Designing a medical device is not a lighthearted or straightforward task. Every design choice during the development process can influence how the device is used, whether it is effective and if it has the potential to cause its user or intended patient harm.

The vast majority of medical device failures stem from use errors. While this may lead some to believe that the blame lies on the user, the fact is that use errors are frequently the result of unintuitive device design choices.

With this in mind, the FDA and its supporting standards organizations continue to advance effective regulations, standards and guidelines. Developers must embrace proper practices and methods relative to usability research and human factors methods when designing medical devices. But despite their absolute necessity, the sheer number of regulatory and standards documents — and the intricacies of usability research and human factors standards — can overwhelm medical device developers.

Where do you even begin? Start your medical devices development journey by identifying, studying and understanding the most fundamental and essential components of usability research and human factors engineering for the device in question. These three primary, baseline components are the device users, use environment and user interfaces.

1. Device Users

The FDA defines device users as “the intended user group of a medical device” who “should be able to use the device without making errors that could compromise the medical care, patient or user safety.” Device users are the first consideration developers must identify and address. A medical device’s user groups can be highly variable depending on the device type. Often, they extend beyond the patient.

When evaluating a user group’s ability to operate a device, human factors engineers must observe and document a wide range of unique criteria. They need to consider users’ physical characteristics, such as size, strength, stamina, dexterity, flexibility and coordination, as well as sensory abilities and cognitive abilities such as memory. Other usability factors to be considered for the device/user relationship include the proposed device’s method of communicating information concerning the patient’s status, the disorder the device will be used for, and any patient comorbidities.

2. Use environment

Use environment for a medical device is the second essential baseline component for medical device usability research professionals to identify and study. Environmental conditions can significantly impact how a device should be designed and used. Of equal importance is to keep in mind that there can be a wide range of environmental settings in which care may be provided. While some devices are intended for clinical environments, others find use in patients’ homes and other non-clinical environments. Additionally, medical devices have been designed for use within the most challenging uncontrolled environments, including moving vehicles.

You must consider a wide variety of use environment conditions when establishing a complete picture for a medical device’s design. For example, environmental lighting can make it difficult to read displays or identify controls. High ambient noise levels may prevent the user from hearing important device feedback or cause a user to mistake one alert for another. If an environment is heavily cluttered with equipment, a device’s maneuverability can be compromised, and users may become distracted.

3. User Interface

User interface for a medical device is the third — though no less critical — essential baseline component. When applying usability research to medical devices, the FDA defines the user interface as including “all points of interaction between the product and the user, including elements such as displays, controls, packaging product labels and instructions for use.”

Software as a medical device (SaMD), graphical user interfaces (GUIs) and the Internet of Things (IoT) have become more common. Therefore the scope of usability research must support emerging digital disciplines together with the physical device design and controls. Development professionals must consider that a medical device’s user interface could be used at any time during setup activities like unpackaging and calibration, during device operation and while performing maintenance.

The natural manifestation of usability research, observations and data collection during the early development stages should reveal the opportunity zones for a medical device’s user interface design. User interface discoveries yield appropriate information delivery systems as well as device size and shape, particularly in handhelds, wearables and disposables. A well-designed user interface will also inform the cognitive logic workflow of the overall user-system interaction. This includes the how, when and why for a medical device to provide information and feedback to the user.

It can also make sense to identify hardware components intended for device operation like switches, buttons and knobs — and any accessories or components connected to the device or patient. Device user interface considerations should also include any components that connect, reposition, configure or manipulate the device. Lastly, usability information collected should also inform the design of device packaging, labeling, operating instructions and training manuals.

Supporting patient safety

With healthcare moving forward with the combined forces of patients, healthcare professionals, legislation, technology and marketplace influences, it is clear that we are at the precipice of monumental shifts in healthcare and its delivery.

As these shifts occur, we must support user and patient safety as a top priority through effective human factors engineering and usability development methods. The future of healthcare truly lies with the development of devices with designs centered on the safety, needs, desires and challenges of their users.

Gregory Montalbano is the principal of MIDI, a turnkey product development consulting firm specializing in the design and development of medical, biotech, life sciences and home healthcare devices and systems. With 30-plus years of experience, Montalbano has serviced clientele ranging from startups and emerging companies to Fortune 500 organizations representing industry segments from both domestic and international markets.

Article source: MDO