Medical Device & Diagnostic Industry
October 1996 MD&DI
Selected Contents
Editor's Page
Coming Soon to a Monitor Near You: A New Information Source
John Bethune
Experienced Web surfers also know that the value and accessibility of the information on the web are substantial, and growing every day.
Guest Editorial
Beyond the Elections: The Device Industry in "Little-Unit" America
Ted Mannen
Over the past two years, the device industry has made legislative reform of FDA its top public policy priority, and appropriately so. But this intense effort has masked broader trends that will shape the industry's policy environment, whatever the outcome of FDA reform and the November elections.
Interview
Working toward Harmonization—One Standard at a Time
Wolfgang Muller-Lierheim
In this interview, Wolfgang Müller-Lierheim, chairman of the International Organization for Standardization's technical committee on the biological evaluation of medical devices (ISO TC 194) discusses his vision for ISO TC 194 as well as his thoughts on how ISO 10993 may be used throughout the global device community.
Washington Wrap-Up
FDA Document Leaks Revisited
James G. Dickinson
After seven months of inaction by FDA's Office of Internal Affairs (OIA), the FBI has taken over investigation of the most serious breach of security at FDA since the generic drug scandal.
Quality
Improving Quality with Integrated Statistical Tools
John S. Kim
When used appropriately, statistical tools can make a significant contribution
to the improvement of quality and productivity in medical device manufacturing.
Regulatory Affairs
FDA Plans GMP Education Blitz
Greg Freiherr
As members of the medical device industry eagerly await the release of the revised rule on GMPs, there is little doubt that the new regulation will have an extraordinary impact on the device community. But before manufacturers can comply with the GMPs, they must understand them.
Business and Marketing
Changes in the Japanese Distribution System Offer Good Opportunities
Ames Gross and Elaine Conavay
Following a period of rapid expansion, Japan's economy has experienced slow economic growth since the late 1980s. Nevertheless, the Japanese medical and dental supplies import market has shown steady growth over the last several years.
Business and Marketing
Steep Learning Curve Challenges European Device Regulators
Norbert Sparrow
As the world's second-largest consumer of medical products, the European Union is a market U.S. manufacturers cannot afford to ignore. Harmonized legislation allows CE-marked products access to markets in all member states, and Europe's third-party review system has slashed premarket approval times compared to those in the U.S.
Regulatory Affairs
FDA's New MDR Regulations: What Manufacturers Need to Know
Edward M. Basile
On July 31, 1996, the new medical device reporting (MDR) regulations for medical device manufacturers and user facilities became effective—at least for
the most part.
Materials
Selecting Materials for Medical Products: From PVC to Metallocene Polyolefins
Sherwin Shang
As a prospective replacement for PVC, the family of polymers known as metallocene polyolefins has shown great potential. When considering the use of components made from metallocene polyolefins, however, medical producers will also need to assess their suitability from the viewpoints of design, processing, and product performance.
Testing
Managing Positive Biocompatibility Test Results
Nancy J. Stark
Manufacturers have the freedom, and the
responsibility, to apply the ISO biological evaluation standard in a way that ensures the biological safety of their devices while conservatively managing resources.
Electronics
Why Choose Color Displays?
Michael Wiklund
Information display and control actions previously assigned to
dedicated-purpose meters, counters, knobs, and switches are now handled
via interactions with software. The ubiquitous control panel has been replaced
with the increasingly ubiquitous computer display and input device, such as a trackball or arrow keys.
