On June 26, the FDA hosted an Executive Forum on the “Case for Quality Initiative.” The forum brought together Industry Executives, FDA Officials and Industry Advisors in a series of roundtable discussions and presentations.
After the event, I had the opportunity to converse with two FDA Officials to gain their perspectives on the forum.
“For the Case for Quality Initiative to be successful, we need sustained, collaborative discussions with stakeholders about the practices that relate to the design and development of high-quality medical devices,” commented Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health (CDRH).
“Through regular engagement with stakeholders the FDA is learning about the impact and limitations for our current regulatory models. Using that feedback we are exploring how the FDA can align its regulatory approach with manufacturer practices that promote high-quality device production,” noted Francisco Vicenty, Acting-Branch Chief of the Respiratory, Ear/Nose/Throat, General Hospital, and Ophthalmic Devices Branch within the Division of Manufacturing and Quality in FDA’s CDRH Office of Compliance.
The Executive Forum afforded participants the opportunity to have open, candid, and constructive discussions on ways to improve interactions between industry and FDA. I was especially heartened by the willingness of all participants to look beyond the current state and envision a more collaborative relationship which benefits all constituents.
The forum included industry presentations from:
- Covidien: Enhancing quality and risk-benefit decision making
- Boston Scientific: How quality is creating a competitive patient care & business advantage
- Terumo CVS: Advancing product quality
In addition, a series of roundtables provided ample opportunity for healthy and constructive exchanges on topics including:
- Stakeholders objectives, measurements, and product quality fit
- Investing in prevention and product quality – barriers & business justification
- Removing barriers to invest in prevention and product quality
My presentation at the forum focused on the industry’s need to stop chasing defects and instead start improving processes. I also provided a roadmap for the journey from recurring Corrective Action (CACA) to a primary focus on Preventive Actions (PACA). Stay tuned for more on this presentation in a later article.
Some of the interesting ideas from our discussions included:
- Appointing an FDA focal point or navigator for each company
- Allowing FDA to have an advisory and consulting role, not just enforcement
- Requiring company CEOs to be present during inspections
- Use of quality data to target inspections
- Inspections based on changes / events, instead of time
- Job swaps and internship between FDA and industry
- Pitching submissions to FDA (akin to investor pitch or defending a dissertation)
“We have been very pleased with the feedback and level of engagement that we have received from industry. There is real value in regular stakeholder engagement to explore and identify topics that advance the Case for Quality,” observed Steve Silverman.
I expect that significant progress will result from these open, candid, and constructive discussions on ways to improve product quality and facilitate interactions between industry and FDA.
It was an honor and a pleasure participating in the event and I look forward to continuing to contribute to the Case for Quality Initiative.
To learn more about the Case for Quality Initiative, read our interview series with Steve Silverman, Director of the Office of Compliance at FDA’s CDRH.