Bridging the Gap: How Industry-Clinic Platforms are Reshaping Medical Device Development

The development of medical devices has reached a critical juncture. As regulatory requirements become more complex and healthcare needs more pressing, the traditional divide between medical device manufacturers and clinical practitioners threatens to slow innovation and impact patient care. Industry-clinic platforms have emerged as a vital solution to this challenge, creating structured pathways for collaboration and innovation in medical device development.

The VDI Technologiezentrum (VDI TZ) has made a significant contribution to supporting the development of the industry-in-clinic platforms. Thanks to its expertise and commitment, decisive progress has been made that will strengthen cooperation between industry and clinics in the long term. In close cooperation with the Federal Ministry of Education and Research, the VDI TZ organized a panel discussion at MedtecLIVE 2024. This event provided a valuable opportunity to discuss current topics and challenges and to jointly develop solutions.

The New Regulatory Landscape: Understanding MDR's Impact

The Medical Device Regulation (MDR) implementation has fundamentally changed the development landscape for medical devices in Europe since May 2021. According to industry experts at the MedtecLIVE 2024, while the regulation's goals of ensuring higher safety, transparency, and comparability are well-intentioned, these objectives haven't been achieved in Germany. Dr. Jens Elsner points out that manufacturers face significant challenges in both launching new products and maintaining legacy products in the market, largely due to the bureaucratic burden and limited capacity of notified bodies. The regulatory burden has become so significant that many companies are choosing to launch products in the U.S. market first, before attempting European approval. As one expert noted, "The innovations are developed here but won't arrive directly in care," highlighting a concerning trend for European healthcare innovation.

The impact on specialized medical devices has been particularly severe. Dr. Nadine Leistner, scientific director of MEC-ABC GmbH, notes that many manufacturers are removing niche products from their portfolios, especially those serving smaller patient populations such as children, premature infants, and patients with rare conditions. This rationalization is driven by the economic reality of meeting new regulatory requirements for products with limited market size.

The timeline for full MDR adaptation extends to 2027-2028, following recent extensions. However, experts warn that this extension shouldn't be seen as a reason to delay preparation. Instead, it should be viewed as an opportunity to build proper foundations for future compliance while maintaining innovation momentum.

The Industry-Clinic Divide

Communication between medical device manufacturers and healthcare providers has traditionally been challenging due to different priorities and operational cultures. Clinicians focus on patient care and have limited time for product development input, while manufacturers need detailed feedback to meet regulatory requirements and market needs.

Digital platforms are emerging as a key solution to this communication challenge. Dr. Enrico Pannicke, CEO of mediMESH GmbH, describes how their clinical insights platform enables focused communication through video documentation of medical procedures and structured feedback channels. Operating for two years, the platform allows developers to create videos visualizing their problem statements and share them with clinical experts who can respond when their schedules permit. "What has positively surprised us is how both sides really want to pull together," notes Pannicke. "The clinicians are very eager to show what they do and how they do it on our platform, and this is well received by our customers who can then view these processes through the platform." This approach not only accommodates busy healthcare professionals but also helps bridge the language gap between engineers and medical professionals, who often "talk completely past each other" despite speaking the same language.

The cultural divide between technical and medical sectors remains a significant challenge. Platform providers report that even when both sides are eager to collaborate, different professional languages and priorities can lead to misunderstandings. Successful platforms act as translators and moderators, helping both sides understand each other's constraints and requirements.

Innovation Under Pressure: Balancing Progress and Compliance

The current regulatory environment has led to more conservative innovation approaches. Manufacturers are making smaller, incremental improvements rather than pursuing breakthrough innovations due to the increased burden of proving safety and efficacy for novel solutions. This shift threatens to slow the pace of medical advancement.

Platform solutions are helping companies maintain innovation momentum through several key approaches. As Dr. Nadine Leistner emphasizes, success requires taking a "bird's eye perspective" that considers the product from all angles early in development. Platform solutions are specifically helping by:

●       Providing early clinical input to guide development decisions and intended use specifications

●       Streamlining documentation and approval processes through structured approaches

●       Facilitating efficient data collection and analysis, particularly for clinical evidence

●       Creating structured frameworks for user feedback and validation

●       Supporting quality management system requirements

●       Helping companies build the right mindset and awareness across their organizations

As Leistner notes, "It's important to think through the product from a bird's eye view at all ends. That means having a strategic component, playing through all things in the development chain. This conceptual strength must be built up with companies because it's often very isolated in individual departments."

Looking Ahead: Shaping the Future of Medical Device Development

The future of medical device development depends on finding better ways to balance innovation with regulatory compliance. Industry experts recommend several key improvements:

●       Development of standardized data protection guidelines for clinical collaboration

●       Increased support for clinics participating in research and development

●       Better alignment between European and U.S. regulatory approaches

●       Enhanced digital tools for communication and documentation

Conclusion

Industry-clinic platforms are proving essential in navigating the complex landscape of modern medical device development. While challenges remain, particularly around regulation and communication, these platforms are creating new pathways for collaboration that benefit manufacturers, healthcare providers, and ultimately, patients. Success will require continued innovation in platform solutions and a commitment to breaking down traditional barriers between technical and medical sectors.

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Editorial notice:
This article is based on the corresponding presentation during MedtecLIVE 2024 and was created with the support of AI. The supporting programme of MedtecLIVE 2026, which will take place from 5 to 7 May 2026 in Stuttgart, also offers numerous lectures. The trade fair brings together suppliers, providers from the development and production of medical technology, OEMs, distributors and other players in the medical technology community.