
econside ed, and he numbe o di e en ma e ials needs o be
minimised. The connec ions be ween di e en pa s need o be
designed o ecycling as well so ha i is possible o sh ed he de ice
in o pieces la ge enough o p ope sepa a ion.
This concep is an endocu e made o ou main pa s; he sha om
su gical s eel, he handle om ecyclable plas ic, he eload, and
he elec onics ( igu e 49). These pa s do no need o be designed
o manual disassembly, bu he e should be no pe manen ix u es
be ween hem o allow o p ope ma e ial sepa a ion a e sh edding.
Whe he o no his is possible needs o be e alua ed a e an in-dep h
p oduc analysis.
I assume ha cu en ly he pa s o he
endocu e made om s ainless s eel
al eady ha e ecycled con en , bu ha he
plas ics a e made om i gin ma e ial. This
is why looking a ecycled plas ic con en in
he handle could be in e es ing.
One o he main ba ie s o ecycling mixed
plas ics is polyme con amina ion in he
esul . P ope ies could be ha d o p edic
because o impu i ies since he composi ion
o he ecycled plas ic is no always clea
[90]. This could be an issue o ma e ials
included in medical de ices because he e
needs o be a high le el o ce ain y ha
ma e ials coming in o con ac wi h pa ien s
a e biocompa ible and non- oxic.
Hospi als ha e a la ge was e s eam o polyp opylene (PP), pa ly
because o he la ge boxes some medical de ices a i e in and pa ly
because o he blue PP w ap used o pack he ne s s o ing s e ile
su gical ools. This was e s eam is uncon amina ed, and he ma e ial
is easily sepa a ed. This makes hospi al PP a g ea esou ce o
ecycling and po en ially a base ma e ial o new medical de ices, as
demons a ed by an S a en [83].
I migh be possible o make he handle o he endocu e om ecycled
hospi al PP. The handle does no en e human issue, so maybe high-
g ade ecycled PP would be app o ed in his applica ion ( igu e 48).
| 50
Mas e ’s hesis - Do ien an Dolde en
4.4. E alua ion and e lec ion
igu e 49. Ini ial e alua ion ecycling concep s
Bo h concep s could be in e es ing
bu depend on hospi al logis ics
and de ailed p oduc design. I
migh no be possible o educe
ma e ials and choose non-pe manen
connec ions wi hou comp omising
he unc ionali y o he endocu e . On
op o ha ecycling some ma e ials
equi e so much ene gy, ha choosing
incine a ion and ene gy eco e y
ins ead o ecycling migh be he mo e
en i onmen ally iendly op ion. This
decision would equi e an LCA. The
inclusion o ecycled ma e ial depends
on egula ion and he app o al o
indi idual de ices, which needs o be
looked in o u he a e his design
sp in .
Bo h concep s need o be e alua ed u he o de e mine whe he o no hey mee
all he equi emen s. They sco e lowe on he c i e ia compa ed o he concep s
om p e ious lows, because a lowe le el o p oduc in eg i y is p ese ed. Design
o ecycling could apply o many simila p oduc s as well, which makes i wo h
in es iga ing u he , especially i i goes hand in hand wi h a scale-up o in-hospi al
medical was e disin ec ion o ecycling. The inclusion o ecycled ma e ial is no a e y
impac ul di ec ion bu , i he de ice could ge app o ed, ela i ely easy o implemen .
Possible u he esea ch in o medical de ice ecycling includes inding example de ices
To al sco e concep :
Concep s:Requi emen s and c i e ia:
Rq1
++ = de ini ely (Rq) o 2 (C ) + = p obably (Rq) o 1 (C ) +- = maybe (Rq) o 0 (C ) - = maybe no (Rq) o -1 (C ) -- = de ini ely no (Rq) o -2 (C )
2 -1
Design o
ecycling
Inclusion o
ecycled
ma e ials
+-
++
+
+-
+
+
++
+-
++
-
++
-
The endocu e main ains i s unc ionali y a e edesign
The endocu e is sa e o use on pa ien s (i.e. biocompa ibili y)
The endocu e does no pose a con amina ion isk o anyone
A high le el o p oduc in eg i y is main ained ( his c i e ium weighs double)
The endocu e i s wi hin he cu en logis ics and in as uc u e o he hospi al
and he OR
The edesign concep is applicable o mo e han jus he E hicon endocu e
and se s an example o he medical de ice indus y
Rq2
Rq3
C 1
C 2
C 3
Recycling
which include ecycled ma e ials and looking in o he legal app o al o hese example
de ices. I would also be use ul o look in o he equi emen s and isks o including
high- isk p oduc s like he endocu e in ecycling schemes.
| 51
Mas e ’s hesis - Do ien an Dolde en
Use
Sh ed
Sh ed
Collec ion
Disin ec
Disin ec
P epa e use o
endocu e
Sepa a e
P ocess
Pa
manu ac u e
P oduc
manu ac u e
S e ilize
Package
In ec ious
non-In ec ious
Dis ibu ion
In ec ious
anspo a ion
non-in ec ious
anspo a ion
Non- ecyclable
ma e ials
Recycled ma e ial
Sold o o he
manu ac u e s
Recycled ma e ial
sold o OEM
imp ope
sepa a ion
Packaging
ma e ial
O
E
M
H
o
s
p
i
a
l
R
e
c
y
c
l
i
n
g
a
c
i
l
i
y
4.5. The ecycling lows
igu e 50. A schema ic o e iew o di e en ecycling lows
| 52
Mas e ’s hesis - Do ien an Dolde en
5. Design sp in bioma e ials
The CRF o bioma e ials goes in o eco e y ia he biological
cycles ins ead o he echnical cycles o he bu e ly diag am
[57]. Bioma e ials a e ma e ials ha (1) a e biodeg adable,
o (2) may o may no be deg adable bu a e p oduced om
biological ma e ials o enewable eeds ock (adap ed om
A iwesh e al. [2]).
Fo his low, I made he assump ion ha only he handle and
he eload could possibly be made om bioma e ials because
he sha should be made ou o su gical s ainless s eel. The e
a e many di e en bioma e ials, bu o his applica ion, I will
only go in o he bioplas ics, because I assume hese a e he
mos sui able o use in he handle and eload.
Bioplas ics a e plas ics ha (1) a e biodeg adable, o (2) may
o may no be deg adable bu a e p oduced om biological
ma e ials o enewable eeds ock [2].
5.1. Resea ch
5.1.1. Ad an ages o bio-plas ics
5.1.2. Disad an ages o bio-plas ics
Bioplas ics a e plas ics ha (1) a e biodeg adable, o (2) may o may no
be deg adable bu a e p oduced om biological ma e ials o enewable
eeds ock. Many pe oleum-based plas ics a e no biodeg adable,
which means hey don’ de e io a e o e ime and emain whe e hey
ha e been disposed o , ha ming he en i onmen . Nondeg adable
plas ics can ake decades o e en cen u ies o b eak down [2].
Bio-plas ics could ha e a lowe ca bon oo p in compa ed o
con en ional plas ics; gene ally, hey a e made om enewable
esou ces, gene a e ewe g eenhouse gases and he p oduc ion
equi es less ene gy [93].
The bioplas ic indus y some imes compe es wi h ag icul u e o
he esou ces necessa y o p oduc ion. A edis ibu ion o a mland
owa ds he p oduc ion o bioplas ics could lead o a ise in ood p ices,
a ec ing mos ly poo e egions o he wo ld [2], [93].
A end-o -li e, bioplas ics a e ha d o sepa a e om o he plas ics,
which could lead o p oblems wi h ecycling. Compos ing usually
equi es indus ial ea men as well, some imes a le els which a e
no widely a ailable [93]. Du ch compos ing acili ies o en only handle
biodeg adable was e o 6 weeks, while bioplas ics could ake up
o 12 weeks o decompose (appendix 1.3). Acco ding o Eu opean
guidelines plas ics ha decompose a e 12 weeks a e s ill labelled as
“biodeg adable”. This means a e he indus ial p ocess, so-called
biodeg adable p oduc s could be s ill pa ly le in ac . On op o ha ,
decomposi ion p oduces me hane, a g eenhouse gas much mo e
po en han ca bon dioxide [2].
Cu en ly, bioplas ics a e abou wo imes mo e cos ly o p oduce
compa ed o con en ional plas ics, bu his di e ence in p ice could
sh ink in he u u e when p oduc ion is expec ed o scale up.
I is impo an o e alua e he use and en i onmen al impac o
bioplas ics compa ed o con en ional plas ics using an LCA [2].
Guzzo e al. [40] men ion ha he inclusion o bio-based plas ics could
be an al e na i e o ecycling SUDs. Since bio-based plas ics a e made
om enewables, ewe ossil uels a e used in p oduc ion compa ed
o ossil uel-based plas ics. This does howe e no gua an ee a lesse
en i onmen al impac in e u n [92].
Jus as no all pe oleum-based plas ics a e nondeg adable, no all bio-
based plas ics a e biodeg adable. Some bioplas ics e en con ibu e
signi ican ly o global wa ming, pollu ion and d as ic change in land
use. The sou ce o he plas ics and he needed acili ies o possible
compos ing has a g ea in luence on he en i onmen al impac o he
de ice [62]. To know o su e i a bioplas ic makes a good subs i u e, a
li ecycle compa ison is necessa y [2].
The e a e ou ca ego ies o biodeg adabili y [92]:
Biodeg adable; 90% o he ma e ial can be decomposed and he
o he 10% is non- oxic o he en i onmen .
Compos able; he es s o decomposi ion o m less han 10% o
he o iginal mass and ha e no oxic e ec s.
Bio- agmen able; blends o syn he ic and na u al elemen s. The
na u al elemen s disappea o e ime and agmen s o syn he ic
polyme s emain.
Oxo-bio-deg adable; he moplas ics wi h addi i es ha can
be decomposed o agmen ed, bu o which he oxici y is no
e alua ed.
1.
2.
3.
4.
Biodeg adabili y is s ongly de e mined by ac o s like humidi y,
empe a u e and mic o-o ganisms, and condi ions in na u e a e o en
e y di e en om hose in a labo a o y [93].
| 53
Mas e ’s hesis - Do ien an Dolde en
| 53 igu e 51. The pha ma il e sys em [86]
5.1.3. Biodeg adable medical was e
5.1.4. Bioplas ics o medical applica ions
The Du ch company Pha ma il e de eloped a solu ion o he
ea men o (in ec ious) hospi al was e, a sys em ha is ins alled a
E asmus MC in Ro e dam ( igu e 52). Nex o he disin ec ion and
sh edding o was e men ioned in he p e ious eco e y low, he
Pha ma il e is also designed o compos he biodeg adable ac ion
o hospi al was e [86]. This sec ion o he ins alla ion is cu en ly no
unc ional, because he e is a sho age o compos able was e coming
h ough he sys em. The lack o nu ien s kills he mic obial cul u es
necessa y o he compos ing p ocess (appendix 1.3).
Mos PHAs (polyhyd oxyalkanoa es) a e sui ed o use in bo h medical
de ices and issue enginee ing, because o hei biodeg adabili y
wi hou being oxic [94]. This ma e ial is made by mic oo ganisms and
can display simila he mal and mechanical p ope ies o PP [95]. PHAs
a e he mos widely used ype o bioplas ic in biomedical applica ions
[96].
PLA (polylac ic acid) is also biocompa ible and biodeg adable and has
a wide ange o applica ions in biomedical design. De ices con aining
PLGA (polylac ic-co-glycolic acid), a syn he ic biodeg adable polyme ,
ha e also been app o ed by he FDA and he Eu opean Medicine
Agency [96].

| 54
5.2. Design oppo uni ies
5.3. Concep ing
5.3.1. Biodeg adable plas ics
5.3.2. Biobased plas ics
The in i o (inside a li ing body) biodeg adabili y o some plas ics
makes hem in e es ing o use in implan s. Maybe he s aples could be
edesigned o decompose in o he su u ed issue. This echnique has
al eady been p o en [94].
Apa om he eload, he handle is he only pa o he endocu e
ha could be made om bioplas ics. I assume he sha needs o be
manu ac u ed om su gical s eel o e ain i s unc ionali y.
Biodeg adable plas ics could ei he be decomposed inside he
hospi al o ex e nally. Inside he hospi al, hey would be decomposed
by o example a Pha ma il e ins alla ion, which un o una ely cu en ly
is unable o do so. This s a egy would equi e less in ec ious was e
anspo a ion, which is a huge ad an age, bu would only be sui able
o la ge hospi als. Ex e nal decomposing would be a bigge challenge
since he was e would ei he need o be disin ec ed be o e anspo
o need o be anspo ed acco ding o haza dous was e egula ions.
