Medical Device & Diagnostic Industry
August 1998 MD&DI
Selected Contents
PACKAGING:
The Packaging Sector Responds to Challenges from Industry
by Erik Swain
Spurred by economic and regulatory pressures, device packaging is going through an upheaval that's leaving innovative materials and improved service in its wake.
1998 SALARY SURVEY:
Device Professionals Enjoy Solid Salary Gains and a Hot Labor Market in 1998
by Stacey L. Bell
Respondents to MD&DI's 10th annual salary survey say challenging assignments are sometimes more important than hefty paychecks.
WIRELESS TECHNOLOGIES:
Wireless Technologies Find Niche in Patient Care
by Greg Freiherr
Wireless and remote-access technologies facilitate patient data gathering in hospitals and home-health-care environments.
YEAR 2000 COMPLIANCE:
Who Pays to Fix Year 2000 Problems?
by Jeffrey K. Shapiro
FDA compliance and product liability concerns are part of the equation in determining who should bear the costs of correcting year 2000–deficient devices.
ISO 10993:
A Practical Guide to ISO 10993-6: Implant Effects
by Richard F. Wallin and Paul J. Upman
Implant tests can be used to assess the local effects of device material on living tissue at both the macroscopic and microscopic levels.
WASHINGTON WRAP-UP:
FDA Emphasizes CEO Accountability
by James G. Dickinson
- A recent Mentor Corp. consent decree draws in corporate subsidiaries and personnel
- Faster, better-targeted quality inspections
R&D HORIZONS:
The Next Wave in Minimally Invasive Surgery
by Gabriel Spera
Research is heating up in the area of RF, microwave, and high-frequency ultrasound for use in therapeutic devices.
BOTTOM LINE:
How to Evaluate Medical Device Technologies
by Robert C. Faulkner
Taking a close look at clinical value, barriers to entry, and market size can help investors determine where to put their money.
HELP DESK:
The Differences between U.S. and E.U. Laser Standards
Karl J. Hejlik, writer and editor for the Laser Institute of America, a professional society that fosters laser applications and safety, describes the differences between U.S. and European standards for medical laser products.
EMI FIELD NOTES:
Using IEC 60601-1-2 for Testing Medical Devices
by Gary Fenical
For effective EMC testing, medical manufacturers should customize a standards document such as IEC 60601-1-2.
FIRST PERSON:
FDA's New Financial Disclosure Rule: An Unnecessary New Burden
Jeffrey N. Gibbs
A partner at the law firm of Hyman, Phelps & McNamara discusses how FDA went too far in requiring financial disclosure forms in device marketing applications.
SNAPSHOT
Preparing for the future of orthopedics: A Joint Venture
by Kassandra Kania
INSIDE MD&M:
Y2K: Not Just a Technical Issue
by Stacey L. Bell
EDITOR'S PAGE:
THE YEAR 2000: FDA's Absolute Last Word (for the moment . . .)
by John Katz
Issues of liability and cost allocation add more rings to the Y2K circus.
1998
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