Medical device regulation and its impact on the industry: A case study of Czech companies

Business Adminis a ion and Managemen 32 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 Medical de ice egula ion and i s impac on he indus y: A case s udy o Czech companies Jan Maci1, Ma in Ma ejicek2, Lukas Pe e 3, F ank Le ley4, Pe a Ma eso a5 1 Uni e si y o H adec K alo e, Facul y o In o ma ics and Managemen , Depa men o Economics, Czech Republic, ORCID: 0000-0002-6315-7991, [email p o ec ed]; 2 Uni e si y o H adec K alo e, Facul y o In o ma ics and Managemen , Depa men o Economics, Czech Republic, ORCID: 0000-0002-8548-3114, [email p o ec ed]; 3 Uni e si y o H adec K alo e, Facul y o In o ma ics and Managemen , Depa men o Economics, Czech Republic, ORCID: 0000-0003-4351-8291, [email p o ec ed]; 4 Uni e si y o H adec K alo e, Facul y o In o ma ics and Managemen , Depa men o Economics, Czech Republic, ORCID: 0000-0001-8367-7102, [email p o ec ed]; 5 Uni e si y o H adec K alo e, Facul y o In o ma ics and Managemen , Depa men o Economics, Czech Republic, ORCID: 0000-0002-1218-501X, [email p o ec ed]. Abs ac : The implemen a ion o egula ions is o en seen as a necessa y ool o mi iga e ma ke ailu es and sa egua d consume in e es s. The Medical De ice Regula ion (MDR) is a ecen egula ion speci ically designed o he p oduc ion o medical de ices, aiming o ensu e hei sa e y and e ec i eness. This a icle ocuses on Czech companies and seeks o examine and quan i y he e ec s o he MDR on hei ope a ions, conside ing bo h economic and p ocedu al impac s. Th ough he analysis o p ima y and seconda y da a, his s udy endea o s o shed ligh on he epe cussions o he MDR on he companies in ques ion. The indings sugges ha he MDR will ha e a nega i e impac on he p o i abili y o hese companies, consequen ly in luencing hei ope a ional s a egies. One key ac o con ibu ing o his nega i e ou come is he inabili y o he companies o ans e he inc eased cos s esul ing om egula o y equi emen s o hei cus ome s. As a esul , a ec ed companies a e o ced o make adjus men s o hei p oduc po olios, educing hei ange o o e ings. The esea ch e eals ha he pe cep ion o he MDR among he companies is p edominan ly nega i e. This nega i e sen imen a ises p ima ily due o he inancial bu dens imposed by he egula ion and he o he associa ed impac s discussed in he a icle. Fu he mo e, he MDR is no pe cei ed as a ca alys o inno a ion wi hin he indus y. By quan i ying he e ec s o he MDR on Czech companies, his a icle p o ides aluable insigh s in o he eal-wo ld implica ions o his egula o y amewo k. The indings highligh he challenges aced by companies in adap ing o and complying wi h he MDR, pa icula ly in e ms o i s impac on p o i abili y and p oduc o e ings. This esea ch se es as a eminde o he complex in e play be ween egula ions, economic ou comes, and indus y dynamics. Ul ima ely, i emphasizes he impo ance o conside ing he po en ial ami ica ions o egula ions and hei e ec s on businesses and ma ke s. Keywo ds: Medical de ice egula ion, egula ion, economic impac , inno a ion, p oduc po olio. JEL Classi ica ion: K23. APA S yle Ci a ion: Maci, J., Ma ejicek, M., Pe e , L., Le ley, F., & Ma eso a, P. (2024). Medical de ice egula ion and i s impac on he indus y: A case s udy o Czech companies. E&M Economics and Managemen , 27(2), 32–49. h ps://doi.o g/10.15240/ ul/001/2024-2-003 Business Adminis a ion and Managemen 33 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 In oduc ion Regula ion is used o co ec ma ke ailu e, p o ec consume s, and imp o e he business en i onmen . I has bo h posi i e (e.g., g ea e consume sa e y) and nega i e (e.g., inc eased cos s o companies) impac s and can also d i e inno a ion (Blind, 2016). F om a b oade pe spec i e, he e ec s o egula ions can be moni o ed by a ious indica o s (Baya & Diaconu Maxim, 2020; B oughel & Hahn, 2022; Raza i e al., 2017). Ac- co ding o Maci and Ma eso a (2022), cos s a e he mos commonly conside ed a iable when e alua ing he impac o egula ions om an in- di idual mic oeconomic poin o iew. Tu (2020) no es ha legisla i e changes can inc ease cos s o businesses in he medical de ice sec- o , leading o a nega i e ela ionship be ween egula o y bu den and p oduc i i y. Speci ically, a 1% inc ease in cos in ensi y educes labo p oduc i i y by 0.1%. Tu (2020) also ound ha compliance cos s a e lowe o la ge companies wi h highe e enue. Ma kiewicz e al. (2017) o e a de ailed insigh in o he hough p ocess o manu ac u e s when de eloping a medical de- ice, speci ically in he ea ly assessmen s age, h ough esul s de i ed om semi-s uc u ed in e iews. Awa e o his p oblem, go e nmen s a ound he wo ld a e coming up wi h new egula ions ha should ideally educe he social as well as medical cos incu ed o medical inno a ion (Konishi e al., 2018) and he eby enhance he chance o he eme gence o such inno a ions ha will inc