breathe ilo is the world’s first fertility tracker to use breath analysis technology for fertility prediction. Here’s the story of how they outsourced production of their cutting-edge device to launch internationally.
Unlike other fertility devices that rely on insertables, wearables, or manual period tracking, breathe ilo offers a non-invasive solution that is both reliable and convenient.
breath ilo: the birth of a company
The entrepreneur Dr. Horst Rüther, came up with the idea for a fertility tracking device after he and his wife struggled to become pregnant. In their journey to conceive, they met the fertility researcher Professor Wildt, who had been exploring the correlation between levels of CO2 in breath and the stages of the female menstrual cycle.
Inspired by this work, Dr Rüther (with the help of Prof Wildt) set about researching and building a new kind of portable fertility device that could help other couples in their quest to conceive.
A device is born
The finished breathe ilo device measured CO2 levels in the breath of users and transmitted the data to a smartphone app to report on the hormone levels that indicate fertility status. A self-learning algorithm got to know the user better with each cycle, helping make its predictions of fertility windows ever more accurate.
From conception to production
Following a successful launch in Germany, by 2022 the company were ready to bring their product to an international market.
The race was on to find a manufacturing partner that could help them scale at the pace they needed.
Co-CEO of breathe ilo, Lisa Krapinger-Rüther takes up the story:
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.
Quality and speed to market is vital in the femtech sector
Competition is ramping up in the Femtech sector, there are new and exciting developments in fertility tracking and treatment emerging every year. Research in the BMJ estimated 200 million women around the world are using period tracking apps to assist with their reproductive health.
But the quality and accuracy of many fertility tracking devices have been the subject of hot debate in an often unregulated space.
The breathe ilo team needed to meet the rigorous standards of ISO 13485:2016, FDA regulation, and international GMP. They wanted to ensure the quality of their product was never compromised, while offering the best possible value for their customers through production innovation and supply chain efficiencies.
Supply chain management was a top priority
The issues of supply chain management were top of mind for the brand:
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”
ESCATEC wins the contract
Following a competitive tender process, ESCATEC were appointed as manufacturing partner for breathe ilo:
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”
From NPI to manufacturing at scale
With an NPI and prototyping team in the EU and production facilities in Malaysia, breathe ilo could work closely with local experts while levering the scale and cost advantages offered by a global business with cutting-edge manufacturing expertise.
The Swiss NPI team were expert, professional and supportive. “ says Lisa Krapinger-Rüther, “Communication was transparent on expectation management for the timeline and cost. We had short iteration cycles, which enabled us to implement all our learning in a timely manner.”
Local and international teams offer flexibility and value
The local NPI support and their close integration with the Malaysian team, meant breathe ilo could be confident of a successful transition process. ESCATEC's value engineering capabilities ensured lines and processes were optimised for manufacturing the device as efficiently as possible.
ESCATEC’s global approach meant a smooth transfer from low-volume into high-volume manufacturing. Setting up mass production lines is complex at the best of times, but ESCATEC ensured any problems were proactively discovered and jointly overcome in an efficient manner. This was enabled by transparent communication and the solution-oriented mindset of ESCATEC employees around the world, working together”
breathe ilo visited Malaysia
As part of their transition process the breathe ilo team visited the plant in Malaysia.
They gained insight and reassurance from watching the international team at work:
We saw that ESCATEC had a first-class production facility. We saw how professional and efficiently managed all their processes and operations were. The visit was an incredible hosting experience and deepened our relationships with the manufacturing team on site - as well as ESCATEC’s local and global management. We experienced Penang as a thriving ecosystem for medical electronics manufacturing operations. It was also a beautiful and exciting place to visit!”
ESCATEC support future plans
Born from a personal journey, and developed through innovative research, breathe ilo's solution stands out among traditional fertility devices. As the company expands internationally, they’ve found in ESCATEC a manufacturing partner that can maintain their quality vision while helping them focus on future innovation:
With this partnership in place, we are now able to continue scaling production to meet changing international demand. We have plans to add new functions to the fertility tracker, making it into a potential contraceptive device in the long-term future. We are sure ESCATEC will be the right partner to help us realise those ambitions”