Human Factors + (HF+) is a natural extension of Noble’s deep understanding of the patient experience relative to self-administering drug therapies
By Tim McLeroy, Executive Director of Marketing & Patient Services
The global market for medical devices is approximately $436 billion, bolstered by an aging population, according to data from hfMEDIC, the University of Utah-led Human Factors MEdical DevIce Consortium. The associated cost estimate of human error relative to use of medical devices—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.
To help combat the causes of these startling numbers, Noble, an Aptar Pharma company, recently announced an extension of its services for its clients—from patient training and onboarding programs and services—into human factors engineering with its Human Factors + (HF+) service.
The benefits of human factors range from producing easier-to-use devices and better patient understanding of device use, to more effective and efficient training that improves patient compliance and medical outcomes. Human factors engineering also helps reduce the risk of user errors, product complaints and recalls.
The “Plus” in Noble’s HF+ Program
The additional benefits that Noble provides its clients beyond core human factors capabilities include becoming a single source partner working with clients throughout the entire process from delivery device selection to post-market assessment. This can help to simplify a client’s supply base, leverage insights at each step in the human factors process, and can create a bridge between a client’s device, regulatory and brand teams. In addition, Noble has access to and a strong understanding of the “voice of the patient,” which enables Noble to capitalize on learnings at multiple points in the product development process. Finally, Noble is uniquely positioned to leverage its experience and understanding of training analogues as a critical discovery tool.
Noble’s HF+ capabilities include:
- Consultation: Assess the device risks and define user groups to formulate a regulatory study and submission plan.
- Risk Assessment: Collaborate with the client to analyze user data and generate the requisite risk assessment documents.
- Formative Studies: Define the studies needed to collect critical inputs from statistically valid user groups.
- HF Validation Studies: Protocol development and execution for the Human Factors Validation Study for regulatory submission.
- Regulatory Submission Support: Collaborate with the client’s regulatory teams to draft the Human Factors Submission Report and support the client with regulatory queries.
- Training Strategy Program Development: Assist clients in developing a patient training and onboarding strategy that will help to optimize patient adherence based on the study results.
Noble’s Expansion Offers Further Support for Clients
Noble has traditionally combined its knowledge and understanding of the patient’s needs and anxieties along with its design and engineering expertise to develop and commercialize training devices that mimic the exact feel, force and function of the real drug delivery device—including autoinjectors, prefilled syringes, nasal devices and pulmonary devices—in order to help increase patient confidence and adherence self-administering drug therapies. In addition, Noble assists brands with training utilization, training device Instructions for Use (IFUs) and product launch strategy programs to support both the devices’ end users and to help brands optimize their performance.
This new service further optimizes the patient self-administration experience by supporting Noble’s pharma clients in bringing new products to market. In addition to Noble’s HF+ program, Noble has joined the hfMEDIC consortium to leverage the organization’s resources and to provide comprehensive human factors services to clients.
Noble’s human factors efforts also broaden the existing range of value-added benefits from Aptar Pharma Services. Noble’s new HF+ services complement Noble’s expertise in conceptualization, design and development, mechanical/electrical/software engineering, project management, quality management, manufacturing, commercialization and logistics services as well. In addition, it enhances the organization’s commitment to providing pharma brands with the resources that can help to deliver optimal performance of their devices while meeting the needs of the patients.
“Noble is proud to be the voice of the patient and to support the patient across every stage of their journey,” explained Tim McLeroy, executive director of marketing and patient services. “We understand how to leverage the application of human factors engineering and we know how to build a better patient experience. Together, HF+ engineering and building a better patient experience are a powerful combination to support product development and FDA approval for our clients and their combination products.”
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