ease he desi able eel- ing o sa is ied heal h ca e needs o he popula- ion (An ošo á e al., 2022). The complexi y o egula o y changes is e iden in he Eu opean medical de ice ma ke , including he Czech Republic. Regu- la ion 2017/745 EU (MDR), e ec i e since May 26, 2021, aims o enhance consume sa e- y and heal h p o ec ion. Howe e , i poses chal- lenges, pa icula ly o small and medium-sized companies. The new MDR imposes s ic e equi emen s han he p e ious Medical De ice Di ec i e (MDD), such as mo e p ecise equi e- men s o clinical sa e y e alua ion. Assessing clinical sa e y based on simila i y o exis ing p oduc s is now mo e challenging; he manu- ac u e will now need access o he compe ing p oduc ’s echnical documen a ion. Pos -ma ke moni o ing and clinical da a collec ion a e also mo e de ined. Highe equi emen s usually en- ail highe cos s o inno a ion, p oduc launch, dis ibu ion, sale, and se ice o medical de ices. Such an assump ion in he o m o in- c eased cos s o MDR in he case o so wa e was also exp essed by Becke e al. (2019). In esponse o he implemen a ion o he Eu- opean Union’s Medical De ice Regula ion (MDR), se e al academic au ho s ha e al eady add essed a ious aspec s and b oad impac s o his legisla ion. Wilkinson and Van Box el (2020) discuss he new app oach o he clini- cal e alua ion o medical de ices in he EU, emphasizing he addi ion o in ended clinical bene i s o adi ional sa e y and pe o mance conside a ions. Niemiec (2022) exp esses conce ns ega ding he pe o mance o medical a i icial in elligence de ices and examines how he MDR, wi h i s s ingen sa e y and quali y s anda ds, aims o imp o e hei sa e y and pe - o mance. Bianchini and Maye (2022) highligh he necessi y o unde s anding he key aspec s o MDR, unde lining i s implica ions o he en- i e li ecycle o medical de ices and i s po en ial o enhance he e iciency o he inno a ion p ocess. Ca l and Hochmann (2023) p esen a wo-yea compa a i e s udy assessing he im- pac o he MDR on he o hopedic aids indus y, ocusing on challenges aced by companies, such as inc eased wo kload, esou ce expen- di u e, and downsizing o p oduc po olios. Collec i ely, hese s udies unde sco e he mul- i ace ed impac s o he MDR on he medical de ice indus y, anging om clinical e alua- ion o ma ke inno a ion, and he o e a ching necessi y o companies o s a egically adap o hese egula o y changes. Jus like he abo e, his a icle also seeks o p o ide a pe spec i e on he impac s o MDR. I speci ically ocuses on he impac on busi- nesses om he poin o iew o hei economy and managemen . In e ospec , we can ob- se e and e alua e whe he his egula ion, among o he impac s, can be classi ied as one ha has become a ca alys o u he g ow h and de elopmen o companies and hei inno- a ion o whe he he opposi e is he case. This is whe e we see he cu en gap in p ac ical, bu also heo e ical, obse a ion-suppo ed knowl- edge abou he e ec s o egula ion on p ocess and inancial managemen , as well as he inno- a i e ac i i y o companies in he sec o . The e o e, his pape aims o e alua e he impac o newly e ec i e egula ions on he medical de ice indus y in he Czech Republic. Da a om a ques ionnai e su ey Business Adminis a ion and Managemen 34 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 and economic indica o s o su eyed com- panies, along wi h o he common indica o s, such as de ice classi ica ion, a e analyzed. Howe e , i should be no ed ha he ull im- pac o he egula ion is no ye known due o ongoing adap a ion and po en ial e ec s o he COVID-19 pandemic. In keeping wi h he aim o he pape , he ol- lowing esea ch ques ions ha e been se . RQ1: Does he company size a ec he po- en ial o pe cei ed impac s o MDR? RQ2: Do economic condi ions o he com- pany, such as business pe o mance o inan- cial heal h, in luence he adap a ion o ac i i ies o comply wi h MDR, as well as he pe cep ion o MDR as such? RQ3: A e he e ec s o MDR e lec ed in he p oduc po olio o he company? RQ4: Can sa is ac ion wi h he o m o MDR be an inno a ion d i e o medical de ice de elopmen ? The s udy is di ided in o ou hema ic a eas, each ocusing on a ious aspec s o MDR. The i s a ea, explo ed h ough RQ1, examines how MDR a ec s companies o di e se sizes. The aim is o de e mine i MDR ha ms some companies due o limi ed esou ces while o h- e s ha e an easie ime wi h he egula ion due o mo e esou ces. The second a ea, co e ed by RQ2, ocuses on he economic impac o MDR on businesses. The esea ch a ea aims o de e - mine how companies adap o he economic im- pac o MDR, including shi ing inc eased cos s on o cus ome s o adjus ing p oduc po olios, while also examining he impac o hese chang- es on inno a ion ac i i y. The hi d a ea (RQ3) o e laps wi h he second bu ocuses mo e on he p ocesses in ol ed in changes o p oduc po olios and inno a ion ac i i y. The aim is o iden i y how businesses adap o MDR and e eal any ad e se e ec s