Plan with confidence. Avoid costly surprises.

Developing a medical device requires significant funding, expertise, and foresight. On average, bringing a Class II 510(k) cleared medical device to market requires around $30M in total company funding, with $2–5M of that typically spent on development and engineering.

But the true cost depends on regulatory pathway, clinical studies, and device complexity. That’s why we created this free whitepaper — to give medical device innovators, startups, and investors a credible framework for planning.

Why Use This Whitepaper?

Unrealistic estimates can derail programs, delay funding, and undermine investor confidence. This guide helps you:

• Understand average costs and timelines for device development
• Build estimates even when project details are incomplete
• Create projections that earn investor and stakeholder trust
• Avoid overruns with a structured, bottom-up planning approach

What’s Inside?

• Cost benchmarks from four proven methods: FDA industry survey, public funding data, diagnostic commercialization study, and a “no design” thought experiment
• Typical timelines (20 months for concept & proof of concept, ~6 years average to commercialization)
• Insights on how regulatory strategy and clinical studies drive cost
• Practical steps for building a credible, investor-ready plan

Who Should Download This Whitepaper?

• Medtech startup founders preparing for fundraising
• Product managers and R&D leaders mapping roadmaps
• Investors and advisors seeking reliable benchmarks
• Executives planning for market entry

Frequently Asked Questions

What is the average cost to develop a medical device?
Around $30M in total company funding for a Class II 510(k) device, with $2–5M for development and engineering.

What factors influence cost the most?
Regulatory pathway, clinical requirements, and technology complexity.

Why is this important for startups?
Accurate estimates build investor confidence and reduce the risk of costly delays.