Medical Device & Diagnostic Industry

November 1998 MD&DI
Selected Contents

COVER STORY:
Laser Micromachining Technology for Device Manufacturing
by Bo Gu, Rich Hunter, David Wall, and Mike Frechette

The keys to successful manufacturing using laser micromachining include knowing the limits of the technology as well as the capabilities of contract service providers.

TRACKING FDA PERFORMANCE:
Using Receipt and Decision Cohort Data to Monitor Premarket Review Activities
by Gary E. Blanken

Keeping track of the status of investigational device exemption, premarket approval, and 510(k) applications is daunting, but FDA has simplified its performance monitoring and reporting analyses by using receipt and decision cohort information.

ISO 10993-4:
A Practical Guide to ISO 10993-4: Hemocompatibility
by J. Matthew Buchanan, Paul J. Upman, and Richard F. Wallin

The structure of ISO's test-selection system is described for those devices that come into contact—directly or indirectly—with circulating blood.

WASHINGTON WRAP-UP:
Henney delivers positive message to device makers
by James G. Dickinson

Also:

• Draft pilot program to reduce warning letters
  
• Additional device standards recognized
  
• HIMA wants FDA to use entire standards
  
• FDA needs more device review prototypes
  
• HIMA seeks further-expanded MRA
  
• Ruling satisfies Myo-tronics—for now

R&D HORIZONS:
Embedded Computers Add Power at Bargain Prices
by Greg Freiherr

Older technologies still have a place in medical devices, but the upcoming models of high-performance chips may well pay for themselves in speed and flexibility.

BOTTOM LINE:
Vendor leasing programs cut risks for customers, bolster profits for manufacturers
by James G. Gaspard II

Healthcare equipment providers can increase their revenues and profits by establishing a relationship with a leasing vendor that suits their clients' needs.

HELP DESK:
Clarifying device history record issues

Fred Hooten, a regulatory and compliance issues consultant (Damascus, MD), explains some of the terms relating to original and updated device history records.

EMI FIELD NOTES:
Electromagnetic compatibility in microcontroller applications
by Clark Vitek

Combining a number of options can reduce electromagnetic interference at the integrated-circuit level.

SNAPSHOT:
Advice from an entrepreneur of the year: Success requires vision
by Leslie Laine

EDITOR'S PAGE:
When Less Is More: Minimally Invasive Therapies Herald Maximally Influential Changes
by John Katz

A surgeon's vision of the future includes a critical role for the contributions of biomedical design engineers.