Many early-stage medical device founders face a major dilemma: how do you prove regulatory maturity to investors and partners before you actually hold a final CE mark or FDA approval? Waiting until the end of a long development cycle creates significant commercial risk. By treating regulatory readiness as a continuous maturity process rather than an all-or-nothing milestone, startups can build trust early and avoid costly late-stage surprises.
In this episode, host Etienne Nichols sits down with Malte Knowles Schmidt, Global Portfolio Lead for Medical Device Software, AI, and Cybersecurity at TÜV SÜD. Drawing from his background as an ICU nurse, an R&D product leader for Class III cardiac implantables at Biotronik, and now a notified body leader, Malte breaks down how startups can step out of their silos. He emphasizes that notified bodies and medical device companies must both "leave the ivory tower" to establish practical, real-world communication long before a formal audit occurs.
The conversation explores concrete strategies for demonstrating regulatory maturity during development, including standing up an enterprise Quality Management System (eQMS), securing partial ISO 13485 certification for core design processes, and leveraging external testing as strategic "breadcrumbs." Malte also cautions founders against chasing "Pyrrhic certifications"—winning regulatory approval at the cost of commercial viability—and shares practical guidance on when and how to initiate early structured dialogues with notified bodies.
Key Timestamps
- 00:00 - 02:15 | Introduction to the "Regulatory Ivory Tower"
- Etienne introduces guest Malte Knowles Schmidt and sets up the challenge of proving regulatory maturity early in the startup lifecycle.
- 02:16 - 05:04 | Why Communication Gap Exists Between Startups & Notified Bodies
- Malte discusses why structured dialogues often feel too abstract for founders and why concrete examples are needed to make early engagement approachable.
- 05:05 - 08:30 | Defining Regulatory Maturity & The Agile QMS
- Exploring how investors view regulatory progress, why build-measure-learn mindsets belong inside a QMS, and how an eQMS acts as a foundational framework.
- 08:31 - 12:10 | Unlocking Value Through Partial ISO 13485 Certification
- A breakdown of how certifying core design and development processes early builds commercial credibility and attracts investor funding before full scope audits.
- 12:11 - 16:45 | Leveraging External Testing & Avoiding "Pyrrhic Certifications"
- How penetration testing and biocompatibility act as evidence breadcrumbs, plus the trap of sacrificing commercial viability just to get a certificate.
- 16:46 - 20:30 | When and How to Initiate Contact with a Notified Body
- Practical advice for founders on overcoming the fear of reaching out, preparing essential homework (intended purpose, risk classification), and taking the first step.
Quotes
"A Pyrrhic certification comes from a Pyrrhic victory, where you win the battle, but the losses are so great that the victory is basically meaningless... startups make the certification their core goal and not the commercial success." - Malte Knowles Schmidt
"If you're asking yourself the question, 'Should I be talking to a notified body?'—then stop right there, because the answer is yes." - Malte Knowles Schmidt
Key Takeaways
- Establish Early Regulatory Breadcrumbs: Investors want to see continuous progression. Utilizing an eQMS, conducting third-party testing (e.g., penetration or biocompatibility testing), and mapping regulatory roadmaps provide tangible proof of maturity long before final approval.
- Consider Partial ISO 13485 Certification: Startups do not need to wait for full scope certification. Certifying core design and development processes first demonstrates organizational discipline and can unlock major funding rounds.
- Avoid the Pyrrhic Certification Trap: Do not sacrifice your core business model or reduce critical product capabilities solely to make certification easier. Always align regulatory strategy with ultimate commercial viability.
- Treat Your QMS as an Agile System: Quality management is not a static set of restrictive rules; it is an iterative framework that should evolve alongside your product and team processes.
- Initiate Dialogue Early: Notified bodies are accessible for preliminary discussions. Reaching out early helps validate your intended purpose, risk classification, and submission assumptions before sinking capital into the wrong pathway.
References
- White Paper: Leaving the Regulatory Ivory Tower: How Early Notified Body Dialogues Reduce Business Risk by Malte Knowles Schmidt (TÜV SÜD).
- ISO 13485 Standard: Quality management systems requirements for regulatory purposes in the medical device sector.
- Host LinkedIn: Etienne Nichols on LinkedIn
MedTech 101 Section
- Pyrrhic Certification: Named after King Pyrrhus of Epirus, whose army won a battle against the Romans but suffered devastating losses in the process. In MedTech, a Pyrrhic certification occurs when a company successfully gets a medical device certified, but had to compromise so many features, intended uses, or commercial claims during the process that the resulting product has no real value in the market.
- Notified Body: An independent organization designated by an EU member state to assess whether a medical device complies with applicable regulatory standards (such as EU MDR) before it can be placed on the European market. Think of them as accredited referee agencies that verify safety and performance.
- Partial ISO 13485 Certification: Instead of waiting until an entire company, manufacturing line, and distribution network are fully operational to get audited, a company can undergo a certified audit specifically for a limited scope—such as its initial design and development processes.
Feedback Call-to-Action
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Sponsors
This episode of the Global Medical Device Podcast is brought to you by Greenlight Guru.
Navigating the regulatory landscape requires a solid foundation built on quality and clear clinical evidence. Greenlight Guru provides the only dedicated eQMS (Quality Management System) and EDC (Electronic Data Capture) platform purpose-built for medical device and software-as-a-medical-device (SaMD) companies. Whether you are aiming for partial ISO 13485 certification, setting up your first design controls, or running clinical trials to collect vital regulatory breadcrumbs, Greenlight Guru helps you scale efficiently while keeping you audit-ready. Learn more about how Greenlight Guru's modern QMS and EDC solutions can accelerate your path to market at www.greenlight.guru.
