August 2005
Medical Device & Diagnostic Industry
Selected Contents
From the Editors
No More Excuses for Medical Errors
The still-too-high rate of medical errors could be cut if more device companies used human factors research early on in product design.
Cover Story: Molding
Finding a Fit with Rapid Injection Molding
Bradley Cleveland
Rapid injection molding may be a good fit for design engineers looking for quality first-run parts. But they should first know the basics.
Cover Story: Molding
Gas-Assist Injection Molding: An Innovative Medical Technology
Michael Hansen
In certain medical device applications, gas-assist molding can provide solutions that conventional injection molding cannot.
Cardiovascular Trends
Advances in Devices Lead to Hope for Heart Patients
Erik Swain
As cardiovascular technologies and the devices that incorporate them continue to improve, heart patients have a host of new options for treatment.
Sidebar:
Imaging
Coatings
A Look at Parylene Coatings in Drug-Eluting Technologies
Lonny Wolgemuth
The continued success of drug-eluting stents relies heavily on little-known technologies. Parylene, for example, could have far-reaching applications.
Surface Treatments
The Role of Antimicrobial Silver Nanotechnology
Bruce Gibbins and Lenna Warner
A new silver nanotechnology chemistry can prevent the formation of life-threatening biofilms on medical devices.
Guide To Outsourcing
A Plan for Picking an EMS Partner
William Leventon
Industry experts help you zero in on the right provider of electronics manufacturing services.
Sidebar:
Outsourcing Electronics:
Special Considerations
Guide To Outsourcing
Good Contracts Lead to Good Relationships
David A. Vogel
Both parties should benefit when it’s time to outsource. Comparing proposals and selecting the right kind of contract are two ways companies can develop good relationships with outsourcing partners.
Guide To Outsourcing
Outsourcing Medical Products to Asia
Ames Gross and Rachel Weintraub
Asian countries, particularly India and China, are making vast regulatory and industry improvements to attract more outsourcing business. And Western countries are responding favorably.
Guide To Outsourcing
Intelligent Outsourcing Means Global Reach
Andrew Diston
When taking a product to the global market, outsourcing can help get through regulatory, cultural, and other differences.
WASHINGTON WRAP-UP
Can Product Recalls Be a Good Thing?
James G. Dickinson
The director of the CDRH Office of In Vitro Diagnostic Device Evaluation and Safety makes waves when he claims that recalls prove a QA system is effective.
NEWSTRENDS
OUTSOURCING NEWS
R&D DIGEST:
Product Development Insight
Return on Investment in Human Factors
Michael E. Wiklund
Although the cost of human factors programs may seem daunting, the savings realized from them more than justify their expense.
Regulatory Outlook
Optimizing Regulatory Compliance: Nine Strategies for Success
Nancy Singer and Richard DeRisio
Compliance-Alliance LLC and Kinetic Concepts Inc.
Medical device firms need to create an organizational structure around the QSR, and they need to follow the procedures it prescribes.
Sidebar:
Evaluating Management’s Commitment to Quality System Compliance
Q&A
The Modernization of ODE
Erik Swain
Former ODE Deputy Director for Science and Regulatory Policy Phil Phillips helped streamline the way CDRH handles premarket submissions and interacts with industry. He’s now able to try to effect change from the outside.
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