4 DeepTech Barriers Blocking Your Scale (And Fixes)

Jan de Vries · 2026-07-01

Silicon Valley's unofficial motto is "Move fast, break things." Software companies build, launch, iterate, and scale, hoping that by the time debt catches up, you have enough customers and resources to deal with it. And when the main risk is a bug your client most likely ignores, this approach to scaling is completely justified. But not all fields are so forgiving. In this article, we'll walk through scaling your company in DeepTech, where sectors are usually highly regulated. Think DefenceTech, energy, FoodTech, and medicine. Growing your company in DeepTech markets is significantly harder. You'll face four main barriers as a founder. Let's break them down and figure out how to overcome them. ### The Cost of Launch All DeepTech markets have a very high barrier to entry. Mostly, that's because of the research and development process. Developing a new medical device, for example, is an incredibly long and capital-intensive process. You're building labs, iterating through trial and error, and moving through preclinical and clinical validation. Unlike software, where products can be tested and deployed almost instantly, medical innovation requires years of experimentation. And it carries a high risk of failure. The average concept-to-market cost of a medical device is over $31 million. The average time for releasing the device is 3 to 7 years. That combination of expensive and long R&D unavoidably leads to a roughly 75% failure rate among all medical startups. Regulations are also a significant factor. Many DeepTech markets are subject to much stricter government oversight. Whether it's sanitary compliance in FoodTech or extensive background checks in energy and defense, you'll have to deal with significant regulatory requirements. In medical devices, for example, you can't just enter a market because you see it's underserved. You enter it only after you're allowed to. Often, regulations are the main reason behind underserved markets. There's simply too much compliance and too many tests needed to receive certification for a certain medical device. ### Navigating Regulation There are more than 190 countries worldwide, and all of them have different approval pathways and testing requirements for DeepTech companies. Major medical regulatory frameworks include the FDA in the U.S., the National Medical Products Administration in China, the Pharmaceuticals and Medical Devices Agency in Japan, ANVISA in Brazil, Health Canada in Canada, and the Medical Device Regulation in the EU. To operate in global markets, your product must meet each regulatory framework separately. There's no overlap between the different sets of rules. Another thing to keep in mind is that regulations and frameworks are constantly evolving. For example, we launched Efferon in Europe right in the middle of the transition from the Medical Devices Directive (MDD) to the European Medical Device Regulation (MDR). That significantly raised the bar for clinical evidence and slowed down approvals across the board. According to the 2026 EU Notified Bodies Survey, out of 33,175 MDR applications, only 17,549 certificates were issued. That means only about 53% of all applications result in approval. When acquiring our MDR, we tried to rely on external consultants. But after failing twice during the internal pre-audit, it became clear that no one could navigate the complexity of our product better than we could. Understanding that there's no easy way to receive the certification, we made the decision to acquire EU regulatory expertise ourselves. So here's a key takeaway for every founder: do the hard work of researching the frameworks yourself. It will pay off in the long run. ### Hiring a Team When it comes to hiring, it's good to keep an open mind toward a wide range of opportunities. Building and maintaining a strong community within your field is essential. Being physically present at conferences and industry events plays a key role in this. It opens doors. You need people who understand both the technical depth and the regulatory landscape. They're hard to find. But you can grow them. Invest in training your early hires on compliance and regulatory pathways. That builds a team that can adapt as regulations shift. A great tip: look for talent with cross-industry experience. Someone who worked in both medical devices and aerospace might bring fresh perspectives to your energy startup. Diversity of thought is your secret weapon. ### The Funding Gap DeepTech startups often fall into a funding gap. Traditional venture capital expects quick returns, but DeepTech takes years to generate revenue. You need patient capital. Look for government grants, strategic partnerships with established companies, and impact investors who understand the long game. The European Innovation Council and similar bodies offer non-dilutive funding. Use them. Also, consider milestone-based fundraising. Break your development into clear phases, each with a tangible deliverable. This makes it easier for investors to see progress and reduces their perceived risk. ### Final Thoughts Scaling a DeepTech company is not for the faint of heart. But the barriers are surmountable. Focus on mastering your own regulatory pathway, build a team that learns together, and find funding that matches your timeline. Remember: the hardest challenges often lead to the most meaningful innovations. Keep pushing.