KEYNOTE SPEAKER
Creating and Maintaining Supplier Files to Meet FDA Expectations
John Avellanet, Managing Director and Principal, Cerulean Associates LLC, Williamsburg, VA
Learn the questions FDA inspectors are trained to ask, the supplier management documents most frequently requested, and the red flags the inspector looks for. Understand how to maintain a supplier dossier in a cost-effective manner. And obtain a proven FDA-compliant process flow for creating and maintaining supplier dossiers. Supplemental reference materials will be made available to attendees after the talk. Download a PDF of this presentation.

John Avellanet is managing director and principal Cerulean Associates LLC. He has earned international acclaim for his business-savvy, pragmatic compliance advice, and his engaging, no-nonsense speeches and workshops. He was the winner of the 2009 Best of Business award by the Small Business Commerce Association. His blog has been named one of the top 10 blogs on FDA enforcement and compliance for two years running. Avellanet’s latest book, Get to Market Now! Turn FDA Compliance into a Competitive Edge, has won praise from industry publications, former FDA officials, and Amazon.com reviewers. For more than 15 years, Avellanet served as a compliance executive, most recently as a C-level executive for a Fortune 50 combination device subsidiary. He has a breadth of experience designing, implementing, and running compliance systems to meet FDA, ICH, GHTF, and ISO compliance. In 2006, he founded his lean FDA compliance consulting firm, Cerulean Associates LLC. Learn more about Avellanet and Cerulean at www.Ceruleanllc.com.

Integrating Silicone Parts into Medical Device Assemblies
David Wolgemuth, Senior LSR Engineer, Phillips Plastics MS LSR Facility, Hudson, WI
This presentation will cover integrating silicone parts into medical device assemblies for robust products. It will start by examining an assembly or product design issue, followed by a walkthrough of the design considerations, materials selection, and tooling allowances for two-shot molding with LSR. The speaker will show some initial part designs, followed by a walkthrough as the design changes with each modification for the required tweak or allowance. Download a PDF of this presentation

David Wolgemuth has over 15 years of experience within the plastics industry, and in particular, multi-shot molding. This started with a bachelors degree in both Chemistry and Plastics Engineering from Illinois State University in 1997. His past roles within Phillips Plastics have included the following: project engineering; new business and technology development; tooling engineering and design. For the last 4 years, he has lead the launch of one of Phillips newest business units, Multi-Shot LSR molding. The new production facility has a specifc focus on multi-material molding with silicone and thermoplastics, building on the 25 plus years of multi-material molding experience at Phillips.

Silicone Material to Control Bacterial Growth: Approaches, Regulations, Roadblocks
Olga Hoy, Senior Scientist, Bluestar Silicones, Rock Hill, SC
A rising number of hospital-acquired infections, increasing cost of medical care, projected growth of the population age – all of these factors contribute to ongoing interest in products, both consumer and healthcare devices that can mediate these factors. However, there are a few points to be aware of before deciding to manufacture such goods. Coloring issues, cycle time changes, cleaning and disposal of the scrap material, and required regulatory approvals are just a few. This presentation will overview regulatory concerns of use of antimicrobial additives in medical devices and consumer goods as well as issues molders and manufacturers should be taking into consideration when making the decision to proceed with producing goods containing antimicrobial additives. Current approaches taken to provide antimicrobial solutions for the market will also be discussed. Download a PDF of this presentation

Olga Hoy received her doctoral degree in material sciences and engineering from Clemson University, Clemson, SC. Her research work was focused on surface modification with polymer brushes for controlled protein adsorption. Before attending Clemson , she worked as a junior scientist at Lviv Polytechnic National University, Lviv, Ukraine, from which she also got her M.S. degree in pharmaceutical technology. Currently, Hoy is working in the research and development department of Bluestar Silicones, Rock Hill, SC. She is engaged in development of new silicone materials for medical applications.

Factors Required For a Successful Silicone Molding Program
Mark Hammond, General Manager, GW Silicones
In order to have complete success for a silicone molding program, both the OEM and molding supplier need to fully understand the requirements and needs of each other. Developing the program in the right manner using proper part design, prototype techniques, material selection, tolerances, mold design, and production method are vital to success. This presentation will discuss the many factors involved in a silicone program and provide some helpful tips for the medical OEM when it comes to launching a project. Download a PDF of this presentation.

