Overcoming Barriers to Medical Device Quality


A recent study by the FDA reviews the state of medical device quality and the challenges and opportunities for improvement available to medical device manufacturers. The results of “Understanding Barriers to Medical Device Quality” indicates that medical device manufacturers are experiencing key challenges relating to improving product quality:

  • Low quality transparency limits significant quality upgrades. This is driven by a lack of information for consumers and decision makers around comparative quality (i.e., quality differences among competing products), time to market competition, and cost pressures.
  • Increasing complexity of medical devices and their usage environments is straining the current quality system infrastructure. Companies report that they have not systematically upgraded their quality infrastructure due to the unclear economics and concerns about regulation.
  • The corporate perception that the regulatory framework is misaligned with assurance of quality outcomes hinders both compliance and quality. Companies perceive that compliance with regulations does not ensure quality, and that current intervention practices may be de-incentivizing improved quality.

Further, the report posits seven major opportunities for improving quality within the industry. Three relate to enhanced operating systems:

  • Improved design and reliability engineering, specifically validation of product use, design-for reliability and manufacturability, and software robustness
  • More robust postproduction monitoring and feedback into design and manufacturing that goes beyond base compliance requirements
  • Better supplier management processes in material and process change controls

Three relate to enhanced management infrastructure:

  • Quality metrics and measurement systems that go beyond regulatory compliance measures
  • Development of a quality organization that integrates cross-functionally throughout the organization rather than solely focusing on compliance
  • Improving performance management, where those in key roles associated with quality outcomes are measured and rewarded based on quality performance

The final one relates to the behavior and mindsets of employees:

  • Establishing a quality culture

By providing an ERP system based on the architecture of compliance, Epicor for Medical Devices not only supports the standards that medical device manufacturers need to meet for the FDA, but provides a powerful tool for manufacturers to overcome the challenges and seize the opportunities the FDA has identified. In this increasingly competitive market, such a tool can prove invaluable in achieving goals and establishing market standing.

Posted by the Epicor Social Media Team


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