Oliver Bisazza, CEO, MedTech Europe, explains what was discussed at the recent MedTech Forum taking place in Dublin.
Its design Shutterstock
1033778413
Dublin skyline
First, the 2023 edition of the MedTech Forum took place in Dublin, why?
We were absolutely delighted to host this year’s edition of the MedTech Forum in Dublin, given Ireland’s status as a global medtech powerhouse. Ireland’s manufacturing output generates more than €13 billion worth of medtech exports. There are some 450 medtech companies in Ireland, and they employ more than 48,000 people.
Ireland has proven it possible to create the right conditions for the innovative medtech industry to thrive.
Were there any common challenges at the MedTech Forum that were discussed?
Yes, it was definitely a red thread during the whole MedTech Forum. We discussed not only Europe’s fundamental strengths in delivering health and medical solutions, but also the actions needed to make the European regulatory environment for medical technologies more predictable, less prone to delays, more conducive to innovation, and overall, more sustainable in the long-term.
Many sessions concluded that to remain a global leader in medical technologies, the EU must deliver a more patient-centered and innovation-friendly regulatory framework that addresses the system-level challenges of today while preparing for the opportunities of tomorrow.
How has the medtech landscape changed lately, in the eyes of MedTech Europe?
Fundamentally! Beyond the medical technology industry’s sector-specific developments, the mega trends of digitalisation and sustainability have contributed to a revolution in the way innovation in medical technologies is happening. They also drive the need for a more forward-looking regulatory mentality to allow innovation to thrive.
Legislative activity of the EU in this area has been, rightly, immense – and much more needs to be done to ensure that all the rules-in-development which will impact medical technologies will actually work together to deliver products to patients. The EU’s Digital Strategy, driving regulation on artificial intelligence, cybersecurity, and data, including the European Health Data Space and the European Green Deal will legislate tectonic changes, including in the area of product design, are coming with a substantial set of new or updated requirements for medical technologies.
Against this background, substantial legislations are also being revised, such as the ones on Product Liability and Corporate Sustainability Due Diligence. It is paramount to include principles that ensure patients across the EU can benefit from a high level of protection and businesses are provided with legal certainty.
All these new rules will significantly impact the way and speed in which technologies can be brought to and accessed by patients and healthcare professionals.
Anything else you’d like to add?
Sure, let’s look at the near future for a second. This EU legislative cycle is slowly approaching an end (NDRL: in 2024). So now is a good time to reflect on what has been achieved and what is still to be done.
We need to solve existing challenges in a comprehensive, sustainable manner, setting the tone for a future environment that will allow patients to continue benefiting from first-line, quality medical technologies and more equitable access to healthcare, and health systems to build the long-term resilience they need.
All healthcare stakeholders will have a role to play in shaping a healthier Europe and the medical technology industry in Europe stands ready to contribute and collaborate to make this a reality!
