MDDI Online

On Product Liability: Stupidity and Waste Abounding

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August 1996 T he sky did not fall on June 26, 1996. As noted on page 12 of this issue, the Supreme Court's ruling on that date in the Medtronic, Inc. v. Lohr case was indeed...

Industry Embraces UPN

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August 1996 Bar Coding Just a short 18 months ago, the Department of Defense (DOD) announced that by July 1 its suppliers would have to provide universal product numbers (UPNs) on all health-care...

Lohr Ruling Creates Doubt about Future of Preemption

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August 1996 Product Liability According to device manufacturers, industry innovation may be the primary victim of the Supreme Court's ruling in the Medtronic, Inc. v. Lohr case...

Leadership and Reform: FDA's Ongoing Duty

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August 1996 Robert L. Sheridan Vice President for Device Evaluation C. L. McIntosh & Associates, Washington, DC V irtually everyone, it seems, is in favor of FDA reform. Such...

WASHINGTON WRAP-UP

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August 1996 James G. Dickinson Although the Federal Trade Commission (FTC) was assigned by Congress to be the lead agency in regulating the marketing of medical devices, FDA's expansion into this...

The Role of Product Testing in CE Marking

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August, 1996 Greg Freiherr Except for the simplest of medical devices, such as tongue depressors and wheelchairs, there is no direct route to a CE mark--no easy way to win approval to sell that...

INDUSTRY PROFESSIONALS GAIN GROUND AGAINST CHANGING MARKET

Eighth Annual MD&DI Salary Survey Steven Halasey Introduction Salary, Raises, and Compensation The Employee | The Company Conclusion | Survey Methodology Order the Full Report | Salary Estimator D evice industry professionals who have been wondering what will be the effects of...

MEETING THE CHALLENGES OF MEDICAL PACKAGING

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August, 1996 MD&DI ROUNDTABLE For packaging engineers, meeting the demands of an increasingly globalized device industry brings a wide variety of challenges. Faced with conflicting regulatory...

FDA'S ENFORCEMENT OPTIONS IN CLINICAL TRIALS

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August, 1996 Halyna Breslawec and Nancy Teague FDA regulates all aspects of clinical trials for medical devices through enforcement of a variety of regulations. The investigational device exemption...

Using Grounding to Control EMI

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August, 1996 William D. Kimmel and Daryl D. Gerke Electromagnetic compatibility is an important consideration in the design and operation of today's sophisticated medical electronic equipment,...

Investigating and Preventing BI Sterility Failures

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published August, 1996 Paul J. Sordellini and Marjorie Lang Because microbiological destruction is logarithmic and therefore can only be expressed in terms of the probability of a survivor, the term sterile...

Helpful Design Guidance, or Stealth Regulation?

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published July 1996 L ast March, FDA released two important draft guidances on design, entitled "Design Control Guidance for Medical Device Manufacturers" and "Do It by Design." These are both important...

Manufacturers Turn to In-House Packaging

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published July, 1996 Packaging Many medical device manufacturers are bringing their packaging processes in-house, according to a recent study by Frost & Sullivan (Mountain View, CA), a health-care market...

Roadblocks on the Medical Superhighway?

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published July, 1996 Thanks in large part to computer-aided medical devices and decision support software, it's only a matter of time before full-scale telemedicine is common practice. Many in the device...

International Conference to Highlight European Union Markets

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published July, 1996 Packaging and Sterilization Medical device packagers and manufacturers interested in the European market will soon have the chance to learn about that region's packaging and...