imds: Innovative Medical Device Solutions
Expertise and innovation in product development and pre-clinical testing
Transcutaneous Intramedullary Prosthetic Limb
Challenge
IMDS Discovery Research pioneered the development of a research model for a prosthetic limb. The sponsor was a government entity working through a grant. We were contacted by the sponsor regarding development of a prosthetic limb model to evaluate the tissue compatibility, bone integration, load bearing, strain tolerance, and site infection characteristics.
Solution
Working in conjunction with the sponsor and adhering to all government rules and regulations, we aided the sponsor in developing the appropriate research model and device for this study. We designed, built and tested original proof of concept with the sponsor, which included several pilot studies in various research models. We achieved a specialized research laboratory accreditation in order to be able to perform this study at our facility. With the project languishing and time for receiving the grant running out, IMDS Co-Innovation™ was enlisted to finalize the design implant and manufacture the implant.
IMDS Discovery Research coordinated all aspects of this study. The sponsor valued our ability to move the project along with speed and efficiency and bypass the stumbling blocks which the sponsor was experiencing through the government entities associated with the project. Our project management included preparing the protocol to be approved by three separate ethics review boards; procuring significant study resources in a very short time frame for the study; and providing all clinical follow-up for the study. We performed all aspects of the study at our facility, which included designing and building a specialized chute for a weight-bearing testing apparatus. The study consisted of 100 subjects, with four data collection points, at three, six, nine and 12 months. Our facilities, personnel, and capabilities allowed us to perform a study of this size, complexity, and length.
Results
The current study is ongoing, and we are assisting the sponsor in working through objectives to move the implant toward clinical trials. The preliminary results from the study have been extremely positive, and based on the initial results, the sponsor is prepared to move forward with the next level of testing. We provided unparalleled support to the sponsor in the design, development and implementation of their device. This study is an excellent example of our ability to assist a sponsor in every aspect of a study from conception to completion.
Product
Transcutaneous Intramedullary Prosthetic Limb
Services Utilized
