Regulatory affairs

Major changes are on the horizon with the implementation of the European Medical Device Regulations (MDR). Both conference stages will bring medical device regulation to the forefront of discussion. Alan Johnson, Technical Director at product design group Tactiq is set to talk about the design challenges of wearable devices on the HealthTech Stage. “An immediate impact will be on devices for which the classification changes. This will particularly impact IVDs (in-vitro diagnostics) and software-only medical devices. Work will be needed to bring existing devices into compliance and some devices may be withdrawn”, said Johnson. “Another issue at the moment is that the notified bodies are overloaded, and this is a problem particularly for new businesses.”

Apps

Not all of the regulatory discussion will centre around EU MDR, however. Liz Ashall-Payne is the founder and CEO of ORCHA – an organisation which reviews apps in the healthcare space. On the Med-Tech Innovation Conference stage, she will discuss the mHealth landscape; one in which regulation continues to evolve. “Those of us who are concerned with proactively managing our health are increasingly turning to mobile (or ‘mHealth’), and the use of unregulated apps”, explained Ashall-Payne.

“The widespread availability of mobile health solutions presents an accessible, affordable and inviting opportunity. Yet there was little regulation within this growing industry. My idea was to provide a review system, which would guarantee quality to the end user, and to provide health and care systems with a vehicle which would enable them to get the best apps to their patients and citizens.”

Manufactoring and Industry 4.0

Medical device manufacturers have a wealth of opportunity in the years to come. Industry 4.0 holds masses of potential, particular where compliance and quality control are concerned. But the manufacturing supply chain is changing shape in other ways, too.

Jim Reed, Vice President, Business Development & Marketing at Minnetronix will be discussing virtual development partnerships across the medtech supply chain. He believes that sourcing partners from around the globe for specialist manufacturing requirements is increasingly important for British firms to stay competitive. “The industry has evolved to the point where highly specialised companies exist for nearly all kinds of manufacturing processes or technologies, component expertise, or development domain. In fact, it has become extremely difficult for traditional medical device companies operating as generalist organisations to compete with outside firms in their areas of specialisation, in terms of cost, quality and capability. “Expertise rather than co-location is what matters and virtual organisations leverage the specialised skill set from each firm to improve business objectives. This macro trend is very positive for the UK and Ireland, where the specialist infrastructure is not as well-established as medical device hubs like Boston, the Bay Area, and Minneapolis. Minneapolis, for example, has sixty years of cumulative medical device expertise, talent pools, infrastructure, and vendor base density in a fifty mile radius.”

Market access

The UK’s medtech sector faces considerable challenges on home turf. This is especially true in terms of access to the NHS. In recent years the government has started responding to these concerns. Alan Sumner Head of Public Affairs, Healthcare Development & Strategic Services at Roche Diagnostics will discuss the government’s Accelerated Access Review in his presentation.

Sumner explained the need for the AAR to succeed: “The Commonwealth Fund ranks our healthcare system number one out of 11 healthcare systems including the US, Canada, Nordic Countries, France and Germany. However, our outcomes don’t fare as well as these other countries. Can the AAR deliver for patients by accelerating access to new technology and treatments – and really improve outcomes for patients?”

Brexit – a new relationship

Inevitably, Brexit is set to feature throughout the agenda with uncertainty still present in industry generally. Professor Alexander M. Seifalian from NanoRegMed will be discussing the development of medical devices using graphene nanomaterials in his presentation on the HealthTech stage. He was happy to talk Brexit though, and has a balanced view on the transition which will directly impact his work: “The negative side is that we have been doing lots of collaboration with SMEs as well as academics throughout the EU, including testing the medical device under GLP (good laboratory practice) in EU countries. This is significantly cheaper for us. However, Brexit may bring new opportunities. This could include a closer direct link to North America and Asian countries. It could make it easier, simpler and less costly to obtain permits for medical devices through the UK’s regulatory bodies.”

Medical device innovation

Of course, it wouldn’t be the Med-Tech Innovation Expo without a focus on innovation itself. Dr Chris Subbe is someone who knows about this. He’s a Consultant Physician & Senior Clinical Lecturer at Betsi Cadwaladr University Health Board & Bangor University. He’s also very keen on working with industry to create better healthtech. His talk will examine the lessons we can learn from social media when it comes to making hospitals safe.

For Subbe, innovation in healthcare is increasingly a consumer concern: “Integration of medical technology with consumer technology is the area where I see the greatest scope for immediate innovation. It is not by accident that Apple is increasingly active in this field. Knowledge about what ‘normal’ and ‘well’ looks like for individual patients is crucial to understand what ‘unwell’ and ‘at risk’ looks like. And in patients with chronic illnesses this can only be delivered by collected data while patients don’t feel as ‘patients’.”

Med-Tech Innovation Expo will be held at the Ricoh Arena, Coventry (UK) 25 – 26 April 2018. More information at www.med-techexpo.com

Source: Med-Tech Innovation Expo