Your international clinical data is not enough for NHS buyers

NHS clinical decision-makers routinely reject evidence that doesn't reflect UK patient populations, care pathways, or healthcare economics. Without UK-specific data, adoption stalls regardless of how strong your global evidence is.

steps: 7; steps
to start: 2 to 3 days; to start

The short answer

UK buyers want evidence from UK patients, UK pathways and UK costs. You do not always need a trial: a well-designed service evaluation or real-world evidence study at one or two UK sites, often an independent provider that can move faster, is what most first buyers actually ask for. Decide what each buyer needs to see, then generate the smallest credible study that answers it.

7 steps

Do it yourself: step by step

0 of 7 done

List every study, audit and case series you hold. For each one note country, setting, sample size, outcome measured and whether it is published. Mark which questions it answers for a UK buyer
Time
2 to 3 days
Typical cost
£0
Who does it
Clinical or medical affairs lead
Done when: One table showing evidence against buyer questions with gaps highlighted
Match the gap to the cheapest design that answers it: service evaluation or audit (no research ethics review usually needed), real-world evidence from routine data, or a prospective study (needs HRA and ethics approval). Use the HRA decision tool to check which you are doing
Time
1 week
Typical cost
£0
Who does it
Clinical lead
Done when: Study type agreed and HRA decision tool result saved
Approach consultants already using or interested in your product. Independent hospitals and clinics can often start faster than NHS trusts. In England, your regional Health Innovation Network (there are 15) can introduce NHS sites
Time
1 to 6 months
Typical cost
£0 to £5,000 site set-up (Solvable estimate: site governance, contract review and set-up fees, which vary by site)
Who does it
Founder and clinical lead
Done when: Signed agreement with a named site and principal clinician
Objective, population, outcome measures, data to collect, how long, who analyses it, and how results will be published. Agree data protection terms and a data processing agreement with the site
Time
2 to 4 weeks
Typical cost
£2,000 to £10,000 if written with an academic or CRO partner (Solvable estimate: about 4 to 15 days at £500 to £700 a day)
Who does it
Clinical lead with site
Done when: Protocol signed off by the site clinical lead and governance
Collect data for the agreed period. Report interim findings to the site at the halfway point
Time
3 to 12 months
Typical cost
£10,000 to £40,000 for a single-site evaluation (Solvable estimate: about 20 to 60 days at £500 to £700 a day); £150,000 or more for a multi-site prospective study (Solvable estimate: several sites, approvals, monitoring and statistics over 12 to 24 months)
Who does it
Site team and your clinical lead
Done when: Final dataset locked and analysed
Aim for a conference abstract then a peer-reviewed paper. Produce a two-page summary for buyers, and present it with the site clinician
Time
3 to 12 months to publication
Typical cost
£0 to £3,000 open-access fees (Solvable estimate: journal article processing charges vary widely; check the target journal)
Who does it
Clinical lead and marketing
Done when: Summary in every proposal and the clinician willing to take reference calls

This problem is Solvable.

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UK evidence gap audit and study planning table

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Table

Part 1: Evidence you already hold

Study	Country	Setting	Sample	Outcome measured	Published?	Answers which buyer question?
[Study name]	[ ]	[Hospital / clinic / community]	[n]	[ ]	[Journal / no]	[ ]

Part 2: What UK buyers are asking

Buyer	Their question	Evidence we have	Gap
Consultant user	Does it work in my patients?	[ ]	[ ]
Clinical governance or medical advisory committee	Is it safe here, and who is accountable?	[ ]	[ ]
Operations or theatre manager	What does it do to time, throughput and staffing?	[ ]	[ ]
Finance director or clinic owner	What does it cost or save per patient?	[ ]	[ ]
NHS commissioner (if relevant)	Is it cost-effective for our population?	[ ]	[ ]

