In MedTech and diagnostics, the conversation about evidence often begins and ends with the clinical trial. That’s understandable. Clinical evidence helps demonstrate that a device achieves its intended purpose, that its benefits and risks are understood, and that its safety and performance claims are supported. It can support regulatory submissions, labelling, instructions for use and the claims an organisation can substantiate, while giving clinicians a basis for deciding whether a product deserves serious consideration. Without the right evidence, an organisation may not be able to secure approval, make the claims it wants, gain professional support or justify changing established practice.

Across more than 20 years working in medical devices, ophthalmology, consumer diagnostics and molecular diagnostics, I’ve learned that evidence isn’t a single hurdle an organisation clears on the way to market. Regulators, clinicians, patients, procurement teams, distributors and investors may all be considering the same product, but they’re making different decisions, carrying different risks and looking for different forms of proof.

A clinical study may demonstrate that a product performs as intended and delivers the clinical benefit studied yet leave unanswered questions about whether it fits into a real workflow, reduces cost, is easy to use, solves a problem customers recognise, gives a channel partner a differentiated proposition with workable economics and the tools to represent it well, or creates enough confidence for someone to change behaviour. Strong clinical evidence matters enormously, but it isn’t automatically the evidence every stakeholder needs for adoption.

This is where another commercialisation gap can emerge. The organisation has generated the evidence needed for the next technical or regulatory milestone, while the market is still waiting for proof that’s relevant to the decision it’s being asked to make.

Clinical evidence answers an essential question

Clinical evidence has a clear and essential role. Depending on the product and pathway, it may demonstrate safety, accuracy, performance, clinical utility or improved outcomes. It helps show that the product achieves its intended purpose and supports the safety and performance claims the organisation can substantiate. It also allows clinicians to assess the quality of the science and helps the organisation establish credibility in a market that should be cautious about new medical technology.

The difficulty begins when clinical evidence is treated as though it answers every commercial question as well. A study can show that a technology performs under defined conditions without showing how easily it will be introduced into practice, whether the buyer can fund it, how the patient will understand it, what training is required, whether the distributor can sell it effectively or whether the organisation can support adoption after the first purchase.

Those questions don’t diminish the importance of clinical evidence. They reveal the other forms of proof that need to sit around it. A strong evidence strategy therefore begins with more than asking, ‘What do we need for approval?’ It also asks, ‘Which stakeholders must be convinced, and which proof will help each of them decide?’

Different stakeholders are managing different risks

A regulator may focus on whether the evidence supports the intended use, safety and performance claims, while a clinician is also considering relevance to their patients, study quality, comparison with current practice and the professional risk of recommending something new. Procurement and health-service leaders may accept the clinical outcome but still need evidence about workflow, implementation, resource use, budget impact and what adopting another product will demand from an already stretched system.

Patients and consumers are making a different assessment again. They may look for professional endorsement, plain-language explanations, convenience, testimonials, familiar organisations, real-world use cases and signs that the organisation is trustworthy. Distributors need confidence that the product is differentiated, supported, commercially viable and straightforward enough to represent well, while investors are looking beyond the science for proof that customers will pay, channels can scale and early interest can become repeatable growth.

None of those stakeholders is necessarily more rational or more cautious than another. The clinician may be protecting the patient and their professional reputation; procurement may be protecting a budget and operating system; the distributor may be protecting time, margin and focus; and the consumer may be protecting their health, money and confidence. The evidence that matters is shaped by the decision being made and the risk carried by the person making it.

Regulatory approval does not close the evidence gap

I saw this clearly when helping bring a personal defibrillator to market. The product was able to launch under the regulatory pathway before the planned clinical trials were complete. For many consumers, regulatory approval, the logic of making defibrillation more accessible and the urgency of sudden cardiac arrest created enough confidence to consider the product.

Consumers weren’t assessing it as a clinician would. They were weighing a relatively modest purchase against the possibility that a loved one might experience cardiac arrest at home, where most out-of-hospital events occur and survival remains low. For a family with someone at higher risk, the product offered peace of mind and, at minimum, guided resuscitation support while emergency services were on the way. Publicly announced trials with emergency-response organisations also acted as a trust signal: the results weren’t yet available, but the fact that respected organisations were evaluating the product was enough for some consumers to consider it seriously. The proof they needed was therefore a credible combination of regulatory approval, clear explanation, trusted advice and a plausible role in an emergency.

