Approximately 80% of biomaterials used today have been around an awful long time, according to Ekaterina Tkatchouk, PhD, Principal Chemist, Edwards Lifesciences (Irvine, CA). In one sense, that’s reassuring, since a long history of in vivo use provides us with plentiful evidence as to the safety and efficacy of the materials. But over-reliance on tried and true formulas also hampers innovation, which often begins at the material level. Tkatchouk has a real passion for this topic—“As a chemist and materials scientist, I will always defend the magic of chemistry and development of smart materials,” she told PlasticsToday. In this interview, Tkatchouk, who has more than 10 years’ experience developing biomaterials for implantable medical devices, shares some thoughts on the state of biomaterials development. She is scheduled to address challenges in design with biomaterials at next month’s co-located Medical Design & Manufacturing (MD&M) and PLASTEC West trade show and conference.
As everybody knows, developing a biomaterial entails many challenges, says Tkatchouk, from scale up and validation to USP Class VI or ISO 10993 testing. But, for the sake of argument, let’s assume that we have a new polymer that meets all of the compliance requirements and has mechanical properties that are a perfect fit with a given medical device. “You would think it would be easy and straightforward to use this material in a medical device, but that is not happening,” says Tkatchouk. Part of the reason is institutional.