Your Device Supplier Isn’t a Supplier — Why FDA Wants Combination Product Companies to Rethink That Relationship

Episode 4 of the Navigating the Combination podcast is out!

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 sit down with Max Lerman, PhD of Suttons Creek and Courtney Evans of AbbVie (formerly Suttons Creek) — both former FDA reviewers — for a candid look at how oversight expectations for combination products have shifted, where companies commonly get tripped up, and what a genuinely proactive quality culture looks like in practice.

The conversation moves from CAPA philosophy to supplier relationships to statistics, tracing one consistent thread: the companies that treat their device constituent suppliers as co-developers — sharing risk information, establishing subsystem-level requirements, and building systemic (not just action-oriented) CAPA systems — are the ones building resilience into their products long before FDA shows up at the door. Max and Courtney also unpack the reasoning behind FDA’s five-nines reliability expectation for emergency-use auto injectors, and why “designing your way into reliability” beats trying to test your way there.

Key takeaways:

• Pharma-heritage CAPA tends to be action-oriented; device-heritage CAPA is more systemic. Combination product companies need both — investigating the immediate issue and watching for the long-term trend

• “Supplier” is a bit of a misnomer for device constituent partners — sponsors remain the designer and are ultimately accountable, which means treating suppliers as co-developers, not vendors

• One of the most common gaps: pharma companies deferring subsystem-level requirements and tolerances to their device supplier with minimal oversight — a decision that surfaces later as bigger problems in post-market investigations

• Sharing risk information with your device partner isn’t optional — if a supplier doesn’t know the risks of your drug, they can’t design, verify, or validate against them

• CDRH and CDER collaboration isn’t about who “leads” — it’s device-dependent, and often more visible in who shows up to an inspection than in any formal handoff

• How you write a design input requirement shapes how you can test it later — the earlier a team plans for variables data, the fewer surprises down the line

• FDA’s five-nines reliability standard for emergency-use auto injectors reflects a straightforward idea: when the severity of failure is death, the acceptable failure rate has to be vanishingly small — and the goal is to design your way into that reliability, not test your way into it

• A proactive quality culture treats discovery and continuous improvement as a strength, not an admission of failure — and stays open to blind spots through internal and external audits alike

Connect with Max Lerman on LinkedIn | Connect with Courtney Evans on LinkedIn

What is Navigating the Combination? Watch the below quick intro video…