May 8, 2019

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Connected medical device design and develoment paradigm shifting due to impact of Internet of Things (IoT);
  • Closer aligment of human factors research with connected device design and development will help drive adoption rates;
  • Holistic device design approach necessary as IoT impacts healthcare environments more and more.

In the established landscape of the design of digital products, software and UI/UX design is generally broken down into two formats: desktop and mobile. For years, user interactions with “connected” medical devices have revolved around PCs and, more recently, mobile phones and smart televisions.

The Internet of Things (IoT) introduces a break in this paradigm, enabling devices beyond standard PCs, tablets, etc. to not only be digitally connected but to also require users to interact with non-physical outputs. For example, it could be a possibility that a surgical instrument transmits operation information (i.e., number of firings, duration of use, etc.) to a database during a case. The surgical instrument that was once the end-point for the human-machine interaction now becomes a tool for a user to communicate with another system that provides data on device performance. It becomes more of a cycle than a linear process.

When applying the concept of IoT to healthcare, there is a sudden accessibility of knowledge and control of healthcare for patients and their healthcare teams in a way that has not been possible before. For instance, the level and fidelity of data collection on, say, operating room use that humans can obtain simply doesn’t compare to what machines can do. This data can then be translated into something accessible for healthcare teams that may lead to quicker decision making. This raises new questions in the development process:

  • What are some human factors considerations for the design process?
  • How would one design for this?
  • Is some type of button required to “arm” a data transmitter?
  • Is a device “smart” and self-operational?
  • Is a digital screen required to observe function?

With any emerging technology the reception by intended users will determine the success, regardless of how useful the technology is – if people don’t want to use it, they won’t.

Human factors research throughout the device development process will enable designers to incorporate that “human factor” into the product and therefore increase the likelihood of adoption by intended users. However, there are processes within the design development process that also need to be tailored to incorporate the interactivity of the IoT element. IoT thus presents several landscape-shifting questions about design for both traditionally digital and non-traditionally digital products.

The human factor

Use environment - Outside of the usual usability engineering concerns, such as regulatory factors or safety (e.g. lighting levels and distractions), the addition of digital communication between a medical device, a system, and a user adds a new dimension to the use environment. When a medical device is made into a “smart” device, the manufacturer should first consider the use environment and how this communication may impact the surrounding area, i.e., the consideration of the potential for causing distraction to other members of staff.

Intended users – The intended users of devices may shift, whereby a surgeon would be the primary user of a surgical instrument, but it may be that an assistant is required to monitor the outputs from the surgical instrument. Therefore the actual user of the output is the assistant and not the surgeon. The corresponding UI would need to be designed with the assistant in mind, but with an understanding of how surgeons use the instrument.

Data – There is a question of to whom the data belongs. This may seem less of a human factors consideration, but it still considers the users and human interaction with the information. Some questions that would need to be considered early would be: under new Data Protection Legislation, would the patient need to provide their consent before their data is used to inform a smart technology? Is the data the patients or the surgeons?

As IoT becomes more prevalent, designers, engineers, and researchers will need to consider a holistic approach that fully integrates the digital with the physical. No longer will digital design simply apply to desktop and mobile applications, but to every physical product that can be enhanced by connectivity.

Joe Fegelman is Senior Product Designer and Natalie Shortt is Senior Human Factors Specialist at Emergo by UL’s Human Factors Research & Design.

Learn more about human factors, usability and healthcare IoT at Emergo by UL:

  • Human factors design and prototype development support
  • Human factors engineering (HFE) user research for medical devices and IVDs
  • Whitepaper: Applying HFE to wearable medical devices
  • Webinar: HFE for medical devices