This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.
This report finds that non-clinical and clinical phase costs account for 37 percent ($20 million in $2018) and 59 percent ($32.1 million in $2018), respectively, of R&D expenditures for therapeutic complex medical devices. When capital costs and the fact that not all products move successfully from one development stage to another are taken into account, the share of non-clinical stage costs rises to 85 percent ($442.8 million in $2018) while the share of clinical costs becomes 15 percent ($76.8 million in $2018). Including FDA review, the total estimated cost of development is $53.9 million or $526.4 million (in $2018) when capital cost and the cost of failures are included
Among the examined strategies, the strategy with the largest expected impact on overall therapeutic complex medical device development costs is Simplified Clinical Trial Protocols and Reduced Amendments (-33.4 percent), followed by Improvements in FDA Review Efficiency and Interactions (-22.4 percent) and use of Adaptive Design in clinical study designs (-18.0 percent). Those strategies with the lowest expected development cost savings include use of Electronic Health Records (-2.9 percent), Reduced Source Data Verification (-6.0 percent), and use of Standardized Contracts (-8.3 percent).