Vol. 5 (Part 2) | What is kegg? Can it not be a medical device? Yet, we didn't give up. The 10 years spent grappling with kegg and the Japanese system [Amina's Lense]
kegg
Products don't reach people just by being made.
kegg is a fertility device that measures changes in cervical mucus and records the body's signs approaching ovulation.
This article looks back at the background behind the notification as a general medical device, the medical device notification number, and the social implementation of a product related to women's health.
Click here for the kegg product page.
View kegg product page1｜Products don't reach people just by being made.
No matter how good a product is, it won't spread in society just by being made.
This is especially true for products related to women's health, which often encounter systemic and cultural barriers.
kegg was no exception.
A device inserted into the vagina.
It may indicate the approximate time of ovulation.
What category would it fall under in Japan?
Or something else?
The decision was by no means easy.
2｜The Choice of a General Medical Device
When I decided to bring kegg to Japan, the first thing I did was consult the Ministry of Health, Labour and Welfare.
In the US, kegg is treated as an FDA-registered medical device.
However, Japan has its own criteria for judgment.
A device inserted into the vagina.
"Is it a miscellaneous good?"
"Is it treated as a pleasure device?"
If so, it would be difficult to properly convey its efficacy, safety, and quality.
On the other hand, if it became a controlled medical device, the hurdles for approval would be higher, and it would take more time and cost to sell.
As a result, there was a possibility that it would become less accessible to those who truly needed it.
I want to make it available to society as an option for home use.
However, at the time, Japan's Pharmaceutical and Medical Device Act did not have a framework that anticipated products like kegg.
Even if we wanted it to be a medical device, there was no such category.
So we persevered in our discussions.
With the cooperation of Diet members, we formed a parliamentary league and engaged in repeated dialogues with the Ministry of Health, Labour and Welfare.
A new generic name, "Household Cervical Mucus Measuring Device," was established under the Pharmaceutical and Medical Device Act.
In 2024, kegg completed its registration as a general medical device.
Medical Device Manufacturing and Sales Notification Number: 13B2X10428006001
And in 2026, kegg's expansion in Japan began.
Find the most rational 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 in vitro fertilization.
However, the burden surrounding fertility treatment and infertility care has not yet been sufficiently reduced.
The age of first childbirth is rising, the number of dual-income households is increasing, and the burden of hospital visits is significant.
Women bear the brunt of much of this.
The problem is not just cost.
- Knowing one's condition early
- Judging the timing to proceed with necessary medical treatment
- Reducing unnecessary burden
This flow is not yet sufficiently streamlined.
However, it has the potential to prepare the groundwork before treatment.
Instead of merely "groping by feel," it creates an opportunity to understand one's body rhythm through daily data.
4｜The Future of Data
Today, kegg has grown into a company with one of the world's largest cervical mucus databases.
This is not just about "a lot of data."
Cervical mucus is one of the biological signs that reflect hormonal changes.
It changes throughout the menstrual cycle and is related to hormonal fluctuations not only during the period of considering pregnancy but also postpartum and around menopause.
as a "line" rather than just "points"?
- Understanding your cycle trends faster
- Noticing changes in postpartum hormone balance
- Being able to describe pre-menopausal fluctuations in your own words
Such possibilities are gradually emerging.
Furthermore, through the combination of large-scale data and AI, changes in the body that have previously been described as individual sensations may be organized as statistical trends.
- The relationship between diet or stress and cervical mucus changes
- Patterns of cycle fluctuations
- The range of changes at different life stages
Everyday data, which medical and research institutions have not been able to fully obtain, is now being collected from daily life.
5｜Data is not a panacea
However, data is not a panacea.
It merely complements it.
Respecting both quantitative data and subjective sensations.
And only when the following three conditions are met does data become valuable:
- Transparency
- Designed to avoid misunderstanding
- Appropriate connection with medical care when needed
Precisely because it is a fertility device related to women's health, it needs to be designed not only for convenience but also to include connectivity with systems, information, and medical care.
6｜Finally
It's been about 10 years since we first met in 2017.
It was a time of structural change rather than technological advancement.
To place women's health within the continuum of daily life, rather than isolating it as something special.
To arrange the right tools and the right framework.
and a society that increases "sustainable designs."
Which future is more peaceful and sustainable?
I am still in the midst of this inquiry.
Placing Options Within the System
The social implementation of kegg was not merely about bringing an overseas fertility device to Japan.
It involved the framework of a general medical device, a medical device notification 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's necessary to build bridges between technology, systems, and culture.
Leave a comment