MedTech Horizons diagram mockup on MacBookMedTech Horizons diagram mockup on MacBook

MedTech Horizons

MedTech
Horizons

Researching new opportunities for the creation and approval of medical devices and health technology.

Role

UX Researcher
Intern

Timeline

Three months
Summer 2021

Scope

UX Research
‍Data Analysis
Figma
Miro
the process
The process: project overview, diagram, workshop, and analysis
✦ 01. project background
project Overview

The FDA Approval Process

I had the pleasure of working alongside MedTech Horizons’ design team at the Center For Health Design, UCSD Design Lab as a UX Research Intern. The team’s main goal was to redesign the FDA regulatory framework for the approval of new medical devices through a human-centered design process.

Over the course of the summer, I contributed directly to these goals by visually improving our regulatory pathway diagram, preparing and running a design workshop at the Innovator MD conference with my team, and analyzing that data to find potential opportunities for our stakeholders.
problem context

Restrictions, Obstacles, and Innovation

Bringing new medical devices into the market is not a fast process, and the restrictions placed by various agencies are often thought of as slowing down innovation. Obtaining FDA approval for medical technology varies in difficulty depending on the class of the device, novelty of the technology, and even the lack of knowledge and guidance through this complicated process.
PROBLEM STATEMENT
How might we improve the regulatory structure of medical devices to efficiently allow innovative products and production processes to enter the market, while also maintaining safety?
We tackled this problem of understanding the medical regulation process through the different perspectives of our stakeholder groups. These 8 groups include: 
Physician entreprenuers
Physician Entrepreneurs
Lead users
Lead Users
Start ups
Start-Ups
Medium to large companies
Med-Large Companies
Mentors
Mentors
Accelerators
Accelerators
Regulators
Regulators
Funding agencies
Funding Agencies
role

How Did I Help?

When I was recruited onto the team, user research of the regulatory process was already completed. My team analyzed data gathered from the many interviews they conducted held to find any common themes between groups, and used those insights to create a first draft of the diagram of the regulatory process.
‍
My main responsibilities were to:
  1. 📈 Visually upgrade the diagram so that it’s easier to understand the flow, different steps, and many branches of the regulatory process
  2. 🔬 Conduct further research into a new stakeholder group, FDA consultants, and dive deeper into the experiences of the Physician Entrepreneur group through leading a participatory design workshop
✦ 02. DIAGRAM
TASK 1

Visually Improving The Diagram

Here is what the first draft of the diagram looked like when I joined the team. They had a rough outline of the current process that stakeholders typically went through, and identified barriers and new opportunities within that pathway. It was an amazing start, but it was hard to follow the flow of the diagram and understand what was going on as a whole. Here are the changes I made —
Pathway diagram old

Phases of the timeline

Before and after of timeline phase labeling
✦ what changed
I changed the pill-like capsule representing the phases of the timeline to a simple grouping of the steps, since it seemed like the length of the capsule represented how long the process took, which is incorrect. Every device has a different timeline, and it can’t definitively be said how long each phase will take.

clarifying context & roles

Added titles and icons to cards
✦ what changed
Short titles and stakeholder icons were added above each box to help bring a user’s attention to what steps they should be focusing on, depending on what stakeholder group they belong to.
Recommended steps are highlighted in green
✦ what changed
We identified 3 steps that would be useful for stakeholders to perform early, however most don’t start until much later in the process or entirely skip the step. I coded these steps in green in hopes to help decrease stakeholder’s difficulties later on when getting approval.

improving overall flow

Red split boxes to signify steps of the pathway that split
✦ what changed
The more difficult task was to improve the flow of the diagram as a whole. I needed to better signify the break in the either-or pathway. I added disconnecting arrows and a surrounding split red box to signify the either-or split.
Gray surrounding boxes to group steps of the similar phases together
The surrounding red box clearly represents a break in the diagram, compared to the light gray that groups paths that don’t split up (pictured above). Adding grouped boxes also allowed me to replace the previous unintuitive bracket arrows. This greatly reduces the user's cognitive load when first trying to digest the information.
Finally, a title and legend was added and our working diagram was as polished as it could be for our workshop!  
Pathway diagram new
✦ 03. Design Workshop
TASK 2

