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Commercialising a diagnostic innovation is one of the most complex balancing acts in healthcare.
The science has to work.
The regulators have to agree.
The market has to care enough to pay for it.
And, perhaps most critically, the company has to survive long enough to get there.

Here’s what I’ve learned about how boards can make or break that journey.

1. The Commercial Clock Starts Ticking Early
Many founders think commercialisation starts after regulatory approval. In reality, the commercial strategy should be shaped from the moment the prototype exists.
Boards need to ensure marketing, distribution, reimbursement, and pricing models are in parallel development not afterthoughts (Bain & Company, 2023).

2. Funding Milestones Should Match Development Milestones
I’ve seen boards approve technical plans that assume funding will ‘just be there’. That’s wishful thinking.
In diagnostics, delays in validation, ISO accreditation, or clinical trials can cause capital gaps that force down-rounds or unfavourable terms.
Boards must help the CEO map fundraising tranches to realistic not optimistic milestones (Ernst & Young, 2024).

3. Market Access is a Risk Factor, Not a Footnote
A brilliant test with no reimbursement code is a commercial orphan.
Boards should ask early: Who will pay for this test? and What evidence do we need to prove value? Even if the answer is that the product is a research use only (RUO) for the foreseeable future.
Securing adoption in the NHS, Medicare, or private systems can take longer than the science itself and needs the same level of governance attention.

4. Partnerships Can Accelerate or Derail
Whether it’s a hospital group for pilot studies or a global distributor for scale-up, partnerships are tempting shortcuts.
Boards should stress-test any deal for alignment of incentives, control over IP, and financial impact. The wrong partner can eat your runway faster than any lab mishap.

5. Protect the Pivot Option
Markets shift. Competitors emerge. Reimbursement rules change.
Smart boards preserve the option to pivot without bankrupting the company whether that means shifting to a different target market, repurposing technology, or licensing instead of direct sales.

Final Thought:
In diagnostics, commercial success isn’t just about the quality of the science — it’s about strategic navigation through regulation, market access, funding, and timing.
Boards that can integrate these threads don’t just protect shareholder value — they give the science its best chance of changing lives.

References
Bain & Company (2023) Diagnostics: Competing in a Shifting Landscape. [Online] Available at: https://www.bain.com(Accessed: 8 August 2025).
Ernst & Young (2024) Medical Technology Outlook: Risk and Growth. [Online] Available at: https://www.ey.com(Accessed: 8 August 2025).