Originally published October 1995
With the new good manufacturing practices regulation now appearing close to inevitable within the next year, mandatory design
control procedures will soon be a reality for most medical device companies. While FDA may ultimately find a way to phase in
the design control requirements gently, as the Health Industry Manufacturers Association and others have urged, for those
companies that have delayed the inevitable, now is the time to begin planning implementation of those requirements.
Thus it may soon become a moot question whether design controls - essentially a system of principles to manage and
document the design process - are counterproductive. Still, I think the question remains a vital one that all manufacturers must
ask themselves as they implement the new system.
I've argued before in this column that design controls are not merely another regulatory burden, but in fact a valuable tool for
manufacturers seeking continuous quality improvement. Even if you strongly oppose design controls, you should consider the
arguments in their favor. After all, if you must comply with a regulation, you might as well get the most benefit from it.
For those who remain unconvinced, I recommend a recent article, "Gagging on Chaos," by Christopher K. Bart, a business
professor at McMaster University in Ontario, Canada. First published in the September/October 1994 issue of Business
Horizons, it was reprinted in IEEE's Engineering Management Review Summer 1995 issue, where I read it.
Bart argues that the common reaction of blaming bureaucracy in business for a lack of innovation is understandable but
simplistic. By contrast, he explores several examples of how "bureaucracy and tight controls are facilitating, contributing to, and
supporting the innovation efforts in some large, diversified, and well-known corporations."
Bart does not say that bureaucracy is inherently good, noting that "excessive amounts of formal controls - especially the wrong
kind - will kill innovation." But at the same time, he says, "too-loose control may cause firms to gag on the chaos that must
inevitably result if innovation is pursued in an undisciplined and unbridled fashion." Order without rigidity, he concludes,
"represents the ultimate objective."
Even if you oppose design
controls, you should
consider the arguments
in their favor.
In introducing design controls to their companies, device company managers and design engineers alike should try to keep this
goal of order without rigidity in mind, and avoid unnecessary rules. While it may be true that paperwork is often necessary to
satisfy FDA, as much as possible the test should be whether it truly contributes to effective control of the design process.
One test case of this approach might be the design history file, a parallel of sorts to the device history record currently required
by the GMP. Some commentators have suggested that attempts to turn the design history file into something other than a
repository for historical design documents unnecessarily burden companies with excess paperwork. Others argue that, if
actively managed, it can be a useful foundation for the device master record. Both arguments have some merit, but in my mind,
the advantages of avoiding excess paperwork favor the passive approach to the design history file.
I know that, on this issue, I hardly need to invite opposing viewpoints or queries. Nevertheless, I encourage you to contact me
either by mail or phone or at my new and allegedly permanent E-mail address, [email protected].
(This article originally appeared in the October 1995 issue of Medical Device & Diagnostic Industry. © 1995 CanonCommunications, Inc. All rights reserved.)