January 2004
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
U.S.
Device Firms Must Choose European Contacts Wisely
COVER STORY
Medical
Packaging: Achieving a Single Global Standard
Michael H. Scholla
A
harmonized medical packaging standard will alleviate confusion and provide a
single document that will ensure worldwide conformity.
Tubing
Assembly
Hub
Optimization and Integration of High-Performance Catheters
Ron Roth and Alvin Coats
Improving
the design of a device such as a high-performance catheter must start with the
components—from tubing to luers to final assembly.
Software
Modeling
Understanding
Soft Tissue and Stent Design Behavior
Chris
Teague and Chris Feezor
Finite-element
modeling software enables simulations that provide otherwise
elusive knowledge of soft tissue and stent behavior.
Product
Development
Faster,
Cheaper, Better Products?
Bill Evans and Lisa Scheinkopf
Tips and tricks from insiders for freeing the product development logjam.
Sidebar: Top
10 Ways to Fool Yourself You’re Getting There Faster, Cheaper, and Better
Sidebar: Resourcing: Bad Ideas That Sound
Good
Systems
Development
A
Blueprint for Quality
Beth Crandall
Guidant
reveals its strategy for reengineering the 12 procedures that guide its
business-software system development process.
Sidebar: Translating
Compliance Requirements into Procedures
Reimbursement
Preventing Coverage Delays Is Key to
Device Profits
Greg Radinsky
Securing reimbursement requires careful consideration of many options. Moving
quickly through the process is crucial to the profitability of a device.
Sidebar: Applying for an IDE
Labeling
Patricia A. Patterson
Understanding how patients interpret instructions can help manufacturers design better labeling and improve customer performance and satisfaction.
Risk Assessment
Using FMEA to Develop Alternatives to
Batch Testing
Peter
S. Lee, Bryan Plumlee, Terri Rymer, Robert Schwabe, and Joyce Hansen
Failure mode
and effects analysis can be used as an assessment tool to identify potential
risk associated with bacterial endotoxin contamination.
WASHINGTON WRAP-UP
Global Harmonization Seen at RiskJames G. Dickinson
More standards and requirements worldwide may impede the ultimate goal of harmonization and seamless borders.
NEWSTRENDS
- Government Pledges to Increase CDRH Funding, but Will It Be Enough?
- FDA Inspector: Device Firms Have Problems with CAPA, Complaint Handling
- AAMI Releases Guide to Dialysis Standards
- AAMI Revises Sterilization Standards
- Medtronic Acquires Spine Technology Firm
- Insurance for Medical Device Firms: What You Need to Know
- New Technology Could Improve Microbial Resistance of Hospital Linens
- Surgeons Honor Innovative Products
- Ozone Sterilization System Approved; Could Compete with EtO, Gas Plasma
- FDA to Create Advertising Policy for Medical Device Manufacturers
- MD&DI Welcomes New Board Member
- Jury Selection Begins for Medical Design Excellence Awards
R&D DIGEST:
- Researchers Find New Method to Grow Tissues
- NASA Helps Firm Launch New Type of Glass for Lasers
- Synthetic Vascular Sealant Could Have Many Applications
- “Programmed” Cells Could Combat Cancer
- Outlook
for Medical R&D Spending Positive
Product Development Insight
Getting Better Results in Design Concept SelectionDavid Warburton
Product development teams should explore many design concept options to determine which best suits user requirements.
Q & A
Carl Zeiss: Innovative Vision for Eye-Care TechnologyErik Swain
Developing solutions for real-world clinical problems rather than products in search of a market is key to the firm’s success in the ophthalmic arena.
Regulatory
Outlook
Part
11: New Guidance Provides Little Guidance
Barbara Immel
With
enforcement discretion and a confusing new guidance, FDA may be undermining the
effectiveness and intent of its electronic records rule.
Sidebar: FDA
Enforcement Discretion
Sidebar: ENSURING
Part 11 Compliance
Sidebar: Inventory Form Ideas
Sidebar: Resources:
A Partial List
