Don't Know Much About Biology? It's Time
to Learn
Physics and engineering are the sciences most often associated with medical device development. But because most devices come into contact with the human body, knowledge of biology, and by extension, biocompatibility, is essential as well. In the September issue of MD&DI, you will find an article that will help you learn what you need to know about biology and biocompatibility.
David Albert and Amy Hoffmann of NAMSA (Northwood, OH) have written an article about how to assess biological risk as part of the chemical characterization process during medical device development. An adequate assessment of biological or toxicological risks from extractables that can compromise patient safety must be performed. To understand what affect your materials could have on the human body, you have to understand the human body.
Albert and Hoffmann argue that what is needed is an appropriate scientific evaluation program based on the specifics of the device. A collaborative approach emphasizes the need for an overall scientifically valid risk assessment. They add that all parties involved, including the manufacturer, analytical chemists, and toxicological risk assessor, must have input and be a significant contributor to the assessment process.
Consultant Michael Drues, a frequent speaker at the Medical Design & Manufacturing shows, has a mantra for manufacturers of implantable medical devices: “Design with the body in mind.” He believes that device companies don’t take biology and biocompatibility issues seriously enough. Given the increasing sophistication of implantable medical devices, that message has never been so important.
Erik Swain
erik.swain@cancom.com
MD&M Midwest
September 23–25, 2008 | Donald E. Stephens Convention Center, Rosemont, IL
Attend the Midwest's new event for medical design and manufacturing—MD&M Midwest. See, compare, and evaluate the complete range of product and service resources for designing and manufacturing your current and next-generation medical devices and equipment. For complete event details including expo hall highlights, a current list of exhibitors, information on the co-located MD&M Midwest conference program, and easy online registration for free expo hall admission, visit www.mdmmidwest.com.
Molding
Molding: Take Two
By Sarah Voss
OEMs can satisfy demand for innovative designs and high quality with two-shot molding.
Web Exclusive!: Watch a demonstration video of two-shot molding.
Chemical Characterization
What's in a Polymer?
By David Albert and Amy Hoffman
The medical device industry faces a significant challenge in measuring extractables.
Tubing
Harnessing Extruded Tubing for Balloon Production
By Eric Mabry
Manufacturers need a thorough understanding of the balloon-forming process for catheters.
Web Exclusive!: See a video of the stretch blow molding process.
Design
Designing off the Beaten Path
By Michael Wiklund and Allison Yale
People with diabetes and other medical conditions may not be best served by traditionally designed devices.
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