Medical Device & Diagnostic Industry

April 1996 MD&DI
Selected Contents

FDA

Burlington to HIMA: A Challenge, or a Threat?
John Bethune

Relationships between FDA and the medical device industry are not supposed to be cozy. Even when the two are cooperating, their interests should never fully align.

Packaging

FPA Awards Medical Packagers for Environmental Achievement
Sashi Sabaratnam

The Flexible Packaging Association recently honored two medical industry packagers with its top environmental award.

Sterilization

New EtO Association Vies for Device Market
Steven Halasey

Gamma sterilizers may be hearing footsteps. After years of experiencing diminishing market share, the makers and users of EtO sterilization technologies have banded together to form a new trade association designed to promote the benefits of using EtO.

Washington Wrap-Up

Reporting Rule Serves as a Test of Agency Reform
James G. Dickinson

A major FDA final rule on medical device manufacturer reporting procedures has become an unintended test of the agency's readiness to reform itself internally in the face of congressional efforts to inflict reform externally.

Asian Markets

Changing Regulatory Climate Improves Korean Market for U.S. Companies
Ames Gross and Pat Dyson

Asian countries represent the fastest developing area for medical technology in the world, with an expected 15–20% annual growth rate in that area in the near future.

Diagnostics

Positive Signs: Regulatory Changes for the IVD Industry
Constance Finch

A number of FDA actions and proposals over the last several months appear to indicate a more flexible and, hopefully, more practical approach to the regulation of in vitro diagnostic devices.

Regulatory Affairs

Current and Future FDA Initiatives in Clinical Trials
Susan Alpert

The primary mission of the Office of Device Evaluation of FDA's Center for Devices and Radiological Health is to ensure timely delivery of safe and effective medical products to patients.

Manufacturing Technologies

Injection Molding
Thomas L. Miller

Injection molding is commonly used to manufacture medical parts in large quantities with reliable consistency. Understanding all the variables of injection molding and their impact on successful processing is particularly important for medical device manufacturers, who require tight tolerances and unique performance requirements.

Manufacturing Technologies

Extrusion
Paul Hendess

Plastic extrusion is a steady-state process for converting a thermoplastic raw material to a finished or near-finished product.

Manufacturing Technologies

Insert Molding
Jim Vance

Insert molding is an injection molding process whereby plastic is injected into a cavity and around an insert piece placed into the same cavity just prior to molding. The result is a single piece with the insert encapsulated by the plastic.

Manufacturing Technologies

Liquid Resin Casting
James E. Snyder

Pouring liquid rubber or plastic into molds, then allowing it to cure to solid form, describes the fundamentals of liquid resin casting. A technically refined version of this decades-old process is a reliable and cost-effective choice for manufacturers of sophisticated medical devices.

Manufacturing Technologies

Pressure Forming
Al Scovill

Although comparatively few companies are familiar with pressure forming, this technique is being used increasingly to produce low-volume products that can match the aesthetics of injection-molded, high-volume parts.

Manufacturing Technologies

Rotational Molding
Mike Greer

Although the term rotational molding is unfamiliar to many, the products produced by the process are visible and familiar in a wide variety of everyday settings.

Manufacturing Technologies

Reaction Injection Molding
Fred T. Wickis

Reaction injection molding creates parts by using impingement mixing to combine reactive liquid intermediates as they enter a mold.

Design

Applying Reliability Engineering during Product Development
Lee Heydrick and Kenneth A. Jones

A familiar term from advertisements for products and services reliability is the probability that an item will perform as intended, under specific conditions, for a specified time.