|From the Editor|
If there’s one thing we know for sure about the manufacturing of precision medical devices, it’s that there is almost no margin for error. The smaller a part you have to make, the more accurate and repeatable the manufacturing process has to be. Since many of these products are implanted in the body or cut tissue, an error in manufacturing that is allowed to go unnoticed could very well mean an injury to a patient. And when you are talking about parts that are in some cases microscopic, it is very easy for errors to go unnoticed.
That’s why you can’t assume that what works in the manufacturing of conventional medical devices will work in the manufacturing of precision medical devices. Miniaturized parts need processes optimized for miniaturization.
Many of the articles in this, the first Fall Edition of Med-Tech Precision, show you what you can do instead of making assumptions.
One way in which we are trying to help is by presenting a special section on micromolding. Some medical manufacturers don’t understand the difference between small part molding and micromolding. Others assume that conventional molding equipment can handle molding jobs of any part size. Both attitudes can lead to faulty manufacturing processes. Freelance writer Beth Orenstein explains what micromolding is all about, what techniques are being used to optimize the process, and what forces are driving its adoption in the precision medical field. Scott Herbert, president of Rapidwerks Inc. (Pleasanton, CA), explains what can go wrong when a precision medical device maker tries to make a micromolded part with a conventional molding machine.
Eric Schwarzenbach, president of Rollomatic Inc. (Mundelein, IL), discusses how the design and manufacturing of orthopedic cutting tools suffer from faulty assumptions as well. In particular, the tools are often not made in a way that complements the design of the implants. In an article you can find here, he reviews what orthopedics manufacturers need to know to do proper cutting-tool design and manufacturing.
If a precision medical device is going into the body, it needs to have a good coating in order to ensure that it will not cause an adverse reaction in the patient. And not just any coating will do. In afeature, Lonny Wolgemuth, senior medical marketing specialist for Specialty Coating Systems (Indianapolis), discusses one family of conformal coatings, parlyene. It has a very good track record of preventing adverse reactions, and of use on cardiological and minimally invasive surgical devices.
If you’re reading this magazine, chances are you’re making a product that is no ordinary medical device. Therefore, you shouldn’t be content with ordinary manufacturing processes and material choices. We hope you find the insights in this issue’s articles helpful.