Navigating the Combination

SE01 E07 Understanding Human Factors in Combination Products | Karthik Yadav Janga

Parth Kothari and Jonathan Amaya-Hodges — Tue, 06 Oct 2026 09:00:00 +0100

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.

SE01 E06 Why Combination Products Can't Be on the Critical Path | Adam Kalbermatten

Parth Kothari and Jonathan Amaya-Hodges — Tue, 22 Sep 2026 09:00:00 +0100

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

SE01 E05 From Insight to Impact: Serving Pharma Better in Drug Delivery | Nadine Brun

Parth Kothari and Jonathan Amaya-Hodges — Tue, 08 Sep 2026 09:00:00 +0100

This interview contains the personal and professional opinions of Nadine Brun which are not necessarily those of BD or any of its affiliates.

Nadine Brun, recently appointed Vice President, Greater Asia, Pharmaceutical Systems at BD, and formerly VP Global Marketing & Strategy for BD Pharmaceutical Systems, brings over 20 years of experience in clinical diagnostics and life sciences to a conversation about what it really takes to serve pharma customers well. Drawing on the parallels between diagnostics and drug delivery — regulation, time to market, and patient outcomes at the center of both — Nadine shares how her background shaped a systems-level approach to combination product development. She unpacks the tension at the heart of the industry: unprecedented scientific innovation on one side, and deep resistance to change on the other, and why that gap is only going to matter more as biologics and complex therapies become the norm...etc.

The conversation covers the real difference between what pharma customers ask for and what they actually need, how to de-risk drug development from early-stage material selection all the way through to commercial supply, and why co-creation with the right partners at the right time is the fastest route to market — not a slower one. Nadine also shares her definition of genuine thought leadership in pharma, what a strong operating model looks like when you are bridging technical and commercial teams, and the one piece of advice she would give any pharma company before they engage a device supplier.
Key takeaways:

Clinical diagnostics and pharma share more than people think — regulation, time-to-market pressure, and patient well-being as the core objective are common threads
The biggest paradox in pharma right now is the push for scientific innovation running alongside deep institutional resistance to change
Large established pharma and emerging biotech have fundamentally different needs from suppliers — one size does not fit all, and a strong operating model reflects that
De-risking is not just about early-stage testing — it is an end-to-end process that includes scalable supply capacity from day one
Co-creation with the right expertise around the table — MedTech, pharma, machine makers, service providers — is what actually accelerates development, not what slows it down
Marketers in technical environments need genuine scientific knowledge; removing that understanding makes it impossible to serve customers well
Thought leadership means identifying customer pain points, building solutions around them, and being willing to take the innovation risks that drive the market forward
NPS surveys and structured customer feedback are practical tools for aligning what you offer with what different customer segments actually value
Engage your supplier partner at the earliest possible stage — waiting until phase two or later to think about regulatory affairs or supply chain is one of the most common and costly mistakes in combination product development

Connect with Nadine Brun on LinkedIn: https://www.linkedin.com/in/nadine-brun-8515011/

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

SE01 E04 Supplier Management in Drug Delivery Systems | Courtney Evans & Max Lerman

Parth Kothari and Jonathan Amaya-Hodges — Tue, 25 Aug 2026 09:00:00 +0100

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

SE01 E03 Revolutionizing Drug Packaging | Matt Wills

Parth Kothari and Jonathan Amaya-Hodges — Tue, 11 Aug 2026 10:20:25 +0100

The container a drug product lives in has always mattered, but as biologics and gene therapies push the limits of sensitivity and complexity, it matters a great deal more. Matt Wills has spent over a decade at the intersection of material science and primary packaging, and in this episode he breaks down what is actually happening at the drug contact surface — and why that surface, not the bulk material, is where the real compatibility story plays out. He explains why glass is hitting its limits with certain advanced formulations, what is lost and gained in a switch to plastic, and how PECVD-based coating technology is opening up a third option that was not on the table a decade ago.
The conversation goes well beyond material selection. Matt walks through how siliconisation introduces risk that teams often underestimate, why container closure integrity failures are rarely a single-component problem, and why the weakest link in a syringe system is so often the interface between components rather than any component in isolation. He also introduces the concept of maintaining a common drug contact surface across the entire manufacturing chain — from API storage through to the final filled container — and what that approach could mean for bridging studies, regulatory validation, and the speed at which programmes can progress.
Key takeaways:

The drug contact surface is the critical parameter in container selection, not the bulk material — glass, plastic, and hybrid containers all behave differently at that surface layer, and understanding the mechanism of interaction is what drives root cause investigations
Glass remains robust and well-characterised, but faces real limitations at high pH (risk of delamination), in complex formulations, and in design flexibility for combination product integration
Plastic offers more design freedom and better compatibility with auto injectors and on-body devices, but introduces trade-offs including oxygen barrier performance and different CCI behaviour at cold storage temperatures
PECVD-based coatings (such as SiO2's technology) allow the drug contact surface to be engineered independently of the bulk container, combining glass-like inertness with the design flexibility of plastic — but regulatory data, while growing, is still newer than glass
Siliconisation solves a real engineering problem but introduces its own risk profile; the question is not whether silicone oil is harmful, but whether its interaction with a specific molecule is acceptable and controllable — and whether an alternative lubrication system might be easier to design around.
Container closure integrity is a pass-fail requirement, not a nice-to-have — Teflon-coated plungers can compromise CCI at cold storage conditions due to differential shrinkage rates, and this needs to be understood before committing to a system
The syringe is a multi-component system, not a single unit — plunger, barrel, siliconisation, needle geometry, and luer design all interact, and optimising components in isolation without understanding their interfaces is where programmes run into trouble
Maintaining a common drug contact surface across the full manufacturing chain (API storage, processing, final container) can reduce validation unknowns, support bridging arguments, and shift the focus from reproving drug-surface interaction to proving like-for-like equivalence between container sizes.

