UpFront: Thoughts on Medical Manufacturing
By Brian J. Hogan
Whenever manufacturing people sit down and try to scope out markets that will need manufactured products, the medical field comes near the head of the list. The aging of populations all over the world, and significant advances in medical technology, have combined to create a growing need for shops and personnel able to manufacture advanced products and devices for the medical market.
We look at medical manufacturing in this issue, presenting articles on production of special medical products, precision metalworking with Swiss automatics, and part marking (which is vital to traceability, a critical factor in a field bedeviled by ravening packs of lawyers). And we also offer a preview of the annual EASTEC exposition, which will include technical sessions on the unique problems facing medical manufacturing.
Medical manufacturing work is interesting for many reasons, one being that it's always possible to imagine the day when you or someone you love might need to make use of the product you're making. And there's deep satisfaction in the idea that the component you've produced is going to help someone. On the other hand, it's worth remembering that if everyone wants to get into the act, the stage may soon be overcrowded.
No doubt you've been looking at the margins involved in medical manufacturing work. For sure, not many patients will haggle over the price of a pacemaker. But before committing capital and time to organizing your shop for medical work, be certain you know what's involved.
For the most part, the dimensional accuracies required to produce high-value medical devices and components aren't a great challenge. The materials are certainly another matter—titanium, stainless, ceramics, and other tough stuff are used to make many medical products. Often, your processes will come under scrutiny.The OEM will not only want to know what you've made, but how you make it. If you go into this market, expect a higher degree of attention from your customer than you've been accustomed to.
Be sure, also, that you understand the reporting requirements you'll face, and concentrate on developing a good relationship with your customer. If you're going to be a supplier to medical OEMs, you must earn and retain trust. Remember: A defective part isn't just a contractual problem for a medical manufacturer; it can cause loss of life, and expose the OEM to huge, long-term legal problems.
All opportunities involve challenges.A decision to enter the medical manufacturing field should be made only after a serious examination of your operation's capabilities, the potential for profitable operations, and the costs involved. Think it over, look before you leap, and base your decision on information, not emotion.
This article was first published in the May 2008 edition of Manufacturing Engineering magazine.