Do it safely and do it fast — translating medical devices from idea into use
The coronavirus pandemic has demonstrated how crucially important it is to bring new and innovative medical products to market as quickly as possible, while still ensuring they are safe and effective and perform as intended. If new discoveries and products linger in the lab or in research, they provide no benefit to patients. Taking too long to reach market also can starve a startup of funding or make an established company cancel a project, with the promise of the research never realized.
Take as an example medical devices. These range from tongue depressors and exam gloves to implanted defibrillators and joint replacements, to MRI and X-ray machines, to Covid-19 tests and apps on your smartwatch or smartphone. There also are “combination” products — which integrate a device with a drug or a biologic product. For example, a stent is a small metal tube implanted in a blood vessel to help open the vessel. The stent is a medical device, but if you add a drug coating to help keep the vessel open longer, it’s a combination product with additional regulatory requirements.
Medical devices and combination products are developed within a regulated environment. Design and testing must be documented, and there are standards and guidances to consider when designing a test plan and performing non-clinical and clinical studies. This requires a close working relationship among regulatory professionals, engineers, clinical experts, business leaders, and others. Engineers and scientists often make very effective regulatory professionals, because they have the technical background and knowledge to understand the product and speak the same “language” as the device developers and regulators.
The speed of new product development often outpaces the ability of regulators to remain current on a technology. As a result, those developing new devices become the world’s experts on their technology, and it is their responsibility to help educate regulators. For example, new technologies may require novel test methods to evaluate safety or performance. Additionally, new tools are emerging that can more efficiently evaluate devices — for instance, via simulated, “in silico” clinical trials that can be completed quickly and safely without enrolling or treating any patients, to partially replace the need for human clinical trials.
Rapid communication can help resolve questions swiftly and minimize delays in moving product development or testing forward. The FDA has something called Sprint Discussions as part of its Breakthrough Devices Program for medical devices and combination products that offer more effective treatment or diagnosis of diseases or conditions that are life-threatening or irreversibly debilitating. These frequent, interactive reviews can speed consensus on specific issues while there still is time to make changes and modify plans during product development.
In three graduate-level courses at Purdue, I share regulatory knowledge (acquired in a former role as director of regulatory science at device maker Cook Medical) to help bring new discoveries and medical products from research to clinical use, and ultimately to regulatory approval and commercial availability. Leaders in industry and the FDA help us develop course content, and teach students via case studies, examples, and experiences. We also are creating a Graduate Certificate in Regulatory Affairs and Regulatory Science for Medical Devices.
Additionally, we work closely with the Indiana Clinical and Translational Sciences Institute (CTSI) to assist faculty and researchers in navigating the regulatory process. We also aid investigators at Purdue, Indiana University and the University of Notre Dame in bringing their ideas to market.
Moving forward, we want to continue to increase the amount of experiential learning in our courses to better prepare students to develop successful regulatory strategies and leverage cutting-edge regulatory programs to accelerate product development. We recently talked with the FDA about how the Weldon School of Biomedical Engineering may be able to contribute to advancing the work of the FDA Office of Science and Engineering Labs (OSEL) by identifying and developing new tools — in such areas as additive manufacturing, material science and digital technology — to assist with medical device development and evaluation. To provide our students a global perspective on medical device development and harmonization of regulations, we are planning a study abroad program with regulators, researchers, device developers, and industry partners in Japan.
Maintaining the status quo will not lead to improvements — we have to take risks, and try innovative ways of doing things if we want to be more effective and efficient. The FDA and industry response to the pandemic has given us many examples of a flexible approach tailored to the situation while meeting scientific and regulatory requirements. The pandemic also highlighted the importance of good communication, as well as communication pathways.
The optimal future for translation of medical devices and combination products into commercial use involves open communication and collaborative partnership among researchers, regulators and other stakeholders, along with a continuous effort to find more efficient techniques to bring safe, effective and innovative new products to patients.
Aaron Lottes, PhD, MBA
Associate Professor of Engineering Practice
Weldon School of Biomedical Engineering
College of Engineering, Purdue University