Medical Devices and In-Vitro Diagnostics
We believe that the essence of speed to market for developing medical devices or in-vitro diagnostics is to develop the right assumptions early in the life cycle (concept to commercialization), use design input and output documentation and build toward a specific regulatory claim and commercial application.
Our approach is to assist companies at the earliest possible stage of product development to gain these goals without costly changes in time or money requirements that might otherwise occur.
Utilizing our full device and therapeutic expertise and experience, we tailor our services to the needs of the customer. There are thousands of medical devices being developed. Each has its own unique pathway to approval and commercial success. There are different considerations in the US vs. international requirements. We apply our domestic and international knowledge of the product development and regulatory pathway issues for devices, understanding the difference between device development and clinical trials, and pharmaceutical development and trials. By also understanding the implications imposed by the therapeutic area involved we bring deep knowledge to the important aspects of the product development cycle and the tie-in of the device or in-vitro diagnostic to the targeted health care outcomes.