Owl Studios
NHS route to market

Good products fail in the NHS for boring reasons.

Not because the technology is wrong, and usually not because the clinical case is weak. They fail because the steps were done in the wrong order, or because one was skipped and nobody noticed until it was expensive. We have watched it happen from inside the NHS system suppliers and from inside the companies trying to get in. We know what order it goes in.

Book a route to market assessment hello@owl-studios.co.uk
The problem

Nobody sells you the map.

There are regulatory consultants who will do your MHRA classification. Clinical safety officers who will write your safety case. Procurement specialists who know the frameworks. Integration people who know IM1. Every one of them will sell you their step, competently.

What kills companies is not knowing which step comes first, which ones they did not need, and what each one costs in time they have not budgeted. We have seen companies with real published outcome data from real NHS trusts run out of money before anyone could buy them, because the order was wrong.

A pilot or two proves the idea. It does not get you deployed. What gets you deployed is a route, and a route is a sequence.

The route

Six things stand between you and being bought.

Not all of them apply to every product. Working out which ones do not apply to you is a large part of the value.

01
Classification

Are you a medical device?

What you claim the product does decides how it is regulated. Get this wrong early and the evidence you gather afterwards is aimed at the wrong target.

Specialist partner, we manage it
02
Clinical safety

DCB0129 and the hazard log

A named Clinical Safety Officer, a safety case and a live hazard log. Not paperwork for the end. Nothing else moves without it.

Specialist partner, we manage it
03
Information governance

DSPT, DPIA and DTAC

The assessment every NHS buyer will run at you covering clinical safety, data protection, security, interoperability, usability and accessibility.

Owl Studios
04
Route to purchase

Frameworks and buying routes

Wanting to buy you is not the same as being able to. Without a purchasing route, a keen clinician cannot get you past their own finance team.

Owl Studios
05
Integration

IM1 and the GP record

Reading from, extracting from and writing back into GP clinical systems. It is the plumbing, but completing it also puts you on a public NHS England list, which buyers use as proof you can be deployed.

Owl Studios
06
Evidence

Proving it works, to their standard

Pilot data and the evidence a commissioner asks for are usually different things. Knowing which one is being asked of you saves a lot of wasted work.

Owl Studios, with clinical input

We hold the plan and stay accountable for all of it. Where a step needs a specialist, we bring in someone we have worked with and manage them. You get one contract and one person to call, not four suppliers and a spreadsheet.

How we work

Three ways in, depending on where you are.

01

Route to market assessment

Fixed price / Two weeks

You tell us what you are building, what you claim it does, and who has said they want it. We go through all six steps and tell you which apply, in what order, what each will cost in money and time, and what you can skip.

You get a written plan you can put in front of a board or an investor, with the sequence and the numbers in it.

A fair share of the companies we run this for are told to wait, or told the route they were planning is the expensive one. That is the answer more often than anyone selling you a single step will say.

02

Route to market programme

Retainer

We run the plan. One contract, one accountable party. We deliver the integration, governance and evidence work ourselves, and bring in specialists for classification and clinical safety, managed by us and priced through us.

If you would rather contract the specialists directly, we will introduce you and charge nothing for it. Some clients prefer that. It is a fair question to ask.

Retained rather than fixed price, because the timeline depends on queues that belong to other organisations. Anyone quoting a fixed price for an assurance process is pricing in a margin for that risk, and you are paying for it.

03

Build

Day rate or by the project

Sometimes the route is not the problem and the product is. We build that too. Data platforms, integrations, reporting, clinical workflow, the unglamorous back end. Twenty years of it, most of it in health.

We also work outside health. Health is what we are known for, not the only thing we do.

Why us

We have seen this from the other side of the table.

Almost everyone advising on NHS integration has only ever seen it from the outside, as a supplier trying to get through.

Graham Downhill led the partner product team at EMIS and ran the IM1 programme there from a technical product point of view. That is the other side of the table. It means knowing why a submission gets bounced before it gets bounced, and how a principal supplier actually reads a request rather than how the guidance says they should.

He has also been through onboarding several times as a customer, for multiple products. Products he has built appear on NHS England's published list of suppliers who have completed IM1 assurance, which is a better reference than a case study we wrote about ourselves.

Product Director for Data and Analytics at EMIS Health / CEO at Promatica Digital / earlier work at Medicalchain

Straight answer

When you should not start yet.

We would rather tell you this now than take your money.

No confirmed deployment site

If no practice, trust or ICB has committed to taking the product, there is nothing to integrate into yet. Get that commitment first. It makes every step after it easier and cheaper.

Product claims are not yet fully defined

What you claim the product does decides whether it is regulated as a medical device, and that decides what evidence you need. If the claim changes later, the work is done again.

Less than six months of funding

Much of the elapsed time is spent waiting on NHS England and the system suppliers. Running out part way through means paying for an assurance you never finish.

A simpler route may be available

Not every product needs IM1, and not every product is a medical device. Worth checking before committing to the expensive version.

A note on AI

Passing IM1 does not mean your AI has been assured.

NHS England is explicit that IM1 pairing does not include AI specific technical assurance. Assessment of the models, the algorithms and the associated risks sits outside the process, and until further guidance is issued, deploying organisations are responsible for that assurance locally.

Two consequences. First, getting through IM1 does not mean your AI has been assured, and the organisation deploying you will eventually ask. Second, if you already have an assured product and you are adding AI to it, that is a change to your assured use case and it needs a formal Request for Change with an updated SCAL.

Plenty of companies are walking into both without knowing. If that sounds like you, it is worth an hour of conversation.

Before you ask

Questions about IM1 and GP integration.

What IM1 actually is, whether you need EMIS or SystmOne or both, what it costs beyond our fees, what a SCAL is and why it constrains you later, and what changes when you add AI to a product that is already assured. Plain answers, no sales copy.

Read the NHS integration FAQ NHS procurement frameworks
Start here

Tell us what you are building.

A short conversation now is worth months later. No pitch, and if the honest answer is that you are not ready, we will say so.

Start a conversation hello@owl-studios.co.uk
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