Connect with Matt Wills on LinkedIn: https://www.linkedin.com/in/mattswills/

Visit SiO2 Materials Science: https://sio2med.com/
Subscribe to Navigating the Combination for more conversations on primary packaging, drug-device integration, and the science behind combination product development.
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

SE01 E02 The Combination Product Blind Spot | Nathan Kast

Parth Kothari and Jonathan Amaya-Hodges — Tue, 28 Jul 2026 09:00:00 +0100

In this episode, Parth Kothari and Jonathan Amaya-Hodges sit down with Nathan Kast, a seasoned combination product professional whose career has spanned SHL, Becton Dickinson, and now Stevanato Group. Nathan shares how he stumbled into the drug delivery space entirely by accident, why being a great mentee matters more than finding a great mentor, and what it actually takes to build the kind of supplier-pharma relationships that get therapies to patients faster.
The conversation digs into one of the most persistent gaps in the industry: the tendency of smaller and mid-sized pharma companies to treat drug containment and delivery systems as packaging rather than as integrated parts of the development process. Nathan breaks down why that mindset is rational but costly, how pricing pressures and supply chain regionalisation are reshaping device strategy, and why standardisation is rapidly becoming table stakes rather than a differentiator. A candid, experience-driven episode for anyone working at the intersection of device development and pharmaceutical commercialisation.
Key takeaways:

Being a good mentee — staying humble, open to mistakes, and eager to learn — is what attracts strong mentors, not the other way around
Smaller pharma companies often treat drug delivery systems as packaging rather than as integrated development components, leading to costly late-stage surprises
Framing decisions around total cost of ownership (TCO) helps pharma partners see the downstream risks of deferring device integration conversations
True supplier-pharma partnership means transparent dialogue about constraints on both sides — not just pushing risk downstream
Supply chain regionalisation post-COVID is accelerating, and pharma is now making strategic asset-level decisions about what to near-shore versus centralise
Device differentiation has largely shifted from a competitive advantage to a reliability and scalability question — it's now table stakes for at-home care
Pharma companies are splitting into two camps: those adopting standardised platform devices from suppliers, and those building proprietary internal platforms across their whole portfolio
Understanding why a request is being made — not just what is being asked — leads to better outcomes for everyone in the development chain

Connect with Nathan Kast on LinkedIn: https://www.linkedin.com/in/nathan-kast-4568641b/

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

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

SE01 E01 From Medical Devices to Combination Products: Navigating FDA, Reliability, and Quality Leadership | Jeff Gensler

Parth Kothari and Jonathan Amaya-Hodges — Tue, 14 Jul 2026 10:33:10 +0100

Welcome to the first episode of the Navigating the Combination podcast!

When Jeff Gensler walked into Pfizer Meridian on day one, FDA had left the building just a week earlier. What followed — a warning letter response, 15 FDA meetings in four months, a CDRH site audit, and an agency directive to redesign the entire product — was a challenge, but also an opportunity for in-depth examination of the company’s quality systems. In this episode, Jeff joins Parth and Jonathan to unpack those early days, the gaps he found between pharma and device quality thinking, and how that experience shaped his entire approach to process capability, CAPA, and compliance.
Jeff breaks down why the transition from attribute to variable data is so much more than a methodology switch — and shares a real example of how catching a single worn mould cavity early saved millions of dollars in scrapped components. He also makes the case for why quality professionals need to stop speaking compliance-only and start building business cases that leadership can actually act on. Now Chief Quality Officer at Exela Pharma Sciences, Jeff reflects on what the shift to the CDMO space looks like, where the industry is heading, and why he believes quality is becoming a competitive advantage rather than a cost center.

Key takeaways:
Pharma and device quality systems differ fundamentally in CAPA philosophy - pharma treats CAPA as actions from investigations, while device uses it systemically for trend violations and major issues
Switching from attribute to variable data requires process improvement work first — you'll surface capability gaps that were invisible before
Variable data allows earlier detection of process drift, as demonstrated by catching a degraded mould cavity before a single out-of-spec part was produced
Quality improvements need a business case, not just a compliance argument — linking changes to cost savings significantly increases the chance of leadership buy-in
Process validation should go deeper than IQ/OQ/PQ checkboxes — centring processes within OQ limits prevents failures down the line
Continuous process monitoring catches variation sources that a three-lot PQ simply cannot represent CDMOs are often out of sight with FDA — building a proactive quality culture internally is both a compliance strategy and a market differentiator
Run towards the fires — warning letters, drug shortages, and enforcement actions are where quality professionals learn the most, fastest

Connect with Jeff Gensler on LinkedIn: https://www.linkedin.com/in/jeff-gensler-67a54a1a/.

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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