MDDI Online

Top Ten Tactics for Surviving Medicare Reform

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI June 1997 Column BOTTOM LINE How successful medical device companies manage costs and deliver superior products and services. Medicare poured $178 billion into the United States health-care...

Using Patents to Secure Rights to Concepts and Inventions

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI June 1997 Column HELP DESK Securing a patent on a new concept or invention is key to maintaining a competitive edge. Delays can mean loss of the patent to a competitor or to the public domain,...

Software Risk Management: Not Just for the Big Manufacturers?

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI June 1997 Column Cover Story Risk management is not as complex or expensive as many small device manufacturers may think. In fact, it can actually save money. The use of software to control...

Using Pilot Studies to Chart a Course in Clinical Research

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI June 1997 Column CLINICAL TRIALS Pilot studies can help manufacturers not only make better devices, but also save time, money, and resources. Considerable time and financial resources are...

Plugging into an Untapped Business Development Resource

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI June 1997 Column SITE SELECTION Public utilities offer a variety of business development services to entice medical device companies to relocate to--or expand in--their areas. It might at...

Assessing Pass/Fail Testing When There Are No Failures to Assess

QUALITY PRODUCTS

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI June 1997 Column SNAPSHOT Günter Frey sees a change in the role of regulatory affairs. Sherrie Steward As a young nurse orderly in the German military, Günter Frey saw firsthand that patients...

ESCAPING THE PRISONER'S DILEMMA

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI May 1997 Column EDITOR'S PAGE In the managed-care marketplace, medical device companies may increasingly find cooperation more beneficial han competition. One of the benefits of making...

FDA INSPECTIONS

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI May 1997 Column FIRST PERSON Associate vice president and special counsel for HIMA commends FDA for its recent reforms but urges the agency to continue change. If FDA wants to promote rather...

European Industry's Role in a Rapidly Globalizing Market

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI May 1997 Column VERBATIM An interview with Michael Baker, director-general, European Confederation of Medical Devices Associations (EUCOMED) With the increasing globalization of the medical...

3-D Object Printing Improves Designer Communication

Medical Device & Diagnostic Industry MagazineMDDI Article Index An MD&DI May 1997 Column DESIGNER'S TOOLBOX A new way to make 3-D objects can help designers communicate better early in the product design and development cycle.

Politics as Usual

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI May 1997 Column WASHINGTON WRAP-UP The Clinton administration is advocating user fees for medical device review--but neither industry nor Congress is buying in. When to File a 510(k)...

Digital Sensors to Launch Revolution in Medical Imaging

Medical Device & Diagnostic Industry MagazineMDDI Article Index An MD&DI May 1997 Column R&D HORIZONS New digital technology promises to improve image quality and give health-care providers faster access to images.

Keeping Up with Changes in the Japanese Medical Device Market

Medical Device & Diagnostic Industry Magazine MDDI Article Index An MD&DI May 1997 Column BOTTOM LINE For manufacturers exporting medical devices to Japan, understanding the recent regulatory developments there is essential to success. Although Japan has...

Determining Sample Size for Testing Equivalence

An MD&DI May 1997 Column HELP DESK Director, corporate statistical resources, at Medtronic, Inc. (Minneapolis), explains the statistical strategies used during clinical trials for determining equivalence and offers ways to calculate sample sizes.