Rewrite the rules

How will Brexit impact medical device regulation? Will this add barriers to approval, investment and ultimately patient access? Can new regulations create more opportunities?

I had the pleasure of facilitating a panel to discuss these issues at MedTech Integrates. I was joined by Karen Taylor (Director of the Deloitte Centre for Health Solutions), Michael Kipping (Innovation Lead in the Health Sector Team at Innovate UK), Tim Andrews (Chief Operating Officer and Co-founder of ORCHA) and Paolo Guerra (MedTech Lead at ProductLife Group).

It was timely to have the discussion, at a time when we are seeing such a rapid acceleration of innovation and change in medtech and healthtech, to consider whether current regulatory systems are fit for purpose, what the line of travel looks like and what role the UK might have in shaping the future of medtech innovation. Advanced technologies, such as those driven by AI, will drive the future of health. But the success of the wave of innovation will require regulation to support and enable, rather than impede, development.

The key themes discussed were as follows:

A balancing act?

We discussed the balancing act that regulation represents. With no or limited regulation, there can be very serious harms like those seen with the thalidomide scandal of the last century. But at the other end of the spectrum, burdensome regulation itself impacts patient safety by restricting innovation. Getting this balance right within the UK will be absolutely key.

Following another more recent scandal involving breast implants, the existing EU Directives were revisited, leading to the development of the MDR and the IVDR. These are not being adopted in the UK, and the way that they are being implemented leaves challenges for innovators. This is exacerbated by a current lack of harmonisation of standards, and limited resource within Notified Bodies and guidance. The position should hopefully improve over time.

Boundaries and cliff-edges

Tim explained how ORCHA, in its work reviewing around 70 new products a week, and it is often difficult to define boundaries between products that are or are not medical devices, and different classes of device. There are cliff edges in the regulatory requirements (particularly acute within Europe) with some products having little or no product assurance, but similar products having significant regulatory burdens.

A better system may be to deal with products along a graded continuum of increasing risk with increasing oversight. This may also help business to manage compliance requirements – currently a small change to a product can take it from one side of the line to the other.

Options for the UK

The panel referenced the Taskforce on Innovation, Growth and Regulatory reform report which was “hot off the press” at the time of the panel discussion. This report envisages a new framework for digital health in the UK that would combine flexibility with post-marketing surveillance.
Several of the panellists queried whether an entirely new system would be feasible, and agreed that the best approach for the UK may be to accept approvals of products granted in other jurisdictions such as the EU and the US. This would be akin to the Swiss system, where the regulator accepts the EU CE mark. In any event, the UK has an opportunity to learn from the best approaches used elsewhere and tailor accordingly. Regulatory cooperation across jurisdictions will be key.

Three areas of focus were identified:

• Legislation – The MDR and IVDR are not perfect but form a good basis.
• Regulatory science and innovation – There is a need to develop an appropriate evidence base to support new approaches. Alex talked about the work that his group was undertaking in using in silico trials to develop data evidence to directly compare between solutions.
• Regulatory delivery – the use of Notified Bodies may not be the best model, and a continuum of assessment may be more appropriate.

How do we drive the change?

COVID-19 helped us to define a common enemy. We need to identify areas enabling quick wins and use this to generate the right approaches that can then be applied more widely.

Once a system is established, enabling companies to navigate the regulatory requirements will be key. Innovators, and SMEs in particular, need support so they can develop the right evidence base at the outset and understand the costs and timelines involved.