Part 3: Choose the study

Option	Answers	Approvals	Typical time	Solvable estimate of cost
Service evaluation or audit at one site	Local outcomes and operational impact	Site governance sign-off; usually not research ethics	3 to 6 months	£10,000 to £40,000
Real-world evidence from routine data	Outcomes at scale over time	Data sharing agreement; ethics depends on design	6 to 12 months	£20,000 to £80,000
Prospective study	Comparative effectiveness	HRA and research ethics approval	12 to 24 months	£150,000 or more

Part 4: Plan

Chosen study: [ ]
Site and principal clinician: [ ]
Primary outcome: [ ]
Start: [ ] End: [ ]
Publication target: [conference] then [journal]
Buyer summary owner: [ ]

Avoid these

Common mistakes

Commissioning an expensive trial before asking buyers what they need to see.
Calling a research study a service evaluation to avoid ethics review, which can make the data unusable.
Choosing a site because it is convenient rather than because its clinician is respected by your buyers.
Running the study and never publishing it, so buyers treat it as marketing.
Assuming international evidence will carry if the pathway or comparator differs in the UK.

Free personal check

Done by Paul Robinson, not software

I'll compare the evidence you have with what UK buyers ask for and tell you the smallest study that closes the gap

What I need from you

Answers to 8 tap questions
Your device name and what it is for, in one line

What you get

The evidence question your first buyers are really asking
Which study type answers it
Who could help you run it

Within 2 working days

No sign-in, no sales call. I read every request myself and reply on WhatsApp.

Free tools

Check where you stand

Your illustrative estimate

£90,000

Solvable estimate. Rounded to the nearest £500. Updates as you type.

Target accounts waiting on UK evidence

Starting figure 10 (from 10 (Solvable estimate)). Change it to match your practice.

Average annual contract value

Starting figure £30,000 (from £30,000 (Solvable estimate; use your own)). Change it to match your practice.

Months of delay

Starting figure 12 (midpoint of 12 (Solvable estimate: a single-site evaluation takes 3 to 12 months plus write-up)). Change it to match your practice.

Share that buy once the evidence exists

Starting figure 30% (midpoint of 30% (Solvable estimate: evidence removes one objection, not every reason not to buy)). Change it to match your practice.

Formula

target accounts that will not buy without UK evidence × average annual contract value × (months of delay ÷ 12) × share that buy once the evidence exists

Variables and defaults

target accounts waiting on UK evidence: 10 (Solvable estimate)
average annual contract value: £30,000 (Solvable estimate; use your own)
months of delay: 12 (Solvable estimate: a single-site evaluation takes 3 to 12 months plus write-up)
share that buy once the evidence exists: 30% (Solvable estimate: evidence removes one objection, not every reason not to buy)

Defaults only. Change them in the calculator to use your own numbers.

Assumptions and defaults

target accounts waiting on UK evidence = 10 (Solvable estimate)
average annual contract value = £30,000 (Solvable estimate; use your own)
months of delay = 12 (Solvable estimate: a single-site evaluation takes 3 to 12 months plus write-up)
share that buy once the evidence exists = 30% (Solvable estimate: evidence removes one objection, not every reason not to buy)

Solvable estimate. Revenue held back while buyers wait for UK data is about £300,000 with these defaults; the recoverable share is about £90,000. Treat it as £60,000 to £120,000 and compare it with the cost of the study.

Benchmarks

Tiered evidence by risk of the technology
The NICE Evidence Standards Framework sets out the evidence expected for digital health technologies, with more required for higher-risk functions
Source: NICE Evidence Standards Framework for digital health technologies
Research or service evaluation
The HRA decision tool tells you whether a study counts as research under the UK Policy Framework for Health and Social Care Research
Source: Health Research Authority
£10,000 to £40,000
Typical cost of a single-site UK service evaluation including analysis
Solvable estimate

NHS clinical buyers are sceptical of international evidence that doesn't reflect UK patient populations, care pathways, or healthcare economics. Without UK clinical evidence, adoption is slow regardless of the international evidence base.

