Silicones, with their unique material properties, have found widespread application in healthcare. And, according to Andre Colas and Jim Curtis (both of Dow Corning) in the book Biomaterials Science, the key properties attributed to silicone—biocompatibility and biodurability—provide such benefits as hydrophicity, low surface tension, and chemical and thermal stability. Silicone has simply become an essential material in the design and development of many medical devices.

And so it made sense to launch the next Medical Silicone Conference in the Boston area, home to many medical device manufacturing companies and a great area of device innovation and development. The conference, being held October 4–5 in Framingham, MA, will cover topics ranging from developing a successful molding program to designing microscale components.

The speakers are exploring the cutting edge of silicone, with a goal of helping device manufacturers deliver innovative designs that provide benefits including antimicrobial properties to precision and functionality. At the heart of it all is innovation, a major concern for device makers.

Device manufacturers have a greater role than ever in reducing hospital-acquired infections. Olga Hoy, senior scientist at Bluestar Silicones, Rock Hill, SC, will tackle the rising number of hospital-acquired infections and how silicone material can be used to control bacterial growth. An in-depth look at the regulatory concerns of use of antimicrobial additives in medical devices is on tap to help you decide what approach to take and then how to navigate the regulatory process for devices that contain antimicrobial additives. She will address critical issues, including coloring, cycle time changes, cleaning and disposal of the scrap material, and required regulatory approvals, all of which must be considered when using antimicrobial additives.

And, with less-invasive procedures becoming the new norm, reducing the scale of surgical instrumentation is critical to limiting operating room and patient recovery times. Jeff LeFan, applications engineer at Saint-Gobain Performance Plastics, Portage, WI, will look at the challenges the medical device community faces when asked to deliver innovative designs that provide the same level of precision and functionality in packages that are smaller packages than ever before. He will examine the critical role that liquid silicone rubber now plays in producing elastomeric products that can be used independently or produced as an overmold with more rigid materials. Advances in tool manufacturing, dimensional capabilities of molded components, and downstream process changes will be explored, all with an eye toward innovation.

The keynote session will address the daunting task of maintaining supplier files that meet FDA expectations. Attendees will hear from John Avellanet, managing director and principal for Cerulean Associates LLC, Williamsburg, VA, as he addresses the questions FDA inspectors are trained to ask, the supplier management documents most frequently requested, and the red flags the inspector looks for.

Most of you probably know what actions to take, but do you know how best to document the actions and the results, and how long should you should retain that documentation? What if you no longer work with that supplier? And what if you get into a product liability lawsuit along with a supplier? What documentation do you need to have? Those are all the questions Avellenet will address.

“Supplier records aren’t sexy, fashionable, or fun,” says Avellanet. “Yet if you don’t have the right records, and you don’t keep them the right length of time, an FDA 483 citation will be the least of your worries.” He adds, “Between product liability lawsuits, contractual relationships gone bad, financial losses, and investigator scrutiny, defensible documentation is the difference between bottom line success and product failure.”

For more on the speakers, topics, and sponsors, see the preview on page 47. To register for the conference, go to www.medicalsiliconeconference.com.

See you there!

Sherrie Conroy, Director of Content
sherrie.conroy@penton.com
Twitter @SherrieConroy