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Masters Final Project September 2011 Author: Elie Elia Abou Jaou Director: Pablo Laguna Lasaosa Programa Oficial de Postgrado en Ingenierias Master de Ingenieria Biomedica Merlin.net Patient Care Network Cardiac Device September 2010 - Curso 2010-2011 Elia Abou Jaou de Pablo Laguna Lasaosa Programa Oficial de Postgrado en Ingenierias Transversales Master de Ingenieria Biomedica Merlin.net Patient Care Network Cardiac Device Remote Care System September 2010 – February 2011 Programa Oficial de Postgrado en Ingenierias Merlin.net Patient Care Network Remote Care System 1 CONFIDENTIAL Acknowledgments First of all, I would like to thank St. Jude Medical for the opportunity they offered me to be part of the company for six months and their warm welcome. I would also like to thank my internship supervisor, Professor Pablo Laguna Lasaosa, for his kind attention, his advice and availability. And last but not least, all my thankfulness to the St. Jude Medical CRM team, and all the back-up teams for their help in making this project a success. Thank you all, 2 CONFIDENTIAL RESUMEN: El crecimiento de la población vieja aumenta la presión sobre los sistemas de salud tradicionales que sufren de un aumento de los costos y la disminución de los recursos materiales y humanos. La telemedicina aplicada a dispositivos cardíacos nos permite la monitorización remota del estado clínico de los pacientes con insuficiencia cardiaca, y allane el camino a un enfoque amplio y multidisciplinario de gestión de la enfermedad, que ofrece ventajas tanto en términos de resultados clínicos y de ahorro económico. A través de los últimos años, la telemedicina ha demostrado tener el potencial para mejorar la seguridad de los pacientes con respecto a los acontecimientos espontáneos clínicos y eventos relacionados con el dispositivo implantado. El objetivo principal del proyecto es la implementación de la solución de Telecardiología en los hospitales franceses. Este objetivo envuelve una amplia serie de misiones y funciones a partir de la comprensión técnica del sistema y pasando por la tareas de soporte técnico de formación y de marketing. La gestión de un proyecto de Telecardiología comienza con un conocimiento general pero esencial de las arritmias cardíacas, y los dispositivos proveídos por la empresa en términos de desfibriladores y marcapasos, lo que me permite entender los aspectos médicos del sistema que estamos presentando a los hospitales. Una vez que la patología clínica y los aspectos de su tratamiento se aclararon, entré en los detalles del dispositivo de Telecardiología y sus parámetros; más concretamente, los datos transmitidos por internet, y el análisis y la comprensión de estas transmisiones. Esta parte fue seguida directamente por una auto-formación sobre los aspectos técnicos del sistema: la comunicación por radiofrecuencia, los circuitos, la transmisión por red celular, la base de datos y el servidor web. Este período de formación técnica no se ha definido realmente en el tiempo, sabiendo que la parte de práctica se inició desde el primer día con el apoyo técnico y los casos reales. Mi misión consistió en el despliegue del sistema, con todos los aspectos complementares que incluyen la inauguración de nuevos centros, el apoyo técnico para los pacientes, médicos, profesionales de la salud y representantes de ventas. Otros aspectos de mi proyecto, como documentos de marketing, capacitación de personal y redacción de procedimientos también serán cotizados y detallados con otros aspectos complementarios, incluidos los aspectos reglamentarios y legales de la telemedicina. 3 CONFIDENTIAL SUMMARY: The growth of the aging population increases the pressure on traditional healthcare systems that suffer from increased costs and diminishing resources. Remote care as it is today is revolutionizing the cardiac implantable devices’ monitoring methods, by shifting from devicecentered safety follow-up, to patient centered solutions and individualized patient care, in order to improve alert management, and patient heart condition monitoring. The cardiac prosthesis communicates with the transmitter installed at the patient's home. The transmitter uses the telecommunications network, to transmit cardiac, device data and parameters to the server. The main objective of this project is the implementation of St. Jude medical‘s remote care solution in the French hospitals. This objective covers a wide series of missions and starting from the technical understanding of the system and going through the different marketing, regulatory and technical support tasks. Once the clinical pathology and the treatment aspects are clarified, the project goes through the details of the device follow-up and parameters and more specifically, the data transmitted on the server and the analysis and comprehension of the technical aspects of the system: the RF communication, the circuits, the cellular transmission and the web server. My mission consisted on the system’s deployment, with all the aspects complementing this phase, including the opening of new centers, personnel training, technical support for patients, doctors, healthcare professionals and sales representatives. Other aspects of my project, like marketing documents, personnel training and procedures redaction will also be listed and detailed with other complementary facets, including regulatory and legal aspects. 4 CONFIDENTIAL Contents Chapter 1 : The Context ........................................................................................................ 7 I - The Company ................................................................................................................ 7 II - What is Remote Care?.................................................................................................11 III - Mission and Objectives: ..............................................................................................13 Chapter 2 : Cardiac Rhythm Management ............................................................................14 I - The Heart: Briefly ..........................................................................................................14 II - Arrhythmias and Solutions ...........................................................................................16 a) Bradycardias and Pacemakers ...............................................................................16 b) Tachycardia, Fibrillation and Defibrillators ..............................................................19 Chapter 3 : Check-up and Remote Monitoring ......................................................................21 I - Remote Monitoring Advantages ....................................................................................21 a) Patient Safety .........................................................................................................21 b) Event Detection and Patient Treatment ..................................................................22 c) Efficiency and Costs ...............................................................................................23 II - The transmitter: Merlin@home .....................................................................................24 a) Reading: Transmitter - Device Communication ......................................................24 b) Transmission: Transmitter - Server Communication ...............................................25 III - Merlin.net: The Patient Care Network .........................................................................27 a) Merlin.net General Configuration ............................................................................27 b) Patient Enrollment ..................................................................................................28 