Dr Rajiv Chandegra

Why Health Tech Companies Should Set Up in the UK

The standard advice for health tech founders goes something like this: avoid regulated markets early on. Get traction first. Deal with compliance when you have to.

I think this gets it backwards. There's a case to be made for starting in one of the more regulated markets—specifically, the UK—and using that friction as a foundation rather than treating it as an obstacle.

The friction that teaches

The UK regulatory landscape looks intimidating from the outside. The MHRA has its requirements. NHS Digital has clinical safety standards. There's GDPR and its UK-specific additions. Layer on DTAC assessments for NHS adoption, and the compliance burden feels substantial.

It is substantial. But the questions these frameworks force you to answer—What's your clinical safety case? How do you handle data? What evidence supports your claims?—aren't bureaucratic make-work. They're the questions you should be asking regardless.

Regulation doesn't create the hard problems. It forces you to address them earlier than you might otherwise.

Companies that build in unregulated environments often defer these questions. When they eventually have to answer them—to enter new markets, to secure enterprise clients, to satisfy increasingly demanding investors—they find the answers expensive to retrofit. The shortcut becomes the long way around.

The reference that opens doors

Selling to the NHS is genuinely difficult. Procurement timelines are long. Budgets are constrained. Getting from pilot to scale requires navigating complex stakeholder landscapes. These aren't stereotypes; they're accurate descriptions.

But there's a flip side. NHS adoption carries weight that few other references can match. When you tell a potential customer in Germany or Singapore or the UAE that your product is used by the NHS, it signals something. It says your product survived scrutiny from one of the world's largest, most demanding healthcare systems. Investors notice this. International buyers notice it. Regulatory bodies in other countries notice it.

The NHS is simultaneously one of the hardest customers to win and one of the most valuable references to have. That combination isn't accidental.

One puzzle, many markets

Here's what makes the effort worthwhile: UK regulatory frameworks share significant overlap with those in other major markets. The underlying principles of the EU MDR are similar. The quality management systems that satisfy UK requirements get you most of the way to FDA submission readiness. Data governance practices built for UK compliance transfer cleanly to other jurisdictions.

You're not solving seven different regulatory problems. You're solving one that happens to unlock access to seven markets.

The companies I've seen struggle with international expansion are often the ones who deferred compliance. Each new market becomes a separate project. Each requires its own evidence gathering, its own quality systems, its own documentation. The companies that built these foundations early scale faster and cheaper.

A word on discipline

Something interesting happens when companies build in regulated environments from the start. They tend to build better products.

It's not that regulation makes products better directly—bureaucratic compliance doesn't improve clinical outcomes. But the discipline that regulation imposes has side effects. When you know someone will scrutinise your clinical safety case, you think harder about edge cases during design. When you know you'll need evidence, you build measurement into the product. When you know data handling matters, you architect security thoughtfully from the beginning.

This discipline becomes embedded. It shapes how teams think, not just what they document.

The real obstacles

Most health tech companies don't fail because of regulation. They fail because they build products that don't solve real problems, or don't integrate with existing workflows, or don't demonstrate clear value to the people making purchasing decisions.

Regulation is navigable. Building something genuinely useful for healthcare is hard. The companies that focus on the hard problem while treating regulation as a constraint to work within—rather than an enemy to avoid—tend to be the ones that succeed.

The counterintuitive bet

If I were starting a health tech company today, I'd seriously consider the UK as a launch market. Not despite the regulation, but partly because of it. The early constraints force good practices. The NHS reference creates lasting credibility. The frameworks transfer to other markets.

There's something to be said for doing hard things early, when you're small and adaptable, rather than later when you're big and set in your ways. Regulation is one of those hard things. It's going to shape your company eventually. Better to let it shape you into something strong than to let it catch you unprepared.

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