Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published January 2000

Two new columns for 2000 reflect MD&DI's continually sharpening focus on device design information and Internet developments.

In the beginning was the . . . Design? There is a well-known image from the Middle Ages, preserved in a Bible in Vienna, that shows God as the architect of the universe. The circular cosmos is depicted as a kind of holiday wreath, which God, bent over, supports with one hand. In his other hand he holds a long-sided compass that he is using to measure out the primordial proportions of all things. His look of intense concentration would be familiar to any product design engineer who has scrutinized a CAD rendering.

The bedrock importance of device design in its many manifestations has always been a central theme of this publication: MD&DI is, after all, as the journal line on our cover proclaims, "The Magazine of Medical Product Design, Manufacturing, and Marketing." More of our subscribers work as product design engineers than in any other job function, and much of the information we present concerns the initiation, enactment, regulation, or results of the design process. MD&DI is the founding sponsor of the Medical Design and Manufacturing (MD&M) East and West Conferences and Expositions, and this year is also sponsoring the third annual Medical Design Excellence Awards (MDEA).

In light of recent technological advances and regulatory initiatives such as the design control provisions of the quality system regulation, design issues have become more critical than ever. And so, as MD&DI begins the year 2000, we are pleased to reaffirm our commitment to design coverage by introducing a new column dedicated specifically to... design (we didn't think you needed any more millennial surprises!).

Each month, Designer's Notebook will examine one or more of the myriad aspects of medical device design: from materials selection, prototyping, and computer-assisted design to statistical models and cost/benefit analyses; from product evaluation studies to design control verification and validation; from tooling and package design to failure/risk analysis; from documentation and regulatory compliance to testing and simulation. Design topics treating both electronic and nonelectronic devices will be featured, as will occasional design case histories.

Our first Designer's Notebook is written by a category of author too little represented in these pages—the physician as ultimate end user of a device. In "User-Centered Design: A Clinician's Perspective," Matthew Weinger, MD, offers a compelling summation of the need for human factors engineering and a user-focused, systems approach to device design. Weinger's admonition that poorly designed devices "frequently contribute to medical error" is especially pertinent in the wake of the Institute of Medicine study released in November that ascribed more deaths to medical mistakes than to auto accidents, breast cancer, or AIDS. Although the majority of problems cited in the study appear to involve procedural or institutional lapses, it seems undeniable that device design flaws also play a part. It is our hope that Designer's Notebook will be another resource in the effort to promote good design.

One thing that hasn't changed: our special gratitude to MD&DI's editorial advisory and reader boards, contributors, reviewers, advertisers, and subscribers—to whom we extend our best wishes for the New Year!

Jon Katz
[email protected]

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