Insights13 March 2026

How Startups Can Break Into the NHS

Key Takeaways

NHS is funding digital innovation: Early pilots get attention and resources.
Plan regulatory now: DTAC/DCB ~3 mo, MHRA 6–18+ mo.
Confirm device & compliance status: Avoid surprises in procurement.
Find clinical champions: They open doors and accelerate adoption.
Prove impact with data: Show efficiency, patient benefit, cost savings.

What makes the UK HealthTech market unique, and where are the biggest opportunities for startups?

Tom: The HealthTech market in the UK is growing rapidly and gaining real momentum. The government is actively pushing the healthcare system to move from what it calls an “analog to digital” model, which is creating significant opportunities for innovation.

As a result, there is increasing funding available within the NHS and a strong appetite for new digital technologies that can improve healthcare delivery. From both a regulatory and market perspective, there’s also a clear effort to make it easier for companies to work with the NHS. The system is gradually opening up, with attempts to reduce some of the regulatory barriers for both international manufacturers entering the UK and domestic startups trying to break into the NHS. The goal is to make that journey more accessible.

That shift is creating a lot of opportunity right now. I attend many events in London and across the north of England, and there’s a huge amount of energy in the ecosystem. You see some familiar faces, but there are always plenty of new startups emerging with fresh ideas. It’s genuinely impressive to see how creative people are becoming in finding new ways to improve healthcare across the country. Overall, it’s a very exciting space to be in.

With all this momentum, what regulatory or safety hurdles most commonly slow down NHS adoption?

Tom: That’s a big question. In the UK, there are two main regulatory areas HealthTech companies need to address. First, you need to determine whether your product qualifies as a medical device under the MHRA definition. If it does, it must be registered accordingly traditionally via CE marking, now increasingly UKCA marking, which involves registering with the MHRA and classifying the device as Class I, IIa, or III.

The second key area is compliance with DTAC and DCB standards, which cover clinical safety, cybersecurity, information governance, and accessibility. These frameworks apply across England, Wales, and Northern Ireland and are currently being updated as part of changes expected by 2026.

Meeting these requirements typically involves clinical risk management expertise. Oversight from a registered Clinical Safety Officer ensures compliance. In our case at BMS Digital Safety, I’m a medical doctor registered with the UK’s General Medical Council, with additional training in clinical risk management and AI in healthcare from the University of Oxford, helping companies navigate regulations and deploy solutions safely within the NHS.

How do UK standards like DCB0129, DCB0160, and DTAC differ from EU regulations, and what should teams know before entering the market?

Tom: The main difference is really about scope. Medical device regulations often aligned with standards like ISO 14971 focus on the safety of the product itself, assessing what could go wrong within the device and how those risks are mitigated.

The distinction between for example DCB0129 and DCB0160 is mainly responsibility. DCB0129 is completed by the manufacturer and outlines the product’s safety profile, while DCB0160 is carried out by the healthcare organisation adopting the system, applying that risk assessment to their specific environment.

So, even if a company is already active in the EU, these UK requirements still need to be completed. However, existing risk assessments and real-world use cases usually make the process faster. In practice, it typically takes around three months, so starting early helps avoid delays in NHS procurement.

From your experience, how can founders quickly assess if their product is NHS or UK market ready?

Tom: One of the simplest ways is to speak with someone who understands the NHS regulatory landscape early on. A big part of my motivation for moving into this space was the slow adoption of technology within the NHS, and I wanted to help companies navigate that process more effectively. Through platforms like R2Gconnect, we focus on discovery conversations understanding your product, what you’ve already achieved, and where you want to go. From there, we can help founders break down the regulatory and procurement landscape and identify what actually applies to them.

Not every product needs the same approvals. Some may require medical device registration and clinical safety work, while others may not. The key is understanding which regulations apply and what steps are needed to enter the NHS market, so founders can approach it in a structured and efficient way.

What is a typical investment of time and resources for a startup to get NHS-ready or complete a regulatory assessment?

Tom: It really depends on the type and complexity of the product. If we’re talking about DTAC and DCB compliance, the process typically takes around three months from start to finish. We usually run both streams in parallel to make it more efficient. The timeline can be shorter if a company already has certain foundations in place for example ISO 27001 certification for data governance and cybersecurity, or existing medical device documentation. Those elements can speed up parts of the assessment.

Medical device regulation is a different process altogether and takes longer. If a product needs to be registered as a medical device, timelines depend on the classification and existing documentation. Class I devices may take around six to nine months, while Class IIa and above can take 18 months or more, with significantly higher costs depending on the regulatory pathway.

