01/12/2025

Q&A with Gabi SmartCare

 

Q&A #2

 

Be ready to pivot

 

In this second edition of our Q&A series, we talk with Edouard Carton - who founded Gabi SmartCare with Jonathan Baut - about fundraising during COVID, updating preconceptions and seizing market opportunities. (Read #1 of our series here.)

How did you approach the early stages of R&D? Were there any major pivots?

The initial product idea was not considered a medical device, and we began R&D towards delivering a proof of concept. While developing this, we ran into two difficulties. The first was fundraising, which we began in February 2020 just before waves of lockdowns. At the same time, we were doing a lot of market and user research, and we began to understand that the true value we could bring was for the medical field, as doctors needed a solution similar to what we were working on. That’s when we decided to pivot towards developing a medical device used by both parents and doctors for pediatric populations suffering from respiratory and cardiac diseases.

With that shift in focus we began working with an ISO 13485–certified company for hardware development, while most of the software development and technical documentation were handled internally.

 

When did COVARTIM get involved?

The initial product made certain medical claims which we needed to validate and assess their impact on the regulatory strategy. COVARTIM engaged with us early on for strategic support in that area. Once the medical pivot was confirmed, we needed more extensive support and at this point we grew the collaboration with COVARTIM. They first implemented a 21 CFR and ISO 13485 compliant quality management system within the company and then took on the role of QARA, supporting our regulatory strategy, compliance efforts, and product development.

 

Your device consists of both hardware and software – how did this impact the product development and certification process?

Having both hardware and software components significantly influenced the development and certification process, especially in terms of documentation. Compliance with numerous standards was required of course, such as IEC 60601 for hardware and IEC 62304 for software. Tight project management of the different components was essential since different parts of the product were completed at different times. It was crucial to strictly adhere to the technical documentation that we put into place.

 

What commercial challenges did you experience post-launch, and how did you handle them?

Before attempting a large-scale commercialization, we chose to partner with around 30 U.S. hospitals as part of clinical research activities. This served somewhat as a soft launch, allowing many patients to use the device, and Gabi to collect valuable usability and hardware data, which allowed us to make improvements. One of the issues we identified, and implemented, was the need to set up a dedicated support platform to provide fast and effective assistance, effectively a level of service equivalent to after-sales support of a fully commercialized device.

 

What advice would you give to other innovators developing medical technologies?

My key advice is to put medical development and strategy at the center of decision-making from the very beginning. Have a clear idea of what you’re building but be ready to quickly update your preconceptions: we pivoted within a matter of weeks when we identified new market needs. Finally, move toward market entry as early as possible. Today, traction is just as important as certification for attracting investors, so demonstrating real-world use can make a significant difference.

 

Find out more

Discover how COVARTIM supported Gabi SmartCare in determining their regulatory strategy and managing regulatory and quality assurance process. Read our case study.