on p oduc g oups. Finally, RQ4 examines o e all sa is ac ion wi h MDR in ela ion o he inno a i e ac i i y o he company. The aim is o de e mine i busi- nesses pe cei e MDR as a new challenge p o- iding new business oppo uni ies. The pu pose o he esea ch p esen ed in his pape is o iden i y hose impac s o MDR ha a e al eady appa en in o de o d aw a - en ion o any possible o e egula ion and s a a discussion on any possible MDR adjus men s ha migh be needed o easy, e icien , bu sa e p ac ice in he medical de ice indus y. 1. Speci icso  hemedicalde ice ma ke – Eu opean Union and he Czech Republic The MDR is a Eu opean egula ion a ec ing he en i e EU ma ke , o which he Czech Repub- lic is a pa . Fo his eason, we p esen selec ed cha ac e is ics o he medical de ice ma ke in he EU as a whole and in he Czech Republic, which is he coun y whe e he ques ionnai e su ey was conduc ed. Bo h hese economic a eas a e cha ac e ised below in e ms o inno- a ions (pa en s), employmen , companies, ex- pendi u es, MedTech ma ke olume, and ade. 1.1 Medical de ice ma ke in he EU In 2020, app oxima ely 33,000 medical echnol- ogy companies we e ope a ing in Eu ope, wi h Ge many ha ing he mos signi ican numbe , ollowed by I aly, G ea B i ain, F ance, and Swi ze land. Small and medium-sized en e - p ises (SMEs) comp ise a ound 95% o he in- dus y, wi h he majo i y employing ewe han 50 people (Med ech Eu ope, 2021). Heal h- ca e spending in Eu ope is es ima ed o be 11% o GDP, wi h less han 1% o his spen on medical echnologies. The Eu opean ma ke o medical de ices and in i o diagnos ics is es ima ed o be a ound EUR 140 billion, wi h Ge many, F ance, he Uni ed Kingdom, Spain, and I aly ha ing he la ges ma ke s (Med ech Eu ope, 2020). Eu ope has a posi i e medical de ice ade balance o EUR 8.7 billion (2020), wi h he US, China, Mexico, and Japan being Eu ope’s main ading pa ne s o medical de- ices. The medical echnology indus y in es s hea ily in esea ch and de elopmen , wi h an a e age global R&D in es men a e es i- ma ed a a ound 8% (E alua e, 2018). The in- dus y iled o e 14,200 pa en applica ions wi h he Eu opean Pa en O ice in 2020, wi h medical echnology ep esen ing 8% o he o- al numbe o applica ions (Eu opean Pa en O - ice, 2021; Med ech Eu ope, 2021). The medical echnology indus y in Eu ope employs a ound 760,000 people, wi h Ge many ha ing he la g- es sha e (Med ech Eu ope, 2021). 1.2 Medical de ice ma ke in he Czech Republic Un o una ely, agg ega e da a o his indus- y is no publicly a ailable. Thus, se e al sou ces o in o ma ion we e used o summa ise he Czech en i onmen . Speci ically, we used da a om The Associa ion o Manu ac u e s Business Adminis a ion and Managemen 35 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 and Supplie s o Medical De ices (AVDZP), he Regis e o Medical De ices (RZPRO), i- nancial indica o s om he Albe ina da abase, and he Pa en Inspi a ion web applica ion. Acco ding o da a om Pa en inspi a ion. com (2021), membe s o he AVDZP had 448 ac i e pa en s in he medical de ice sec o as o No embe 30, 2020. As o employmen , he medical de ice indus y in he coun y em- ployed o e 10,266 people as o he same da e, wi h la ge en e p ises employing 7,370 people, almos 72% o he o al. The e we e 105 membe companies in he AVDZP, wi h small en e p ises being he mos nume ous (41.8%). The Czech ma ke segmen o medical de ices and in i o diagnos ics was es ima ed a USD 1.48 billion in 2016 by Eme go (2022), which was ela i ely small compa ed o o he Eu opean ma ke s. In e ms o ma ke alue pe capi a, he alue in he Czech Republic was USD 140, while i is USD 315.7 in Ge many, USD 205 in F ance, and USD 160 in G ea B i ain. The Czech Re- public had a sligh ly nega i e medical de ice ade balance o EUR 1 million in 2020, wi h expo s eaching a alue o EUR 1.194 million and impo s amoun ing o EUR 1.195 million (Med ech Eu ope, 2021). 2. Resea ch me hodology This pa o he a icle desc ibes he me hodo- logy used o he esea ch. The s udy’s design, da a collec ion h ough a ques ionnai e su ey and da a p ocessing a e desc ibed. Fu he - mo e, esea ch limi a ions ha we a e awa e o a e men ioned. 2.1 Design o he s udy As s a ed in he In oduc ion, his pape aims o e alua e he impac o newly e ec i e egula- ion on he medical de ice indus y in he Czech Republic using selec ed, p ima ily economic, and ope a ional indica o s. Da a om he Albe ina da abase we e used o his s udy, plus a ques ionnai e su ey was conduc ed among companies (na u al pe - sons and legal en i ies) egis e ed as impo e s, dis ibu o s, o manu ac u e s o gene al medi- cal de ices in he Czech Republic. Companies egis e ed wi h con ac de ails in he da abases o he AVDZP and he S a e Ins i u e o D ug Con ol se ed as he ini ial sample (N = 3,053). Due o budge cons ain s, we aimed o col- lec 100 comple ed ques ionnai es, esul ing in a sample se o 100 (n = 100). A