c) Scheduled Transmissions ......................................................................................29 d) DirectAlert ..............................................................................................................30 Chapter 4 : The Project ........................................................................................................33 I - New centers and system deployment ...........................................................................33 a) Procedures .............................................................................................................33 b) Physician’s expectations and Merlin.net configuration ............................................35 c) Staff Training and First Enrollment .........................................................................36 II - Technical Support and Trouble-shooting .....................................................................38 a) Remote Monitoring – Technical support .................................................................38 b) Issues at the center ................................................................................................39 c) Issues at patient’s house ........................................................................................42 5 CONFIDENTIAL d) Field and quality reporting ......................................................................................44 e) Trouble-shooting Database ....................................................................................45 III - Marketing, clinic and legal ...........................................................................................47 a) Marketing and competition .....................................................................................47 b) Clinical and legal approach ....................................................................................48 Chapter 5 : Prospective analysis & conclusion .....................................................................50 I - Challenges and prospective analysis ............................................................................50 a) Professional Contribution .......................................................................................50 b) Personal Contribution .............................................................................................50 II - Conclusion ...................................................................................................................52 References ...........................................................................................................................53 Books and Publications .....................................................................................................53 Websites ...........................................................................................................................53 Appendix ..............................................................................................................................54 6 CONFIDENTIAL Introduction The growth of the aging population increases the pressure on traditional healthcare systems that suffer from increased costs and diminishing resources. Recent advances in biosensor and communications technologies enable the design of advanced and cost-effective Telehealth monitoring solutions that promise to improve the level of care and quality of life for patients, and to expedite the shift in healthcare delivery from hospitals to the community. Although different definitions may be found for Telemedicine and Telehealth, and while the differences between them are a source of constant debate, the definition commonly accepted as I see it is that "Telemedicine is the delivery of healthcare services, where distance is a critical factor, using information and communication technologies for the exchange of information for diagnosis, treatment and prevention of disease". Remote care as it is today is revolutionizing the implantable device monitoring methods, by shifting from device-centered safety follow-up, to perspectives centered on individualized patient care, in order to improve alert management, and patient heart condition monitoring. This shift enabled the remote monitoring of the clinical condition for heart failure patients, and paved the way to a broad, multidisciplinary approach of disease management, offering advantages both in terms of clinical outcome and economic savings. Through the last years, remote monitoring has proved to have the potential to improve patients’ safety regarding both spontaneous clinical events and device-related events. This medical revolution is at the same time a technical and engineering challenge that goes from the elaboration and design of the system to the implementation of the remote care solution in the medical centers and the patients’ home. 7 CONFIDENTIAL Chapter 1 : The Context I - The Company St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible, and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minnesota and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. The St. Jude Medical product portfolio includes implantable cardioverter defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, pacemakers, electrophysiology catheters, mapping and visualization systems, vascular closure devices, heart valve replacement and repair products, spinal cord stimulation and deep brain stimulation devices. St. Jude Medical develops and manufactures the following types of products:  Cardiac resynchronization therapy devices for heart failure  Artificial pacemakers and implantable cardioverter defibrillators (ICDs) for treating cardiac rhythm disorders  Diagnostic and therapeutic electrophysiology catheters  Introducers, catheters, and vascular closure devices for cardiology and vascular access  Mechanical and tissue heart valves plus valve repair products  Spinal cord stimulators for intractable pain 8 CONFIDENTIAL Company Facts Headquarters St. Paul, Minnesota, USA Stock Exchange New York Stock Exchange (NYSE) under STJ symbol Founded 1976 in St. Paul, Minnesota 2009 Net Sales $4.681 billion Employees More than 14,000 worldwide Global Reach Products sold in more than 100 countries Highlights St. Jude Medical is committed to continuous innovation and growth in its people, product portfolios and clinical research programs. The company sees growth opportunities in each of its technology platforms: Atrial Fibrillation St. Jude Medical is a pioneer and leader in the AF market, which is estimated to be about $2 billion. The company offers the industry’s broadest product portfolio for the EP lab, aiding physicians in the diagnosis and treatment of cardiac arrhythmias. Their sponsorship of IRASE AF, which could lead to an AF indication for an ablation catheter, and CABANA are reflective of the company’s commitment to advancing the management of AF through important clinical research. Cardiac Rhythm Management The worldwide CRM market was approximately $11 billion in 2010. The St. Jude Medical CRM business launched several new devices in 2010 including RF pacemakers, an ST segment monitoring ICD. The company will begin clinical trials on a number of new technologies in 2011, including a left atrial pressure monitor, an MRI-compatible pacemaker and a quadripolar pacing system. CONFIDENTIAL The heart is effectively a syncytium contiguous cytoplasmic bridges. This relates to electrical stimulation of one cell spreading to neighboring cells. 