Dr. Wayne A. TaylorDr. Taylor is a leading expert on the application of Statistics to the Medical Device and other FDA regulated industries.  His book Statistical Procedure for the Medical Device Industry sets the standard for applying statistics in compliance with Section §820.250, Statistical Techniques of the Code of Federal Regulations.

He is the founder and chairman of Taylor Enterprises, Inc. where he is responsible for the development of the VarTran®, Change-Point AnalyzerSampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics and the Six Sigma approach and tools including Robust Design, Tolerance Analysis, Design of Experiments, SPC and Acceptance Sampling.

In 2000, Dr. Taylor retired from his position as Director of Quality Technologies at Baxter Healthcare Corporation where he was responsible for Baxter’s Six Sigma program.  He and his staff have trained over 800 of Baxter’s engineers to serve as Six Sigma black belts.  He had been with Baxter for 22 years.

He is also the author of the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling.  The first book outlines the approach implemented at Baxter for achieving six sigma quality.  The second book outlines a simple to use approach for selecting and justifying sampling plans as well as reducing inspection costs that is used throughout the medical device industries.  This system has saved Baxter over 30 million dollars annually.

Dr. Taylor is the leading expert on acceptance sampling in the pharmaceutical, medical device and diagnostics industries.  His articles on selecting statistically valid sampling plans have become standards in the industry and are used by the FDA in their new inspector training.  He has taught his 2-day course Successful Acceptance Sampling to over 5,000 students and 50 companies including the CDRH (Center for Devices and Radiological Health) of the FDA.

Dr. Taylor is also a leading expert in Process Validation.  He is the author of Annex A of the Global Harmonization Task Force guideline Quality Management Systems – Process Validation Guidance – Edition 2.

His clients include over 200 medical device companies.  He has served as part of the third party to close to a dozen companies under consent decrees.  He has served as an expert witness in several court cases, including the blockbuster drug Gabapentin.

The VarTran software and Dr. Taylor’s course Robust Tolerance Analysis have rapidly become a key component of many companies DFSS (Design for Six Sigma) programs.  Honeywell, the Six Sigma Academy, and numerous other companies have adopted VarTran as an essential tool for designing high-quality products.

He has made many key contributions to the field of Quality including Variation Transmission Analysis, Process Tolerances, Quick Switching Systems, Change-Point Analysis, and Normalized Individuals Control Charts.  He has dozens of articles and hundreds of presentations to his credit.

Dr. Taylor received his Ph.D. in Statistics from Purdue University.  He is a fellow of the American Society for Quality as well as a member of the American Statistical Association where he is an Accredited Professional Statistician™.


1996 – Elected a Fellow of the American Society for Quality

2008 – Recognized as one of  100 Notable People in the Medical Device Industry by MD&DI Magazine (alphabetical, Wayne Taylor is near the bottom of page)

MD&DIArticle Overview:  In this issue, MD&DI honors some of the people who make these advances possible and who ensure that those devices can treat patients safely and effectively. If we tried to list everyone who has made a significant contribution to medical technology, we would have to publish an issue larger than a phone book. So we are highlighting 100 of them on the following pages. 

It was not easy coming up with a representative list. We started with nominations from readers, Editorial Advisory Board members, and staff. We took those who made particularly notable contributions to the industry and made sure that we had as diverse a group as possible. On the list you will find a sampling of inventors, executives, consultants, engineers, academics, and regulators. Some of them you will know from previous coverage in MD&DI or accolades elsewhere. Others you might be hearing of for the first time. 

2012 – Purdue University – Distinguished Science Alumni Award – Dr. Wayne Taylor

Awards are given to alumni whose work and achievements have made a significant difference in our communities and lives. We are very proud to claim them as part of the Purdue Science family, and we thank them for the valuable contributions they continue to make to our college, the University, and our world.

Purdue Science StatisticsThe College of Science has launched its 2008–2014 strategic plan with key themes including launching tomorrow’s leaders, discovery with delivery, meeting global challenges, and creating diverse communities for excellence. In so many ways, our distinguished alumni embody these goals and live the college’s mission. Their work and accomplishments are “real world” proof that a Purdue degree in science can lead to professional success and also help to solve some of the enormous challenges facing modern society. They are inspirational role models for us all.

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