In direct response to the rapid growth of the recently launched Human Factors + (HF+) program, Noble, an Aptar Pharma company, announces the appointment of two new members to its internal HF+ team. In the four months since launch, the HF+ service has experienced this growth across each of its patient-administered medical device programs.
Current HF+ projects for clients include formative studies, threshold analyses and use-related risk analyses for biopharmaceutical companies, whose patients use autoinjectors, prefilled syringes and nasal drug delivery devices to self-administer their drug therapies. In addition, Noble 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.
“The strong response to our HF+ service offerings is an indication of the crucial need for biopharma companies and original equipment manufacturers to understand the user experience across the entire lifecycle of a medical device, beginning with product development through regulatory approval and post-market analysis,” said Tim McLeroy, Noble’s executive director of marketing and patient services.
To support the rapid growth of the HF+ program, Noble has expanded its team and added two new HF-focused positions to better serve its clients. These two new team members bring human factors engineering experience to support the growing demand for Noble’s HF+ service offerings:
- Aditya “Adi” Jagannathan, Patient Services New Business Development Manager brings a decade of experience in developing combination products for leading pharmaceutical companies, including eight years of human factors engineering experience. Most recently, he served as clinical and human factors program leader for a global medical device company, where he led clinical product safety, efficacy and usability development for wearable drug delivery devices. Jagannathan holds a Master of Science in biomedical engineering from Northwestern University.
- Mikey Brogdon, Senior Human Factors Specialist is responsible for human factors research and project development. Prior to Noble, Brogdon worked as a research consultant, providing Fortune 100 companies with human factors and user-experience research services as moderator, lead researcher and project manager. He holds a Master of Science in human systems engineering from Arizona State University.
“Expanding our HF+ team was essential to continuing our mission to be a single source partner, leveraging the voice of the patient throughout the entire product launch process,” added McLeroy. “The addition of Adi and Mikey will broaden the range of value-added benefits Noble and Aptar Pharma Services can deliver to our clients and their patients.”
Noble has traditionally developed training devices and onboarding solutions for pharma and biotech companies. As it expands its services for clients, Noble’s patient-centered approach focuses on fully understanding patient needs and providing data as well as anecdotal information to help ease the burden and anxiety connected with self-administration.
The U.S. Food & Drug Administration (FDA) considers human factors engineering an essential component for drug delivery and medical device product development. It 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.