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 completed all the V&V testing, are writing the 510(k) and submitted it to the FDA. Because of Actuated my patent is a medical device.”

– Brian Shippert, DO, Emergency Physician, Shippert Tech, LLC