4 DeepTech Barriers to Scaling and How to Beat Them

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 that your client most likely ignores, this approach to scaling is completely justified. But not all fields are that forgiving. In this article, we're diving into scaling your company in DeepTech. We're talking about sectors that are usually highly regulated, like DefenseTech, energy, FoodTech, and medicine. Growing in these markets is a whole different beast, and there are four main barriers you'll have to overcome as a founder. ### The High Cost of Launch All DeepTech markets have a very high barrier to entry, mostly 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. It's a grind. 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, and the average time for releasing the device is 3 to 7 years. This combination of expensive and long R&D unavoidably leads to a roughly 75% failure rate among all medical startups. That's not a typo. Three out of four won't make it. ### Navigating the Regulatory Maze Regulations are also a huge 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 will have to deal with significant regulatory requirements. In medical devices, for example, you can't just enter a market because you see that 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 testing needed to receive a certification for a certain medical device. 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 (MDR) in the EU. To operate in global markets, a product must meet each regulatory framework separately, with no overlap between the different sets of rules. It's like learning a new language for every country you want to sell in. Another thing to keep in mind is that regulations and frameworks are constantly evolving. For example, one company launched its product in Europe right in the middle of the transition from the Medical Devices Directive (MDD) to the European Medical Device Regulation (MDR). This shift 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. Less than a coin flip. When acquiring their MDR, this company 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 their product better than they could. Understanding that there's no easy way to receive the certification, they made the decision to acquire the EU regulatory expertise themselves. So a key takeaway for every founder: do the hard work of researching the frameworks yourself. It will pay off in the long run. ### Hiring the Right 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, as it opens the door to finding people who truly get what you're building. You need people who aren't just looking for a paycheck but who are passionate about solving hard problems. ### The Long Road to Revenue Even after you've launched, the path to revenue in DeepTech is slow. You're not going to see the hockey-stick growth that SaaS companies brag about. Instead, you're looking at long sales cycles, pilot programs, and months of evaluations before customers commit. This means you need to plan your finances carefully. Runway isn't just a nice-to-have; it's everything. You need to have enough cash to survive the valley of death between development and your first big contracts. ### Wrapping It Up So, there you have it. The four barriers every DeepTech founder hits before they scale: the high cost of launch, the regulatory maze, hiring the right team, and the long road to revenue. Each one is tough, but they're not insurmountable. The key is to go in with your eyes open, do the hard work yourself when you can, and build a community that supports you through the grind. It's a marathon, not a sprint, but the impact you can make is worth every step.