Vol. 5 (Part 2) kegg | Can't it be a medical device? Yet, we didn't give up. 10 years of persistent engagement between kegg and the Japanese system

Keywords: General Medical Device / Fertility Device / Medical Device Registration Number / Social Implementation

A product, no matter how good, won't reach its full potential if it's only made.

No matter how good a product is, it won't spread throughout society if it's merely created.

Especially for products related to women's health,
they often encounter barriers of systems and culture.

kegg was no exception.

First, the systemic barrier.
A device inserted into the vagina.
Potentially indicating the timing of ovulation.

In Japan, what classification would it fall under?

A medical device?
Or something else?

It wasn't easy.

(Participated in a kegg photoshoot around the time I met Kristina in 2017)

The Choice of a General Medical Device

When I decided to bring kegg to Japan, the first thing I did was consult with the Ministry of Health, Labour and Welfare.

In the US, it's an FDA Class I medical device.
However, Japan has its own assessment criteria.

A device inserted into the vagina.

"Is it a miscellaneous item?"
"Is it treated as a pleasure device?" If so, it would be difficult to appropriately communicate its efficacy and effects, let alone its safety and quality.

On the other hand, if it were classified as a controlled medical device, the hurdles for approval would be higher, and it would take more time and cost to sell.
As a result, it might become harder to reach those who truly need it.

I thought.

I want this to be available in society as an option for home use, not just for medical institutions.

However, at that time, Japan's Pharmaceutical and Medical Device Act (PMDA) had no framework that envisioned a product like kegg.
Even if we wanted it to be a medical device, such a classification didn't exist.
So, we engaged in persistent discussions.

With the cooperation of Diet members, we established a parliamentary league,
and held numerous dialogues with the Ministry of Health, Labour and Welfare.

Then, in 2023,
a new general name, "Household Cervical Mucus Measurement Device," was established under the PMDA.

In 2024, the registration as a general medical device was completed.

Sales are scheduled to begin in Japan from May 2026.

Instead of avoiding regulations,
we sought to find the most reasonable place within them.

That was the form we aimed for.

(With Minister of Health, Labour and Welfare Kato in 2022)

(With Minister of Economy, Trade and Industry Saito in 2024)

The Reality of Fertility Treatment in Japan

Japan has one of the highest numbers of IVF treatments globally. However, the success rate is not necessarily high.

(Source: ICMART World Report 2016 (International Committee for Monitoring Assisted Reproductive Technologies))

The average age for first pregnancies is rising,
the number of dual-income households is increasing,
and the burden of hospital visits is significant.
Women bear the brunt of most of this.

The problem is not just cost.

• ✔︎ Understanding one's own condition quickly
• ✔︎ Determining the right time to proceed with necessary medical treatment
• ✔︎ Reducing unnecessary burdens

This flow is not properly established.

kegg is not a treatment.

However,
it has the potential to streamline the pre-treatment phase.

The Future of Data

Today, kegg has grown into a company with one of the world's largest collections of cervical mucus data.
This is not simply about "having a lot of data."

Cervical mucus is a biological sign that reflects hormonal changes.
It changes throughout the menstrual cycle and is related not only to the period when one is trying to conceive but also to hormonal fluctuations post-partum and around menopause.

What if we could accumulate such changes not as "points" but as a "line"?

・Understanding the trends of one's cycle earlier
・Noticing changes in hormonal balance after childbirth
・Being able to describe the fluctuations leading to menopause in one's own words

Such possibilities are gradually emerging.

Furthermore, through the combination of large-scale data and AI,
body changes that were previously described as individual sensations
may be organized as statistical trends.

For example,
the relationship between diet, stress, and cervical mucus changes,
patterns of cycle fluctuations,
and the range of changes at different life stages.

Everyday data, which even medical and research institutions could not sufficiently possess,
is now beginning to be collected from daily life.

However, data is not omnipotent.

Data does not replace the body.
It merely supplements it.

Respecting both quantitative data and subjective sensations.

And,

Being transparent.
Designed to avoid misunderstanding.
Connecting appropriately with medical care when needed.

Only then does data hold value.

Finally

Approximately 10 years have passed since we met in 2017.

It was a time not so much for technological advancement,
but for moving structures.

To not isolate women's health as something special,
but to place it as an extension of everyday life.

To establish the right tools and the right framework.

A society that continues to view fertility efforts as "something to strive for," and
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.