Mark Hammond is the general manager at GW Silicones, the silicone molding division of GW Plastics in Royalton, VT. GW is a global healthcare company providing injection molding and contract manufacturing in thermoplastic and silicone. Hammond has been involved in the rubber industry for his professional career, working in various engineering positions at Cooper Standard Automotive and more recently in the Thermoset Technology Group at Engel Canada where he was responsible for liquid silicone and rubber molding machines and turnkey projects. GW Silicones has a focus on providing flashless and automatic molding of liquid silicone along with the efficient combination of liquid silicone and thermoplastic materials for the medical industry.

Project Management: Identifying Critical Process Parameters of Molded LSR Components
Nirav Patel, General Manager, G&F Medical, Danvers, MA
Molding process parameters play significant role in shrinkage and product performance of the molded LSR components. How do you identify the most critical process parameters and establish solid process to maintain shrinkage and product performance consistent over time. Download a PDF of this presentation.

Nirav Patel has held the position of general manager at G&F Medical (Danvers, MA) since 2008. G&F Medical is a contract manufacturer in medical industry, specializing in silicone molding. Patel is responsible for managing manufacturing operations, customer relations, supplier relations, P&L, sales and marketing for the company. He was formerly engineering manager at Helix Medical from 2000 to 2007. He has an MBA from Babson College and a BS and MS from the University of Massachusetts, Lowell.

Liquid Silicone Rubber (LSR) Micromolding for Medical Markets
Jeff LeFan, Applications Engineer, Saint-Gobain Performance Plastics, Portage, WI
With less-invasive procedures becoming the new norm, reducing the scale of surgical instrumentation is critical to limiting operating room and patient recovery times. As a result, the medical device community is challenged with delivering innovative designs that provide the same level of precision and functionality in a smaller package. Liquid silicone rubber (LSR) injection molding has been taken to the microscale, resulting in elastomeric products that can be used independently or produced as an overmold with more rigid materials. This presentation provides a comprehensive overview of the current capabilities of micro-LSR components: advances in tool manufacturing, a review of current dimensional capabilities of molded components, and downstream process changes affecting part handling and metrology. Download a PDF of this presentation.

Jeff LeFan is an applications engineer with Saint-Gobain Performance Plastics, located in Portage, WI. He specializes in thermoplastic and elastomer component manufacturing, with an emphasis on injection molding and design for manufacturability. LeFan earned a master of engineering in polymer engineering and science from the University of Wisconsin – Madison and is approaching a decade of experience in the automotive and medical markets.

UV Cured Silicone Elastomers: A New Approach to Silicone Rubber Fabrication
Mel Toub, Senior Application Development Engineer, Momentive Performance Materials, Columbus, OH
Silicone rubber is a thermoset elastomer typically processed at elevated temperatures using standard fabrication methods familiar to the organic rubber industry including molding, calendering, and extrusion. A new cure technology platform for silicone elastomers based on exposure to UV light provides a fresh alternative to thermal vulcanization. This presentation will describe practical application of this technology to extruded tubing and profile and will explore several potential advantages in manufacturing efficiency, energy savings, and product design enabled by this technology. Download a PDF of this presentation.

Mel Toub currently directs application development and product development activities for both high consistency and liquid injection molding silicone elastomers at Momentive Performance Materials. He attended Rensselaer Polytechnic Institute, where he obtained bachelors and masters degrees in materials engineering and an MBA. From 1973 to 1975, he worked for the Coated Abrasives Division of the Norton Company in the areas of textile backings and latex

The Evolution of Silicone Molding
Kevin Franzino, Project Engineer, Albright Technologies Inc, Leominster, MA
The silicone molding industry has grown in leaps and bounds in recent years. This has created opportunities for silicone distributors and molders alike to spring up and fit niches in a rapidly evolving field. Distributors are developing highly specialized materials to achieve case-specific goals, while silicone molders are experimenting with novel processing techniques to meet unique customer demands and specifications. This presentation will explain the properties of different silicone materials, and the ins and outs of more commonly used processing methods, as well as providing a brief synopsis of silicone’s booming emergence into the materials industry. Download a PDF of this presentation.

Kevin Franzino is project engineer for Albright Technologies Inc in Leominster, MA. Kevin received a bachelor of science degree in biomedical engineering from the University of Connecticut in Storrs, CT. He has been with at Albright Technologies Inc for more than two years where he does development work on silicone medical devices. He lives in Connecticut with his wife (Megan) and their two dogs (Abby and Ripley).