Defined by the FDA, a preclinical device prototype is an early version of a medical device prototype used to elicit important information about the products potential use for people.
A medical device prototype incorporates engineering, design, and human factors into a functional, proof of concept model that defines your design. These are the prototypes that should be used in all your research activities, from early contextual research to late stage formative usability studies. In the end, these prototypes should be as close as you can get to production.
We use every tool in the trade to make sure we represent the design details, when creating a medical device prototype. From machining engineering plastics such as ABS, delrin, and nylon on one of our five CNC milling centers, to casting V0 fire rated, glass filled, or crystal clear material in our world class casting lab, our team of prototyping experts assures you get the details needed to express the function and look you intended. When it comes to making your prototype look like the finished product, our finishing experts and their two full size spray booths can handle anything from a hand held glucose meter, to a full scale clinical analyzer.
Frequent feedback from users is critical to the success of any product development effort. For medical devices, it helps reduce the potential risks and reduces overall development time. Our pre-clinical prototyping capabilities provide high fidelity prototypes that are sure to elicit valuable feedback during testing; and with our ISO 13485 Quality Management System (certification est. Q3 2017), our services are sure to meet your quality expectations.