FDA: Understanding Barriers to Medical Device Quality

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This report, issued in 2011, is the result of an initiative launched by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), as part of an effort to assess and understand gaps in medical device quality.  It is a great read and has a lot of valuable information to take back to your design teams and CMOs.

Key facts about marketed medical devices as well as potential catalysts for quality improvement:

  1. The medical device industry has enjoyed tremendous growth in both revenues and the technical complexity of the products that it produces over the past 10-20 years.
  2. Serious adverse event reports related to medical device use have outpaced industry growth by 8% per annum since 2001.
  3. Quality risk is not evenly distributed across the industry, reflecting the heterogeneity and complexity of the devices, manufacturers, and use environments. Cardiovascular, in vitro diagnostic (IVD), and general hospital/surgical devices account for nearly 60% of adverse events reports. Only 20 of the 1189 active product codes account for 65% of all serious adverse events reports between 2005 and 2009.
  4. An analysis of root cause data reveals that failures in product design and manufacturing process control caused more than half of all product recalls. The root causes of quality issues are tied closely to device type. Therapeutic area was not as strong a predictor for recall root cause, as life-sustaining devices are responsible for an increase in adverse events, but not in recalls. Class 2 devices are responsible for the majority of adverse events and recalls.
  5. There are seven major opportunities for improving quality within the industry:Enhanced operating systems
    • Design and reliability engineering – specifically, validation of actual product use, design-for-reliability and manufacturability, and software robustness.
    • Robust postproduction monitoring and feedback into design and manufacturing that goes beyond base compliance requirements.
    • Supplier management processes, particularly in material and process change controls.

    Enhanced management infrastructure

    • Quality metrics and measurement systems that go beyond regulatory compliance measures.
    • Quality organization that integrates cross-functionally throughout the organization, rather than solely focused on compliance.
    • Performance management, where those in key roles associated with quality outcomes, like design engineers, are measured and incentivized around quality performance.

    Enhanced mindsets and behaviors

    • Quality culture can be improved where companies have experienced severe quality-related issues.

Read the full report here.