So, you want to play in Japan's Regulatory Sandbox?

Disruption comes slowly to medicine.  And that's a good thing.

Since the ethos of the profession is "First, do no harm", it makes sense that safety and efficacy are prioritized over rapid innovation.

But innovation does happen, and the Japanese government is working to make sure it happens faster. Today we sit down with Taro Ueno of Susmed and talk about the challenges and tradeoffs in innovative medicine.

We talk about why he left medical research for entrepreneurship, and how iPhone apps and blockchain are being used clinically in Japan. And in both cases, I assure you, it's not what you think.

It's a great conversation, and I think you'll enjoy it.


Show Notes

Why leave medical practice to start a startup
Why Japan just can't fall asleep
Why Japan over-prescribes sleeping pills and other drugs
Why it's very hard to get apps approved as medical devices in Japan
The reason so few medical apps have been approved in Japan
The importance ofJapan's regulatory sandbox
How blockchain is actually helpful in clinical trials
What kinds of medical apps are we most likely to see first on mobile phones?
Why so few apps have been approved and why that might be changing


Links from the Founder

Everything you ever wanted to know about Susmed

Connect with Taro on LinkedIn


Transcript
Welcome to Disrupting Japan, straight talk from Japan's most successful entrepreneurs. 
I'm Tim Romero and thanks for joining me.
Today, you're going to learn about how to make money in blockchain. No, no, no, it's not like that, it's not what you think. Today, we're going to sit down with Taro Ueno of Susmed, and we'll talk about how Japan's new regulatory sandbox has enabled his startup to get approval for their blockchain-based platform for clinical trials. The platform prevents trial results from being changed after they've been recorded, which as Taro will explain, has been a real problem in Japan.
Taro is also a medical doctor and a PhD, and he's developed an insomnia app that he is in the process of getting approved as a medical device. We talk about the challenges of getting mobile apps approved for clinical use in Japan, why this technology is so frustratingly slowed to come to market, and why people in Japan just can't seem to fall asleep.
But you know, Taro tells that story much better than I can, so let's get right to the interview.

Interview
Tim: So, I'm sitting here with Taro Ueno of Susmed, and thanks for sitting down with me today.
Taro: Thank you.
Tim: Now, Susmed is an app-based solution for insomnia and you also make a platform to improve clinical trials, but you can probably explain Susmed much better than I can, so tell me a bit about the company.
Taro: Susmed stands for 'Sustainable Medicine.' This is our vision and we are developing digital therapeutics using smartphone apps, and we are now developing several apps for diseases like insomnia and cancer, and so on.
Tim: Tell me a bit about your customers, so are these apps designed for doctors to use in a clinical setting? Are they designed for consumers to use on their own?
Taro: Doctors prescribe this app for insomnia patients. This is alternative for treating patients
Tim: Before we dive into everything that's going on with medical technology in Japan, I want to ask a little bit about you. You got your MD and then your PhD, what drove you to startup after that? I mean, you put a tremendous amount of work into becoming a doctor.
Taro: Yeah, I agree. Yes, as you mentioned, I have a background of medical doctor and especially in psychiatry. I got PhD in basic research over sleep medicine. I have seen so many patients with overprescription with sleeping pills. That's why I try to develop DTx for insomnia patients.
Tim: I mean, I find that fascinating, the ability to develop software for an app gave you greater ability to help people than practicing medicine or research?