2.1 The Heart’s conduction system Signals arising in the SA node (and propagating to the le stimulates the atria to contract. In parallel, action potentials travel to the AV node via internodal pathways. After a delay, the stimul bundle branches and then to the heart, then finally to the ventricular myocardium. Microscopically, the wave of depolarization propagates to adjacent cells via located on the intercalated disk freely between cells in every direction, so that the myocardium functions as a sing contractile unit. This property allows rapid, synchronous depolarization of the myocardium. While normally advantageous, this property can be detrimental as it potentially allows the propagation of incorrect electrical signals. These gap junctions can or dying tissue, as in a myocardial infarction syncytium , a meshw ork of cardiac muscle cells interconnected by contiguous cytoplasmic bridges. This relates to electrical stimulation of one cell spreading to 2.1 The Heart’s conduction system Signals arising in the SA node (and propagating to the le ft atrium via Bachmann's bundle stimulates the atria to contract. In parallel, action potentials travel to the AV node via internodal pathways. After a delay, the stimul us is conducted through the bundle of His bundle branches and then to the Purkinje fibers and the endocardium at the apex of the heart, then finally to the ventricular myocardium. Microscopically, the wave of depolarization propagates to adjacent cells via intercalated disk . In a functional syncytium, electrical impulses propagate freely between cells in every direction, so that the myocardium functions as a sing contractile unit. This property allows rapid, synchronous depolarization of the myocardium. While normally advantageous, this property can be detrimental as it potentially allows the propagation of incorrect electrical signals. These gap junctions can close to isolate damaged myocardial infarction . 15 ork of cardiac muscle cells interconnected by contiguous cytoplasmic bridges. This relates to electrical stimulation of one cell spreading to Bachmann's bundle ) stimulates the atria to contract. In parallel, action potentials travel to the AV node via bundle of His to the the endocardium at the apex of the Microscopically, the wave of depolarization propagates to adjacent cells via gap junctions . In a functional syncytium, electrical impulses propagate freely between cells in every direction, so that the myocardium functions as a sing le contractile unit. This property allows rapid, synchronous depolarization of the myocardium. While normally advantageous, this property can be detrimental as it potentially allows the close to isolate damaged 16 CONFIDENTIAL II - Arrhythmias and Solutions Arrhythmia is a term for any of a large and heterogeneous group of conditions in which there is abnormal electrical activity in the heart. The heart beat may be too fast or too slow, and may be regular or irregular. Some arrhythmias are life-threatening medical emergencies that can result in cardiac arrest and sudden death. Other arrhytmias cause symptoms such as an abnormal awareness of heart beat (palpitations), and may be merely annoying. These palpitations have also been known to be caused by atrial/ventricular fibrillation, wire faults, and other technical or mechanical issues in cardiac pacemakers/defibrillators. Still others may not be associated with any symptoms at all, but may predispose the patient to potentially life threatening stroke or embolism. a) Bradycardias and Pacemakers Bradycardia is a slow cardiac rhythm, (less than 60 beats/min). This may be caused by a slowed signal from the sinus node (termed sinus bradycardia), a pause in the normal activity of the sinus node (termed sinus arrest), or by blocking of the electrical impulse on its way from the atria to the ventricles (termed AV block or heart block). Heart block comes in varying degrees and severity. It may be caused by reversible poisoning of the AV node (with drugs that impair conduction) or by irreversible damage to the node. Bradycardias may also be present in the normally functioning heart of endurance athletes or other well conditioned persons. A Pacemaker is a medical device which uses electrical impulses, delivered by electrodes contacting the heart muscles, to regulate the beating of the heart. The primary purpose of a pacemaker is to maintain an adequate heart rate, either because the heart's native pacemaker is not fast enough, or there is a block in the heart's electrical conduction system. Modern pacemakers are externally programmable and allow the cardiologist to select the optimum pacing modes for individual patients. CONFIDENTIAL Permanent pacing with an implantable pacemaker involves transvenou more pacing electrodes within a chamber, or chambers, of the heart. The procedure is performed by incision of a suitable vein into which the electrode lead is inserted and passed along the vein, through the valve of the heart, until p is facilitated by fluoroscopy which enables the physician or cardiologist to view the passage of the electrode lead. After satisfactory lodgment of the electrode lead is connected to the pacemaker generator. 2.3 Right atrial and right ventricular leads as visualized under x pacemaker implant procedure. The atrial lead is the curved one ma There are three basic types of permanent pacemakers, classified according to the number of chambers involved and their basic Permanent pacing with an implantable pacemaker involves transvenou s placement of one or more pacing electrodes within a chamber, or chambers, of the heart. The procedure is performed by incision of a suitable vein into which the electrode lead is inserted and passed along the vein, through the valve of the heart, until p ositioned in the chamber. The procedure which enables the physician or cardiologist to view the passage of the electrode lead. After satisfactory lodgment of the electrode is confirmed the of the electrode lead is connected to the pacemaker generator. 2.3 Right atrial and right ventricular leads as visualized under x - pacemaker implant procedure. The atrial lead is the curved one ma king a U shape in the upper left part of the figure. There are three basic types of permanent pacemakers, classified according to the number of involved and their basic operating mechanism Single-chamber pacemaker : In this type, only one pacing lead is placed into a chamber of the heart, either the atrium or the ventricle. 17 s placement of one or more pacing electrodes within a chamber, or chambers, of the heart. The procedure is performed by incision of a suitable vein into which the electrode lead is inserted and passed ositioned in the chamber. The procedure which enables the physician or cardiologist to view the passage of the electrode is confirmed the distal end - ray during a king a U shape in There are three basic types of permanent pacemakers, classified according to the number of : In this type, only one pacing lead is placed into a chamber of the heart, either CONFIDENTIAL Most commonly, the pacemaker above the muscles and bones of the chest. Ho case basis. Dual-chamber pacemaker : Here, wires are placed in two chambers of the heart. One lead paces the atrium the other paces the ventricle. This type to the natural pacing of the heart. It coordinating the function between the atria and ventricles. Rate-responsive pacemaker : This pacemaker has sensors that detect changes in the patient's physical activity and automatically adjust the pacing rate t the body's metabolic needs. The pacemaker generator is a hermetically sealed device containing a power source, usually a battery , a sensing amplifier which processes the electrical manifestation of naturally occurring heart beats as sensed by the heart electrodes, the logic for the pacemaker and the output circuitry which delivers the pacing impulse to the electrodes. pacemaker is placed below the subcutaneous fat of the chest wall, above the muscles and bones of the chest. Ho wever, the placement may vary on a case by 18 : Here, wires are