Medical Device & Diagnostic Industry
May 1996 MD&DI
Selected Contents
FDA Reform
Partnership Efforts Take Roots-Up Approach
Greg Freiherr
Judging from a number of developments at both the national and regional levels, FDA appears to be undergoing a veritable transformation—a shift in culture that is bringing many in the agency to view device manufacturers as partners rather than as adversaries.
Regulatory Affairs
Electronic Submissions Aim at Faster FDA Product Reviews
Greg Freiherr
FDA has worked out the kinks in its process for reviewing electronic submissions, opening the door for industry to submit in electronic form every type of medical device application from investigational device exemptions to premarket approvals (PMA)
Business & Marketing
Unclogging the Distributor Drain
Christopher Bale
If your medical device business revolves around product development and manufacturing, you may have begun to suspect that something is clogging the other end of the supply channel where traditionally products have flowed smoothly into the nation's hospitals and doctors' offices.
Regulatory Affairs
The Development of the Medical Device Amendments
Peter Barton Hutt
Twenty years ago, the Medical Device Amendments of 1976 were enacted—14 years behind schedule. They were supposed to be written up and put into law during the early 1960s, but Congress got sidetracked. Only when FDA pushed—and pushed hard—in the early 1970s did the amendments become reality.
Washington Wrap-Up
Heroic Efforts to Save FDA Reform
James G. Dickinson
Mid-March was the last chance for the medical device and biotechnology industries to steer FDA reform legislation in their favor and realistically expect passage this year.
Regulatory Affairs
A Global Perspective for the 21st Century
Wallis Weiler Cady and Debbie Iampietro
Medical device reporting regulations in both the United States and the European Union require that adverse events relating to medical devices be reported and tracked. These regulations ultimately ensure patient safety.
Distribution
The Coming Supply Chain Revolution
Greg Freiherr
The medical device supply chain is on the verge of a revolution, one that has as much to do with the way companies operate and what their customers are demanding as it does with technology and its implementation.
Exporting
Personal Relationships Are Key to Finding an Asian Distributor
Ames Gross
Setting up a good distribution network is fundamental to the success of U.S. medical manufacturers exporting to the Asian market; distributors generally provide a host of services including warehousing, shipping, marketing, sales, and service support for the products being sold.
Regulatory Affairs
FDA Regulatory Programs: Cooperation and Common Sense Typify A Record of Success
Jonathan S. Kahan
For a good portion of the past 20 years, FDA worked in partnership with industry to ensure that safe and effective devices proceeded expeditiously to market while unsafe and ineffective devices were the subject of agency enforcement action. Unfortunately, the 1990s have been extremely detrimental to the growth and profitability of the medical device industry.
Industry
The Making of a Regulatory Profession
Richard E. Greco
A case study in how one individual formed a corporate regulatory affairs department.
Liability
The Evolution of Biomaterials Liability
James S. Benson
On March 11, James S. Benson visited the White House to encourage President Clinton to sign legislation that would protect the makers of biomaterials from liability. In those discussions, Benson was a representative of the medical device industry, but he brought to bear experience gained in a number of top-level positions at FDA and HIMA.
Regulatory Affairs
The Changing Role of Education in FDA's Regulation of Medical Devices
John C. Villforth
FDA has for years struggled with the merits of voluntary compliance and education as complements to its traditional regulatory role.
Regulatory Affairs
A Brief History of FDA Good Manufacturing Practices
W. Fred Hooten
Two years after the Medical Device Amendments of 1976 were enacted, FDA issued its final draft of the medical device good manufacturing practices regulation, a series of requirements that prescribed the facilities, methods, and controls to be used in the manufacture, packaging, and storage of medical devices.
Regulatory Affairs
FDA Enforcement Policies: A 20-Year Perspective
Larry R. Pilot
From FDA's founding in 1938 to the mid-1970s, seizures, injunctions, and criminal prosecutions entered into by the agency were confined primarily to devices associated with fraud or quackery. Few actions were directed against devices applied by licensed practitioners.
Regulatory Affairs
The Demise of Rule Making and the Rise of Guidances
Bradley M. Thompson
Over the past two decades, the process of regulating the medical device industry has changed profoundly.
Regulatory Affairs
FDA and the Device Industry: A Tale of Suspicion
James G. Dickinson
Perhaps more than anything else, the regulatory history of the 1976 Medical Device Amendments has been characterized by mutual suspicion.
Business & Marketing
Big Emerging Markets Fuel U.S. Export Opportunities
Victoria Kader, Paul Barry, and Mark Cooper
In 1993, the Clinton administration launched a national export strategy designed to streamline and focus U.S. government resources to help U.S. exports.
Clinical Trials
The Logistics of Conducting Clinical Studies
Frank L. Hurley and David L. West
From the selection of clinically significant end points to the analysis of the final patient data, sponsors of clinical trials are awash in details that must be handled accurately and properly if the overall investigational findings are to be sound.
Manufacturing
Selecting and Using Protective Gloves: An Overview of the Critical Issues
Wava Truscott
Gloves routinely serve a dual purpose: protection of the employees and of the products they manufacture. Glove selection must not only be based on their ability to protect employees from processing agents used in manufacturing and microorganisms in laboratory environments, but the choice must also take into account the very real problem of potential reactions related to wearing the gloves themselves.
Quality
Conducting Internal Audits: Taking the Company's Pulse
John Sawyer
Of all the continuous improvement tools available, conducting quality audits is by far the best way for a company to ensure that its quality system is adequate and effective.
Design
Planning for Concurrent Engineering
Susan E. Carlson and Natasha Ter-Minassian
Among the bevy of techniques and tools that have been advanced to solve the problems faced by design and manufacturing firms, concurrent engineering has had a significant impact on the quality and development cycle of products in large corporations.
Quality
Conducting Cost/Benefit Analyses of Implementing Total Quality Management
Ashweni Sahni and Chris Gaertner
In the 1980s, total quality management was successfully adopted by a large number of U.S. companies, including many device manufacturers. In the 1990s, however, the usefulness and cost-effectiveness of TQM has received mixed reviews.
Packaging
A Discriminating Method for Measuring the Microbial Barrier Performance of Medical Packaging
Alan Tallentire and Colin S. Sinclair
Microbial barrier performance is a critical factor in the selection of packaging materials for use with sterile medical devices.
