eMedical Record

Prototyping health records in a digital world

Listen.
Our paper system has a purpose. Please don' t change that!

Reframe.
What if we build the solution together?

Build.
We made a functional prototype and a process to make improvements.

Impact

Centralized records ready for FDA approval
The donor operations team  uses a scalable and unified electronic platform to manage the health records. This is a vital step towards bringing more fecal microbiota drugs to market.

Background

Finch Therapeutics is a biotechnology startup reverse engineering the microbiome. The startup seeks to bring a drug to market. Specifically, they are developing a poop-derived drug to treat Clostridium difficile, a common hospital infection known to be treated with Fecal Microbiota Transplants. All poop is collected from donors daily and each donor requires constant health monitoring. A compliant and traceable health monitoring is critical to its success.

Problem Space

Clinical donor procedures were clear about documenting health data, but the requirements for supporting operations had to be discovered. It was not clear what data had to be recorded and when.

We needed to produce a user-friendly system that met FDA clinical trial regulations and Good Documentation Practices (GDP), Good Clinical Practices (GCP), and HIPAA guidelines.

Solution

With so many moving pieces, we started simple by creating a system that collects all the data in one place.  In future releases, we upgraded to electronic workflows that lead the user through each step of data collection and reporting.

Process

1. Conduct User Research
My team and I focused stakeholder input on the “what,” not the “how” to better understand what activities the database system needed to support. We started this project by talking to the donor operations team about what features the system needed, what data the system should be able to collect, and in what ways they would reference the information. 

2. Map the User Journey
After these initial sessions, we set up observation sessions to fill in the omitted or implied assumptions.

3. Integrate User Journeys and Technical Processes
We created process flow and UML-like diagrams to synthesize process information for our contracted development team. 

4. Validate our system
Once configured, we worked with the quality team to validate the system to meet FDA Phase I /II and GDP/GCP/ HIPAA compliance regulations.

5. Train and support our users
My team’s responsibilities extended to training sessions before and after the launch.  

Prototyping session with users
Photo: Gina Mendolia

Brainstorming session
Photo: Gina Mendolia

Preliminary user journey mapping
Photo: Gina Mendolia

Role

User Researcher, Product Designer

When

2018-2019

Company

Finch Therapeutics, biotechnology startup