Open Problems and Challenges in a Regulated Industry

• Activity Number: 472
• Type: Topic Contributed
• Date/Time: Wednesday, August 7, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Section on Physical and Engineering Sciences
• Author(s): Willis Jensen*+
• Companies: W.L. Gore & Associates
• Keywords: R&D ; Innovation ; New Products ; Medical Devices

Abstract

We address some problems and challenges in industrial statistics, from the perspective of a statistician who works in a regulated industry. The focus is to challenges related to manufacturing and new product development. While a current focus within the ASA is on the big data problems that are available, we emphasize the many challenges that are not necessarily related to "big data". These arise from a more competitive regulatory environment, where an increasing focus on new innovation results in products that are more complex and customized and where the users of statistics are more knowledgeable, more reliant on software and have a greater sense of urgency. By presenting some real challenges, we hope to increase understanding among both academia and statistical practitioners.