I've mentioned before some of the fall out from the Evonik fire/explosion in March of this year. The initial concerns were regarding the shortages of nylon-12 for the auto industry. While that situation is being addressed, a new issue has arisen in the medical device industry - the explosion is now leading to a shortage of Pebax as well.
Pebax is a polyether-block-amide copolymer, meaning that there are alternating blocks of polyethers and polyamides, with the polyamides in this case, being nylon-12 (although other nylons are used depending on the particular grade). The materials are nice soft elastomers that have lots of uses, but the most important use is as balloon catheders used in angioplasty procedures. Since the nylon-12 is only part of the polymer, the demands that Pebax production places on the supply are less, but that doesn't make life any easier for the product development engineers.
I already have spoken before about the challenges that automakers will have with "drop-in replacements", but for medical device manufacturers, there is no such thing - by law. All these devices have FDA approval, so using alternative materials would require resubmitting the whole new device for reapproval, a long and expensive option not only to get the submittal papers together (with experimental data), but also to get the FDA to respond. For now, Arkema, the manufacturer of Pebax, is triaging their clients needs and applications and has stated that they will dole out their limited supplies to "life-saving" applications (such as the balloon catheders), and everyone else will just have to make do without.
Yet another example of how important ring-opening polymerization, that oddity of polymerization mechanisms, can be.
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