Many healthcare professionals approached the same product differently. They understood the limitations of regulatory approval and remained cautious or non-committal while they waited for product-specific clinical data and peer-reviewed evidence. A smaller group of innovators and early clinical advocates were willing to engage earlier, not because evidence mattered less to them, but because they wanted to help shape the real-world evidence pathway. The product hadn’t changed, but the evidence required for recommendation and advocacy had.

That experience changed the way I think about early and late adopters. Reluctance isn’t always resistance to innovation. It can be a rational response to an evidence gap, and the same approved product can produce different conclusions because consumers, clinicians, distributors and government buyers are evaluating different risks.

The evidence plan shapes the future commercial story

Evidence decisions are often made early, while the organisation is focused on development, regulatory strategy and funding milestones. Study populations, endpoints, comparators, intended use and data-collection methods can determine what the company will later be able to say. By the time product marketing or commercial leadership arrives, those choices may already have narrowed the future story.

I’ve inherited products where the available evidence was scientifically sound but didn’t support the most commercially important benefit in the language customers needed. The study had answered the question it was designed to answer; the commercial problem was that no one had asked early enough whether that question would also help a clinician, buyer, patient or distributor understand why the product was worth changing for.

This doesn’t mean commercial teams should dictate clinical science or design studies around marketing slogans. It means future customer and market questions should be represented while evidence plans are still being formed. Clinical, regulatory, medical, product, human factors, health economics and product marketing perspectives can then help distinguish what must be proven for regulatory approval from what different stakeholders will need to understand for adoption.

Evidence does not only come from a clinical trial

Across ophthalmology, the level and type of evidence varied with the device’s risk, novelty, intended purpose and the body of existing clinical experience. Some products had a strong body of clinical literature, while others were adopted through a combination of established science, surgeon experience, demonstration, product performance, workflow fit and confidence in the supplier. A paper could help open the door, but the surgeon still needed to believe the product would perform in their hands, the theatre team needed to understand how it fitted into practice and the hospital needed confidence in training, supply and value. The full adoption decision was supported by several forms of proof working together.

Consumer diagnostics created a different evidence challenge. The biomarkers and laboratory methods behind tests such as PSA, HbA1c or TSH were established, but home collection using dried blood spot testing represented a less familiar category. Customers weren’t reading a clinical paper before ordering. Confidence came from the scientific basis of the test, laboratory quality, alignment with clinical guidance, clear education and a service experience that made the result understandable and actionable.

Trusted intermediaries also mattered. Recognised experts, clinical advisers, professional bodies and trusted organisations didn’t replace the evidence, but their willingness to educate, communicate, participate in an evidence program or be associated with a new category signalled that the proposition had received a level of scrutiny. That trust was valuable precisely because it was difficult to earn. Early advocates needed enough understanding of the science, product and service to be comfortable lending their reputation to it.

The market generated further evidence after launch. Repeat purchases showed that customers continued to see value, but their behaviour also revealed unintended consequences in the commercial model. Frequent promotions trained some customers to wait for the next discount rather than choose membership, so sales data became more than a revenue result. It was evidence that pricing and promotional decisions were shaping future behaviour.

In molecular diagnostics, the technical and analytical story can be highly sophisticated, but the value proposition still needs to translate that capability into the laboratory’s operational reality. Technical differentiation may make an assay more resilient as pathogens evolve and reduce how often sequence changes force redesign and revalidation. The commercial challenge is to connect that technical performance to the point the laboratory cares about and articulate the time, workflow and risk implications in terms the customer can recognise. The challenge isn’t always an absence of proof. Sometimes the evidence exists, but the commercial story hasn’t connected the dots or articulated why it matters.

The market generates evidence too

Evidence continues to develop once the product enters the market. Early customer use, implementation experience, support enquiries, repeat purchase, retention, distributor performance, peer advocacy and real-world case studies can reveal whether the proposition is translating into behaviour. These signals don’t replace formal clinical evidence and should never be presented as though they do; they answer different questions.