The primary root cause is the NHS's inherent scepticism towards international clinical evidence, which may not accurately reflect the unique characteristics of the UK patient population, care pathways, or healthcare economic landscape.
This is compounded by stringent NICE guidelines that prioritise evidence generated within the UK context to ensure clinical and cost-effectiveness for the NHS.
Furthermore, a lack of proactive engagement with UK clinical partners and a clear evidence generation strategy from the outset contribute to significant delays.

MedTech products without sufficient UK clinical evidence often face significant delays in NHS adoption, potentially leading to substantial foregone revenue. The cost of generating robust UK clinical evidence, while considerable (e.g., clinical trials can range from hundreds of thousands to millions of pounds), is typically a fraction of the long-term revenue lost due to prolonged market access delays. (NIHR, 2025; ABPI, 2024)

Increased resource allocation to address evidence gaps and repeated submissions
Diversion of R&D efforts from new product development to retrospective evidence generation
Significant loss of potential revenue from delayed or denied NHS market access
Increased operational costs associated with prolonged market entry efforts
Delayed access for UK patients to potentially beneficial MedTech innovations
Suboptimal patient outcomes if less effective, but locally evidenced, alternatives are adopted
Perception as a company unable to meet local regulatory and evidence standards
Damage to brand credibility within the UK healthcare ecosystem

What it looks like in practice

Repeated rejections or prolonged evaluation cycles by NHS procurement teams and NICE
Difficulty securing pilot sites or early adopters within NHS trusts
Sales teams struggling to articulate product value without compelling UK data
Competitors with UK evidence gaining significant market share

While a precise '4x higher adoption rate' is not directly verifiable from official NICE publications, numerous NHS and NICE documents underscore the critical importance of UK-specific clinical evidence for successful MedTech adoption within the NHS, implying that international evidence alone is often insufficient and leads to significantly slower uptake. (NHS England, 2024; NICE, 2023)

Source: https://www.england.nhs.uk/long-read/building-an-integrated-rules-based-medical-technology-medtech-pathway-engagement-on-proposals/ | https://www.nice.org.uk/what-nice-does/our-guidance/about-healthtech-guidance

Paul Robinson

14 years in UK private healthcare

I solve this one for healthcare companies

Want a hand? I'll look at your situation and tell you the three things I'd tackle first.

A few quick questions, about two minutes. I read every one myself and usually reply the same day.

No sales call unless you ask for one. Just a straight answer from me.

I reply personally, usually the same day.

Questions

Frequently asked questions

Do we need a randomised trial?

Rarely for first adoption. Most buyers want credible UK outcomes and operational data. Trials matter more for NICE guidance and large NHS rollouts.

Is a service evaluation real evidence?

Yes, if it is designed properly, has a clear outcome measure and is written up. Use the HRA decision tool to confirm it is not research.

Should we start in the NHS or private sector?

Independent providers often start faster and can show operational impact. NHS data can carry more weight with commissioners. Many companies do one of each.

Who owns the data?

Agree it in writing before you start. The site is usually the controller of patient data. You get the anonymised results and the right to publish.

Can we pay the clinician leading it?

Yes, at fair market value for their time, documented in a contract and declared as an interest by the clinician.

Last reviewed: 30 October 2026

Sources

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The short answer

Do it yourself: step by step

1Audit what you have2 to 3 days · £0

2Define the buyer's evidence question2 to 4 weeks · £0

3Choose the right study type1 week · £0

4Find a UK site and clinical lead1 to 6 months · £0 to £5,000 site set-up (Solvable estimate: site governance, contract review and set-up fees, which vary by site)

5Write a short protocol2 to 4 weeks · £2,000 to £10,000 if written with an academic or CRO partner (Solvable estimate: about 4 to 15 days at £500 to £700 a day)

6Run and analyse3 to 12 months · £10,000 to £40,000 for a single-site evaluation (Solvable estimate: about 20 to 60 days at £500 to £700 a day); £150,000 or more for a multi-site prospective study (Solvable estimate: several sites, approvals, monitoring and statistics over 12 to 24 months)

7Publish and use it3 to 12 months to publication · £0 to £3,000 open-access fees (Solvable estimate: journal article processing charges vary widely; check the target journal)