Credit score: College of Twente
The College of Twente is introducing its first MDR-compliant open-source medical system: the 3D base plate. This open-source initiative gives an alternate path to low-risk medical units that aren’t commercially viable. Nonetheless, it does have a medical added worth for the affected person.
One such non-commercially viable device is the 3D footplate, a rearfoot pathology medical imaging device quickly to be made by docs at a value value with corresponding MDR documentation through open-source.
Inside the chair, Biomedical Machine Design & Manufacturing UT (TechMed Middle) is investigating various routes to make medical units obtainable as an open-source medical system, together with associated MDR documentation (Medical Machine Regulation). This allows medical professionals to supply the units at a value value and cut back the burden of documentation. The 3D base plate is the primary open-source UT’s medical system, however actually not the final.
The event and market introduction of medical units typically require a variety of time and value. Along with compliance with strict MDR laws, financing and drawing up a enterprise case are additionally main challenges. Particularly for units aimed toward small affected person teams or uncommon ailments, it’s tough to arrange a worthwhile income mannequin. In consequence, many progressive instruments by no means attain the customers who may gain advantage from them.
The 3D footplate
An instance of such a non-commercially viable device is the 3D footplate, a medical imaging device for complicated hindfoot pathologies. This “Class I Medical Device” helps to place the foot to the decrease leg, permitting medical stress assessments to be simulated throughout CT scans. The photographs obtained present quantitative knowledge, comparable to relative bone actions that contribute to the prognosis and evaluation of surgical procedures.
Since this device is principally utilized in educational medical facilities, such because the AUMC and the MUMC, and the potential market is small, a standard enterprise mannequin shouldn’t be possible.
So as to make this device accessible to the clinicians involved, the UT has redesigned the unique 3D base plate in line with the “Design for Assembly methodology.” This resulted in an IKEA-style prototype that’s straightforward to fabricate, with laser-cut components, 3D printing know-how and normal parts. This retains manufacturing prices low, and meeting is straightforward.
As well as, many of the MDR documentation has been ready utilizing UT templates. Together with a danger evaluation, danger mitigation methods, analysis assessments, an meeting handbook and the technical file. This whole package deal—together with invoice of supplies, technical drawings and documentation—is obtainable through an open-source platform. Medical facilities can thus produce the bottom plate at value value and adapt the documentation to their high quality administration system.
The 3D base plate is the UT’s first open-source medical system, however actually not the final. The Biomedical Machine Design & Manufacturing chair continues to work on new circumstances and a broader design technique for “Class I Medical Devices.” Providing these instruments open-source not solely will increase accessibility within the Netherlands, but additionally creates the chance for cooperation in low- and middle-income international locations. This contributes to the worldwide influence of this initiative and the development of well being care.
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Open supply availability accelerates entry to medical units for small affected person teams (2025, June 17)
retrieved 18 June 2025
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