Cost Concerns Loom Over Success of CDRH Quality Device Manufacturing Pilot Program

A pilot program at US Food and Drug Administrations (FDA) Center for Devices and Radiological Health (CDRH) aimed at identifying best practices for quality manufacturing and medical device development is underway with more industry participants than previously anticipated, despite the cost constraints that caused some to dropout, among other challenges.

CDRH’s Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ) – launched last December with a limit of no more than nine participants with demonstrated compliance to quality system regulations – racked up a total of 13 participants with 17 different facilities enrolled, as noted in the first quarterly update on the program.

Among the participating medical device companies, which are collaborating with FDA and the Medical Device Innovation Consortium (MDIC) to understand how an appraisal model can be used to reduce the number of site inspections that may lead to unnecessary disruptions in operations, as well as the associated costs, six appraisals have already been conducted by the CMMI Institute, program manager Kimberly Kaplan, said during a CfQ webinar on Tuesday.

An additional three appraisals are on track to be completed next month, Kaplan said.

The time companies are spending from enrollment to appraisal completion is averaging about 98 days, according to Kaplan’s survey results of the program’s effectiveness.

She added that 91% of the surveyed companies agreed the appraisal helped identify areas for improving the work related to increasing product quality, while only 2%  reported the appraisal’s 11 practice areas have conflicted with their regulatory compliance assessments. Yet several challenges remain with the program uptake process, particularly with retaining smaller firms, as the development process requires feedback to ensure future success.

Compared to the agency’s routine two-day site inspections of manufacturing facilities, the appraisal mindset is “very radically different,” CDRH’s Francisco Vicenty said, adding that the CfQ undertaking enables different conversations around what defines quality management systems.

The data gathered and shared as part of the CfQ process will allow agency officials to focus on finding new ways to help drive improvements at the company level, rather than just making decisions on whether enforcement actions are needed, Vicenty said. 

From using a defined maturity model to identifying improvement areas to faster turnarounds with 30-day submissions to FDA and expedited product approvals and/or clearances, there are several potential benefits made available to those companies deciding to participate in the program.
 

Cost Concerns

As the participants explore these new opportunities, however, lessons learned have emerged. For example, Kaplan learned companies face difficulties with shifting away from the audit mindset toward one that allows for more collaborative, informal interactions via the appraisal approach. 

Also, some smaller medical device companies have disenrolled due to unanticipated cost constraints – an issue the agency hopes to address with ongoing feedback throughout the program’s co-creation process, Vicenty said. According to Vicenty, the long onboarding process has been a major driver of participation costs. “We need more feedback to address this,” he said.

A solution to address manufacturers’ cost concerns that FDA is currently working on involves adjusting when it starts making regulatory modifications to appraisals. CMMI and other participants are also developing and providing additional options to manage costs, Vicenty said.

The challenges with preparing for a visit from an appraisal team, unsurprisingly, has also differed among companies of different sizes. Boston Scientific  – a multinational device manufacturer –  found participating in the program could bring “very attractive” benefits, but it also required assessing different product lines, and a new discussion around resource allocation, quality assurance director Joe Friedrich said during the webinar.

Still, Friedrich argued appraisals could help streamline the process in providing FDA with the needed assurance of quality manufacturing practices with significantly less time and resources spent preparing for an appraisal team compared to site inspections due to the more casual nature.

Some of the key differences between CMMI appraisals and FDA inspections, according to Friedrich, include minimal disruption to device manufacturing site resources, and a larger, more collaborative conversation, involving a greater number of stakeholders to “truly understand how the business operates relative to best practices.”

Further, participants are only required to focus on their appraisal’s 11 practice areas – derived from the 2016 CfQ concept pilot – as opposed to all the 21 CFR Part 820 requirements.

Quarterly progress updates will continue as CDRH and participants such as Boston Scientific seek to ease concerns over the pilot’s execution. A second appraisal expanding on the in-scope practice areas for greater participation in the 510(k) space, set definitions of key terms, and modifications of the pilot metrics are among the topics of interest for future discussions on the CfQ development.