Easing medtech regulation can help strengthen safety standards

NHS surgeon and founder of Cinapsis Dr Owain Rhys Hughes on why simplifying regulation doesn’t have to mean compromising on patient safety.

As the UK’s regulatory frameworks for AI-based and digital health products grow more complex, many innovators are considering developing their tech elsewhere. But at such a critical juncture for UK medtech innovation - with services crying out for new solutions and the NHS investing £10 billion per year on tech - we cannot afford to let regulation become a barrier to innovation.

Recent moves by the UK government to improve patient safety by strengthening medtech regulation are a positive step - but we must ensure we are not unwittingly placing hurdles in the way of innovation by overcomplicating the rules of play. Calls to ease regulation are understandably often met with concerns over watered-down patient safety. As both a surgeon and a healthtech founder I believe regulation is essential; but we need to make it easier for innovators to access and navigate it, to strengthen safety standards and improve the quality of patient care.

To develop pioneering tech solutions safely and compliantly, we need regulation which is adaptable and keeps pace with innovation across the industry; whilst presenting clear and practical steps to help people adhere to its aims. By making regulation more transparent, flexible, and easier to understand, we can better support responsible innovation, which strengthens patient safety across the board.

Here are three ways that I believe can help us to facilitate easier, more accessible medtech regulation which boosts innovation and improves outcomes for the patients we’re trying to support.

Build clearer, standardised frameworks and guidelines

Regulatory compliance has an essential role to play in guaranteeing patient safety, but it is too often tied up in complicated frameworks, incoherent guidelines, and contradictory advice. As a result, it can be an impossible maze to navigate. Innovators can be left at sea when it comes to practically implementing the right measures, hindering their ability to bring innovative products to market safely and efficiently.

By making regulation clearer and easier to navigate, we can create guidelines which are more accessible and practical for innovators to use. Providing regulation in a clear, digestible format, which points to direct action and practical steps for implementation, can help innovators to more easily meet the broader safeguarding aims regulation is trying to achieve.

In turn, it becomes easier for innovators to work in line with these aims, reducing the risk of compliance errors or complications that may delay innovative products from being brought to market, or allow unsafe solutions to slip through the net. Companies will also be able to save time and resources navigating regulation, speeding up development, while maintaining safety and compliance. This will allow patients to begin benefitting from innovative new solutions sooner, while ensuring they are kept safe, their care always the priority.

Facilitate the wider sharing of best practice

There is already a vast amount of responsible innovation happening within med tech, but this is too often occurring in silos. It can be difficult for individual innovators to observe how others in the space are acting, and to compare themselves against those who are getting it right. To solve this, we need to encourage consistent sharing of best practice throughout the healthtech community, to facilitate mutual learning and drive up standards across the board.

By exchanging their experiences regarding safeguarding and regulation, providers can pinpoint common challenges and develop more effective strategies to overcome them. This can promote transparency and accountability, helping provide a clearer understanding of the standards which need to be met, and how they can be effectively achieved.

To encourage this culture of sharing best practice, medtech providers should be proactive in creating communities and interest groups, in which they can discuss their own experiences and learn from others in the space. These should be used as a platform for sharing both successes and failures, enabling companies to learn from each other and improve their approach.

Encourage collaborative innovation

It is crucial for medtech providers to work with end-users from day one to understand the nuanced needs and challenges faced by the frontline healthcare teams their solution will serve. Close collaboration can provide a deeper understanding of the safety risks and patient needs that must be acknowledged and mitigated against - which form the backbone of regulation.

Gaining this knowledge early can help to feed safe and ethical innovation into product development from the start, removing the need for retrofitting to meet regulatory requirements further down the line. At Cinapsis, we communicate consistently with our NHS partners at every stage of development to ensure we are keeping pace with evolving needs and can identify any risks as and when they may arise.

Building strong partnerships in this way can lead to safer, smoother implementation, and ensure that the solution continues to deliver impact while protecting patient safety as time goes on. It can make it easier for providers to adapt to new practices and requirements and ensure that solutions can maintain compliance and remain fit-for-purpose, because safeguarding is baked in.

Improving safety standards in med tech does not require the watering-down of regulation. Instead, a clearer, more streamlined and collaborative approach must be taken to support innovators to navigate and meet requirements more easily.

By signposting the actions required to meet regulatory standards, promoting the wider sharing of best practice, and encouraging innovators to work closely with frontline healthcare teams throughout product development, we can foster safe, effective innovation that delivers genuine impact for patients, with safety at its core.