Medical Device & Diagnostic Industry

December 1998 MD&DI
Selected Contents

ETO STERILIZATION:
EtO Sterilization: Principles of Process Design
by Paul J. Sordellini, Susan Edel Satter, and Vincent A. Caputo

By following a structured method, process engineers can design and validate safe and efficacious EtO steilization cycles.

ISO 10993:
A Practical Guide to ISO 10993-12: Sample Preparation and Reference Materials
by Timothy Jansen and Richard F. Wallin

Critical to all types of biocompatibility studies, the methods for preparing device materials for testing are covered in this standard.

WASHINGTON WRAP-UP:
FDA Promotes Shorter PMA Summaries, Faster Inspections
by James G. Dickinson

Also:

• Shorter Device Inspections Tested
  
• Yet Another Inspection Technique
  
• FDA Web Link to Companies?
  
• Five Reforms Emerge from FDA Stakeholders Process
  
• Communications Change Boosts Dialogue

BOTTOM LINE:
Maximize Return on Investment by Patenting What Counts
by Edward A. Schlatter

Strategies for patent filing help companies get the most for their money and prevent competitor access.

HELP DESK:
Establishing a Supply Agreement That Benefits Both Parties

Larry R. Pilot, an attorney with McKenna & Cuneo, LLP (Washington, DC), discusses how companies should establish supply agreements.

EMI FIELD NOTES:
Shielding Against Electrostatic Discharge
by William D. Kimmel and Daryl D. Gerke

When electrostatic discharge cannot be prevented, effective shielding is vital to protecting devices.

SNAPSHOT:
A company's Devices Aim to Change the Nature of Healthcare Delivery
by Jennifer M. Sakurai

EDITOR'S PAGE:
Toy Story: Media Relations Are Anything But Child's Play
by John Katz

The increasing influence of the media as a source of medical information places a premium on effective public relations.