Innovative devices
America's cardiac device market yeilds innovative solutions

At the heart of Minnesota’s medtech industry is the cardiac device market. Home to global industry giants Medtronics (Minneapolis) and St. Jude Medical Inc. (St. Paul), the Twin Cities area has cultivated an active supplier base and innovative R&D environment for supporting the design and development of cutting-edge cardiac devices. Catering to this local market, the MD&M Minneapolis trade show will, for the first time, feature a series of presentations focused exclusively on innovative solutions for cardiac device manufacturers.

Consisting of 11 half-hour presentations, the free event covers topics that run the gamut from novel enabling technologies to the impact of healthcare reform on the supply chain. The latter topic will be addressed by Chris Oleksy, president of Atek Medical (Grand Rapids, MI), in a talk entitled, “Navigating Health Care’s Impact on Medical Device Value Chains.”

“No matter where your organization sits within the value chain of healthcare, we must navigate properly the winds of healthcare change,” Oleksy says. “Topics such as automation, off-shore manufacturing, product development, and product redesign are only some of the topics that will be discussed. What is key is proper value-chain configuration in order to navigate correctly. Incorrect configuration could lead to your organization solving the wrong problem and not surviving healthcare reform’s changes.”

A need for change is also among the central themes of the presentation, “Technology with Heart: Developing User-Centered Solutions.” In this case, however, the need for change applies to OEMs’ approach to product design. Too often, the needs and abilities of end-users have taken a backseat to clinical, technical, and business goals, according to presenter Ed Geiselhart, director of product development and planning for Insight Product Development (Chicago). Overlooking or disregarding user-centric solutions could ultimately compromise the success of the finished device, he says.

“Accounting for user-centered considerations is a critical aspect of development that is absolutely within reach for any medical device manufacturer,” Geiselhart asserts. “The development process, if navigated effectively, can integrate the necessary activities that will ensure a device effectively accounts for utility, usability, and emotional connections. This can serve to provide distinct competitive advantages for device manufacturers and identify new opportunities for growth and profit.” Geiselhart will discuss the potential benefits of user-centric design and will provide real-world case study examples involving St. Jude Medical and Thoratec (Pleasanton, CA).

In addition to examining how to optimize design with users in mind, Cardio Innovation Briefs will focus on various topics relating to materials for cardiac device applications. NuSil Technology (Carpinteria, CA), for example, will elaborate on “Using Silicones for Drug-Delivery Applications.” Biocompatible, customizable, and processable by various manufacturing techniques, silicones are suited for cardiac applications that can benefit from the inclusion of anti-inflammatory, antimicrobial, or antibiotic agents, notes presenter Brian Reilly, product director, healthcare materials.

“Silicone is one of the most diverse and well-established biomaterials in the healthcare industry; it can be processed in a variety of ways and offers a wide variety of mechanical properties,” he says. “Silicone chemistry isn’t simply compatible with a host of actives but can be customized to deliver dramatically different customer-specified elution curves.”

Materials for cardiac devices are also the subject of a presentation by Larry D. Hanke, principal engineer at Materials Evaluation and Engineering Inc. (Plymouth, MN). “The reliability of these devices is strongly dependent on the quality and integrity of the materials from which they are manufactured,” Hanke states. “For metals, nonmetallic inclusions are one inherent feature of the material that has a strong influence on the mechanical behavior and corrosion resistance of the device. ” In the presentation, “Characterizing Inclusions in Materials for Cardiac Devices,” Hanke will highlight the company's systematic process for characterizing the size and type of inclusions for common cardiac device metals, which can help determine the reliability of the end product.