May 2005
Medical Device & Diagnostic Industry
Selected Contents
Cover Story
The Many Facets of Modern Molding
William Leventon
New developments make their mark on molded devices and components.
Adhesives
Advances in UV Curing for Medical Applications
Jeff Scullion
Light-cure adhesive technology has been around for a long time. But recent advances in automated assembly and other areas make it a cost-effective method for bonding.
Plastics
Using Implantable-Grade PEEK for In Vivo Devices
Stuart Green
PEEK, which has significant benefits in vivo, may be what OEMs want for implant devices.
Biomaterials
Biomaterials: We Have the Technology
Heather Thompson
The biomaterials market stands on the cusp of technological breakthroughs.
Testing
A New Mouse Model for Carcinogenesis Testing of Medical Implants
Glenda J. Moser, Michael A. Streicker, and William Wustenberg
The rasH2 mouse model can help device manufacturers and FDA make a safe and accurate decision regarding the carcinogenic potential of a device.
Risk Management
Develop Defensively: Control Risk and Predict Results
Stan Telson
Using risk management during product development is a given. But to achieve better and more-predictable results, it is important to take all aspects of risk into consideration.
Medical Electronics
Moving Toward Lead-Free Products
Dean Miller
Although medical devices will not need to be lead free by the July 1, 2006 deadline, manufacturers should start to address their use of lead-bearing solder.
Combination Products
Regulatory Strategy: Preclinical Testing of Combination Products
Stuart Portnoy and Steven Koepke
Many regulatory considerations may be unfamiliar to manufacturers pursuing market approval of combination products. Understanding and planning for these considerations can significantly affect FDA review and approval times.
Surface Modification
Nanotech Silver Fights Microbes in Medical Devices
David Tobler and Lenna Warner
Nanoengineering could solve problems associated with applying silver as an antimicrobial agent to medical devices.
WASHINGTON WRAP-UP
Crawford Promises Pediatric Devices Office
James G. Dickinson
Using the pediatric drug legislation as a model, a new FDA office will address the lag in developing medical device technology that is appropriate for children.
NEWSTRENDS
- Taxus Provides Lessons in Rapid Product Adoption
- Ethox Acquires STS, Could Become Large Player in Contract Manufacturing
- Don’t Be Shortsighted About RFID, Experts Say
- J&J Seals Bond with Closure Medical
- European Tissue-Product Rules Nearing Completion
- Small Stent Firm Strives for Legitimacy in Big Market
- AAMI Clarifies Risk Management for Software
- Medication Management Systems: A Slow but Steady Road to Acceptance
- CDBM and Lean Manufacturing Can Work for Devices
- Engineering Scholarship Contest Under Way
- Breast Implant Maker Diversifies
R&D DIGEST:
- Technology Offers New Way of Seeing Blindness
- Blood Vessels Boosted by Gassy Plastic
- Drug Delivery May Become Safer
- Aneurysm Risk Can Now Be Detected
Product Development
Insight
Looking Good Matters for Devices, Too
William A. Hyman and Mary Beth Privitera
Texas A&M University and University of Cincinnati
Aesthetics shouldn’t be an afterthought when designing medical devices.
Regulatory Outlook
Federal and State Requirements for HCT/Ps: An Overview
Jeffrey K. Shapiro
Hogan & Hartson LLP
With new regulations for tissue-based products coming into effect soon, it’s important that manufacturers understand FDA’s requirements.
Q&A
Shaking Up FDA
Erik Swain
It’s not easy to effect change at FDA, but former chief counsel Daniel E. Troy and his special assistant Coleen Klasmeier did just that during their tenure. In a rare and exclusive interview, they reflect on some of the issues they took on.
