Contact Information: Contact: Henry Stimpson Stimpson Communications 508-647-0705 HStimpson@StimpsonCommunications.com David A. Vogel Intertech 781-255-5420 dav@inea.com
Following Medical-Device QSR Shortens Product Development, Intertech's Vogel Writes
Regulations Spur Faster Development of High-Quality Embedded Software
| Source: Intertech
NORWOOD, MA -- (MARKET WIRE) -- February 9, 2007 --The FDA's quality system regulation, or QSR, is
often seen by medical-product software developers as a nuisance that slows
product development, but following it helps speed development, David A.
Vogel, Ph.D., president of Intertech Engineering Associates, writes in the
January issue of Medical Device & Diagnostic Industry.
"Understanding and following the good engineering and project-management
principles outlined in the QSR can help manufacturers shorten the
development cycle. Not only is the time to market faster, but the end
result should also be a more stable, more reliable, and higher-quality
product. The difference in both timeliness and quality can be enormous," he
writes.
The regulations require developers to plan before they act -- a step too
often overlooked. No builder would pour concrete without building forms
first, but some software developers do the equivalent by coding before they
have requirements settled.
"Software without a detailed set of requirements or specifications is like
wet concrete without forms. It must be shaped and reshaped, designed and
redesigned, until it hardens. If the end result doesn't meet the customer's
needs, software, like concrete, becomes difficult to change late in the
project," Vogel writes.
And, like concrete, patched-up software isn't as structurally sound.
Some think that design control requirements stifle the creativity of the
programmers and software engineers. That's not true because the
requirements apply only to the development phase, not the research phases,
he asserts.
But they do speed the product-development process.
"Gathering requirements, communicating through written documentation and
verification of testing activities are three areas that are critical to
increased efficiency. Gathering requirements early cuts down on the number
of implementation iterations. By starting the implementation process before
the requirements and designs are complete, people get a false sense that
the schedule is being advanced," Vogel writes.
The full article can be read at
www.devicelink.com/mddi/archive/07/01/012.html.
Intertech Engineering Associates, Inc. (www.inea.com) in Norwood, Mass.,
provides hardware and software development, requirements and quality
engineering, product validation services, training and consulting for
medical device manufacturers.