From prototype to market-ready medical device: FreeO2 oxygen therapy for respiratory patients
Our team accelerated development of this innovative medical device. We used a strategic design approach to
- Optimize the full potential of OxyNov’s invention
- Identify the needs and human factor requirements of the primary users for FreeO2
- Streamline the hardware, mechanical, and industrial design with digital components including embedded and application software
FreeO2 medical innovation ready to launch in 18 months with CE compliance
Typically, administering oxygen requires frequent manual monitoring and resetting to comply with recommendations and clinical oxygenation targets.
The process that the founders of OxyNov created for automating oxygen therapy provides a more efficient, safe and comfortable treatment option. OxyNov developed the algorithm for the automation, but needed assistance moving their innovation beyond a prototype used for research. Our Novo team provided consulting, design, engineering and embedded software development services to launch a redesigned CE compliant product.
To ensure that the final product would meet the needs of all users, our industrial and user experience designers and business strategists collaborated with OxyNov to streamline their vision. Using our strategic design approach, we conducted extensive research and collected end user feedback from a rough wireframe we developed to define expectations, usability requirements, and key features, including introducing a wireless oxygen therapy device.
We also worked with OxyNov early in the design process to define a vision for FreeO2 that includes cloud connectivity and remote monitoring with a dashboard to be implemented in a later release.
Where our approach makes a huge difference is the way our engineers work with our usability designers. To ensure that the final FreeO2 product would function as envisioned, we started industrial design early in the process to consider factors such as overall size and where external connections should be made. We took all the human factors into consideration in the early design stages to create the best user experience.
Using our integrated approach, the concept was defined in parallel with the engineering team working on the internal architecture for overall design synergy. Integrating these teams early ensures a smooth transition when moving to manufacturing.
Our team managed all the physical aspects of development including hardware, mechanical, and industrial design, as well as digital components. The embedded software we developed provides critical safety functions to ensure that the device is working properly.
The first prototype was used for testing, validation, and verification. After modifying the second prototype, the third prototype received CE approval in Europe, and is undergoing the FDA approval process.
“Working with Novo allowed us to quickly show investors a certified, effective, ready-to-market medical device that addresses critical human factors in a hospital environment. We’re moving forward with additional certification and collaborating with our Novo team on the next phase of development.”
François Lellouche MD, PhD,
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