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.

Most combination product conversations start on the device side. Karthik brings the opposite perspective — over 15 years in drug product development, formulation science, and biologics manufacturing — and that pharma-first lens reveals a set of blind spots that quietly derail programmes. In this episode, he unpacks why treating a delivery system as a commodity is one of the most common and costly mistakes in the space, and why the shift from a vial to a pre-filled syringe is never the simple "like-for-like" switch it appears to be.
From late-stage presentation switches and in-licensing due diligence to human factors timelines and essential drug delivery outputs, Karthik walks through the full arc of where pharma teams get caught short. He covers the regulatory reclassification burden under 21 CFR Part 4, the gap between supplier documentation and a sponsor-owned design history file, and why a human factors programme needs to start in Phase 2 — not Phase 3. If your organisation is moving a biologic from physician-administered IV to patient self-administered auto-injector, this episode maps the terrain.

Key takeaways:

Devices are co-equal partners in combination product development, not packaging decisions — the sooner development teams internalise this, the fewer surprises they will face
Formulation, device, and manufacturing outputs cannot be validated in isolation; they must be treated as one integrated system
Late-stage presentation switches trigger regulatory reclassification work (Request for Designation under 21 CFR Part 4) that is consistently underestimated for both time and cost
Supplier/device master file documentation provides a starting point, but sponsors must build their own design history file — FDA has issued CRLs specifically for this gap
Due diligence for in-licensed compounds should include container closure re-evaluation, shipping and distribution validation for finished combination products, and post-market surveillance infrastructure for MDR reporting
Human factors programmes typically run 18–36 months from early formative work through summative validation — budgeting for this at Phase 2, not Phase 3, is critical
User definition must reflect actual intended users (e.g., elderly patients with reduced grip strength), not healthy research staff
Regulatory literacy across both frameworks — 21 CFR Part 4, ISO 13485, IEC 62366-1, EU MDR Article 117, QMSR — is still relatively rare and represents a genuine competitive advantage for practitioners who develop it early

Follow Navigating the Combination for more episodes on combination product development, drug-device integration, and the regulatory frameworks shaping the space.

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. 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.