What is the next step once a product is ready for the NHS? Should a startup approach each trust individually, or is it better to have a partner?

Tom: There’s no single “magic bullet.” The NHS isn’t one organisation you have NHS England, NHS Wales, Northern Ireland, and Scotland, and within those, regional Integrated Care Boards (ICBs) control funding for primary care, hospitals, social care, and charities. ICBs are often a good starting point for engagement.

You can also approach individual NHS trusts, departments, or GP practices directly. Having clinical champions or advocates within the relevant specialty can be extremely helpful in opening doors and supporting conversations. There are also central procurement routes, like the G-Cloud framework, and partnerships with delivery-focused scale-up companies who have established NHS contacts. I would say, the approach really depends on your product, the area of healthcare it serves, and your overall strategy, but building relationships and having clinical advocates is the most powerful way to gain traction within the NHS.

What common missteps do startups make when aligning clinical safety, cybersecurity, and procurement requirements?

Tom: The biggest mistake is delaying these processes until it’s too late. Some startups are already in live use when they realize they haven’t completed essential clinical safety or regulatory work. Others experience cybersecurity incidents or have interested hospitals but lack the necessary regulatory approvals. These delays can result in lost opportunities, funding, or allow competitors to move ahead.

Another common challenge comes when seeking investment. Investors want to see a clear regulatory path, with costs and timelines considered, because regulations can impact time-to-revenue. Many startups find they need some regulatory groundwork completed before they can secure funding. We help companies at every stage whether that’s creating a regulatory roadmap, understanding principles, or completing full clinical safety, cybersecurity, and medical device compliance to ensure they can safely and efficiently move into the NHS market.

Tom: One great example is a startup focused on occupational therapy in Leeds. They needed clinical safety work to get their product into a pilot. We worked with them in an accelerated, structured way, completing all necessary documentation so they could safely and efficiently reach clinicians. This support was key to their growth and will help reduce delays in occupational therapy assessments and patient discharge across the NHS.

For startups engaging with clinicians, investors, or NHS teams, the most important steps are understanding your market and the specific problem you’re solving. Identify clinical champions who can articulate real-world benefits, demonstrate how your solution addresses the trust’s or ICB’s needs, and show measurable efficiency or cost savings. Having regulatory work in place strengthens your case, but being able to clearly link your product to tangible NHS outcomes is what drives adoption and investment.

What one practical piece of advice would you give founders preparing for UK market entry this year?

Tom: The key is to combine regulatory readiness with real-world engagement. Find a clinical advocate and a clear use case, then gather demonstrable benefits or performance metrics for example from EU deployments or other organisations to show how your solution solves a specific problem. That evidence helps you get NHS buy-in and generates excitement around your product.

Which begs, why should a startup consider entering the UK market, compared to other European countries?

Tom: While the UK healthcare market isn’t as large as the EU overall, there are several advantages that make it attractive for startups. First, the NHS is centrally funded, so there’s reliable, ring-fenced investment that continues to grow year on year.

Second, there’s a strong push from the government for digital adoption, so the market is open and receptive to innovative solutions. Successfully piloting a product within the NHS carries significant credibility. Despite its challenges, the NHS is internationally respected, and success here can be a springboard into the US or EU markets. UK regulations are also currently less onerous than the EU in some areas, and companies often streamline UKCA and EU CE marking together for efficiency.

Ultimately, the UK offers funding stability, an open market for innovation, and a chance to prove real-world impact in a globally recognized healthcare system. Early engagement and specialist guidance can make entry smoother and less daunting for startups. At the same time, ensure the infrastructure is in place: regulatory compliance, data security, incident monitoring, and technical support. Being able to deliver reliably whether for a pilot or full deployment is essential when the opportunity arises. Having both the proof of impact and the operational readiness positions a startup to succeed in the UK market.

R2GConnect: Thank you very much for the insights, Tom.

To help startups tackle regulatory, clinical, and cybersecurity challenges in the UK, EU, and US, BMS Digital Safety is offering four exclusive expert sessions on R2GConnect, each including a complimentary consultation. They provide practical guidance to move AI and digital health products from prototype to deployable solution.

Free AI Compliance Discovery Document: Clinical AI Deployment Gap Analysis for UK, EU MDR, FDA & EU AI Act - learn more here
AI SaMD Regulatory Position & Readiness Diagnostic (Free 45‑min expert session + written regulatory map) - learn more here
Free NHS Market Entry Roadmap : Exactly What to Do, Step by Step (RRP £1200)- learn more here
Get Your Health-Tech NHS Ready. Free NHS Regulatory Gap Analysis - learn more here