Drawing on our executive search practice, we put this together to give employers a grounded, practical view they can act on. Combination products, where a device and a drug or biologic come together in a single therapy, create a hiring problem that neither pure device nor pure pharma experience solves. These products sit across two regulatory frameworks, two development cultures, and two commercial models, so the leaders who run them need genuine fluency in both worlds, and that profile is rare.
Key Takeaways
- Combination products span device and pharma regulatory frameworks.
- Neither pure device nor pure pharma experience is sufficient alone.
- Leaders must navigate which FDA center has primary jurisdiction.
- Development cultures differ sharply between device and pharma.
- Look for genuine dual fluency or demonstrated ability to bridge both.
Two Worlds in One Product
A combination product, a drug-eluting stent, a prefilled autoinjector, an inhaler with an integrated drug, is regulated, developed, and commercialized across two traditions that do not naturally align. Device development tends to be iterative, faster, and engineering-led; pharmaceutical development is longer, more heavily clinical, and chemistry- and biology-led. The regulatory frameworks differ, the quality systems differ, and the commercial models differ. A leader steeped in only one of these worlds will systematically misjudge the other, which is why combination-product leadership demands genuine dual fluency rather than depth in a single tradition.
Regulatory Jurisdiction and Its Consequences
For combination products, the FDA assigns a lead center based on the product’s primary mode of action, which determines the governing framework, the submission pathway, and much of the development and quality burden. A leader who does not understand how jurisdiction is determined, and what follows from it, can build a development and regulatory plan on the wrong assumptions. Assess whether a candidate genuinely understands the jurisdictional question and has worked through its consequences, since combination-product regulatory strategy begins there and everything downstream, timelines, evidence, quality systems, flows from it.
Bridging Development Cultures
Beyond regulation, combination products require leaders who can bridge two working cultures. Device engineers and pharmaceutical scientists approach risk, iteration, documentation, and timelines differently, and combination-product programs frequently stall on that friction rather than on technical problems. A leader who can translate between these cultures, set expectations that respect both, and build a team that works across them adds enormous value. In assessment, probe whether the candidate has actually operated across device and pharma organizations, and how they handled the cultural and process differences, since this bridging capability is often what determines whether a combination-product program moves.
What This Looks Like in Practice
A company hiring for a combination product looks for genuine fluency across both device and pharma, or demonstrated ability to bridge them: understanding of how FDA jurisdiction is determined and what follows, experience with both quality frameworks, and a track record of working across device and pharmaceutical development cultures. It probes actual cross-world experience. It does not assume a strong device leader or a strong pharma leader will naturally handle the other side.
The Mistake Employers Keep Making
The most common mistake is hiring an excellent leader from one tradition and assuming they will pick up the other. A device leader may underestimate the clinical and chemistry burden of the drug component; a pharma leader may underestimate design controls and device quality requirements. Either way, the plan is built on incomplete assumptions and the gap surfaces late, when timelines and budgets are already committed. The company mistakes depth in one world for the dual fluency the product actually demands.
Device and Pharma Traditions Compared
| Dimension | Device Tradition | Pharma Tradition |
|---|---|---|
| Development rhythm | Iterative, faster cycles | Longer, sequential phases |
| Primary discipline | Engineering-led | Chemistry and biology-led |
| Quality framework | Design controls | GMP-centered |
| Evidence burden | Varies by pathway | Typically heavy clinical |
| Combination product | Requires fluency in both | Requires fluency in both |
The Bottom Line
Combination products span two regulatory frameworks, two development cultures, and two commercial models, so hire leaders with genuine dual fluency or demonstrated ability to bridge device and pharma, rather than assuming depth in one tradition will carry the other, since the gap tends to surface only after timelines and budgets are committed. Get this right and the hire becomes a genuine multiplier; get it wrong and no amount of general talent compensates.
Related Reading
For more, see How to Hire a Medical Device CEO Who Understands FDA Pathways, Top Qualities to Look for in a VP of Regulatory Affairs (MedTech), What to Look for in a Head of Quality Systems (MedTech).
Frequently Asked Questions
- Q: What is a combination product?
- A: A therapy that brings together a device and a drug or biologic in a single product, such as a drug-eluting stent or a prefilled autoinjector, spanning both regulatory frameworks.
- Q: Why is hiring for combination products hard?
- A: Because these products span device and pharma regulatory frameworks, development cultures, and commercial models, so neither pure device nor pure pharma experience is sufficient alone.
- Q: How does FDA jurisdiction work for combination products?
- A: The FDA assigns a lead center based on the product’s primary mode of action, which determines the governing framework, submission pathway, and much of the development and quality burden.
- Q: What goes wrong when the leader knows only one side?
- A: A device leader may underestimate the clinical and chemistry burden; a pharma leader may underestimate design controls and device quality requirements, so the plan rests on incomplete assumptions.
- Q: What should I assess in candidates?
- A: Genuine experience across both device and pharma organizations, understanding of the jurisdictional question, familiarity with both quality frameworks, and the ability to bridge two development cultures.
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Tanya Gallardo
Managing Director, Executive Search & AI Talent Strategy
Tanya Gallardo is the Managing Director of Executive Search & AI Talent Strategy at JRG Partners, leading C-suite and Board engagements across key growth sectors including Technology, Financial Services, and Manufacturing.
With over 18 years of experience specializing in disruptive technology leadership, Tanya is recognized as a leading authority on talent architecture for future-focused executive roles, such as the Chief AI Officer (CAIO) and Chief Digital Officer (CDO). Her expertise lies in accurately assessing the cultural fit and technical depth required to ensure a high return on investment (ROI) for critical leadership appointments.
Prior to her role at JRG Partners, Tanya held senior roles directing global talent acquisition strategies at a major publicly-traded technology firm, advising on organizational design and succession planning for emerging executive functions. She is a recognized speaker and contributor to industry events, sharing data-driven insights on executive compensation, leadership development, and the measurable business impact of C-suite talent.
