Scaling a DeepTech startup is harder than software. From regulatory hurdles to high costs and funding gaps, learn how to overcome the four main barriers founders face in defense, energy, food, and medicine.
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 so forgiving. DeepTech sectors like defense, energy, FoodTech, and medicine are heavily regulated. Scaling here is a different beast entirely. You face four major barriers, and if you don't plan for them, they'll stop you cold.
### The High Cost of Launch
All DeepTech markets have a steep barrier to entry, mostly because of the research and development phase. Developing a new medical device, for instance, is a long, capital-intensive process. You're building labs, iterating through trial and error, and navigating preclinical and clinical validation.
Unlike software, where products can be tested and deployed in days, medical innovation requires years of experimentation. The average concept-to-market cost for a medical device is over $31 million, and the timeline is 3 to 7 years. That combination of expensive, lengthy R&D leads to a roughly 75% failure rate among medical startups.
### Navigating Complex Regulations
Regulations are a massive factor in DeepTech. Markets face strict government oversight, from sanitary compliance in FoodTech to background checks in energy and defense. You can't just enter a market because you see it's underserved. You enter only after you're allowed to. Often, regulations are why markets remain underserved in the first place.
There are over 190 countries with different approval pathways. Major medical frameworks include the FDA in the U.S., China's NMPA, Japan's PMDA, Brazil's ANVISA, Health Canada, and the EU's MDR. To go global, your product must meet each framework separately, with no overlap.
Regulations also evolve constantly. For example, when launching Efferon in Europe, we hit the transition from the Medical Devices Directive (MDD) to the European Medical Device Regulation (MDR). This raised the bar for clinical evidence and slowed approvals. According to a 2026 EU Notified Bodies Survey, only about 53% of MDR applications result in approval.
We tried relying on external consultants, but after failing twice during internal pre-audits, we realized no one could navigate our product's complexity better than we could. So we built that regulatory expertise ourselves. The takeaway: do the hard work of researching frameworks yourself. It pays off in the long run.
### Hiring the Right Team
When it comes to hiring, keep an open mind. Building a strong community in your field is essential. Being physically present at conferences and industry events opens doors to talent and partnerships. You need people who understand both the science and the regulatory landscape. It's not just about finding engineers; it's about finding those who can thrive in a high-stakes, slow-moving environment.
### The Funding Gap
Finally, there's the funding gap. DeepTech requires patient capital. Unlike software, where you can show quick traction, DeepTech often needs years before generating revenue. Investors used to fast returns may not understand the timeline. You need to find investors who specialize in deep tech or are willing to wait for a bigger payoff. Grants and government programs can also help bridge the gap.
Scaling in DeepTech is tough, but not impossible. Focus on understanding regulations, hiring smart, and finding the right funding. Each barrier is surmountable with the right strategy.