From the March 2017 issue of HealthCare Business News magazine
Seasoned medical professionals can help entrepreneurs better understand and identify relevant clinical challenges and how they can best be addressed, as well as provide immediate feedback on device concepts. There needs to be a very tight fit between the clinical and medical technology community to develop optimal solutions to advance the field.
A healthy regulatory Environment
Streamlined and expedited processes will go a long way in helping med-tech startups get to market faster. The medical device industry and regulatory entities have not always seen eye to eye on the most effective and efficient ways to bring innovative technology to market. In fact, onerous regulations have frequently been cited as a major obstacle for the industry, driving products to be developed outside of the U.S.
But, in the past few years, we have been heartened by significant, positive developments made by the FDA, as the agency has prioritized protecting and promoting health by ensuring that innovative technology reaches patients. We know about these efforts firsthand, since the Fogarty Institute is one of the organizations with which the FDA has collaborated as it works to support and accelerate medical innovation. In 2015, we launched a first-of-its-kind educational program with the agency with the goal of improving communication, collaboration and understanding between the FDA and early-stage medical device innovators. The program was so successful that it doubled in size in 2016.
This is just one point underscoring that advancements in medicine are made via interdisciplinary collaborations. It is up to all of us to ensure that more of these types of programs are created, not only with startups, but also with physicians and hospitals. The result will be enhanced communication and a clearer understanding of the industry’s needs, challenges, and ultimately, solutions.
Access to hospitals to conduct clinical trials
Innovation is validated in clinical settings. These trials are an essential step for medical technology to satisfy the regulatory process, but also to provide meaningful feedback to startups on the technical feasibility of their device. Many startups have turned to foreign countries to conduct their trials due to accessibility and lower costs. It is time to turn the tide. Having access to hospitals, qualified staff and patients that will help startups test and improve their devices is critical in helping advance innovation. We need to do that here in the U.S. to maintain our innovative edge and provide our citizens with the best available health care solutions.
