CASE STUDY

Scaling production of a ground-breaking fertility tracking device

Breathe ilo is the pioneering company behind the world's first fertility tracker to use breath analysis technology for ovulation prediction. Here’s how they value engineered and outsourced production of their cutting-edge device to launch internationally.

Breathe ilo's journey began when its founder, Dr. Horst Rüther, and his wife were struggling to become parents. Alongside fertility researcher Professor Wildt, they began to explore a correlation between CO2 levels in breath and the stages of the female menstrual cycle.

Their successful use of breath monitoring technology in their own fertility quest, led the entrepreneurial couple to develop and market the breathe ilo device.

Breathe ilo is a discrete and portable device that measures CO2 levels in the breath of users to track and predict the menstrual cycle. It transmits hormone data that indicates fertility status to a smartphone app. A self-learning algorithm gets to know the user better with each cycle, helping make its predictions of fertility windows ever more accurate.

breathe ilo device with smartphone application

We had shown product-market fit in the German-speaking area of the EU and were now in a position to scale breathe ilo internationally. But we needed a partner who could easily scale production to several thousand per year and meet our goals for substantial growth every quarter.

Lisa Krapinger-Rüther, Co-CEO of breathe ilo

The Challenge

Following a successful launch in Germany, by 2022 the company were ready to bring their product to an international market. But they needed to find a manufacturing partner that could help them value engineer their product and scale at the pace they needed. 

The Breathe ilo team needed to:

  • Meet ISO 13485:2016, FDA regulation and GMP 

  • Overcome supply chain challenges

  • Find new efficiencies in component procurement 

  • Create new value for customers while safeguarding quality

Lisa Krapinger-Rüther, Co-CEO of breathe ilo said:

 

"breathe ilo is a very complex and innovative technology with hundreds of components. The stress of the pandemic had made all necessary components more expensive and existing sourcing routes more unreliable. Supply chain management presented one of the biggest challenges for us and any potential partner." 

The Solution

ESCATEC's value engineering expertise played a pivotal role in optimizing breathe ilo's manufacturing processes for maximum efficiency.

With an NPI and prototyping team in the EU and production facilities in Malaysia, breathe ilo leveraged ESCATEC's local expertise while harnessing all the advantages of a global manufacturing partner.

 

Lisa Krapinger-Rüther, Co-CEO of breathe ilo said:

 

"We spoke to a lot of partners, advisors and similar companies. But it became clear that only ESCATEC had the facilities and staff to match all our future needs. ESCATEC could help us in sourcing large quantities of components, which we needed to grow and scale in the near future. But they also had the skills to help us continually modify and improve the product to meet the latest, global med tech standards."

 

breathe-ilo-prototypes

breathe ilo is the world’s first fertility tracker to use breath analysis technology for fertility prediction.

 

The Results

ESCATEC's expertise and global capabilities empowered breathe ilo to meet international demand, maintain the highest quality standards, and focus on future innovations. This collaboration exemplifies the potential for partnerships in the femtech sector, where quality, innovation, and efficient supply chain management can pave the way to more commercial success.

  • Seamless transition from low-volume to high-volume manufacturing

  • Seamless communication between design and manufacturing teams

  • Streamlined production lines, enabling efficient mass production

  • Proactive problem-solving through collaboration and continual improvement

Lisa Krapinger-Rüther, Co-CEO of breathe ilo said:

 

"With ESCATEC as our partner, we can confidently scale up production to meet evolving international demand. We have exciting plans to enhance our fertility tracker's functionality, potentially transforming it into a contraceptive device in the future. ESCATEC's expertise and support will be instrumental in realizing our vision."

 

breathe-ilo-device