A major motivation for Point-of-Care Manufacturing is to shorten lead times and increase access to personalized medical devices. This can be a tremendous benefit to patients who require definitive surgical treatment in a short window of time (e.g., trauma, cancer). A successful model to implement Point-of-Care Manufacturing is for medical centers to partner with medical device vendors to recreate FDA-approved methods for a specific device currently produced in a corporate headquarters/factory setting. This approach is similar to setting up a corporate branch for the production of personalized medical devices. Limiting personalization to a constrained fabrication process, one which limits investment in software and fabrication hardware, is central to the current “Design for Manufacture” paradigm. One of the benefits of Digital Twin modeling of fabrication processes as well as the performance of the final part is to design the fabrication process simultaneously with the performance of the resulting device, so-called “Manufacture for Design”. The flexible design of a fabrication process (e.g., CNC, forging, rolling, extrusion, casting, 3D printing, etc.) must be aware of the effect that each step has on the final part’s material properties. The goal is then to design a fabrication process that obtains optimal device geometry, as well as mechanical and material properties, for each patient. The distributed use (e.g., at the point-of-care) of sequencing and control strategies for this convergent use of available fabrication methods is referred to as “Hybrid Autonomous Manufacturing”. It is anticipated that standards for device performance validation immediately prior to use in medical interventions (e.g., surgically implanted medical device) will be key to the regulation and reimbursement of devices produced using Manufacture for Design principles. This presentation will review near-term opportunities to use a Manufacture for Design approach to design personalized medical devices for rapidly emerging musculoskeletal, cardiovascular, craniofacial, and neurological conditions.
Learning Objectives:
- Upon completion, participants will have a strong understanding of the nature and extent of current Point-of-Care Manufacturing activities.
- Upon completion, participants will understand how a "Manufacture for Design" approach to Point-of-Care would benefit patients with rapidly emerging conditions (e.g., trauma, cancer).
- Participants will understand how simultaneous design and optimization of a medical device’s function and Point-of-Care Manufacture process will shift the medical device landscape.
