Medical Device Development Challenges: What the Numbers Reveal
Medical device development is a high-stakes journey, shaped by funding pressure, technical complexity, regulatory scrutiny, and market realities.
In this session, Justin Bushko shares real-world data and firsthand insight into where MedTech companies struggle most and why choosing the right partners early can make a meaningful difference. Understanding these challenges helps teams plan smarter, adapt faster, and improve their odds of long-term success.
The Funding Funnel Narrows Quickly
Early-stage funding is one of the first major hurdles for MedTech startups. Only about one in four companies successfully raise an initial friends-and-family or pre-seed round. The challenge intensifies at the next stage, where roughly 10% of those companies move on to secure additional funding. As capital becomes harder to access, selecting the right partners and using funds efficiently becomes critical to survival.
While recent years have brought volatility to funding markets, capital continues to flow toward strong, well-positioned teams. Those that advance tend to demonstrate clear progress, credible execution, and thoughtful risk management early on.
Clinical, R&D, and Regulatory Roadblocks
Even after securing funding, development challenges remain significant. Around 40% of products encounter clinical issues that require major pivots, whether due to usability concerns, clinical fit, or unmet user needs. Staying open to feedback from clinicians and end users is essential to navigating these hurdles.
R&D introduces another layer of risk. Approximately 50% of products face engineering challenges such as late-stage failures, tolerance issues, or manufacturing constraints like injection molding variability. These issues reinforce the importance of strong engineering discipline and early validation.
Regulatory approval is another critical bottleneck. Only about 11% of devices are cleared on their first FDA submission, even within the 510(k) pathway. This underscores the need for careful regulatory strategy, thorough documentation, and realistic timelines.
Exits, Scale, and the Role of the Right Partner
Ultimately, many companies aim for acquisition, strategic partnership, or an IPO but the odds are slim. Roughly 5% reach a meaningful exit, and fewer than 1% successfully go public. These outcomes depend not only on innovation, but on execution across engineering, manufacturing, regulatory, and commercialization.
Concise Engineering supports MedTech teams as a CDMO, helping navigate these challenges with a flexible, deliverable-driven approach. Based in Tampa Bay, the team works across orthopedics, surgical tools, implants, electromechanical devices, and wearables. By bringing in the right experts at the right time and supporting everything from prototyping to pilot and small-batch manufacturing, Concise helps teams reach critical inflection points without unnecessary overhead.
Medical device development is complex, but with the right strategy and partners, it’s possible to move forward with clarity and momentum.
Justin Bushko
President, Concise Engineering
Next Steps
We hope you find this newsletter valuable and insightful.
If you have any questions, if you have feedback or would like to explore any specific topics further, please feel free to reach out to us.
Please email me at jbushko@concise-engineering.com or to book a call with me, click this link.
Stay tuned for future editions where we'll continue to share valuable information and industry updates.