High-level representatives from the MedTech industry gathered at the eleventh PTC Life Sciences Exchange, held at the Tower of the former Munich-Riem Airport, where Brainlab now has its state-of-the-art headquarters. An unprecedented number of experts took the opportunity to gain valuable insights and new inspiration in this inspiring atmosphere, to exchange ideas with representatives of other companies and to network.
Situation: innovations
At the beginning of the event, René Zölfl, host of the event and Global Industry Advisor Life Sciences at PTC, outlined the current situation of the MedTech industry – and thus also the most important fields of action: the companies are united by the goal of enabling ever better treatment outcomes and improving people's lives – especially when they are struggling with health problems. They work passionately and innovatively to achieve this.
One trend is towards personalized treatments. Jose Coronado, Director Creo Manufacturing at PTC, presented an impressive project in this regard: Within just one week, a team of experts from PTC, the Tel Aviv Medical Center and Hexagon created a fully patient-specific scapula implant for a 16-year-old cancer patient.
New competitors and mega-disruptions
But the market is tough, says René Zölfl: Mega-disruptions such as global political developments and climate change also influence the MedTech industry.
New competitors such as Google & Co. blur the line between consumer and medical products. This could significantly change the patient relationship and challenge the business models of traditional medical device manufacturers.
Regulatory complexity
In addition, there is the growing regulatory complexity. “An explosion,” said Prof. Dr. Christian Johner, founder and owner of the Johner Institute: Not only has the number of regulations increased significantly in recent years, but also their complexity and the pace of change. This applies to industry-specific regulations such as the European Medical Device Regulation (EU MDR), but also to industry-independent ones such as the EU AI Act – and this applies globally, at EU level and nationally.
One question that those responsible should ask themselves: Is it just about complying with regulations? Or does the company see this as an opportunity to develop a strategy that strengthens its competitiveness? The title that Lydia Eckhard from Deloitte and Michael Löffler from Fresenius SE gave their presentation is quite to the point: “Beyond Compliance: Turning Regulations into Real Impact”. They described the challenges associated with the Corporate Sustainability Reporting Directive (CSRD) – but also the opportunities, especially for companies in the MedTech industry. For these companies, the “S” in the ESG criteria (Environmental, Social, Governance) of the CSRD plays the main role. Fresenius SE, for example, uses the directive to strengthen its commitment to saving and improving people's lives and to making the company even more attractive for employees, partners and customers.
Skills shortage
Nevertheless, the effects of the proliferating reporting requirements are serious, according to Prof. Dr. Johner. Additional specialists for this job are hard to find, because there are hardly any. And the task is not very attractive. The result: developers have to use their valuable time for documentation tasks. This is already evident in the steadily decreasing number of registered innovations.
The way out: digital transformation
René Zölfl sees the way out in digital transformation and resilient business strategies. But how can MedTech companies successfully implement digital transformation and achieve their associated goals?
In a presentation titled “Streamlining Compliance and Innovation: The Windchill+ for MedDev Advantage,” Leopold Islinger, Digital Transformation Manager at Gerresheimer, and Benjamin Kirsch from PDSVision, reported on Gerresheimer's PLM journey. It started with a product data management (PDM) system so that documents of all kinds could be replaced by reliable and qualified data. This laid the foundation for a PLM. From numerous systems, Gerresheimer chose Windchill+ for MedDev from PTC as the backbone and PDSVision as the integrator. According to Islinger, the advantages of the SaaS solution from Windchill included higher IT security, cost advantages for maintenance and licensing, and scalability.
The Digital Thread
In an interview with Steve Dertien, CTO at PTC, Christian Vogelei from Fresenius Medical Care emphasized that the digital transformation should not only consider the product. Rather, the entire value chain should be integrated into a digital thread. Fresenius Medical Care, for example, is currently connecting its production sites in a transparent, end-to-end workflow in order to flexibly produce products where they are needed.
Artificial Intelligence and Generative AI
Christian Vogelei sees enormous transformative potential in artificial intelligence, especially in generative AI (GenAI): it enables companies to increase their efficiency and innovative strength. In addition, manufacturers can gain new, comprehensive insights into how their products are used. This allows them to develop more robust designs that are even better adapted to the needs of doctors and nurses, as well as patients.
Steve Dertien reported on PTC's AI initiatives, in particular the GenAI-based assistants that are currently being developed. The first is ServiceMax AI, an assistant specially tailored to field service. It supports technicians with real-time information, for example, on work orders or scheduling, enabling them to work more efficiently.
Service and support as a product
Brainlab began digitizing its service and support 20 years ago. Since 2021, it has really taken off: Based on ThingWorx, it has become its own product as “Brainlab Connected Care”. Today, more than 3,000 Brainlab devices are connected, and 73% of service requests for radiotherapy applications have been resolved remotely. This helps Brainlab to keep pace with regulations and increasing fragmentation, while also ensuring cybersecurity and uptime guarantees and fulfilling value-based contracts.
Challenges: from transformation fatigue and analysis paralysis
The hurdles that need to be overcome on the road to digital transformation were also discussed.
On a technical level, these are primarily data silos that prevent or complicate the linking of relevant data. Holger Brämer and Enric Cullell from USDM identified a solution: reliable data pipelines that centralize data from different sources.
The participants identified “transformation fatigue” and “analysis paralysis” as challenges on the human level. David Stokar from F. Hoffmann-La Roche described where these challenges come from: if the focus is only on technology, people get lost on the digital journey – and with them the benefits of the transformation.
Conclusion
The PTC Life Sciences Exchange has shown that there is an enormous need for discussion in the industry. The digital transformation is on the minds of all companies. And even if the implementation looks different for each company, everyone can learn from each other. We are pleased that we were able to create a framework for this with the PTC Life Sciences Exchange.
Join us next time and benefit from inspiring lectures and intensive discussions with experts who are helping to shape the future of the MedTech industry.
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