Medical devices represent a diverse set of products that employ a wide range of functional materials to aid in the diagnosis, treatment, or prevention of disease. To address the complexity of these technologies, iFyber provides expertise across a range of areas pertinent to the industry, including synthetic and analytical chemistry, chemical engineering, microbiology, molecular and cell biology, and regulatory affairs.
Because of the vast array of technologies that can be considered medical devices, the intended use and technological characteristics for each device must be considered to design the appropriate testing strategy. Our application-specific assays and testing plans produce relevant data that can guide the design, verification, validation, and clearance/approval of medical device technologies.
Some examples of relevant services:
- Antimicrobial efficacy of medical device coatings (e.g., indwelling urinary catheters or PIC lines)
- Cell and bacterial attachment on orthopedic implants and other medical implants and prosthesis
- Design, characterization, and functional testing of biomaterials and coatings in relevant models
- Drug loading efficiency, release profiles, and efficacy testing of combination products
- Lateral Flow Assay (LFA) feasibility, characterization, and development services for clinical diagnostics applications
- Initial in vitro biocompatibility screening of new technologies
- Development, synthesis, and residual testing of bioabsorbable polymers
- Enabling technology landscape research and Scientific Advisory Board creation
Contact us to learn how iFyber can help advance your medical device technology.