March 2001
Medical Device & Diagnostic Industry
Selected Contents
EDITOR'S PAGE:
The Meet Market:
Biomedical Firms on the Make for Funding
Jon Katz
For emerging companies making their pitch to venture capitalists and other potential backers, beauty is in the pocketbook of the beholder.
COVER STORY:
2001 Business Outlook: Prescription for Prosperity
Jon Katz
Confident executives delineate the state of the industry in MD&DI's exclusive survey.
Hardness Testing of Medical Device Components
Steve Ferry
Experiments reveal that the accuracy of microhardness measurements of test samples depends on the sample preparation technique.
Integrating Risk Management into the Design and Development Process
Andrew Snow
Meeting the regulatory requirements for risk management means starting early in the design process and managing risks throughout a product's life cycle.
Using R&D Outsourcing as a Competitive Tool
Don W. Caudy
Outsourcing R&D can be a valuable part of a company's business strategy, so long as the partnership is constructive and mutually satisfying.
Preparing for an FDA Advisory Committee Meeting
Karen J. Harder and Virginia Perry
A clear, informative presentation can alleviate agency concerns about a product and introduce it favorably to the public.
Establishment Registration: Keeping Pace with an Evolving IndustryRobert Drummond
Increases in outsourcing and corporate acquisitions make establishment registration issues relevant to all manufacturers—not just start-ups. With changes to the current regulations pending, manufacturers need to understand their responsibilities.
WASHINGTON WRAP-UP:
FDA and the Temptations of Expanded Authority
James G. Dickinson
Proposed rule establishes procedures that the agency will follow to rescind 510(k) clearance decisions.
R&D HORIZONS:
Matters of the Heart: AEDs Go Public
by Gregg Nighswonger
Legislation aimed at saving lives by ensuring access to automated external defibrillators is promoting the development of systems that are smart and reliable.
MEDICAL PLASTICS &
BIOMATERIALS:
Assessing Core Competencies to Reduce Cycle Time and Costs
Robert T. Alvarez
A manufacturer striving to bring quality products to market quickly must understand its own strengths, manage its assets wisely, and take advantage of
strategic alliances with suppliers.
2000
December |
November |
October |
September |
August | July |
June |
May |
April |
March |
February |
January
1999
December |
November |
October |
September |
August |
July |
June |
May |
April |
March |
February |
January
1998
December |
November |
October |
September |
August |
July |
June |
May |
April |
March |
February |
January
1997
December |
November |
October |
September |
August |
July |
June |
May |
April |
March |
February |
January
1996
December |
November |
October |
September |
August |
July |
June |
May |
April |
March
