Why Most Medical Device Startups Fail – and How to Avoid It
May 20, 2025 – A recent LinkedIn article from one of PASB’s partners, OVA Solutions, notes that roughly three-quarters of medical-device startups fail before even making an FDA submission. This is usually not from lack of innovation, but from overlooking regulatory compliance: teams often “build first and figure out FDA later,” a mistake that yields fundamental design flaws and wasted investment.
Other common pitfalls include:
- inadequate data-integrity processes (which can invalidate critical test results or even trigger market bans)
- overlooking cybersecurity requirements (leading to costly redesigns or reclassification by regulators)
- selecting the wrong regulatory pathway (for example assuming a 510(k) clearance when a full PMA is required)
- skipping mandatory design controls and risk-management processes
As a solution, the article stresses that “winners start with regulation in mind, test thoroughly early on, and partner with experts”. In practice, this means integrating regulatory considerations into product development from day one. This includes:
- identifying applicable global standards and regulatory requirements
- conducting early usability and bench testing
- embedding cybersecurity and quality controls by design
- meticulously documenting every step
This proactive, compliance-focused approach is presented as the key to avoiding late-stage setbacks and actually bringing life‑saving devices to market.
The most successful medical device companies recognize that technical development and regulatory strategy must progress in tandem. This is where partnerships between hardware development experts like OVA Solutions and regulatory specialists like PASB become critical.
If you’re a medtech startup struggling to integrate regulatory compliance with your development activities we can help. Book a free 30-min call with us or fill in the contact form on the right to get started.