placed in two chambers of the heart. One lead paces the atrium while paces the ventricle. This type is more similar assists the heart in coordinating the function between the atria and the : This pacemaker has sensors that detect changes in the patient's physical activity and automatically adjust the pacing rate t o fulfill hermetically sealed device containing a power source, usually a lithium , a sensing amplifier which processes the electrical manifestation of naturally occurring heart beats as sensed by the heart electrodes, the computer logic for the pacemaker and the output circuitry which delivers the pacing impulse to the electrodes. is placed below the subcutaneous fat of the chest wall, wever, the placement may vary on a case by 19 CONFIDENTIAL b) Tachycardia, Fibrillation and Defibrillators Tachycardia, in adults and children over 15, is a resting heart rate faster than 100 beats/minute. It usually results from the addition of abnormal impulses to the normal cardiac cycle. Abnormal impulses can begin by one of three mechanisms: automaticity, reentry or triggered activity. A specialized form of re-entry problem is termed fibrillation. Fibrillation is when an entire chamber of the heart is involved in a multiple micro-reentry circuits, and therefore quivering with chaotic electrical impulses. It can affect the atrium (atrial fibrillation) or the ventricle (ventricular fibrillation); ventricular fibrillation is imminently lifethreatening. Atrial fibrillation affects the upper chambers of the heart, known as the atria. Atrial fibrillation may be due to serious underlying medical conditions, and should be evaluated by a physician. It is not typically a medical emergency. Ventricular fibrillation occurs in the ventricles (lower chambers) of the heart; it is always a medical emergency. If left untreated, ventricular fibrillation (VF, or V-fib) can lead to death within minutes. When a heart goes into V-fib, effective pumping of the blood stops. V-fib is considered a form of cardiac arrest, and an individual suffering from it will not survive unless cardiopulmonary resuscitation (CPR) and defibrillation are provided immediately. Defibrillation is performed by applying an electric shock to the heart, which resets the cells, permitting a normal beat to re-establish itself. For patients that are considered at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia, an implantable cardioverter-defibrillator (ICD) is advised. 20 CONFIDENTIAL Implantable cardioverter-defibrillator (ICD) is a small battery-powered electrical impulse generator which is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect cardiac arrhythmia and correct it by delivering a jolt of electricity. In current variants, the ability to revert ventricular fibrillation has been extended to include both atrial and ventricular arrhythmias as well as the ability to perform biventricular pacing in patients with congestive heart failure or bradycardia. ICDs constantly monitor the rate and rhythm of the heart and can deliver High Voltage therapies, by way of an electrical shock, when the electrical manifestation of the heart activity exceeds the preset number. More modern ICDs at St-Jude Medical can distinguish between ventricular fibrillation and ventricular tachycardia (VT), and may try to pace the heart faster than its intrinsic rate in the case of VT, to try to break the tachycardia before it progresses to ventricular fibrillation. This is known as fast-pacing, overdrive pacing, or anti-tachycardia pacing (ATP). ATP is only effective if the underlying rhythm is ventricular tachycardia, and is never effective if the rhythm is ventricular fibrillation. 2.4 The Unify™ CRT-D and Fortify™ ICD can deliver 40J, the highest energy of any ICD available today 21 CONFIDENTIAL Chapter 3 : Check-up and Remote Monitoring Once the device is implanted, it is periodically checked to ensure the device is operational and performing appropriately. Depending on the frequency set by the following physician, the device can be checked as often as necessary. Routine device checks are typically done inoffice every six months, though will vary depending upon patient/device status. Historically, this has been done via scheduled clinic appointments. Current technology allows doing it by remote monitoring (RM). Evidence supports RM as a safe and effective tool for evaluating patient status. Research has demonstrated that patient and clinician satisfaction with RM is very high. The technology is easy to use, and it saves time and money when compared with traditional clinic visits. I will try to explain the use and advantages of remote monitoring through facts and examples and then develop the technical aspects of our technology. I - Remote Monitoring Advantages a) Patient Safety There has been a significant increase in the number of patients receiving implanted cardiac devices, and cardiology clinics are struggling with the burden of routine follow-ups: Researchers estimate that the number of patients receiving implanted cardiac devices such as implantable cardioverter defibrillators (ICDs), cardiac resynchronization devices (CRTs), and pacemakers will double, thus increasing the need for monitoring. Current standards recommend clinic visits every 3 to 6 months, with increased frequency as the implanted device ages: this monitoring must be done by clinicians with specialized electrophysiological training, and there are not enough specialized physicians to handle the increasing number of patients requiring surveillance. Some clinicians hoped to reduce the frequency of patient follow-up visits. However, recent situations with device malfunctions have led to a need for more monitoring. CONFIDENTIAL Scheduled visits are insuff icient rarely found during routine follow 3.1 Value of Scheduled Visits versus Unscheduled Visits [Source: Heidbüchel et al. (2008) N=1,739] b) Event Detection and Patient Treatment Rem ote monitoring is an effective tool for evaluating patient status: It enhances patient safety by allowing medical staff to identify and treat problems early and provide individualized optimal care. RM results in the earlier detection of many conditions asymptomatic and minimally symptomatic conditions to be detected signi several recent studies, medical staffs were able to catch device issues earlier with RM than with routine visits and physicians Researchers have established that most of the problems caught during clinic visits would have been found by RM and a effective as a clinic visit in 94% of 1,739 evaluated ca icient and often unproductive. Actionable problems that found during routine follow -up. Value of Scheduled Visits versus Unscheduled Visits [Source: Heidbüchel et al. (2008) N=1,739] Event Detection and Patient Treatment ote monitoring is an effective tool for evaluating patient status: It enhances patient safety by allowing medical staff to identify and treat problems early and provide individualized RM results in the earlier detection of many conditions ; it asymptomatic and minimally symptomatic conditions to be detected signi several recent studies, medical staffs were able to catch device issues earlier with RM than physicians were able to design more individualized therapy. Researchers have established that most of the problems caught during clinic visits would and a research team found that RM would have been just as effective as a clinic visit in 94% of 1,739 evaluated ca ses 22 and often unproductive. Actionable problems that occur are Value of Scheduled Visits versus Unscheduled Visits ote monitoring is an effective tool for evaluating patient status: It enhances patient safety by allowing medical staff to identify and treat problems early and provide individualized ; it specially allows asymptomatic and minimally symptomatic conditions to