Daysy Fertility Monitor is a Certified Medical Device
Effectiveness, Certification and Quality
Daysy is designed and certified as a medical device with registration in Europe (CE Marking). This is a claim that not every other fertility monitoring technology on the market can make (although legally they should).
What does it mean to develop a medical device?
First off, we have a quality management system. Valley Electronics AG is certified with EN ISO 13485:2012, the latest harmonized standard for medical devices. What this means to you as a consumer is that every step of the product cycle is guided by processes which are consistent with state-of-the-art engineering and management processes, and places you, the user, at the center of any decisions that need to be made regarding risk or safety. Processes at Valley Electronics AG are regularly audited both internally and externally to maintain a consistently high standard for everything we do.
From early in the development of a new product, the user is considered as the central focus for usability and risk management. At each stage of the design, user feedback is gathered through formally conducted usability studies, and integrated into design decisions. State-of-the-art risk analyses and verification processes are used to ensure that the product does what it is intended to, every time. The test-suite for daysy alone takes over two months to perform, and involves extensive electrical, mechanical, and software testing.
The algorithm used in daysy is based on that used by the devices from Valley Electronics GmbH, which have been validated by over 28 years of use. The core fertility-tracking algorithm was extensively studied in 1997 in Germany. Over a period of more than 2 years, 686 users in Germany Switzerland, and Mexico were questioned about their experiences with the LadyComp and BabyComp devices. The study measured 10601 months and did register 39 unplanned pregnancies. Of those, 6 occurred during a “green” day leading to a method safety pearl-index of 0.7, and 33 occurred during a “red” or yellow “uncertain” day leading to a usage safety pearl-index of 3.8. This can be compared to the results of the 2011 study by J. Trussel, which indicates a method safety of 0.3 (slightly better than LadyComp) for the pill and a usage safety of 9 (worse than LadyComp). Experts in fertility awareness methods assess any adjustments in the algorithm to ensure that daysy has the highest level of performance possible.
Finally, all of this is compiled, registered, and reviewed with SwissMedic in Europe and the FDA in the United States. Even after bringing a product on the market, our development process continues to monitor the devices in the field and feedback from users to look for trends and ways we can improve.
It’s a long process from product conception to having a device in your hand, but we know it is well worth the expenditure of time and money. We understand that the reliability of daysy is of principal import to our users, and continuously strive to go above and beyond what is required.
To design a world-class product, one must get the little things right as well as the big.