March 2005
Medical Device & Diagnostic Industry
Selected Contents
Editor's
Page:
Get It Right the First Time
Cover Story
New Benefits Flow from Pumps and Valves
William
Leventon
Top suppliers can help you ask the questions that will enable you to find the right components for your devices.
Sterilization
Global Sterilization: Making the Standards Standard
Robert Reich, Philip M. Schneider, and Carolyn Kinsley
The new harmonized documents may hold the key to sterilization standards, but critical changes are in store for manufacturers.
Software
Bridging the Gap: Medical Device Communication with XML
Brendan Gill
XML has the potential to make widespread improvements in data management for the medical device and healthcare industries. The only problem is, it’s just not there yet.
Coatings
Coated Combination Products: Regulation and Technology
Phil Triolo
Combination products face different, and often more difficult, hurdles to jump for FDA approval.
Sidebar:
Risk Analysis of Coated Combination Products
Material
Meeting the Joint Replacement Challenge with UHMWPE
Steven M. Kurtz, Harvey L. Stein, and Gunther Redeker
Ultra-high-molecular-weight polyethylene has been the gold standard for 40 years. New technology and new materials can now offer even more options.
Outsourcing Trends
Outsourcing Partners Take on a Bigger Role
Andrew Kinross
Medical device outsourcing partners pursue innovation, low-cost manufacturing, and more business from OEMs.
Guide to Outsourcing
Designing Products with an Outsourcing Partner
Christina Elston
As contract firms handle more aspects of device manufacturing, to what extent should OEMs outsource their new-product development?
Guide to Outsourcing
Risk Factors: Deciding to Outsource Product Development
Tilak M. Shah
Outsourcing product development can be an attractive option for medical device OEMs. For certain devices, outsourcing partners closer to home can be just the ticket.
Guide to Outsourcing
Outsourcing Regulatory and Legal Functions: Choose Carefully
Erik Swain
With more and more resources being devoted to R&D and marketing, medical device companies are seeking outside help with regulatory and legal issues.
Sidebar:
FDA’s Guidance to Selecting
a Regulatory Consultant
Guide to Outsourcing
Quality Systems 101: Virtual Manufacturers
Ellen Esterline and Floyd Larson
Nearly every aspect of a medical device business can be outsourced, but to satisfy FDA, one company has to be accountable for the finished product.
Sidebar:
Responsibilities of the Virtual Manufacturer
WASHINGTON WRAP-UP
David Beats Goliath: FDA Reverses on FOI Exemptions
James G. Dickinson
FDA withdraws a direct final rule in the face of one man’s significant adverse comment.
NEWSTRENDS
- Safety-Needle Manufacturers Finally Reaping Rewards
- Reducing Recalls Possible with Risk Assessment Tool
- When Plastic Devices Fail, Many Clues Are Left Behind
- More Consistency Needed for Combination Product Regulation
- Medicare Reform May Take Time to Affect Industry
- Manufacturing Technique Reduces Inventory, Costs
- There is More to Packaging than Just a Box
- First OTC Commercial Defibrillator Debuts
OUTSOURCING NEWS
- EMS Facility Certified for Medical Device Manufacturing
- What’s In a Name? UTI Reinvents Itself as Accellent
- The MedTech Group Goes to Costa Rica
- Avail Breaks Ground on China Facility
- Medtronic Buildings Purchased by Atek Medical
- The Tech Group Is All Set for Indiana
- Hi-Tech Rubber Expands Manufacturing Capabilities
- Pelikan Boosts Diabetes Management
- Ionic Fusion Launches New Corporation
R&D DIGEST:
- Patient-Centered Network Could Go Wireless, Bringing Together Multiple Devices
- Chip-Scale Magnetic Sensor Offers Cardio Possibilities
- Sugar-Based Skin Could Function Like Real Skin
Product Development
Insight
Factoring the Law into Medical Device Design
Milton Bordwin
Rubin and Rudman LLP
Although product litigation is unavoidable, certain steps during the design process can reduce a manufacturer’s risk.
Regulatory Outlook
IEC 60601-1, 2005: A Revolutionary Standard, Part 2
Mike W. Schmidt
Strategic Device Compliance Services
The third edition of the standard has significant technical changes that must be carefully examined and fully understood to achieve compliance.
