How Accelerators are using RegMetrics to support their Startups to navigate Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

by Francesca Davis on 10 Dec 2024

Reading time: 2 minutes

In a recent interview, I spoke with Dr Bodo Brückner, the Coordinator of the Life Science Accelerator at Stadt Mannheim (“LSA BW”), about how the RegMetrics tool is lowering the barriers to entry and providing medical device innovators with the regulatory expertise they need to succeed.

By way of background, the LSA BW is an accelerator program in Baden-Wuerttemberg and supports startups (Digital Health, MedTech, Biotech) in the following ways:

  • Acceleration: Helping startups grow and developing student entrepreneurial skills.
  • Networking: Providing opportunities for the Startup ecosystem to connect.
  • Funding: Access to university, municipal, and regional funding opportunities
  • Mentorship: Experienced entrepreneurs serve as mentors and speakers.

For medical device innovators, navigating complex regulatory frameworks like the MDR and IVDR can be one of the biggest challenges on the road to market. We discussed how RegMetrics has been used to soothe this pain point for his Startup accelerator cohorts.

Is my product a Medical Device?

As Bodo pointed out, one of the most critical regulatory questions MedTech startups must ask is, “Am I a medical device?”, and if so, “What is my classification?” Whether you’re developing hardware or in vitro diagnostics, your classification under MDR or IVDR has significant implications on your regulatory journey.

"Understanding your classification is essential because it dictates everything from your development process to your business model," Bodo explained. For example, a Class I device has different requirements compared to Class II or III devices, and each classification brings different documentation and quality management obligations.

Introducing RegMetrics - A Game-Changer for Regulatory Compliance

RegMetrics, a digital tool designed to simplify the regulatory process, has become an indispensable resource for startups in the Life Science Accelerator. According to Bodo, "RegMetrics helps answer the question, 'Am I a medical device?' and if so, why. It provides all the information you need to communicate your classification to regulators or investors". This clarity is essential for startups seeking early-stage investment, as investors need to know the regulatory path the product will take.

Regulatory Support for Startups - Overcoming the Fear of Compliance

For many MedTech innovators, especially those without a regulatory background, understanding MDR and IVDR can be intimidating. RegMetrics simplifies this process by offering personalised, step-by-step guidance. "Many of our teams come from universities with no regulatory experience. RegMetrics reduces the fear and complexity of regulatory compliance," Bodo noted.

The software’s design is user-friendly, breaking down complex workflows into manageable steps and explaining each regulatory requirement in plain terms. "You don’t need to be a regulatory expert to use it," Bodo emphasised. This makes RegMetrics especially useful for early-stage startups, allowing them to move forward without the need for expensive regulatory consultants right away.

Combining Pedagogical Expertise with Technology

A key strength of RegMetrics is its unique combination of intuitive software and pedagogical expertise. Bodo highlighted that while many regulatory experts offer guidance, not all have the ability to teach effectively. The workshops provided by experts like Rita, one of the brains behind RegMetrics, have received excellent feedback for their interactive and engaging approach.

"Rita’s workshops are very interactive, which helps startups better absorb and understand the regulatory requirements. It’s more than just information; it’s about making sure they can apply that knowledge," Bodo explained. This combination of easy-to-use software and expert-led workshops provides startups with a solid foundation for regulatory compliance.

Conclusion - Simplifying Regulation for Medical Device Innovators

For medical device innovators, staying compliant with MDR and IVDR is a critical but often overwhelming task. Tools like RegMetrics are changing the game by providing startups with the guidance they need to navigate these regulations confidently and efficiently.

As Bodo noted, “RegMetrics lowers the barrier for startups, making it easier for them to bring innovative medical devices to market while staying compliant with regulatory requirements.” Whether you’re an early-stage MedTech Startup or a seasoned innovator, having the right tools and support can make all the difference in your journey to success.

By simplifying complex regulatory frameworks and providing actionable insights into device classification, RegMetrics is empowering MedTech innovators to focus on what they do best - developing life-saving technologies.

Looking ahead

Bodo looks forward to continuing to partner with RegMetrics and says that he would certainly continue to use the tool to support startups to simplify their regulatory journey.