11 Oct How Can You Listen to Your Medical Device Users?
When MediPurpose first introduced its babyLance infant heel incision device, we had high hopes for the product. However, the babyLance’s innovative design did not fully meet the preferences and expectations of all our infant heelstick customers in the U.S. market.
Although we had obtained the input of several users during the design process, the results showed that we had not consulted with enough neonatal heelstick end-users and/or perhaps we were not really listening to what they were telling us.
When we started redesigning babyLance, I was determined to be more actively involved with end-users throughout the development process so that we could truly learn about their requirements. To achieve this, we adopted the following approaches:
- Documenting the end-users’ requirements
- Validating their trigger activation preferences in a quantitative survey
- Translating the end-users’ requirements into design specifications
- Comparing and verifying the incision profile of our new design against competing products
- Validating the final product in simulated use studies (SUS)
Translating User Requirements into Design Specifications
End-users of infant heelstick devices are neither product designers nor engineers — and thus, they cannot be expected to provide the exacting design details that satisfy their subjective preferences for an ideal device. However, their clinical experience makes them very knowledgeable about what they like and don’t like about a device.
Throughout our redesign of the babyLance infant heelstick, I was keenly aware that we owned the burden of developing processes that competently gather end-users’ preferences and to translate that information into design specifications that would drive the redesign of the new device.
It is not sufficient to just document what heelstick end-users tell you. Along with end-users’ feedback, we evaluated the parameters that influenced their usage of the device and their preferences. We must then integrate the expectations of the end-users with our analysis of the usage parameters into a set of objective design specifications for the development team.
Learn More About This Process in Our Latest White Paper
Last week, we published Reinventing a Better babyLance Infant Heel Incision Device: Translating User Requirements Into Design Specifications — Optimizing Ease-of-Activation. In this white paper, we described how MediPurpose gathered users’ preferred requirements for a neonatal heelstick device that would be easy to activate and then translated that information into design specifications so that our engineers could develop a babyLance that met their requirements.
Our latest white paper is part of a series of publications that illustrate MediPurpose’s intensive research and testing for our new neonatal heel incision device, and we will continue to share our experience in the reinvention of the babyLance in more white papers to come.
In the meantime, what are your thoughts about our process, our white papers, and our new babyLance? Can you relate your own experiences to the processes you used to develop and introduce a new medical device?