Abstract:

“Should medical device organizations focus more on Six Sigma re-certification than on initial training?” The answer is yes! The aim of this research was to further an understanding of Six Sigma training in this highly specialized community through the context of leadership, strategy, and the development of people.

Six Sigma is a business methodology, a vision, a symbol, a philosophy, a goal, and a metric that is widely practiced across many organizations around the world. It requires cultural change and the development of people as an organization continues to grow and improve products and/or services. However, there are no commonly held practices for re-certification for these individuals and, ironically, the regulatory and quality system requirements that govern the medical device industry around the world require medical device organization to document continuous improvement.

This research study explored how medical device professionals are being taught in Six Sigma methodologies and what teaching strategy or method has been utilized for growing or maintaining their knowledge. It has explored other industries and professions that require re-certification as a benchmark. Impacts from company size and areas of responsibility were assessed in understanding the perceived impact of Six Sigma for quality performance, customer satisfaction, and meeting company goals for customer satisfaction and have found similar results based on a previous earlier study for the automotive industry.

Keywords:

Training, Education, Re-certification, Six Sigma, Medical Device, Continuous Improvement.