3 Things MedTech Startups Get Wrong About IP & Regulatory Strategy

In the webinar, Anne-Sophie Grell (QbD Group) was unequivocal: regulatory strategy needs to be built into the development process from the very beginning, not added once a prototype exists.

Why? Because early regulatory thinking shapes everything downstream. It determines which standards apply to your device, which materials and components are permissible, what clinical evidence you will need, and how long your development timeline will realistically be.

A regulatory remediation, having to revisit and correct a development process that wasn't aligned with MDR or IVDR requirements, is not just a delay. As Anne-Sophie explained, it can have "huge consequences time-wise, but also financially."

One concrete example she highlighted is planning for interactions with Notified Bodies or competent authorities. Unlike internal development milestones, those timelines are outside your control. If companies only discover these requirements late in development, they often face major delays.

💡 What to do instead: Define your regulatory roadmap from day one. Identify your device classification, applicable standards, and conformity assessment pathway before development is far advanced.

Another key point Anne-Sophie emphasized during the webinar was the importance of clearly defining intended use early in development.

Many regulatory problems arise not because the science is wrong, but because the product definition and its intended use are vague or poorly described. Borderline cases are common: products that could be classified as cosmetics, medical devices, medicinal products, or consumer products depending on how their intended use is defined.

Anne-Sophie illustrated this with examples such as colored contact lenses, which are aesthetic devices but still regulated as medical devices, and contrast agents that have historically sparked classification debates between regulatory authorities.

The precision of your intended use statement determines:

• whether your product is regulated as a medical device or something else
• which regulatory framework applies
• what clinical evidence is required

At the same time, this definition also influences IP strategy. As Stijn Lagaert noted during the discussion, the strongest position is when patent claims and the regulatory intended use ultimately align.

💡 What to do instead: Invest serious time upfront in defining your product: what it does, for whom, and by what mechanism. This definition becomes the foundation for both your regulatory pathway and your IP strategy.

Another theme from the webinar was that IP strategy should not be developed in isolation from regulatory and product strategy.

Anne-Sophie stressed that companies need to think about how their product will ultimately compete in the market and how regulatory requirements will shape what is feasible. Product profiles, evidence requirements, and development timelines all influence whether an innovation will remain competitive by the time it reaches the market.

During the session, Stijn illustrated this with a case where a company was developing a therapy competing with an existing monthly-injection treatment. Patent monitoring revealed that competitors were already filing patents targeting a three-month dosing interval. Even a product with slightly improved efficacy would have struggled commercially against that convenience advantage.

Insights like these rarely come from press releases or product announcements. They come from analyzing patent filings and understanding where competitors are investing their development efforts.

💡 What to do instead: Combine regulatory thinking with early IP landscape analysis. Understanding both the regulatory pathway and competitor innovation helps define a product profile that is realistic, protectable, and competitive.