The amount of total company funding to develop a Class II 510(k) cleared medical device is approximately $30 million. The development and engineering costs comprise approximately $2-5 million of this total. This estimate is built upon a meta-analysis of various references as well as our experiences in engaging with companies. Many factors influence these costs, including the need for clinical studies, regulatory pathway, and technology complexity. Refinement of these numbers requires a professional team to understand the technology, regulatory, and business opportunities.

The best approach in defining the answer to how much it costs to develop a medical device is to work with a multidisciplinary team, decompose the device into its specific design architecture elements, and then engage a team of experts to collaborate design solutions and provide estimates.

This bottom up approach ensures appropriate steps are being followed to create a successful product. A detailed plan is often a deliverable in early stage work and provides meaningful details for future project planning and investor engagement. This method is most useful when built on a foundation of device-specific needs and design.

This whitepaper answers:

• What are the nominal development costs and time needed for developing a medical device?
• How can a medical device development estimate be gleaned without going through detailed planning and forecasts, particularly if not all of the details have been determined?
• How can a start-up be confident that their medical device development cost projection is accurate?
• How can a start-up gain investor confidence in their cost projection?