Before a single line of code is written or a regulatory document is submitted, clinician-founders need to ask one critical question: What is the true cost of building a medical-grade digital product in the UK?
For many healthtech startups, particularly those led by clinicians, the cost landscape is murky. Regulatory frameworks, NHS procurement pathways, and trial expectations can feel overwhelming—and very few early-stage founders know what ballpark they’re even operating in. This guide was created to bring clarity.
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This breakdown wouldn't be possible without the insights of key collaborators:
Each of these contributors has worked with dozens of startups, helping founders avoid expensive missteps—and their input has helped anchor this guide in both accuracy and pragmatism.
Building a Software as a Medical Device (SaMD), especially a Class IIa product, is not a single-step process. The costs emerge across eight interrelated domains:
Let’s unpack each of these in detail.
The journey typically begins with understanding the problem space and shaping the early product. At this stage, you’ll need to register your company, gather user feedback, and build a basic MVP. Costs here can vary - from lean, bootstrapped prototypes to more polished early-stage products with outsourced design.
This stage will depend largely on your approach to design and software development. If you're building in-house, you'll save on outsourcing but increase your burn rate through payroll.
Moving into the regulatory space is where many clinician-founders start to realise the complexity of SaMD. If you're aiming for a Class IIa product, you’ll need to register with the MHRA, implement an ISO 13485-compliant Quality Management System, and often work with a Notified Body to assess your technical file.
This phase also requires you to build a legal framework around your product -covering GDPR, privacy policies, terms of use, and possibly intellectual property protections. You’ll also need a Clinical Safety Officer to meet NHS requirements.
This is the most variable cost category. Why? Because the scale of your clinical validation depends on your device’s classification, risk profile, and intended use.
At one end of the spectrum, you might only need a small pilot study with 20–30 users. At the other, you may require a full multi-site RCT. Along the way, you’ll also need to consider NHS data access, ethics approval, statistical support, and trial insurance.
If you're targeting NHS adoption, budget impact modelling and health economic analysis are increasingly expected.
Once your MVP is validated and your compliance plan is underway, the technical infrastructure becomes a priority. This includes cloud services like AWS or Azure, secure development operations, testing tools, cybersecurity readiness, and internal documentation (especially for the technical file).
If you plan to sell to the NHS, you’ll need to comply with the Digital Technology Assessment Criteria (DTAC). This includes submitting a Data Security and Protection Toolkit (DSPT), clinical safety documentation (DCB 0129), and ensuring technical alignment with NHS systems (e.g. FHIR, IM1 Integration).
Altogether, this stage will likely cost between £12,000 and £56,400+, depending on the routes you take and whether you use consultancies or internal teams.
You’ve built your product. It’s compliant. Now you need to get it into the hands of users - and for many founders, this is the most underestimated cost category.
Whether you're attending NHS expos, hiring tender writers, or running targeted digital ad campaigns, you’ll need both budget and time. NHS sales cycles are infamously slow and high-touch, and most companies struggle to scale unless they’ve invested in business case development and strong NHS-facing materials.
Once the product is live and clinical activity ramps up, your team becomes the largest cost driver. Hiring a full team including developers, a regulatory lead, a business development lead, and clinical advisors - can push annual overheads above £400,000.
However, many start-ups mitigate this by starting with fractional hires or outsourced contractors.
After launch, your financial focus shifts to scaling infrastructure, supporting users, and maintaining compliance. This includes cloud expansion, post-market clinical follow-up (PMCF), customer onboarding, and keeping up with MHRA audits and ISO renewals.
If you're building lean, outsourcing smartly, and avoiding full-scale clinical trials, you may be able to get to market for around £500,000.
If you're building a team-heavy, RCT-backed product with full NHS integration, costs can easily reach £2 million or more.
The good news? Much of this can be offset. Innovate UK, SBRI Healthcare, and NIHR i4i offer non-dilutive funding that can support many of the critical components listed above.