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.
ORLANDO, Fla. (PRWEB) June 10, 2021
In direct response to the rapid growth of the recently launched Human Factors + (HF+) program, Noble, an Aptar Pharma company, today 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.
HF+ applies Noble’s deep understanding of the "voice of the patient" to the product launch process in successive activities that include product development, HF regulatory approval, training and onboarding strategy development, and post-market confirmation of training effectiveness.
Noble offers a robust suite of capabilities as part of its HF+ program, which include:
- Regulatory submission support
- Contextual inquiry – observation of users in their environments
- Formative and HF validation studies – iterating usability testing and applying learnings to improve or demonstrate the user interface
- Heuristic evaluations – HF expert review based on experience
- Task, IFU and training analyses
- Threshold analysis – systematic comparison to approved products
- Use-related risk analysis – hazards, severity, harm, mitigations
- Design of drug delivery and medical training devices and prototypes
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.
Noble develops robust onboarding solutions and training devices for the world’s top pharma brands and biotech companies, focusing on fostering healthy patient outcomes for those who self-administer drug therapies. Noble manufactures and commercializes training devices that mimic the exact feel, force and function of drug delivery devices such as autoinjectors, prefilled syringes, onbody, nasal and pulmonary to increase patient adherence and confidence and decrease usage errors. Noble was founded in 1994 and is based in Orlando, Florida. For more information, visit http://www.gonoble.com.
Noble is an Aptar Pharma company, which is part of AptarGroup, Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active material science solutions. Aptar’s innovative solutions and services serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. For more information, visit http://www.aptar.com.