Health tech product development challenges for start-ups
The UK has a large health technology base. Official statistics recorded 4,360 MedTech companies in 2023/24, employing around 196,000 people with turnover of £48.0 billion, and the sector is characterised by a large number of small companies, many of them university spin-outs (ICAEW industry profile, citing Office for Life Sciences). Most of those companies are building products with small teams and finite runway, in a market that behaves unlike any other software market.
Here is what changes when your users wear scrubs.
The product has to fit a workflow you do not control
Clinical work is interrupted, time-boxed and governed by protocol. A tool that adds thirty seconds per patient will be abandoned regardless of its merits, and a tool that requires a second login often will not be adopted at all. The 10 Year Health Plan even singles out repeated sign-on as a persistent staff complaint (Nursing Times, 2025).
The implication for product teams is that usability testing has to happen in the real setting, with real time pressure, not in a meeting room with enthusiastic early adopters.
Integration is a feature, not an afterthought
Almost nothing in healthcare is useful in isolation. Your product will be asked to read from and write to electronic patient records, order communications systems, patient administration systems and increasingly national services. Every integration involves a supplier, a trust IT team, a data flow agreement and a queue.
Interoperability is one of the five assessed areas in the NHS Digital Technology Assessment Criteria, alongside clinical safety, data protection, technical security, and usability and accessibility (NHS England). Teams that leave interoperability until a customer asks for it routinely underestimate the documentation involved, which is a common source of delay.
Safety changes how you build, not just what you ship
Health IT systems supplied to the NHS in England fall within clinical risk management standard DCB0129, which requires a clinical risk management plan, hazard log and clinical safety case report, overseen by a named clinical safety officer; deploying organisations run the equivalent process under DCB0160 (NHS England). A product may hold one manufacturer-side safety case, but each deploying organisation carries out its own assessment (JMIR study, 2025).
If the product is also a medical device, software lifecycle and risk management standards apply on top. The change is cultural as much as procedural: features become hazards to be analysed, releases become controlled events, and “move fast and fix it” stops being available as a development philosophy.
Data is harder to get and heavier to hold
Development that depends on clinical data runs into information governance, ethics approvals, data sharing agreements and legal bases for processing. Health data is special category data, which raises the bar for lawful processing, documentation and security. Training an AI model on real patient data is a project in its own right, with a timeline that is rarely compatible with a twelve-month runway plan drawn up without it.
Security expectations are similarly non-negotiable: buyers look for data protection impact assessments, security certification and evidence of secure development practice before they look at features.
The roadmap has three masters
Consumer software teams serve users. Health technology teams serve users, buyers and regulators at the same time, and these groups want different things. Clinicians want fewer clicks. Buyers want reporting, integration and assurance artefacts. Regulators want traceability, risk control and post-market surveillance. A roadmap that serves only the first group produces a delightful product nobody can purchase. A roadmap that serves only the second produces an unloved product that clinicians quietly stop using.
Bespoke requests are the quiet killer
Every prospective customer wants a small change. Each one seems cheap. Twenty of them produce a product with multiple deployment variants, a support burden that scales linearly with customers, and no repeatable offer. Small companies with strong engineering cultures are especially prone to this, because the requests are technically easy and commercially flattering.
The discipline is to distinguish between requirements that belong to the market and requirements that belong to one customer, and to price the second accordingly.
What helps
- Recruit or contract clinical input early, and give it real authority over the roadmap.
- Treat integration, safety and information governance as product workstreams with owners, not as compliance chores.
- Test in situ, under real conditions, with people who are not your champions.
- Build the assurance artefacts as you go, because they will be requested at the least convenient moment.
- Decide explicitly what you will not build, and hold that line.
How FastForward can help
We have built and taken regulated health technology products to market, and we work alongside product teams rather than around them.
- Product strategy for regulated health technology. Roadmaps that balance clinical usability, buyer requirements and regulatory obligations.
- Clinical workflow and adoption design. Making the product fit the way care is actually delivered.
- Assurance by design. Clinical safety, information governance, interoperability and security planned into development rather than retrofitted.
- Scope discipline. Distinguishing market requirements from one-off customer requests before they reach the backlog.
To discuss your product, email hello@fwdtech.co.uk.
References
1. ICAEW, MedTech in the UK: industry profile (citing Office for Life Sciences statistics) — https://www.icaew.com/library/industry-profiles/medical-technology
2. NHS England, Digital Technology Assessment Criteria (DTAC): assessment criteria — https://transform.england.nhs.uk/key-tools-and-info/digital-technology-assessment-criteria-dtac/assessment-criteria-assessed-section/
3. Digital health technology compliance with clinical safety standards in the NHS in England (2025) — https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12619009/
4. Nursing Times (2025), NHS 10 Year Health Plan: what it means for digital transformation — https://www.nursingtimes.net/digital-and-technology/ai-apps-and-robots-technology-pledges-in-the-10-year-health-plan-04-07-2025/