Adam Kalbermatten has spent thirty years moving across the drug delivery landscape, from engineering programmes at Becton Dickinson through global marketing leadership at Terumo, to building and scaling ZebraSci as CEO before its acquisition by BD. Now CEO at Koru Medical Systems, he's focused on large volume subcutaneous infusions and expanding the label for IG patients in the SKIG market.

In this conversation, Adam talks about what actually reduces risk in combination product development, why pharma partners often underestimate the complexity they're introducing, and why the most important thing a device supplier can be is a partner rather than a vendor. He's direct about what keeps him up at night, what it means to build a cross-functional team that actually works, and why the biggest mistake development programmes make is ending up on the critical path at all.
Key takeaways from this episode:

Why following proven regulatory pathways beats developing custom specifications, almost every time
How to surface risk cross-functionally before it becomes a programme-level problem
What the supplier-partner distinction means in practice and where pharma companies get it wrong
Why combination products that land on the critical path rarely escape it

Connect with Adam Kalbermatten:

https://www.linkedin.com/in/adamkalbermatten

https://korumedical.com
If your development programme is already feeling the pressure of the critical path, this one's worth your time.

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.