Feature Article

By: L. Woo, Baxter Healthcare and L. Woo Associates LLC, Libertyville, Illinois, USA

In celebrating the 20 years of this publication, one reflects that there have certainly been profound evolution and revolutions taking place during that time. For anyone who uses history as a guide for future developments, there are plenty of lessons.

 

One profound evolution has been the material selection debate over whether or not the industry should switch from using polyvinyl chloride (PVC). The debate had just started and there was considerable skepticism over the likelihood that a suitable alternative candidate could be found. Skeptics pointed out that the concern over PVC would be just like many previous false alarms over di(2-ethylhexyl) phthalate (DEHP), the most widely used plasticiser for PVC. We can see now that not only was it possible to find alternatives—in fact, chlorine- and plasticiser-free products are rapidly dominating the marketplace. However, instead of a debate over PVC and plasticisers, a new focus over bisphenol A BPA has gained a lot of regulatory and consumer attention. Here the concerns are that the BPA could mimic some natural hormones with harmful effects on pregnant women and children and the effect could be nonlinear.

 

Another global issue that has taken centre stage is climate change and the focus is on everyone’s “carbon footprint.” As responsible global citizens, we in the medical device industry should take steps to ensure that our burden on future generations is minimised. In this way, lead for electronic instrument assembly and chlorofluorocarbon (CFC) for much of the cleaning of electronics and devices have mostly disappeared as a result of environmental regulations.

 

Metallocene, the single site catalyst for polyolefins, can be considered a major revolution for medical materials. Today, many high-performance polyolefins are rapidly replacing PVC and rigid materials such as the cyclic olefin polymer (COP) and cyclic olefin copolymers (COC) that are finding increasing applications in the medical device marketplace. 

 

Twenty years ago, sterilisation by means of ionising radiation was just gaining a foothold in the medical device industry. While gamma sources and contract sterilisers were rapidly expanding to meet market demand, the beta or electron beam modality was viewed as untried and unreliable. Currently, many high powered (high throughput) and high energy (penetration) electron beam facilities are operating reliably in in-house and contract facility settings globally. Ethylene oxide gas sterilisation has been reduced to much more limited application when no other modality is suitable.

 

Coinciding with this period is the much heralded nanotechnology revolution, initially with fullerenes and single- and multi-walled carbon nano-tubes and later extending to everything below the micron dimension. As any seasoned observer would comment, the shine from “nano” is gradually wearing off and only a few truly useful inventions will remain. The recent spotlight on nanotechnology reminds us that age-old entities such as silica fillers, carbon black for reinforcement and block copolymer phase morphologies are truly unrecognised heroes indeed.

 

The rapidity of change is astounding. The rise of China and India—not merely as locations to outsource manufacturing but as significant marketplaces for medical devices—has already gained the attention of many visionary entrepreneurs. Changes such as these remind us to stay constantly abreast of material and regulatory developments for our future product successes. 

 

is Baxter Distinguished Scientist Emeritus, Baxter Healthcare, and Founder of L. Woo
Associates LLC, Libertyville, Illinois, USA
tel. +1 847 367 6804
e-mail: leconwoo@gmail.com
lwooassociates.com