Looking back to 2012, a few points from my speech at MD&M West related to production launch recommendations were quoted in Qmed by Shana Leonard. A link to her article is below, but the key points that she transcribed from my presentation are still relevant today and paraphrased below:

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. Phil likes to see each of these steps taken for all new products:

Production Release Recommendations

  • Testing During Initial Production. As soon as initial production starts, Phil recommends pulling samples off the line and running them through the full list of tests to make sure nothing has changed. From preproduction runs to the first production run, Phil recommends that any given component and the entire assembly is thoroughly tested to ensure that they pass all requirements. During engineering development, subassemblies are tested before the overall product is assembled and tested. Anthony 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