The e is only one in ec ious was e p ocessing acili y in he Ne he lands;
Za in in Do d ech [97]. Za in cu en ly incine a es in ec ious was e
along wi h he bins i is anspo ed in and would need o d as ically
al e i s was e handling p ocess o include compos ing acili ies. I he
was e was disin ec ed be o e anspo , i could be sen o a egula
compos ing acili y, whe e compos ing could maybe be combined wi h
egula ecycling o o he componen s o he de ice. As shown in igu e
55, he CRF o bioplas ics is no ac ually a closed ci cula low. Maybe
he eco e ed nu ien s om he compos ing p ocess could con ibu e
o new g ow h o bio-based eeds ock, bu his is unlikely.
The inclusion o biobased plas ics in he handle is ela i ely easy o
implemen bu would equi e an LCA o alida ion.
igu e 52. Idea ion on he CRF o bioma e ials
| 55
Mas e ’s hesis - Do ien an Dolde en
5.4. E alua ion and e lec ion
igu e 53. Ini ial e alua ion bioplas ics concep s
Since bo h concep s s ay e y close o
he o iginal endocu e , and biobased
ma e ials a e al eady app o ed in
medical applica ions, bo h concep s
mee all he equi emen s. Howe e ,
hey sco e e y low on he c i e ia.
Biodeg ading plas ic is a ype o
e ia y ecycling, whe e only chemical
cons i uen s o ma e ials a e eco e ed
[84]. This means ha a e y low le el
o p oduc in eg i y is main ained
which makes his eco e y low qui e
undesi able om a ci cula economy
poin o iew.
To al sco e concep :
Concep s:Requi emen s and c i e ia:
Rq1
++ = de ini ely (Rq) o 2 (C ) + = p obably (Rq) o 1 (C ) +- = maybe (Rq) o 0 (C ) - = maybe no (Rq) o -1 (C ) -- = de ini ely no (Rq) o -2 (C )
-6 -4
Biodeg adable
plas ics
Biobased
plas ics
++
++
+
--
+-
--
++
++
++
--
++
--
The endocu e main ains i s unc ionali y a e edesign
The endocu e is sa e o use on pa ien s (i.e. biocompa ibili y)
The endocu e does no pose a con amina ion isk o anyone
A high le el o p oduc in eg i y is main ained ( his c i e ium weighs double)
The endocu e i s wi hin he cu en logis ics and in as uc u e o he hospi al
and he OR
The edesign concep is applicable o mo e han jus he E hicon endocu e
and se s an example o he medical de ice indus y
Rq2
Rq3
C 1
C 2
C 3
Bioma e ials
The non-deg adabili y o plas ics in land ill is no a conce n o haza dous was e, since
his ype o was e is no sen o land ill bu incine a ed ins ead. I hink I can sa ely
assume ha endocu e s do no con ibu e o linge ing plas ic in oceans o on land,
which akes away one o he main bene i s o including biodeg adable plas ics in
he design. This s a egy would ha e minimal impac and equi e qui e he logis ics
al e a ions o implemen .
The inclusion o enewables is easy o implemen , i is howe e unclea i his s a egy
is ac ually an imp o emen compa ed o he use o ossil uel-based plas ics. I no o he
CRFs a e possible o he endocu e his could be an op ion, bu i would depend on
he esul s o an LCA.
| 56
Mas e ’s hesis - Do ien an Dolde en
Pa
manu ac u e
P oduc
manu ac u e
S e ilize
Package
bio-based
ma e ials Renewables
Packaging
ma e ial
Imp ope
sepa a ion
non-deg adables
Cu en ly he Pha ma il e
decomposi ion p ocess
is no unc ional,
e e y hing is incine a ed.
Nu ien s
Use
Collec ion
P epa e use o
endocu e
Sh ed
Sh ed
Disin ec Disin ec
Decompose
Decompose
In ec ious
non-In ec ious
Dis ibu ion
P
h
a
m
a
fi
l
e
O
E
M
H
o
s
p
i
a
l
Z
a
i
n
?
In ec ious
anspo a ion
5.5. The bioma e ial lows
igu e 54. A schema ic o e iew o di e en bioma e ial lows
| 57
Mas e ’s hesis - Do ien an Dolde en
6. Conclusion
To al sco e concep : 6 7 4 2 5 4
Concep s:
In-hospi al
s e ilisa ion Fixed cycles Hyb id
design
S aple
compa ibili y
Sepa a e
classi ica ion
Ex e nal
ep ocessing
Requi emen s and c i e ia:
Rq1 +
+
+
++
++
+-
++ = de ini ely (Rq) o 2 (C ) + = p obably (Rq) o 1 (C ) +- = maybe (Rq) o 0 (C ) - = maybe no (Rq) o -1 (C ) -- = de ini ely no (Rq) o -2 (C )
++
++
+
++
++
+
++
++
+
+
+
+
--
++
+
+
+-
+
++
++
+-
+
+
++
++
++
+
++
-
+
3 2 -1 -6 -4
In e na ional
collabo a ion
Design o
ecycling
Inclusion o
ecycled
ma e ials
Biodeg adable
plas ics
Biobased
plas ics
+-
+
+
+
-
++
+-
++
+
+-
+
+
++
+-
++
-
++
-
++
++
+
--
+-
--
++
++
++
--
++
--
The endocu e main ains i s unc ionali y a e edesign
The endocu e is sa e o use on pa ien s (i.e. biocompa ibili y)
The endocu e does no pose a con amina ion isk o anyone
A high le el o p oduc in eg i y is main ained ( his c i e ium weighs double)
The endocu e i s wi hin he cu en logis ics and in as uc u e o he hospi al
and he OR
The edesign concep is applicable o mo e han jus he E hicon endocu e
and se s an example o he medical de ice indus y
Rq2
Rq3
C 1
C 2
C 3
Rep ocessing Remanu ac u e Recycling Bioma e ials
igu e 55. The compa ison o all concep s om he design sp in s
Figu e 56 shows a compa ison be ween all he concep s om he ou design sp in s.
The sco es and e alua ions a e highly subjec i e because o he limi ed esea ch ha
can be done in a one-day sp in , so u he alida ion will be necessa y. The esul s
o he design sp in s a e in line wi h he indings o Guzzo e al. [40] and Kane e al.
[11]. They ad ise ocusing business models and ins umen design o high-c i icali y
and high- alue de ices like he endocu e on hygienic eco e y, and he concep s
o igina ing om he CRF o ep ocessing sco e bes acco ding o he c i e ia. Because
o his le el o unce ain y, choosing a ew p omising design di ec ions ins ead o one
single concep is p e e ed.
| 64
Mas e ’s hesis - Do ien an Dolde en
Idea gene a ion and selec ion
PART 4
This sec ion o he epo desc ibes he p ocess o gene a ing and
compa ing ideas o di e en ypes o se ice designs o he End o Li e
o lapa oscopic de ices. I decided o ocus on he edesign o s uc u es
a ound he endocu e ins ead o he endocu e i sel , because I hink
he endocu e design should be adjus ed o he s uc u e ha i is a
pa o . I I i s design a se ice model ha i s my ision, The p oduc
design can la e be al e ed o i his se ice.
Ideas a e gene a ed h ough di e en me hods based on he p e iously
desc ibed ision and ea lie esea ch. The mos p omising one is
selec ed by es ing he ideas on di e en equi emen s and c i e ia.
The selec ed idea will be de eloped u he in o a se ice concep ,
which will be discussed in he nex pa o he epo .
Concep design in he con ex o ansi ion managemen is a
connec ion be ween long- e m ision and sho - e m goals. I aim o
design a possible ou e o he en isioned u u e, some hing ha is
almos easible in he p esen bu s ill adical in na u e. Expe imen ing
h ough design is a way o unpack complexi y and ind ou wha hinde s
o suppo s he desi ed ansi ion [20].

| 65
Mas e ’s hesis - Do ien an Dolde en
Mas e ’s hesis - Do ien an Dolde en
| 65
1. Me hod
1.1. How o’s
1.2. Mo phological cha
1.3. Idea selec ion
1.3.1. Requi emen s and c i e ia
1.3.2. Ha is p o ile
Fo he idea-gene a ing phase o his p ojec , a combina ion o wo
me hods was used. The i s is he ‘How o’ me hod, and he second
is he ‘Mo phological cha ’ me hod. The how- o me hod allows o
ini ial ee hinking and he gene a ion o a lo o ideas o each quali y
h ough quan i y. This is ideal o idea ing on an abs ac ision and o
he explo a ion o he whole design space. The Mo phological cha
me hod is a way mo e s uc u ed and analy ical me hod and is used o
na ow down a e aking ull eedom wi h he How o’s.
A e he idea gene a ion, a se o equi emen s and c i e ia we e
o mula ed which we e used o es and selec he ideas. The bes idea
is de eloped u he in la e design s ages.
How- o’s a e p oblem s a emen s o mula ed as ques ions o suppo
idea gene a ion. They a e mos sui ed o he beginning o idea
gene a ion and can be used o o example idea e on elemen s o a
ision. I is impo an o de e mine he how- o ques ions om a a ie y
o pe spec i es and on a ying scopes o he bes esul [31].
The Mo phological cha is a me hod ha helps gene a e solu ions
analy ically and sys ema ically by decons uc ing he o e all unc ion o
a p oduc o se ice in o sub- unc ions. The goal is o gene a e a ma ix
o he di e en sub- unc ions and hei possible solu ions (pa ame e s
and componen s). F om he ma ix, you can combine di e en solu ions
o sub- unc ions o desc ibe possible p inciple concep s [31]. No mally
mo phological cha s a e made o physical p oduc s, and sub- unc ions
a e e y p ac ical. In his case, I decided o desc ibe he sub- unc ions
mo e as elemen s o a possible se ice and keep hem a bi mo e
abs ac . igu e 61. The mo phological cha me hod
desc ibed in he Del Design Guide [31]
Ideas we e selec ed by e alua ing and compa ing hem acco ding o
di e en c i e ia.
A lis o equi emen s can be composed based on all he ga he ed
in o ma ion on he design p oblem. This lis is a li ing documen , and
du ing di e en s ages o he design p ocess, di e en equi emen s
and c i e ia play oles o a ying impo ance. As he design becomes
mo e de ailed and conc e e, so does he p og am o equi emen s.
Requi emen s need o be me , o he wise, an idea is simply no easible,
iable o desi able. They se e as simple yes o no ques ions. C i e ia
a e no as bina y and can be used as a kind o scale o compa e and
selec ideas [31].
The Ha is p o ile is a me hod o isually compa e ideas based on design
c i e ia o you design. A Ha is p o ile consis s o an assessmen o o
which ex en each idea mee s each c i e ium, usually, a ou -poin scale
is used [31].
| 66
Mas e ’s hesis - Do ien an Dolde en
| 66
Mas e ’s hesis - Do ien an Dolde en
2. How o’s
2.1. Ques ions
2.1.1. Con ex le el
2.1.2. In e ac ion le el
2.1.3. P oduc le el
The how- o ques ions a e based on keywo ds om my ision. I wo ked
om a highe le el o abs ac ion owa ds mo e speci ic ideas, so he
ques ions will be so ed om con ex le el o p oduc le el. How- o’s
can be pa o a g oup b ains o m, bu equi e all pa icipan s o ha e
su icien insigh in o he design space. This is why I decided o use his
me hod on my own o his g adua ion p ojec .
Make he medical de ice indus y open o change?
Design o us in he sa e y o de ices?
Inc ease us be ween OEMs? And be ween OEMs and
hi d pa ies?
Policymake s acili a e a high- us MedTech indus y?
Make he in e ac ion be ween an EoL se ice and
heal hca e acili ies anspa en ?
Make he in e ac ion be ween an EoL se ice and
heal hca e acili ies coope a i e?
Make he in e ac ion be ween an EoL se ice and
heal hca e acili ies accessible?
Design a sel less EoL se ice?
Design an hones EoL se ice?
Design an open EoL se ice?
Design a esponsible EoL se ice?
How o...
How o...
How o...
How can...
How o...
How o...
How o...
How o...
How o...
How o...
How o...
igu e 62. How o’s on he ci cula li e o a lapa oscopic de ice
| 67
2.2. Ideas 2.3. Knowledge gaps
2.2.1. Con ex le el
2.2.2. In e ac ion le el
2.2.3. P oduc le el
The comple e How- o wo kshee s can be ound in appendix 3. The mos in e es ing
di ec ions a e g ouped, connec ed, and summa ised below. They a e sepa a ed by
con ex le el, in e ac ion le el and p oduc le el.
