case study

Supporting a new biosensor and mobile app for launch

Innovative medical management platform to launch streamlined mobile app experience with medical hardware for FDA approval.

ui component from the one drop mobile app

Services

Design, Development, Product Management

Platforms

Mobile, Medical Device

Industry

Healthcare

Users

1.5M

Funds Raised

$106.2M

What is One Drop?

One Drop is an award-winning diabetes management system that empowers users to take control of their health by managing diabetes, blood pressure, heart health, and weight all in one place.

Client Testimonial

The challenge

Strategy, design, and development for FDA approval

One Drop is bringing One Health, a brand new biosensor to market, and it all starts with blood glucose. Their flagship software currently pairs with other hardware providers, but they don’t control the experience nor the quality of insights derived from the data.

They reached out to Headway to partner and help strategize, design, and develop One Health from the ground up.

Creating a smooth onboarding experience with hardware

To facilitate One Drop’s goals, Headway came in as their full-service product team. That included product strategy, design, and development as well as working with their clinical team to design an effective onboarding experience.

HIPAA compliance support for the FDA approval process

The new app is a streamlined version of One Drop’s original, more robust app. While the first app integrates all health information in the user’s account, the new app only provides specific readings, as required to gain FDA approval. To remain HIPAA compliant, the FDA does not want readings to be connected to a user’s full health profile.

The results

Effective onboarding

Headway’s development team made the new user onboarding between the physical monitor device, the patch, and software simple and fast.

FDA support and HIPAA compliance

One Drop needed an app that could go through the FDA submission process, and adhere to the highest levels of HIPAA compliance. Headway supported the the needs for approval.

Shared ownership

When given the opportunity, Headway will own the entire project for a client. In One Drop’s case, that included everything from how users connect to the patch to preparing for users as they enter later stages of use post-onboarding.

Understanding the market

Headway enabled One Drop to launch a new business model. This is a brand new, core business offering that's going to differentiate One Drop in the market.

client testimonial

"I've have worked with many partners who say that 'they are an extension of our team,' but Headway is the first that has truly embodied it. The quality of work, genuine care, and proactive spirit they bring every day demonstrates just how much they take that expression to heart."

Joscelyn Daguna

Biosensor Launch Lead