The challenges of medical manufacturing, from evolving quality system requirements to determining whether to outsource a technology or keep it in house, will be explored at free conference sessions during the upcoming Advanced Design & Manufacturing (ADM) Expo in Cleveland, OH. The trade show and conference comes to the Huntington Convention Center of Cleveland on March 7 and 8.
A panel discussion on March 7 will dive into ISO 13485 certification, including the latest version of the international standard for medical device quality management systems. ISO 13485:2016 introduces a number of revisions that medical device manufacturers and their critical suppliers must implement if they are to achieve compliance by the March 1, 2019, deadline. First and foremost is a broadening of risk management principles to include all aspects of a quality management system. The panel also will discuss the benefits of ISO 13485 certification in terms of access to global markets and how certification can help meet regulatory requirements and customer expectations. Consultant Laura Green will moderate the conversation and panelists include Dominick Villani, Vice President of QA/RA at Enable Injections; Christopher Basil, Technical Program Manager for ISO 13485 at Smithers Quality Assessments; and Ken DiFranco of Manufactured Assemblies Corp.
Also on March 7, Jeff Ellis, Principal Research Scientist at Battelle, will discuss how to reduce risk and avoid product recalls through the appropriate use of materials science. He will identify common deficiencies in material property data sheets and illustrate common themes in material failures with case studies.
On March 7 and 8, ADM Cleveland attendees can participate in à la carte hands-on workshops articulated around design-driven development led by Minneapolis-based design bureau Kablooe. President and CEO Tom KraMer and Director of Design & Development Brian Mullins will lead three 30-minute workshops devoted to identifying product gaps and performing user analysis, brainstorming and sketching concepts that lead to real results, and creating mockups and simulated use tests. The focus will be on innovating health-related wearables that win in the marketplace, according to Kablooe. Attendees have the option of attending individual 30-minute sessions or participating in all three.
3D printing has found fertile ground for innovation in the medical space, and a panel of experts will discuss some of these advances during a session—“Building the future one layer at a time”—on March 8. Panelists include Thomas W. Hughes, CEO, FibreTuff Medical Biopolymers LLC; Pete O'Neill, Executive Director, Cleveland Clinic Innovations; and Dr. Jayanthi Parthasarathy, PhD, Manager, 3D Printing Lab at Nationwide.
Deciding whether to outsource or keep a technology in house depends on a number of factors beyond simply cost. A panel discussion on March 8 will debate the pros and cons and articulate best practices and strategies for companies wrestling with this decision. Moderated by Vijay Iyer, Vice President of Business Development at BioEnterprise, the panel includes Bill Flickinger, CEO and Managing Partner at MedInvent LLC; Dave Lapeus, Director of Design Engineering, Sparton; and Karen Spilizewski, Vice President of Medical Devices at BioEnterprise.
Numerous conference sessions at the event will explore various facets of smart manufacturing, including artificial intelligence applications and automation, and battery technologies. More than 250 suppliers of materials, equipment, products and contract services will display their wares in five dedicated expo zones: PLASTEC, MD&M, Design & Manufacturing, Pack and ATX Automation Technology.
Cheers star and indefatigable advocate of U.S. manufacturing John Ratzenberger is scheduled to deliver a keynote address on March 7 at 1 PM.
For more information about ADM Cleveland, go to the event website.