A customer testimonial can’t prove clinical efficacy, but it can help another customer understand the experience. High retention doesn’t establish safety, but it can indicate ongoing value. A distributor’s ability to sell repeatedly doesn’t validate the science, but it can demonstrate that the market story, training and economics are workable. Real-world workflow data may not replace a controlled study, but it can show whether a promised operational benefit appears in practice.

The strongest commercial organisations know what each form of evidence can and can’t support. They don’t use anecdotes to make clinical claims or assume a clinical endpoint proves willingness to pay. They build a connected body of proof that helps different stakeholders make different decisions with confidence.

The evidence stack

These different layers are why I find it more useful to think about an evidence stack than a single evidence milestone. The layers will differ by product, stage and market, but they may include scientific and clinical evidence, usability and workflow evidence, economic and operational evidence, customer and behavioural evidence, and market or commercial evidence.

Scientific and clinical evidence establishes whether the product performs as intended and supports the claimed benefit. Usability and workflow evidence shows whether people can use it safely, effectively and within real practice. Economic and operational evidence helps the buyer understand cost, resource requirements and value. Customer and behavioural evidence reveals whether the problem is recognised, the proposition is understood and people are willing to change, while market and commercial evidence tests willingness to pay, channel viability, repeatability, retention and the organisation’s ability to support growth.

Not every product needs every layer at the same depth before launch, and some forms of proof can only be generated through early access, implementation or real-world use. The task is to decide which uncertainties must be reduced before launch, which risks the business and market are willing to carry temporarily, and what the next evidence point needs to demonstrate. The purpose isn’t to create an endless research program or delay commercialisation until uncertainty disappears. It’s to sequence the evidence deliberately and close the most consequential gaps as the product moves from one proof point to the next.

Where organisations get stuck

Evidence gaps often appear as commercial symptoms. Clinicians may show interest but remain nervous about recommending the product, procurement may value the clinical outcome but struggle to justify the operational cost, consumers may visit the website without feeling confident the product is relevant to them, and distributors may sign an agreement yet struggle to create demand. Investors can recognise the quality of the science while still questioning the route to scalable revenue.

Some innovators and early adopters may accept a degree of uncertainty because they believe in the mission, want to help shape the product, generate real-world evidence or establish a new standard of care. The wider market will usually expect a more complete proof base. That makes identifying and supporting the right early advocates an evidence strategy decision, not simply an influencer or communications exercise.

The instinct is often to solve each symptom with more communication, another sales tool or a stronger campaign. Sometimes that’s exactly what’s needed. At other times, the message isn’t the problem; the organisation is asking a stakeholder to make a decision without the proof that stakeholder considers credible.

That distinction matters. Better promotion can improve access to evidence that already exists, but it can’t manufacture missing proof. Product marketing can translate and connect evidence, identify where stakeholders remain unconvinced and help shape future evidence priorities, but it shouldn’t disguise the limits of what the organisation currently knows.

Define the evidence need early

The most valuable time to ask what evidence the market will need is before the protocol, product requirements, pricing model and launch pathway are locked. At that point, customer and commercial insight can sit alongside clinical, regulatory, technical and usability considerations without compromising their independence.

That doesn’t mean predicting every objection or proving every aspect of the business before launch. It means being deliberate about the next adoption decision and the evidence required to reach the next proof point. A pre-MVP company may need to prove that the problem and use case are real. A business approaching approval may need to understand the clinical, workflow and economic proof required for launch. A product already in market may need real-world evidence, retention insight or stronger proof for a new customer segment or geography.

The question isn’t simply whether the organisation has evidence. It’s whether it has the right evidence for the right stakeholder at the moment that stakeholder is being asked to make a decision.

Questions worth asking

If your organisation is planning evidence, preparing for launch or trying to understand slow adoption, these are the questions I would encourage the leadership team to discuss:

1. Which stakeholder decisions matter most at the next stage of commercialisation?

2. What risk is each stakeholder trying to manage, and what proof will they consider credible?

3. Which evidence supports regulatory approval, and which evidence supports adoption?

4. Do the study endpoints and claims address the benefits customers care about most?

5. What workflow, usability, economic or behavioural evidence is still missing, and which gaps must close before launch?

6. What can early market behaviour legitimately tell us, and are we mistaking a communication gap for missing proof?