Medtech due diligence can become a document-completeness exercise: Is there a regulatory plan? Is there a clinical study? Is a manufacturer identified? Those checks matter, but they do not establish whether the plans are coherent, achievable or capable of supporting the investment case.
The following questions help expose the operating assumptions and dependencies that can materially change value, timing and capital requirements.
1. What exactly is the product?
The answer should go beyond the underlying technology. It should define intended use, users, patient population, setting, workflow, configuration, claims and the performance required for clinical and commercial value.
If management, engineering, clinical and commercial teams describe different products, the programme is carrying hidden scope and evidence risk.
2. Which results are demonstrated, and which remain assumed?
Separate observed data from modelling, expert judgement, extrapolation and aspiration. Review the samples, methods, comparators, conditions and repeatability behind key performance claims.
3. What must be true for the clinical proposition to hold?
Identify the causal chain from product use to clinical or operational value. This often exposes dependencies on prevalence, user behaviour, workflow, turnaround time, interpretation, follow-up or access to treatment.
4. Are the claims aligned with the evidence plan?
Every material claim should connect to suitable analytical, technical, clinical and usability evidence. A broad claim can create a disproportionately difficult development and regulatory path.
5. Is the regulatory route grounded in the actual product?
Test the proposed classification, intended purpose, markets, standards, quality-system needs and submission route. The plan should reflect the current product and claims, not an earlier or strategically convenient version.
6. Can the product be manufactured and controlled at the required scale?
Review design transfer, suppliers, process capability, critical materials, quality controls, yield, cost and scale. A technically successful prototype may still depend on a fragile process or unsuitable supply chain.
7. Does the budget buy the next credible value inflection?
Map the use of funds to specific evidence, risk reduction and decision gates. Check that the budget includes enabling work such as quality, regulatory, usability, manufacturing transfer, data, programme management and contingency.
8. What would cause the programme to stop or change direction?
A mature plan includes acceptance criteria and negative outcomes. If every result leads to continuation, the programme is not using evidence to control capital.
9. Who will adopt the product, and why?
Test the buyer, user, beneficiary, payment route and pathway fit. Determine whether the evidence plan answers the questions that clinicians, providers, procurement teams, commissioners or partners will actually ask.
10. Can the current team and partners execute the plan?
Assess whether accountability, competence, capacity and governance match the next stage. External partners do not remove the need for informed internal ownership. Identify key-person dependence and functions that exist only in a presentation.
Translate findings into decision consequences
The most useful diligence output distinguishes between ordinary development work, material uncertainty and a fundamental challenge to the investment thesis.
For each material finding, ask:
- What is the consequence for value, timing, safety or capital?
- What evidence would resolve or reduce the uncertainty?
- Can the risk be mitigated, transferred, priced or gated?
- Who must own the action after the transaction?
This turns diligence from retrospective inspection into a practical basis for the investment decision and post-deal value-creation plan.