By Tom KraMer, president and CEO, Kablooe Design
Mitigating risk is one of the cornerstone activities of medical device design. The FDA’s goal is to only approve devices that are safe and effective, which means all risk would necessarily be removed from the use of the device. However, the definition of “safe” can be debated among developers because all risk can never be fully removed from any device. No matter how safe you make your device, if I want to poke myself in the eye with it, I can find a way if I really try.
With the surge in home healthcare these days, the topic of risk mitigation is becoming increasingly important, especially as it relates to home and remote healthcare devices. Designers now have to approach risk very differently than when devices were being designed solely for use by clinical personnel. This rise in home healthcare is driving the need for increased risk scrutiny for a few reasons.
First, the U.S. and many other countries are seeing a sharp rise in the number of seniors in their populations This means more people want to address their healthcare issues from a “healthy at home” standpoint, so the desire to address issues outside of the clinical environment is rising.
Pushing this desire to even higher levels is the pandemic. The psychological programming to alleviate boredom and seclusion by getting outside and being active is so pervasive that even folks who usually spent most of their pre-pandemic time inside are now finding a need to get outside… a very positive effect in the circumstances. This has also led people to want to monitor their health conditions while they are active and away from a clinical environment.
We have also seen an amazing convergence of clinical technology and consumer devices in the last decade. This has created a consumer appetite for healthcare items that users can obtain outside of the healthcare system, which can also produce risks due to the lack of clinical training with the device. Add to this the affordable care idea of penalizing hospitals for patients returning within 30 days of discharge, and you end up with a large number of people who have little or no clinical training interfacing with devices that affect their health outside of the clinical environment.
When we design devices for home or consumer use, there are many unique risk-related challenges we have to think about. Some of the most obvious are:
- How do we handle private medical information over digital networks?
- How do we prevent hacks into and breakdowns of devices over digital networks?
- How do we make sure the device is simple enough for a senior home user but sophisticated enough to provide quality data/services?
- How are we going to ensure sufficient manpower is available to screen data if we are generating more of it?
- If it is a constant use device, how can we ensure it is being used safely when care nurses are not with patients at all times?
- How can we get data to be useful across many information platforms?
- How can we make the use scenario well understood by seniors?
I would like to suggest four activities/mindsets that device developers can engage in while designing devices that can help mitigate the risks involved with failures in the seven areas above:
- Get a good understanding of what the end user really needs. We hear a lot about user needs, and the FDA mandates that we do verification testing to these needs. But understanding what the user really needs to be successful with the device can be a much deeper endeavor than most developers realize, including using ethnographies and other observational techniques to see what users actually do, rather than relying on what they merely say they do. Deep insights lead to strong innovations that reduce risk.
- Understand situational differences among demographics. A clinical device that a technician uses may have only one demographic, while a home-use device with the same function may have multiple demographics. Each of these users will live and operate in a different environment, using a different mindset, and will have different limitations and capabilities. Understanding these differences is the first step to solving the associated risk problems. Observational research with each of the different demographics is the key to this understanding.
- There is no replacement for the personal touch. In the quest to have technology solve our healthy at home needs, let’s not forget that so much more is learned about a patient through personal interaction. Whatever new technology you are developing, leave in the ability for a personal touch between caregiver and patient. You might get data from your device that tells you the patient has an elevated heart rate, but how will you know that it is due to worry over whether the patient’s dog will come back when she lets him out into the yard to go to the bathroom? What will your device do about that? Probably nothing. That takes a caring advocate in human form to help.
- Lastly, don’t design your device to randomly send data to some magic place in the cloud. That system is filled with people who have full-time jobs doing something else. And that system probably cannot afford to add more workers, especially the way hospitals are hurting financially right now. Make sure data gets sent to the appropriate people at appropriate times. Perhaps family members or other caregivers should be getting notifications first, before data gets sent to the doctor in the sky who has nothing better to do than wait around for data to come in from the millions of people using your device.
If you keep these things in mind at the inception of your project, and all throughout the development timeline, your homecare device should bear the honor of reducing risk and being safe and effective. I like to remember what I think of as the inverse rule, which claims that the more likely you are to need technology, the less likely you are to be savvy with it. I think of this when my elderly parents ask me for help with their email or when I ask my kids for help getting text on a video for my Instagram post.
About The Author:
Tom KraMer, president and CEO of Kablooe Design, has been a product innovator for over 30 years. He holds a certificate in master of product development from Northwestern University and a bachelor’s degree in industrial design from the Minneapolis College of Art and Design (MCAD), as well as a certificate from Stanford University’s Cardiovascular System in Health and Disease program. KraMer has created revenue for countless customers by delivering innovative product solutions to their portfolios. He spearheaded the D3 Process (Design Driven Development), a vehicle to provide these results to customers, and he teaches this process by traveling as a lecturer and speaking about innovation and development processes.