be detected signi ficantly earlier. In several recent studies, medical staffs were able to catch device issues earlier with RM than more individualized therapy. Researchers have established that most of the problems caught during clinic visits would research team found that RM would have been just as CONFIDENTIAL c) Effici ency and Costs RM allows physicians to evaluate patient data in less time than conduc visits. It takes less time to evaluate data from remote transmissions than it doe standard visits. Alternate organizational system to sift through data and bring only important information to the attention of the doctors. addition to reducing clinician and staff time healthcare providers in terms of There is a significant burden due to travel, time off from work, lodging expenses, and needing caregiver assistance when patients have to go to the clinic for follow monitoring resulted in considerable associated with traveling to the clinic, lost work time, and visit co 3.3 Average Time Required, Including Travel, per Followup for Study Participants [Source: Raatikainen et al. (2008)] ency and Costs RM allows physicians to evaluate patient data in less time than conduc ting in evaluate data from remote transmissions than it doe Alternate organizational system s allow qualifi ed nurses or software systems to sift through data and bring only important information to the attention of the doctors. addition to reducing clinician and staff time , RM can also decrease expenses to patients and terms of clinic face to face visits , and transportation. burden due to travel, time off from work, lodging expenses, and needing caregiver assistance when patients have to go to the clinic for follow considerable cost savings for patients, by eliminating the costs associated with traveling to the clinic, lost work time, and visit co -pays. 3.2 Average Travel Dis Required per Clinic Visit for Study P articipants [Source: Raatikainen et al. ( Marzegalli et al. Average Time Required, Including Travel, per up for Study Participants [Source: Raatikainen et al. (2008), Marzegalli et al. 23 ting in -person clinic evaluate data from remote transmissions than it doe s during ed nurses or software systems to sift through data and bring only important information to the attention of the doctors. In can also decrease expenses to patients and , and transportation. burden due to travel, time off from work, lodging expenses, and needing caregiver assistance when patients have to go to the clinic for follow -up. Remote by eliminating the costs Average Travel Dis tance Required per Clinic Visit for articipants [Source: Raatikainen et al. ( 2008), Marzegalli et al. (2008)] 24 CONFIDENTIAL II - The transmitter: Merlin@home The Merlin@home transmitter system allows remote patient monitoring and follow-ups. The transmitter is typically set-up by the bedside for communication while the patient sleeps (2AM to 4AM). It collects nightly diagnostic readings from the ICD and securely transmits the data to the physician’s office via the Merlin.net server. The transmitter is also updated with the follow-up schedules, entered on Merlin.net by the clinician, each time it connects. A weekly maintenance check and software updates are also operated by the server on the patient’s transmitter. a) Reading: Transmitter - Device Communication The Merlin@home transmitter communicates with the St-Jude Medical devices equipped with RF antennas. Two separate circuits are used during this communication: The St. Jude Medical devices already support a 2.45 GHz band based asynchronized wakeup and 400 MHz (MICS: Medical Implantable Communication Service) band based synchronized wakeup. The 2.45 GHz band base asynchronized wakeup uses 2.45 GHz band to wake up the RF transceiver in the ICD and then switches to 400 MHz band for communication. This scheme is asynchronized so the ICD is always listening for base station’s request for wakeup and communication can be established anytime. The MICS band based synchronized wake up uses 400 MHz band to wake up the RF transceiver as well as for communication. This scheme is synchronized so the ICD listens to the base station’s request for wakeup periodically. The base station can wake up the ICD and establish communication only at a predefined time (typically every 2 hours when the ICD is listening for wakeup request from the base station). However, there are drawbacks for both these wakeup schemes. Once the communication is established the transmitter (base) recuperates the data from the device and sends it to Merlin.net server using landline or cellular connection. 31 CONFIDENTIAL The alerts will then be split into three types:  Urgent: These alerts are commonly sent to the clinician and the medical team. The urgent alerts are commonly the device/patient life threatening ones.  Standard: The standard alerts are generally sent to the healthcare professionals and assistants so they can be taken into account and treated with a lower emergency level.  Off: Some alerts are turned off due to the patient’s condition, to avoid receiving them frequently, knowing that they will be triggered very often, and that they don’t represent any significant diagnosis. 3.10 ICD Alert configuration example 32 CONFIDENTIAL 3.11 Alert distribution example The optimization of the alert management allows a more efficient monitoring of each patient and a very high safety standard. For example, an alert marked as urgent for an out of range high voltage lead’s impedance allows the clinician to convene the patient to check his lead’s integrity and connectivity. That would eventually avoid inappropriate shock delivery, increasing with that the treatment efficiency, as well as the patient’s safety and well-being. Remote monitoring is revolutionizing the implantable device care system: The risk factor is lowered for the patient and the clinician has a better view on the disease and the emergency alerts. Yet, deploying a new process in the traditional medical care habits is always a challenge, especially when high-tech machines and software are involved. On the other hand, remote monitoring is an efficient yet time-consuming process: The patient needs to be informed on how the system works and the clinician needs to take the time to read the transmissions, monitor the alerts and schedule the follow-ups. The engineering role in the remote monitoring deployment goes beyond the ability to understand the system’s functioning and to troubleshoot: We are introducing a new healthcare method, and our challenge is to train and follow the clinician and the patients through all the steps, to insure that their usage of the system remains efficient and easy. 33 CONFIDENTIAL Chapter 4 : The Project In this chapter I will go through the detailed missions of my project with the difficulties and challenges of each task. Deploying remote monitoring includes the opening of new centers, technical support for patients, doctors, healthcare professionals and sales representatives. Other aspects of my project, like marketing documents, personnel training and procedures redaction will also be listed and detailed with other complementary facets, including regulatory and clinical aspects. I - New centers and system deployment Merlin.net has been deployed for the first time in 2008. Until now, the number of centers equipped was limited and the patient enrollment has been slow. The deployment has been slackened by the French healthcare system, and by the costs that are covered by St-Jude Medical. Another aspect, that remains undeniable, is the change of the physician’s conventional methods by introducing a new way to monitor the implantable devices. Starting September 2010, the company’s strategy has changed due to the increasing need for remote care that was sensed on the field. The results of the forecast I have made in December with our sales representatives, expected to multiply by three in 2011 the number of actual enrolled patients. To be able to ensure the same service quality with this fast increasing centers number, we had to “industrialize” our methods and procedures. a) Procedures The best way to gain time and efficiency, was to create procedures to make the centers autonomous on the system’s management as fast as possible. We decided to create a “Merlin.net Reference Guide” that would include the different procedures, check-lists and all the information the center would need to enroll and monitor its patients using our system. 