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Digital Health: Why Evaluating Human Factors is Essential

With the rapidly evolving technology, digital health is transforming healthcare, emerging as a promising solution to reduce rising healthcare costs and improve patient care. According to ResearchAndMarkets.com, the global digital health technologies market is set to grow from USD 174.7 billion in 2021 to USD 384.8 billion by 2026. Digital health technologies are increasingly more patient-centric as devices are made available for home use by patients. This usage model provides more frequent patient data, and enables early interventions based both on daily monitoring of data by clinicians, together with well-constructed software algorithms detecting early signs of health exacerbations. 

With this transformation comes challenges of user adoption and adherence. Patients with compromised health often have cognitive impairments and may be overwhelmed by technology used in the devices, such as Bluetooth, and may struggle with adoption and/or adherence to new digital health technologies. When this happens, it can negatively impact the value and efficacy of these technologies to patient outcomes and healthcare costs, affecting data quality, data validity and data reliability.

So what can be done to combat user adoption and adherence challenges?

To combat user adoption and adherence challenges, it is necessary to incorporate the evaluation of Human Factors, also referred to as usability engineering, positioning the patient at the centre of the digital health technology development. It is important to understand the intended patient’s needs and related variables such as patient  behaviour, physical and cognitive abilities, technological abilities, accessibility, mobility, anticipated operating environments and other demographic characteristics.  This includes gaining an understanding of how a user may perceive/interpret information, how a user utilizes the software within the use environment, how input is received from a user and how the software responds and provides feedback to the user as a result of actions taken by the user.  Gaining understanding of human factors enables mitigation of potential use error risks, including risks related to technology adoption and adherence, throughout device design and development.

For example, if a patient has dexterity difficulties, it may be challenging for the patient to enter data via a keyboard so your device may need to incorporate an alternate method of data entry to mitigate this risk.  Another example would be if your patient has cognitive issues, it may mean that the patient could forget to use the device so you may need to incorporate some form of reminder mechanism.  Language proficiency could be another concern as vocabularies differ between age groups and other demographic characteristics, so your device needs to consider this in all types of labelling. 

Instructions for use need to be clear enough for patients with impairments to understand the steps they need to take when using the device.  In the past, most medical devices (https://www.iconplc.com/therapeutics/medical-device)  were used by clinicians in hospitals or doctor’s offices; now that this has changed, instructions for use need to target patients without technology or clinical training. 

For digital health devices, as for other medical devices, the primary goal of human factors is to minimize use-related hazards and risks during user interface (UI) design in order to enable the intended users to operate the device safely and effectively in the intended use environment.  The UI consists of all components of a digital health device with which a user may interact including software UI labelling and user labelling.

It is especially important to assess risk related to the use of the digital health device in advance of performing a clinical investigation for if a digital health device’s usability is lacking, user task completion may be hindered and error-prone.  Resulting use errors, especially those that could result in adverse events, can be detrimental to the success of a clinical investigation, even possibly resulting in the need to cancel a clinical investigation. Typically, use-related risk assessment will involve performing a human factors study in advance of the clinical investigation to maximize the likelihood that the digital health device can be used safely and effectively by the patients and/or device users during an investigation.

ICON understands the importance of human factors to the success of digital health and can guide and assist you in your human factors journey with your digital health technology.  ICON can help you build human factors into your device development processes throughout your product development life cycle, including the incorporation of use risk evaluation that looks at the many variables that could pose challenges for the patient adopting and adhering to your digital health device.

Contact us to learn more about how we can support your digital health product development needs.

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