Masters Thesis

Risk-based design control process to promote a Quality by Design infrastructure in the medical device industry

The Food and Drug Administration (FDA) has issued increasing numbers of warning letters to medical device manufacturers, citing deficiencies in design control and risk management processes. Though FDA provides guidance through the Code of Federal Regulations (21.CFR.820.75), 44% of recalls and 30% of warning letters over the last several years have resulted from inadequate design control procedures (Drues, 2015). FDA regulations can be vague in describing how to ensure compliance. Manufacturers justify their approach led by engineers, who are complacent to the demands of manufacturing, content to a reactive work culture that discourages innovation, and unlikely to challenge the habitual perspective “we’ve always done it this way.” Deming’s Plan-Do-Study-Act model serves as the theoretical basis to propose a risk-based design control process promoting Quality by Design. Quality tools are utilized to assess, interpret and mitigate risk factors in current design control practices within the medical device industry.