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Managing Device Changes Streamlines Product Development

CONFERENCE NEWS: MD&M MINNEAPOLIS

Nelson finds device platform planning essential for future improvements.
In terms of safety and efficacy, managing change provides better product performance, lower risk and increased predictability for new products, and reduced risk related to regulatory approval and noncompliance risk. Managing change—that is, making planned changes instead of unplanned changes—also affects time and cost to market, according to Randall Nelson, president of Evergreen Medical Technologies (St. Paul, MN).

“Managing change accelerates time to market for new product introduction. Managing change effectively also reduces development costs, processing costs, component costs, and field service costs,” Nelson said. A successful medical device, he said, is one that integrates safety and efficacy, cost to market, and time to market.

“The purpose of change management is to maximize the lifetime revenue generation potential of a medical device and to minimize the stress on the organization,” said Nelson. “The mission is to find potential changes before they happen and understand what can go wrong. The cost of a reactive change is much higher than planned change.”

Nelson provided the following five key questions that should be answered as part of the change management process:

  • What is the change?
  • Why is the change required?
  • What are the effects of the change on the system?
  • What are the effects of the change on the program?
  • How can the change be avoided in future projects?

Change can be caused by unclear project requirements, the addition of future versions of a device currently in development, and modified device requirements or designs. Sometimes a change is necessary because the original design doesn't meet manufacturability or other requirements, said Nelson.

“If you alter a design early, you have a chance to mitigate the effects,” explained Nelson. “Without having a good idea for a whole family of products, for example, it may be difficult to see what a future product would look like.”

The effects of not implementing such a plan are costly. With no change management, noted Nelson, partially completed projects get canceled, and budget overruns are typical. Other effects include schedule overruns, loss of market share, and loss of revenue, as well as a weak foundation for future products.

Device platform planning is essential to allow for future device expansion and to plan in future improvements, Nelson said. Such planning prevents what he called “creeping elegance” and enables a company to develop a component library and to develop standard processes. “Platform planning enables companies to keep up with future trends. For example, you can create a range of sizes that compare to a competitor's portfolio or that allow for feature sets that are expected to become more complicated,” he suggested.

Change management also enables a company to anticipate change, especially with a large platform. “Sometimes we don't know from which direction the train is coming,” he said. “How you see what may change depends on your knowledge and experience; however, it is essential to anticipate market changes, technology changes, and regulatory approval changes.”

A critical element is to understand why the project is being done, said Nelson. “Know the visible and hidden agendas,” he advised. “Know the design requirements and the driving factors behind them.”

Copyright ©2007 Medical Device & Diagnostic Industry
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