Webinar Highlights: MedTech World and Arena by PTC Address Compliance and Innovation in Medical Devices

On September 11th, 2024, MedTech World hosted its first-ever live webinar in collaboration with Arena by PTC. The webinar, held on the ON24 platform, brought together a panel of industry experts to discuss regulatory compliance, innovation, and the evolving role of technology in the medical device industry. Led by Rodney Moses, MedTech World’s Client Success Manager, the event featured insights from key leaders including Amy Bennett, Markus Fleckenstein, and Konrad Dobschuetz.

Navigating Regulatory Complexity in the MedTech Industry

A major focus of the webinar was the challenge of navigating an increasingly complex regulatory landscape. The introduction of the EU Medical Device Regulation (MDR) in 2021 brought significant changes, imposing stricter rules around post-market surveillance and product approvals.

Markus Fleckenstein, Head of Solution Consulting, International at PTC, highlighted the importance of staying ahead of these changes through continuous education and training. He noted that organizations must ensure all employees understand the regulatory landscape and its implications. Fleckenstein stressed the need for companies to adopt software solutions that automate compliance processes to keep up with rapid regulatory changes.

Amy Bennett, Quality Assurance and Regulatory Affairs Manager at PhenUtest Diagnostics, reinforced this point by emphasizing the importance of developing a strong regulatory strategy early on. She pointed out that understanding where to market a device and having clear communication with the commercial team are crucial steps for any MedTech company aiming to manage risks and meet market access requirements.

Innovation and Compliance: Striking the Right Balance

The rise of AI, digital health, and robotics is transforming the MedTech industry, and companies are heavily investing in research and development (R&D) to stay competitive. MedTech companies, on average, allocate 5.1% of their annual revenue toward R&D. However, as Bennett noted, regulatory bodies like the FDA are catching up by issuing guidelines for AI-driven medical devices.

For startups, establishing a strong foundation early on is essential. This includes implementing a robust quality management system (QMS) and building a multidisciplinary team to ensure compliance and product quality. Bennett emphasized that identifying potential risks early in the product development process is critical. By incorporating risk assessments into design verification and validation testing, companies can address issues before entering pre-clinical testing phases.

Konrad Dobschuetz, Senior Advisor Health at Clarity Global, discussed the challenge of balancing global regulations with innovation. With over 20 years of experience in healthtech and digital marketing strategy, Dobschuetz highlighted that a solid compliance strategy is not only necessary for patient safety but also essential for long-term business growth.

Leveraging Technology to Enhance Compliance

Both Fleckenstein and Bennett agreed on the vital role technology plays in streamlining compliance efforts. With cloud-native QMS solutions, companies can automate quality processes, analyze trends, and easily track information. Fleckenstein explained that these platforms can significantly reduce manual workloads, enabling teams to focus on more strategic tasks. He also noted that while investing in technology may seem costly upfront, it delivers long-term benefits by making companies more efficient and scalable. 

Bennett supported this perspective, explaining that automating QMS processes allows companies to monitor product quality more effectively. Early identification of trends can prompt corrective actions before issues escalate, improving both product readiness and compliance. 

Preparing for Regulatory Approvals in the U.S. and EU

For MedTech manufacturers seeking regulatory approval in the U.S. and EU, early engagement with regulatory bodies is essential. Bennett underscored the importance of initiating conversations with the FDA early in the design process. This early feedback can significantly impact the development of a regulatory strategy. 

In the EU, Bennett advised companies to carefully consider the risk classification of their devices and determine how they will meet general safety and performance requirements (GSPR). By thoroughly addressing these factors, manufacturers can better mitigate risks and ensure compliance with MDR regulations.

Building a Strong Compliance Strategy for the Long Term

As the webinar concluded, the discussion turned toward the long-term benefits of building a strong compliance strategy. Fleckenstein encouraged manufacturers to keep future goals in mind when planning for compliance. He explained that investing in resources like an electronic QMS (eQMS) can help companies scale more efficiently, both in terms of product development and market expansion. 

Bennett emphasized the importance of not only investing in technology but also in people. She advised companies to invest in their team’s development and skill sets to ensure they remain adaptable to evolving regulatory landscapes. Regular monitoring of processes and identifying areas for improvement will also help organizations stay compliant with changing regulations.

A Roadmap for MedTech Success

The webinar provided valuable insights for companies navigating the intersection of innovation and regulatory compliance. As the industry continues to evolve, MedTech manufacturers must be proactive in adopting new technologies, developing comprehensive risk management strategies, and engaging with regulatory bodies early in the product development process. By doing so, they can ensure compliance while delivering innovative solutions that improve patient outcomes and drive business growth.

Up Next: MedTech Malta 2024

Explore the latest in healthcare innovation and engage with top industry leaders at MedTech Malta! Join us from November 6 to 8 at the iconic Mediterranean Conference Centre in Valletta. Don’t miss your chance to be part of this transformative event—book your spot today!