Virtual systems can help reviewers assess stent designs, says Daniel Schultz.
CDRH unveiled its contribution to FDA's Critical Path Initiative in May. The Medical Device Innovation Initiative is a plan to help get transformative technologies, such as molecular diagnostics and nanotechnology-based products, to market more efficiently.
“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 FDA,” the agency stated in its announcement of the initiative. “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.”
According to the agency, that means that it “will need to develop better ways to predict earlier in the process which new products are likely to be safe and effective in patients and how best to deploy technologies to maximize benefits and minimize harm. In particular, we need to ensure that clinical trials, product reviews and approvals, and manufacturing processes are conducted in the most efficient and effective ways,” said FDA. “Failure to take appropriate steps now may stifle future innovation and delay patient and practitioner access to important safe and effective devices.”
The initiative consists of three major efforts. The first is promoting scientific innovation in product development. That includes stepping up production of guidance documents for innovative products. But it also has to do with guiding the development of new tools that industry can use.
FDA developed anatomically and physiologically accurate adult and pediatric virtual circulatory systems for reviewers to use as tools. These virtual systems can help reviewers assess the safety and effectiveness of stent designs prior to fabrication and physical testing. CDRH Director Daniel Schultz referred to their tools at a celebration of the 100th anniversary of U.S. food and drug regulation, held in May in Philadelphia.
“We envision using computer models of human physiology to create a virtual family,” he said. “The idea is that you could assess a design without having to test it on animals or patients. The models could identify problems or concerns before [testing].”
The second effort is focusing device research on cutting-edge science. CDRH plans to use its laboratory research staff to support efforts to improve the device development process. For example, its staff has played a major role in creating new models and methods for assessing computer-aided diagnostic systems.
The third effort is modernizing the review process of innovative devices. This effort, in part, means not only reducing review times, but also helping industry get applications right the first time. It also means producing guidances for things like Bayesian statistical analysis methods for clinical trials.
This effort also includes leveraging information technology (IT) solutions. CDRH hopes to develop new IT systems that better track and monitor premarket submissions and improve coordination among reviewers. Modernizing the process also means expanding the Medical Device Fellowship Program to bring in outside experts with specialized knowledge.