Mark Rutkiewicz, Innovize Quality VP and Founder of Consiliso, attended the 5/3/19 FDA meeting with the leading stakeholders in the FDA’s Voluntary Medical Device Manufacturing and Product Quality Pilot Program (also known as Case for Quality Voluntary Improvement Program or “CfQ VIP”).  The meeting, held by Dr. Jeff Shuren (head of FDA CDRH), included a select group to discuss their experiences with the voluntary program.  Attendees included FDA, CMMI, MDIC, Two Harbors Consulting, Grant Thornton and industry participants: Medtronic, Baxter, Edwards Lifescience, Illumina, Steris and Innovize.

Industry representatives provided Dr. Shuren with their inputs on how to improve the incentives for this voluntary program and take the assessments (conducted by CMMI) even further.  Over 90 minutes, Dr. Shuren asked questions of industry on what the FDA can do to improve the program, including additional changes to standard QSIT inspections.

The main message delivered: this CfQ VIP encourages a fundamental change in a company’s culture from strictly compliance-based to encouraging continuous improvements. Mr. Rutkiewicz stressed how the current Quality System enforcement culture leads companies to make product quality decisions based on enforcement and the cost/effort of providing regulatory notices, versus making best product decisions for patients.  The CMMI assessments allow groups outside of Quality to become involved with evaluating and changing company methods for being compliant and producing safe and effective devices.  Cisco Vicenty (FDA Case for Quality director) noted that the program has been a learning experience for the FDA, and that additional incentives would be helpful.  The group agreed to continue collecting metrics, feedback from industry, and to determine how to scope ongoing CMMI reassessments.

Innovize and it’s sister company, Consiliso, have made a significant commitment to the CfQ VIP and will continue to work closely with the FDA on its improvement. As the first medical device manufacturer to undergo a CMMI assessment under the pilot program (three completed to date), Innovize and Consiliso remain leading partners between regulators and industry as we continuously improve not only our own company, but the compliance and quality culture of the medical device industry.

For more information on the CfQ VIP, see the FDA Case for Quality Pilot Program page at www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality-pilot-activities

For information on how Consiliso helps medical device companies create efficient, compliant business processes that support instead of hinder continuous improvement, see www.consiliso.com

To learn more about Innovize and its world-class capabilities as a medical device converter, visit www.innovize.com