Medical Device & Diagnostic Industry
January 1997 MD&DI
Selected Contents
Cover Story
The Future Arrives for Medical Displays
Greg Freiherr
Flat-panel displays, holograms, and head-mounted displays are dramatically changing the way medical messages are communicated. They are being used to show patient and equipment status, as well as patient anatomy in two and three dimensions.
Challenges to Competitiveness in a Changing Medical Device Market
A. Jay Graf
The basis of competition will not change in the future. But it will be challenged by the expectations of the capital markets and the dynamics of the rapidly changing healthcare marketplace. . .
Interview
Today's Healthcare Industry Focuses on Cost Containment
What are the major changes occurring in today's healthcare marketplace,
and how are they affecting device companies?
Clateo Castellini, chairman, president, and CEO of Becton Dickinson, discusses the trends and challenges that will face medical product manufacturers in the years ahead.
Task Analysis: Understanding How People Think and Behave
Bryce G. Rutter
Through use of task analysis, a product can be developed that incorporates the most efficient path for users. The resulting redesigned device should be easier to use and better
organized than the original.
Washington Wrap-Up
Another Bloody Season in the FDA-Congress Wars?
James G. Dickinson
The departure of David A. Kessler as FDA commissioner is being seen as
cause for optimism in the medical device industry. Not much consideration has yet been given to the possibility that the selection process for Kessler's successor could be the precursor to a season of FDA-congressional warfare.
Greg Freiherr
Medical device and pharmaceutical firms are joining forces to advance the uses of light-activated drugs, opening up new applications for lasers and fiber optics.
Medical Device Distribution in an International Market
Lew Parker
Distribution in foreign countries can pose special difficulties; unless manufacturers take steps to avoid these problems, profits will suffer.
Quality
First Device Firm to Win Baldrige Award Finds Profit in Quality
Greg Freiherr
Four years ago, using the Baldrige criteria as a starting point, ADAC
Laboratories launched a thorough reform of its quality processes. The
changes are now paying off.
International Dilemmas in Labeling Medical Devices
Steven Halasey
Meeting the international requirements for medical device labeling is a bigger headache than you thought—and it's getting bigger.
Regulatory Focus
FDA Makes Quality the RuleW. Fred Hooten
On October 7, 1996, FDA published the long-awaited revision of the medical device GMPs. Manufacturers that have not remained current with the changes in the regulation that the agency has proposed over the past six years are in for a major surprise.
Manufacturing
Microtechnology Opens Doors to the Universe of Small Space
Peter Zuska
Highly innovative microfabrication techniques have emerged from the laboratory during the last decade, creating a new method for developing and producing microstructures and tiny microsystems. What began with the 3-D micromachining of
silicon wafers has since become a technology that holds much promise for the medical device industry.
Global Markets
Thailand Will Enter 21st Century With A Growing Device Market
Ames Gross
Once counted among the world's poorest nations, Thailand has recently
developed one of the world's fastest-growing economies, and is following
closely in the footsteps of the other Asian Tigers.
Hemocompatibility: Not All Devices Are Created Equal
Sharon Northup
Current standards for hemocompatibility are too broad; they don't take into account the unique demands of the many types of blood-contacting medical devices.
GMPs
Remanufactured Devices: Ensuring Their Safety and Effectiveness
Edward M. Basile
Medical device remanufacturing carries an indisputable benefit—reduced healthcare costs. With that benefit, however, comes an increased risk that the original device's safety and effectiveness may be compromised.
Clinical Trials
The Clinical Research Industry: New Options for Medical Device Manufacturers
Nancy J. Stark
The number of groups involved in conducting clinical trials is growing. To make well-informed choices, device manufacturers need to be aware of them all.
Help Desk
EtO Sterilizers Must Revalidate When Changing Their Procedures
Marjorie Lang instructs readers to revalidate their sterilization processes when changing the
levels of sterilants. She also explains why bioburden studies are necessary for
devices to be sterilized with gamma irradiation.
Snapshot
The Key to Product Development: Visualization
Greg Freiherr
More than a quarter of all people suffer from some type of eye problem,
mostly near-sightedness, far-sightedness, or astigmatism. Tom Loarie hopes to do something about that.
1996
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