Point-of-care Manufacturing: The HAMMER Engineering Research Center Approach

Now in its third year, the National Science Foundation-supported HAMMER (Hybrid Autonomous Manufacturing, Manufacturing Evolution to Revolution) Engineering Research Center is working to create technologies that would create a new industry focused on Point-of-Need manufacturing of devices with performance optimized to meet local conditions. One application of these technologies is the Point-of-Care Manufacture (POCM) of personalized medical devices. We recommend that the rationale and technologies for POCM allow co-design of device and fabrication process engineering. That is central to HAMMER’s focus on “Manufacturing for Design”. A flexible design process that uses hybrid technology, likely in FDA-approved, GMP desktop fabrication units, at or near the point-of-care can move between forming methods (e.g., deformation, CNC, forging, rolling, extrusion, 3D printing, etc.) to simultaneously achieve personalized geometry, mechanical properties, and performance.

This presentation will highlight two forming methods, skeletal fixation plate bending and Melt Electrowriting (MEW) biotextile weaving, that can provide good performance and meet regulatory requirements for GMP (Good Manufacturing Processes) manufacturing using desktop fabrication units at or near the point-of-care. Finally, examples of the application of these POCM technologies will be shown to result in manufacturing procedures and resulting performance prediction and achievement that should facilitate widespread availability of POCM.