March 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
One Way to Reduce Medical Errors
COVER STORY
Miniaturized
Electronics: Driving Medical Innovation
Gary Pinkerton
Electronic assemblies keep shrinking, and the medical device industry is finding myriad uses for them.
STERILIZATION
Process Dynamics of EtO Sterilization
Zhangwu Zhu and Ian P. Matthews
A mathematical model that uses microwave spectroscopic methods to interpret EtO measurements may provide a powerful software tool for process engineers.
MOLDING
Material Progress toward Better Molded Parts
William Leventon
New molding materials and additives offer many properties that can enhance medical product quality.
PRODUCT
SAFETY
Avoiding Last Minute Design Changes to Meet Safety Requirements
Michael L. Marcus and Brian R. Biersach
Product safety requirements impact the entire design process. This article offers guidance on complying with these regulations, providing tips on everything from evaluation and documentation to methods for avoiding common mistakes.
WASHINGTON
WRAP-UP
James G. Dickinson
CDRH
Improves PMA Review Times by 11%
The Office of Device
Evaluation takes most of the credit for the improved numbers. A closer look
reveals industry deserves even more credit.
Plus:
- Guidance on Sharps Injury Prevention Devices
- FDA Seeks Quick Input from Industry
- Ulatowski to Head Device Compliance at FDA
- FDA Reassures Public on Dental Amalgams
- Warning on Diathermy Risks
NEWSTRENDS
- Medical Design Excellence Awards Announced for 2003
- Disaster Recovery Provides Critical Lessons
- FDA Initiative to Speed Availability of Innovative Medical Devices
- Harmonization of Medical Packaging Standards Envisione
- FDA Publishes Susceptibility Test System Guidance
- Letter
to the Editor
R&D
DIGEST
- Next-Generation Laser Welding Produces Cancer Therapy Products
- Novel Battery Could Power Microdevices
- Exploring Free Energy Conversion Processes Could Aid Gene Delivery Research
- Microneedles Measure Muscle Cell Force
PRODUCT DEVELOPMENT INSIGHT
The
Risk of Talking about Risk
Preston G. Smith
Despite a reluctance to address it, risk is a productive focus for guiding a project to success.
REGULATORY OUTLOOK
Getting
Started with a Combination Product: Part I
Barry S.
Sall, Peter Lassoff, and Bruce Babbitt
Overcoming
the regulatory challenges in this ever-expanding field yields rewards.
GUIDE TO OUTSOURCING
Optimal Outsourcing for Medical OEMs
Stacey L. Bell
The question for device makers is not whether to outsource—it’s what to
contract out, where to do it, and how to begin.
Sidebar: No Risk, No Reward
GUIDE TO OUTSOURCING
International Outsourcing:
Is It Right for You?
Lori Bryan
Experts in contract manufacturing and their device-company clients offer advice for those considering an offshore move.
