BioInteractions launched an expanded Product Pathway Partnership service incorporating bespoke coatings, optimized application and tooling, testing, regulatory support and commercial production, at MD&M West.
The company, which developed TridAnt, a coating technology for medical devices, as well as the widely proven Astute® and Assist™ solutions, said the new service aimed at advancing an organization’s ability to navigate the complicated medical device market quicker and more efficiently.
“Universally, medical product developers and manufacturers navigate a highly regulated and particularly constrained environment,” said Arjun Luthra, commercial director. “Our Product Pathway Partnership team closely work with you to navigate all areas including fixture design and tooling, biocompatibility testing, optimizing the coating application process, regulatory compliance and optimizing your commercial manufacturing. We provide guidance along a strategic pathway with a focus on offering a flexible approach to meeting all of the ever-revolving regulatory demands, the aim of which is to get you to market in the most effective way possible.”
A critical part of ensuring that medical devices meet regulatory requirements is to test for coating efficacy and biocompatibility. During this process, the coating functions are examined to ensure that they are effective, as well as ensuring that the device is durable and safe for patients.
BioInteractions said that it can improve coating efficacy for devices with complex geometries by optimizing its materials for use with their broad portfolio of products. The company offers various high-performance biocompatible coatings with proven engineered clinical efficacy that expand functionality and broaden design options for engineers including; TridAnt® a non-leaching, safe and durable antimicrobial coating that has been proven effective against a broad spectrum of pathogens.
The application of TridAnt® to medical implants reduces the risk of infection, shortens the treatment time, and helps to improve the well-being of patients who undergo a range of clinical procedures. The technology is a culmination of three decades of dedicated research and trials, the result of which is a highly effective material which complies with the latest medical device regulations and has been independently tested by medical device manufacturers to international standards (ISO, EN, PAS).
The multi-disciplinary team works with a variety of innovators including skilled technicians and scientists, regulatory experts and industry experts. “In an increasingly complex market, rigid thinking is no longer viable for the medical product development process. As advances in medical device manufacturing progress towards more efficient design and quicker manufacturing process, OEMs are highly motivated to find reliable innovations and flexible partners,” explained Jim Veitch, medical device consultant at Synthetic Solutions Group Ltd.