new subjec was andomly selec ed i any ques ionnai es we e iden i ied as inco ec ly illed in. A o al o 139 comple ed ques ionnai es we e an- domly selec ed om he ini ial sample om Augus o Oc obe 2021. A e excluding o y ques ionnai es o a ious easons, such as in- comple e o inco ec esponses, oo young en i- ies ( oun ded wi hin he las wo yea s), en i ies p o ducing only one medical de ice, o en i ies no obliga ed o no i y p oduc s o isk class I in he RZPRO da abase, he inal esea ch sample consis ed o nine y-nine business en i ies. The ques ionnai e was designed based on es ablished esea ch ques ions s a ed in he in oduc ion o his pape . Like o he p ojec s using a ques ionnai e o da a col- lec ion, we ca e ully conside ed he numbe and sensi i i y o ques ions ega ding com- pany in o ma ion. The esea ch ques ions a e now elabo a ed in o he hypo heses below. Q in pa en heses deno es ques ionnai e ques- ion numbe . Va iable in ela ionship depends on seconda y da a. The ques ionnai e is in- cluded as an Appendix. H1: The e ec s o egula ion in e ms o he p oduc po olio, inno a ion ac i i ies, and managemen do no depend on he size o he company (Q11 s. size; Q13 s. size; Q17 and Q18 s. size). H2: The capabili y o ans e he e ec s o MDR in he o m o inc eased cos s on cus- ome s does no depend on he size o he com- pany (Q20 s. size). H3: The sa is ac ion o companies wi h he o m o MDR does no depend on he size o he company (Q27 s. size). H4: The expec ed impac on p o i does no depend on he expec ed impac on cos s (Q17 s. Q18 – e i ies ma ch wi h Q20 s. size). H5: The expec ed impac on p o i does no depend on he capabili y o shi ing egula o y cos s on cus ome s (Q18 s. Q20). H6: P oduc po olio change does no depend on he pe cep ion o he impac on he economic pe o mance (cos s, p o i ) (Q11 s. Q17 o Q11 s. Q18). H7: The decision o s op manu ac u ing a p oduc does no depend on he 3-yea end o ope a ing esul s (Q11 s. p o i end). H8: The decision o s op manu ac u ing a p oduc does no depend on he 3-yea end o deb (Q11 s. deb end). H9: The ex en o he pe cei ed impac o MDR on he company’s cos s does no Business Adminis a ion and Managemen 36 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 depend on he ex en o he company’s linea end line o deb . H10: The numbe o medical de ices ha a e subjec o con o mi y assessmen o ha al eady ha e o mee he equi emen s o MDR o o which he company pa icipa es in clinical e alua ion does no depend on he expec ed im- pac on he company’s cos s o p o i (Q5 o Q7 o Q9 s. Q17 o Q18). H11: The pe cep ion o MDR as an impe- us o inno a i e ac i i y does no depend on he expec ed economic impac s (cos s, p o i ) (Q17 o Q18 s. Q13) H12: The company’s sa is ac ion wi h he o m o MDR does no depend on he pe cei ed impac s on cos o p o i (Q27 s. Q17 o Q18). H13: P oduc po olio change does no de- pend on he pe cep ion o MDR as an impe us o inno a ion (Q11 s. Q13). H14: P oduc po olio change does no depend on he pe cei ed sa is ac ion wi h MDR (Q11 s. Q27). H15: The impac o he egula ion in e ms o he p oduc po olio does no depend on he numbe o medical de ices ha a e subjec o con o mi y assessmen o al eady ha e o mee he equi emen s o he MDR o o which he company pa icipa es in clinical e alua ion (Q11 s. Q5, Q7, Q9). H16: The company’s sa is ac ion wi h he o m o MDR does no depend on i s pe - cep ion o MDR as an impe us o inno a ion (Q13 s. Q27). As can be seen om he hypo heses, he ques ionnai e ocused on ques ions con- ce ning he p oduc ion i sel (numbe and s uc- u e o p oduc s) and economic and inancial ma e s and impac s. In e ms o he economic p ocess, we we e also in e es ed in he impac o MDR on inno a ion ac i i y. Some hypo heses we ha e es ablished es ed he independence o p ima y da a om ques ionnai e su eys and seconda y eco- nomic da a om he Albe ina da abase o 2018–2020, be o e he in oduc ion o MDR. We conside ed a h ee-yea pe iod o elimina e he subjec i e pe cep ion o he si ua ion due o he impending e ec i e da e o MDR. Due o he a ailabili y o economic da a only o en i- ies obliga ed o publish inancial s a emen s unde Czech legisla ion, he esea ch sample was na owed down om nine y-nine subjec s o o y- wo subjec s wi h “ inancial s a emen s in ull” a ailable, pe Czech accoun ing legisla- ion equi emen s. These inancial s a emen s in ull include balance shee and income s a e- men s (i.e., s uc u ed da a on asse s, owne ’s equi y, liabili ies, e enues, expenses/cos s, and p o i /loss). 