Innovator MD Conference

Our team received the opportunity to hold a design workshop at the Innovator MD Physician Innovation Conference. It was a great honor for me to be a part of this, and a great chance for the team to find out more about the experiences and struggles physician entrepreneurs face when getting FDA approval. We had 40+ "doctorpreneurs" (aka physician entrepreneurs) participate in activities revolving around our diagram. I co-hosted a breakout room of 10 doctorpreneurs, and although I was very very nervous, our group discussion continued on smoothly!

We planned two activities:
  • Since the pathway is a representation of the interviews we held, we facilitated open discussions in our first activity to see if our diagram accurately represents this group of doctorpreneurs' first hand experiences as well.
  • For our second activity, we assumed that a majority of the participants have not gone through the entire regulatory process yet. We wanted to see what their expectations of the later phases in the process are by removing the content of the later half of the diagram. Miro was a note-taking savior for our design workshop!
✦ 04. analysis
analysis & exploration

Consolidating Our Workshop Findings

After the conference, my team member and I analyzed the notes we took from all breakout rooms to find common barriers and struggles participants had. Our main findings included:

finding their team

🔎 Most doctors struggle finding their team. More specifically, they struggle to find a strong and passionate team.
Trying to find a mentor if their device is novel or in a very niche industry proves to be very difficult. Not to mention, it can also get very expensive when looking for those niche mentors. Finding people or engineers who share the same passion and fire for their work, and overcoming any distance barriers is also quite a challenge.
✦ side note
I believe the COVID pandemic also exacerbated the problem due to time zone differences, lack of interaction and collaboration, and the ability to keep the momentum of the project going in a virtual setting.  

Overall process complexity

😵‍💫 Doctors struggle with unknown knowledge of the entire FDA process.
The struggle with knowing what is needed from them at every step, and the business model and lingo that come along with putting a product into the market. Not only are there business obstacles, but legal regulations to also overcome. They lack access to those resources, which sets them back greatly.
Miro board of our workshop findings
Our Miro board organizing our workshop findings by common themes.
Knowing this, we drafted an idea of a verified network of doctors, mentors, and resources. This gives aspiring doctorpreneurs the ability to connect with whomever they need for their project–a mentor for guidance, an engineer to build their product, or team members with the same passions to recruit. The process, start to finish, of putting a new product onto the market looks daunting at first thought but we hope with this network, stakeholders are able to find the tools necessary to succeed.

My last job before my internship ended was to add these barriers as an interactive layer to our diagram. Using a "Wizard of Oz" toggling technique, I wanted these boxes to look like a layer on top of the original steps where the barrier was faced.
Pathway diagram with common struggles and barriers
Takeaways and reflection

Wrapping Up The Internship

Although this internship was remote due to the pandemic, I am incredibly grateful I got the opportunity to work on this project with a great team. I learned so much, as this was my first internship, and left with a lot of key takeaways for any future endeavors I tackle:

Keep iterating
It was difficult condensing a lot of information into one clean diagram. I was challenged to keep making different versions and experimenting with ways to visually represent information. Having it visually appealing is important, but making sure it’s also easy for users to understand is arguably even more important.

Don't be afraid to ask for help
There were many points in the project where I was confused or needed some advice, but being me, I was scared to ask for help because I wanted to prove to myself that I was capable. But I realized that my mentors chose me for this role and that they’re there to help me grow. I learned to not handle everything on my own, and to reach out to my team when I need it.
↑

More Projects

Insomniac redesign casestudy
Insomniac Redesign
Slack redesign case study
Slack Redesign
WeStudy case study
WeStudy
Personally made with ♡ Catherine Dinh