Leading hospitals are establishing medical device manufacturing capabilities at the clinic to meet the need for access to on-demand patient-specific solutions. Establishing a point of care program can take many forms, but the most successful endeavors require dedicated champions and deep partnerships to deliver value to the hospital, clinicians, and ultimately the patient. This is especially true for the manufacturing of patient-specific implants which carry important considerations to ensure success and mitigate risk. One example of a successful point of care deployment for the manufacturing of patient-specific cranial implants is at the University Hospital Basel (Switzerland).
In collaboration with Prof. Florian Thieringer, Chairman CMF Surgery of the University Hospital Basel (Switzerland), an end-to-end additive manufacturing solution for PEEK cranial implants was deployed within the clinic. Furthermore, a quality management system was established to govern the processes required to ensure safety and regulatory compliance. Upon successful validation of the solution and acceptance for clinical use, a first-in-human PEEK cranial implant was fabricated and used in surgery. During this session, Prof. Thieringer will be joined by Stefan Leonhardt, director, medical devices, 3D Systems, to highlight the technology, processes, and partnership efforts that resulted in the successful deployment of this innovation.
Learning Objectives:
- Upon completion, participant will understand what it takes to develop and deploy a point of care AM program.
- Upon completion, participant will receive a thorough overview of the steps to design and manufacture a patient-specific device at the point of care.
- Upon completion, participant will understand how a quality management system was established to ensure safety and regulatory compliance.
