Image courtesy of Design Concepts Inc.
Best practices in medical device innovation call for capturing end-user needs. But how do you identify those needs and make sense of everything need you uncover?
To understand such needs, "you have to get out of your bubble, your lab, to see what pain points your device is solving and causing and any workarounds that will inform your work," Marlisa Kopenski, director of business design, Design Concepts Inc., told attendees during the BIOMEDevice San Jose presentation, "Case Study: Using Project Frameworks to Create Order out of Chaos."
"You have to see how your device is being used," she said.
Kopenski served as a project manager for Abbott Point of Care's new strategy for its i-STAT handheld blood analyzers. Named after Orion, a constellation that can be seen from both hemispheres, Kopenski later told MD+DI, the global project entailed developing pricing and messaging strategies. (Kopenski recently wrote about the project.)
Markets in six different countries were studied during the 9-month-long project, resulting in 150 interviews with different users in different circumstances. "We watched them in their natural habitat," co-speaker Narendra Soman, PhD, director, R&D for Abbott's Point of Care diagnostics business, told the audience. "Seeing these things in action was a game changer for me."
Often there are differences in how products are used from country to country. For instance, "Nurses draw blood in the United States, whereas doctors draw blood in China," he said.
And the process of drawing blood from premature babies itself presents unique challenges. “Some premature babies only have about 1.5 ounces of blood, and may need to be transfused if blood is removed, such as for blood testing,” he said. He asked the audience to envision the challenges nurses face when they have just one hand available for getting a blood sample from the baby's heel, he said.
Kopenski told MD+DI that her team went out into the field, observed how the device was used, and talked to users. They then had to make sense of all the interviews. “For every hour of observation, you need three hours to make sense of what is seen and heard.”
She told BIOMEDevice attendees that they uncovered about 112 use cases for the device.
A framework was developed to help the team make sense of the information gathered from observations and interviews, she told MD+DI. “We distilled observations down to ‘actions’ of how the device was used and ‘site of care,’ ” she said, a process that “propelled the team to a deep understanding of how valuable the device is to end-users.”
Her team also shared raw footage of the device in use.
Studying user behavior also provided insights into emerging trends and unfolding developments. For instance, Kopenski expects to see "more unskilled labor running lab tests." And "the site of care is changing, too," she added. She asked the audience to consider what such trends mean for innovation.
Having learned much from the Orion project, Kopenski offered the following 9 tips:
- Get to know people in your neighborhood---take the time to get to know your team.
- [Seek] unconventional collaboration--you don't always have to stay on script.
- Manage with an iron fist in a velvet glove—establish a rigid structure for reporting, etc.
- Balance what you hear with what you see. [Remember] that what people tell you is different from what they do.
- Tell me what you don't know. In other words, what did you see in the field that you didn’t understand?
- When the project gives you lemons, figure out a way to make lemonade. You may uncover critical insights for innovation.
- Pull it apart and put it back together. Again. And again.
- Show, don't tell. There is power in seeing firsthand.
- Make people think in pictures. Photographs can help tell stories and get everyone on the same page.
For more details, please read Kopenski’s article.
MD&M West 2018 will also feature a full education program with sessions to inpsire your own product development. One session in particular is "Developing your Medical Device: From Concept to Completion," presented by Dan Golka (Med Tech Council), at Connection Corner Tuesday, February 6 4:00pm - 5:00pm. Please click here to register.