Medical Device & Diagnostic Industry
March 1996 MD&DI
Selected Contents
Industry
The Device Industry Looks Up—and to the East
John Bethune
Although grousing about FDA remains prevalent in the medical device industry it's been refreshing this year to see that the industry is equally quick to acknowledge and reinforce improvements in FDA performance.
Business & Marketing
IPO Market Best in Years, Say Analysts
Sherrie Steward
Faster FDA review and the force of the managed-care marketplace are contributing to one of the best financing climates for young medical device companies in the last 18 years, according to industry experts.
Legal Affairs
Supreme Court May Resolve Liability Preemption Dilemma
Greg
Freiherr
The most important court case in the recent history of the medical device industry is scheduled to begin this spring.
New Technologies
Device Manufacturers Say Yes to EDI
Steven Halasey
If electronic data interchange (EDI) is the destination of the future, U.S. device manufacturers are halfway there—sort of.
Industry
First FDA Reform, Then a New Agenda
Henry A. McKinnell
"Increasing FDA demands on new
product development and delays in new product reviews are reducing
incentives for research and development, encouraging American companies to
locate abroad, delaying Americans' access to new pharmaceuticals and
medical devices, and costing American jobs."
Washington Wrap-Up
When Saving Money Costs Just Too Much
James G. Dickinson
When it comes to regulatory gray zones, a company's natural tendency to avoid what it considers needless expense can produce a penny-wise, pound-foolish result—a hazard that may be diminished if FDA's new culture of openness is successful.
Regulatory Affairs
FDA Yields on Text Dissemination
James G. Dickinson
In a major policy move designed to defuse the ticking First Amendment time bomb that threatens its control of product marketing, FDA in December unveiled two draft guidances that offer relief to product marketers.
Manufacturing
Optimizing Regulated-Vendor Audits
Glen Paul Freiberg
Many well-run device companies have already audited their vendors.
Nevertheless, FDA has found sufficient deficiencies in this regard among
device companies to specifically address the topic in its proposed revision to
the GMP regulation.
Site Selection
Corporate Incubators Provide Refuge for Fledgling Device Firms
Greg Freiherr
The process that transforms inventors into entrepreneurs is inextricably linked to the selection of the new company's first home.
Industry
MD&DI Executive Roundtable
MD&DI invited six such company executives to join in a roundtable discussion about the current status and future directions of the device industry.
Manufacturing
Design of Experiments: An Overview and Application Example
John S. Kim
DOE techniques are not new to the healthcare industry. Medical researchers
have long understood the importance of carefully designed experiments.
These techniques, however, have not been applied as rigorously in the
product and design phases as in the clinical evaluation phase of product
development.
Quality
The ISO 9000 Journey
Stephen L. Thoresen
An RA/QA expert recounts one company's journey toward ISO 9000 certification and gives some common-sense advice, based on experience, for others that go down this path.
Design
Requirements Management in Medical Device Development
Alan Davis and Dean Leffingwell
To managers, developers, QA personnel, and others on the front line of the rapidly evolving medical device industry, the complexity of device technology seems to be growing almost exponentially.