2.2 Da a collec ion – ques ionnai e su ey A pilo e i ica ion o he unc ionali y o he ques ionnai e p eceded he su ey i sel . In coope a ion wi h AVDZP, eigh een comple- ed ques ionnai es we e ob ained as pa o he p elimina y esea ch. The collec ed su - eys con ibu ed eedback on he basis o which he ques ionnai e unde wen mino modi ica- ions wi h he aim o inc easing i s e u n h ough comp ehensibili y and con enience o illing and, abo e all, i s usabili y o he subsequen da a analysis. Changes o he ques ionnai e did no hinde he applicabili y o he com- ple ed ques ionnai es o he o e all e alua ion, and hese ques ionnai es we e also used in he o e all assessmen . Conside ing he esea ch objec i e, he ques ionnai e was di ided in o he ollowing hema ic a eas:  The company’s basic cha ac e is ics and p oduc po olio;  The company’s pe cep ion o he e ec s o egula ion on he in e nal ope a ion o he company (po olio, pe sonnel, inan- cial esou ces, and managemen );  The company’s pe o mance based on eco- nomic indica o s;  The company’s pe cep ion o he impac o egula ion on he gene al de elopmen o he ma ke o medical de ices;  Du ing da a collec ion, we aimed p ima - ily a CEOs and CFOs o p e en po en ial esea ch limi ing ac o s such as espon- den s wi h limi ed knowledge o he com- pany’s p ocesses. 2.3 S a is ical p ocessing In he Resul s sec ion o his pape , desc ip- i e cha ac e is ics a e p esen ed, including absolu e and ela i e equencies, measu es o loca ion (e.g., a i hme ic mean, median), and a iabili y (s anda d de ia ion). The es ed hypo heses we e p e iously p esen ed in he s udy design sec ion. Gi en he ca ego ical o o dinal na u e o he da a, he non-pa ame ic Spea man’s ho co ela ion Business Adminis a ion and Managemen 37 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 coe icien was calcula ed o e i y he (in)de- pendence o ela ionships be ween a iables, conside ing he impo ance o hei o de o e hei alues. IBM SPSS S a is ics 28 p og am was used o calcula ions. 3. Resul s This chap e i s p esen s he basic business cha ac e is ics o he esea ch sample. These cha ac e is ics a ec ed da a a ailabili y and collec ion (business legal o m). P oduc po - olios a e hen discussed. A quan i a i e e alua- ion o he ques ionnai e is p esen ed, ollowed by economic indica o s o su eyed compa- nies. The chap e concludes wi h an analysis o he ela ionships be ween ques ionnai e da a and inancial/economic da a. 3.1 Cha ac e is ics o he esea ch sample As s a ed in he p e ious chap e , 139 e- sponses we e ini ially ob ained h ough he ques ionnai e su ey. A e excluding o y ques ionnai es ( o exclusion c i e ia, see chap- e 2.1), he sample was educed o nine y-nine esponses om business en i ies ope a ing in he medical de ice sec o . The ollowing pa a- g aphs p esen cha ac e is ics ha end o sig- ni ican ly in luence he esul s o ques ionnai e su eys in en e p ises, such as he business’s legal o m, he business, he business’s size, and he p oduc po olio’s s uc u e. The legal o m o business Rega ding he legal o m o businesses, wo esponden s a e sel -employed, eigh y-nine a e limi ed liabili y companies, eigh a e join -s ock companies and ze o o he s (i.e., limi ed pa - ne ship o gene al pa ne ship). Size o businesses Rega ding business size, he sample consis ed o ou (4.04%) la ge en e p ises, hi een (13.13%) medium en e p ises, o y- h ee (43.43%) small en e p ises, and hi y-nine (39.39%) mic oen e - p ises, based on he EU classi ica ion o en e - p ise size. The majo i y o he sec o is comp ised o small and medium-sized en e p ises (SMEs). As pe Czech accoun ing legisla ion, he le- gal o m o business and size o he company a - ec ed he a ailabili y o inancial and economic da a in subsequen analysis s eps. The e o e, he esea ch sample had o be educed in some analysis s eps o main ain objec i e economic pe spec i es (indica ed below when applicable). P oduc po olio The composi ion o he company’s p oduc po - olio is one o he mos impo an cha ac e is ics wi h ega d o he ocus o he esea ch. Tab. 1 shows ha 46% o esponden s a e manu ac u - e s, wi h class I medical de ices mos ep esen - ed (33%), ollowed by IIa and IIb (15% and 14%, espec i ely). Only 21% o companies do no ope a e as dis ibu o s, wi h IIa and IIb de ices mos abundan in dis ibu ion. Six y pe cen do no ac as impo e s, and IIa and IIb de ices a e mos ep esen ed in impo s. The medical de ice companies in ou e- sea ch sample a e p ima ily small o mic o-sized limi ed liabili y companies ac ing as dis ibu o s o class IIa medical de ices. Manu ac u e s, among hem, mainly p oduce class I medical de ices. Financial cha ac e is ics Because only o y- wo ou o nine y-nine busi- ness subjec s had comple e da a a ailable in I am no M/D/IMP I Im Is IIa IIb III IVD Manu ac u e s (%) 54 33 3215 14 6 1 Dis ibu o s (%) 21 36 0 1 59 46 21 2 Impo e s (%) 60 15 0 0 33 28 8 1 No e: I am no M/D/IMP – such a company does no ha e a p oduc in i s po olio ha would place he company in he ca ego y manu ac u e (M)/dis ibu o (D)/impo e (IMP); companies can ha e wo o mo e oles, so he column o al may no add up o 100%. Sou ce: own Tab. 1: Classes o medical de ices in he su eyed companies Business Adminis a ion and Managemen 38 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 he Albe ina da