imds: Innovative Medical Device Solutions
Helping secure FDA approval through pre-clinical testing
Bone Void Filler Product
Challenge
The IMDS Discovery Research team was contacted by a large medical device company to perform a study on a bone void filler product. The sponsor requested a one-year study to be performed in an appropriate comparative medicine model.
Solution
IMDS Discovery Research worked through study objectives with the sponsor and developed a protocol and an appropriate comparative medicine model, making necessary modifications to satisfy FDA requirements for the sponsor’s product.
Our project management included assisting the sponsor in preparing the protocol for ethics board review and approval; procuring resources for the study; and performing all aspects of the study. The data collection points for this study were 12 weeks, 26 weeks, and 52 weeks. We also provided histology and assisted with biomechanical testing for this project.
Results
The sponsor was extremely pleased with our ability to:
- Initiate and work through the study objectives and develop a protocol
- Schedule and initiate the study in a short time frame
- Rapidly procure study resources
- Personalize service and expertise to fit their needs
Based on the study results, the sponsor received FDA approval and announced an exclusive marketing and distribution agreement for its product.