34 CONFIDENTIAL This reference guide is structured and indexed to help the clinician/CRA (Clinical Research Associate) find the detailed procedure for every task. To replace a patient’s transmitter for example, the center can find the accurate step by step procedure: 4.1 Transmitter replacement procedure Challenge: How would a clinician/patient think? When writing a procedure, I had to put my system’s knowledge aside and think how to make this information understandable by any person who will have to operate the system. I always began by drawing the procedure’s step by step plan and try to develop each step, by referring either to other procedures or to simple tasks the operator could easily accomplish. Before validating a procedure with my superior, I always used to give it to any employee in the company, who wasn’t familiar with the system, and ask him to complete the procedure with our system to see if the steps were clear and explicit. This test phase was necessary to confirm that the information was accessible by any operator and that the “language” used was simplified, yet precise. 35 CONFIDENTIAL b) Physician’s expectations and Merlin.net configuration After the decision has been taken to open a new center, discussions are initiated with the concerned physicians to present the system and listen to the physicians’ expectations and needs, in term of follow-ups, alert distribution and center configuration. The questions and outlook are different from a physician to another depending on their work methods and task distribution in their teams. At this stage, we define the different accounts that should be created on Merlin.net (Physician, Healthcare Professionals and Assistants) gathering all the medical staff of the center depending on their role and responsibilities. The doctors will then have to define the DirectAlert distribution (urgent and standard alerts) as discussed in Chapter 3: Usually the device related alerts are marked as urgent and the rest are commonly marked as standard. Challenge: Who is responsible for what? Our main concern is to define the responsibilities to ensure that the alerts will be read and the transmissions will be consulted and analyzed: Merlin.net Accounts:  Healthcare Professional: By default, He can see all the center’s patients. He can perform all the “daily” tasks in Merlin.net, including the transmissions archiving.  Physician (administrator or not): By default, He can only see his patients. Can be given access to all the center’s patients.  Assistant: Can only consult the transmissions and schedule the patient’s follow-up dates.  When a "Healthcare Professional» or "Physician" reads a Transmission, it is marked as "Viewed" and Merlin.net remembers the last account and date of visit. 36 CONFIDENTIAL Usually this task is assigned to a healthcare professional, typically a CRA that will receive a special training and will have the following responsibilities:  Enroll the patients on Merlin.net and deliver their transmitters at the hospital (training, pairing, patient consent form…)  Consult their mailbox daily to check for eventual alerts.  Consult regularly (at least weekly) Merlin.net for patients’ monitoring:  Reading/archiving transmissions  Reading eventual messages  Follow-up schedules My mission is to ensure that these tasks are assigned to the right staff. For example, if the alerts and transmissions are not read by the medical staff, the purpose of remote monitoring is lost: This is why responsibilities are the main objective of our discussion with the physician, and always remind them that remote monitoring helps them monitor their patients in a more efficient way, but will never do the monitoring alone. All these discussions then allow us to configure the center’s Merlin.net profile and accounts. The “default” parameters discussed in Chapter 3, are then configured with the healthcare professional according to the physician’s expectations and the center is now ready to enroll its first patient. c) Staff Training and First Enrollment We always try to have the staff trained and the first patients enrolled the same day, so we can cover all the training aspects, especially the ones related to the transmitter’s pairing and handling. The first part of the training consists on presenting all the aspects of Merlin.net and ensuring that the staff understands how to configure the different parameters like alerts, schedules, transmissions, archiving and others. 37 CONFIDENTIAL Next, we start by enrolling the first patient on merlin.net as explained in Chapter 3 and then we assist the staff on their first transmitter delivery/pairing while explaining every single step along with the issues that can eventually be encountered and the basic trouble-shooting actions. If we have the opportunity, we try to enroll more than one patient, so different cases can be covered, and we get the opportunity to show the staff how to explain (training) to the patient everything he should know about our system and about the way it should be handled. Challenge: Trouble-shoot simple cases and always give an explanation On the training day, we try to be exhaustive and cover all the possible cases. We also use the “Reference Guide” to show all the different situations and the easy way to solve/manage them. Example: Reading issues upon transmitter’s pairing: Upon pairing the transmitter goes on “Read Error” after trying to read the device: Read Icon and five Leds Blinking: 4.2 Read Error This behavior means that the transmitter can not find the device or can not finish reading the information. The typical solution for such an issue would be to get the transmitter closer to the device (patient’s chest) and re-launch the pairing. The proposed solution would eventually solve the problem: The given reason is simply the distance between the device and the transmitter. This is how we simplify the real reason why this is happening: The wake-up circuit (2.45GHz) has a short (low power) range causing the transmitter not to be able to call the device and establish a communication if the device is far (>2m) as explained in Chapter 3.II.a. 38 CONFIDENTIAL II - Technical Support and Trouble-shooting Like every complex system, our remote monitoring network encounters slight or more complicated issues either on the transmitters, on Merlin.net or on our servers. Other issues can also be encountered with the usual procedures or simple wrong entries. For the remote monitoring technical support, I had the responsibility of all the French centers assistance and trouble-shooting. I was also responsible for the field and quality reporting, as well as the investigations with the European remote monitoring technical support. a) Remote Monitoring – Technical support The European technical support for St-Jude Medical’s Remote Monitoring is centralized in Veddesta – Sweden. Three correspondents are responsible for the investigations on the different cases we submit. In France, the law prohibits us to have any access to the center’s profiles and data, in order to protect the patients’ privacy: Our technical support can help us with this restriction and even give us