Cu en ly, he e a e a lo o ba ie s in place ha hinde he MedTech indus y om
opening up o change. We should ind hese ba ie s and challenge hem. Fo example,
can we e-e alua e when a de ice is sa e o use? How clean is clean enough? A e he
cu en p ac ices o sa e y necessa y, o a e hey going way oo a wi h no ega d o
hei en i onmen al impac ? I possible, we should ocus mo e on oppo uni ies ins ead
o ba ie s. Wha kind o good examples o he implemen a ion o he ci cula economy
can we se o he indus y h ough case s udies, LCAs and cos analyses? Can we show
wha is possible, ins ead o jus showing wha is no ?
Wha i he EU would play a cen al ole in he EoL o medical de ices? They could
se up a non-p o i , in e na ional se ice aking esponsibili y o he ep ocessing,
emanu ac u ing and, i necessa y, ecycling o medical de ices. Maybe he EU
could change he Eu opean Medical De ice Regula ions in a way ha would make i
manda o y o OEMs o le hei p oduc s be pa o his se ice i hey aim o sell hei
p oduc s on he Eu opean ma ke . The EU could demand OEMs o sha e spa e pa s
and p oduc speci ica ions, and make hem design de ices wi h disassembly in mind. In
e u n, OEMs could ecei e some o he e u ns o he se ice pe ep ocessed de ice.
The EU could also look in o he acili a ion o in e na ional in ec ious de ice
anspo a ion. Ano he in e es ing di ec ion is looking in o he ules o app o al o
SUDs compa ed o eusables. Cu en ly, i seems o be easie o OEMs o label de ices
as single-use ins ead o eusable, can his be u ned a ound and suppo companies
ha a e looking o b ing eusable de ices on he ma ke ?
o us ha i has been handled wi h ca e. Ano he solu ion is o p o ide some so
o p oo o he sa e y and s e ili y o a de ice. This could be done h ough a ack and
ace sys em, which is al eady implemen ed, bu maybe also h ough he use o physical
ma ke s on he de ices showing he numbe o cycles a de ice has gone h ough o
whe he o no i has been s e ilised. Ce ain p oduc quali ies could e oke a sense
o us as well. I a de ice looks du able and dependable i is easie o assume i can
wi hs and a lo o ep ocessing cycles. A polished design wi hou many c e ices in which
di can s ick could gi e he imp ession o be cleane compa ed o oughe designs.
Maybe a anspa en in e ac ion could be ealised by making he in e ac ion pe sonal.
The se ice should be ailo ed o each hospi al, made as easy as possible o sign up o
and s a i s implemen a ion, and he con ac pe son should be consis en . A he same
ime, he se ice should be easy o each, quick o eply o ques ions and make eal-
ime insigh s o s a us epo s a ailable. The in o ma ion p o ided should be accessible
and speci ic; wha happens o which de ice, when and how?
In a coope a i e in e ac ion, i should be clea o all pa ies in ol ed wha hey ge
ou o he collabo a ion. E e yone should be open o eedback and inpu , and i
possible e en pa o he design p ocess. The e should be mul iple pa ies in ol ed,
each wi h hei unique ole o play, hei con ibu ion and hei in insic mo i a ions o
pa icipa ing. Pa ies should be awa e and conside a e o each o he ’s mo i a ions and
ese a ions and aim o help come o he bes sha ed esul s possible.
One cha ac e is ic ha would make a se ice sel less by de ini ion, is o make i a non-
p o i o ganisa ion. This would communica e clea ly ha he only goal o his se ice
is o p o ide a esponsible end-o -li e o medical de ices, wi h no con lic ing in e es s.
An hones se ice has ull insigh in o i s wo k so ha i can sha e hese insigh s wi h
clien s oo. I needs o be esponsible and should be awa e o i s en i e impac and
esponsibili ies in all di e en pa s o i s sys em. Liabili y mus be clea and aceable.
A esponsible se ice is ully awa e o and anspa en abou he sa e y o he medical
de ices hey handle. An open EoL se ice is accessible o bo h hospi als and OEMs
and makes i as easy as possible o ac o s o implemen he se ice in hei way o
wo king.
Since i is di icul o us some hing you don’ unde s and, design o ease and
accessibili y could possibly inc ease us in de ices. The se ice should be as consis en
and use - iendly as possible. Maybe us can be gene a ed by designing an almos
pe sonal ela ionship be ween he s e ilisa ion depa men pe sonnel and he use s o
de ices. I you know he pe son who cleans he de ice in you hand, i would be easie
The idea ion did no jus esul in new
ideas, bu also a lo o new ques ions
and esea ch di ec ions.
Fi s , i is clea ha he MedTech
indus y is highly compe i i e, bu why
is ha ? Is his le el o compe i ion
be ween OEMs a bad hing? A e he e
examples o success ul collabo a ions
be ween OEMs? I is no like he
ma ke o medical de ices canno
be called a ee ma ke , since i is
highly egula ed and consume s a e
o en no awa e o , and in luenced
by, he p ice o a de ice. I he e was
mo e anspa ency in he p icing o
de ices, how would he na u e o he
compe i ion be ween OEMs change?
Also, i I wan o design o us i
would be use ul o ind ou wha he
leas us ed pa o he ep ocessing
p ocess is; is i he cleaning, he
s e ilisa ion, he anspo a ion o he
handling o de ices be o e su ge y? I
could also be in e es ing o look in o
he ack and ace sys em and see
how OR pe sonnel expe ience insigh
in o he sa e y o de ices.
Las ly, I wonde i in e es ing examples
exis o o example non-p o i was e
managemen companies o EU- unded
EoL p ojec s ha push OEMs o
con ibu e by sha ing p oduc de ails
o spa e pa s.
| 68
Mas e ’s hesis - Do ien an Dolde en
3. Mo phological cha
3.1. pa ame e s
igu e 63. The mo phological cha o he ci cula li e o an endocu e
Usually, a mo phological cha
desc ibes he sub- unc ions o a
physical p oduc , bu in his case,
I ha e adap ed he me hod o
se ice design. The i s s ep is o
decide on he a iable pa ame e s
o sub- unc ions, and nex on he
componen s o solu ions ha could i
each pa ame e . F om he e you can
make in e es ing combina ions and
gene a e possible solu ions.
The key pa ame e s ha I decided on
a e:
- Loca ion and scale; on wha scale
will he EoL s a egy be execu ed?
- Re e se logis ics; how will he
de ices be collec ed and
sepa a ed?
- Liabili y; Who is esponsible o he
EoL?
- EoL s a egy; Which s a egies a e
included in he se ice?
- Business model a che ype; Wha
kind o ci cula business model is
connec ed o he se ice [1]?
Fo each pa ame e , I b ains o med on
possible solu ions. Some componen s
a e connec ed and some canno be
combined, which means no e e y
combina ion o componen s is
possible ( igu e 64).
| 1
Mid e m epo - Do ien an Dolde en
The ci cula li e o an endocu e (mo phological cha )
Solu ions 1 2 3 4 5
In e nal SDRecycling schemes Ex e nal ep ocesse Remanu ac u e s Solu ion 2 Solu ion 3Solu ion 1 Solu ion 4
Sub unc ions
Loca ion/scale
Re e se logis ics
Liabili y
EoL s a egy
Business model a che ype
Pe indi idual hospi al
Collec ion in OR
(all de ices, also SUDs)
Hospi als a e esponsible
and own he p oduc s
h oughou hei li e
Recycling
Linea business model
Regional
Collec ion in OR
(all eusable de ices)
Hospi als keep owne ship,
bu OEMs a e esponsible
o he EoL
Rep ocessing
Gap exploi e model
( ep ocessing se ices)
Na ional
Collec ion in OR
( eusable de ices
sepa a ed by OEM)
OEMs buy ins umen s
back and a e esponsible
o he EoL
Rep ocessing and
emanu ac u e
Gap exploi e model
(selling ep ocessed/
emanu ac u ed p oduc s)
In e na ional
Hospi als keep owne ship,
bu a hi d pa y is esponsible
o he EoL
Rep ocessing, emanu ac u e
and ecycling
Access model
A hi d pa y buys he used
ins umen s om hospi als and
is esponsible o he EoL
| 69
Mas e ’s hesis - Do ien an Dolde en
| 69
Mas e ’s hesis - Do ien an Dolde en
3.2. Resul s
3.2.1. Exis ing solu ions
Recycling scheme
In e nal S e ilisa ion Depa men
Ex e nal ep ocesso
Remanu ac u e
The do ed g ey lines in he mo phological cha ep esen some o he
solu ions ha al eady exis in some shape o o m o o he medical
de ices, bu cu en ly do no exis o he endocu e . I is good o
be awa e o hese solu ions, and hey a e use ul examples, bu new
di ec ions could be mo e in e es ing.
An in e nal s e ilisa ion depa men inside hospi als is usually managed
by he hospi als hemsel es. Howe e , he in e nal ep ocessing can be
ou sou ced and ollow a gap exploi e model. Cu en ly, endocu e s
a e no included in his solu ion because hey a e labelled as single-use
and no designed o cleaning p ocesses (Appendices 1.1 and 1.5).
An ex e nal ep ocesso ope a es on a egional le el. They can
collec bo h single-use and eusable de ices oge he , o only collec
he eusable de ices om he OR. Hospi als e ain owne ship o he
de ices, bu he hi d pa y is esponsible o ep ocessing. The se ice
wo ks acco ding o a gap exploi e model and o e s cleaning se ices
o hospi als. Cu en ly, endocu e s a e no included in his solu ion
because hey a e labelled as single-use and no designed o cleaning
p ocesses (Appendix 1.5).
Recycling schemes o SUDs do no ye exis , bu J&J is cu en ly
a pa o a ecycling pilo o he ecycling o single-use endocu e s
in collabo a ion wi h se en Du ch hospi als, he Del Uni e si y o
Technology and was e handling company G eencycl (appendix 1.4).
They ope a e on a na ional le el, collec only speci ic de ices om
ORs, disman le hem and ecycle he sepa a e componen s. Because
o he indi idual collec ion o de ices and he manual disman ling, i is
unclea i his kind o ecycling scheme will be iable in he long un.
I is also possible o downcycle in ec ious was e inside hospi als h ough
he use o specialised was e handling machines (Appendices 1.2 and
1.3). Howe e , because o i s me al componen s, he downcycling o
endocu e s in his way could damage hese machines.
A medical emanu ac u e ope a es on a na ional o in e na ional le el
and collec s de ices only om speci ic OEMs. They collec o buy used
de ices om hospi als and ake up comple e esponsibili y o hei
EoL. Thei se ices include bo h ep ocessing and emanu ac u ing,
and hey esell he de ices hey buy o a lowe p ice compa ed o he
se p ices o OEMs. Rep ocesso s wo k acco ding o a gap exploi e
model. The e is a Eu opean medical emanu ac u ing company based
in Be lin ha emanu ac u es single-use lapa oscopic ins umen s, bu
endocu e s a e no (ye ) pa o hei p oduc po olio [98].
igu e 64. Recycled sc aps om in ec ious
was e a UMC U ech (appendix 1.3)
F om he mo phological cha me hod, eigh possible solu ions
eme ged om which a leas ou al eady exis in some o m in he
indus y ( igu e 64). The exis ing solu ions a e all la gely explained in
p e ious sec ions o he epo , so only ha e a small desc ip ion in his
chap e . The possible new solu ions equi e a mo e ex ensi e and isual
explana ion. Some ini ial bene i s and d awbacks o each solu ion a e
summed up as well.

| 70
Mas e ’s hesis - Do ien an Dolde en
3.2.2. Solu ion 1
Regional – All eusable de ices collec ed oge he – Thi d pa y buys
used ins umen s and is esponsible – ep ocessing – gap exploi e
model (selling ep ocessed de ices)
The i s possible solu ion is an ex e nal ep ocessing se ice in na u e.
The main di e ence be ween his solu ion and exis ing ep ocesso s is
ha his se ice pu chases con amina ed de ices om hospi als ins ead
o jus aking up he esponsibili y o cleaning hem. In his case, he e
is a shi in owne ship. Clean de ices a e la e sold back o hospi als, so
hospi als do no ecei e he same ins umen s ha hey sell.
The e a e se e al po en ial bene i s o using his ex e nal ins umen
ep ocessing se ice. One ad an age is ha i can be a cos -e ec i e
op ion o hospi als, as hey can sell hei used de ices a he han
paying high ees o dispose o hem. Addi ionally, he wai ing imes o
clean ins umen s do no depend on he ep ocessing p ocess, as hey
a e wi h egula ex e nal ep ocesso s. This se ice can also be lexible
in e ms o which OEM de ices can be included, as he e is no access
o spa e pa s equi ed.
Howe e , he e a e also some po en ial d awbacks o conside .
