What does it really take to build a successful combination product—and why do so many companies struggle with quality and compliance?

In this episode of Navigating the Combination, we sit down with Kalpita Mehta, a quality and compliance leader with experience spanning pharmaceuticals, medical devices, and combination products. Drawing from her unique background as a licensed pharmacist and medical device quality professional, Kalpita shares practical insights into the challenges companies face when developing drug-device combination products.

The conversation explores why design transfer is one of the most overlooked yet critical phases of product development, how poor CMO (Contract Manufacturing Organization) oversight can lead to costly delays, and what organizations can do to strengthen their quality systems before FDA inspections. Kalpita also explains the differences between pharmaceutical and medical device quality philosophies, and why integrating both is essential for long-term compliance and commercial success.

In this episode, you'll learn:
Why design transfer is a major risk area for combination products
How to improve CMO qualification and oversight
Common FDA 483 observations and compliance pitfalls
Best practices for FDA inspection readiness
The importance of Design History Files (DHF) and traceability
How pharmaceutical and medical device quality systems differ
Lessons from the generics industry that improve speed without sacrificing quality
The role of AI in quality assurance and regulatory compliance
Risk-based approaches to building stronger quality systems
Strategies for developing compliant, market-ready combination products

Whether you're involved in combination product development, regulatory affairs, quality assurance (QA), quality control (QC), pharmaceutical manufacturing, medical device engineering, or FDA compliance, this episode provides actionable advice to help you reduce risk, improve operational excellence, and bring safer products to market.

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

#navigatingthecombination #suttonscreek #combinationproducts #drugdelivery #pharmaconsulting #regulatoryaffairs #medicaldevices #biotech #pharmabiotech #fdaregulation #drugdevicedevelopment #lifesciences #combinationproductdevelopment #pharmapodcast #devicestrategy
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.