Rapid and Secure Deployment of Medical Devices

Medical devices are highly regulated, and during production they undergo multiple checks and verifications to ensure that they function safely and as-designed. However, in emergencies, rapid redesigns are often necessary, and delays can cost lives. During the COVID-19 pandemic, for example, some clinicians made decisions to put two patients on one ventilator because ventilators were in short supply, even though it was not an approved use. In emergencies such as these, it is necessary to rapidly compare new designs to existing, proven design models to determine which tests, simulations, and checks need to be re-evaluated. All of these procedures take time, which can translate to increased patient suffering.

This project team will demonstrate a Digital Methodology Framework for rapidly evaluating new and revised medical devices. By connecting performance and safety requirements along a digital design thread, the redesign process can be done faster and with more certainty of the end result. Combining this digital framework with 3D printing will enable rapid prototyping and iteration so models of medical devices can be refined using real-world data. The team will demonstrate this methodology with a two-patient-ventilator redesign and with patient-unique surgical guides.

These advances will shorten the time it takes for medical devices to reach patients. In the case of the surgical guides, point-of-care manufacturing for personalized medical devices has the potential to drastically reduce the time to produce, verify, and validate the device, reducing a patient’s wait for a procedure. And patient-unique surgical guides produced with 3D printing can be customized to a patient’s specific anatomy, reducing their size and impact. With the ventilator project, the Digital Methodology Framework will help manufacturers, healthcare organizations and regulatory bodies adapt to future emergencies with greater confidence and reduce the chance of unexpected, dangerous design problems.