Our 13th Year of Publication
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Cover Story


Medical Device Innovations

Innovation for medical devices differs from innovation for pharmaceuticals. Device innovation includes both giant leaps and incremental changes with life cycles as short as 18 months. Unlike many pharmaceuticals, the effectiveness of such improvements depend on a continuing dialogue between product developers and the ultimate end-users about what works, what doesnt, and what the best solution to problems might look like, because devices generally require the skill of the end-user.

The Center for Devices and Radiological Health (CDRH) has recently  announced  steps to expand its current efforts to foster the development of safe and effective medical devices through a variety of initiatives and regulatory process improvements.

Over the next decade, medical technology innovations will fundamentally transform the health care and delivery systems, providing new solutions with medical devices that will challenge existing paradigms and revolutionize the way treatments are administered. Already medical innovations that would have been considered the stuff of science fiction just a few years ago are quickly becoming the standard of care. Such advances that the Food and Drug Administration (FDA) has recently approved include drug-eluting stents designed to slowly release a drug to significantly reduce the rate of re-blockage of metal stents inserted into the coronary blood vessels to maintain blood flow to the heart and imaging devices that utilize Computer Aided Detection software to assist radiologists in the detection of cancers.

With the convergence of many scientific and technology breakthroughs, the pace of medical invention is accelerating, inspiring hope for better clinical outcomes with less invasive procedures and shorter recovery times, all in lower cost settings. There are powerful forces at work that are driving rapid fundamental change in healthcare delivery.

New innovations and developments suggest an unfolding pattern of "smart" technologies that integrate engineering and biological approaches, and that enable increasingly precise clinical interventions as well as a progressively decentralized health care delivery system. The FDA is already seeing a steady increase in the number of requests from developers for pre-submission meetings to seek advice on the best approaches for scientific and clinical testing and evaluation of cutting-edge technologies, such as molecular medicines (genetic and proteomic diagnostics and therapeutics) and products developed using nanotechnology.

As these technologies advance, the critical path from promising new science and lab discoveries to applications that treat patients may present greater challenges for both innovative device manufacturers and for the FDA, because the current paradigms for assessing the safety and effectiveness of these products may not be optimal for timely, efficient, and effective product development and premarket review. Similarly, the ability to develop reliable information to more effectively guide clinical practice and inform medical decisions must keep pace with the rapidly increasing complexity of the underlying products.

Post-market systems that enable constant learning and feedback not only spur continued innovation but help support best medical practices to ensure safe use of devices with maximum effectiveness. Therefore, opportunities exist to enhance medical device innovation at every phase of the total product life cycle.

To meet these challenges of today and the future, the Center for Devices and Radiological Health (CDRH) is taking new steps to expand its current efforts to foster the development of safe and effective medical devices through a variety of initiatives and regulatory process improvements. Below, we describe the specific actions the FDAs CDRH plans to take under the Medical Device.


Innovation Initiative. Following the discussion, we provide a table showing the impact these actions will have on the predictability, timeliness, consistency, transparency and efficiency of the device development and application review process while also helping to reduce regulatory burden. This initiative includes the following efforts:

  • Promoting scientific innovation in product development;

  • Focusing device research on cutting edge science; and

  • Modernizing review of innovative devices.

(more information available at : http://www.fda.gov/cdrh/ocd/mdii.html)

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