Why Medical Device Manufacturers Must Practise Future-Minded Purchasing Today

July 16, 2012 – 9:01 am

Guest blogger Dave Selin, European Sales Manager, Uson, writes:

The EU directive on the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) is a fine example of why device manufacturers making instrument and equipment purchasing decisions today must anticipate the medical device designs of the future.

RoHS restricts the use of lead and other potentially hazardous substances such as cadmium and mercury that historically have been at the heart of electronic products of all kinds. The medical device industry has been exempted from compliance for now by the EU because of product failures that might occur if substitute materials prove unreliable over the long term in real-world conditions.

Many agency reviewers are now at work to determine if implanted devices should be permanently excluded from RoHS restrictions. Meanwhile, research continues on the likes of lead-free alloys for use in device electronics. In other words, nobody really knows what the future holds and how product designs will need to change in the coming years or decades.

This is one of many examples showing why purchasing decisions must take into account much more than the grid of products being made today. Test instruments and assembly equipment must be evaluated in terms of how flexible they are in adapting to product specs of the future.

For example, the leak tester you purchase today for testing laparoscopic surgery devices, drug-eluting stents, insulin pumps or other devices likely will need to handle new product designs many times during its economic life. Surgical techniques continue to improve. Smartphone-operated devices of all kinds are about to become the norm. Innovation happens, RoHS inspired or otherwise.

Leak detector manufacturers who are intimately involved in the medical device industry (such as Uson) have responded to the needs of device makers to stretch their capital equipment investments. In fact, it was the overriding design concern in our most recent leak tester that has v for versatility in its name.

Many of the specifications that build in versatility for unimagined future applications are the same as many other capital expenses. First, it is a given that equipment support should extend over its full life, not just for the immediate application for which it is being used. Second, if it is a test instrument, ensure that it can do many variations and types of testing and that the permutations of how test sequences can be set up are nearly unlimited. Third, considering the rate at which data tends to multiply, look for instrumentation that can manage and store the maximum amount of data. I/O capacity is a relatively rapid way to zero in on whether an instrument or other equipment is versatile. As a rule of thumb, the models for any type of equipment or instrument that are most programmable are the ones that are built to last and are workable for newer product iterations.

Future-minded purchasing is a different mindset. Just look beyond the application at hand to anticipate ones not yet on the drawing board.

— Dave Selin, Uson

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