Keynote Presentation

Preparing for an Evidence-Based Future

Steve Halasey, Vice President for Programs, Institute for Health Technology Studies (InHealth), Washington, DC

For medical technology companies, healthcare reform remains a work in progress. With its full impact yet to be determined, medtech companies remain ill prepared for what lies ahead. Whatever else may grow out of recent reform legislation, one outcome is certain: health policy is headed for an evidence-based future for which there are many questions:

• How will the role of the Patient-Centered Outcomes Research Institute be defined and carried out?
• What will it mean for medtech manufacturers if federally funded comparative effectiveness research becomes the only source of gatekeeping data for product commercialization?
• What opportunities will be made available to manufacturers for demonstrating the health and socioeconomic value of medical technologies, or to show the utility of new products for enhancing workforce productivity, reducing health system costs, and improving both health outcomes and lifestyles?

Steve Halasey of InHealth, a research and analysis organization, will address these questions as he looks at the new and ever-greater demands for evidence emerging from healthcare reform, and how those demands will reshape the way medical device companies develop and commercialize future generations of medical products.

General Sessions

The ABCs of NDAs

Ted Kucklick, Medical Design contributor, author of The Medical Device R&D Handbook, and founder and President of Cannuflow, San Jose, CA

The development of intellectual property is key to the value of any medical device business and confidentiality is key to protecting intellectual property during its crucial formative stages. The NDA, or "non-disclosure agreement," is an accepted mechanism for maintaining g confidentiality among parties collaborating on a new technology. What are some of the basic elements of an NDA? What is needed in addition to the NDA to make it enforceable? What are some terms in an NDA that you should not sign? This practical and informative talk will answer those questions, and more.

Ted Kucklick of Cannuflow, specialists in the development of devices for arthroscopic surgery, will share his insights during this important session. A frequent speaker on medical device entrepreneurship and innovation, Kucklick is also a regular Medical Design columnist (R&D Notebook) and author of The Medical Device R&D Handbook.

The Ins and Outs of Intellectual Property

Davy Crockett, Principal, Crockett & Crockett, Laguna Hills, CA

This information-rich session will discuss patents, trade secrets, trademarks, copyrights, and requirements for establishing each, with an emphasis on requirements for patentability and the function of patent specifications and patent claims. Learn about claim forms, strategies for pursuing claims, obstacles to foreign patent protection, and how not to get “hamstrung” by FDA documentation.

Davy Crockett of Crockett-Crockett, specialists in portfolio management and strategic planning, will share his expertise. His practice includes all aspects of intellectual property law, including U.S. and foreign patent and trademark prosecution, infringement and validity analysis and opinions, and investment due diligence and litigation.

Multi-component Molding of LSR Over Thermoplastics

Eric Bishop, Marketing Manager, Shin-Etsu Silicones, Akron, OH
David Wolgemuth, Senior LSR Engineer, Phillips Plastics, Hudson, WI

Liquid silicone rubber (LSR) innovations allow for two-shot and insert over molding of silicone on a variety of engineering thermoplastics, including polycarbonate, without the use of primers or pretreatment. These innovations are resulting in more versatile product design while reducing cost and improving reliability with multi-component molding of LSR over thermoplastics. Further, the LSR bonds chemically to the substrate in the mold, yielding 100% cohesive failure in pull testing. Products are compliant with USP Class VI and ISO 10993 standards.

Shin-Etsu's Eric Bishop and Phillips Plastics' David Wolgemuth will present their insights on what all this means for medical device manufacturers.

Real World LSR Simulation Applications

Torsten Kruse, Founder and President, Kruse Analysis, Naples, FL

From mold filling and part curing to mold temperatures over an entire cycle, state-of-the-art simulation considers every technical detail of the injection molding process. Yet, the complete potential of simulation is often not turned into full real world value. That is, until now. What are real world LSR simulation applications?

Kruse Analysis Founder and President Torsten Kruse will answer that question and more as he provides a detailed look at simulation advancements

Factors for Successful Surface Treatment Using Antimicrobials

Mark Wiencek, Senior Microbiologist, Milliken & Company, Spartanburg, SC

Biofilm (the growth of microbes on a surface) is a serious threat for medical devices such as implantables, catheters, IV connectors, and respiratory therapy. It can lead to infections that are difficult to treat because the biofilm is more resistant to systemic antibiotics, topical antiseptics, and host immune defenses than are the microbes.

Milliken Senior Microbiologist Mark Wiencek will present important information on advanced antimicrobial materials for battling this infectious threat, what device manufacturers can do to make their products more resistant, and tests used to measure materials effectiveness.

The How-To's of Mold Selection

George Kipe, Founder and President, Kipe Molds, Placentia, CA

When molds are built without fully considering the factors that define successful molding platforms, the results can be disastrous. This presentation will explore the variables and questions to consider when choosing a molding platform, including: How many cavities in a tool are best without sacrificing performance?; When does it make sense to have a cold runner mold?; Under what conditions should automatic molding be considered?; What's needed for flash-less molding?; Does validation protocol have any bearing on tooling choices?; How important is the grade of silicone?; and How elaborate should prototypes be?

Answers to these questions will be presented by Kipe Molds Founder George Kipe who is widely known as a leading innovator in silicone molding technology. A regular guest instructor at the University of Wisconsin's Silicone Molding Seminars, Kipe is often referred to as the grandfather of silicone molding in North America for his cold runner systems and valve gate technology.

Silicones for Long-Term Implantable Devices

Brian Reilly, Product Director–Healthcare Materials, NuSilTechnology LLC, Carpinteria, CA

This session is designed to provide attendees with an understanding of silicones for long-term implantation and the importance of support for applicable regulatory standards and requirements, including FDA Master Files.

NuSil Product Director of Healthcare Materials Brian Reilly will look at the future of devices and the increasing demands for combination products, and the benefits of finding a supplier than can incorporate Active Pharmaceutical Ingredients into their silicones, and further, provide regulatory support such as Drug Master Files.