Medical devices worn outside the clinic must be designed differently than those designed for clinic use. Here are several factors to consider when planning for a successful wearable or smart device development effort.
Tom KraMer, Kablooe Design
When developing new, innovative medical devices, designers and engineers have always had to take into account the needs of physicians, nurses, technicians, hospital and clinic buyers, and the patients. These considerations allowed them to make a device that would be properly used and adopted.
The rise in patient-worn and -operated devices dictates different needs than those of the past. Many are used at home or in public, and device designers must take into account the environmental challenges posed by these settings. They include:
- Weather, e.g. moisture and temperature;
- Abuse (asphalt, trees, bleach, shampoo, motor oil);
- The ambulatory nature of the user in the space.
These challenges pose new and different ways that a user could break or abuse a device that might not be possible in the clinical setting. Finding a way to study the users in their environment is critical for success. Here are some of the several factors to consider when planning for a successful wearable or smart device development effort.
Perhaps the most important thing to consider is device adoption. Without this, you have no sales, and your innovation will not reach those whom you intend to help. Let’s face it, no one will want to continue to use your device if it is difficult to operate in the home or in a public setting. They can just take it off, leave it behind, or turn it off, and no nurse will be there to put it or turn it back on.
The users we are targeting with home healthcare devices need to figure out how to use it themselves. Even if they have a bit of initial training from a caregiver, when they are on their own and have a question or a problem (which they will), they most likely don’t have the medical training that their caregivers do and will have to figure things out for themselves. We must target our device features to be used and understood by this population.
Do the research
One of the best ways to do this is with ethnographic research. An ethnography is an observational episode in which the developer or researcher watches users interacting with the predicate device or situation to learn about the users’ needs during this episode of care. Ethnographic research can often be done during the course of product development and used as early formative studies. Finding usability data early and showing how your design fulfilled the user needs uncovered in the data does three things:
- Generates input to direct the design of your device;
- Helps you design a device that users won’t quit using;
- Creates a formative study to supplement your FDA submission.
A good action plan for the proper development of in-home, wearable, connected devices must include these steps:
- Conduct observational research with all types of users;
- Find pain points by watching and probing, not asking for answers;
- Convert these pain points to design inputs;
- Use the design inputs as part of your design requirements;
- Let all early, front-end development work use these inputs as a checklist for success.
Employing these principles will greatly increase the chances that users will successfully adopt your device, comply with the usage requirements and see better outcomes. It may also help you get to market more quickly and realize a more successful product launch and lifecycle, too.
Tom KraMer is president & CEO of Kablooe Design, a design and development firm for medical and consumer products.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design and Outsourcing or its employees.