detailed information about the connection parameters and the profiles configuration that allows us to better understand and solve the issues. We usually turn to them when the basic trouble-shooting fails. Their level of access allows them to have a global view on the different parameters that may be causing the problem and give us their advice. Challenge: How to prevent an issue to occur again? I usually used to submit the issue to them as fast as possible to gather more information about the problem’s possible reasons. This information would then allow me to intervene in a more efficient and targeted way. Remote Monitoring’s support also helped me give a more precise answer to the centers in many situations: For me, it was never about solving the problem but always about three basics that allowed me to succeed in this trouble-shooting task:  Find the precise reasons of the issue  Define the steps that will lead to an eventual solution  Go back to the reasons and see how we can prevent this issue to occur again 39 CONFIDENTIAL b) Issues at the center Two main parts of the remote monitoring circuit take place at the hospital: The Merlin.net entries and the Transmitter pairing. Merlin.net as described above is an interactive website that coordinates the follow-ups and alerts of each patient with the entries of the clinic. This coordination job depends on many human factors, especially on the transmitter’s side (unplugged, unable to connect), but also on the clinic’s side where the patient’s information, preferences and schedules are entered. This can lead to multiple misunderstandings related to the system, leading to a total confusion of the medical staff. They spontaneously call us for trouble-shooting: Challenge: Master all the Merlin.net possible behaviors and messages When the clinic staff called, they explained the issue they were having on Merlin.net as clearly as they could, and then, it was up to me to define exactly in which section their issue was situated and how to guide them through it and explain the situation: As a simple example, let’s take a follow-up schedule: The nurse goes to the Data Entry Schedule of one of the patient’s center and schedules a transmission in the next couple of days; when saving she gets the following message: 4.3 – “Send a transmission” message on Merlin.net Before calling the patient, the nurse calls me and explains approximately the situation. It is up to me then to determine the exact situation from the cases I have already seen, and explain the origin and reasons of this message: 40 CONFIDENTIAL  When a follow-up is scheduled for a date that is closer than one week from today this message will automatically appear. As a matter of fact, for the transmitter to download the next follow-up date it should connect to the server.  As discussed in Chapter 3 II – b, a communication between a transmitter and the server can be initiated for four main reasons: o Manual Patient initiated transmission o Scheduled transmission set-up by the center o Alert initiated transmission o Weekly maintenance check and software update  Knowing that the weekly maintenance check can take a whole week to happen, Merlin.net asks the operator to perform a manual transmission which is the only other choice that guaranties the connection to the server and the new schedule download. Solution: If the nurse absolutely needs this transmission at this precise date, she should indeed ask the patient to perform a manual transmission after she has entered the new follow-up date. If not, we advise the centers to schedule the next transmission more than one week before the due date to be sure to have it downloaded and performed by the transmitter. This solution is a typical example on how I had to communicate my knowledge of merlin.net to the centers, case by case, and how I had to analyze the different issues to be able to always give a pleasant solution. The transmitter pairing is also a multifactor procedure, knowing that it implies a matching between the data on Merlin.net and the information that is retrieved on the implanted device. This procedure is typically operated by the staff at the hospital upon the transmitter’s delivery to the patient: At the training stage, this procedure is explained and demonstrated on first enrollments, yet many issues can result on a pairing failure and the need for assistance: 47 CONFIDENTIAL III - Marketing, clinic and legal I decided to talk about the marketing, clinic and legal aspects in the same section because in remote care these domains are still mutually dependent. In France, Telemedicine is just starting to be recognized by the healthcare system as a medical care method, but it still is not legally equivalent to a classic follow-up visit. The legal aspects have evolved in the last few years after the first clinical trials have shown the benefits of remote care. Our role as manufacturer is to help the medical society discover and adopt remote monitoring, by offering the service and leading clinical trials in order to fasten the identification of remote care. a) Marketing and competition Marketing is a total system of business activities designed to plan, price, promote and distribute want-satisfying goods and services to present and potential customers. To be able to price Remote Monitoring as a service, St-Jude Medical and its competitors are still promoting the service by offering it to their French centers. This marketing strategy encourages the medical society to discover RM and to integrate it in their classical follow-up procedures. Once it is integrated, the service should become indispensable allowing us to distribute it. My role in this strategy is to valorize the benefits of our system and to make it seem easy to use by helping the centers with technical support, and providing them with the easy and understandable procedures. In this role, communication skills are a must to gain our clients’ confidence. On the other hand, competitive intelligence is also necessary to be able to emphasize the qualities of our system. During my project, I did a lot of research about our remote monitoring competitors and their systems and analyzed the following points:  System features and advantages  Clients satisfaction and complaints about the competitors systems  Press releases and marketing strategies  Market study and competitors expansion 48 CONFIDENTIAL 4.10 Remote Monitoring competition All four systems have their pros and cons in terms of connectivity, reliability and size. Most importantly, Remote Monitoring, as it is today, remains sales argument for the implantable devices of each of the companies: For the centers that have adopted remote monitoring as a classical procedure, the surgeons will implant the devices with the best remote care system. This is the only financial factor of remote care systems today in France, while waiting for the systems to be priced. b) Clinical and legal approach In France, Telemedicine has been a debate subject for the last few years with the publication of the first positive clinical results. The first French decree concerning Telemedicine has been released during my internship on October the 26 th as a first step towards the full integration of remote care in the French healthcare system. 