SOURCE: Intertech

July 29, 2005 11:01 ET

Medical Device Development Must Balance Quality, Speed and Cost

Disciplined Engineering and Project-Management Processes Leads to Success, Says Intertech's Vogel

NORWOOD, MA -- (MARKET WIRE) -- July 29, 2005 -- The complexities of developing a high-tech medical device are so daunting it may seem luck determines success.

But some managers and companies are consistently more successful than others at completing projects and introducing successful new products, says David A. Vogel, Ph.D., president of Intertech Engineering Associates, Inc.

"Successful managers and companies aren't 'lucky.' They adopt disciplined engineering and project-management processes and constantly strive to improve them," he says.

Quality, speed, and cost efficiency are the hallmarks of success for any engineering project, but maximizing all three qualities simultaneously is next to impossible. Maximizing speed or quality is often less cost-efficient, while reducing cost usually comes at the expense of quality or speed, or both.

"The successful project manager must determine the right balance of these three attributes and communicate those priorities to the project team," Vogel says.

Since regulators, users and the manufacturer's sales and service departments view "quality" differently, the project manager must consider all dimensions of quality and arbitrate the difficult trade-offs when different quality measures conflict.

Time to market is crucial, and the best way to shorten a schedule is to improve processes and streamline communications among project team members, he says.

"Basic time management is probably the most obvious, most overlooked and most resisted way of keeping a project on schedule," Vogel says.

Too often, development projects are squeezed into an existing budget or a budget set by someone outside the development group. The project manager responds by cutting corners where he can.

But cutting corners usually results in additional costs to maintain and service the resulting product. "This is not really reducing development cost as much as it is shifting development cost into the maintenance phase," he says. "It can hurt product sales and the company's long-term reputation and profitability."

Regulatory compliance trumps everything. If the FDA doesn't accept the product or the processes used to develop it, the project is a failure. "Experienced, successful project managers take regulatory compliance into consideration right from the start of the project and follow the FDA's design control requirements rather than try to 'retro-control' near the project's end," he says.

Projects that are highly process-driven with a disciplined engineering environment are more successful projects by the measures of quality, speed, and cost efficiency -- and they also win FDA approval. By introducing formal processes into the development environment, a manager can optimize these three measures to meet the company's desires and goals.

Intertech Engineering Associates, Inc. ( provides hardware and software development, requirements and quality engineering, product validation services, training and consulting for medical device manufacturers. Vogel can be reached at

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