May 2003
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S
PAGE:
MD&DI’s
Medical Manufacturer of the Year: Our Search Begins
COVER STORY
Critical
Care in Dispensing
Jerry Drake
Recent
advances in pump technology can optimize the delivery of adhesives in medical
device assembly applications.
ADHESIVES
Using
UV Adhesives to Optimize the Bonding Process
by B. G. Yacobi, Chris Le
Conte, Kevin Davis, and Manfred Hubert
A
review of the use of adhesives for device assembly, focusing on optical
radiation curing using UV light.
Design Control
Applying Session-Based Testing to Medical Software
by Bill Wood and David James
A
cost-effective means of identifying defects, the session-based testing method is
simple to understand, easy to implement, and an asset in achieving regulatory
compliance.
Outsourcing/site
selection
Medical Manufacturing in Asia: An Update
by
Ames Gross and Caroline Tran
Asian
nations continue to offer a wealth of opportunities and incentives for U.S.
medical manufacturers.
SURFACE CHARACTERIZATION
Using
SEM for Medical Applications
by
John Humenansky
A
variety of scanning electron microscopy techniques are available to medical
manufacturers to assist in analyzing and characterizing material surfaces.
WASHINGTON
WRAP-UP:
James G. Dickinson
A
One-Size-Fits-All GMP Inspection?
The use of third-party
inspectors, allowed by recent federal legislation, may pave the way for a
universal quality system inspection, says an FDA official.
Plus:
- Business Motives for Compliance Beat Regulatory Ones
- Baxter Dialyzer Deaths Probe Goes to Justice
- No User Fees to FDA, Please!
- Sterilizer Makers Indicted for Fraud
NEWSTRENDS
- Cypher Approval Marks New Era in Cardiac Intervention
- Bar Code Rule Reflects How Devices and Drugs Differ
- FDA Veteran Tapped for AdvaMed Post
- Investors Warm To Promising New Medical Firms—And Fund Them
- Abbott
Completes Bar Coding Initiative
R&D DIGEST:
- Flexible Polymers Display Properties of Hard Crystalline Sensors
- Advanced Fuel Cells May Power Medical Implants
- Contact Lenses Used to Deliver Eye Drugs
- Using “Nanoplug” Technology to Detect Blood Glucose
PRODUCT DEVELOPMENT INSIGHT
Using
Project Management Metrics as a Tool to Achieve Product Development Objectives
by Richard
Rosen
Translating an unmet market need into a product made on time and under budget requires precise operational execution. Project metrics can help.
REGULATORY OUTLOOK
IDE
Status Offers Direct Route to Reimbursement
by Ted
Mannen
If a device
meets certain criteria, clinical investigators in an IDE trial can seek Medicare
reimbursement for the device.
Call for Nominations
In Search of the Medical Manufacturer of 2003
The editors of
MD&DI are now accepting nominations for the Medical OEM of the Year