One conce n is ha he le el o us in ep ocessed de ices may be
lowe han ha o ully emanu ac u ed de ices because ep ocessed
ins umen s could ha e isible damage. Addi ionally, each su geon
and hospi al may ha e indi idual p e e ences o he con en s o hei
su gical ne s, which can be be e me by ecei ing hei ins umen s
a e cleaning. Finally, only pu chasing used de ices would no mee
he en i e demand o hospi als, so hey would need o pu chase om
mul iple di e en pla o ms.
igu e 65. Solu ion 1
Disassemble
and disin ec ion
Reassemble
and s e ilisa ion
Packing, so ing
and dis ibu ion
Rep ocessing
De ice s ock
De ice use
De ice so ing
De ice collec ion
( eusables + SUDs) ecyclable SUDs
and un eco e able
de ices
non- ecyclable SUDs
and un eco e able
de ices
In ec ious
Non-in ec ious de ices
anspo o
ep ocessed
de ices
T anspo
o used
de ices
I
n
s
i
d
e
h
e
h
o
s
p
i
a
l
I
n
d
e
p
e
n
d
e
n
h
i
d
p
a
y
| 71
Mas e ’s hesis - Do ien an Dolde en
3.2.3. Solu ion 2
In e na ional – All de ices collec ed oge he – Thi d pa y buys used
ins umen s and is esponsible – ep ocessing, emanu ac u e and
ecycling – gap exploi e model (selling emanu ac u ed de ices)
This solu ion is e y simila o exis ing in e na ional emanu ac u e s.
Howe e , on op o cleaning, epai and emanu ac u ing se ices,
p oduc s o componen s which a e oo damaged o wi hs and ano he
li ecycle can go h ough a ecycling scheme ins ead. This makes his
solu ion one comple e EoL se ice. Also, all de ices a e collec ed
om he OR oge he , and eusables a e sepa a ed om SUDs a he
EoL acili y so he e is no need o ex a was e s eams inside he OR.
This would open mo e doo s o he ecycling o SUDs as well since
he e is mo e space o ma e ial sepa a ion in a specialised acili y
compa ed o was e sys ems inside hospi als. I would be ideal i
he e is a collabo a ion be ween his se ice and OEMs so ha he
emanu ac u e has access o all he necessa y spa e pa s.
One ad an age o his solu ion is ha i can main ain a high le el o
p oduc in eg i y by combining di e en CRFs. The la ge scale o
his se ice may also make i economically iable, as a collabo a ion
be ween hospi als and OEMs could make he li e o almos any de ice
ci cula . In addi ion, placing he esponsibili y o emanu ac u ing on
an impa ial hi d pa y could make i easie o OEMs o sha e p oduc
de ails and spa e pa s.
Howe e , he e a e also some challenges o conside when
implemen ing his solu ion. One limi a ion is ha his solu ion may only
be easible wi h a la ge numbe o pa icipa ing heal hca e acili ies,
as i would equi e a signi ican amoun o anspo a ion. Addi ionally,
designing and implemen ing his se ice would likely equi e a sys emic
change and a la ge collabo a ion be ween he emanu ac u e , was e
managemen and ecycling companies, policymake s, and hospi als.
I may also be necessa y o c ea e a inancial cons uc ion ha shi s
he posi ion o he emanu ac u e om compe i o o collabo a o o
ge he suppo o OEMs. Finally, he supply o emanu ac u ed de ices
would comple ely depend on he pa icipa ing heal hca e acili ies and
hei was e s eams. igu e 66. Solu ion 2
Disassemble
and disin ec ion
Reassemble
and s e ilisa ion
Packing, so ing
and dis ibu ion
Remanu ac u e
Rep ocessing
De ice s ock
De ice use
De ice so ing
De ice collec ion
( eusables + SUDs) ecyclable SUDs
and un eco e able
de ices + pa s
non- ecyclable SUDs
and un eco e able
de ices
In ec ious
Non-in ec ious de ices
non-in ec ious pa s
anspo o
ep ocessed and
emanu ac u ed
de ices
T anspo
o used
de ices
O
E
M
O
E
M
O
E
M
I
n
d
e
p
e
n
d
e
n
h
i
d
p
a
y
I
n
s
i
d
e
h
e
h
o
s
p
i
a
l
| 72
Mas e ’s hesis - Do ien an Dolde en
3.2.4. Solu ion 3
In e na ional – Reusable de ices collec ed sepa a ed by OEM –
OEM buys used ins umen s and is esponsible – ep ocessing and
emanu ac u e – Access model
This solu ion would equi e each OEM o ake esponsibili y o he
EoL o hei own de ices. This does no only equi e mo e wo k and
e o om each OEM, bu also om hospi als since hey would need
o collec de ices and sepa a e hem acco ding o hei espec i e
manu ac u e s. This se ice would be an access model, which means
ha hospi als buy access o clean and sa e ins umen s. Whe he hese
ins umen s a e ep ocessed, emanu ac u ed o b and new is no o
hei conce n and can be decided by he OEM based on hei a ailable
s ock.
One po en ial bene i o using a cen alized emanu ac u ing se ice o
medical de ices is ha i allows o easy access o p oduc speci ica ions
and spa e pa s, wi hou any issues ela ed o con iden iali y. This
model also p o ides an oppo uni y o OEMs o p o i om he ci cula
li e o hei de ices, which may gi e hem he incen i e o design o
du abili y and end-o -li e s a egies.
Howe e , he e a e also some challenges o conside when
implemen ing his se ice. One po en ial d awback is ha i equi es
hospi als o sepa a e used de ices by OEM, which can be an ex a
bu den in he ope a ing oom. Addi ionally, his solu ion is only sui able
o a small ange o de ices, as many de ices om smalle o o he
OEMs may s ill ollow a linea model. The anspo a ion o jus a ew
de ices pe hospi al can also make his solu ion ela i ely expensi e.
Finally, OEMs may no cu en ly be able o emanu ac u e de ices,
so hey would need o make signi ican adjus men s o hei business
model and alue chain o pa icipa e.
igu e 67. Solu ion 3
Sepa a e
collec ion
pe OEM
SUDs om
o he OEMs
Disassemble
and disin ec ion
Reassemble
and s e ilisa ion
De ice s ock
De ice use
Remanu ac u e
P oduc ion
Un eco e able
endocu e s and
pa s
Re u n o used
de ices
Access o clean
and sa e de ices
( eman/new)
Was e o ecyclables
om emanu ac u e
p ocesses
I
n
s
i
d
e
h
e
h
o
s
p
i
a
l
O
i
g
i
n
a
l
E
q
u
i
p
m
e
n
M
a
n
u
a
c
u
e
Packing, so ing
and dis ibu ion
In ec ious
Non-in ec ious de ices
Non-in ec ious pa s
| 73
Mas e ’s hesis - Do ien an Dolde en
3.2.5. Solu ion 4
In e na ional – All eusable de ices collec ed oge he – Thi d pa y
buys used ins umen s and is esponsible – ep ocessing, emanu ac u e
and ecycling – Access model
This solu ion is a combina ion be ween he second solu ion and he
hi d solu ion. I is based on an access model whe e hospi als pay o
access o clean and sa e ins umen s bu is managed on an in e na ional
scale h ough a la ge collabo a ion be ween OEMs. The se ice
includes ep ocessing, emanu ac u ing and ecycling. OEMs supply
spa e pa s o emanu ac u ing and new de ices o be dis ibu ed
along wi h he s ock o eused de ices.
An ad an age o his solu ion is ha i can main ain a high le el o
p oduc in eg i y by combining di e en CRFs. This se ice would also
be e y accessible o hospi als, as o de s and EoL a e simpli ied o one
cen al pla o m and one was e s eam, espec i ely. Addi ionally, his
solu ion could po en ially ha e a signi ican impac on he sus ainabili y
o he MedTech indus y, as i ep esen s a sys emic change. Placing
he esponsibili y o emanu ac u ing on an impa ial hi d pa y could
also make i easie o OEMs o sha e p oduc de ails and spa e pa s.
Howe e , he e a e also some challenges o conside when
implemen ing his EoL se ice. One limi a ion is ha i may only be
easible wi h a la ge numbe o pa icipa ing heal hca e acili ies, as
i would equi e a signi ican amoun o in e na ional anspo a ion.
Addi ionally, designing and implemen ing his se ice would equi e
a complica ed collabo a ion be ween he emanu ac u e , was e
managemen and ecycling companies, policymake s, and hospi als.
I may also be necessa y o c ea e a inancial cons uc ion ha shi s
he posi ion o he emanu ac u e om compe i o o collabo a o o
ge he suppo o OEMs. Finally, his se ice could po en ially equi e
OEMs o collabo a e on he dis ibu ion o new de ices as well, which
can be e y ime-consuming and esou ce in ensi e.
igu e 68. Solu ion 4
Disassemble
and disin ec ion
Reassemble
and s e ilisa ion
Packing, so ing
and dis ibu ion
Remanu ac u e
Rep ocessing
De ice s ock
De ice use
De ice so ing
De ice collec ion
( eusables + SUDs) ecyclable SUDs
and un eco e able
de ices + pa s
non- ecyclable SUDs
and un eco e able
de ices
In ec ious
Non-in ec ious de ices
non-in ec ious pa s
Access o clean
and sa e de ices
( eused/new)
T anspo
o used
de ices
O
E
M
O
E
M
O
E
M
I
n
d
e
p
e
n
d
e
n
h
i
d
p
a
y
I
n
s
i
d
e
h
e
h
o
s
p
i
a
l
| 80
Mas e ’s hesis - Do ien an Dolde en
2. Design p ocess
2.1. Ini ial se ice idea - Solu ion X
A he end o he idea gene a ion and selec ion phase o his
g adua ion p ojec , I p oposed an inc emen al bu adical “Solu ion X”.
The s o yboa d o his ini ial p oposal can be ound in appendix 4.3.
Solu ion X is an ex e nal ep ocessing se ice o heal hca e acili ies
in close collabo a ion wi h medical de ice OEMs. All de ices a e
collec ed by he se ice and go h ough a p ocess o disassembly,
cleaning, disin ec ion, checking and so ing. The de ices ha a e no
ep ocessable a e so ed by hei espec i e OEMs and sen back when
enough de ices a e collec ed. The OEMs ake ull esponsibili y o he
emanu ac u ing o hei own de ices and ha e he possibili y o sell
he same p oduc s again. This shi o esponsibili y also gi es hem
he incen i e o ake EoL in o accoun in hei p oduc design. The
ex e nal ep ocessing and so ing o de ices pe OEM allows hospi als
o alloca e mo e ime, space and esou ces o hei co e business.
Figu e 74 shows he di e en de ice eco e y s eps and he
esponsibili ies o di e en ac o s wi hin solu ion X.
Use
Remanu ac u ing
Manu ac u ing
De ice
p epa a ion
Disassembly,
cleaning and
disin ec ion
De ice
collec ion
Repai and
main enance
Checking
and so ing
Reassembly
and s e ilisa ion
So ing
pe OEM
So ing
pe hospi al
De ice
s ock
SUDs
Packaging
Un eco e able
de ices
In ec ious
Non-in ec ious
New and
emanu ac u ed
de ices
Rep ocessed
de ices
Remanu ac u able
de ices
In ec ious
de ices
O
E
M
s
E
x
e
n
a
l
R
e
p
o
c
e
s
s
o
H
o
s
p
i
a
l
igu e 73. An o e iew o he ini ial solu ion X

| 81
Mas e ’s hesis - Do ien an Dolde en
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2.2. Expe eedback and i e a ions
2.2.1. Rep ocessing o emanu ac u ing - p oduc design How o design an endocu e o ep ocessing
How o design an endocu e o emanu ac u ing
Th ough he di e en conduc ed
in e iews I i e a ed upon he
concep , i s o e iew isual and he
s o yboa ds. He e I will discuss he
main conside a ions ha shaped he
ini ial solu ion X in o my inal concep
p oposal; MedFlo.
I i is possible o design an endocu e o ep ocessing wi hou losing usabili y, sa e y
and cos , ep ocessing is he mo e a ou able op ion compa ed o emanu ac u ing.
This edesign would mean he de ice can be cleaned inside a hospi al h ough exis ing
in as uc u e and logis ics, and ha a high le el o p oduc in eg i y can be e ained.
Bu is comple e ep ocessing e en a possibili y o a de ice as complex and c i ical as
he endocu e ?
The e a e a lo o challenges o co e when edesigning he single-use endocu e o a
p oduc se ice sys em. Fi s , he unc ion o he endocu e is highly c i ical. I is used
o ope a e on he mos impo an essels in he human body, and a mal unc ion o
he de ice can easily be a al. This means ha sa e y s anda ds o his ype o de ice
need o be excep ionally high. Also, he size o he end-e ec o limi s he possibili ies
o a ci cula edesign. The end-e ec o needs o go h ough a oca (a so o po al
de ice used du ing lapa oscopic su ge y) and needs o ope a e wi h high p ecision a
i s inal des ina ion. Because i is so small, he designe s ha e eally pushed he ma e ial
bounda ies in e ms o s eng h and sa e y ac o s. Especially he end o he de ice is
o en de o med du ing su ge y. On op o ha , he design o he endocu e includes a
lo o small and in ica e pa s, which a e especially ha d o clean (appendix 5.3).
