Materials Insights: FDA Prioritizes Reprocessability of Devices

Tim Cabot, CEO of coatings company Katahdin Industries and president of metal and anodizing finishing services subsidiary DCHN LLC, discussed materials science with MPO for the March issue. Here is his extended interview.

Ranica Arrowsmith: What about medical device-related materials science is exciting you today?
Tim Cabot: A 2016 FDA Top 10 regulatory science priority is to improve the quality and effectiveness of reprocessing reusable medical devices. This formalizes a need that has been apparent for quite some time about how devices need to be engineered for cleaning and sterilization and have validated processes that demonstrate the effectiveness of these processes. While some companies are further ahead than others in implementing these requirements, all companies will be impacted. What we are interested in is how to protect aluminum devices and the printing on these devices through repeated cleaning, disinfecting, and sterilization cycles. Anodizing is commonly used for aluminum parts used for handles, couplings, housings, and other components of surgical power tools, scopes, and a range of ancillary equipment such as cases and trays. While anodizing initially looks great and can be decorated to meet a wide range of branding needs, it doesn’t perform with many common cleaning chemistries and a variety of sterilization methods. This is the area that we are really excited about as we are working with some of the top medical device companies to upgrade their aluminum finishing specs and meet the FDA’s challenge.

Arrowsmith: What challenges in R&D, testing, sterilization, packaging, etc. do the different materials you work with pose?
Cabot: One of the complicating factors is there is a broad range of cleaning and disinfecting processes. (And “processes” may not always be an accurate representation of what people are actually doing, given that a lot of cleaning and disinfecting hasn’t always been standardized.) A separate problem is that when people start validation studies, they often want to get accelerated results; and the design of these DOEs can sometimes include conditions that are bound to fail and are not representative of what anybody would do in real life given inherent dangers from chemistry and conditions used. So one of the first areas of collaboration is to work through the testing and validation requirements and adopt best practices.

Arrowsmith: What advancements in recent years have occurred in materials science in the medical device industry? What do you see coming down the pipeline?
Cabot: We see a conversion of medical device companies moving away from normal type II and type III anodizing to new anodic coating technologies better suited for the end application. The most innovative and highest performance of these is microcrystalline andodizing or Micralox.

Arrowsmith: Are there any new categories of devices that have posed interesting or exciting materials challenges for you? How about old devices that are being updated?
Cabot: The main areas of interest are those with the highest risk. Drug resistant bacteria has changed the risk profile for many common procedures; and there have been some widely publicized incidents from cross infection with devices such as endoscopes and duodenoscopes.