Three years designing Ultralight, from day zero to acquisition

Ultralight helps medical device manufacturers navigate the regulatory landscape from design through to FDA approval. We partnered with them on day zero, working directly with CEO Monik Sheth and CTO Shiv Ghai to shape a product that served the company's mission: unlocking more innovation in medtech by simplifying and streamlining an incredibly complex compliance process.

Understanding FDA approvals

Right at the beginning of our partnership we began deconstructing how medical software and hardware devices actually get approved. Over a number of weeks we worked through the FDA's own documentation, looking for ways to contextualise it inside a product rather than reproduce it.

That quickly started turning into rough, preliminary mockups of what would eventually become Ultralight's Design Control feature.

Design Control

The Design Control module is the core of the product: where design decisions, requirements and review take place. From the conception of a medical device, every decision made has to be documented. Design Control lets engineers and managers note decisions as they make them, which is what turns a future approval from an archaeology project into a report.

Design Review

Every core component of a product has to go through a clear approval process. Ultralight streamlines this by pulling together all the information reviewers need in one place, reminding the right team members automatically, and handling rejections and approvals without anyone chasing a signature.

Parts

Simple parts supply chain documentation.

Quality Events

Critical decision or change events are handled inside Ultralight, with the compliance steps pre-defined for the team to work through rather than assembled from scratch each time.

Documents

Company and product documentation needs approval under FDA regulations, the same as design specifications do. Ultralight handles document storage and approval using the same process users already know from Design Review, so there is one mental model instead of two.

Supplier management

Teams using Ultralight can ensure the ongoing compliance of their suppliers from inside the platform.

Three years, to an acquisition

We served as Ultralight's product and design team for three years, complementing their in-house engineering team, and were proud to work with them right up to their acquisition by Greenlight Guru in 2025.

See the full set of screens in the Ultralight gallery.