Nemedio is a startup that helps medical device engineering teams to compliantly manage their documentation process. I joined in November of 2018 to design and ship the MVP of the product. Over my two years, I also established and maintained Nemedio's design system, shipped additional features and organized the design workflow for easier onboarding for new designers.
In efforts to comply with my non-disclosure agreement, I omitted confidential information in this study. All information and designs are for the sole purpose of the study and does not necessarily reflect the views of Nemedio.
All devices require FDA clearance to register as a medical device. However, the documentation that are required in the FDA rules and regulations are hard to comply with because of extensive paperwork.
I was presented with collection of user pain points with the current paper process that needed to be solved in our software. Outside of addressing users’ needs, I also worked with our quality engineer, who guided me through the requirements for FDA compliance. Because there was a disparity between how the information FDA wants to see documented versus how device engineering teams organized information, there was a lot of back and forth.
My designs principles were to make the documentation user friendly, while still remaining compliant with FDA guidelines.
The goals laid out for the MVP was for the product to be:
First we wanted to create a design philosophy that centered around flexibility. The users should be able to view things in a way that makes sense to them, while still keeping compliance in check.
While deciding on if the items will be a modal or a separate page, we decided to create a separate page for each item. While modals would be convenient for quick-viewing for stakeholders to look at all items at once, this item page allowed for more flexibility and functionality when adding various components such as dropdowns, WYSIWYG textboxes.
Each compilation of data was considered its own entity. This part is what would be looked at by the FDA to make sure it is consistent with existing guidelines. The FDA requires a quality officer’s signature on each part. We incorporated a multi step approval workflow for each item type so that it is compliant with the FDA’s requirement of a signature, while also being able to track the status of each part for the users.
Once a part is released and signed, the system would allow creating multiple versions of the same item to account for revisions. Each item is versionable, keeping the same title and references to another item.
Each class of a part has different requirements, which meant I needed to anticipate different types of data incorporated in each part. A modular design allowed the flexibility of adding or subtracting certain information for different parts.
As a team we decided to design our platform using Google Material for consistency, and efficiency to build on a tight timeline. Over time, we expanded our design system which became more complex over time. Throughout my time at Nemedio I did my best to maintain a consistent design system while expanding for more complex designs.
One of my biggest challenges was keeping up with the constantly expanding design system. Initially, we had only a few components, which made it challenging to stick within those boundaries. I realized that a design system is something that requires ongoing maintenance and expansion. Therefore, I continuously expanded the design system as necessary to keep up with our evolving needs.
I initially struggled to choose the appropriate fidelity and presentation style to present our designs. While I wanted to create an all-in-one place where interactions, specs, and designs could be easily accessed, I found it challenging to find an ideal platform. Ultimately, we settled on a Google doc that hyperlinks to all screens, gifs, requirements, and tasks, which were also linked in our Jira/Trello.
Since database designs require scaling, I had to consider use cases where there is a ton of data. I had to decide when to use modals, when to use drawers, and where information should hide/show.
Working at a startup meant balancing feasibility, build time and design. Acknowledging that pivots will occur, I had to find ways to move quickly without compromising on design. I used Material libraries to identify what was feasible and quick to build and designed around these constraints.
After shipping the MVP, we continued to build out features that were necessary for team management. My next large project was to design the overall employee training module experience.