Vol.5 (Part 2) | What is kegg? Can't it be a medical device? But we didn't give up. 10 years of facing kegg and the Japanese system [Amina's Lens]
kegg
A product is not delivered just by being made.
kegg is a fertility device that measures changes in cervical mucus and records the body's signs as it approaches ovulation.
This article looks back at the background of its notification as a general medical device, its medical device registration number, and the social implementation of products related to women's health.
You can view kegg's product page here.
View kegg's product page1｜A product is not delivered just by being made.
No matter how good a product is, it won't spread throughout society just by being made.
Products related to women's health, in particular, often encounter institutional and cultural barriers.
kegg was no exception.
A device inserted into the vagina.
It may indicate the approximate time of ovulation.
In Japan, what category would it fall under?
Or something else?
That decision was by no means easy.
2｜The choice of general medical device
When I decided to bring kegg to Japan, the first place I consulted was the Ministry of Health, Labour and Welfare.
kegg is treated as an FDA-registered medical device in the US.
However, Japan has its own criteria.
A device inserted into the vagina.
"Is it just a miscellaneous item?"
"Is it treated as a pleasure product?"
If so, it would be difficult to appropriately communicate its efficacy and effects, as well as its safety and quality.
On the other hand, if it becomes a controlled medical device, the hurdles for approval will be higher, and it will take more time and cost to sell.
As a result, it may become harder to reach the people who truly need it.
I want to put it into society as an option for home use.
However, at that time, Japan's Pharmaceuticals and Medical Devices Act did not have a framework that anticipated products like kegg.
Even if we wanted to make it a medical device, such a category did not exist.
Therefore, we engaged in persistent discussions.
With the cooperation of Diet members, we formed a parliamentary league and engaged in dialogue with the Ministry of Health, Labour and Welfare.
A new generic name, "household cervical mucus monitor," was established in the Pharmaceuticals and Medical Devices Act.
In 2024, kegg completed its notification as a general medical device.
Medical Device Manufacturing and Sales Notification Number: 13B2X10428006001
And in 2026, kegg's Japan launch began.
find the most reasonable place within the regulations.
That was the form we aimed for.
3｜The Reality of Fertility Treatment in Japan
Japan is one of the countries with a high number of infertility treatments, including IVF.
However, the burden surrounding fertility treatment and reproductive activities has not yet been sufficiently lightened.
The age of first birth is rising, the number of dual-income households is increasing, and the burden of hospital visits is significant.
Women bear much of this burden.
The problem is not just cost.
- Early understanding of one's own condition
- Determining the timing to proceed with necessary medical treatment
- Reducing unnecessary burden
This guidance is not yet sufficiently well-established.
However, it has the potential to prepare the pre-treatment stage.
It creates an opportunity to understand one's own body's rhythm through daily data, rather than just "feeling it out."
4｜The Future of Data
Today, kegg has grown into one of the world's largest companies in terms of cervical mucus data.
This is not simply about having "a lot of data."
Cervical mucus is one of the biological signs that reflect hormonal changes.
It changes during the menstrual cycle and is related to hormonal fluctuations not only during conception planning but also postpartum and around menopause.
as a "line" rather than just "points"?
- Understanding your cycle trends earlier
- Noticing changes in hormone balance postpartum
- Being able to describe the fluctuations leading up to menopause in your own words
Such possibilities are gradually emerging.
Furthermore, through the combination of large-scale data and AI, bodily changes that have previously been discussed as individual sensations may be organized as statistical trends.
- The relationship between diet, stress, and changes in cervical mucus
- Patterns of cycle fluctuations
- The range of changes at different life stages
Daily data that even medical and research institutions could not fully obtain is now being collected from everyday life.
5｜Data is not omnipotent
However, data is not omnipotent.
It merely complements it.
To respect both numbers and sensations.
And data only becomes valuable when these three things are present:
- Transparency
- A design that avoids misunderstandings
- Appropriate connection to medical care when needed
Precisely because it is a fertility device related to women's health, it must be designed to include not only convenience but also connections to systems, information, and medical care.
6｜Finally
About 10 years since we first met in 2017.
It was a time not so much for technological advancement, but for moving structures.
Not to isolate women's health as something special, but to place it as an extension of everyday life.
To provide the right tools and the right framework.
a society that increases "designs that can be sustained."
Which future is quieter and more sustainable?
I am still in the midst of this question.
Placing options within the system
The social implementation of kegg was not simply about bringing an overseas fertility device to Japan.
It involved the framework of a general medical device, a medical device registration number, language to convey safety and quality, and a design as an option for home use.
To deliver a product to society, I believe it is necessary to build bridges between technology, institutions, and culture.
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