Multi-component molding: material and design considerations

Eric Bishop, North American Marketing Manager, Shin- Etsu Silicones, Akron, OH

Multi-component molding of liquid silicone rubber over thermoplastic offers numerous opportunities for increased productivity, part reduction, and design improvement. This presentation will explore compatible materials that are suitable for two-shot molding and part design enhancements that can be facilitated via the process.

Silicone material to control bacterial growth: approaches, regulations, and potential roadblocks

Betsy Carlton, Director of Toxicology, Bluestar Silicones, Raleigh, NC

Molders and manufacturers of medical devices and consumer goods are often presented with the challenge of producing materials or devices containing antimicrobial additives. However, there are few points that they must be aware of before deciding to manufacture these kinds of products. The introduction of antimicrobial additives may impact the look, feel, smell, color, or physical properties of the material. It may impact production by inducing cycle time changes; cleaning processes, and requirements may change; and requirements for disposal of the scrap material must be considered. This presentation will provide an overview of regulatory concerns related to the use of antimicrobial additives in medical devices and consumer goods as well as issues molders and manufacturers should consider when making the decision to proceed with producing goods containing antimicrobial additives.

Dr. Betsy Carlton is the Director of Toxicology, Bluestar Silicones North America. Dr. Carlton has been a toxicologist with Bluestar Silicones and its predecessor companies since 1989. Dr. Carlton chairs Bluestar Silicones’ International Medical/Healthcare Application Review Team, and provides regulatory, toxicology, and product stewardship support to Bluestar’s Healthcare Silicones business. She is active in the Silicones Environmental Health and Safety Council (SEHSC) and the Society of Toxicology. In her previous employment, Dr. Carlton was responsible for the development of health-based consensus-derived Direct and Indirect Drinking Water Additives Standards at the National Sanitation Foundation (now NSF International) in Ann Arbor, Michigan. She developed the reproductive toxicology and teratology programs at Battelle Columbus Laboratories in Ohio where she served as Associate Section Manager in Toxicology. Dr. Carlton holds a Bachelor of Science degree in Biological Sciences and a PhD in Developmental Biology from the University of Cincinnati, and held a 2-year NIEHS postdoctoral fellowship in Toxicology at the Massachusetts Institute of Technology. She is a Diplomate of the American Board of Toxicology, a member of the Society of Toxicology’s Medical Device, Regulatory Toxicology, and Reproductive and Developmental Toxicology Specialty Sections, and is past-president of the Society of Toxicology’s Reproductive and Developmental Toxicology Specialty Section. Dr. Carlton is a peer reviewer for three scientific journals, Toxicological Sciences, Food & Chemical Toxicology, and Chemico-Biological Interactions.

Factors Required For a Successful Silicone Molding Program

Mark Hammond, GW Silicones

In order to have complete success for a silicone molding program both the OEM and molding supplier need to work together to fully understand the requirements and needs of each other. Developing the program in the right manor 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.

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. Mr. Hammond has been involved in the rubber industry his entire 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.

Effective Ways to Swell Silicone

Todd Kullmann, Regional Sales Manager, MicroCare, New Britain, CT

Silicone has a longstanding history as being one of the most commonly used biomaterials in the healthcare industry. Due to silicone’s biocompatibility, it has been the material of choice for tubing or molded parts used in many medical devices. Although there are currently a number of different methods used to attach silicone parts to each other or to hard plastic or metal parts, one effective solution is using silicone swelling agents. This presentation explores several cased studies that demonstrate the use and benefits of this method to create a tight and sturdy connection.

Todd Kullmann joined MicroCare Corporation in 2010 to help continue the successful launch of MicroCare Medical. He has more than 20 years’ experience in the pharmaceutical, medical device, and laboratory testing industry. Mr. Kullman has been recognized for top sales performance and leadership within these industries. He has been instrumental in the successful launch of new pharmaceuticals and medical devices within four different medical market segments throughout his career. He has held a number of management positions, including Regional Sales Trainer, District Sales Manager, Regional Sales Manager, National Sales Manager, and VP of Business Development. He attended the University of Wisconsin, River Falls, where completed two B.S. degrees in the studies of Business Administration and Statistical Economics.

