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Report Indicates Many Medical Device Manufacturers Overdoing Compliance Checks

Most companies in the medical device industry are growing, but only a quarter have managed to both grow and make major improvements in business performance.

This is just one finding from the new market study "Beyond Tradeoffs in Medical Device Manufacturing: Balancing Innovation, Quality and Compliance While Improving Profit," released in July 2012 by Cambashi ( , a leading research and consulting firm for production industries. The companies that did both, defined as “Advancers,” are more likely to be accelerating their pace of innovation plus are twice as likely to have made major improvements on key quality metrics such as audit results, complaints, adverse events and supplier quality.

By focusing on product quality at the source rather than just quality inspections, Advancers have lowered their cost of quality and compliance. In fact, the majority of survey respondents, including quality professionals, executives and others (except regulatory affairs staff) believe their company does more quality checks than are actually required by the regulations. Even 40 percent of the regulatory professionals are in agreement. Clearly, unnecessary checks, balances, and error-proofing add cost and time to the process, which may be hurting profitability and business performance.

While logic says it’s easier to grow dramatically as a small company, the Advancers are somewhat more likely to be large. Advancers are far more likely to use software of all kinds. Still, when faced with a need to grow, companies of any size can create the discipline and implement systems that work. About an equal portion of advancers are small (under $25M annual sales), medium (between $26M and $1B annual sales) and large (over $1B annual sales).

“Respondents say that the top two challenges to high quality are changes in regulations and changes in products. Changes in regulatory requirements are simply a fact of life, and the data shows that the pace of innovation is likely to increase. Clearly, companies must find better ways to address these changes and keep quality high. Spreadsheets, homegrown software, and paper-based processes will be unable to keep up with this pace of change. Fortunately, applications do exist to serve nearly any functional need for companies of all sizes in the medical device industry,” according to lead researcher Julie Fraser.

The study is based on over 120 responses from individuals in medical device manufacturers or their direct materials suppliers.  The study focused on the challenges Medical Device manufacturers face in seeking to not only grow but also to increase quality and financial performance in the face of complex and changing regulatory requirements.  

This on-line survey covered respondents’ current situation, challenges and approaches for improvement as well as performance improvement accomplishments.  Questions also asked about processes, suppliers, software technologies, information flows and strategic actions to support reliable, safe and high quality medical device manufacturing through the global supply chain and the product lifecycle.  In addition to the on-line survey, some Advancers were interviewed by telephone and their insights are quoted in the comprehensive report.

This research is made possible with the support of the UBM Canon Medical Device Media Group, plus the financial backing of premium sponsors Apriso Corporation ( and Dassault Systèmes (, and supporting sponsor Epicor Software Corporation (  These companies seek to serve the MedTech industry by offering software and deep expertise on how to best ensure quality, growth and profits in this highly regulated operating environment.

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