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Noble Launches Human Factors Engineering Services to Support Product Development and FDA Approval of Med Devices and Combination Products

Human Factors Plus (HF+) is an extension of the company's understanding of the patient experience when it comes to self-administering drug therapies.

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Noble, an Aptar Pharma company and provider of drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, announced 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 “Plus” in Noble’s HF+ program comes from the company’s extensive research and experience in understanding the needs and concerns of patients who self-administer drug therapies. In addition, Noble can provide clients with “one-stop shopping” through patient training devices and onboarding platforms, training utilization programs, training Instructions for Use (IFU), video programs and product launch strategy programs.

The 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. Device deficiencies can result in a delay in patients receiving otherwise effective treatment, and lost time and revenue for the sponsoring company. In the competitive medical healthcare environment, delays can also mean lost market share that is difficult to recover.

“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. “This process involves testing the numerous touch points where patients interface with a drug product, including packaging, IFUs, prescribing information, quick reference guides and device indicators and controls.”

“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 customers and their combination products.”

Noble’s HF+ capabilities include:

•          Strategic planning for regulatory approval pathways

•          Contextual inquiry – observation of users in their environments

•          Formative and summative 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 benefits of human factors engineering 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. It also helps reduce the risk of user errors, product complaints and recalls.

Noble’s human factors capabilities broaden the existing range of value-added benefits from Aptar Pharma Services. These new services also complement Noble’s expertise in conceptualization, design and development, mechanical/electrical/software engineering, project management, quality management, manufacturing, commercialization and logistics services, as well.

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