A Better Way to Develop A Medical Device with Digital and Physical Elements (Part 2 of 2)

Below is an overview of that process, overlaid with a classic design-thinking double diamond diagram.

A New Way to Design Medical Devices for a More Cohesive Software and Hardware Experience

Reflecting on the Baebies case study in our previous post gave us the opportunity to ask: How might we further break down the silos between digital and physical design?

Phase 1: Configuration Exploration

In this phase, we:

• Define foundational hardware and software elements and the key inputs and outputs of the system.

• Explore digital and physical system architecture that would enable an effective ergonomic and interactive experience.

• Validate that the most promising concept supports the future state workflow via low-fidelity prototypes.

^{Questions about system architecture were fundamental in the early phase of our design work for the GenMark ePlex molecular testing device. The large central screen was key to creating an effective mapping experience across the user interface and the modular testing bays.} 

Defining the digital and physical system architecture of the device

In this early design phase, the main question we ask is: What might the overall digital and physical system architecture be for this device?

• Does it have a screen to serve as a link between digital and physical interactions with the device? What is the size and orientation of the screen? Is the screen touch enabled or complemented by physical controls?

• Is the software embedded, a connected app, or a connected workstation?

• What inputs and outputs do we need to provide feedback for?

• What other physical interactions and controls might complement the digital?

• Is this the primary device vs. associated accessories or consumables?

The GenMark ePlex molecular testing device, above, is an example of a past project in which we knew from a very early stage that system architecture would be fundamental to our design. The device incorporated modular testing bays in columns that that could be arrayed from one to four units.

To produce a cohesive digital/physical experience, we needed to ensure that the mapping experience between the screen and the position of the cartridge bays would be seamless. So, a large central screen that could map those testing bays as accurately as possible was fundamental to the system architecture of this particular project.

Low-fidelity mockups representing different available touchscreen components and early electromechanical test bay volumes allowed us to dial in what system architecture options were most intuitive for users in a modular system.

Phase 2: Interaction Development

In this phase, we:

• Define how hardware and software elements and interfaces work together.

• Create synergy across all digital and physical touchpoints and feedback mechanisms across different workflows.

• Validate the intuitiveness, effectiveness, efficiency, and safety of interactions via mid-fidelity prototypes.

Creating Harmony Across the Device’s Digital and Physical Touch Points and Feedback Mechanisms

Once we have defined the overall configuration and system architecture of the device, we start thinking about how the different hardware and software elements and user interfaces can be used in concert to safely, effectively, and efficiently operate the system.

This requires creating harmony across all of the system’s digital and physical touchpoints and its different feedback mechanisms:

• The user provides input through their interaction with the system via its different user interface touch points

• The system responds to the user to let them know it is working properly, or in some cases, alerts the user that it is not working properly.

In this phase, we use mid-fidelity prototypes to validate that we have achieved our design objectives. It is important at this stage that the prototyping is able to demonstrate both the hardware and software interactions.

The ultrasound system shown in the image above is an a good example of interaction development from our previous work.

Our client’s previous ultrasound system did not fully leverage its touchscreen. The client also had some concerns about moving too quickly to a fully touch-screen-based system architecture.

Working with our client, we explored what controls should remain on the physical control board of the system. 

^{Creating a consistent visual and brand experience can also enhance the usability of the system. Aesthetic refinements should never undermine our primary design objective: to create a system that is intuitive, efficient, and safe.} 

Creating a Consistent Visual and Brand Experience Across Software and Hardware Touch Points

In the aesthetic refinement phase, we create shared visual brand language across the software and hardware parts of a system to enable the workflow and support the cohesiveness of the user experience.

It’s also important that our aesthetic choices at this stage enhance the usability of the system and not detract from it in any way.

Our work on a cryo-thawing system for BioLife Solutions illustrates the importance of this. The system allows people to steadily and very carefully thaw genetic material, including stem cells, at a controlled rate. There are some safety implications to this device, because the drawer in which the genetic material is placed has pinch points and heating elements. So, it can be dangerous to use.