There is no shortage of discouraging news these days for the medical device industry. We continue to hear how the recession is curtailing investment and venture funding of new medical technologies. Many start-ups find they are unable to attract new funding for projects or have to delay major expenditures for product development. Moreover, FDA is under new leadership and promising increased enforcement in food and drug programs and is taking a hard look at device programs, particularly the 510(k) process. Despite the headlines, there are activities that can be completed to keep your device development process moving forward.
Although the economic downturn has put increased pressures on medical device companies to curtail spending and has limited the available sources of venture funding, there are opportunities to continue product development activities while avoiding significant capital expenditures. Given the lengthy approval process for many devices, it is prudent to continue to add value to the technology and demonstrate incremental progress toward premarket review and approval. To that end, there are numerous regulatory and clinical activities that may be undertaken that do not necessarily require large outlays of capital to complete. Even though the U.S. regulatory environment for devices is in midst of potentially significant changes as FDA examines its policies and programs, taking steps to add a degree of clarity to your product development pathway may be helpful in attracting investments for your product.
This process is particularly important in the current environment at FDA. In September, the FDA commissioned the Institute of Medicine to evaluate the premarket 510(k) clearance process. This is in response to reports from within CDRH that certain products were allowed by Agency management to be cleared through the 510(k) process rather than the more stringent PMA process recommended by CDRH review staff. Despite this uncertainty it is imperative for device companies to continue developing and maintaining a collaborative approach with CDRH for new medical devices. The pre-IDE process remains a valuable tool in getting early FDA feedback on key issues particularly for innovative devices in which there are no obvious predicate devices or for new intended uses. Topics that are typically addressed in the pre-IDE process include:
While the pre-IDE process is non-binding and informal, it provides a device sponsor the opportunity for early collaboration with CDRH. This interaction is important because a device company can get more clarity of the likely data requirements and review process before making significant expenditures for preclinical and clinical studies. More importantly they can get some insight into whether a new product is a likely candidate for a 510(k), or because of technological features, device risks or labeling claims, the agency is more likely to require a PMA.
From a regulatory perspective, the company can be strategic and creative in its approach to managing the change process. First and foremost, the company needs to establish a documented change control policy through which it consistently evaluates whether the proposed change could affect the safety and effectiveness of a device. This policy needs to take into account the FDA guidance on 510(k) and PMA changes but also needs to be linked to a well-defined design control system. From there the company can evaluate all planned changes to a product or process and strategically decide which changes could be made with appropriate testing and documentation and which changes would more than likely require a new 510(k) or PMA Supplement. In this regard the company can make minor incremental changes to existing products and submit new 510(k)s or PMAs at defined stages of development when the economic or regulatory environment is more favorable.
Many small companies view Quality Systems as another burden in an already daunting product approval process. However, long-term success is enhanced when companies embrace quality system requirements to create value and strengthen operational excellence.
Having addressed these questions the company would be in a better position to discuss the program with FDA at a pre-IDE meeting and will have a much more productive discussion with the CDRH review staff. This in turn gives the firm a much clearer picture of the likely regulatory pathway and milestones in the product development process.
While the product development, clinical evaluation and regulatory approval of medical devices requires substantial capital investment, the strategies and activities described here are just a few opportunities a firm should consider to add value to an emerging medical technology so that the company is well-positioned and more attractive for significant investment in pivotal clinical trials and regulatory approval efforts as the economic outlook improves.
Ronald S. Warren, RAC, CTBS (AATB), Principal Consultant -Ron has more than twenty-five years of regulatory and clinical affairs experience, with specific expertise in human-derived tissue engineered products and cardiovascular devices. He has coordinated and led multiple pre-IDE meetings and been involved in the submission and preparation of PMAs, 510(k)s, PMA Supplements, and IDEs for various clinical indications. He also has expertise in tissue establishment registration and Good Tissue Practice regulations. Prior to joining MDCI in 2006, he served as executive director, regulatory affairs and quality assurance for Smith & Nephew Wound Management and as head of regulatory affairs at Advanced Tissue Sciences, Inc. Prior to that, he was with Sorin Biomedical, Inc., where he managed regulatory and clinical activities for the company's complete line of cardiovascular and cardiopulmonary products including heart valves, catheters, oxygenators, and blood cardioplegia delivery systems. At Baxter Healthcare Corporation, Edwards Cardiovascular Surgery Division, Ron was responsible for clinical and regulatory activities supporting the company's prosthetic heart valves and biological vascular grafts. He holds a B.S. in biology from the University of California, Irvine and an M.B.A. from California State University, Long Beach. He is a certified Tissue Bank Specialist and is Regulatory Affairs Certified. Contact him at firstname.lastname@example.org.
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