During his presentation, "The Importance of Design and Material Selection for Successful Medical Devices," at MD&M West this week, Phil Anthony, president of product design and development consulting firm Design Integrity Inc. (Chicago), shared four important production release recommendations for new medical products. "I like to see all of these steps taken for all new products because it allows you to learn what you did well and what you could potentially improve upon, and then apply those lessons learned to the next project," he says.

Production Release Recommendations

• Test During Initial Production. "As soon as initial production starts, I like to pull 5, 10, or 20 samples off the line and run them through the whole line of testing to make sure nothing has changed. From production run to production run, [I like to ensure that] any given component or the entire assembly is thoroughly tested to pass all requirements. From an engineering perspective, you're testing on initial subassemblies before the overall product is assembled," Anthony says. He also recommends that, once tooling is released, team members perform rigorous functional tests on tooling samples


• Track Returns and Reliability. "Monitor field test data from the first unit shipped," Anthony suggests. "Refine the design, if necessary, to improve reliability levels. Try and gain initial feedback on user likes and dislikes, how is [the device] working, any failures, early concerns, any room for improvement. Capture all those notes, document them, and make running changes or improvements to the next-generation device."


• Reduce Costs. Once production has begun, current team members or new manufacturing team members should immediately begin to explore options for cutting device costs, according to Anthony. "In the ideal world, the project team has already reduced the cost to the lowest possible point where the device still meets all requirements," he says. "But, typically, some of those corners are cut in the interest of expediency and launching as soon as possible."


• Conduct Customer Interviews. "Talk to customers and end-users and get their initial feedback on how well the device works and any concerns or areas of improvement," Anthony recommends. --Shana Leonard