abase comp ising inancial s a emen s om 2018 o 2020 (see mo e in he sec ion on he design o he s udy abo e), he desc ip ion o he inancial cha ac e is ics o he esea ch sample is limi ed. Since he a icle ocuses on he economic impac s o MDR, cos s ( he dominan consid- e a ion in ela ion o egula ion), p o i , p o i - abili y, and selec ed inancial heal h indica o s a e commen ed on in he medium e m be o e he MDR comes in o e ec . The cos s o analyzed en e p ises cons an ly g ew, eaching CZK 9.42 billion (EUR 366.8 mil- lion) in 2018 and CZK 11.27 billion (EUR 425.3 mil- lion) in 2020. Cos s pe a e age company we e CZK 224.3 million (EUR 8.73 million) in 2018 and CZK 268.2 million (EUR 10.12 million) in 2020, wi h he median en e p ise ha ing cos s o CZK 77.7 million (EUR 3.03 million) in 2018 and CZK 94.5 million (EUR 3.57 million) in 2020. The annual g ow h a e o cos s o all o y- wo companies accele a ed om 3.82% in 2018/2019 o 15.20% in 2019/2020. Ope a ing p o i , which is no a ec ed by inancing me hods, dec eased by 21.26% be ween 2018 and 2019 bu e i ed in 2020 wi h a p o i g ow h a e o 198.82%. The a - e age company achie ed an ope a ing p o i o CZK 21.25 million (EUR 0.83 million) in 2018 and CZK 50 million (EUR 1.89 million) in 2020. In 2020, se en en e p ises we e loss-making, and he moni o ed o y- wo companies achie ed an ope a ing p o i o CZK 2.1 billion (EUR 79.25 million) oge he . Bo h he e u n on equi y (ROE) and e u n on sales (ROS) indica o s inhe en ly ack p o i de elopmen (despi e he ac ha only ope a - ing p o i de elopmen is p esen ed abo e, while ROE is calcula ed om EAT). The a e - age and median alues o 2018–2020 a e shown in Tab. 2. Tab. 2 shows ha ROE eaches abou 20% o a e age alues, excep in 2019. The me- dian ROE g ew signi ican ly in 2020. In 2020, ROS b ough in sligh ly o e CZK 0.06 o p o i pe CZK 1 o sales. S anda d de ia ion inc eased Yea 2018 2019 2020 ROE (%) A e age company 19.31 14.38 22.28 Median company 8.94 8.02 20.20 ROS* (%) A e age company 5.31 3.83 6.37 Median company 3.06 3.11 6.47 No e: *Two companies we e disca ded as ou lie s due o ex eme alues. Sou ce: own Yea 2018 2019 2020 Indeb edness (%) A e age company 41.34 43.06 43.88 Median company 41.12 42.78 41.52 Ta le A e age company 1.08 0.85 1.37 Median company 0.65 0.69 0.84 Index IN99 A e age company 1.44 1.21 1.40 Median company 0.99 0.90 1.17 No e: Ta le > 0.3 low p obabili y o bank up cy o he company; IN99 om he in e al [1.42, 2.07] – he business c ea es alue o he owne ; IN99 om [1.089, 1.42] – i is no possible o de e mine whe he o no he business c ea es alue o he owne ; only in e als impo an o he in e p e a ion o he able a e gi en in he no e. Sou ce: own Tab. 2: ROE and ROS p o i abili y indica o s in 2018–2020 (n = 42, o 40*) Tab. 3: Indeb edness and inancial heal h indica o s in 2018–2020 (n = 42) Business Adminis a ion and Managemen 39 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 o ROE and ROS in 2020, indica ing g owing business pe o mance dispa i y. See Tab. 3 o he de elopmen o he indeb edness indica o , ep esen ing inancial s abili y and heal h ia he bank up cy/c edi wo hiness model. The a e age and median indeb edness alues a e simila . Businesses a e no gene - ally o e -indeb ed ( he 2020 s anda d de ia ion is 42.54, d opping o 28.37 a e emo ing an ex- eme alue o 248.82). Ta le ’s model shows low bank up cy p obabili y o mos companies, wi h only h ee ha ing inc eased isk (Ta le < 0.2). The Index IN99 sugges s ha i is unce ain whe he businesses a e c ea ing alue, wi h 16 (38% o he sample) c ea ing li le o no alue (IN99 < 1.089). The sample displays posi i e inancial cha ac e is ics, wi h p o i able, s able, and minimally indeb ed en e p ises. Unless signi i- can ly a ec ed by MDR, hei exis ence should no be h ea ened. 3.2 Inno a ion ac i i y and pe cep ion o he impac o egula ion on he de elopmen o medical de ices Vi ually e e y indus y egula ion impac s businesses in ha indus y o closely con- nec ed ones. His o y shows egula ions can ha e posi i e/nega i e e ec s on inno a ion (Ma eso a e al., 2020). In he ques ionnai e, we asked abou he impac o MDR on inno a- ion. Tab. 4 shows mos esponden s (57.58%) iew MDR as an inno a ion obs acle. Howe e , 36.36% say MDR has no e ec , and only 6.06% see i as an inno a ion impulse. F om Tab. 4, i is e iden ha he majo i y o su eyed businesses a e dissa is ied wi h he MDR (29.29% somewha dissa is ied and 26.26% e y dissa is ied, o alling 55.55%). Abou 35.35% o esponden s did no ha e an opinion on he o m o MDR a he ime o he su ey, and only 9.09% we e somehow sa is ied wi h he egula ion. The e seems o be an o e lap be ween inno a ion ac i i y and sa is ac ion wi h MDR, indica ing a po en ial dependence ( u he explo ed in chap e 3.4 h ough s a is i- cal es ing). Be o e del ing in o he es ing, he a icle examines selec ed p ocedu al and economic ques ions conside ing ha he com- pany’s inancial si ua ion may a ec he pe - cep ion o MDR (independence es ing o be discussed in chap e 3.4). 