For digital health innovators, the NHS can seem like a maze. It’s vast, decentralised, and full of confusing acronyms. But behind that complexity is a set of real people, teams, and incentives that, once understood, can help shape the routes to market access.

Many startups rush to build products without deeply understanding NHS problems. This leads to poor adoption, even when the technology is strong. To succeed, you need to ensure your product solves a real NHS problem, one with clear unmet needs, decision-makers, and budget pathways.

SaMD regulatory requirements are fast evolving, with international efforts to harmonise frameworks still taking shape. Yet manufacturers must navigate jurisdiction-specific rules—especially as the US aligns more closely with ISO 13485:2016 in its Quality System Regulation. Whether you're targeting EU, US, or emerging markets, understanding the SaMD regulatory landscape is a critical first step.

Expertise is needed to conduct thorough due diligence in the highly regulated and evidence-based healthcare sector. Hardian covers key clinical and regulatory points when conducting DD for investors, mergers, or acquisitions of an SaMD or AIaMD company.