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Medical Product Changes Stemming from User Centered Design

Live from MD&M BIOMEDigital: a startup, a consultancy, and a large brand owner talk about how interacting with end users changed their medical device and machinery designs.

The SentiAR Wearable Command Center is an interprocedural augmented reality (AR) system—with the user interface built off the Microsoft HoloLens—that enables the electrophysiologist to model the heart.
The SentiAR Wearable Command Center is an interprocedural augmented reality (AR) system—with the user interface built off the Microsoft HoloLens—that enables the electrophysiologist to model the heart.

At this week’s MD&M BIOMEDigital, industry experts held a discussion on the role of user centered design (UCD) in next-gen medical product development.

As Tor Alden, global design, engineering and human factors lead at HS Design, Inc., explained, UCD is a methodology that focuses on gaining a deeper understanding of the product end user. It outlines the phases throughout a design and development life cycle in creating a product that fits within the user's environment. Some of the key benefits are:

  • User needs are clearly communicated.
  • It provides a clear framework for documentation for the FDA.
  • It helps capture and translate user needs early in the process to allow for product pivots.
  • It helps manage technical and marketing trade-offs.
  • It allows early feedback from the users to see if products are actually responding to them.

The panelists discussed how they approached the UCD process in their fields and how it led to success in development.  

Lab automation equipment

Aleksandar Vacic, chief operating office and co-founder of Selux Diagnostics, Inc., presented a case in which they were new to UCD. They brought in advisors from HS who started embedding it into their culture and process at the outset of developing the SeLux Dx Next Generation Phenotyping Platform, which aims to transform the treatment of infectious disease by fast-tracking targeted patient therapies within 24 hours. “When done well, UCD can turbocharge your development process. It's really kind of meant for agile development because it brings you closer to the users, and shortens that feedback loop which is very important,” said Vacic.

He noted some key actions that led to their success. From the beginning, when introducing voice of customer studies, contextual inquiries, and usability and formative studies, they encouraged engineering team members to visit the labs, and participate with the end users in real life. 

They also hired potential users who were in the clinical labs, bringing on “internal customers.”  This helped in bridging the gap between marketing and development teams. Third, they developed good relationships with industry leaders both for immediate insights but also to have perspective on where the market is headed five years now to stay ahead of competitors.

Three key learnings: Architectural learnings were really important as they had initially envisioned a tabletop system. As we started interacting with users, exploring their workflows, we realized they want higher throughput, higher capacity, and walk-away capabilities,” said Vacic. They pivoted to a floor-standing, two-floor system to save lab space and footprint.  

The second example was in user touchpoints. There’s a lot of potential for use errors in today’s labs as medical technologists are incredibly busy.


Read article   Read 6 Tips for Preventing Use Errors


“There's a shortage of labor. There's hundreds of samples that need to be processed per day, and they are stretched between different departments,” he explained. “So really the goal is to load the machine and let it run and then move their focus toward results, and sending those results to the people who make clinical decisions: infectious disease doctors and pharmacists.” They decided to reduce the number of reagents, for example, into a single pack that is enough for a full shift’s operations allowing for a 24-hour walk-away system. 

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