May 11, 2022

The Medical Device Innovation Consortium (MDIC) has had the privilege
of partnering with the FDA Center for Devices and Radiological Health (CDRH)
to advance the Case for Quality, a transformational initiative to shift the medical device industry from a focus on regulatory compliance to a focus on quality maturity.

This kind of cultural shift doesn’t happen overnight. MDIC, FDA and our industry partners have worked together to develop tools and methods to encourage and appropriately incentivize quality practices.

Beyond the tools, MDIC has sought to cultivate trust between medical device manufacturers and the FDA. That trust is fundamental to developing a culture based on a mutual commitment to quality maturity practices, rather than “check the box” compliance activities.

In December 2017, CDRH launched the Voluntary Medical Device Manufacturing and Product Quality Program Pilot, utilizing a maturity model refined
in collaboration with the Capability Maturity Model Integration (CMMI) Institute, MDIC, and regulatory and industry partners. The maturity model is leveraged as a resource for medical device organizations to measure their capability to produce high quality, safe and effective devices.

This measurement can then be used by organizations to drive targeted continuous improvement activities throughout their facilities. For manufacturers who complete the independent (third party) appraisal of quality maturity, the FDA will adjust their engagement activities and modify their submission requirements and routine inspection plans.

Industry participation is critical to long-term implementation of the maturity model as an alternative to the traditional path of a routine FDA inspection. Participation in the pilot requires an investment, both of personnel and money.

However, companies will receive many valuable benefits. Participating companies can expect to improve organizational processes and reduce variability that could lead to reduced costs of quality, decreased rework, and increased return on investment.

The FDA will also benefit from this program by potentially reducing the internal resources required for evaluation of inspections and manufacturing review submissions. The combined focus on safety and quality can be a win-win for both FDA and manufactures as we advance the health and safety of patients.