Benchmarking Quality Assurance

Best Practices, LLC recently released a study that provides insights into the amount of resources pharmaceutical and medical device companies allocate to ensure their products meet quality and regulatory standards.  The study includes aggregate and anonymized data from 31 large medical companies, including Fisher & Paykel Healthcare, ResMed, Smith & Nephew, and Medtronic, among others.  The majority of the surveyed companies operate primarily in the medical device field, but the data also includes results from diagnostic and pharmaceutical companies.

According to Best Practices, the study benchmarks the amount resources spent on quality assurance systems, regulatory affairs, and post-market surveillance of products. One exemplary finding was that, for the average company, the resources expended on the combined quality and regulatory systems amounted to nearly 8% of all company FTEs (full-time employee equivalence).  The report further observes that more resources should be spent on the quality assurance system as company revenues increase to maintain consistent quality practices during expansion of operations.

Other sections of the report include data and analysis regarding the particulars of quality assurance systems including the number of CAPAs, NCEs, field actions, change requests, and FDA warning letters reported by individual companies.  The study also includes data on the volume and duration of complaints received through post-market surveillance and benchmarks the amount of employee time spent addressing theses complaints.

The complete study is available for purchase through Best Practices, LLC.

 

 

 

 

 

Mark Davis
Mark Davis is an associate in our Orange County office. His practice is focused on patent litigation and prosecution. Mr. Davis earned his Bachelor of Science in Mechanical Engineering at Brigham Young University, where he competed in the international University Rover Challenge. After graduation, he worked as a regulatory compliance engineer at Novarad, a small medical device company. Following his work as an engineer, Mr. Davis attended the University of Texas School of Law. At Texas, he was an officer in the Texas IP Law Society and served as an associate editor of the Texas Law Review. He also represented small business owners and nonprofit groups as a member of the Texas Clinical Law Programs. He joined the firm in 2015.
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