Clinical & Regulatory

Clinical & Regulatory

European MedTech Forum: the conference captured



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Health journalist Karen Finn shares the key topics discussed and conclusions reached at the hugely important European medtech conference held in Brussels at the end of November

MedTech Forum

The Fourth Industrial Revolution (4IR) ‒ a term first coined by the World Economic Forum (WEF) ‒ is now upon us. It marks an unprecedented convergence of digital, physical and biological systems, and is expected to transform healthcare. With this in mind, the European MedTech Forum kick-started a debate on how the 4IR will impact on the industry and its stakeholders at its ninth annual MedTech Forum held in Brussels from 30 November to 2 December.

In his opening address, MedTech Europe Chairman Rob ten Hoedt said that the 4IR was already raising a number of questions. These ranged from regulatory and ethical implications to data privacy, as well as how all of this will affect business models, healthcare professionals and patients. By its very nature, the 4IR involves an overlapping and disruption of different industries, and it will thus require greater collaboration and trust between stakeholders. Who is going to lead the way? ‘It’s nobody or it’s everybody,’ ten Hoedt emphasised.

Although stakeholders are all in this together, the medtech industry is well placed to be at the forefront of this revolution. ‘Integrated healthcare is the future and we’re in a unique position to facilitate this,’ commented Jürgen Schulze, MedTech Europe’s Vice Chairman. ‘Our industry isn’t just about products. It’s about technology and delivery. We should use that muscle to be a catalyst for sustainable change in healthcare,’ he told delegates.

Evening things up

MedTech Forum

Following on from this opening talk, Arnaud Bernaert, Head of Global Health and Healthcare Industries at the WEF, noted that inequity is one of the key drivers of industrial revolutions. In the case of healthcare, costs are not being contained, and value, therefore, needs to be embedded into innovation in order to achieve equity and improve access. This is why, in his view, the 4IR is not being driven by technology, but rather by society. However, it is the technology that can make societal transformation possible.

‘I’m hoping that with the Fourth Industrial Revolution, equity will become the norm,’ he said. He added that for this to happen, ‘we need to qualify each innovation with three filters: Firstly, does it improve healthcare delivery in a value-based way? Secondly, can we create an ecosystem of partnership? Finally, and most importantly, is there a societal filter? So far, the patient hasn’t been at the centre. Trust in the healthcare industry is broken. The system will be broken if prices continue to rise.’

In a pre-conference interview, Bernaert talked to us about societal change in the context of disruptive innovations such as 3D printing, bioprinting, neuroprosthetics and gene editing. ‘This will have more impact than the way in which science transforms industries. It can affect future generations as well as their values and identities. There are also bioethics considerations,’ he said.

Tackling chronic diseases

As for specific diseases, ‘much of the focus is on cancer, but the Fourth Industrial Revolution is also relevant to major chronic diseases. For instance, the treatment of diabetes stands a chance of being revolutionised with the possibility of an artificial pancreas,’ Bernaert said. International Diabetes Federation Europe board member and medtech entrepreneur Kyle Jacques Rose continued in this vein during a panel discussion on addressing patients’ needs. As a Type 1 diabetes patient himself, Rose is passionate about ensuring that the patient is always at the centre of healthcare delivery, including product design and development.

MedTech Forum

‘Patients are involved to some degree today but often it feels as though patient involvement is merely a bullet point on a pre-product launch checklist. Patients should be involved earlier in the process. After all, it is our pain issues that are being addressed,’ he said. To this end, Rose is part of a major EU-funded diabetes research project called INNODIA, which is made up of a consortium of academic, industry and patient partners from across many European countries. ‘We have created a patient advisory committee to help communicate in a patient-friendly manner and recruit patients to get more involved.’

When asked about the potential benefits of an artificial pancreas designed to ‘talk’ to doctors, Rose suggested that, ‘many patients would say they want an artificial pancreas that is good enough to not need to involve doctors after the initial set-up. New solutions from medtech industry should aim to help minimise the constant burden of diabetes management and allow us to focus on living our lives, day to day, like everyone else.’

Patients, manufacturing and AI

Indeed, there was much deliberation among MedTech Forum delegates about the future role of healthcare professionals and whether algorithms and Artificial Intelligence would eventually replace the human element.

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‘Design thinking’ was a continual theme across a number of sessions at the forum. On more than one occasion, panellists observed that the job of engineers and the needs of patients and healthcare professionals are at odds, and this is a challenge that needs to be overcome. ‘Products often look like they’re designed by engineers, for engineers. We have to make the technology invisible and seamless. We have to think of the end user,’ remarked John Carlson, President of FlexMedical Solutions.

Carlson also observed that the medtech industry had fallen behind other industries when it comes to manufacturing, as did Olivier Scalabre, Senior Partner and Director at the Boston Consulting Group (BCG). Scalabre said that the 4IR is ‘a chance for medtech to catch up to “best in class”. Medtech has been leading the pack in areas such as implantables and imaging systems, but these are all applied outside of manufacturing.’

The thorny issue of regulation

Another issue that’s weighing heavily on the minds of manufacturers is whether the upcoming new Medical Device Regulations (MDR) will be able to cope with the 4IR or whether they will hinder the speed of change. Two panellists from the European Commission, John McEvoy (DG SANTE) and Salvatore D’Acunto (DG GROWTH) both believe that the regulations are adequately future-proof. ‘I think there’s sufficient flexibility to anticipate likely changes in technology that will be regulated,’ explained McEvoy. D’Acunto agreed, with the caveat that the regulations ‘have to be implemented with common sense’.

Offering the perspective of a national regulator was John Wilkinson, Director of Medical Devices at the UK’s Medicines and Healthcare products Regulatory Agency, who said that although the regulations are flexible enough, he had some concerns about understanding new technology and applying this to the MDR. ‘The prospect of what’s going on in the IT space, such as algorithms, is probably our biggest challenge,’ he indicated. (When asked about the implications of Brexit, he said: ‘We’re in Europe until we’re not.’)

Despite reassurances from the European Commission, MedTech Europe’s Director of Regulations and Industrial Policy John Brennan called for more clarity on how the MDR will be implemented so that companies can address practical concerns such as the acceptability of clinical trial data.

MedTech Forum

So, is the European medtech industry ready for the 4IR? Robert Madelin, Chief Strategist at Fipra International and former Senior Adviser to European Commission President Juncker, believes the answer lies in the population and how people perceive innovation. ‘How do you bring people along so they think medtech is relevant?’ he asked. In order for Europe to be a front runner, ‘It’s not about the money [spent on R&D]. A design-, holistic-, person-centred approach is what makes tech sell,’ he said.

A common thread throughout the forum’s two days was that the 4IR requires society to move forward together, leaving nobody behind. This also applies beyond EU borders. In the developing world, for example, so-called ‘leapfrogging’ is becoming the norm. ‘There’s a move towards patient-centred solutions. We’re going to see the developing world skip some huge infrastructure costs such as hospitals and go straight to what works for them,’ MedTech Europe’s Director of International Affairs Jesύs Rueda Rodrίguez said. ‘This can benefit European countries where healthcare systems are slow to change. When we see it working elsewhere, then maybe people will accept it here. It’s not a one-way street.’

All images by Vivian Hertz

About the author

Karen Finn is a freelance writer and editor specialising in health, pharmaceutical and medtech regulatory, legal and policy issues, international trade and business writing.

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