2025 Conference Insights: What industry trends may impact your business?
This year Lumis attended 14 conferences – ensuring we are up to date with the latest industry trends and news. Our experts presented at conferences, sharing their experience, insights, and demonstrating their thought leadership.
Here is a distilled summary of the most critical takeaways and what they mean for your company.
Executive Summary: Critical Trends to Watch
- Clinical Trials Outsourcing: Sponsors are consolidating vendors to simplify trial management, but the rise of separate legal representative outsourcing demands a harmonized approach to contracts and project oversight across all partners.
- Medical Device Global Expansion: Small medtech companies often underestimate the value of CE-marking in global registrations. To avoid reduced market agility from relying heavily on distributors, more companies are seeking independent partners for global registrations.
- Artificial Intelligence (AI): AI is a core theme in biotech and medtech, used in products and drug development (e.g., digital twins). It may also reduce operational costs for greater competitiveness, which could be particularly powerful for Notified Bodies. This innovation, however, comes with distinct regulatory challenges
Expert Insights on Industry Shifts
“Biopharma: There is a growing shift in combining the economic health technology assessments with the regulatory market authorisation applications. This was evident at the Orphan Congress where the Joint Clinical Assessments (JCA) was a major topic, although the scope and capacity of JCA is currently limited. Interestingly, 50% of orphan drug applications are from emerging biotechnology companies which shows the importance of a diverse small-to-medium sized ecosystem for addressing rare diseases.
Artificial Intelligence (AI) is a key theme in the medical technology industry. It is being applied as a medical technology, which poses regulatory challenges with the MDR/IVDR but also the AI Act. However, it is also being utilised by service providers to streamline regulatory document preparation. A key opportunity for me is if Notified Bodies can utilise AI to reduce their operational costs. This could make Notified Body fees more affordable to small MedTech companies and increase the supply and competitiveness of the market, helping combat the repercussions of the MDR and IVDR.
Combination Products: 20% of market authorisation applications are combination (drug-device) products. Hence, an understanding of Article 117 (MDR) and device classification rules is crucial. The EU’s COMBINE project is helping address the challenges of complying to the MDR/IVDR and Clinical Trials Regulations (CTR) for combined product studies.
Funding: The last few years have proven challenging for fundraising biotech and medtech start-ups. For example, only 0.2% of proposals to investors are funded. However, there are ways to maximise the chances. Start-ups should carefully select venture capitalists to align with their company’s strategy. Furthermore, there are growing opportunities in big pharma VCs and mergers and acquisitions. Lastly, for early start-ups there are ‘outside the box’ finance options, particularly for medtech, such as the ‘Defence and Security Accelerator’.”
Liam Spencer
Senior Regulatory Project Manager
“Clinical trials: CROs are increasingly stepping away from handling Legal Representation due to the conflict of interest and the added burden it brings, and sponsors now recognise that regulators and even investors can view it more positively when an independent partner oversees the trial.
MedTech: There is still a lot of hesitation from small and non-EU manufacturers about entering the EU market, mainly due to the high cost, long timelines, and complexity of CE marking. Quite a few underestimate what it takes, especially for higher-risk classes requiring NB.
Global Expansion: We met several early-stage MedTech teams who are unsure which markets to prioritise; some chase EU entry before realising it may not be the most strategic first step, while others avoid the topic altogether and overlook the opportunities EU market can bring. Overall, there is a strong need for expert-led planning and independent partners who can help companies navigate these decisions confidently and consciously.”
Stella Vu
Business Development Manager
“Clinical trials: Having attended Clinical Outsourcing Group Nordics, BioSpain and the Barcelona Health Hub congress, my main takeaway is that sponsors are consolidating vendors and expect outsourcing partners that combine specialized regulatory expertise with very clear contractual, operational and financial structures. At Clinical Outsourcing Group Nordics, including my session, the focus was on how outsourcing models, contracts and project oversight need to be aligned so that responsibilities, risks, and escalation paths are transparent for both sponsor and service provider.
Spain: In the Spain-focused events, the message was that the local ecosystem is growing fast, but still needs partners who can translate complex European requirements into clear service packages and predictable pricing, especially for small and medium biotechs using Spain as a strategic entry point to Europe.
Digital innovation: Across all meetings, digital innovation and artificial intelligence were very visible, with a particular interest in the potential of digital twins in clinical research, where sponsors see opportunities but still look for guidance on contractual frameworks, data governance and regulatory expectations.”
Andrés Aguilar Caro
Head of Contracts and Proposals
Next Steps: Partner with Lumis
Ready to translate these insights into a decisive advantage for your business? We understand how the medtech and biotech industries are changing and can help you leverage these shifts to your advantage.
Get in touch with our Lumis experts to learn more.