Case Study

Overview

Overview

This case study highlights the design process for a diabetes care device, spearheaded by a medical device startup preparing for FDA submission. With proven technology but no in-house design team, I joined to collaborate closely with the talented product owner and brought on another design expert to join.

This case study highlights the design process for a diabetes care device, spearheaded by a medical device startup preparing for FDA submission. With proven technology but no in-house design team, I joined to collaborate closely with the talented product owner and brought on another design expert to join.

We began with a discovery phase and expert review, guided by a custom set of heuristics tailored for medical devices. Insights were prioritized focusing on risk factors and usability. We then transitioned into iterative design, championing a more formal design process incl. tools for research and strategy.

We began with a discovery phase and expert review, guided by a custom set of heuristics tailored for medical devices. Insights were prioritized focusing on risk factors and usability. We then transitioned into iterative design, championing a more formal design process incl. tools for research and strategy.

Tools &
Methods

Tools & Methods

Tools

Figma

Adobe XD

FigJam

HTML, CSS

Keynote

Methods

Heuristic Analysis

In-depth Med Device UI/UX analysis based on bespoke set of at-home healthcare heuristics

Prototyping & User Testing

Iterative design of Med Device digital interface using custom-built emulator

Concept Validation, Strategy

Concept testing (both internal, external) with final resultant next-phase UX Strategy

Tools & Methods

Methods

Workshopping

A beautiful clean typeface with punch.

Prototyping

So much character in this one.

Validation

So much character in this one.

Tools

Adobe XD

Keynote

Miro

Figma

Stakeholder Needs

Stakeholder Needs

Stakeholder Needs

The primary Stakeholder on this project—other than the end-user—was a very strong Product team; I cover a broader set of Stakeholders to share full context with you.

The primary Stakeholder on this project—other than the end-user—was a very strong Product team; I cover a broader set of Stakeholders to share full context with you.

The primary Stakeholder on this project—other than the end-user—was a very strong Product team; I cover a broader set of Stakeholders to share full context with you.

View the Table

View the Table

Business Challenges

Business Challenges

Business Challenges

As the company transitioned from proving its technology to preparing for FDA submission, the absence of in-house design capabilities highlighted critical gaps.

As the company transitioned from proving its technology to preparing for FDA submission, the absence of in-house design capabilities highlighted critical gaps.

As the company transitioned from proving its technology to preparing for FDA submission, the absence of in-house design capabilities highlighted critical gaps.

Read More

Read More

iLet insulin pump
iLet insulin pump

Healthcare Obstacles

Healthcare Obstacles

PHI, HIPAA, Staffing, Pandemic demand, Governmental engagement; UX work in Healthcare involves unique challenges.

PHI, HIPAA, Staffing, Pandemic demand, Governmental engagement; UX work in Healthcare involves unique challenges.

Learn More

Healthcare Obstacles

PHI, HIPAA, Staffing, Pandemic demand, Governmental engagement; UX work in Healthcare involves unique challenges.

Learn More

Learn More

Approach

Approach

Overall, the strategy involved two parallel efforts: conducting ‘actual’ HFE/UX consulting work and establishing a dedicated Design Function at the medical device startup. Although the Product team was robust, it had not yet expanded to include a dedicated Design team, which is where my role came into play.

Overall, the strategy involved two parallel efforts: conducting ‘actual’ HFE/UX consulting work and establishing a dedicated Design Function at the medical device startup. Although the Product team was robust, it had not yet expanded to include a dedicated Design team, which is where my role came into play.

Timeline

01

Baseline Product Analysis

Baseline Product Analysis

Although the Product Owner had made significant progress with the design, it was clear that the design and UX required further evolution before the FDA submission and Go To Market campaign. I was brought in as a consultant, and my initial task was to conduct a comprehensive Expert Review using custom Heuristics to pinpoint all observable issues.

02

Backlog / Feature Prioritization

Backlog / Feature Prioritization

Once the initial Heuristic / Expert Review was conducted, I spent time with the Product Team, as well as Sales & Marketing, Development and Clinical to further identify ancillary issues and used a 'spider chart' Scorecard system to prioritize.

03

Recruit Additional Designers

Recruit Additional Designers

Although I am an accomplished UX professional, I have never claimed to be a world-class Visual Designer. I negotiated with the client to bring in one of my top-tier designers who could enhance ongoing efforts with Branding, Logo Design, Iconography, and collaborate on all UX aspects.

04

Establish Tools & Methods

Establish Tools & Methods

With the involvement of the soon-to-be first-ever full-time designer, we enhanced the Design Toolkit and streamlined the Design Process for an effective handover. Simultaneously, I continued to consult with the client to refine their Research Process, Prototyping, and reporting methods.

05

Expand Testing Capability

Expand Testing Capability

Due to challenges with testing the UI/UX in a heavily regulated environment, I built a new testing platform that allowed would-be Patients and their Caregivers to hold a similarly-sized device (mobile phone) in their hands, and interact with the actual device's digital interface in a remote—albeit more realistic—setting. This greatly expanded the reach of the participant pool and sped up iteration.

06

UX Strategy & Mobile App

UX Strategy & Mobile App

Once the enhanced in-house Design and Research functions were operational, we concluded the project by planning a forthcoming Mobile App and introducing comprehensive mapping tools (Journey Maps, Customer Value Propositions, Ecosystem Map) that defined a next-phase UX Strategy.

The Plot Twist

Generally speaking, this project went forward quite well, but there were unique challenges!

Listen to the Salty Details

0:00/1:34

The Plot Twist

Generally speaking, this project went forward quite well, but there were unique challenges!

Listen to the Salty Details

0:00/1:34

The Plot Twist

Generally speaking, this project went forward quite well, but there were unique challenges!

Listen to the Salty Details

0:00/1:34

Outcomes

Outcomes

FDA Approval

FDA Approval

In May '23, the manufacturer announced FDA clearance

Design & Research Process Improvements

Design & Research Process Improvements

An improved Design Process and Toolkit was established, along with new Research platform including automated Consent forms

HFE/UX Feature Prioritization Framework

HFE/UX Feature Prioritization Framework

A custom set of Heuristics was developed specifically for at-home-use Medical Devices, incorporating industrial design, NN/g Usability principles, ISO standards, and FDA guidelines

Internal Design Function

Internal Design Function

By the end of the project, Design was fully operational with the first full-time Designer

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JD Moore

Moorefficient.Design

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Sections

Overview

Tools & Methods

Stakeholder Needs

Business Challenges

Healthtech Obstacles

Approach & Plan

The Plot Twist

Outcomes