The University of Twente is introducing its first MDR-compliantĀ open-sourceĀ medical device: the 3d base plate. ThisĀ open-sourceĀ initiative provides an alternative route to low-risk medical devices that are not commercially viable. However, it does have a clinical added value for the patient. One such non-commercially viable tool is the 3d footplate, a rearfoot pathology medical imaging tool. Soon to be made by doctors at a cost price with corresponding MDR documentation viaĀ open-source.
Within the chair,Ā Biomedical Device Design & ProductionĀ UT (TechMed Center) is investigating alternative routes to make medical devices available as an open-source medical device, including related MDR documentation (Medical Device Regulation). This enables medical professionals to produce the devices at a cost price and reduce the burden of documentation. The 3d base plate is the first open-source UT's medical device, but certainly not the last.
A difficult profitable revenue model
The development and market introduction of medical devices often requirea lot of time and cost. In addition to compliance with strict MDR regulations, financing and drawing up a business case are also major challenges. Especially for devices aimed at small patient groups or rare diseases, it is difficult to set up a profitable revenue model. As a result, many innovative tools never reach the users who could benefit from them.
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