Proof of Concept is the first step in many projects.
Before a project manager or engineer contacts Omnica, they usually have a good idea what they need or they have a specific list of requirements. Sometimes, however, the proposed project lacks one or more critical elements. That missing element could require a new process, an unproven technology, or the need to modify an existing system to fit the application.
Here is a scenario that often occurs when we are introduced to a fresh challenge by a prospect or a new client.
When customers visit Omnica, the first order of business is a facility tour, followed by a brainstorming session. The fact-finding meeting is when the Advanced Technical Services team typically offers a number of possible solutions and ask some key questions the customer may not have considered. The meeting evolves into a thought provoking experience for everyone. The usual result is renewed excitement and a more well defined project direction. We can’t take too much credit. Synergy often develops when professionals see a challenge from a different point-of-view.
Our client faced a challenge. Could we solve it?
As an example, a long-standing client came to us with an established product that needed some revisions. Elements of the technology used in their medical device had become outmoded, and many of the existing components were too large for the next-generation product. We looked closely at the assignment, and considered searching for answers outside the medical industry.
Brad designed the accelerated testing device (above) to collect data.
It would serve to establish the reliability of critical infusion pump components.
One of the possibilities involved the use of a force sensitivity sensor, a “switch” commonly found in devices like keyboards and touch pads. It was certainly small enough to be considered, and initial evaluation for use in this application was encouraging. Brad Sargent Ph.D., our Vice President of Engineering, headed the testing and qualification protocol. For more than a decade he has written instrument control and data acquisition software for custom-designed equipment.
Brad’s first challenge was to prove that the component would perform as anticipated over a period of time. He used a combination of digital and analog technology (and our CNC machine shop) to build an accelerated testing apparatus. Since the keyboard sensor was to be used in a Class II medical device, our client needed performance statistics which exceeded the manufacturer’s certifications. It was critical that after thousands of cycles, its function would be stable, repeatable and accurate. Over a period of weeks Brad’s specially designed computer program collected all data for later analysis and the design control documentation.
The experiment and the development program were successful. Accelerated life-testing validated use of the sensor when combined with the specified motor, seals, and several other custom-made parts to be used in the final product. The FDA submission would reference those tests, procedures, and results.
The sensor was eventually incorporated into the Paradigm™ insulin pump marketed by Medtronic MiniMed. Omnica contributed to the broadly worded patents. In the years to come they would protect our client’s future exclusive use of the sensor for similar applications.