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Electronic Pressure Control In Medical Tubing Extrusion

Medical Plastics and Biomaterials Magazine MPB Article Index Originally published March 1997 EXTRUSION Over the last few years, medical tubing has evolved into one of the most critical medical device components, placing ever more difficult demands on the manufacturing process. Tubing...

Design Solutions Using Microporous Hydrophobic Membranes

Medical Plastics and Biomaterials Magazine MPB Article Index Originally published March 1997 MEMBRANES A microporous membrane is a thin, flat sheet of polymeric material, superficially resembling paper, that contains billions of microscopic pores. Depending on the membrane, these pores...

Superelastic Nitinol for Medical Devices

Medical Plastics and Biomaterials Magazine MPB Article Index Originally published March 1997 METALS Superelastic nickel-titanium (Ni-Ti), or nitinol, alloys are becoming integral to the design of a variety of new medical products. The enormous elasticity of these alloys is the most...

Chlorine-Free Blends for Flexible Medical Tubing

Medical Plastics and Biomaterials Magazine MPB Article Index Originally published March 1997 TECHNICAL PAPER SERIES Polyvinyl chloride (PVC)based tubing and film are used in numerous medical products. The material is easy to formulate and process, is relatively inexpensive, and performs...

Stabilization of Gamma-Irradiated Polycarbonate

Medical Plastics and Biomaterials Magazine MPB Article Index Originally published March 1997 TECHNICAL PAPER SERIES Bisphenol Abased polycarbonate (PC) is a well-known engineering thermoplastic with an excellent balance of optical, physical, mechanical, and processing characteristics...

FDA's Third-Party Pilot in Need of Submissions

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published February, 1997 Even after six months of operation, FDA's third-party product review pilot program isn't quite off the ground. Deemed capable by FDA of handling as many as 1500 premarket...

Consolidations Put the Squeezeon Small Manufacturers

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published February, 1997 Small medical manufacturers are feeling squeezed by rampant industry consolidation and see dwindling prospects for success and survival--at least, that was the underlying theme at "...

MR Innovation to Allow Scansof Standing Patients

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published February, 1997 The painful back and knee problems that convince patients to seek medical attention are not always obvious on magnetic resonance imaging (MRI) scans. Fonar Corp. (Melville, NY)...

Manufacturers Move Ahead to Meet New Regulations

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published February, 1997 Many manufacturers are not hesitating to begin following FDA's new quality system regulation. A recent survey of the medical device industry in Minnesota by Medical Alley (...

Medical Device Packagers Honored for Innovation

Medical Device & Diagnostic Industry Magazine | MDDI Article Index Originally published February, 1997 Four medical device packagers were recently honored for their products by the Institute of Packaging Professionals (IoPP; Herndon, VA). Winning awards in the medical device packaging...

Quality Systems on the Fast Track Toward Implementation

Medical Device & Diagnostic Industry Magazine | MDDI Article Index An MD&DI February 1997 Column For more than three years, Kim Trautman has been at the center of FDA's efforts to revise the medical device good manufacturing practices (GMP) regulation. Now issued as a...

Using a Matrix to Incorporate Values into Products

Medical Device & Diagnostic Industry Magazine | MDDI Article Index An MD&DI February 1997 Column DESIGNER'S TOOLBOX Developing products that meet the needs of all stakeholders requires a tool that measures and scores those characteristics. It's easy for an engineer or...

After Kessler, What Kind of FDA?

Medical Device & Diagnostic Industry Magazine | MDDI Article Index An MD&DI February 1997 Column WASHINGTON WRAP-UP The resignation of FDA's most controversial leader in years presents FDA reformers and the medical device industry with a new challenge. No FDA commissioner...

Biotech Devices Promise Benefits in Wound Repair and Surgery

Medical Device & Diagnostic Industry Magazine | MDDI Article Index An MD&DI February 1997 Column R&D HORIZONS The first medical devices to be produced by means of tissue engineering are now on the market. The number of artificial-skin and related products is small...

Becoming the Ideal Engineering Manager

Medical Device & Diagnostic Industry Magazine | MDDI Article Index An MD&DI February 1997 Column BOTTOM LINE Maximizing management and leadership skills produces engineering managers who can meet today's demand for getting innovative products to market quickly. I...