MEDTECH REALITY CHECK #3
For founders, boards and investors, the important question is not only the market-access date — it is what assumptions sit underneath it.
Dates are useful — but they can become facts too quickly
MedTech companies need timelines. Founders need to plan runway. Boards need milestones. Investors need to understand when important value inflection points could occur.
So there is nothing unusual about seeing “CE marking Q2 2027,” “FDA submission next year” or similar targets in a business plan.
The issue is not the date itself. It is whether the company has done enough work to understand the assumptions behind it.
A market-access timeline is a chain of dependencies
Regulatory submissions do not happen in isolation.
The timeline may depend on product definition, qualification and classification, pathway selection, design and development maturity, verification and validation, risk management, usability, clinical evidence, QMS activities, manufacturing readiness and other market-specific requirements.
Not every device requires the same activities, and not every activity sits on the critical path. The point is that the date should reflect the requirements applicable to the actual device — rather than a generic estimate based on how long “a submission” normally takes.
That makes the quality of the assumptions more important than the visual precision of the Gantt chart.
Questions worth asking underneath the milestone
When reviewing a MedTech market-access timeline, I would look beyond “When will you get CE marking or FDA clearance?”
More useful questions include: Is the intended purpose clearly defined? Are the indications, population and claims sufficiently stable? Has device qualification and classification been assessed rather than assumed? Is the proposed regulatory pathway documented? Has available clinical evidence been assessed against the intended device and claims? Are additional clinical activities likely? Are development, verification, validation, risk-management and usability activities reflected in the plan? Are the clinical, regulatory and development plans aligned?
And perhaps most importantly: which assumptions currently being made must remain true for the proposed date to remain realistic?
This is business due diligence, not just regulatory due diligence
A change in the regulatory or clinical plan can affect capital needs, hiring, burn rate, supplier activities, commercialization timing and the point at which revenue may realistically begin.
That means regulatory uncertainty can become business uncertainty.
The goal for founders, boards and investors is not to predict every regulatory outcome or second-guess every technical decision. It is to understand whether the company has identified the major dependencies and uncertainties and whether the timeline reflects them.
Confidence should come from the assumptions
An ambitious target can be useful. It can focus a team and create urgency.
But a target should remain a target until the assumptions have been tested sufficiently to support it.
The strongest planning conversations are not necessarily the ones with the earliest date. They are the ones where management can explain what the date depends on, what could change it and what the team is doing to reduce the uncertainty.
A beautifully presented timeline is still just a timeline if the assumptions underneath it have not been tested.
Before relying on the milestone, look underneath it.
About this series
MedTech Reality Checks is a practical LinkedIn series by Nadira Salah, CEO & Founder of MedQR Consulting, drawing on 10 years of experience in medical-device QA/RA and work with startups and smaller MedTech companies. The series focuses on recurring decision points where product, clinical, regulatory and business strategy meet.