Medical devicemakers soon could have a new way to measure quality, thanks to a program created jointly by the FDA and Xavier Health and recently 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 meeting last month in Washington, D.C. They discussed a number of projects related to the initiative, including a metrics program intended to raise product quality above basic compliance.
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 said that the program is intended to follow devices across the total product lifecycle. It 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.
To start, MDIC, the FDA and Xavier brought in representatives from 15 firms to examine critical systems to ensuring device quality. They eventually focused on 11 systems and identified good quality practices within those systems to bring product quality to the next level.
The team then surveyed industry to determine ways to measure these good quality practices — what have been dubbed gold and silver activities. Members of the team then settled on 17 measures that companies can use during the total product lifecycle to ensure they are going above and beyond the base level of compliance to ensure a higher standard of quality. One example for the production phase was CAPA sustainability, or the percentage of CAPA with no recurrence.
In the next phase, the team chose three of the 17 measures — one in each phase of production — to pilot as a way to validate their use. The team has defined the frequency of taking each measure and how each should be reported.
A pilot involving six firms is set to launch this 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 to be reported back to MDIC in June 2016.
The project’s roots lie in the FDA’s Case for Quality initiative, which was launched in 2011.
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.
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