49 CONFIDENTIAL Another main legal concern in the French system is the data privacy for which the CNIL is responsible: The “Commission nationale de l'informatique et des libertés” or CNIL is an independent French administrative authority whose mission is to ensure that data privacy law is applied to the collection, storage, and use of personal data. The main principles for regulation of personal data processing are as follows:  All illegal means of data collection are forbidden  The aim of the data files must be explicitly stated  People registered in files must be informed of their rights, for example, for rectification and deletion of data on demand  Finally, no decision about an individual can be decided by a computer. Our system is in line with all these regulations and yet many debates are still opened on the data privacy subject, data storage and encryption. During my project, I had to make sure that these regulations were respected and that all our documents and profiles remained anonymous. The patients were always represented by their device serial number and only the medical staff has access to the patient data and information. Clinical studies: All the patients monitored in Merlin.net are systematically enrolled in French St-Jude clinical survey Merlin.fr: In Merlin.fr, we collect all the data concerning the Remote Monitoring system Merlin.net and the Merlin@home transmitter with defibrillators and implantable pacemakers to demonstrate:  Feasibility and Reliability: Remote Monitoring integration in the healthcare facilities  Comparability: between the medical decisions taken by Remote Monitoring and classic follow-ups performed in the center The survey results will soon be subject to publication with very promising results. 50 CONFIDENTIAL Chapter 5 : Prospective analysis & conclusion I - Challenges and prospective analysis a) Professional Contribution The project was for me, one more opportunity towards my future employment goals. After my first internship in a medical device company, this internship was a positive evolution in terms of responsibilities and project management. In fact, I had to develop “Merlin.net” under all its aspects like a product manager. The project enclosed engineering facets, for the technical and implementation parts, as well as marketing and human contact. My position allowed me to work with many internal divisions of St-Jude Medical around the world and discover the company’s work ethics and values. On the client’s side, I have deepened my knowledge in medical practice and environment and I got to meet some of the most talented cardiologists in France. One of the biggest challenges on the professional side was our team size. The only people in charge of the St-Jude medical RM system were my boss and I. We have always managed to overcome this team volume difficulty by prioritizing and splitting the tasks to optimize our work time. Another challenge that helped me develop my communication skills was the patient’s contact in which our speech is always adapted to each case and situation. The project and the company offered me an ideal environment, to strengthen my professional experience, and focalize on my future employment objectives. b) Personal Contribution If I had to change this section’s title, I would put “strictness and communication”: I managed to develop, during these 6 months, an efficient work method to organize my work. I learned to prioritize in task management to always give rigorous and satisfying results. I also succeeded to develop my communication skills and manners in order to adapt them to the each interlocutor and satisfy his needs. 51 CONFIDENTIAL I also developed a weak point I had, which is the ability to learn from others by listening, and founding my answers on their expectations and discourse. This helped me improve my persuasion skills and assert myself on different conflict points. During this second experience in the company environment, I focused on each of my colleagues’ missions and work environment to make my career choice easier according to my personality and potential. I think that the medical device environment suits these expectations and I will carry on in this same sphere for my job. 52 CONFIDENTIAL II - Conclusion To conclude about Remote Monitoring, I would like to quote Dr Kenneth A Ellenbogen (Medical College of Virginia, Richmond): “ICD remote monitoring is an incredibly powerful microscope". In fact, the medical device remote care provides frequent, convenient, safe and comprehensive monitoring of the prosthesis and the patient’s condition. Device and patient related problems can be reliably detected and reduce the frequency of outpatient visits. Patients are highly satisfied with the convenience and ease of use of the systems. The surveillance of device performance is a potentially important future capability. In the future an exponential growth in implementation of remote monitoring is likely to occur in the field of implanted devices including ICDs, pacemakers, and implantable disease monitors. As the positive clinical surveys publications keep on falling, the legal context of telemedicine should be adjusted and allow the growth of remote monitoring. On the other hand, the medical society’s interest in remote care is rising and remote follow-up systems are becoming a must in many centers, making the service’s evolution easier and faster. I enjoyed working in an evolving sphere, where engineering and science are implementing new solutions and contributing to the advance of healthcare and the well-being of patients. Through my experience, I realized that everything is still to be done in this domain, and more remote monitoring applications will rise in the next few years to help clinicians and patients in their daily life. This project just confirmed my will to carry on in the medical device environment as a product manager. My personality and objectives perfectly fit the companies’ expectations for such a position and my job research will be focalized on this domain and activity. 53 CONFIDENTIAL References Books and Publications  Cardiac Rhythm Management – SJM CRM Team  Livre Blanc de la Télécardiologie (2008) – Pr. Salem Kacet & Denise Silber  Telehealth World Magazine – (Spring 2008)  St. Jude Medical: Enhanced MICS - Devanshi Shah – Thesis CPSU 2010  Journal of General Internal Medicine – 2007 Websites  SJM Online Courses: http://corporate.sjm.com  Tic Santé: www.ticsante.com  SJM PROFESSIONALS: o http://www.sjmprofessional.com/Products/US/CRT-Systems/Merlin-net- Patient-Care-Network.aspx o http://www.sjmprofessional.com/unitedkingdom/cardiac-rhythm- management/product-highlights/remote-monitoring-and-patient- management.aspx 54 CONFIDENTIAL Appendix Appendix 1: Personal activity statistics Appendix 2: Merlin.net Spec Sheet Appendix 3: Transmission Summary: Fastpath Appendix 4: Merlin.net Connectivity Fact Sheet CONFIDENTIAL Appendix 1: Personal activity statistics Starting November, I began to monitor my activity on a daily b activity’s statistics for November, December and January: Technical Support / FER Trans. Dispatch Technical support by phone to centers, patients and SJM representatives + FER reporting Transmitter shi pping to individuals/hospitals + warehouse checking Marketing / Docs. Training All procedures and marketing documents preparation All trainings 0% nov.-10 déc.-10 janv.-11 Personal activity statistics Starting November, I began to monitor my activity on a daily b asis and you will find bel statistics for November, December and January: Trans. Return EVATEL pping to individuals/hospitals + warehouse checking Transmitter returns/ Vigilance Department All EVATEL study documents, communications and invoices Training Planning Tests All trainings Discussions and time taken on planning activities + Meetings Tests operated on the remote care system 50% 100% % Activity Technical Support / FER Trans. Dispatch Trans. Return EVATEL New Center Logistics Marketing / Docs. Training Planning Tests 55 asis and you will find bel ow my New Center Logistics All EVATEL study communications New centers documents, opening and support Tests Tests operated on the remote care system Technical Support / Trans. Dispatch Trans. Return EVATEL New Center Logistics Marketing / Docs. Training Planning Tests 56 CONFIDENTIAL Appendix 2: Merlin.net Spec Sheet