Noble, an Aptar Pharma company and provider of drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, has launched “Human Factors Plus” (HF+), a service aimed at 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 optimise safety and efficacy while minimising use errors and the risk of adverse events. The “Plus” in Noble’s HF+ program comes from its research and experience in understanding the needs and concerns of patients who have self-administered drug therapies. In addition, Noble can provide clients with “one-stop shopping” through patient training devices and onboarding platforms, training utilisation 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 maximise 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.
Kevin Cluff, senior research human factors engineer for Noble, said: “Human factors engineering provides empirical and analytical evidence that a device and its labelling can be used safely and effectively by the intended patient. 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.”
Tim McLeroy, executive director of marketing and patient services, added: “Noble is proud to be the voice of the patient and to support the patient across every stage of their journey. 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.”
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.