In he pas , he endocu e was a mechanical de ice ( igu e 75). The mechanical e sion
unc ions in a e y simila way o he powe ed de ice, bu he o ce o he su geon’s
hand ansla es di ec ly o he closing mechanism, and de e mines how well he de ice
can close a ound issue. Su geons a e using he endocu e on p og essi ely hicke
and hicke issue, which can equi e almos 400 N o o ce om a su geon’s hand. The
s uggle o closing he de ice wi h his much o ce can lead o shaking o he end-
e ec o and inc eases he isk o ea ing agile issue. The powe ed design allows
he su geon o cu hick issue while keeping he de ice absolu ely s ill. Technology
is s ill e ol ing and endocu e s will only become mo e complex in he u u e. These
inno a ions imp o e pa ien sa e y and su ge y esul s, bu hey a e a majo ba ie o
eusabili y (appendix 5.3).
Designing an endocu e en i ely i o ep ocessing is e y di icul . I s complexi y,
use in e ace and small end-e ec o wi h lo s o mo ing componen s a e some o he
ba ie s o an en i ely s e ilisable edesign.
Because he dis al pa is so small, complex and agile, i is unlikely ha his pa can
be edesigned o ep ocessing. Howe e , he handle could be made ep ocessable bu
should p e e ably be designed o hyd ogen pe oxide s e ilisa ion, which is less ha sh
on he de ice, ins ead o s eam s e ilisa ion. Designing o s eam s e ilisa ion would
equi e he mal p o ec ion o componen s like ba e ies. This shielding o componen s
adds a lo o bulk and weigh and hu s he useabili y o he de ice. On op o ha ,
you would need o minimise any poin s whe e luid can be apped a e he cleaning
p ocess. This would mean a edesign o some o he con ols in he cu en endocu e .
I is possible o design a hyb id de ice in which some pa s a e single-use and o he s
a e eusable, bu he e a e a lo o ade-o s o be made wi h his kind o s a egy
(appendix 5.3).
Compa ed o design o ep ocessing, design o emanu ac u ing is a lo mo e
s aigh o wa d. One o he main weaknesses wi h ega d o emanu ac u ing he
cu en endocu e is ha in p oduc ion, he sh ouds o he de ice a e p ess- i
oge he ins ead o connec ed by sc ews. Fo una ely, changing his design elemen is
no a huge obs acle. The pa s inside he handle should be able o wi hs and mul iple
li ecycles and con ain mos o he highe - alue componen s. Howe e , he dis al pa
o he de ice is hea ily damaged du ing su ge y because o i s size and is a lo mo e
challenging o eco e (appendix 5.3).
Fo he emanu ac u ing o endocu e s, he edesign o he de ice is no he main
ba ie . The business case and logis ics will de e mine whe he o no his is ealis ic.
Ano he challenge is ha he e a e a lo o small componen s inside he endocu e
which indi idually do no con ain much alue. As a whole, he alue o hese componen s
adds up, bu some ho ough calcula ions a e needed o de e mine i emanu ac u ing
is economically iable (appendix 5.3).
igu e 74. An example o a mechanical
endocu e
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Mas e ’s hesis - Do ien an Dolde en
The bes i o solu ion X
Design o ep ocessing is mo e o a challenge compa ed o design
o emanu ac u ing. Howe e , i is de ini ely possible wi h a modula
app oach. The e a e some unce ain ies a ound he op ion o
emanu ac u ing he endocu e since he indi idual pa s a e no e y
aluable, and he de ice is e y complex o emanu ac u e, i is unclea
i he business case o his s a egy is alid. On op o ha , ep ocessing
allows o a highe le el o p oduc in eg i y o be p ese ed. This is why
I hink ep ocessing is he bes cou se o ac ion o solu ion X, gi en
ha (pa s o ) he endocu e can be edesigned acco dingly.
The e a e a lo o edesign possibili ies o he endocu e , bu each
comes wi h a adeo . Some o he adeo s a e isualised in igu e 76.
igu e 75. T ade-o s in endocu e design (appendix designe )
Design o s eady
manual con ol
Mo e s e ilisable
componen s
A gua an eed sha p
kni e e e y i ing
Modula i y
Recha geable
ba e y
Reusabili y
Inc eased complexi y
and added elec onics
Highe cos and mo e was e
A decline in he numbe o
con ols and he usabili y
Inc ease in weigh and bulk
Mo e ma e ial disposed pe
i e (bigge eload)
Mo e complexi y o
OR s a
Highe isk dead ba e y o
de ice una ailable o su ge y
challenges o s e ili y alida ion
and complexi y o hospi al s a
2.2.2. G een se i isa ion
Se i isa ion is a s a egy whe e manu ac u e s ex end hei business
in o se ices as a way o de elop new e enue s eams and gene a e
g ea e alue o hei cus ome s. The ocus shi s om jus de eloping
and selling physical p oduc s o ex ending he business p oposi ion
o alue-added se ices ha suppo cus ome p ocesses h oughou
he p oduc li ecycle. They cal also choose o ou sou ce his s a egy
o a hi d pa y. Se i isa ion can con ibu e o mo e en i onmen ally
iendly solu ions and mo e esilien supply chains. The e m ‘g een
se i isa ion’ e e s o se i isa ion wi h ecological sus ainabili y in
mind [101]. Resea ch in o g een se i isa ion a ound single-use medical
de ices is un o una ely sca ce and ela i ely new (appendix 5.1).
A p oduc -se ice sys em (PSS) can be p oduc -o ien ed, use-o ien ed
o se ice-o ien ed. A p oduc -o ien ed sys em is a sys em whe e
owne ship o he p oduc is ans e ed o he consume , bu addi ional
se ices a e p o ided. A use-o ien ed PSS is a sys em whe e he
owne ship o he p oduc is e ained by he se ice p o ide , who sells
he unc ion o unc ions o he p oduc . A esul -o ien ed sys em is a
sys em whe e p oduc s a e eplaced by se ices en i ely [102].
In he single-use medical de ice indus y, p oduc -o ien ed sys ems a e
he mos common. This means ha hospi als own hei own de ices
and pay o example o cleaning and epai ing se ices. The e a e also
examples o use-o ien ed se ices whe e he OEM e ains owne ship
o he de ice h ough i s en i e li e and he hospi al pu chases access
o i , wi h no dis inc ion be ween new and emanu ac u ed p oduc s.
The e a e no examples o esul -o ien ed models in his indus y, as he
choice o a de ice o use on a pa ien needs o be made case-by-case
and canno be ou sou ced o he OEM because o he possible impac
on pa ien sa e y.
Se i isa ion can lead o a dema e ialisa ion o he economy; i can
educe he ma e ial lows in p oduc ion and consump ion and lowe he
en i onmen al bu den while s ill o e ing he same le el o pe o mance
o consume s [103].
igu e 76. An example o g een
se i isa ion in heal hca e; he
e u bishmen o a Philips MRI
scanne [104]
| 83
Ba ie s o g een se i isa ion o SUDs The bes se ice model o solu ion X
In he EU, a medical emanu ac u e mus assume he same obliga ions
as he de ice’s OEM and ake ull esponsibili y o a emanu ac u ed
de ice’s quali y and pe o mance [17]. Remanu ac u e s a e equi ed o
p o ide alida ion da a ega ding cleaning, s e ilisa ion, and unc ional
pe o mance o show ha he emanu ac u ed de ice is “subs an ially
equi alen ” o he o iginal de ice [105]. De ices mus be app o ed
and ecei e a CE ce i ica e jus like new de ices be o e hey a e sold
(appendix 5.3).
Addi ionally, he cu en business model o OEMs depends on selling
as many new, single-use de ices as possible. This makes hi d-pa y
emanu ac u e s di ec compe i o s o OEMs since emanu ac u e s
cu in o new p oduc sales. This compe i ion has led some OEMs o
in e e e wi h emanu ac u ing o hei de ices h ough es ic i e
echnologies, o ced obsolescence and con ac ing es ic ions [105].
The e is a lack o collabo a ion amongs di e en OEMs and be ween
OEMs and emanu ac u e s. A collabo a ion could inc ease he scale o
a se ice, and p o ide easie access o necessa y compe encies o a
success ul emanu ac u ing model. Some o hese capabili ies include
emanu ac u ing echnologies, es ing p ocedu es, de ice design,
so wa e skills and logis ics [101].
The ba ie s o se i isa ion a ound ep ocessing a e less
s aigh o wa d. In he Ne he lands p oduc s ha ollow his CRF
a e designed o be eusable, and he business models o OEMs a e
adjus ed acco dingly. When subs an ially al e ing de ices h ough
epai o main enance, you s a o en e a g ey a ea. A which poin a e
you changing he o iginal p oduc so much ha you en e he domain
o emanu ac u ing ins ead? Wha le els o epai and main enance
would equi e he de ice o be e alida ed be o e use?
igu e 77. A specialised su gical ne ollowing an access model
Since esul -o ien ed models a e no sui ed o he MedTech indus y
and P oduc -cen ed se ice sys ems al eady exis in he Ne he lands
(appendix 1.5), i migh be in e es ing o look in o an access model o
solu ion X. The e a e examples o access models whe e an OEM e ains
owne ship o e a de ice, bu sells access o i o hospi als, bu his
model is limi ed o de ices o su gical ne s which a e e y cos ly and
highly specialised ( igu e 78). Hospi als pay o access o hese de ices
whene e hey plan he speci ic su ge y ha he de ice is designed o .
The OEM e ie es he used de ice a e he su ge y o ep ocessing
(appendix 5.5). Wha i he e was an access model managed by a hi d
pa y ins ead o by indi idual OEMs, and i i would p o ide mo e han
jus highly specialised de ices?
2.2.3. T ack and ace
In exis ing in e nal ep ocessing sys ems, eusables a e aced
h oughou he cycle. The hospi al needs o know exac ly whe e hey
a e a all imes. This acking is usually done by scanning he ne s ha
de ices a e s o ed in. Indi idual de ices a e no o en acked, and
SUDs, excep o implan s, a e no acked a all. I mo e and mo e
p oduc s ha a e cu en ly disposable a e edesigned o be (semi-)
eusable o modula , he acking sys em needs o change. Ins ead o
acking he ne s o de ices, he e needs o be in o ma ion a ailable
on all he indi idual modules wi hin a p oduc because hey would all
lead sepa a e li es. I needs o be clea o how many cycles a module
is designed, a e how many cycles main enance o he module is
planned, and how many cycles a module has al eady gone h ough o
de e mine ollow-up ep ocessing ac ions.
One company ha can help c ea e de ailed p oduc passpo s wi h
in o ma ion on all he di e en pa s and ma e ials, is Ci cula ise [107].
They use blockchain o combine in o ma ion om aw ma e ials and
di e en p oduc ion p ocesses o gi e a de ailed o e iew o he
composi ion and impac o a p oduc . This in o ma ion can be used
o o example op imise ecycling because you know exac ly wha
kind o ma e ials wi h which composi ion make up a p oduc and can
decide wha is possible a end o li e wi h all ha a ailable in o ma ion.
Blockchain allows companies o e e o a sha ed ledge o in o ma ion
ha hey know canno be ampe ed wi h, which c ea es a whole new
le el o alue chain anspa ency.
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Mas e ’s hesis - Do ien an Dolde en
3. MedFlo - he inal design
De ices ha e become e en mo e complex.
Regula ion has made SUDs e y expensi e,
which is why eusable de ices ha e gained
popula i y. In cases whe e eusing he
en i e de ice is no possible,
modula design is he no m.
