Your product stalls at NHS procurement because the clinical evidence bar keeps rising

NHS buyers increasingly expect evidence that sits well above pilot data and testimonials. Without it, even a genuinely effective healthtech product can be blocked indefinitely at the procurement stage.

steps: 6; steps
to start: 1 to 2 days; to start

The short answer

The evidence you need depends on what your product does, not how good it is. Classify it against the NICE Evidence Standards Framework, compare what you have against what that tier expects, and plan the cheapest credible study to close the gap. Private providers usually accept lighter evidence to start, so use them to generate real-world data while you build towards NHS standards.

6 steps

Do it yourself: step by step

0 of 6 done

Use the NICE Evidence Standards Framework to place it in tier A (system services), B (communicating about health and care, health diaries, promoting good health) or C (informing or driving clinical management, diagnosing or treating a condition). Check whether it is also a medical device.
Time
1 to 2 days
Typical cost
Free
Who does it
Founder and clinical lead
Done when: Tier and device status written down with reasoning.
Options: service evaluation in a private provider, prospective real-world study with a Health Innovation Network or university partner, or a pragmatic comparative study for tier C. Check whether HRA approval is needed.
Time
4 to 8 weeks to design
Typical cost
£5,000 to £100,000+ depending on design (Solvable estimate)
Who does it
Clinical lead with academic or evaluation partner
Done when: Protocol agreed with a named site and evaluator.

This problem is Solvable.

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Evidence gap table against the NICE Evidence Standards Framework

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Table

Evidence gap table for [Product name]

ESF tier: [A / B / C], reasoning: [ ] Medical device: [yes, class [ ] / no], reasoning: [ ]

Claim we want to make	Evidence the tier expects	Evidence we have	Gap	Cheapest credible way to close it	Partner	Cost estimate	Target date
[Reduces admin time per clinic by X%]	[Real-world evaluation in relevant setting]	[Single-site pilot, internal data]	[No independent evaluation]	[Service evaluation at two private sites]	[Evaluation partner]	£[ ]	[ ]
[Improves patient outcome Y]	[Comparative study with relevant outcome]	[User feedback]	[No outcome data]	[Prospective study with comparator]	[University or HIN]	£[ ]	[ ]
[Saves money]	[Budget impact or economic analysis]	[Our own calculator]	[No independent economic analysis]	[Budget impact model reviewed by health economist]	[ ]	£[ ]	[ ]

Also check

Clinical safety case and hazard log (DCB0129)
DTAC completed
MHRA registration if a device
HRA approval needed for any research element: [yes / no]
Publication plan: [journal / conference / independent report]

Avoid these

Common mistakes

Generating evidence for claims buyers do not care about.
Relying on user satisfaction surveys as clinical evidence.
Running a study without an independent evaluator, so buyers discount it.
Starting research activity without checking whether HRA approval is needed.
Not publishing, so the evidence cannot be cited in procurement.

Free personal check

Done by Paul Robinson, not software

I'll compare your evidence with what NICE expects for your product and show you the cheapest way to close the gap

What I need from you

A list or summary of the evidence you have
Your product's intended use in one line

What you get

Your likely NICE evidence tier and the gap
The cheapest credible study to close it
The three changes that matter most

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

Formula

Cost of the evidence gap = deals stalled per year for lack of evidence × average annual contract value × average contract length in years

Variables and defaults

deals stalled per year: 3
average annual contract value: £40,000
average contract length: 3 years

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

Assumptions and defaults

deals stalled per year = 3
average annual contract value = £40,000
average contract length = 3 years

Solvable estimate. 3 × £40,000 × 3 = £360,000 of contract value at risk; compare with the cost of the study that would unlock it.

Benchmarks

NICE Evidence Standards Framework sets evidence expectations for digital health technologies by tier
Use to decide what evidence buyers and evaluators expect
Source: NICE ECD7
Evaluation costs range from about £5,000 for a service evaluation to well over £100,000 for a prospective comparative study
Depends on sites, sample size and data collection
Solvable estimate

NHS procurement increasingly requires clinical evidence that goes beyond user testimonials and pilot data. NICE's evidence standards framework for digital health technologies sets out a hierarchy of evidence, and many healthtech companies find their product stalls at procurement because they haven't invested in generating the right type of evidence for their stage of development.

The primary root cause is a mismatch between the rapid development cycles of healthtech products and the rigorous, often lengthy, evidence generation requirements of NHS procurement and NICE.
Many companies prioritise product functionality and user experience over robust clinical trial design or real-world evidence strategies from inception.
This is compounded by a lack of understanding of the specific evidence hierarchies and methodological expectations of UK health technology assessment bodies, leading to insufficient investment in appropriate evidence generation at critical stages.

No verified UK data available for these specific figures (NICE, 2024)

Increased development costs due to retrospective evidence generation efforts
Diversion of R&D resources from product innovation to evidence remediation
Significant revenue loss from inability to access the lucrative NHS market (estimated £500,000-£5m annually per product)
Increased operational expenditure on belated clinical studies
Delayed access for patients to potentially beneficial digital health interventions
Inconsistent adoption of effective technologies across the NHS
Perception as an unproven or unreliable solution within the UK healthcare ecosystem
Difficulty attracting partnerships with NHS organisations or private providers

What it looks like in practice

Product demonstrations failing to progress past initial NHS procurement stages
Repeated requests for additional clinical data from NHS trusts or integrated care boards (ICBs)
Difficulty securing investment due to unproven clinical efficacy
Delayed or denied market access to the NHS and private healthcare providers

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 private providers need NICE-level evidence?

Usually not to begin with. They want credible evidence that it works in a setting like theirs, plus safety and IG assurance. Their data can then strengthen your NHS case.

Is a randomised controlled trial always needed?

No. Tier A and B products rarely need one. Tier C products may need comparative evidence, but pragmatic designs are often accepted.

Do we need HRA approval for an evaluation?

Service evaluations often do not, research usually does. Use the HRA decision tool and agree with the site's research and governance team.

Who should own evidence in the company?

A named clinical lead with time set aside, supported by an external evaluator.

How long will this take?

Plan on 6 to 24 months from design to a citable output. Start before you need it.

Last reviewed: 30 October 2026

Sources

NICE ECD7

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The short answer

Do it yourself: step by step

1Classify your product1 to 2 days · Free

2Audit what you already have2 to 3 days · Free

3Agree the claims you want to make1 day · Free

4Design the cheapest credible study4 to 8 weeks to design · £5,000 to £100,000+ depending on design (Solvable estimate)

5Run it and publish6 to 24 months · Varies

6Build an evidence dossier1 week · Free