Healthcare technology’s transition into the home means that a large number of users will not be clinicians trained to operate the devices. As such, the technology’s design must appeal to the sensibilities of the user, who more often than not will have a layman’s understanding of the device. While it’s true that users could potentially receive training in the device’s operation before use, successful home healthcare technology should be universally both easy to use and appealing. To discuss this, MDT spoke to Laurie Reed, VP of research and usability at Farm. She offered her insights on the design challenges and concerns of human factors engineering for home healthcare technology:

Brusco: What considerations must be made in interface design?

Reed: Interface design must take into account the physical, emotional, and cognitive limitations of its users and the intended use environment. This means developing an interface that’s easy to use by a people with various levels of education, abilities, and experience with medical devices, in many different settings. Imagine a common home medical product such as an inhaler – a device that may be used by anyone with asthma or COPD. This could include children as young as three, elderly adults as old as 93, everyone in between, and their caregivers. The product may be used anywhere, including patients’ homes, cars, workplaces, the outdoors, in public spaces, etc.

There must be a robust set of user requirements and design constraints which reflect the needs of the end users, something which is best achieved through user research. In the case of the inhaler, these design requirements should include intuitiveness, portability, and ergonomic achievement. Preventing error and assisting users in recovering from error is of the utmost importance for any medical device, even more so in a home scenario. Special consideration should also be given to the product’s supporting documentation, including user manuals, quick reference guides, and training videos. These references are key components in the successful use of a home medical device, especially in circumstances where the end user does not receive any form of training from clinicians.

Brusco: What are the challenges of/how important is designing for aesthetics?

Reed: Achieving an easy-to-use and safe design are higher priorities in home healthcare technology, but aesthetics should not be overlooked. An aesthetically pleasing and non-threatening home healthcare device leads to both increased user adoption and compliance. Non-threatening products allay users’ fears about operation outside of the clinical environment. Familiar user interface elements familiar (e.g., ones that mimic well-known consumer products) may feel more approachable by untrained lay users. When users get to choose their medical device rather than being prescribed a specific one by their healthcare professional (perhaps a blood glucose meter), aesthetic appeal may give manufacturers the edge over their competitors. Users don’t want to be seen as “being sick;” they may prefer to use something that could be mistaken for a cell phone or a small consumer electronic device, rather than as a product associated with the stigma of a medical device.

Brusco: How are environmental concerns addressed?

Reed: Identify and define what the environmental concerns are for the specific home medical device. Early user research is critical at this stage. Contextual inquiry or ethnography (i.e., direct observation of the potential use environment(s) coupled with direct user interviews usually leads to a rich set of findings related to environmental needs and issues. These findings become inputs into the design as the team turns them into user requirements and design constraints. For example, when designing a system for drug delivery in the home, user research may indicate that ensuring that the medication is used with an aseptic technique and remains free from contamination will be a key challenge. During concept development, the team will attempt to create designs that address these issues – whether it be a bag system that automatically fills up with the drug aseptically or a housing made out of material which protects the medication from bacterial pollution.

Brusco: Where’s the direction of the market headed?

Reed: As medical technology makes this transition from the clinical space into the home, the application of human factors research and engineering will be critical in ensuring safe and successful use of these devices. In October 2013, an AAMI/FDA Summit was held on ‘Healthcare Technology in Nonclinical Settings’. The five clarion themes identified at the summit included:

• Deepen all stakeholders’ understanding of use environments—and their remarkable variability.
• Coordinate multiple and recurring transitions in care to improve patient safety.
• Adopt a systems approach—encompassing people, workflows, therapies, technology, and payment—to redesign the full spectrum of healthcare in nonclinical settings.
• Standardize and simplify.
• Design with empathy.

All of these themes involve human factors skills or principles. Furthermore, regulatory bodies have recognized the important role of human factors engineering. The FDA, in 2011, released an important guidance document that defines how they expect human factors to be applied to the design of medical devices. And as the EU Medical Device Directives now include requirements for the establishment of a Usability Engineering Process, other countries are starting to adopt a similar stance on usability. The human factors regulatory requirements center largely on safety and ease of use. Ultimately, medical device manufacturers need to incorporate human factors engineering into the design of their home healthcare devices in order to have a successful submission and a safe product.

Brusco: Is there anything else you’d like to say regarding human factors engineering for home healthcare medical technology?

Reed: Some companies worry over the time and costs associated with integrating robust (i.e. iterative) human factors engineering activities into their product development process and instead prefer to pick and choose single activities that are required by regulatory bodies. I have seen companies follow both approaches and routinely it is the manufacturer who involves users early and often that ends up ahead. Investing in human factors engineering from the start results in safer and more usable products, fewer recalls and ultimately a quicker time to market.