Your user data won't unlock NHS contracts without clinical and economic evidence

Commissioners require a cost-effectiveness case before they can justify investment. Without one, the average healthtech company waits many months longer for commissioning, and the contracts at stake can be worth millions a year.

steps: 8; steps
to start: 1 day; to start

The short answer

Work out what evidence your product actually needs before generating more of it. NICE's Evidence Standards Framework sets expectations by tier and asks for budget impact analysis across all tiers, with cost-effectiveness analysis only for higher financial risk products. Map what you have against it, close the gaps buyers ask about first, and build real-world evaluation into live sites rather than waiting for a trial.

8 steps

Do it yourself: step by step

0 of 8 done

Use the NICE Evidence Standards Framework to set your tier by intended purpose, and confirm your regulatory class (UKCA or CE)
Time
1 day
Typical cost
Free
Who does it
Founder with regulatory lead
Done when: Tier and class written down with reasoning

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Evidence gap table

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Table

Evidence gap table

Product: [name] NICE ESF tier: [A / B / C], because [intended purpose] Regulatory class: [UKCA / CE class, or not a medical device] Financial risk: [higher / lower], because [annual cost to buyer and scale]

Evidence inventory

Evidence	Type	Setting	Size	Outcome measured	Quality (high / medium / low)
[e.g. pilot at [trust]]	[real-world evaluation]	[UK NHS]	[n=]	[e.g. follow-ups avoided]	[ ]
[e.g. published study]	[observational / RCT]	[country]	[n=]	[ ]	[ ]
[e.g. safety data]	[incident log]	[ ]	[ ]	[ ]	[ ]

Gaps against the framework

Area	What it asks for (summary)	Our status	Gap	Action and owner	Date
Design factors	Safety, data protection, usability, clinical input in design	[met / partial / missing]	[ ]	[ ]	[ ]
Describing value	Intended purpose, target population, current pathway, proposed pathway	[ ]	[ ]	[ ]	[ ]
Demonstrating performance	Evidence the product does what it claims, at the level for our tier	[ ]	[ ]	[ ]	[ ]
Deployment	Implementation, training, ongoing monitoring	[ ]	[ ]	[ ]	[ ]
Budget impact (standard 17)	Budget impact analysis in buyer terms	[ ]	[ ]	[ ]	[ ]
Cost-effectiveness (standard 18)	Required if higher financial risk	[ ]	[ ]	[ ]	[ ]

What buyers have asked for

Buyer	What they need to decide	Do we have it?
[trust / group]	[e.g. results from a comparable district general hospital]	[yes / no]

Next 6 months

[Highest-priority gap and action]
[Second]
[Third]

Avoid these

Common mistakes

Commissioning an expensive trial before checking what your tier and buyers actually require.
Presenting non-UK evidence without showing why it transfers to an NHS pathway.
Offering usage and satisfaction data as if it were outcome evidence.
Building a health economic model so complex finance cannot check it.
Generating evidence once and never updating it with live site data.

Free personal check

Done by Paul Robinson, not software

I'll map the evidence you have against the NICE framework and show you which gaps buyers will ask about

What I need from you

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

What you get

Your likely NICE evidence tier
The gaps buyers will ask about first
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

Opportunities stalled at evidence review × average annual contract value × months of delay ÷ 12

Variables and defaults

opportunities stalled a year: 5
average annual contract value: £50,000
average delay: 9 months

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

Assumptions and defaults

opportunities stalled a year = 5
average annual contract value = £50,000
average delay = 9 months

5 × £50,000 × 9 ÷ 12 is roughly £190,000 of revenue deferred each year; Solvable estimate, rounded.

