Medical Device & Diagnostic Industry
January 1998 MD&DI
Selected Contents
PACKAGING:
Two Packaging Standards Give Manufacturers the Ability to Pick and Choose
by Greg Freiherr
Deciding which packaging standard to follow depends largely on whether the device will be marketed overseas.
TUBING APPLICATIONS:
Characterizing Silicone Elastomers for Pump Tubing Applications
by Judith Fairclough Baity
Knowing how to determine the performance capabilities of silicone elastomers will enable manufacturers to pick the best one for a specific application.
PROCESS VALIDATION:
Conducting Process Validations with Confidence
by Daniel L. Weese and Vera A. Buffaloe
By applying the appropriate statistical technique to various process validation steps, medical product manufacturers can improve quality, increase confidence in those products, and reduce costs.
MICROELECTRONICS:
Electrical Testing and Environmental Screening of Hybrid Microelectronic Devices
by Terry Outcalt
There is a fine line between rigorous validation procedures and overtesting for conditions unrelated to the part's intended environment.
ISO 10993:
A Practical Guide to ISO 10993:
Part 1—Introduction to the Standards
by Richard F. Wallin and Paul J. Upman
In the first of a series of articles, the authors discuss the basics behind harmonized standards of the biologic evaluation of medical devices.
FDA REFORM:
Reengineering at CDRH: A Work in Progress
by Jonathan S. Kahan
New procedures for product submissions may significantly speed time to market.
EMC TESTING:
Benchtop EMC Testing Techniques for Medical Equipment
by Scott Roleson
Magnetic field loop tests prove to be a relatively simple and cost-effective approach to benchtop EMC testing.
DEVICE PATENTS:
Refurbishment of Medical Devices: Patent Infringement or Permitted Repair?
by Daniel L. Dawes and Stefan Kirchanski
The boundary between altering a device for repair and affecting a patent is not always obvious, but studying prior cases can help clarify the difference.
THERMAL MANAGEMENT:
Thermal Management Techniques for Medical and Laboratory Equipment
by Robert Smythe
Keeping hot designs cool requires a thorough consideration of thermal management options early in the design stage.
TESTING:
Calculating Factors of Safety for Package Burst and Creep Test Fixtures
by Stephen Franks
Proper design of flat restraining plates for inflation-seal strength testing can protect operating personnel.
MANUFACTURING:
Using Asynchronous Process Manufacturing for Product Development
by Ty Griffin
By using APM, manufacturers can reduce production time and cost, compared to larger, more typical assembly systems.
DESIGN CONTROLS:
Creating a Functional Requirements Management System with Existing Office Tools
by Edward V. LaBudde
Rather than spend money on a fancy requirements management system, most manufacturers can meet their needs with a basic computer.
VERBATIM:
Australia's Medical Device Industry Is Harmonizing From Down Under
W. S. Vallance, CEO of the Medical Industry Association of Australia, explains the state of the Australian medical device industry and how Australia plans to increase its role in the global marketplace.
WASHINGTON WRAP-UP:
A Troubled Affair
by James G. Dickinson
FDA fails to apologize for mishandling Myotronics device evaluations.
R&D HORIZONS:
Battery Scientists Seek Smaller, Lighter Cells
by Gabriel Spera
Lithium chemistries have altered the industry, but safety is still a concern.
BOTTOM LINE:
To Outsource or Not to Outsource?
by Deborah Conn
As manufacturers face rising costs, shrinking staffs, and increasing time pressures, outsourcing may be the answer to their needs..
HELP DESK:
Biocompatibility Guidelines, Using EtO with Parylene
by Richard F. Wallin, David W. Eaker, and Robert R. Reich
SNAPSHOT:
Funding Your Bright Idea
Electric Geodesic's president Ann Bunnenberg.
EDITOR'S PAGE:
The FDA Modernization Act: STAYING A NEW COURSE
by Stacey L. Bell
In addition to improving patient access to needed medical device technologies, the new act may also trigger some changes within the industry.
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