March 2000
MD&DI
Selected Contents

EDITOR'S PAGE:
Joining The Party
by John Katz

What do installation production orders, instantaneous power outputs, and intellectual property owners have in common? They are all semantic has-beens, outmoded claimants to an acronym throne now ruled by the one-and-only IPO—the almighty initial public offering.

INSIDE MD&DI:
Evolving Device Designs Require New Test Technologies
by Gregg Nighswonger

The rapidly changing nature of medical devices submitted for FDA approval will require more advanced testing technologies. There are four underlying reasons for this: increased specimen durability requirements, the desire for faster tests with better accuracy, the use of new materials, and a lack of good animal models

ARTIFICIAL INTELLIGENCE

Adding Intelligence to Medical Devices
By Ralph J. Begley, Mark Riege, John Rosenblum, and Daniel Tseng

An overview of decision support and expert system technology in the medical device industry.

DESIGNER'S NOTEBOOK:
Creative Collaboration: User-Centered Design in Practice
by Duane D. Bray

A case study of the development of a blood parameter monitor illustrates the benefits of teamwork and human factors engineering during the design process

COVER STORY:
2000 Business Outlook: Creating the Future
by Jon Katz

At a time of tremendous technological innovation, device executives responding to MD&DI's exclusive annual survey express unprecedented optimism regarding current and near-term business conditions.

TESTING:
Mechanical Testing: Accelerated Protocol Development and Advanced System Design
by Kent S. Vilendrer

Accelerated benchtop testing plays a prominent role in bringing new devices to market. With a well-reasoned protocol in hand, the test engineer can focus on actuator and controls selection—the two most important elements in designing a powerful test system.

CLEANROOMS:
Qualification of Cleanrooms for Injection Molding
by Gernod Dittel and Erwin Bürkle

Product specifications, regulatory guidelines, and ambient conditions all influence the fundamental design considerations for cleanroom facilities intended for injection molding applications.

VERBATIM
Shaping initiatives that lead to Stronger Healthcare

Working to implement a public policy that supports HIMA's strategic plan, the organization's president, Pamela Bailey, is looking to medical manufacturers for help in meeting her objectives.

WASHINGTON WRAP-UP:
FDA to Industry: Keep Your Own Secrets
by James G. Dickinson

Also:

• Stepped-up FDA Enforcement
• Pacemaker Lead Clinical Tests
• Explants Prompt Recall
• Labeling Copyright Risk
• More on Device Tracking
• Another Reprocessor Cited

R&D HORIZONS:
Blood Substitutes: Recreating the Fluid of Life
by Gregg Nighswonger

Efforts to develop viable alternatives to human blood are beginning to prove successful in both operating suites and emergency rooms

BOTTOM LINE:
Working with Economic Developers To Make Smart Relocation and Expansion Decisions
by David T. Ginn

Treating the site-selection process as a team effort will ensure the best results.

SNAP SHOT:
Cold-Weather Forecast
by Ani Grigorian

John Dobak, MD, founder, president, and CEO of Innercool Therapies Inc. (San Diego), was unexpectedly introduced to the field of cryosurgery nearly five years ago after a mishap occurred in a clinic where he was working.