Industry and FDA One Step Closer on Case for Quality Guidance

July 1, 2016

FDA anticipates releasing its draft guidance on quality metrics for medical device firms in the next few months, the agency said.

The quality metrics initiative will allow firms to determine how products are performing in real-world scenarios during all three lifecycle stages: premarket, production and post-production. By developing metrics across the total product lifecycle, companies will be able to better assess their critical quality practices.

In 2014, the Medical Device Innovation Consortium created a quality forum in collaboration with the FDA and Xavier Health to develop key quality metrics (IDDM, Sept. 25, 2015).

Representatives from the consortium presented results from an initial pilot project during a June 28 MDIC meeting in Washington, D.C.

The goal of the pilot was to determine which metrics would be most indicative of quality.

Abbott, Baxter, Biomerieux, Boston Scientific, J&J, Meridian Bioscience, Stryker and WL Gore participated in the pilot program.

Participants collected data from October through March, and conducted a two-year retrospective analysis on three specific metrics. Only in-company comparisons were made at this point, since company-to-company comparisons would involve too many variables.

Participants discussed and identified metrics that went beyond compliance, and labeled those as gold and silver activities that could reduce risk.

The pilot began with a focus on the following 11 critical systems:

  • CAPA;
  • Change control;
  • Complaint handling;
  • Customer Related;
  • Design controls;
  • Distribution;
  • Management controls;
  • Post-launch surveillance;
  • Production and process controls;
  • Servicing; and
  • Supplier controls.

The road to creating meaningful metrics began with identifying activities that set the best companies apart from average companies.

Examples of these include: design controls that ensure minimal quality changes before design transfer, keeping track of trends with no repeat failures and monitoring quality system management.

Pilot companies analyzed which measures could be used to indicate quality and came up with 17 measures that broke down across the total product life cycle as follows: two in enterprise-wide continual improvement, four in the pre-production phase, eight in the production phase and three in the post-production phase.

The top three measures were selected and converted into metrics that included design robustness, right first time (RFT) and post production index. The pilot study examined these top three measures across companies of various sizes with varying products.

The pilot posed six hypotheses for the measures chosen:

  • Metrics improve with product lifecycle maturity;
  • Higher number of complaints and recalls come from products that have a high number of design changes;
  • Low production RFT comes from products that have a higher number of design changes;
  • Products with higher non-conformances have a higher volume of complaints;
  • Products with higher complaints have greater probability of MDRS and recalls; and
  • Risk tolerance.

During analysis of the measures, pre-production was identified as the toughest phase to track changes in improvement due to continuous trial and error which loops back to research and development.

Participants agreed that the goal was to create a self-correcting system across the product life cycle to establish a continuously improving (maturing) system from the earliest point possible.

A number of concerns arose during the pilot project, such as raising awareness and getting approval internally to participate in the program. Other challenges arose due to the complexity of products within portfolios and inconsistency in definitions used. Manufacturers also raised concerns about sharing data between companies and taking company data out of context. Collecting data was also seen to be burdensome on companies.

To drive industry participation in a voluntary program, panelists suggested more incentives were needed beyond being inspected less.

Next steps are a best practices document based on the pilot program to better inform actions in the next few months. — Joya Patel