Innovation and Invention in Medical Devices Workshop Summary (2001) / Chapter Skim
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2 Keynote Session
2 Keynote Session
Pages 9-30
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Mann, Sc.D. Whitaker Professor Emeritus of Biomedical Engineering Massachusetts Institute of Technology The inaugural national effort addressing the issues this Workshop is considering was the Committee on the Interplay of Engineering with Biology and Medicine (CIEBM)
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Symposium participants identified current trends in federal and private support of technological innovation, medical device regulation, product liability, and health care reimbursement. In addition, participants addressed important general issues, such as how to sustain technological innovation and health care quality in a rapidly changing health care environment, and how to encourage and support inventors.
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Clinical trials are expensive and take a long time. Certainly this process is true for medical devices widely deployed, for example, single-use endoscopic instruments, artificial hip and knee joints, stems, and intraocular lenses.
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To today's list can be added tissue engineering,7 developing biological substitutes for natural tissues skin or cartilage for example and ultimately organ transplants, interdigitation of molecular biology and engineering systems analysis through computational modeling of biological systems at the molecular level to understand metabolism, adhesion, mechanical contraction proliferation, differentiation, and molecule-tocell and cell-to-cell signaling.8 The more holistic tissue engineering and more reductionist modeling will in time converge, leading to a more fundamentally based realization of medical devices, to have a profound positive capability to promote, regain, and extend human health. The intervening decade has seen a dramatic increase in university programs, departments, and curricula in bioengineering,9 driven partly by the emergence of biology as a subject common to undergraduate education and partly by the generous and dedicated finding contributed to bioengineering and biomedical engineenug programs by the Whitaker Foundation.~° The more Han 70 biomedical engineenug departments and programs in the United States have benefited greatly Dom the $540 million in grants Tom Whitaker in the past two decades, but how this large enterprise will be sustained when Whitaker spends itself out in 2006 as planned remains to be seen.
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A west coast counterpart is Stanford's Medical Device Network (MDN) , which brings together physicians, engineers and scientists in the San Francisco Bay Area to encourage and facilitate invention, patenting, and early development of biomedical devices and instruments.
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,~2 and responding to new laws. Increasingly complex communications exist among FDA, sponsors, manufacturers, research institutions, IRBs, trade associations, professional societies, third-party payers, and, in some cases, the Federal Trade Commission, depending on the nature of the product.
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Eight thousand United States device manufacturers are joined by thousands of clinical laboratories and hospitals in developing custom diagnostics, implantables, and crafting new devices from tissue. Surgery and clinical pathology are blending into manufacturing.
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It is anticipated that the use of the pulmonary route of administration will increase as the technology associated with these dosage forms improves and the issues surrounding their development and approval are addressed. Such drug-device combination products challenge the regulatory system's approach to review and approval.
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The draft guidance suggests a "one size fits all" approach to several significant specifications, notably particle size distribution and content uniformity (referred to as "dose uniformity" in the European Union FEUDS. The United States requirements for content uniformity are highly prescriptive and apply to both MDIs and DPIs.
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It was not written with consideration of drug device combination products. For example, these products are expected to pass a fluid spill resistance test, also known as drip testing.
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The most difficult provision in the FDA draft guidance is the requirement that the commercial drug device combination be used in pivotal clinical trials to determine safety and efficacy. FDA strongly advises against changes to the device once the pivotal clinical and stability studies are initiated.
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Vice Presidentfor Strategic Planning, ECRI Clinical acceptance of new medical devices, drugs, or biotechnologies and overcoming the hurdles of coverage and payment reimbursements depends heavily on the results of clinical trials and technology assessment. ECRI (formerly the Emergency Care Research Institute)
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INNOVATION AND INVENTION IN MEDICAL DEVICES: IMPLANTABLE DEFIBRILLATORS Glen D Nelson, M.D.
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Unlike pharmaceuticals—where therapeutic formulation remains essentially unchanged for the commercial lifetime of the agent medical device technologies undergo continual and progressive evolutionary improvement. For example, def~brillators were developed over a period of 10 years at Medtronic, yielding a series of improvements in the basic device.
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Figure l illustrates how cost-effectiveness for medical devices typically increases with subsequent device generation. The first generations of implantable defibrillatory were marginally costeffective.
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While this example relates specifically to implantable pulse defibrillators, the pattern of progressive cost-effectiveness and improvement resulting from next generational technological and technique advances is a hallmark for essentially all medical device technology. Thus, each new generation is almost invariably more cost-effective than its predecessor.
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Dramatic quality improvements can result from consistent application of statistically based medical care algorithms based on broad and deep databases. Realtime access of these large databases will identify trends so that the health care system can be more dynamic and at the same time knowledge-based, and perhaps far less dependent on small clinical trials.
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Nelson and the group were whether there are assessment models that work best for those sorts of technologies, and secondly, what is the effect of the imposition of randomized controlled clinical trials on that kind of device-innovation process and the capacity of companies to innovate and attract venture capital? How do researchers create an understanding in Washington that devices are different from drugs and ought to be evaluated with a different model of evidence?
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It makes life easy, but the diversity of medical devices requires a diversity of proving methods, and that is an intellectual and educational challenge for the people in this group and people who pay for patient care. David Feigal from the FDA offered some thoughts on the reimbursement decisions facing HCFA, noting that they have different criteria for reimbursement, one of which is value added, something that is not required for drug approval or device approval by FDA.
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" He gave an example from a recent review of cardiac therapy during which an FDA reviewer pointed to the restenosis rates of the control groups of five randomized controlled trials and said, "They have to do more randomized controlled trials because the control groups vary between 5 percent and 30 percent, which is exactly the same range, maybe a bit higher, as the benefit groups." But whenever there was a direct comparison there always was a benefit! There is not going to be a single answer for this, he concluded, but these are science- and evidence-based decisions, and they require exactly the kind of information clinicians want in making decisions for their patients.
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A car phone is very much like a medical device, he asserted. It is engineering-based.
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