Improved adhesion of liquid silicone rubber (LSR) to medical-grade polymers using atmospheric pressure plasma surface treatment

Jeff Leighty, Sales & Business Development Manager, Plasmatreat US LP, Elgin, IL

Strong, reliable adhesion between medical-grade substrate materials (PEEK, PPSU, LCP, etc.) and silicone rubber can be a challenge. Atmospheric pressure plasma treatment is an economical and environmentally responsible solution for cleaning and activating these materials without the need for primers or manual cleaning operations. The high-energy plasma particles clean the surface of even the most minute contaminants. Once the surface is clean the plasma activates the uppermost molecular layers of the substrate material by adding favorable functional groups. These functional groups become bonding sites for the LSR resulting in significant adhesion improvement. The plasma equipment is designed to be installed in new and existing production lines and requires minimal space. A single plasma jet costs only 25 cents per hour to operate and uses only compressed air and 120VAC power input.

Jeff Leighty has been with Plasmatreat since 2009 when the German parent company opened its first US technical center in Elgin, IL. He serves as Sales and Business Development Manager with a focus on applications for the life sciences market using atmospheric pressure plasma technology. Jeff has a 15-year background in surface finishing.

Saurav Paul, PhD, JD, Director of Innovation Fellows Program at University of Minnesota’s Medical Devices Center, Minneapolis, MN

Saurav Paul has been the Director of Innovation Fellows Program at University of Minnesota’s (U of M) Medical Devices Center (MDC) since August of 2011. Dr. Paul is an alumnus of the U of M. He received his Ph.D. in Biomedical Engineering and M.S. in Civil Engineering from the U of M. Before coming to the U of M, Dr. Paul received his M.S. in Mechanical Engineering from the Indian Institute of Science, Bangalore, India, and B.S. in Mechanical Engineering from the Regional Institute of Technology, Jamshedpur, India. Besides his engineering education and background, Dr. Paul also has a J.D. from William Mitchell College of Law, St. Paul, Minnesota.

Liquid carbon dioxide extraction of silicones for medical device applications

Jon Wikstrom, President and CEO, Cool Clean Technologies, Eagan, MN

Over the past 25 years, significant developments in CO2 cleaning and processing technology have originated from aerospace applications, originally developed by Hughes Aircraft Company. These developments have creatively used CO2 in its liquid, gaseous, and supercritical states to solve a wide range of cleaning and surface preparation challenges. These innovations spread to other market areas including precision electronics and medical device manufacturing. Liquid CO2 extraction has been used successfully to remove volatile compounds from a wide range of materials, including: silicone product, precision wipes, gasket materials, heater tape, bearing holders, connectors, and many other parts. This presentation will present background on CO2, which shows why it is an effective extraction technology, present pros and cons of liquid CO2 extraction, and summarize liquid extraction results achieved to date.

Jon Wikstrom is president and CEO of Cool Clean Technologies. In 2001, Mr. Wikstrom led a private equity buy-out of the CO2 based business from Chart Industries and consolidated the CO2 related assets and IP of Raytheon, Deflex Corp, and Micell Technologies into Cool Clean Technologies. Since 2001, Mr. Wikstrom has led the formulation and execution of three rounds of equity financing and several debt financings for Cool Clean totaling capital raise efforts of $25 million for the successful product development and commercialization of three significant product lines as well as seed funding for the biofuels area. As president and CEO, Mr. Wikstrom has led the company expansion of the IP base into the biofuels area. He has 16 years of experience in technology development companies as president or CEO of both public and privately held organizations. After graduating from the Air Force Academy in Colorado Springs, Mr. Wikstrom spent seven years active duty in the Air Force as an acquisitions officer stationed at Electronic Systems Division in Boston and then held the position of program element monitor for classified programs at the Pentagon in Washington, DC. He spent another 17 years in the reserves and is now a Retired Air Force officer. Following active duty, Mr. Wikstrom joined Chart Industries where he worked his way through several positions until reaching the level of division president of this public company. For nearly a decade, he was involved in the early days of natural gas vehicle conversions to LNG and CNG and served for five years on the Natural Gas Vehicle Coalition Board of Directors in Washington, DC. While at Chart Industries, Mr. Wikstrom started up a dedicated alternative fuels company, NexGen Fueling, of which he served as president and CEO for three years. His division, Chart Applied Technologies, grew from $55 million in revenue to nearly $100 million in three years while maintaining 20% + EBITDA returns. Mr. Wikstrom holds a Bachelor of Science degree in Economics and Engineering from the Air Force Academy, and an MBA, with honors, from Boston University.