Clean de ices eplenish
used de ice s ock
De ices a e s o ed in he
hospi al, bu a e owned by MedFlo
Used de ices
MedFlo is no i ied when a de ice is used,
eplenishes he s ock and picks up used de ices
The hospi al indica es
which and how many
de ices hey need
To deal wi h his complexi y,
hospi als pa ne up wi h MedFlo;
a se ice ha p o ides access
o a clean and sa e in en o y
o de ices
Modula de ices con ain pa s
wi h di e en planned li e imes,
wi h he aim o p ese e as much
p oduc in eg i y and alue
as possible
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Mas e ’s hesis - Do ien an Dolde en
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Mas e ’s hesis - Do ien an Dolde en
A con ac wi h MedFlo
means con inuous sales
o de ices and spa e pa s
OEMs p o ide
new de ices and
spa e pa s
MedFlo s o es he clean
modules and eassembles
and s e ilises de ices
based on hospi al o de s
Ad anced
manual and machinal
cleaning o modules

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Mas e ’s hesis - Do ien an Dolde en
3.1. Wha is MedFlo
De ice
s ock
De ice
p epa a ion
Mild
disin ec ion
Reassemble, check
and package
Manual
cleaning
Checking
and so ing
MedFlo’s
in en o y
Use
S e ilise
O de picking
De ice
collec ion
Repai and
main enance
Manu ac u ing
Manu ac u ing
Manu ac u ing
Disassembly
Machinal
cleaning and
disin ec ion
Single-use
de ices
In ec ious
de ices
Rep ocessed
and new
de ices
SUDs
Pa s a e
max cycles and
single-use pa s
Packaging
Un eco e able
pa s and de ices
In ec ious
Non-in ec ious
M
e
d
F
l
o
H
o
s
p
i
a
l
O
E
M
O
E
M
O
E
M
igu e 78. A schema ic o e iew o MedFlo’s se ice
MedFlo is a p oduc -se ice sys em ollowing an access model. I o e s
hospi als and o he heal hca e acili ies access o an in en o y o clean,
sa e and mo e ci cula medical de ices. I is adap ed o a u u e in which
SUDs ha e become oo expensi e o hospi als because o egula o y
bounda ies, and a shi back owa ds eusables is aking place.
De ices ha e become mo e complex, and i is no always possible o
euse all hei componen s. In cases like his, de ices a e designed
o be modula . Di e en modules ha e di e en planned li e imes
o p ese e as much p oduc in eg i y as possible. This can howe e
lead o an inc eased le el o complexi y in ep ocessing and in en o y
managemen ha hospi als canno always handle by hemsel es. A
collabo a ion wi h MedFlo is he solu ion.
MedFlo has he capabili y o euse ypes o de ices ha a e cu en ly
no sui ed o ep ocessing because hey ha e he acili ies, expe ise
and connec ions wi h OEMs o handle a highe le el o complexi y in
ep ocessing, epai and main enance. Figu e 79 shows an o e iew o
he cycle de ices ollow h ough MedFlo, and he s o yboa d explaining
he en i e se ice can be ound in appendix 6.3.
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Mas e ’s hesis - Do ien an Dolde en
3.2. How does MedFlo wo k
3.2.1. Logis ics
igu e 79. Fo mos hospi als, one box uck o de ice anspo a ion
pe day should su ice.
Hospi als indica e exac ly how many and which de ices o de ice ne s
hey need o ha e a ailable in hei in en o y a all imes. MedFlo o e s
his s ock on consignmen , which means MedFlo s ill owns he de ices,
bu hey a e s o ed in he hospi al’s in en o y. Whene e a de ice is
p epped o su ge y, MedFlo is no i ied o deli e a newly cleaned
p oduc he nex day o es ock he in en o y. Once a day, a uck
deli e s new de ices and picks up he used ones o ep ocessing.
MedFlo closely collabo a es wi h de ice OEMs. OEMs sell new (semi-)
eusable de ices, de ice modules and spa e pa s o he se ice which
allows MedFlo o epai de ices mo e e icien ly. A con ac wi h MedFlo
also s imula es ci cula design ini ia i es because MedFlo c ea es a new
ma ke o de ices wi h longe li e imes, and o e s s abili y o OEMs
which aim o mo e away om a dependence on SUDs.
A blockchain p oduc passpo sys em is used o ack he li ecycles o
indi idual p oduc modules. The passpo shows he planned li e ime
o each module, how many ep ocessing cycles i has al eady gone
h ough, when he module needs o be sen o epai and main enance
and when i is ime o disposal o , i possible, ecycling.
The alloca ion o one box uck pe hospi al pe day should be
su icien o he anspo a ion o de ices om and o mos hospi als
( igu e 80). Only he la ges medical cen es may need a la ge uck o
mul iple deli e ies pe day. Rush deli e ies o any hospi al wi hin he
Ne he lands can be accomplished wi hin one o h ee hou s (appendix
7). This is signi ican ly as e han in e nal ep ocessing, whe e i akes
a ound i e hou s o p ocess a de ice (appendix 5.5).
A possible loo plan o he MedFlo acili y is isualised on he nex
page in igu e 81. I shows he dedica ed a eas o di e en pa s o
he ep ocessing logis ics, as well as possible ou es ha a de ice
module can ollow om a i al a he acili y o depa u e back o a
hospi al. The e a e a ew key di e ences wi h an in e nal ep ocessing
depa men (appendix 5.5).
F om he manual cleaning a ea, he e a e wo se s o washing machines
o machinal cleaning and disin ec ion. One se leads o he checking
and so ing a ea, and one o epai and main enance. This sepa a ion
ea ly on sa es ime, since MedFlo al eady knows whe he o no
a module needs o mo e o epai and main enance by checking
he p oduc passpo be o e manual cleaning. A e epai and
main enance, a de ice always mo es back o manual cleaning i s , o
example o he emo al o oil esidue om he lub ica ing o hinges in
mechanisms.
Also, he e is a la ge s o age a ea loca ed be o e s e ilisa ion ins ead o
a e s e ilisa ion. In a egula in e nal s e ilisa ion depa men , de ices
a e s o ed in hei ne s a e s e ilisa ion. Howe e , o educe he
numbe o modules needed in s o age, de ices a e only assembled,
so ed, packaged and s e ilised a e a hospi al o de comes in. This is
why sepa a e module s o age be o e s e ilisa ion is needed.
Non-s e ile modules o en con ain ba e ies, which a e cha ged in one
cen al a ea. Some ba e ies a e s e ilisable and can ollow he ou e
o egula modules. Non-s e ile modules a e added on he ou side o
packaged ne s a e s e ilisa ion in he ca s o age a ea whe e hospi al
o de s a e comple ed. These modules a e damaged i hey go h ough
s e ilisa ion along wi h he es o he ne .
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Mas e ’s hesis - Do ien an Dolde en
De ice, module and componen s ock is pu chased om OEMs
S e ilisa ion h ough s eam
o hyd ogen pe oxide
Non-s e ile modules
S e ilisable ba e ies
Machinal cleaning
and desin ec ion
Repai ed componen s
Was e
a ea
S o age o a i ed ca s
wi h used de ices
Loading and unloading
o ucks
Disassembly, pa so ing
and manual cleaning
Repai and main enance
De ice and componen
in en o y
Checking componen s
and so ing o s o age
Ba e y cha ging
Ca s o age pe hospi al,
non-s e ile modules a e added
O de picking,
de ice assembly
and packaging
1.
1.
1.
1.
2.2.2.2.2.2.
igu e 80. A possible loo plan o he MedFlo ep ocessing acili y
| 89
Mas e ’s hesis - Do ien an Dolde en
3.2.2. P oduc li ecycle managemen
De ice
s ock
De ice
p epa a ion
Mild
disin ec ion
Reassemble, check
and package
Manual
cleaning
Checking
and so ing
MedFlo’s
in en o y
Use
S e ilise
O de picking
De ice
collec ion
Repai and
main enance
Manu ac u ing
Manu ac u ing
Manu ac u ing
Disassembly
Machinal
cleaning and
disin ec ion
H
o
s
p
i
a
l
M
e
d
F
l
o
O
E
M
O
E
M
O
E
M
Which de ices ha e a i ed
and a e s o ed in he hospi al?
Poin s whe e a ne , de ice
o module is scanned o
whe e he e is in e ac ion wi h
he p oduc passpo
Adding in o ma ion
Reading in o ma ion
Bo h
=
=
=
=
Which ne s will be used?
Med lo is no i ied o eplenish s ock
Which de ices need o
be collec ed by Med lo?
(in o o ne s is connec ed o he
ca s ha hey a e placed in)
Which ca s (and de ices) a e
collec ed by Med lo?
Any aul s in a de ice
a e eco ded h ough
oice ecogni ion
Which ne s ha e a i ed a MedFlo’s acili y?
Which disassembly s eps a e necessa y?
Wha epai o main enance
s eps need o be pe o med?
Which ype o s e ilisa ion is
necessa y o his de ice?
How should de ices be
assembled and checked?
Which ca s need o be shipped
o which hospi al? - o de in ansi
A e he e any non-s e ile modules
ha need o be added?
T ack which modules a e
s o ed whe e
Se up p oduc passpo and
planned li e ime
Which elemen s o a
module need o be checked?
Sub ac a ep ocessing cycle
o he li e ime o he module
Collec modules acco ding
o hospi al o de
Which module is in which de ice,
in which ne and in which ca ?
Decide be ween u he ep ocessing,
epai and main enance and disposal
Pe o med epai and main enance
s eps a e no ed in p oduc passpo
A e he e speci ic cleaning
guidelines o his module?
igu e 81. P oduc passpo in e ac ions isualised
MedFlo wo ks wi h a blockchain
p oduc passpo sys em ha
acks he medical de ices and he
modules wi hin hese de ices. The
p oduc passpo shows how many
ep ocessing cycles a e planned o
a module and how many cycles i has
al eady gone h ough. Based on his
in o ma ion MedFlo can decide o
ep ocess i again, i s pe o m epai s
o planned main enance, o i i is ime
o dispose o he module because i is
a he end o i s planned li e.
The egula scanning o de ices o
ne s can help MedFlo keep ack
o hei exac loca ions and he
nex s eps o ake in ep ocessing.
Modules a e combined in o de ices,
which a e combined in o ne s, which
in u n can be s o ed oge he o
anspo a ion in ca s. I you scan such
a ca you should be able o ind all
he in o ma ion on i s con en s. Figu e
82 shows all he poin s in MedFlo’s
p ocess whe e he e is an in e ac ion
wi h he p oduc passpo , whe he i is
o ind in o ma ion, add o i , o i i is a
combina ion o bo h.
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Mas e ’s hesis - Do ien an Dolde en
5. Conclusion
igu e 88. An example o a non-s e ile module wi hin a s e ile ba ie
Th ough desk esea ch and expe in e iews guided by s o yboa ds, I i e a ed on
an ini ial se ice idea owa ds my inal design named MedFlo. I ound ha i is mo e
s aigh o wa d o edesign an endocu e o emanu ac u ing, bu ha a design o
ep ocessing would be mo e impac ul in e ms o p ese ing p oduc in eg i y and
alue. Rep ocessing he en i e de ice is p obably no possible, e en a e a d as ic
edesign, bu a modula design in which di e en modules ha e di e en planned
li e imes ce ainly is.
In e ms o ci cula business models, a esul -o ien ed model is no sui ed o medical
de ices, bu p oduc - and use-o ien ed models a e g ea op ions. A use-o ien ed model
c ea es a lo o possibili ies o handling highe le els o complexi y in ep ocessing,
epai and main enance, which makes i a ac i e o a u u e whe e de ice complexi y
will inc ease e en u he .
MedFlo is a se ice which o e s hospi als access o a comple e, clean, sa e and high-
quali y in en o y o medical de ices. A collabo a ion wi h MedFlo helps hospi als deal
wi h he inc easing complexi y o medical de ices, and allows he euse o de ices
ha a e cu en ly disposable. MedFlo is a pa ne o de ice OEMs and con inuously
pu chases spa e pa s and de ice modules. This collabo a ion allows o mo e e icien
and highe le els o epai and main enance.
The e a e, howe e , a ew ba ie s ha need o be o e come be o e a se ice model
like MedFlo is ealis ic. Fi s , SUDs need o be mo e expensi e o p oduce, sell and use
o c ea e oom o he de elopmen o (semi-) eusable de ices. This can be ealised
h ough in e en ions like EPR and ma ke isa ion ees o SUDs. Also, p oduc s need
o be edesigned o ep ocessing, and i ha is no an op ion, o modula i y. On
op o ha , OEMs need o change hei business models and mo e away om hei
dependence on SUD sales. Las ly, hospi als need o adjus hei o ganisa ion o access
models and e iew hei de ice in en o y needs.
When all hese ex e nal ac o s a e aken in o accoun he e will be space o de elop
and implemen a ci cula medical access model like MedFlo, and we will mo e a s ep
close o a sus ainable u u e o he MedTech indus y.

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Mas e ’s hesis - Do ien an Dolde en
Conclusions
PART 6
This sec ion o he epo con ains a summa y o he p ojec , an
e alua ion o he indings and he inal design. I also con ains de ailed
ecommenda ions o policymake s, OEMs and heal hca e acili ies o
ollow i hey wan o con ibu e o a sus ainable MedTech indus y.
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Mas e ’s hesis - Do ien an Dolde en
Discussion
Summa y
Resea ch p oblem Me hods
The endocu e is a su gical ool used in lapa oscopic su ge y. I
is a cos ly de ice wi h aluable ma e ials and componen s, and
un o una ely cu en ly designed o be incine a ed a e a single use.
