The Challenge
A ER physician came to Actuated with a patent for a device. The physician had a full-time job, and no time to develop his device. He said to us, “Can you take this product from concept to FDA submission?”
Our Approach
Actuated Medical’s engineering team reviewed the patent. They investigated the design (Stage 1) and built some feasibility prototypes using Actuated Medical’s rapid prototyping facility (Stage 2). After refining the design, a design review was held with the physician and the design was frozen (Stage 3). Verification and Validation (V&V) Protocols were written, testing performed and test reports completed (Stages 4 & 5). Included in V&V was usability testing with 30 participants. The device passed V&V. Actuated Medical’s Director QA/RA and the engineering team are currently writing the 510(k) application.
The Results
Currently, pending FDA clearance.
“I took my patent to Actuated Medical and they have been very thorough. They completed the development, wrote and submitted the FDA 510(k). Because of the Actuated Medical team and their expertise, my patent is an FDA cleared medical device.”
– Brian Shippert, DO, Emergency Physician, Shippert Tech, LLC
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