This reflects what we have learned at JRG Partners doing exactly this kind of work, the distinctions that matter and the mistakes that recur. Diagnostics R&D leadership is distinct from device R&D, because a diagnostic’s value rests on analytical and clinical performance, assay development, validation, and the evidence that a test result actually means something clinically. A VP of R&D for a diagnostics company needs assay and validation depth plus an understanding of how diagnostic claims are supported, which device or pharma R&D experience does not automatically provide.
Key Takeaways
- Diagnostics R&D centers on assay development and rigorous validation.
- Analytical and clinical performance define a diagnostic’s value.
- The regulatory framework differs from therapeutic devices.
- Leaders must connect R&D decisions to claims and reimbursement.
- Look for genuine diagnostics experience, not general device R&D.
What Diagnostics R&D Actually Requires
A diagnostic product succeeds when its results are analytically sound and clinically meaningful, which puts assay development, analytical validation, and clinical validation at the center of the R&D function. The VP of R&D must lead the development of assays that perform reliably across the range of real-world samples and conditions, and the validation work that demonstrates it. This is a different discipline from designing a therapeutic device, and a leader whose experience is in device engineering may underestimate the depth of assay and validation science a diagnostics company depends on.
Analytical and Clinical Performance
Two kinds of performance matter and they are often confused. Analytical performance concerns whether the assay measures what it claims to measure accurately and reproducibly, sensitivity, specificity, precision, interference, stability. Clinical performance concerns whether the result predicts or reflects the clinical condition in a way that changes care. A strong diagnostics R&D leader understands both, designs studies that establish both, and knows which claims require which evidence. A leader who treats analytical validation as sufficient, or who underinvests in clinical evidence, produces a product that may work technically but cannot be marketed or reimbursed on the claims the business needs.
Connecting R&D to Claims and Reimbursement
In diagnostics, the R&D program determines what the company can claim, and the claims determine the commercial and reimbursement case. A test’s intended use, the population it is validated in, and the evidence generated all constrain what can be said and what payors will cover. This means the VP of R&D must think commercially and regulatorily, not just scientifically, planning development so the resulting evidence supports the claims and coverage the business requires. Assess whether the candidate has made these connections in practice, since a scientifically excellent leader who develops evidence disconnected from the commercial case creates expensive problems.
What This Looks Like in Practice
A diagnostics company hiring a VP of R&D probes genuine assay development and validation depth, understanding of both analytical and clinical performance, and the candidate’s track record connecting development decisions to intended use, claims, and reimbursement. It looks for real diagnostics experience rather than adjacent device R&D. It does not assume device engineering leadership translates, or accept analytical rigor without the clinical evidence dimension.
The Mistake Employers Keep Making
The most common mistake is hiring a strong device R&D leader into a diagnostics role, assuming the disciplines are close enough. They are not: assay science, validation methodology, and the evidence framework that supports diagnostic claims are specific, and a leader without that grounding tends to underinvest in validation and clinical evidence. The company discovers the gap when the product performs technically but cannot support the claims or coverage the commercial plan assumed.
Two Kinds of Diagnostic Performance
| Type | What It Establishes | Why It Matters |
|---|---|---|
| Analytical performance | Accuracy, precision, specificity, interference | The assay measures what it claims |
| Clinical performance | Result reflects or predicts the condition | The result changes clinical care |
| Both together | The evidence base for claims | Determines marketing and reimbursement |
The Bottom Line
Diagnostics R&D rests on assay development, analytical and clinical validation, and evidence that supports the claims the business needs, so hire a VP of R&D with genuine diagnostics depth who connects development decisions to intended use and reimbursement, rather than assuming device R&D leadership transfers. 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 Key Traits of a Successful VP of Clinical Affairs, Top Qualities to Look for in a VP of Regulatory Affairs (MedTech), Hiring a Chief Commercial Officer for a Medical Device Company.
Frequently Asked Questions
- Q: How is diagnostics R&D different from device R&D?
- A: It centers on assay development, analytical validation, and clinical validation rather than device engineering, so the underlying scientific discipline and evidence framework differ.
- Q: What is the difference between analytical and clinical performance?
- A: Analytical performance establishes that the assay measures accurately and reproducibly; clinical performance establishes that the result reflects or predicts the clinical condition in a way that changes care.
- Q: Why must R&D connect to reimbursement?
- A: Because the intended use, validated population, and evidence generated constrain what the company can claim, and claims determine what payors will cover.
- Q: Can a device R&D leader run diagnostics R&D?
- A: Only with genuine assay and validation grounding; a leader without it tends to underinvest in validation and clinical evidence, producing a product that cannot support the needed claims.
- Q: What should I probe in candidates?
- A: Assay development and validation depth, command of both analytical and clinical performance, and a track record connecting development decisions to claims and coverage.
![](https://www.jrgpartners.com/wp-content/uploads/2025/12/tanya-gallardo.jpeg")
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.
