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— Aptar Pharma, a global leader in drug delivery systems, services and active packaging solutions, and Noble, an Aptar Pharma company, world leader in drug delivery training device programs, today announced their collaboration with dne pharma, a leader in addiction medicine in Northern Europe. Noble’s Unidose trainer kit, which replicates Aptar’s Unidose device, will be used by dne pharma as part of a broad patient onboarding and awareness program for Ventizolve® in outreach and drug treatment centers across the Nordics – Aptar Pharma’s Unidose Liquid System is the drug delivery device used to administer Ventizolve® and is a ready-to-use, one-step nasal device designed to enable the delivery of a precise, single dose quickly, easily and reliably, and without the need for administration by a trained professional. Noble is providing the training and onboarding component with its Unidose training device that replicates the form and function of Aptar Pharma’s Unidose drug delivery device.
– 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 associated cost estimate of human error, based on the percentage of errors attributed to human error from the U.S. Food and Drug Administration (US FDA) recall and adverse event databases, is $48 million annually, with most due to labeling design, employee error and software-use environment issues. 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.
– Noble, an Aptar Pharma company and world leader in providing drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, today announces the launch of “Human Factors Plus” (HF+), an expanded service to further optimize the patient self-administration experience by supporting its customers in bringing new products to market. HF+ combines the application of human factors engineering with Noble’s expertise in developing patient-centric training solutions and onboarding platforms to advance the development and testing of new self-administered medical products that optimize safety and efficacy while minimizing use errors and the risk of adverse events. The U. S. Food & Drug Administration (FDA) considers human factors engineering an essential component of product development for drug delivery and medical devices and recommends making it a robust part of the design control process to maximize the likelihood that a new device will be safe and effective for its intended users and use environments. Human factors engineering provides empirical and analytical evidence that a device and its labeling can be used safely and effectively by the intended patient,” said Kevin Cluff, Ph. D., senior research human factors engineer for Noble, who holds a doctorate in mechanical engineering and has more than 25 years of human factors experience.
– Noble, an Aptar Pharma company and world leader in providing drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, today announces the launch of “Human Factors Plus” (HF+), an expanded service to further optimize the patient self-administration experience by supporting its customers in bringing new products to market. HF+ combines the application of human factors engineering with Noble’s expertise in developing patient-centric training solutions and onboarding platforms to advance the development and testing of new self-administered medical products that optimize safety and efficacy while minimizing use errors and the risk of adverse events. The U. S. Food & Drug Administration (FDA) considers human factors engineering an essential component of product development for drug delivery and medical devices and recommends making it a robust part of the design control process to maximize the likelihood that a new device will be safe and effective for its intended users and use environments. Human factors engineering provides empirical and analytical evidence that a device and its labeling can be used safely and effectively by the intended patient,” said Kevin Cluff, Ph. D., senior research human factors engineer for Noble, who holds a doctorate in mechanical engineering and has more than 25 years of human factors experience.