3 Questions That Can Define Your Medical Device User Needs
David Rutledge
CEO & Founder of Global Strategic Solutions, LLC | PRRC for the Medical Device Sector | Best Selling Author, Mythical Medical | Podcast - What's in Your Strategy? | Lead Auditor ISO 13485 | Notified Body - BSI Trainer
If you've ever struggled to use a website or app or wondered why your provider's patient portal feels like a chore every time you log in and find new information, you've experienced user design flaws that derail technology. As medical devices become more integrated with technology, user design becomes increasingly important.
?Your device is actually like you: a cohesive, integrated set of experiences. You like to be understood and easily get along with friends, right? It wants friends too.
Take your time with your device to make that happen. After all, you don't want to spend months and millions of dollars on R&D only to have your medical device fail when it hits the market. To nail your user design, take your time exploring these questions that will put you in the end-users’ shoes.
What Does Your Medical Device Do?
The purpose of your medical device will dictate a lot of user design choices. For example, a blood glucose monitor that needs to be simple and easy to decipher for people of all ages and technology levels will be different than a fitness tracker designed for a younger, tech-savvy generation.
From deciding how simplistic the controls should be to how many features you can load onto the device, every decision depends on who will be using it. We recommend that you start with profiling the target audience for your intended device and then invest heavily in market research to get the data right.
A secret to your device's initial success will be to limit bells and whistles for the next iteration. Keep your initial product simple and easy to use.
Related: Are you interested in learning more about how the EU MDR affects medical device manufacturing? If so, learn more about this upcoming book release from David R. Rutledge. Follow this story of intrigue and redemption within an up-and-coming manufacturer, Mythical Medical?. Coming soon!
What Features Are Important?
You'll gain helpful insights on what features are essential as you compile market research. This is a step you absolutely should not skimp on. Start by conducting a thorough competitive analysis to identify existing comparable products. Scour product reviews and complaints on those products to identify opportunities to execute a better design.
Interview as many target users as you can to understand their needs first. These market research interviews should be conducted from a place of empathy. While you will eventually use the data you collect to make design decisions, the only goal of the interviews is to understand needs.
Make sure that you get your target users right. Spend time observing target patients as they interact with similar products or otherwise manage their conditions. Conduct trials in a lab setting to test possible features and then duplicate those experiments in the field. The end product will work best if designed for a specific group of users rather than a broad subset.
Diligently document all your research findings and then translate that data into actionable design goals. This is where your features list begins to take shape.
For example, if you are designing a medical device for it to be used while sleeping, it may be necessary to operate quietly. But 'quietly' is an ambiguous term. You'll want to go one step further and identify what 'quietly' means and set parameters for noise levels in decibels. This detail will help the design team create prototypes that match your goals exactly.
How Will Users Interact With Your Device?
It's vitally important to the success of your device that you do not make assumptions about what users need from your device. Every user needs a simple interface, but simple can mean different things to different people. Elderly users need minimal options, large buttons, and high-contrast text for simplicity. Tech-friendly users will appreciate more features as long as they are accessible and intuitive.?
Think about how users will interact with your device. If they only need to power on and power off, then focus on the placement and function of the power button. You might also consider adding a power light to provide visual confirmation that the device is on or off. If the user takes and stores readings in the device, you will need a simplistic navigational menu that allows them to move between their current reading and their history of readings. And if the user is primarily medical field personnel, you might use technical language, whereas patient-facing interfaces should use the common language.
领英推荐
?Focus on answering these questions:
The problem with user design is that we are full of our own biased assumptions regarding our inventions. Inventors spend a lot of time thinking about things and deciding how they should work. And it feels foreign to interview target users or hold focus groups to find out if people would rather hear a beep when they press a button or feel a vibration. Regardless, you must let go of your agenda and spend a fair amount of time getting acquainted with real users' needs.
Don’t Read These Two Books (Not really.)
As a young father, I learned a simple trick to use on my teenage children. I would tell them not to do something, knowing that would be the first thing they would do. I am not a young father anymore, and you are certainly not a teenager.
There are two books that I would recommend for those of you interested in learning more about this fascinating and critical topic. Applied Human Factors in Medical Device Design edited by Mary Beth Privitera (ISBN: 978-0-12-816163-0) and Humanizing Healthcare – Human Factors for Medical Device Design (ISBN: 978-3-030-64432-1) authors RJ Branaghan, JS O’Brian, EA Hildebrand, and LB Foster.
No, I don’t receive royalties from this recommendation; just the immense pleasure of pointing you to wonderful resources. I am addicted to learning, and I know you are too. I hope this “fix” is as memorable for you as it was for me.
The Takeaway On Defining Medical Device User Needs
Creating a useful medical device can improve or even save lives. When they work well, they are helpful and widely used. But the medical world has seen more than its fair share of flops. User design failures are the quickest way to tank your medical device invention and sentence it to a life of obscurity, from tedious interfaces to devices that you can't seem to figure out. Given the time and money that goes into development, that's not the ending anyone is hoping for. But the good news is that taking the time to understand what users need from your device can keep you from making that mistake.
Do you need help with identifying medical device user needs? Let’s talk. We value, honor, and respect this critical element of R&D.
Global Strategic Solutions in the Silicon Valley area in California is a consultancy firm committed to ensuring safety in the medical field by helping inventors and businesses take the appropriate steps to get their devices approved and ready for sale. Learn more about our services.
David R Rutledge, Pharm.D., FCCP, FAHA
+1 (630) 846-0350 cell