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.
Implantable, Drug-Embedded Polymer Mesh Could Help in Battle Against Opioids
A polymer-based drug-eluting mesh that is implanted in the patient following surgery and dissolves harmlessly after its useful life could
A Prototype of a Car Bumper Made of Graphene Composite
A University of Sunderland academic working on graphene for use in the automotive industry has produced a prototype composite component.
Helios Newest Company to Replace Metal With Plastic for Paint Cans and Pails
For nearly two decades, plastic has proven to be a better alternative to metal for paint cans. Consumer complaints of rusting metal
Novel Ultrafine Polymer Fibers Stronger and Tougher Than Kevlar
Researchers at Massachusetts Institute of Technology (MIT) have developed a process that can produce ultrafine fibers – with diameters
ISO 13485 Revision: Mind the Gap Analysis
Our recent interview with Garth Conrad, Vice President, Quality, at C.R. Bard, now part of BD, discussing the revision of ISO 13485, the international
Pregis Invests $1 Million in Blown Film Testing Lab to Assist Converters in Delivering Performance-Oriented Materials
Pregis LLC has invested $1 million in a new 1,000 square foot testing lab for its Grand Rapids, Michigan, blown film manufacturing facility
Thrace Plastics Co. S.A. Changes Company’s Name to “Thrace Plastics Holding And Commercial Societe Anonyme”
The societe anonyme under the name “Thrace Plastics holding and commercial societe anonyme” with the distinctive title “Thrace Plastics co.