In a rapidly evolving healthtech landscape, regulatory adaptability is becoming just as important as technological innovation.
DayOne recently hosted a webinar for the Accelerator’s current cohort with confinis, a Swiss-based regulatory consultancy specialising in medical devices, in vitro diagnostics and combination products. During the session, confinis’ Andrea Biasiucci and Claudio Alberti unpacked the growing layers of global regulation and offered practical advice for early-stage companies trying to navigate this complexity.
Here are some of the key takeaways from the session…
A Growing Regulatory Ecosystem
Regulations are increasing worldwide – not because authorities want to slow innovation, but because the number of users, devices and potential risks has grown dramatically. For companies operating (or planning to) in Europe, new frameworks like the EU AI Act, alongside existing ones such as the Medical Device Regulation (MDR), create a hierarchy of requirements that companies must understand and respect.
Cybersecurity risks, in particular, are pushing regulators to tighten expectations for software-based and data-sensitive medical technologies. While this might seem overwhelming, founders should not be intimidated: staying informed, remaining flexible and being prepared for change are the best ways to stay compliant without losing momentum.
Compliance as a Strategic Advantage
Rather than seeing regulation as a burden, startup teams should treat it as a tool for building stronger companies. When planned early and properly, regulatory compliance can make operations more efficient, improve product quality and strengthen overall business performance.
Startups often build on assumptions because resources are limited. The key is understanding what is legally required and planning for it in a way that is both practical and compliant. Good regulatory strategy doesn’t just avoid problems – it increases a company’s viability and long-term success.
Where Should a Cash-Strapped Founder Begin?
Early-stage startups often benefit from targeted, low-cost guidance – “an hour here, an hour there” – to avoid critical early mistakes. Experienced consultants or accelerators can help define the next right step, not the entire marathon.
Raising capital is obviously important – not just for payroll, but as validation. If no investor is willing to take the risk, it may signal deeper issues in the business model that are better identified early.
Founders can take a bootstrapped, client-first approach: finding an initial customer and iterating with them. But in regulated industries, this can be challenging and carries the risk of over-tailoring a product to a single customer rather than the broader market.
Strategic Thinking and Lean Innovation
Founders must develop a strategic mindset – choosing carefully where to invest their energy and navigating constraints creatively. For example, exploring business ideas in herbal medicine, where regulatory barriers are significantly lower, enables faster iteration with limited resources. And the practical use of AI tools can support drafting early documentation.
With the right mix of guidance, adaptability and market validation, even teams with minimal resources can make meaningful progress.
From Pitch Deck to Regulatory Pathway: How Beyond Supports Start-ups
Beyond is the regulatory AI solution developed by confinis and Zühlke and helps start-ups translate technical concepts into actionable regulatory plans.
Many companies begin with a pitch deck, a prototype or a minimum viable product. The next challenge is understanding how to transform that concept into a fully compliant, market-ready medical device. Beyond addresses this by:
- Generating regulatory strategy reports covering MDR, FDA, software-as-a-medical-device, cybersecurity and more
- Presenting market pathway options (e.g., EU vs. US, 510(k) vs. de novo) with pros, cons and timelines
- Highlighting how regulatory decisions impact the business model, whether as a service provider, OEM or full manufacturer
- Providing realistic timelines for each phase – from initial classification to post-market obligations
- Offering multi-step guidance for building required documentation, such as MDR-compliant device descriptions
The tool iteratively guides users through each regulatory step, pulling from decades of confinis expertise. Its capabilities also include exporting full conversations for traceability, integrating with tools like Jira, and generating structured documentation that teams can continue refining.
A Practical Path Forward
The message for innovators was clear: successful medical-device development doesn’t require massive budgets – but it does require clarity, adaptability and smart use of resources.
Regulations will continue to grow more complex, but with the right strategy and tools, start-ups can navigate them efficiently and turn early prototypes into viable, compliant products.
Learn more about confinis here. confinis is a partner of DayOne.
