Why Europe could fall behind in the medtech sector

27 Nov 2023

Image: © ArtemisDiana/Stock.adobe.com

While many innovations both in Ireland and wider Europe show why the region is so strong, clunky regulations may hold it back.

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The medtech industry, which comprises medical devices, in vitro diagnostics and digital health wearables, is continuing to grow. In 2022, the European medtech market was estimated to be roughly €160bn.

And in September of this year, a report from intellectual property firm Marks & Clerk found that while AI is changing the future of virtually every industry, it is the medtech sector in particular that is capitalising on the emerging tech. The report found that the number of AI-based patent applications filed by the sector in 2022 had almost quadrupled since 2018.

Tim Hargreaves, partner and medtech specialist at Marks & Clerk, said the medtech sector’s dominance in AI-based patent applications reflects its place at the forefront of innovation. “As the sector continues to drive forward the development of new technologies aimed at enhancing healthcare, it’s heartening to see the industry taking proper steps to secure its innovations.”

This growth in the industry can be easily seen in the success of countless innovations, investments and start-ups advancing within the space, both in Ireland and further afield.

Earlier this year, Galway-based Xtremedy Medical won the MedTech Innovator accelerator for its surgical devices that aim to address deep tissue and bone infections. Galway is also home to many other successful medtech start-ups, including this week’s Start-up of the Week, MedScan3D, which develops patient-specific anatomical models from various human body scans.

Also this year, neurosurgeons in Switzerland restored upper limb function in a patient with a spinal cord injury using a brain-computer interface. This followed a study from May 2023 that used similar tech to help a person with paralysis walk again.

Could regulation hold medtech back?

While Europe is holding strong with its medtech market, one of the region’s strongest assets could also be one of the industry’s limitations: regulations.

It’s safe to say that EU lawmakers have curated some of the most comprehensive sets of rules and guidelines across the tech space and the medical device arena is no different.

In particular, the EU Medical Device Regulations (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR) – which became fully applicable in 2021 and 2022 respectively – aim to establish a robust, transparent and sustainable regulatory framework for medical devices, ultimately seeking to ensure a high level of safety for device users and patients.

While the industry welcomed the regulatory overhaul at the time, major players have since called for change, citing fears that the regulations are not on track to meet their outlined goals.

Medtech Europe, along with 34 national associations, sent an open letter to European commissioner for health, Stella Kyriakides, calling for structural reform of the frameworks.

“It is apparent that there are structural issues in the regulatory framework which cannot be solved simply through its implementation,” the letter stated.

“The regulatory framework is unpredictable, complex, slow and costly. The result is that medical technologies – both those already on the market and future innovations – struggle to reach European patients and health systems.”

In order to reach the objectives the regulations were set out for, the open letter includes a list of changes the organisations propose, including a more efficient CE marking system – which signifies whether or not products have been assessed and proven to meet high safety, health and environmental requirements, stronger support for innovation that sees the latest medical technologies connected to European patients, and a single dedicated accountable structure to oversee the regulatory system.

While regulation is undoubtedly one of Europe’s strongest competitive advantages in many industries and one that the medtech industry supports, it’s important to ensure that these regulations don’t become barriers to future innovations.

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Jenny Darmody is the editor of Silicon Republic