April 2000
MD&DI
Selected Contents

COVERSTORY:
In Vitro Diagnostics: Bringing Testing to the Point of Care
by Thomas H. Grove

Advanced IVD instrumentation promises quicker turnaround for patient testing.

EDITOR'S PAGE:
High Noon in Arizona
by Jon Katz

For small children and other over-impressionable souls, the gift shop in the Pointe Hilton Resort at Squaw Peak, near Phoenix, is a fearsome place. Wolves and coyotes glower from every corner. Scorpions and tarantulas infest the shelves, where rattlesnakes coil and rear to strike.

INSIDE MD&DI:
Building a Better Biomaterial
by Jon Katz

If you ask Robert Ward a question about the latest developments in biomaterials research, you're likely to get a "shallow" answer: "There are a number of surface-modified polymers and materials for tissue engineering that need to be well-characterized in order to relate the surface chemistry to whatever biofunctionality people are after."

WASHINGTON WRAP-UP:
Finally, FDA Moves Broadly on Device Reprocessors
by James G. Dickinson

A draft guidance document issued in February details the agency's new across-the-board enforcement scheme for reprocessed devices.

Also:

• More Trouble for Abbott
• FDA Hepatitis Guidance Needs Expertise
• Special Controls Guidances
• HIMA Urges Easier DEHP Rule

MEDICAL PLASTICS:
Thermoplastic Silicone-Urethane Copolymers: A New Class of Biomedical Elastomers
by Robert S. Ward

As part of the ongoing quest for more effective biomaterials, novel families of copolymers are combining the beneficial properties of silicones and polyurethanes.

MEDICAL PLASTICS AND BIOMATERIALS:
In the Mix: Continuous Compounding Using Twin-Screw Extruders
by Charlie Martin

Versatile twin-screw systems can be used for compounding, devolatilization, or reactive extrusion—with the end products ranging from pellets and fibers to tubes, film, and sheet.

BOTTOM LINE:
How to Win the Selling Game
by George E. Thomassy III

Smaller medical device companies can successfully sell their businesses with the help of an expert and an understanding of the value that they offer larger firms.

DESIGNER'S NOTEBOOK:
Document and Change Control in the Design Process
by Andrew Snow

When properly implemented, document and change controls reduce product defects, minimize field problems, and increase end-user satisfaction.

SNAP SHOT:
Smooth Operator
by Robert Drummond

Building quality into the development process up front (profile of Ross Flewelling, PhD)