What are the biggest combination product compliance risks companies are facing today—and how is FDA enforcement evolving?

In this episode of Navigating the Combination, hosts Jonathan Amaya-Hodges and Parth Kothari are joined by Max Lerman of Suttons Creek and Courtney Evans of Abbvie (formerly Suttons Creek - at the time of recording) for a deep dive into the regulatory and quality challenges shaping the combination product industry. Drawing on their experience as former FDA reviewers, they discuss how FDA expectations for combination product oversight have changed, where companies commonly fall short, and what organizations can do to build more resilient quality systems.

The conversation explores the differences between pharmaceutical and medical device approaches to CAPA, why supplier oversight has become a major FDA focus area, and how sponsors should think about device constituent suppliers as true development partners rather than traditional vendors. Max and Courtney also break down the reasoning behind FDA’s well-known five nines reliability expectation for emergency-use auto injectors, including what it means for design robustness, testing strategies, and lifecycle management.

In this episode, you’ll learn:
The biggest CAPA pitfalls for combination product companies
How FDA views systemic vs. action-oriented CAPA approaches
Why supplier oversight is becoming more rigorous for combination products
The importance of sharing risk information with device partners
When CDRH and CDER collaborate during combination product reviews
How to think about variables data, reliability, and process capability
The regulatory rationale behind five nines reliability for emergency-use injectors
Why quality culture matters more than ever before FDA inspection
Best practices for proactive quality management and continuous improvement

Whether you work in combination products, regulatory affairs, quality assurance, medical devices, pharmaceuticals, supplier quality, manufacturing, or FDA compliance, this episode provides practical insights into building systems that can withstand regulatory scrutiny and support long-term product success.

I hope you enjoy this episode! Give it a like, share, and subscribe to not miss the content coming your way weekly.
– Parth & Jonathan and the Navigating the Combination podcast team

Connect with Parth Kothari on LinkedIn: https://www.linkedin.com/in/parthjkothari/ Connect with Jonathan Amaya-Hodges on LinkedIn: https://www.linkedin.com/in/jonathanwhodges/ Visit the Suttons Creek website here: https://suttonscreek.com
Listen to Navigating the Combination on these podcast platforms:
Spotify: https://open.spotify.com/show/033HRTwEj7aFLx9K8ZEsVG
Apple Podcasts: https://podcasts.apple.com/us/podcast/navigating-the-combination/id6786238670
Amazon Podcasts: https://music.amazon.com/podcasts/12169e2d-2323-41db-bdb4-8a8e7841c799

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Navigating the Combination is the podcast for pharmaceutical and biotech professionals tackling one of the industry's most complex challenges: bringing drug-device combination products to market. Hosted by Parth Kothari and Jonathan Amaya-Hodges of Suttons Creek - the device team for pharma - each episode draws on 650+ combined years of experience and 120+ successful launches to cut through the complexity of combination product development, from device selection and regulatory strategy to OEM alignment, quality systems, and FDA submissions.
Whether you're a VP of Regulatory Affairs weighing your submission strategy, a program director managing a complex OEM relationship, or an executive trying to protect a multi-million-dollar drug investment, this podcast gives you the insight, clarity, and confidence to make the right calls - right the first time.