FDA's Voluntary Improvement Program

March 21, 2024


In this episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Kim Kaplan from ISACA at the MD&M West trade show in Anaheim, California, to discuss the pivotal Voluntary Improvement Program (VIP).

This conversation sheds light on how the program, stemming from FDA’s Case for Quality initiative, utilizes the Capability Maturity Model Integration (CMMI) to push medical device companies beyond compliance, towards excellence. Kaplan elucidates the history of VIP, its benefits, and how it aligns with the FDA’s vision for a more innovative and quality-focused MedTech industry.

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Key Timestamps

  • [00:00:30] Introduction of Kim Kaplan and the Voluntary Improvement Program
  • [00:05:00] Explanation of CMMI and its adoption in the medical device industry
  • [00:15:45] Distinctions between CMMI and other quality methodologies
  • [00:25:30] In-depth discussion on the specifics and benefits of the Voluntary Improvement Program
  • [00:40:00] How companies can implement change based on VIP insights
  • [00:50:00] FDA’s perspective and regulatory opportunities tied to VIP participation

Key Takeaways

  1. Understanding VIP: The program aims to elevate quality and operational efficiency through a collaboration involving FDA, MDIC, industry stakeholders, and ISACA.
  2. CMMI’s Role: CMMI’s flexible, globally adopted framework helps MedTech companies identify and implement best practices in product development and project management.
  3. Benefits of Participation: Beyond improving quality, VIP participation can streamline regulatory processes, fostering quicker innovation and market access.


Memorable quote:

  • “Organizations that are compliant aren't necessarily avoiding the types and numbers of issues faced by non-compliant ones.” - Kim Kaplan
  • “CMMI focuses on the 'what' to do rather than the 'how,' allowing for a framework that compliments existing processes.” - Kim Kaplan
  • “The Voluntary Improvement Program isn't just about compliance; it's about embracing continuous improvement as a culture.” - Kim Kaplan

Practical Tips for Listeners:

  1. Engage with CMMI: Consider how CMMI’s framework could complement your company’s existing quality and project management processes.
  2. Explore VIP: Assess your organization's readiness and potential benefits from enrolling in the Voluntary Improvement Program.
  3. Continuous Improvement: Embrace continuous improvement, not just for compliance, but as a cornerstone of your company culture.


Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.


This episode is brought to you by Greenlight Guru, the only quality management software designed specifically for the medical device industry. Streamline your process and foster innovation with Greenlight Guru’s intuitive platform!

About the Global Medical Device Podcast:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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