Sweden has long been regarded as a leading engineering nation, but how do we stand today in the development of new medical technologies? What works, and what barriers do you see to innovations reaching the patients?
– Sweden has a long tradition of interdisciplinary collaboration between technology and medicine, which has led to groundbreaking innovations such as the implantable pacemaker, dialysis machine, Servo ventilator, Gamma Knife, and inhalers – several life-saving solutions that continue to impact healthcare globally. It’s a legacy to be proud of, and Sweden still has a strong culture of advanced medtech innovation, with a solid scientific and technical foundation.
– At the same time, we see how the European regulation, MDR, has complicated the path from idea to clinical benefit for our patients. In practice, a fully developed product with complete documentation is now required before clinical proof of concept can be achieved, which means higher costs and increased risk for innovation projects. This has led to longer development times and greater uncertainty in the regulatory process. Since MDR came into effect in 2021, only a handful of new medtech innovations based on new technology have been approved within the EU – which says a lot about the current situation. This isn’t just about market access; it also affects companies’ growth opportunities in Sweden and, ultimately, European patients’ access to new medtech. This is an issue the industry must continue to raise.
Since MDR came into effect in 2021, only a handful of new medtech innovations based on new technology have been approved within the EU
– That’s also why many Swedish medtech companies view the US as the primary market. The regulations there are clearer, the path to the patient is somewhat more predictable, and the willingness to pay for new medtech innovation is higher than in Europe.
– At the same time, the global landscape is changing, with increased complexity affecting both how and where new innovations can reach the market. Geopolitical tensions, potential trade barriers, and shifting priorities in healthcare can impact everything from component availability to regulatory processes – raising the need for clear market strategies and greater flexibility. For Swedish companies, this means combining a competitive product with a proactive and adaptable global growth strategy.
How well-equipped do you think the Swedish ecosystem is to support emerging medtech companies, both in the early stages and when scaling internationally?
What’s working well, and where do you see the need for development?
– Sweden has an impressive ecosystem for emerging medtech companies, especially in the early stages. Initiatives from Vinnova and Medtech4Health provide concrete tools and support for companies on their way to commercialization, and our life science incubators have built a strong base of both experience and networks. There is also significant engagement from leaders and specialists with deep industry experience, who make a big difference through their contributions to both medtech company boards and industry organizations.
– There’s also growing momentum to promote Swedish medtech internationally. The government has clearly expressed a desire to strengthen export opportunities for medtech innovation, which is important for Sweden to maintain its leading position in the field. Business Sweden plays a key role in this effort, opening doors to new markets.
– To take a concrete example, for Neola Medical, this support has been valuable in our work in the US market. It also gave us the opportunity to participate in the Swedish delegation at the World Expo in Osaka through the Pioneer Prize, where we are presenting our medtech innovation in a global innovation context at the highest level.
– For continued medtech growth, we need to focus on regulatory relief within the MDR, favorable conditions for attracting both Swedish and international top talent, improved opportunities to conduct clinical trials in Sweden, and not least, long-term funding for this high-tech future industry.
AI and digital modeling are developing rapidly. How do you think this will affect the future of medtech? What’s needed for the technology to truly become part of healthcare and be accepted by regulators?
– I’m convinced AI will play a significant role in the future of healthcare. The potential is enormous – not only to streamline and ease the burden on healthcare but also to increase precision in diagnosis and treatment. We’re already seeing AI in medtech transition from vision to real-world implementation, especially in the US, where the FDA now actively supports the development of AI-driven solutions after a previously more cautious stance. – A key issue for the entire industry is how clinical studies are designed and what kind of data AI models are trained on. For these solutions to be regulatory-compliant, a deep understanding of both technology and regulatory frameworks is needed from the start of development projects. – What’s exciting now is that digital simulation is starting to be accepted as part of the regulatory decision-making process. This could help reduce the need for animal studies and complement clinical data, offering time and cost benefits. – There are also signs that regulatory authorities in the US and EU are beginning to align more closely on how requirements for AI-based medtech solutions can be structured – which could eventually simplify access to patients and reduce regulatory duplication. – We are in a future-facing industry where Sweden has much to contribute. With our strong technical expertise and history of groundbreaking innovations, we have every opportunity to take a leading role in AI-driven medtech as well.
This interview was first published in SwedenBIOs 2024 annual report.
