Evidence generation is a strategic imperative in medtech, driving revenue, market access, and long-term business growth. Yet, the process remains fragmented and slow across the industry.
Global regulations such as EU MDR and IVDR raised the bar for clinical evidence. With the EU AI Act, European Health Data Space (EHDS), and other regulations on the horizon, pressure to generate more comprehensive and continuous evidence is intensifying.
To explore solutions, we interviewed four innovative medtech companies: Smith+Nephew, B. Braun, Philips, and Roche Diagnostics. Their experiences reveal how clinical evidence is shifting from a regulatory necessity to a strategic capability where clinical, medical, commercial, regulatory, and operational teams co-design studies to fuel commercial differentiation.
Core operational challenges
Despite strategic intent, operational barriers remain widespread across the industry:
- Siloed processes: Teams work in isolation, creating inefficiencies.
- Lack of transparency: Visibility gaps across planning, execution, and activation delay delivery.
- Fragmented accountability: Process ownership varies with unclear responsibilities.
- Complexity: Cross-functional misalignment hampers strategic workflows.
These challenges slow down time to market and dilute the impact of clinical evidence.
Best practices from the field
1. Smith+Nephew – governance and focus
Kolja Boese, MD, Ph.D., head of global medical affairs at Smith+Nephew, contributed to establishing a clinical review committee (CRC) that meets monthly to ensure governance, prioritization, and progress tracking. Smith+Nephew focuses each study on a single primary endpoint to reduce ambiguity, accelerate decision-making, and ensure actionable outcomes. Boese noted, “We found we needed to have a better preparation phase for these studies and have better designs” to address expectations of notified bodies and key stakeholders, as well as cost efficiency. The company is also working to use study outputs to support marketing claims and product positioning.
2. B. Braun – breaking down silos
Marius Selig, MSc, director of medical scientific affairs at the B. Braun division Aesculap, and his medical scientific affairs (MSA) team help bridge communication gaps across clinical, marketing, and sales teams. Through educational sessions, they help commercial teams leverage data for market differentiation. Selig explained, “If you want to fully leverage medical insights for a medtech company, all the functions need to work together and swim in the same direction”. Looking ahead, B. Braun is investing in automation, AI tools, and analytical skills to translate medical insights into business value.
3. Philips – building connections through collaboration
Martijn van Steennis, global chief medical officer of diagnostic imaging, helped implement cross-functional boards where leaders meet to review risks, share updates, and align on evidence priorities. This governance structure fosters organizational clarity and early participation. Van Steennis said, “The advantage is we have more oversight of who’s doing what. We can harmonize all the different types of studies that we do across the world a little bit better.” This governance structure fosters clarity, reducing confusion and ensuring proactive participation from critical teams early in the process.
4. Roche Diagnostics – Holistic Ownership
Tilman Rüsike, PhD, lifecycle leader for immunoassays and clinical chemistry, highlights a portfolio lead model where a single individual owns the entire end-to-end evidence process. Rüsike clarified, “There’s one person who owns the full end-to-end delivery of the portfolio. They act as the head of product and global commercialization, and they are the decision maker for any strategic trade-offs.” Roche Diagnostics also emphasizes precisely defining the product and its intended use early on to design targeted studies and integrate regulatory, clinical, and commercial goals.
Industry-wide insights and the future of evidence generation
In addition to timing, three core best practices emerged:
- Holistic ownership: Clear accountability from design to activation speeds execution.
- Clear product definition: Shared understanding of the product’s purpose streamlines study design.
- Unified strategy: Co-created strategies decrease duplication and accelerate decisions.
The future vision centers on automation, integration, and data-driven decision-making. AI will eliminate manual work and accelerate study timelines by drafting protocols and monitoring literature for post-market surveillance. Predictive tools, like site selectors and benchmarking systems, will optimize resource allocation and study design. However, these advances will not replace human judgment, but rather amplify strategic thinking and allow study teams to drive business value and focus on patient outcomes.
Evidence generation is no longer just a compliance exercise - it’s a strategic differentiator. As regulatory expectations rise and market competition intensifies, successful organizations will be those that treat evidence generation as a core business function, not a cost center. They’ll also need to build cross-functional collaboration and clear ownership into their processes, and leverage data and technology to drive transparency, speed, and decision-making.
