Public Health Effectiveness of the FDA 510(k) Clearance Process Balancing Patient Safety and Innovation: Workshop Report (2010) / Chapter Skim
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4 The Medical Device Industry Innovation Ecosystem
4 The Medical Device Industry Innovation Ecosystem
Pages 17-34
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From page 17... ...
Two speakers reviewed the current environment of medical device innovation, including the effect of the current regulatory framework on device development. Panelists then discussed issues related to the balancing of patient safety and innovation STRuCTuRE OF THE MEDICAL DEvICE INDuSTRY INNOvATION ECOSYSTEM Pain, suffering, and death from disease still plague patients worldwide.
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. How Innovations Are brought to Patients The medical device innovation ecosystem has multiple components: • "Fuelers" -- venture capitalists, investors, and public markets that support the process and invest in the innovators.
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From a regulatory perspective, it is important to recognize that patients' access to new health technologies is affected not only by FDA marketing approval or clearance but by the reimbursement process, which is also difficult to navigate. Ensuring Safety in New Technologies Patient safety is delivered primarily through good quality systems, and the vast majority of problems in the field are related to quality.
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Some devices that are cleared through the 510(k) process undergo clinical trials, but many do not require clinical trials to establish safety.
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The Current State of the Device Innovation Ecosystem In the marketplace, physicians are the natural gatekeepers for newproduct implementation. They are cautious adopters, interested in both clinical data and the potential for reimbursement for their services.
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, presented an overview of a commissioned paper that he prepared for the committee on the regulatory burdens required to bring innovative medical technologies to market.1 FDA, Feigal said, is the nation's oldest consumerprotection agency. The public health goals of the agency include safe human experimentation, marketing of products that have demonstrated effectiveness relative to known risks, manufacturing quality, truthful claims, prompt response to hazards, and prompt response to unmet medical needs.
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Diagnostics, among the most regulated devices, are not only overseen by FDA in the United States but regulated under the Clinical Laboratory Improvement Amendments. Instead of thinking only about devices as premarket and postmarket, CDRH looks at device products as a core cycle of concept, prototype, preclinical or bench testing, clinical evaluation, manufacturing, marketing, consumer use, and obsolescence.
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Regulation of Class II Medical Devices Risk Classification Product risk classification can foster innovation if the regulatory requirements are proportional to risk, Feigal said. That is, if a less risky product has to go through less to get to the market, that creates a drive for innovation.
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5 THE MEDICAl DEVICE INDUSTRY INNOVATION ECOSYSTEM A B FIGuRE 4-2 Total product life cycle -- the science cycle (A) and the regulatory cycle (B)
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In other cases, there may be a need for clinical experience to address the human factors associated with the use and performance of a product; that is, clinical experience may be necessary to write effective training materials. Clinical evidence takes longer to obtain, and one approach could be to collect evidence across the entire class II product life cycle, not only before clearance.
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There should be a separate class II approval process based on objective performance standards, clinical safety and effectiveness, and predicates that meet appropriate standards. Feigal recommended removing the reference to
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In handling class II products, he said, there are times when it would be better to rely on absolute performance standards rather than a predicate. Feigal also supported harmonizing the US qualitysystem regulations with the International Organization for Standardization Standard 13485 requirements and allowing mutual recognition.
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process and how such evidence should be obtained. Panelists also discussed how in vitro diagnostics fit into the medical devices structure, the need for consistent decision-making in classifying devices, and FDA's role as an enforcement agency.
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If FDA said that "this is commercially available, but there is no evidence to support X, Y, and Z," that would have a powerful effect on a product's utility. Hutt added that the laws do allow FDA to require clinical utility; that is part of "substantial equivalence." With home uterine monitoring, he said, there was a requirement for a clinical trial, but the end point that was chosen was whether the device allows a doctor to obtain information earlier and therefore be able to intervene to prevent preterm birth.
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process, Feigal encouraged the committee to look for ways to create incentives and rewards for accruing information as a product evolves and the science evolves over the course of the product life cycle. For example, digital mammography was first allowed onto the market for use in patients that were referred because of an abnormality.
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One of FDA's problems occurs when regulatory systems overlap. In this case, there is a gap between supervision of laboratory processes under the Clinical Laboratory Improvement Amendments and FDA supervision of in vitro diagnostics.
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That is essentially the system that is used in countries that require International Organization for Standardization Standard 13485 certification, Feigal said. Companies provide compliance information to the government before they file some kinds of applications, or they have independent audits of their quality systems.
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