Cover Story

Invited Speakers : Abstracts & Introduction

Abstract:

Plastics have made significant inroads in the US$130 - $150 billion global medical device industry due to their design flexibility, cost and the ability of suppliers to tailor and engineer the material properties for targeted performance requirements. With stringent regulations, changing market needs and the need for safe and effective devices, it is important that the right components and materials be chosen for such applications.

A comprehensive one-on-one interactive telephone survey was conducted with over 40 medical device manufacturers targeting only those personnel who use plastics in the design, development and production of components, parts and finished devices. The focus of the survey was to understand and identify the trends and needs of medical plastics from the perspective of the medical device manufacturer. This presentation will provide the attendee with a summary of the results focusing on material performance needs and trends, quality requirements, affect of medical device regulations, and the expectations of buyer-supplier needs and relationships.

Speaker’s Introduction

Vinny Sastri, Ph.D., is the President of WINNOVIA® LLC. His firm provides customized, sustainable solutions, strategies and training in new product development, quality management and high performance materials. His areas of expertise include design controls, process validation, and FDA and ISO Quality Systems for medical devices, quality management and Design for Six Sigma. WINOVIA LLC employs the Six Sigma and Design for Six Sigma philosophy with the goal of strategic market penetration, improving product and process quality, streamlining business processes, reducing operational costs, and increasing revenues and profits for its clients.

Prior to starting his WINOVIA LLC, Dr. Sastri held global leadership positions in technology, quality, manufacturing and marketing in companies like BASF, AlliedSignal and General Electric Plastics. He is a certified Six Sigma black-belt. He has helped clients develop new products, and institute growth and quality initiatives into their organizations around the world, resulting in new product sales and improved quality. His 25 years of experience span technology, manufacturing, marketing and quality in markets like medical devices, automotive, consumer goods, packaging, and textiles.
 

Dr. Sastri earned a Ph.D. from Rutgers University, and completed post-doctoral work at Brooklyn Polytechnic Institute. He was an Adjunct Professor at Virginia Commonwealth University in Richmond, Virginia. Dr. Sastri is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) where he trains medical device personnel on the FDA Quality Systems Regulations for medical devices. He has over 20 publications and 6 patents. He has published articles in the Medical Device and Diagnostic Industry trade journal, and has been invited to many conferences to speak about new product development, high performance materials, Design for Six Sigma and the FDA Quality Systems Regulations in the United States, Europe and Asia.

Representative Articles, Conferences and Webinars:

• Medical Plastics – Future Needs from the Voice of the Medical Device Manufacturer V. Sastri Medical Grade Polymers Conference September 16-17 2008, Philadelphia, PA

• Design for Six Sigma and Product Development in the Plastics Industry V. Sastri ANTEC 2006 Proceedings, Charlotte NC, May 7-11, pp. 1843-1845 (Awarded best paper by the SPE Product Development Group)

• Integrating Product Development Part 2: DfSS and Quality System Regulation V. Sastri Medical Device & Diagnostic Industry pp.56-65 January 2006

• Integrating Product Development Part 1: Design for Six Sigma V. Sastri Medical Device & Diagnostic Industry, pp. 62-68, October 2005

• Critical Material Considerations and Effects of Processing for Medical Device Applications MDM West 2008, Anaheim Ca; MDM East 2008, New York City, NY

• Design for Six Sigma for Medical Devices: Integration with FDA Quality Systems Regulations, Compliance Online Webinar July 19, 2007

• Plastic Materials in Medical Devices Technologies, Trends and Applications Requirements, Medical Device Conference, Institute of Validation Technology, San Francisco August 17, 2006

Book (due late 2009 early 2010)
Plastics in Medical Devices, William Andrew Inc