MDDI Online

Using Parylene for Medical Substrate Coating

Medical Plastics and Biomaterials Magazine | MPB Article Index Originally published January 1996 COATINGS BRUCE HUMPHREY T he issue of biostability has long been a critical concern for manufacturers of medical implants and surgical components. Products ranging from bone pins and...

<B>The Interaction of Plasma Proteins and Platelets with a Homologous Series of Polyurethanes</B>

Medical Plastics and Biomaterials Magazine | MPB Article Index Originally published January, 1996 JAMES M. LAMBERT AND KEVIN G. TINGEY P olyurethanes of similar bulk composition-- all using the same diisocyanate, chain extender, and soft-segment type--were synthesized in microparticle...

The Gamma Radiation Tolerance of Polypropylene: Measurement and Enhancement

Medical Plastics and Biomaterials Magazine | MPB Article Index Originally published January 1996 ROBERT C. PORTNOY

IoPP Honors Device Industry Packaging

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published December 1995 Medical device industry winners of the Institute of Packaging Professionals (IoPP; Herndon, VA) 1996 AmeriStar Packaging Competition were announced at an awards ceremony held in...

Device Groups Reach Consensus on FDA Reform Legislation

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published December 1995 In a display of unity, three leading medical device industry groups have reached a consensus on FDA reform goals and have sent it to Congress in the form of draft legislation. The...

Using IEC 601-1-4 to Satisfy FDA Software Guidance Requirements

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published December 1995 by Debra S. Herrmann and David A. Zier Developed as part of the 601 series of standards for medical electrical equipment, International Electrotechnical Commission (IEC)...

Ohmeda Explores Partnerships with Hospitals

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published November 1995 The economic pressure being exerted on hospitals by capitation and managed care is forcing a reevaluation not only of the way medical equipment is acquired, but of how it is designed...

Spring Release Expected for Revised GMP and Guidances

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published November 1995 Spring 1996 is now the new target date for promulgation of FDA's long-awaited revision of its good manufacturing practices (GMP) regulation, but the agency has yet to determine how...

Product Promotion Strategy Links Drugs and Devices

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published November 1995 The trend toward disease management is forging alliances between device manufacturers and pharmaceutical houses that may ultimately benefit both the patient and the corporate bottom line. The strategy underlying these partnerships makes use of diagnostic products to increase demand for drug treatments.

An Interview with Susan Alpert

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published November 1995 Director, Office of Device Evaluation, CDRH, Rockville, MD In the two years since her appointment as director of the Office of Device Evaluation (ODE) at FDA's Center for Devices and...

Do Bureaucracy and Innovation Mix?

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published October 1995 With the new good manufacturing practices regulation now appearing close to inevitable within the next year, mandatory design control procedures will soon be a reality for most medical...

Exporting:Getting Small Device Companies through the CE Marking Maze

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published October 1995 Robert S. Seeley Lisa Hofmann-Zellerman, president of Accurate Surgical Instruments Corp. (Toronto), puts it bluntly: "You need CE marking if you want to survive and export."...

CAD/CAM and Beyond: New Engineering Software Opens Doors for Medical Device Manufacturers

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published October 1995 by Greg Freiherr Economic forces are pushing medical device designers to rely increasingly on computers to assist in the development of new products. At the same time, market trends...

A Quick Tour of Device Company Web Sites

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published September 1995 Industry Trends: Device Companies Try Out the Internet The Internet - particularly the interactive, graphical part of it known as the World Wide Web - has caught the fancy of...

SOFTWARE : A Maturity Model for Automated Software Testing

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published December 1994 Mitchel H. Krause Aside from their mandate to provide a safe and reliable product, manufacturers of computerized medical devices may have three very practical reasons for automating...