Actuated Medical Offering Specialized Product Development for MedTech Innovators
Actuated Medical specializes in taking medical devices from concept to market-ready products – from start to finish. They have deep expertise in tissue dynamics and penetration, acoustic engineering, electronics and software development, and 3D printing. They focus exclusively on the development of medical devices and are currently helping other Innovators solve design and regulatory challenges. Actuated’s facility doubled in 2021 and has increased its capacity to conduct contract product development and manufacturing including customer equipment placement.
“Our exceptionally skilled team includes electrical, mechanical, and biomedical engineers with expertise in medical device commercialization. We are currently helping several innovators solve engineering problems. With our expansion, we have the capacity to help others,” said Maureen L. Mulvihill, President and CEO of Actuated Medical.
A recent client is an ER physician. He came to Actuated with a patent for a device and asked Actuated to take his product from concept to FDA submission. Actuated’s engineering team investigated the design and built some feasibility prototypes using Actuated’s rapid prototyping facility. Verification and Validation (V&V) protocols were written, testing was performed, and test reports were completed. Included in V&V was usability testing with 30 participants. The device passed V&V, and Actuated Medical’s team wrote and submitted the 510(k) application. The device is pending FDA clearance.
“I took my patent to Actuated Medical, and they completed all the V&V testing, wrote and submitted the 510(k). Because of Actuated my patent is now a medical device,” said Brian Shippert, DO, Emergency Physician, Shippert Tech, LLC.