A recurring theme arose when the FDA invited quality managers from leading medical device organizations to discuss the barriers med-tech makers face in implementing quality measures in design and manufacturing processes:
Device makers want reasonable assurance that the actions they take will be recognized and rewarded by the FDA in a predictable way.
Amid discussions about the long-term costs of poor quality and the price for implementing a quality metric and monitoring standard, industry representatives warned that companies may be unlikely to adopt assurance measures if they fear the FDA will ultimately reject their application anyway.
Quality leaders at medical device titans Johnson & Johnson (NYSE:JNJ), Medtronic Inc. (NYSE:MDT) and GE Healthcare applauded the FDA’s interest in including industry insight in improving quality measures, but voiced concerns that the agency might scare off new measures before they have a chance to make a difference.
While internal measures of the value of a new method as a means of improving quality may hold weight, industry said, FDA endorsement was the real value proposition in the equation.
""It would be great if we could correlate which practices give us the biggest return on the investment – that does give us credibility when we’re talking to our business leaders," GE Healthcare global quality assurance general manager Liz Blackwood said. But, she added, what companies really need is a list of practices endorsed by the FDA. "They’re going to feel more comfortable in endorsing those practices and then they will see the return on investment in those businesses."
Some companies have made efforts to up the ante in quality assurance protocols, Johnson & Johnson chief quality officer Donna Godward said, but were ultimately let down when the FDA rejected their attempts.
"Part of the hesitance by some of our companies is the uncertainty of how the FDA will actually view those new methods," Godward said. "Industry should be more willing to invest in these areas if there was a higher certainty that FDA would readily accept those methods."
Throughout the conversation, the onus of responsibility focused on the agency, its expectations and inspection standards.
"What’s measured becomes important and what’s important gets done," Medtronic global quality VP Luann Pendy said, highlighting the important of using the correct metric to ensure that the issues getting attention are the most important ones for all stakeholders.
"What’s inspected for becomes important and what’s important gets done," FDA Center for Devices & Radiological Health director Dr. Jeffrey Shuren added, urging that the FDA’s inspection process needs to make sure it’s focusing on the right areas so that companies aren’t chasing minor issues of regulatory compliance and missing larger vulnerabilities in quality.
The agency plans a number of actions moving forward to revise the inspection process to highlight quality measures, CDRH office of compliance director Steve Silverman said in his closing remarks. "Today is a starting point and not an ending point."
He added that the agency plans to evaluate its own regulatory practices to address quality gaps and refocus on issues that strongly affect device quality. Also in the works is a public database of medical device quality reports, to ensure that physicians, patients and other stakeholders have access to the most objective data when deciding which device to buy.
Throughout the process, the FDA expects to include voices from the industry to collectively identify areas for improvement and critical practices.
"In the coming months we’re going to complete an in-depth implementation plan and a key part of that plan is going to be outreach to stakeholders, whether through an open docket, public meetings or other venues to make sure that we find and continue to have broad input to guide our efforts," Silverman said.