The S3 Challenge Conference
AAMI and the U.S. Food and Drug Administration (FDA) today announced plans for S3 Challenge 2014—a dynamic new conference set for March that will focus on how to improve the safety of healthcare technology and reduce the time it takes to bring new medical devices to market.
The keywords for the S3 Challenge 2014 are standards, synthesis, and solutions.
“We are excited that this approach will allow us to address constructively those issues that complicate the path to standards compliance, and therefore patient safety,” stated Carol Herman, AAMI senior vice president of standards policy and programs.
The inaugural conference will focus on three broad issues that affect most medical devices: biocompatibility, sterility, and risk management. In addition, participants will explore how the combination of these three factors can apply to a specific class of device.
The conference will bring together industry compliance, design, engineering, and quality systems professionals to work side by side with FDA staff to analyze contributing factors for each issue. Participants will then recommend actions and solutions that address each. AAMI and the FDA plan to release a report on the conference that details the work and recommendations for each issue.
“This is a unique opportunity to positively impact standards and also provide direct feedback to the FDA on specific compliance issues,” Herman added. “Both industry and government want standards that are clearly understood and workable, and the S3 Challenge should help to achieve that.”
S3 Challenge 2014 is scheduled for March 11–12, at the Hyatt Dulles in Herndon VA. More information is at www.aami.org/s3.