Innovotech has a full understanding of the various implanted medical device testing procedures available. Our experience has helped us streamline and problem solve many of the issues that can delay testing.
The Problem with Implanted Medical Devices
Implanted medical devices (joints, catheters, stents, pacemakers, etc.) provide a solid surface for microbial growth upon which biofilms quickly form. A typical biofilm infection can cost as much as US$47,000 per patient to treat, and costs can escalate with chronic and recurrent infections.
Biofilms cause over 2 million infections annually, resulting in an estimated US$11B in additional patient healthcare costs. Hospital-acquired infections cost US$1.8B annually with urinary catheter use associated with up to 90% of these infections. Implanted medical device testing can reduce these costs.
Innovotech’s Solution to Implanted Medical Device Testing
Innovotech’s proprietary technology and industry expertise provide medical device manufacturers with an accepted approach to first, evaluate anti-microbial/anti-adherence biofilm coatings to study biofilm disease and then, develop research studies to validate product efficacy claims suitable for regulatory submission.
Our antimicrobial research team has worked with clients to achieve 510K approval in less than 12 months, owing to the high throughput nature of the company’s in vitro technology.
Utilize our Experienced Team:
- 40+ years of collective experience.
- Knowledge to test a wide range of products.
- Experience testing under aerobic, anaerobic and microaerophilic conditions.
- Experience testing bacterial and fungal strains.
- Experience testing medical devices, textiles, as well as agricultural and oilfield products.