Although the world of medical device manufacturing is complex, there is a time to focus on the basics of getting your devices manufactured and ready for market. Our mission at MD&DI is to ensure that we are providing you with the essential information to do just that.
The cover story in this issue takes a close look at silicone tubing and its increase in use for products such as wound-drainage devices, catheters, and other easily sterilized disposable products. Because silicone tubing can meet some of the emerging demands for developing consistent, high-quality products, it is finding favor with medical OEMs.
The author points to the possibility that the long-term implantable product market has played a significant role in the drive for silicone tubing as medical device manufacturers look for ways to differentiate their products.
At the other end of the product development cycle is the essential need for a sterilization process that is right for the product and its material. In “Sterilizing Combination Products Using Oxides of Nitrogen,” three authors explore a new sterilization method that offers an alternative to device manufacturers—particularly those developing combination devices.
Despite improvements and refinements to existing methods, inherent limitations regarding material compatibility, high equipment costs, long sterilization cycles, sterilant residues, high temperatures, and operator risks have persisted. This article examines a method that opens the door for sterilization of new and developing combination products and delivery systems that cannot be sterilized by conventional methods.
Sherrie Conroy
sherrie.conroy@cancom.com
Sterilization
Move Over Ethylene Oxide
By James Kulla, Robert Reich, and Sheldon Broedel Jr.
Manufacturers developing combination devices may soon be able to use a sterilization process that relies on oxides of nitrogen.
Tubing
Doing Your Part to Prevent Tubing Misconnections
By Jim Brown
Without a standard for connectors, manufacturers should take it upon themselves to limit the dangerous problem of misconnections.
Extrusion
The Migration to Silicone Tubing
By Pradnya Parulekar
Over the last few years, medical device makers have shifted away from tubing made from plastics and thermoplastics.
Product Development Insight
Why It's Time to Woo Nonclinical Buyers
By Tom Hodson and Shaun Inman
As hospitals continue to cut costs, the nonclinical buyer is playing a more significant role in the adoption of medical devices.
Web Exclusive! Use MD&DI's Hospital Needs Integration Questionnaire to find out how responsive your organization is to its hospital customers' needs.
BIOMEDevice
April 22–23, 2009 | Boston Convention & Exhibition Center, Boston, MA
Attend New England’s new MD&M event! The BIOMEDevice exposition will include 300 leading suppliers to the medical device industry and the nation’s top resources for biopharmaceutical and medical device design and manufacturing. For complete event details including expo hall highlights, a current list of exhibitors, information on the co-located BIOMEDevice Executive Forum, and easy online registration for free expo hall admission, visit
www.BIOMEDeviceBoston.com
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Washington Wrap-Up
A Triumvirate of Problems Brews for Device Industry
By James Dickinson
A recent report from the Government Accountability Office is one of three major issues plaguing device makers.
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