US regulators are teaming up with medical device companies and non-profit organizations in an effort to advance better and safer tools for evaluating the safety, quality and efficacy of medical technologies.
The new Medical Device Innovation Consortium (MDIC)—a public-private partnership established jointly by the US Food and Drug Adminsitration (FDA) and LifeScience Alley, a Minnesota-based trade association, and other industry representatives—will “create a safe haven for pre-competitive collaborative research between academia and industry focusing on medical devices,” FDA commissioner Margaret Hamburg said at a press conference earlier today to unveil the initiative.
The path to developing new medical devices for clinical use in the US is a lengthy one. Unlike in Europe, where companies only have to show that a device is safe, in the US they must also demonstrate a device’s clinical effectiveness in treating a disease or medical condition. This has led to an approval lag in which devices typically reach US patients only after they have been on the market in the EU for several years.
To shorten that time lag, the FDA is now looking to industry for ideas—which is where the consortium comes in. By sharing resources between MDIC members, for example, the FDA hopes to create effective, efficient and standardized ways to validate and review devices and to prioritize funding and regulatory science decisions. “For the first time, we can determine priorities, bring together collaborative minds and analyze post-market values to determine safety and efficacy,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said at the press conference.
Dale Nordenberg, executive director of the Medical Device Innovation, Safety and Security Consortium (MDISS), a nonprofit professional organization not associated with MDIC, praised the FDA for bringing together stakeholders through the private-public partnership. “However, the success depends on robust governance by FDA to ensure effective representation across stakeholder groups for public health needs,” he told Nature Medicine.