Wound Care Device Development
Preclinical Support and Expertise for Innovative Wound Care Solutions
iFyber’s diverse team of scientists and engineers have a deep understanding and years of experience in the research and development of wound care devices. Developing wound care devices requires proficiency in both microbial and mammalian cell culture techniques: the devices will be in contact with both microbes looking to colonize the wound, as well as the patient’s own cells. Microbiological skills are essential for testing the antimicrobial properties of wound care materials, ensuring that they can effectively prevent or eliminate infections.
Our models evaluate beyond just planktonic bacteria and extend into barrier studies, direct contact studies, time-kill studies, and biofilm studies to provide a comprehensive way to evaluate antimicrobial efficacy. Mammalian cell culture skills are equally important for assessing the biocompatibility and cytotoxicity of wound care devices. This includes culturing relevant cell lines, such as fibroblasts or keratinocytes, and conducting assays to monitor cell viability, proliferation, and differentiation in the presence of the wound care material.
In addition, our team can evaluate pro- and anti-inflammatory markers in a set of models ranging from simple monolayers of cells, to differentiated human skin equivalent models, to ex vivo living human skin models. iFyber’s mastery of these skills ensures the data that prove our sponsor’s wound care devices are safe and effective for clinical use can stand up to peer and regulatory review.
Contact us to learn how iFyber can help advance your wound care device technology.
510(k) Data Packages and Support
iFyber offers both standard and custom preclinical efficacy testing and data packages that can be submitted to FDA in support of substantial equivalence decisions for traditional medical devices and combination products, such as wound dressings and coated devices. iFyber has a GLP-compliant quality system and can provide GLP testing services upon request.