The MedTech Forum 2025, held in Lisbon, brought together nearly 1000 attendees; the mix of highly distinguished medical technology professionals, decision-makers, and innovators offered a great opportunity for all to engage in deep, meaningful conversations and explore collaborations that will shape the future of healthcare.
For our team on the ground, the forum allowed us to engage in focused discussions about the challenges and opportunities shaping the European landscape.
Unlocking Innovation: Regulatory Hurdles, Data Silos, and the Promise of AI
As the MedTech industry continues to evolve, the European market stands at a pivotal crossroads—brimming with potential yet constrained by structural complexities. At the MedTech Forum 2025, HTEC’s Sava Marinkovich brought a strategic lens to these challenges, drawing from rich conversations and sessions that unfolded throughout the event.
A Rising Tide of Optimism
There’s a growing sense of optimism around Europe’s ability to lead in the development of safe, impactful, and privacy-first health technologies. This optimism is fuelled by the region’s strong academic foundations, robust healthcare systems, and increasing investment in digital transformation. However, optimism alone isn’t enough to drive change. As Sava noted, several entrenched barriers continue to stall momentum and complicate the path to scalable innovation.
Fragmented Regulatory Landscape
One of the most pressing challenges is the fragmented regulatory environment across European nations. Each country’s unique set of rules and frequent updates create a ripple effect that impacts product development, labeling, and commercialization strategies.
“Every regulatory tweak can affect features, packaging, and go-to-market strategies differently per country. This complexity inflates operational overhead and discourages agile innovation,” said Sava.
This patchwork of regulations not only slows down the pace of innovation but also significantly increases SG&A (Selling, General & Administrative) costs. For MedTech companies operating across borders, this means more time spent navigating bureaucracy and less time focused on delivering value to patients.
Inconsistent Cloud and Data Regulations
Another major roadblock is the lack of harmonized cloud and data governance policies. Disparate national rules around data hosting, interoperability, and patient privacy create friction for companies trying to build connected systems or scale digital platforms across markets.
Without a unified framework, even the most promising digital health solutions face hurdles in deployment and adoption. The result is a fragmented ecosystem where innovation is stifled, and patients miss out on the benefits of seamless, data-driven care.
A Call for Regulatory Evolution
HTEC’s Marko Manić, Engineering and Delivery Manager, emphasized the urgency of addressing these issues:
“With Europe facing a confirmed shortage of healthcare professionals, the call to action is clear. Now more than ever, all stakeholders must unite to drive MedTech innovation—ensuring it eases system pressures while keeping patients at the center. Regulatory frameworks should evolve as enablers, not barriers, supporting safe, effective, and accessible solutions for the future of care.”
This sentiment underscores a broader industry need: to reimagine regulation not as a constraint, but as a catalyst for innovation.
Generative AI: A Game-Changer for Compliance
Despite these challenges, there are clear paths forward—and they don’t all require sweeping political reform. One of the most promising solutions lies in the application of generative AI to regulatory workflows.
Drawing on HTEC’s experience with pharmaceutical clients, Sava illustrated how AI-powered platforms can analyze regulatory changes, assess their impact across different jurisdictions, and automatically generate updated documentation and labeling. This dramatically reduces manual effort, shortens time to market, and enables companies to remain agile in the face of regulatory complexity.
A Shift in Mindset
Beyond technology, Sava called for a cultural shift within the industry—one that embraces cross-sector collaboration, practical problem-solving, and a willingness to tackle “low-hanging fruit” while larger systemic issues are addressed.
While harmonizing cloud policies may require political coordination, other areas—like interoperable data frameworks and smarter regulatory planning—can be addressed now. By focusing on what’s within reach, companies can begin to bridge friction points and unlock new opportunities for growth.
Looking Ahead: Megatrends That Will Shape the Next Decade
In the CEO panel and across the event, several key trends emerged as defining forces for MedTech over the next 5–10 years:
- AI, automation, and robotics will continue to transform how we deliver and scale medical solutions.
- Data sharing across borders is a potential game-changer—unlocking everything from targeted therapies to improved system-wide efficiency.
- Personalized and targeted treatments are gaining ground over one-size-fits-all solutions.
- Sustainable healthcare models are essential to preserving the European public health system, with affordability and accessibility at the center.
The Opportunity
For forward-thinking MedTech companies, the message is clear: those who invest in smart tools, strategic partnerships, and regulatory foresight will be best positioned to lead. By moving faster, staying compliant, and delivering better solutions across borders, these companies can help shape a more connected, efficient, and patient-centric future for healthcare in Europe.
If you’re exploring how to develop MedTech solutions that are future-ready, regulation-aware, and built for real-world impact, we’d love to continue the conversation.
