MDIC Makes Case for Quality to Measure Medical Device Strength
Medical devicemakers could soon have a new way to measure quality, thanks to a program created jointly by the FDA and Xavier Health, and adopted by the Medical Device Innovation Consortium.
Representatives from the consortium, the first-ever public-private partnership between the FDA and organizations involved in medical device research, provided an overview of the Case for Quality initiative during a Friday MDIC meeting in Washington, D.C.
The program will include an ongoing quality forum to determine areas of improvement, an analysis to prioritize projects to ensure development and improvement of key quality metrics.
Xavier Director Marla Philips tells IDDM that the program will allow firms to measure design strength and determine how products are performing in a real-world scenario at three lifecycle stages: premarket, during production and post-production.
The project’s roots lie in the FDA’s Case for Quality initiative, which was launched in 2011.
A pilot involving six devicemakers is set to launch next month. Participants will collect data from October through March, and a retrospective analysis will be conducted to assess the results. A report on the pilot is expected in June 2016.
In addition, a Case for Quality working group is looking to develop a quality “SAT score” to generate Consumer Reports-like information about devices. Jan Welch, acting director of CDRH’s Office of Compliance, says the ultimate goal would be a four-star product.
More details on this effort will be spelled out at MDIC’s Oct. 8 meeting in San Diego. — Elizabeth Hollis