MD+DI, January 2012, Volume 34, No. 1

January 2012


This Issue's Articles
All Your Product Design and Life Cycle Management Questions Answered
MD&M West conference sessions focus on applying product design tools and product life cycle management.
by: Jamie Hartford

Blue Skies or Clouds Ahead for Medtech Industry? Experts Make Their 2012 Predictions
by: Heather Thompson

Theoretical Physicist Michio Kaku Predicts the Future of Healthcare
The bestselling author and City College of New York professor delivered the keynote address at TCT2011, a conference covering transcatheter cardiovascular therapeutics held this week in San Francisco.
by: Brian Buntz

FDA: Computational Modeling Could Lead to Big Gains in Device Safety

Medical Device Gets Regulatory Nod in 17 Days

In Study, Hospital Executives Weigh In on Health IT and Medical Device Integration

As Medical Technology Evolves, So Does Intellectual Property Law
by: Brian Buntz

Ultrafast Laser Research Could Lead to New Diagnostic Applications

FDA Needs to Examine Its Institutional Culture
A tendency to close ranks when challenged has kept the agency from making needed changes.
by: Jim Dickinson

CDRH Report Includes Promises to Improve Culture
by: Jim Dickinson

Kay Hagan Backs Legislation for Management Review Board at FDA
The sweeping legislation was drafted by Senator Kay Hagan (D-NC) in collaboration with the Biotechnology Industry Organization.
by: Jim Dickinson

Consumers Union Seeks Stronger Device Law
The consumer advocacy group wants FDA to be stricter in its approach to implants and the postmarket surveillance system.
by: Jim Dickinson

Future Medical Device Regulation in the European Union: Prospects for Reform
The European regulatory regime faces criticism over the complexity of its legal framework, deficiencies in its ability to address emerging technologies, and the lack of uniformity across member states. In late 2010, the EU Commission released a roadmap for a proposed “recast” of the medical device directives.
by: John R. Manthei, Carolyne Hathaway, and Elizabeth Richards

Reimbursement and Coverage Strategies Matter, Here’s Why
Reimbursement and payer’s coverage can make or break medical devices. When two cutting-edge technologies, the Charité and the da Vinci, are compared, the advantage goes to the device with smart coverage strategies.
by: Jeremiah Sparks, Robert Freeman, and Nancy J. Davidson

An MD+DI Exclusive Interview with Medtech Pioneer Thomas Fogarty, MD

Partnership: The Ultimate Expression of Supplier Control
For the medical device industry, the supply chain deserves more attention than ever.
by: Peter Johns and Bob Khin

Toxicology and Biocompatibility Testing of Ophthalmic Drug-Device Combination Products
by: Alan P. Brown, PhD, DABT

Negotiate for Value: Reengineer Your Purchasing
OEMs must manage the value of their needs to get the most bang for their buck.
by: Tom Governale

How to Deal with a Supply Chain that Is Growing Ever More Complex and Global
by: Brian Buntz

Fight Diabetes and Obesity without Surgery
GI Dynamics is taking on obesity and type 2 diabetes with an innovative and noninvasive treatment.
by: Maria Fontanazza