Modernizing usability testing for medical devices, why decentralization works.

Since the beginning of the pandemic, researchers have made an important shift towards the adoption of decentralized methods in clinical studies. While 50% of monthly in-person trial starts were declined from January to April 2020, the industry saw the highest quarterly utilization of decentralized methods in Q4 2021. Decentralized clinical trials (DCTs) are steadily becoming an innovative clinical research strategy.

In the medical device industry, providing real-world data about the safety and effectiveness of a new product during usability testing studies is critical for FDA approval and user acceptance of the device. A decentralized usability testing model widens access to diverse user populations, sheds light on user’s perceptions, examines the real-time interactions between patient-device, and enables manufacturers to optimize the onboarding process.

In our increasingly digitized ecosystem, some medical device companies have begun to move towards developing consumer products that encourage users to manage their own health. For example, think urine tests which detect cholesterol levels, monitoring technology that track blood glucose levels, or pulse oximeters that wirelessly measure blood oxygen levels.

Medical devices range in size from miniscule wireless devices to heavy machines to software products and AI modelss. They can vary in function from assistive technology (prosthetic knees) to remote monitoring devices (blood pressure cuffs); and differ in risk from a class I, low-risk walker to a class III, high-risk pacemaker. With over 1,700 different generic types of devices and 16 medical specialities, the FDA assigns a classification to your medical device. Classification depends on intended use, indications for use, and risk to the patients or other uses. Learn more about your device’s classification here

 

Decentralization ensures you’re reaching all your users. 

Virtual trials allow you to reach a wide array of participants who could use your device. A recent study found that demographic differences influence the safety and effectiveness of medical devices. Traditional in-person clinical trials often lack diversity in research participation, particularly that of women, people of color, and elderly populations, so the approved medical devices may sometimes only be safe and effective for the tested demographic subgroups. 

A decentralized usability testing model also enables you to target a diverse pool of participants from high-risk groups who are unable to leave their home setting to patients geographically and financially constrained. Increased diversity of participants improves sample representativeness, data accuracy, and result generalizability.  

 

Real-world, perception-based data at your fingertips. 

Decentralization also enables you to receive both efficient survey data and enhanced perception-based data, so that you understand your user’s behavior and your device’s usability. In most cases, manufacturers and developers have little to no direct contact with their users. In fact, device users are not the direct purchasers of the product. The device provider or supplier is usually the physician or healthcare professional. 

In a decentralized usability trial, you have immediate access to data about the user’s real-time routines, behaviors, and interactions with devices, including times and duration of use, ease of use, user adherence to the device’s uses. Through personalized feedback, the patient's direct involvement in the usability trial increases, thereby enhancing the generation of high-quality personalized data. 

Another benefit of decentralized usability trials is that it ensures that both the end-users receive the training to use the device correctly and the manufacturers understand and address the users’ concerns with the device. This virtual form of usability testing thus takes into account the real-time interactions between the patient and medical device.

 

A peek into what really goes on at home. 

Medical devices should be tested in the environment in which they are going to be used, to accurately measure their real-world effectiveness and incentivize developers to build safe devices. While they have traditionally been tested in structured, brick-and-mortar clinical settings, medical devices aren’t only used in hospitals or clinics; they’re used at home, work, in transportation systems, schools, entertainment venues, all of which present challenges for device use, effectiveness, and safety. 

In the case of a home setting, decentralized usability studies examine the possible constraints of the home environment. For example, they may take into account the quality and accessibility of utilities, space available, light and temperature levels, household members, and presence of pets or other occupants. To consider these variables, there is a greater need to understand how different user characteristics and settings affect usability; decentralized research methodologies make this possible. 

A recent study found that medical products, designed for at home environments, are more likely to present challenges to the user. For example, infusion pumps in the patient’s home have higher rates of user-device interface issues and are thus more difficult to manage. Decentralized usability testing informs the researchers of design issues, prevents any potential for patient injury, and provides a better understanding of home-related risks.

 

Characterize your patient onboarding experience.

Finally, decentralization helps increase ease and efficiency of onboarding for a usability study. Often, virtual trials can shift the focus from the physical location of the clinical trial to the patient’s experience using an app or digital platform. In a usability study, you’re often testing the user’s understanding of the interface, their interaction with the device, and the sharing of content and medical information from provider or device to patient. Decentralization gives you the unique flexibility to rapidly design controls, buttons, and screens in a way that increases user engagement and retention. 

Regardless of user capabilities, more people are using medical devices at home and away from a purely clinical setting. As medical costs continue to increase, decentralization is proving to be the most efficient, cost-effective, and accurate strategy to design user-centric devices and mitigate any user, device, and environmental concerns. 

 

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