Benchmarks

Budget impact analysis expected for all tiers; cost-effectiveness analysis for higher financial risk digital health technologies
NICE Evidence Standards Framework, standards 17 and 18
Source: NICE ECD7
£5,000 to £25,000
Typical cost of a budget impact model from an independent health economist (assumes about 5 to 25 days of work at about £1,000 a day)
Solvable estimate
£10,000 to £60,000
Typical cost of an independent real-world evaluation at one or two sites (assumes 10 to 60 days of evaluator time at about £1,000 a day, plus data collection)
Solvable estimate

NHS commissioning decisions are evidence-based, and commissioners require clinical evidence and health economic analysis to justify investment in new technologies. Healthtech companies that have not developed a structured evidence strategy are unable to respond credibly to commissioner requests for evidence, and their products stall at the commissioning stage regardless of their clinical value. The evidence required varies by product type and commissioning level, but typically includes real-world evidence of clinical outcomes, a cost-effectiveness model, and alignment with NICE guidance where relevant.

The root causes stem from a lack of understanding of the stringent evidence requirements within the UK healthcare system, particularly for NHS commissioning.
Many healthtech companies, often with a strong technical background, underestimate the need for robust clinical validation and health economic modelling.
This is compounded by a focus on product development over market access strategy, leading to a reactive rather than proactive approach to evidence generation.
Furthermore, the diverse and evolving nature of evidence standards across different UK health bodies (e.g., NICE, NHS England) creates a complex landscape that can be challenging for smaller healthtech firms to navigate without specialist expertise.

A healthtech company without a health economic model faces an average 14-month delay to NHS commissioning. Developing a health economic model and real-world evidence programme costs £30,000 to £80,000 but is typically required to access NHS contracts worth £500,000 to £5 million per year. (NICE, 2024)

Increased resource allocation to reactive evidence generation efforts.
Diversion of R&D and commercial teams from core activities.
Loss of potential revenue from delayed or denied market access (e.g., £500,000 to £5 million per year per NHS contract).
Increased operational costs associated with extended sales cycles and additional evidence generation.
Delayed patient access to potentially beneficial health technologies.
Slower adoption of innovations that could improve patient outcomes.
Damage to the company's credibility and trustworthiness within the healthcare ecosystem.
Negative perception among potential partners and investors.

What it looks like in practice

Healthtech products failing to secure NHS contracts despite strong user data.
Prolonged sales cycles and stalled adoption within private healthcare organisations.
Inability to articulate clear value propositions to payers and commissioners.
Competitors with stronger evidence bases gaining market share.

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 I need a randomised trial?

Usually not for lower-tier digital products. Higher-risk products and devices may need stronger comparative evidence. Check your tier and ask buyers before spending.

What is the NICE Evidence Standards Framework?

NICE's guide to the evidence digital health technologies should have, set by tier and covering design, value, performance, deployment and economic impact.

Does US or European evidence count?

It helps, but buyers will ask whether it transfers to their pathway, population and costs. A small UK real-world evaluation often carries more weight.

Should I seek a NICE evaluation?

Only if your category is being assessed or your product is high cost. Most NHS buyers do not need NICE guidance to buy, but many use the framework as a reference.

Does this apply to independent providers?

They usually ask for less formal evidence, but want outcome and patient experience data, and evidence their consultants trust.

Last reviewed: 30 October 2026

Sources

NICE ECD7

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The short answer

Do it yourself: step by step

1Classify your product1 day · Free

2List the evidence you have2 to 3 days · Free

3Map gaps against the framework2 days · Free

4Ask buyers what they need2 to 4 weeks · Free

5Build a budget impact model2 to 6 weeks · £5,000 to £25,000 with a health economist (Solvable estimate)

6Plan real-world evaluation3 to 12 months · £10,000 to £60,000 (Solvable estimate)

7Fund it without equity3 to 9 months · Free to apply

8Publish and package3 to 12 months · £0 to £3,000 for open access fees (Solvable estimate)

Evidence gap table

Common mistakes

I'll map the evidence you have against the NICE framework and show you which gaps buyers will ask about

What I need from you

What you get

Check where you stand

What's this costing you?Optional: work it out with your own numbers

How we worked this outMethod, formula and assumptions

Why this keeps happening

What it leads to

Evidence

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

Frequently asked questions

Do I need a randomised trial?

What is the NICE Evidence Standards Framework?

Does US or European evidence count?

Should I seek a NICE evaluation?

Does this apply to independent providers?

You're not the only one with this problem.