3.3 P ocedu al and economic impac s We begin his chap e by looking a p ocedu al ma e s signi ican ly ela ed o he e ec i eness o MDR. Speci ically, we ocus on he in ol e- men o a specialis in dealing wi h he egula o y equi emen s o MDR du ing he de elopmen o a new p oduc (see ques ions Q22 and Q23 in he ques ionnai e; p esen ed in Tab. 5). F om Tab. 5, i can be seen ha mos o en, he su eyed companies did no c ea e a new posi ion due o MDR, o hey al eady had such a pe son o he needs o MDD – Medical De- ice Di ec i e (40.40%). On he o he hand, oughly hal o he companies (50.50%) c ea ed such a new posi ion in some a ian . Conce ning he inclusion o a egula- o y specialis in he p ojec de elopmen eam, he esul s show a di ision o companies in o wo oughly equal-sized g oups. While he i s one in ol es he egula o specialis immedi- a ely when c ea ing a eam, he second g oup chooses a iskie pa h, whe e he egula o Q13 MDR & inno a ion ac i i y (%) Ac i i y pos ponemen Wi hou in luence Impulse 57.58 36.36 6.06 Q27 Le el o sa is ac ion wi h egula ion (%) De ini ely no sa is ied Ra he no sa is ied Neu al Ra he sa is ied De ini ely sa is ied 26.26 29.29 35.35 7.07 2.02 Sou ce: own Tab. 4: Pa ial ques ionnai e su ey esul s o ques ions ocused on inno a i e ac i i y and sa is ac ion wi h he o m o he new egula ion Business Adminis a ion and Managemen 40 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 specialis is only in ol ed when he e is a p ob- lem o no a all. The las o he p ocedu al ques ions ad- d essed in ou ques ionnai e was he ques ion o possible changes o he p oduc po olio conce ning MDR (see Q11 in Tab. 5). I can be s a ed ha MDR will impac he p oduc po o- lio, which will be na owed, in 41.28% o com- panies. This means ha MDR will o ce a ce ain pa o medical de ices ou o he ma ke , which can mean bo h a educ ion in supply and a p ice inc ease. F om his poin o iew, MDR can be iewed nega i ely. We will now ocus on economic issues (Q15, Q17, Q18, and Q20 in Tab. 5 and Q25). New egula ions o en b ing abou nega i e and posi i e changes, including he company’s economy. Fo MDR, expec ed inc eased cos s (con i med by Q17 when he majo i y o com- panies (85%) pe cei e inc eased cos s) may lead o educed p o i abili y (ac ually qui e con i med by Q18 – app oxima ely 60% es i- ma e nega i e impac ) and longe e u n on in- es men pe iods. This may impac unding willingness. The assump ion is qui e con i med by Q15, wi h nea ly 50% o esponden s indi- ca ing a nega i e impac on inancing, while abou 31% epo no impac . Inc eased cos s also limi inno a ion ac i i y in he case o al- mos 50% o en e p ises. In addi ion o ha , Q22 C ea ion o a new ex e nal o in e nal posi ion (%) Yes. One in e nal Yes. One ex e nal Yes. One, in e nal-ex e nal combina ion Yes. Two o mo e in e nal Yes. Two o mo e ex e nal Yes. Two o mo e, in e nal-ex e nal combina ion No. We al eady ha e o MDD I do no know. I canno judge 23.23 11.11 5.05 5.05 0 6.06 40.4 9.09 Q23 In ol emen o he egula o y specialis in he eam (%) Immedia ely a he beginning (au oma ically) Only when necessa y We do no engage 52.53 26.26 21.21 Q11 Remo al o p oduc om po olio due o MDR (%) De ini elyno Ra he no I do no know now Ra he yes De ini elyyes 18.18 18.18 22.22 13.13 28.28 Q15 Impac o MDR on unding sou ces and oppo uni ies (abs. alues, selec ed as a ue s a emen o he business) Nega i e in luence Inc eased cos s limi he possibili y o inno a ion Financial esou- ces a e eadily a ailable Wi hou in luence Nei he is ue o us 45 47 5 31 5 Q17 Es ima ed impac o MDR on cos s g ow h (%) Ve y weak Weak Mode a e S ong Ve y s ong No e ec 10.20 20.41 28.57 10.20 15.31 15.31 Q18 Es ima edimpac o MDRonp o i (%) De ini ely nega i e Ra he nega i e Neu al Ra he posi i e De ini ely posi i e No e ec 28.57 31.63 36.73 3.06 0.00 0.00 Q20 Abili y o pass on inc eased cos s o cus ome s (%) De ini elyno abili y Ra he no abili y I do no know Ra he able De ini elyable 24.49 33.67 31.63 7.14 4.08 Sou ce: own Tab. 5: Su ey esul s – ques ions ocused on p ocedu al and economic impac s Business Adminis a ion and Managemen 47 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 Conclusions Implemen ing egula ions is o en seen as necessa y o mi iga e ma ke ailu es and sa egua d consume in e es s. The Medical De ice Regula ion (MDR) is a ecen Eu opean egula ion speci ically designed o he p oduc- ion o medical de ices, aiming o ensu e hei sa e y and e ec i eness. This a icle ocuses on Czech companies and examines he MDR’s e ec s on hei ope a ions ega ding bo h eco- nomic and p ocedu al impac s. The indings o his esea ch in ima e ha he MDR will nega i ely impac a company’s p o i abili y, consequen ly in luencing i s ope a- ional s a egies, and a e in line wi h