A Ci cula edesign is challenging due o he complexi y o he de ice,
and in he heal hca e indus y pa ien sa e y and he aim o imp o ed
su ge y ou comes ha e been de main d i e s o inno a ion.
Heal hca e is a highly pollu i e indus y wi h a massi e was e oo p in ,
pa ly because o i s dependence on single-use de ices like he
endocu e . The aim o his p ojec was o look a a possible ansi ion
in he MedTech indus y, en ision wha a sus ainable u u e could look
like and explo e a possible ou e owa ds ha ision h ough a case
s udy o he single-use endocu e , i s possible ci cula eco e y lows,
and an expe imen al design p ocess.
This p ojec is loosely guided by he ansi ion managemen app oach,
which o e s me hods o in luence socie al change dynamics owa ds
sus ainabili y.
Fi s , sys em dynamics a e explo ed and he main challenge is amed
h ough a e iew o he exis ing li e a u e on he possible ci cula
eco e y lows o medical de ices, he MedTech indus y and he
ci cula economy. Once he possible CRFs we e de ined, a one-day
design sp in was execu ed pe CRF o gain a be e unde s anding o
hei indi idual oppo uni ies and ba ie s and o decide on a p e e ed
ci cula design di ec ion.
Nex , a ision o a sus ainable u u e o he MedTech indus y was
o mula ed using he VIP me hod. This ision se ed as a s a ing poin
and a delibe a e di ec ion o idea gene a ion and selec ion. The inal
se ice design ook shape h ough he use o s o yboa ds, expe
in e iews and addi ional desk esea ch.
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Mas e ’s hesis - Do ien an Dolde en
Findings
The MedTech indus y om a mul i-le el pe spec i e
The Ci cula Reco e y Flows o de ices like he enocu e
A possible sus ainable ansi ion
An inc emen al bu adical s ep in he igh di ec ion
When looking a he MedTech indus y om a mul i-le el pe spec i e,
i is clea ha he e is inc easing p essu e on he egime o become
mo e sus ainable. In e nal o ces con ibu e o he des abilisa ion o
he egime as well; he indus y’s dependence on SUDs is ex emely
was e ul and con ibu es o ising heal hca e cos s. I is ime o a
sus ainable ansi ion away om hese ha m ul p ac ices. The DiCE
p ojec is se up by egime ac o s (OEMs, uni e si ies, go e nmen s),
bu aims o c ea e a niche whe e sus ainable expe imen s ha e oom
o de elop and g ow. This p ojec is an example o such an expe imen
and could hope ully con ibu e o a sus ainable ansi ion away om
SUDs.
The di e en Ci cula eco e y Flows i o de ices like he endocu e
a e: Rep ocessing, emanu ac u ing, ecycling and bioma e ials. The
CRF o epai is no included because i is an in eg al pa o bo h
ep ocessing and emanu ac u ing p ocesses, and does no occu
isola ed in his ield. Re u bishing is also excluded because i is no i
o high-c i icali y de ices. This is due o he high sa e y s anda ds ha
need o be me be o e a de ice is allowed o be eused.
Rep ocessing is he CRF in which he highes le el o p oduc in eg i y
can be e ained. Howe e , his s a egy equi es a d as ic edesign o
he endocu e . Depending on he s e ilisa ion echniques a ailable,
di e en componen s need o be shielded agains hea and mois u e,
and he de ice needs o be designed o pa ial disassembly.
Rep ocessing also equi es complex logis ics and in as uc u e, ei he
inside he hospi al in a specialised s e ilisa ion depa men o managed
sepa a ely by an ex e nal ep ocesso . I he ep ocessing o he en i e
de ice is no possible, modula design op ions should be in es iga ed
in which di e en componen s ha e di e en planned li e imes.
Remanu ac u ing is he bes al e na i e o ep ocessing, bu he
inancial iabili y o a p ocess like his depends on in as uc u e,
he alue o p oduc pa s and he equi ed disassembly and epai
s eps be o e a de ice can be esold. In he MedTech indus y, a
emanu ac u e assumes esponsibili y o he quali y and sa e y o
he emanu ac u ed de ice. This means ha es ing and he c ea ion
o echnical documen a ion mus be aken in o accoun in he cos
o he p ocess as well. I is unlikely ha emanu ac u ing is iable o
he endocu e since i is highly complex and equi es a lo o wo k o
emanu ac u e while none o i s indi idual componen s is e y aluable.
The ecycling o ma e ials wi hin an endocu e is an op ion bu s ill
equi es he de ice o be decon amina ed a e use. This CRF does no
help e ain much p oduc in eg i y, and wi h he ex a wo k o de ice
decon amina ion and disassembly, i is unclea i a ecycling scheme
could be inancially iable. Was e handling company G eencycl is
cu en ly conduc ing a pilo o he ecycling o endocu e s in he
Ne he lands, he esul s should p o ide mo e cla i y on he easibili y
o la ge-scale ecycling.
The CRF o bioma e ials is he leas in e es ing. I is ela i ely
s aigh o wa d o include bio-based plas ics in he design o he
endocu e s since he e a e plen y o examples whe e his has been
app o ed in medical de ices. Howe e , a design choice like his has
minimal impac on he en i e oo p in o he de ice.
In conclusion, i edesigning he endocu e o ep ocessing is a
possibili y, his should be he goal. The bes al e na i e o ep ocessing
is emanu ac u ing, he o he wo CRFs a e less a ac i e. The wo main
design di ec ions ha esul ed om he ou design sp in s a e “design
o in e nal ep ocessing”, and “design o an ex e nal ep ocessing o
emanu ac u ing se ice”.
These di ec ions a e in line wi h he bes s a egies ound in he
li e a u e. Kane e al. and Guzzo e al. [11], [40] ad ise op imising highly
aluable and c i ical de ices o hygienic eco e y, and whe e necessa y
designing a ixed numbe o cycles o a hyb id con igu a ion. In e ms
o business models, hey ad ise ei he suppo ing in e nal ep ocessing
o o e ing an ex e nal ep ocessing se ice.
A possible sus ainable ansi ion is no se in s one. I equi es a
pe sonal iew o he cu en s a e o a ai s and de elopmen s in he
sys em o o mula e a ision o he u u e. I hink a sus ainable u u e
o he MedTech indus y in ol es a lo mo e ci cula design, so an
implemen a ion o (a combina ion o ) he p e iously men ioned ci cula
eco e y lows. On op o ha , I hink he sys em should mo e o a
highe le el o collabo a ion. The e should be us be ween di e en
ac o s like OEMs, go e nmen s and EoL o ganisa ions, bu a he same
ime, he e should be us in he sa e y and a ailabili y o medical
de ices.
“I wan o eshape he MedTech indus y in o a mo e ci cula sys em
based on us and collabo a ion.”
MedFlo is a se ice concep designed h ough backcas ing om my
ision o he MedTech indus y. I o e s heal hca e acili ies access o a
comple e, high-quali y, sa e and clean in en o y o medical de ices and
helps hem ackle he inc eased complexi y o (semi-) eusable de ices
and ep ocessing logis ics and in as uc u e.
MedFlo is an OEM-ce i ied ep ocesso , which allows o a high le el
o us be ween all pa ies in ol ed. The close collabo a ion be ween
MedFlo and OEMs also p o ides he se ice wi h access o necessa y
spa e pa s o imp o ed epai and main enance. The se ice wo ks
wi h a p oduc passpo sys em which acks all indi idual de ice
modules, hei planned li e imes, hei pe o med ep ocessing cycles
and equi ed consequen ac ions. This helps in e aining as much alue
as possible and in minimising he was e om medical de ices.
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Mas e ’s hesis - Do ien an Dolde en
Value o hospi als
Value in a sus ainable ansi ion
Value o OEMs
The alue o he p ojec
The alue o MedFlo
Implica ions
This p ojec shows wha a sus ainable u u e in he MedTech indus y
could look like. I helped p o ide insigh in o he di e en possibili ies
o implemen a ion o he ci cula economy on highly c i ical and
aluable de ices like he endocu e . On op o ha , he p ojec shows
how hese possible ci cula p oduc edesigns could be implemen ed
in p ac ice h ough an access model, and how a con ex can be c ea ed
whe e se ices models like his can exis .
MedFlo can help dec ease he en i onmen al and was e oo p in o
heal hca e. I p o ides he possibili y o euse (pa s o ) medical de ices
o which incine a ion is cu en ly he only EoL op ion. The complexi y
ha MedFlo can handle as well as hei pa ne ship wi h OEMs p o ides
possibili ies o ep ocessing, main enance and epai ha a e cu en ly
no a ailable o indi idual hospi als.
On op o ha , he possible euse o de ices can con ibu e o mo e
esilien supply chains as ewe aw ma e ials a e needed. When we shi
o modula i y and euse, o example a compu e chip sho age like he
one caused by Co id-19 would be less damaging o he indus y.
MedFlo could also s imula e sus ainable inno a ion. As soon as he
company g ows and s a s managing he de ice in en o y o enough
hospi als, hey p o ide a gene ous ma ke o mo e ci cula p oduc
designs. OEMs will s a o compe e o con ac s, and de ices will be
selec ed based on hei planned li ecycle and modula design.
Fo a hospi al, he implemen a ion o mo e modula medical de ices
can lead o a lo o complica ions in s e ilisa ion depa men and
ope a ing oom logis ics. MedFlo O e s o manage many o hese
complica ions ins ead and suppo s hem in a ansi ion away om
SUDs. On op o ha , MedFlo is a se ice in close collabo a ion wi h
medical de ice OEMs. Thei ac i i ies a e OEM-ce i ied, so hospi als
can us he quali y o he de ices hey ecei e.
Ou sou cing mos o he managemen o de ice in en o y, ep ocessing,
main enance and epai , also allows hospi als o ocus mo e on hei
co e business. This could especially be a ac i e o smalle heal hca e
acili ies, which may no ha e he capabili y o deal wi h he inc eased
complexi y by hemsel es. On op o ha , hospi als do no need o
in es in a la ge de ice in en o y o mode n s e ilisa ion depa men ,
hey can cu down on in en o y space, and ush deli e ies by MedFlo
a e as e han a de ice can be ep ocessed in e nally.
Depending on he speci ic egula o y changes implemen ed in he
u u e which could impac he EoL o medical de ices, OEMs could be
o ced o ake esponsibili y o he en i e li e o hei p oduc s. They
will p obably ha e no choice bu o mo e away om SUDs, and MedFlo
can help c ea e a bigge ma ke o hei ci cula ini ia i es.
A concep design can suppo a ansi ion i i challenges exis ing no ms
wi hin he egime and p o ides possibili ies o u he , pe haps mo e
adical changes. I hink ha MedFlo can do bo h. MedFlo challenges
he idea ha complex and c i ical de ices canno be ep ocessed a
all, by showing how modula designs could be implemen ed in hospi al
logis ics. I also challenges he high le el o compe i ion in he MedTech
indus y and shows how OEMs can be pa ne s o an EoL se ice
ins ead o i als. Fu he possible de elopmen s o MedFlo could
include in e na ional expansion, which is cu en ly no possible because
o igh in ec ious anspo a ion egula ions. Ano he possibili y is he
inclusion o he CRF o emanu ac u ing in he se ice o modules a
he end o hei planned li e ime. This would help o p ese e an e en
highe le el o p oduc in eg i y.
T
a
n
s
i
i
o
n
i
m
e
l
i
n
e
The p esen
En isioned
u u e
MedFLo
Also, unlike exis ing medical emanu ac u ing companies, MedFlo is a
pa ne ins ead o a compe i o . A con ac wi h MedFlo means ha an
OEM can con inuously sell new modules and spa e pa s o he se ice
on op o he ini ial sales o (semi-) eusable de ices, o he supply o
many hospi als a once.
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Mas e ’s hesis - Do ien an Dolde en
Limi a ions
P ojec Concep Design
The main limi a ion o his p ojec is i s scope. This is a g adua ion
p ojec spanning 20 weeks, wi h he aim o i s unde s and and
hen sol e a massi e sys emic p oblem. Socie al ansi ions can ake
gene a ions and equi e e o s om ons o di e en ac o s in di e en
sec o s. One mas e ’s hesis is like a d op in he ocean, i can only
con ibu e so much. The ansi ion managemen me hod helps, bu
is a deeply collabo a i e p ocess in ended o be ollowed by a la ge
ansi ion eam. I used his app oach as a guide, bu i is no he mos
applicable o sho , indi idual p ojec s like his one. S ill, i p o ided a
g ea p ojec amewo k, e en i he p ojec was oo small o con ibu e
o a sus ainable ansi ion.
Also, one-day design sp in s can only gi e you so much insigh in o
he comple e pic u e o a ci cula eco e y low. The esul s om hese
sp in s a e inconclusi e, and canno be used o exclude a CRF, o
de ini i ely pick one o e he o he s. This would equi e mo e insigh
in o he possibili ies o endocu e edesigns, as well as he execu ion
o de ailed LCAs, o compa e di e en solu ions.
