Presentation to: IOM Committee on Conflict of Interest in Medical Research, Education, and Practice. Medical Device Considerations

Transcription

1 Presentation to: IOM Committee on Conflict of Interest in Medical Research, Education, and Practice Medical Device Considerations Paul Citron January 21, 2008 Paul Citron 2008

2 Preliminary Comments: Focus will be on medical device education aspects in keeping with meeting theme. Presenter s areas potential conflicts: Draw pension, hold options, and hold equity in Medtronic, Inc. Consult for Medtronic, Ichor Medical (start-up), Ratner Biomedical (start-up), Red Abbey (medical technology VC firm) Hold equity in Arthrocare, Inc. Comments and opinions expressed in the presentation are solely those of the author.

3 Examples of Implanted Medical Devices Spinal Cage Cardiac Pacemaker Deep Brain Stimulation Implanted Defibrillator Hip Prosthesis Mechanical Heart Valve

4 Implants are highly sophisticated, often complex, systems consisting of multiple ancillary and enabling components in addition to the implant itself. Programmers (proprietary computers) Leads Introducers Guide catheters & wires Unique surgical instruments & holders Telemetry & monitoring devices

5 Medical device innovation process is on-going, highly dynamic, highly technical, multidisciplinary, collaborative, and interdependent. In most instances, physicians and industry share a co-dependence: -- Physicians can t independently implement technology -- Industry relies on physicians for patient access and care -- Industry biomedical engineers hold peer status Scenario #1 Physician identifies unmet need Scenario #2 Engineer identifies opportunity engineers implement solution physician applies to patient

6 Pacemakers Through the Years: Process of Technological Evolution Activitrax MicroMinix Thera EnPulse First External Pacemaker* Pediatric Asynchronous Pulse Generator Rate response Radically smaller size First Microprocessorbased, Mode switching Full Automaticity First Implantable Pacemaker Dual chamber rate response Rate response via activity & minute ventilation MVP, Full Automaticity Chardack-Greatbatch Byrel Synergist Elite Kappa Adapta * Battery Powered Each iteration introduces new technical aspects that need to be elucidated!

7 Unlike drugs, devices are not discovered. They are engineered to perform a desired task. Implantable Drug Pump Major components and sub-assemblies Product documentation serve as references to augment, not replace, device training and proctoring. Training is crucial for safe and effective deployment. System Components 60 pages Programming 139 pages Therapy Maintenance 79 pages

8 Medical devices are different than drugs: Bias and related considerations Difficult to blind Randomization and crossover trials raise ethical concerns Clearer, more definitive endpoints vs. drugs Novel device & novel surgical technique inextricably intertwined Clinician-innovator very often the inventor Innovator may be best-suited for early implants (learning curve) Gov ts recognize inventor is entitled to property rights Unpatented innovations will rarely be developed Articulated in U.S. Constitution Article I, Section 8: The Congress shall have power To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;..

9 Medical devices are different than drugs: background COI and bias considerations Difficult to blind Randomization and crossover trials raise ethical concerns Clearer, more definitive endpoints vs. drugs Novel device & novel surgical technique inextricably intertwined Gov ts recognize inventor is entitled to property rights Unpatented innovations will rarely be developed Articulated in U.S. Constitution! Inventor s vision and experience may trump expert opinion and conventional wisdom Cynics -- results too good to be true It ll never work! Comparatively few patient compliance and reporting issues by virtue of implant, automatic function, and objective outcomes

10 Medical device performance depends on: Intrinsic Factors Product specification Power source characteristics + Quality/reliability (perceived & real) feel Software/algorithms Implant longevity Device imposed surgery req ments Durability Size Extrinsic Factors Implantation technique, route Implanter s proficiency Indications for use Patient selection criteria Patient anatomy, age Follow-up protocols Professional staff training In comparison to most pharmaceuticals, devices are definitely not plug & play

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12 Intrinsic plus Extrinsic example: Evolution to transvenous vs. epicardial route Implications implantation time morbidity, mortality complications overall costs indications promotes further innovation Intrinsic: Epicardial leads Extrinsic: Open chest surgery transvenous leads transvenous route (out-patient)

13 Scope of Industry Educational Programs Peer-review literature Society presentations Expert seminars CME/CEU sponsorship Hands-on training Simulator In-vivo Peer-to-peer training Operating room On-site On-line programs Four co-authors are company scientists Literature, brochures, slide series, reference materials

14 An example of an industry program for CRT* Training * Cardiac Resynchronization Therapy

15 Although more than one company may offer the same class of technology, each model has unique features characteristics, functions, and precautions that require elucidation. Device-specific attributes: Features Route of administration Mechanism of action Algorithms/software Programming features, protocols Follow-up protocols Telemetry capabilities Implantation requirements Diagnostics/troubleshooting Aspects unique to A Company A device Common Aspects Aspects unique to B Company B device

16 The FDA can, and does, require company training and restrict device use by untrained medical personnel. Taken from p. 15 of the FDA PMA document: Below is a discussion of FDA action on each of the Panel s recommendations: (1).. (2) The sponsor should develop an in-person training program for physicians and medical staff. The sponsor developed a training program based on an inperson site visit by a CryoCor representative. A checklist of items to be covered must be signed by the trainee prior to use. FDA reviewed the proposed training program and found it to be acceptable. The approval order addresses this condition by restricting the use of the device to individuals who have received training. (3)

17 Professional societies recognize role of industry training programs: Carotid Artery Stenting (CAS) Example From p. 159: In addition to supervised experience, simulator-based training, minimum # of angiograms and peripheral interventional procedures, and proctoring of cases. JACC Vol. 49, No. 1, 2007

18 Device implantation and follow-up is often a small part of a physician s clinical practice even in mature technologies. Maintaining competence, best practices, and proficiency in a rapidly evolving technology that makes up only a part of clinical practice is a challenge. Industry education, training, and support programs play a role in safe and effective technology deployment. JACC Vol. 46, No pp According to Al-Khatib: Annual mean number ICD implants = 7 62% performed 1 to 10 implants/yr 7% performed 29 implants/yr

19 Overall device expertise is often most acute among company technical staff. For most implanting physicians and clinical staff devices are part of their practice, duties, and responsibilities. For company technical staff, it is their job/career.

20 Industry association has adopted a code of ethics regarding interactions with medical professionals

21 Company training conduct standards exist.

22 From: Medtronic Business Conduct Standards 2006

23 Restrictions on training venue and accommodations From: Code Section 1 From: Code definitions From: Medtronic Business Conduct Standards 2006

24 Opportunities for bias and COI in company sponsored training Sponsorships convey commitment to profession Product-specific training is company-centric Company experts and physicians may form collegial, professional, and social relationships Pre-clinical and post-marketing clinical studies are usually financed/underwritten by industry Physician association with company sponsored studies may advance standing Publications Presentations Patient referrals Media visibility