University-led organization aims to improve medical device efficacy through human-centered design
Noble, an Aptar Pharma company, has joined the Human Factors MEdical DevIce Consortium (hfMEDIC), whose mission is to engage industry and universities in a partnership to develop safer and more effective medical devices through human-centered design. Led by the University of Utah, the consortium also includes academic partners North Carolina State University, Rice University, San Jose State University and the University of Maryland, and industry partner AbbVie.
The global market for medical devices is approximately $436 billion, bolstered by an aging global population, according to data from hfMEDIC. The associated cost estimate of human error, based on the percentage of errors attributed to human error from the U.S. Food and Drug Administration (FDA) recall and adverse event databases, is $48 million annually, with most due to labeling design, employee error and software-use environment issues.
hfMEDIC envisions an integrated multi-disciplinary team that builds on the strengths and resources of all stakeholders (for example, patients, healthcare providers, industry, academia and regulators) to address this critical need to reduce errors through human-centered design. The Institute of Medicine has recognized that the solution must include human factors, a scientific discipline that considers the limitations and capabilities of the people who use the devices so that the design results in accurate and safe performance. These limitations can be addressed by bringing together the expertise and resources of universities and industries, which is the purpose of hfMEDIC.
Noble, a world leader in providing drug delivery training device solutions for biopharmaceutical companies and original equipment manufacturers, recently expanded its services to include Human Factors Engineering (HFE). In doing so, Noble aims to better help its customers meet the needs of their patients by advancing the development and testing of self-administered medical products to optimize safety and efficacy while minimizing use errors and the risk of adverse events. The benefits of Noble’s Human Factors Plus service offerings include producing easier-to-use devices, better patient understanding of how the devices operate, more effective and efficient training, improved patient compliance and medical outcomes, and the reduced risk of use error, product complaints and recalls.
“hfMEDIC is doing important work to connect the needs of the industry with the expertise of a network of researchers,” said Tim McLeroy, Noble’s executive director of marketing and patient services. “We’re honored to be a part of this consortium and serve as a consulting resource for medical device manufacturers looking to improve usability and safety of their products.”