I is no possible o conclusi ely answe he esea ch ques ions wi hin
he a ailable ime ame, bu I ha e me he main goal o his p ojec ;
o explo e ci cula possibili ies and de ine a sus ainable u u e o wo k
owa ds. This design explo a ion can be de ailed u he and i e a ed
upon in u u e p ojec s, and hope ully inspi es o he s o wo k owa ds a
sus ainable MedTech indus y.
MedFlo is a his poin e y concep ual and needs a lo mo e esea ch
and de ailing be o e i s eal impac can be de e mined. I am no expe
in he design o a business case, dealing wi h egula ions, o planning
ou logis ics. MedFlo needs inpu om p o essionals in hese ields o
de e mine i s easibili y. On op o ha , an LCA needs o be conduc ed
o de e mine i MedFlo ac ually lowe s he en i onmen al and was e
oo p in s, as well as he cos s, o medical de ices compa ed o hose
wi h a linea model.
The e a e also a lo o con ex ual ac o s ha need o be aken in o
accoun . MedFlo’s success depends on al e a ions in egula ion, OEM
business models and alue chains, p oduc designs and hospi al
o ganisa ion. I also needs o each a ce ain scale o be iable. You
need enough hospi als o collabo a e o be able o a o d he necessa y
acili ies and de ice s ock, and enough pa ne ing OEMs o p o ide
a wide enough ange o medical de ices. The se up o MedFlo will
equi e a la ge e o om a a ie y o s akeholde s.

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Mas e ’s hesis - Do ien an Dolde en
Recommenda ions
Implemen a ion o indings
Policymake s
Med ech
Heal hca e acili ies
Summa y o necessa y ac ions
To make MedFlo ealis ic, he ba ie s o i s implemen a ion explained
in pa 5 chap e 4 need o be o e come.
Policymake s need o incen i ise he ci cula design o medical de ices
o he collabo a ion be ween OEMs and EoL se ices like MedFlo. They
need o look in o ex ended p oduce esponsibili y o medical de ices,
ees o he ma ke isa ion o single-use de ices, and o he ways o
inancially le el he playing ield be ween SUDs and (semi-) eusables. I
needs o become mo e expensi e o p oduce, sell, use and dispose o
single-use de ices. On he o he side, he app o al o eusable de ices
could become mo e s eamlined o subsidised. The igh egula ions
could become an impo an d i e o sus ainable design ini ia i es.
The MedTech indus y should aim o become mo e collabo a i e
and collec i ely wo k owa ds a sus ainable u u e. OEMs should aim
o join o ces wi h each o he and wi h EoL o ganisa ions, ins ead o
compe ing wi h hem. This could s eamline ci cula ini ia i es and
allow p oduc s o be designed wi h hei end-o -li e in mind.
I OEMs wan hei de ices o be a pa o MedFlo’s se ice o e o
hospi als, hey need o look in o he possibili y o sha ing ce ain
p oduc de ails and spa e pa s wi h he se ice. This allows o highe
le el and mo e e icien epai and main enance o de ices and helps
p ese e alue. They also need o adjus hei business models. They
could mo e o sell p oduc modules ins ead o comple e p oduc s, and
p ices need o be adjus ed o longe li e imes.
Hospi als need o e-e alua e hei equi ed de ice in en o y. Do hey
need he same numbe and a ie y o de ices when collabo a ing
wi h MedFlo as hey would when managing hei own s e ilisa ion
depa men ? They also need o look a hei side o he logis ics, o
example, wha kind o ou e should con amina ed de ices ollow inside
he hospi al? Is he e a designa ed con amina ed ele a o down, as
he e would be in case o an in e nal s e ilisa ion depa men ? Las ly,
hey will no ha e access o he same a ie y o de ices hey would
ha e when managing hei own in en o y. They will ha e o implemen
s anda dised su gical ne s o di e en p ocedu es i hey ha e no
done so al eady.
They also need o in es in ci cula edesigns o single-use de ices.
De ices should be designed o ep ocessing i possible, and o he wise,
hey should be sepa a ed in o modules wi h di e en planned bu
indi idually maximised li e imes. These modules need o be easy
o connec and disconnec in o de o s eamline logis ics a ound
ep ocessing. Ba e ies o powe ed de ices should be echa geable
and p e e ably s anda dised.
igu e 89. A summa y o he needed ac ions o key s akeholde s
Ac o
Policymake s
OEMs
Heal hca e
acili ies
Ac ion
Incen i ise ci cula design and place
( inancial) es ic ions on SUDs
Collabo a e wi h each o he and EoL
o ganisa ions – become open o sha ing
ce ain p oduc de ails
Adjus business models and alue chains
o module con ac s ins ead o SUD sales
Redesign SUDs o ci cula i y -
i no ep ocessing, hen modula i y
Re-e alua e in en o y managemen and
logis ics o he implemen a ion o an
access model
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Mas e ’s hesis - Do ien an Dolde en
Sugges ions o u he esea ch
P oduc design
Concep design
Policy
T us
The edesign o he endocu e o compa ibili y wi h a se ice like
MedFlo will equi e a lo o wo k. The e needs o be in es iga ed which
componen s can be g ouped oge he in a module, wha he ideal
planned li e ime o each module is, and how all he modules will be
connec ed. A he same ime, he modules i o s e ilisa ion should
be designed o wi hs and he chosen s e ilisa ion me hod, wi hou
hinde ing he useabili y o he de ice as a whole in e ms o weigh ,
size and con ols.
The concep o MedFlo needs a lo o de ailing. In e ms o logis ics,
he e needs o be an in es iga ion in o which ules o in ec ious
anspo apply he e, wha ou e ucks ollow o hospi als, and i
deli e ies o di e en hospi als can be combined in a single uck. I
would also ad ise eaching ou o ci cula ise, he company specialising
in blockchain p oduc passpo s o a ci cula economy. They a e
g owing quickly a he ime o w i ing his hesis and did no ha e he
capaci y o ex e nal esea ch in e iews, bu hey could ha e g ea
insigh in o how p oduc modules can be acked h oughou hei
li e imes.
One key unknown in he cu en e sion o he concep is he business
model. The e needs o be a ho ough in es iga ion in o he iabili y
o he concep , he scale necessa y o make i ealis ic, he necessa y
in es men s, and MedFlo’s cos s uc u es and e enue s eams. Does
a con ac wi h MedFlo p o ide enough incen i e o OEMs o design
hei p oduc s o as many cycles as possible? Can MedFlo a o o
selec p oduc s acco ding o hei planned li e o do hey need o ake
o he ac o s in o accoun as well?
Finally, he e needs o be an e alua ion o which p oduc s could be
included in his se ice, as well as which s e ilisa ion me hods should
be a ailable in MedFlo’s acili ies.
In e ms o policy, he e needs o be an in es iga ion in o he bes ways
o incen i ise a mo e ci cula design o medical de ices. Wha needs o
change in he app o al p ocess o medical de ices o make SUDs less
a ac i e compa ed o eusables? Would collec i e o indi idual EPR
be mo e sui able o he MedTech indus y? And which (combina ion
o ) EPR ins umen s could help in a sus ainable ansi ion?
Also, MedFlo’s epai and main enance could be mo e ho ough
compa ed o exis ing ac i i ies implemen ed in in e nal ep ocessing
sys ems. When does epai become so d as ic ha i s a s o en e he
ield o emanu ac u ing? Because di e en egula ions apply o hese
wo CRFs, he e needs o be in es iga ed whe e we d aw he line, and
how his line in luences MedFlo’s epai and main enance capabili ies.
Finally, since he p oduc s will be subdi ided in o di e en modules,
would i be possible o classi y each module sepa a ely acco ding o
he medical de ice egula ions? I each module we e o ha e di e en
equi emen s o disin ec ion and s e ilisa ion acco ding o hei
espec i e le el o pa ien con ac , his could educe he ene gy and
ma e ial inpu in he sys em e en u he . Do we need o ea an en i e
de ice as highly c i ical when only a small piece en e s he body?
The one ad ice om he li e a u e ha was no co e ed in he inal
concep , was he sugges ion by Kane e al. [11] o design o us in
eusables. An in es iga ion on he cu en s a e o us in eusables
would be e y aluable. This kind o esea ch should look in o wha
makes people eel a sense o dis us in eusables, which pa o
he ep ocessing p ocess hey us he leas , i i impac s he ype
o medical de ices hey choose, and how us in eusables can be
imp o ed.
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Mas e ’s hesis - Do ien an Dolde en
Conclusion
This hesis explo ed how he ci cula economy could be implemen ed
in complex, c i ical, cos ly and cu en ly single-use su gical de ices
like he endocu e . The bes ci cula eco e y low o hese de ices
appea s o be he CRF o ep ocessing, bu modula solu ions should
be implemen ed whe e he ep ocessing o he en i e de ice is no
possible. Concep ual se ice design “MedFlo” helps heal hca e
acili ies o e come ba ie s in he implemen a ion o modula de ices
in o hei wo k low and logis ics, by p o iding access o a sa e and
comple e in en o y o de ices.
The p ojec ollowed a ansi ion managemen app oach. Fi s , he
socio- echnical sys em, he ba ie s o ci cula design and possible
ci cula eco e y lows we e explo ed h ough a li e a u e e iew and
mul iple design sp in s. Nex , a ision was c ea ed o a sus ainable
u u e o he MedTech indus y, and inally, h ough backcas ing om
his ision, a concep ual se ice was designed. This design is a big s ep
owa ds a sus ainable u u e, bu s ill ac ionable and wi hin each.
MedFlo can help dec ease he en i onmen al and was e oo p in o
medical de ices, c ea e mo e esilien supply chains and s imula e
ci cula design ini ia i es. Howe e , i will equi e e o om mul iple
di e en key ac o s o shape he con ex in a ou o such a design.
Policy needs o incen i ise ci cula ini ia i es and discou age he
p oduc ion, sales and use o SUDs, OEMs need o al e hei business
models and in es in ci cula p oduc designs, and hospi als need
o adjus hei logis ics o he implemen a ion o an access model.
Hope ully, MedFlo can se e as an example o he implemen a ion o
he ci cula economy on highly aluable and c i ical medical de ices,
and be an inspi a ion o u u e p ojec s.
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Mas e ’s hesis - Do ien an Dolde en
Pe sonal e lec ion
As I men ioned in he p e ace o his epo , he cons ain s and complica ions o ci cula
ini ia i es ha exis in he heal hca e sec o in igue me and a e a sou ce o g ea design
challenges. In his ega d, his p ojec has eally me my expec a ions. I is easy o ge
los in all he ules, cons ain s and easons o why a ci cula solu ion is impossible, no
easible, unsa e o oo expensi e, bu whene e I ound a small oppo uni y h ough all
he ba ie s, i was ex a ewa ding and eally pushed me o in es iga e u he .
This p ojec s a ed as an analysis and edesign o a single p oduc , bu i g ew ou o
be a sys em analysis and edesign ins ead. I’ e no iced ha a sys emic app oach eally
sui s me, way mo e han de ailed p oduc design, so I am happy wi h his de elopmen
and he esul s. This app oach also allowed me o implemen insigh s and expe iences
I gained on my E asmus+ exchange o Copenhagen, and helped me o combine some
e y di e en elemen s o my educa ion.
I some imes s uggled wi h he balance be ween adicali y and easibili y when making
design choices. I could be a bi hesi an o y new hings, especially when someone
had al eady explained all he possible nega i e implica ions his new hing migh ha e.
Following wha is known migh make a design ealis ic, bu a he same ime i leads
o a educ ion o i s po en ial posi i e impac . This p ojec augh me o s ep ou side
o my com o zone, and some imes make choices ha someone else migh no ag ee
wi h.
I also no iced ha I could easily ge los in esea ch. I eally enjoy he p ocess o inding
and eading he igh pape s, alking o expe s and in e p e ing new in o ma ion, bu
i also dis ac s om he design challenge a hand. I ha e lea ned ha he e is such
a hing as oo much esea ch, and his p ojec has augh me when i is ime o s a
making choices and ac ually s a designing. The same can be said abou my s yle o
w i ing. I p e e o explain e e y hing I do and include e e y single conside a ion in a
design p ocess. Un o una ely, his has esul ed in a e y leng hy g adua ion epo . In
he u u e I wan o lea n o ge mo e o he poin , and be ca e ul o be awa e o he
p io i ies in my s o y.
O e all I am p oud o he wo k I ha e done and he inal concep I ha e p esen ed.
I hink I ha e g own as a esea che and a designe o e he pas mon hs, and I am
looking o wa d o my nex big challenge.
Do ien an Dolde en
s uden numbe : 4541294
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