Medical device testing encompasses evaluating the risk of a medical device to become infected with microbial contaminants. This can lead to microbial infections, failure of the device, and severe complications for the patient. Consequently, many medical devices are coated with antimicrobial agents, or other coatings that prevent the adhesion of microbes, and some devices actively control microbes with antibiotics.
Innovotech has pioneered high-throughput assays capable of testing real medical devices in their final product form. The testing can occur under near real world conditions such as under flow states, or with physiologically-relevant solutions and clinically isolated microbes.
Implanted medical devices, such as catheters, stents, and joints, provide a solid surface for microbial growth, leading to the rapid formation of biofilms. Innovotech provides proprietary technology and industry expertise to evaluate anti-microbial/anti-adherence biofilm coatings, and design research studies to validate product efficacy claims suitable for regulatory submission.
Innovotech offers multiple standard, specialized, or fully customized methods, with the goal of remaining high-throughput (cost effective), physiologically relevant, and robust. These methods include 22196, TM100, MBEC Assay® kits, BEST Assay™ method and the BESTplus Assay® method.
Innovotech’s team has been leading antimicrobial testing of medical devices for over 20 years. We’re a cross-disciplinary team of Phd and MSc-level scientists, with deep expertise in quality management systems and product regulatory approvals. We have approximately 3000 microbial strains in our collection including many unique clinical isolates and we routinely work under anaerobic conditions when required.
Innovotech performs several recognized standard assays essential for medical devices and materials. These include:
As an accredited laboratory, Innovotech Labs is required to meet regulatory requirements, manage and mitigate risk, and encourage a culture of quality both in and out of the laboratory as part of robust quality management systems. This adds a layer of confidence to the lab work and data generated for your results.
