Pearce developed a set of formulas to quantify the value of open-source hardware design. One way is to compare distributed manufacturing to traditional manufacturing, based on the number of downloads of a design that results in a manufactured product. Another way is to calculate the costs saved by not having to replicate a product design, based on the number of design hours and hourly wage of the designers. A third approach is to calculate the market size of a distributed manufacturing approach based on the number of products and their manufacturing cost.
Using the first approach above, the value of a basic syringe pump design by Wijnen et al [i] was shown to be between 778.000 $ and 12.4 million $ over 1 year. This is called the downloaded substitution valuation, which calculates the annual savings by comparing the cost of purchasing a traditionally manufactured product to the marginal cost of producing the open-source hardware version using distributed manufacturing. The value of the design is further quantified using the number of times that the open-source hardware design is downloaded.
Clinical trials for medical devices may take anything from 2 to 5 years. While 5 years is a long time for a small business, performing the design and development, and the clinical trials, as part of an open-source project means that a small business can share the load. In principle the business would need to be in operation for a much shorter time before it could successfully launch a new product.
[i] Wijnen B, Hunt EJ, Anzalone GC, et al. Open-source syringe pump library. PLoS ONE 2014;9:e107216.