he gene al expec a ions exp essed, e.g., by Becke e al. (2019). In he case o he o hopedic aids sec- o , based on a wo-yea obse a ion, Ca l and Hochmann (2023) also highligh he nega i e impac s o MDR in he o m o inc eased cos s and a educ ion in he p oduc po olio. One key ac o con ibu ing o his nega- i e ou come is he inabili y o he companies o ans e he inc eased cos s esul ing om egula o y equi emen s o hei cus ome s. As a esul , a ec ed companies a e o ced o adjus hei p oduc po olios, educing hei ange o o e ings. The indings o his esea ch show ha app oxima ely one- hi d o he esea ch esponden s (n = 99) decla e ha hey will almos ce ainly discon inue one o he p oduc s om hei cu en po olio. The esea ch e eals ha he pe cep ion o he MDR among medical de ice manu ac u - ing companies is p edominan ly nega i e. A sig- ni ican inding is almos 50% dissa is ac ion wi h he o m o MDR (app oxima ely 35% pe - cei e MDR neu ally). This nega i i y a ises p i- ma ily due o he inancial bu dens imposed by he egula ion and he o he associa ed impac s. Fu he mo e, he MDR is no pe cei ed as a ca alys o inno a ion wi hin he indus- y, as nea ly wo- hi ds o companies epo pos poning inno a ion ac i i y due o he MDR. The e o e, his may be de imen al o he end use in he long e m. By quan i ying he e ec s o he MDR on Czech companies, his a icle p o ides aluable insigh s in o he eal-wo ld implica- ions o his egula o y amewo k. The ind- ings highligh he challenges companies ace in adap ing o and complying wi h he MDR, pa icula ly ega ding i s impac on p o i abili y and p oduc o e ings. This esea ch se es as a eminde o he complex in e play be ween egula ions, economic ou comes, and indus y dynam- ics. Ul ima ely, i emphasizes he impo ance o conside ing he po en ial ami ica ions o eg- ula ions and hei e ec s on businesses and ma ke s. Undoub edly, he MDR will imp o e sa e y, bu a wha cos ? Some o he ami ica- ions a e highligh ed in his a icle. The e is, howe e , a need o deba e on whe he he cu - en se ing o isk elimina ion on he one hand and cos s and es ic ions on he o he is eally bene icial o ei he he consume o he manu- ac u e . This a icle is imely as i add esses an impo an cu en opic o deba e and seeks o ill a gap in he li e a u e. 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The medical de ice egula ion o he Eu opean Union in ensi ies ocus on clinical bene i s o de- ices. The apeu ic Inno a ion & Regula o y Sci- ence, 54(3), 613–617. h ps://doi.o g/10.1007/ s43441-019-00094-2 Business Adminis a ion and Managemen 49 2024, olume 27, issue 2, pp. 32–49, DOI: 10.15240/ ul/001/2024-2-003 Appendix Ques ionnai e (lis o ques ions)  Q1. Company name  Q2. Medical de ice class(es) – p oduc ion  Q3. Medical de ice class(es) – dis ibu ion  Q4. Medical de ice class(es) – impo  Q5. How many medical de ices manu ac u ed/dis ibu ed/impo ed by you a e cu en ly subjec o con o mi y assessmen by a no i ied body o ce i ica ion?  Q6. Which class?  Q7. How many medical de ices manu ac u ed/dis ibu ed/impo ed by you a e al eady subjec o he equi emen s o he new medical de ice egula ion?  Q8. Which class?  Q9. Fo how many medical de ices manu ac u ed/dis ibu ed/impo ed by you do you ac i ely pa icipa e in clinical ials o pos -ma ke clinical ollow-ups?  Q10. Which class?  Q11. A e you planning o phase ou any p oduc om you po olio due o he new egula ion, e en hough you would no ha e done so unde he old egula ion?  Q12. Why?  Q13. Inno a ion wi h espec o he new medical de ice egula ion: Do you see he new egula- ion as an impulse, obs acle, o i ele an ac o ?  Q14. Why?  Q15. Financial esou ces and oppo uni ies: Check all s a emen s ha a e ue o you busi- ness en i y.  Q16. Why?  Q17. The new egula ion has a ec ed ou inancial indica o s in e ms o o e all COSTS.  Q18. The new egula ion will a ec ou inancial indica o s in e ms o o e all PROFITS.  Q19. Why?  Q20. We a e able o shi he inc eased cos s associa ed wi h egula o y equi emen s on ou cus ome s.  Q21. How/in wha way? O why no ?  Q22. Rega ding he new egula ion, did you ha e o c ea e a new in e nal o ex e nal posi ion o a pe son esponsible o egula o y compliance ( egula o y o ice )?  Q23. We usually in ol e an expe on egula o y issues in he p ojec /de elopmen eam.  Q24. How/in wha way? O why no ?  Q25. Which indica o s do you use o e alua e he con ibu ion o he p oduc o he o e all pe o mance o he company?  Q26. I you use o he indica o s, which ones?  Q27. To wha ex en is you company sa is ied wi h he new medical de ice egula ion?  Q28. Which equi emen s o he new egula ion do you pe cei e as he mos bu densome/ p oblema ic? S a e up o h ee answe s bu a leas one.  Q29. Why?  Q30. Wha do you conside he g ea es LIMITATIONS o he new egula ion? S a e up o h ee answe s bu a leas one.  Q31. Wha do you conside he g ea es OPPORTUNITIES o he new egula ion? S a e up o h ee answe s bu a leas one.