Let's say a large medical device company has developed a new computer heart simulator that the FDA thinks is acceptable for running tests--or a new clinical trial design in a cutting-edge field.
In the past, a small, early-stage company would have been in the dark about this. But that could now change under the public-private Medical Device Innovation Consortium rolled out over the past year.
Eventually, early-stage companies could end up striking business deals with the big dogs in order to gain access to the heart simulator or the clinical design. The general information might even be public knowledge.
That was one of the major takeaways from a panel of consortium leaders show spoke Wednesday morning at the trade group LifeScience Alley's 2013 conference in Minneapolis.
"The companies can come together with the FDA and talk about, 'What are these methodologies? What are these tools?' … Everybody can rely on the same tool. You can have common tools that can demonstrate some aspect of your product that you don't have to do yourself," says Susan Alpert, a Minneapolis consultant who was most recently senior vice president and chief regulatory officer at Medtronic.
To support the process, the FDA recently came out with new medical device tools guidance that allows a company's previously approved computer simulators or benchmarking processes to be used again, or even used by another manufacturer, says Michelle McMurry-Heath, associate director for science at the FDA.
William Hawkins III, a former Medtronic CEO who is now president and CEO of Immucor, is chair of the MDIC. He wishes something like it was around years ago so that medical device companies could have worked with the FDA on ways to determine the longterm performance of a medical device wire, a lead.
"We're still struggling to the point that we're not seeing that many new leads coming onto the marketplace," Hawkins says. "If no one is getting a technology approved, it is no advantage for a company to think they have something that is a little bit better."Such a setup through the MDIC could work because, "It's probably 70% that we can share and 30% that we might want to keep proprietary," says Randall Schiestl, vice president of R&D and global technology at Boston Scientific.
The overall goal of the Medical Device Innovation Consortium is regulatory science," in other words the development of methods, tools, and resources for better managing the total product life cycle of a medical device.
William Murray, most recently CEO of Envoy Medical, became CEO of the Consortium in August.
Some of the Consortium's initial projects include:
A steering committee on patient-centered benefit risk assessment is trying to get patients' voices into the device review process. The question is how to better incorporate patient preferences into the benefit risk assessment. How willing are the patients to accepts device-related risks for the potential benefits?A clinical trial innovation and reform project seeks adoption of large, simple trial methods, including a refocus away from the "pre-market – post-market" framework, with rigorous analyses over a total product lifecycle. The idea is to make market release incidental, with the focus more on continuous product updates to inform the target patients, health providers and the public.A computer modeling and simulation project seeks better ways to evaluate new and emerging technologies, and to develop novel ways to use clinical data in evaluating medical devices.
Schiestl says he and other working with the computer simulations steering committee already have pilot projects in the works.
"If industry can come together and create methods and tools the FDA will accept, that will speed up the development cycle for everybody," Schiestl says.
