Nexus Connect: Health Innovation and Regulation

Together, they discussed the current challenges and opportunities around medical device regulation, artificial intelligence (AI), funding, and the importance of building products that are not only innovative but also safe, effective, scalable – and regulatory compliant. Here’s a look back at this conversation.

Regulation is an essential foundation of health innovation. While often misunderstood as mere red tape, it exists to ensure the safety and effectiveness of technologies designed to improve patient care. As one speaker put it, if a loved one were to use a particular device, you’d want full confidence in its safety, efficacy, and reliability. That’s the human reality of regulation – it’s about trust, protection, and accountability.

For those working at the frontline of healthtech, navigating compliance is more than just securing European Conformity (CE) marks or regulatory approvals. It’s about embedding patient safety and ethical considerations into the product from conception through to commercialisation. And yet, despite its importance, regulation remains one of the biggest pain points for innovators in the UK.

A consistent message across the panel was that regulation continues to be underrepresented in the early stages of product development. Many innovators, particularly SMEs and startups, do not integrate regulatory planning from day one – and this can create significant setbacks later. Retrofitting compliance into an existing solution is time-consuming, costly, and often ineffective. The best outcomes arise when organisations engage with regulation experts from the outset and create strategic roadmaps for product pathways and market access.

One recurring challenge is the absence of regulatory capacity – both in terms of industry support and infrastructure. There simply aren’t enough professionals equipped to assess, certify, and monitor the vast number of medical technologies in the market. This is a particular concern when it comes to Class I devices, which many companies self-certify. Without proper third-party checks, the risk of unsafe or ineffective solutions reaching patients greatly increases.

The pace of technological change in health and medtech is relentless – and regulation must evolve alongside it. One of the most discussed topics was artificial intelligence, now the fastest-growing subsector in healthtech. AI has the potential to transform everything from diagnostics to patient monitoring, but it also presents new risks that today’s regulatory frameworks are not fully equipped to address. The consensus was clear: regulating AI with traditional methods is unsustainable. To stay ahead, regulators must embrace the technologies they aim to govern. Using AI to help assess AI-powered tools could be a vital part of the solution.

A broader shift in regulatory thinking is also needed. Today’s systems are not agile enough to keep pace with constant innovation. Without rethinking how regulation is applied and enforced, there is a real risk of either stifling promising innovation or failing to protect patients from unproven technologies. Technological regulation needs a paradigm shift – one that includes real-time monitoring, dynamic assessments, and collaborative oversight models.

Emerging material regulations are also on the horizon. One such development is the planned European ban on Per- and Polyfluoroalkyl Substances (PFAS), which are commonly found in manufacturing processes and materials used in medical devices. From 2026 onwards, any devices containing these substances will be impacted, meaning healthtech companies must proactively explore alternatives now to remain compliant with future regulation.

Meanwhile, policy efforts to reduce the burden of regulation and support innovation are underway. The idea of a UK ‘Regulation Innovation Office’, currently being discussed at the policy level, could offer dedicated support to help life sciences and healthtech firms navigate the regulatory landscape more efficiently.

Despite these challenges, there is growing support for organisations working in the healthtech space. Public funding for research and development is expanding, with more programs now falling within qualifying scopes – and further funding streams are expected to emerge in the near future. However, identifying the right model for your business is crucial. Whether pursuing direct-to-consumer (B2C), business-to-business (B2B), or blended routes, each comes with its own regulatory requirements and commercial considerations.

Joining ecosystems like Nexus, along with leveraging organisations such as the Health Innovation Network, can provide the resources and community needed to navigate the complex world of healthtech regulation.

The healthtech industry is moving fast – but safety, trust, and compliance must remain at the core of every innovation. Without thoughtful, forward-looking regulation, we risk slowing progress or allowing harmful products to reach patients. The answer lies not in avoiding regulation, but in building the systems, support, and infrastructure to make it more practical and future-ready.

Our Nexus Connect event reaffirmed that while the road from idea to impact may be challenging, the community pushing health innovation forward is committed, informed, and collaborative. By starting with compliance, seeking the right partnerships, and staying informed about evolving regulatory frameworks, innovators can not only navigate these challenges – but turn them into their competitive advantage.

Join us next time for Nexus Connect: Sustainability, where industry leaders, entrepreneurs, and innovators converge to explore sustainability and supply chain resilience. This event will showcase how forward-thinking businesses are integrating sustainable practices into cutting-edge technologies, product design, and corporate strategy.