In recent years, the necessity of digital transformation (DX) has been called out in various fields, and it is the same in the medical field. In addition to improving operational efficiency using IT, there is a pressing need to shift to "proactive digitalization" that uses AI and data to transform existing operations and provide new value and experiences to customers. Here, we will focus on the current state of medical technology in Japan and points for promoting DX from three sessions with the theme of "data x medical care".
Challenges and regulations for AI-programmed medical devices
When a new medical device is developed, it must be certified and approved according to its classification. Certification is applied to a specialized certification body, and approval is reviewed by PMDA (Pharmaceuticals and Medical Devices Agency) in Japan. Types (categories) of medical devices are stipulated by government ordinance, and in 2014 a category called "programmed medical devices" was created.
Classification and review of medical devices
Programmed medical devices have a total of 6 types of programs (medical device programs: SaMD) for diagnosis, treatment, and prevention, and 3 types of recording media on which programs are recorded. AI medical devices are included in this program medical devices. However, an application that can record health data, for example, is a medical device program if it is developed for the purpose of preventing aggravation or detecting illness, but if it is only for the purpose of managing and recording data, it is a non-medical (healthcare program). app).
So how will AI be used in the medical field?
Hiroaki Kato, Board Director vice president of Iris, CSO and doctor, said, "First of all, in the medical interview, what was entered on the tablet before coming to the hospital or entered in the online interview was used by AI to create sentences including technical terms in the medical record. It is automatically output.In examinations and examinations, AI marks areas where disease is suspected on CT images, etc., and determines whether there is a tumor in endoscopic images.This will improve efficiency. We are making progress, and in the future, we will be able to achieve higher precision and new detections."
The development of such medical AI is also active in Japan, and the number is increasing. On the other hand, in principle, AI medical devices must be conducted as clinical trials (clinical trials), so it is extremely difficult to comply with GCP (Ministerial Ordinance), create procedure manuals, monitor and statistically analyze data, and submit clinical trials to PMDA. It takes time and costs billions of dollars.
In June 2021, Iris will conduct a prospective clinical trial and apply for approval of an AI medical device that can diagnose infectious diseases by imaging the throat. Since images of the throat have not been accumulated as image data at medical institutions, we created them from a camera and collected more than 200,000 images from scratch.
"Unlike the case of Iris, if we use image data and medical information from existing medical institutions, we will be able to apply for approval in a short period of time without conducting clinical trials for AI medical devices," says Kato.
Challenges of AI Medical Devices and Government Trends
Challenges in development include: “difficult to understand the applicability of medical devices”, “difficult to collect good quality data for development”, “difficult to organize data”, “need insurance strategy”, “post-sales program update” You can't do it arbitrarily." It is also necessary to comply with the Personal Information Protection Law.
Another issue is that the points of contact are scattered and not unified. As a government policy, the "Basic Policy" from the Council on Economic and Fiscal Policy states that it will "promote the development and practical application of programmed medical devices." In addition, as a review of regulations for the digital age, it is written that ``Review of the review system and system that contributes to expediting the development and introduction of programmed medical devices'' will be considered and concluded in FY2021.
The Ministry of Health, Labor and Welfare has announced "DASH for SaMD" as a fundamental reform of the examination of programmed medical devices. This includes ``early identification of embryonic seeds and disclosure of the concept of review'', ``unification of consultation desks'', ``review system based on the characteristics of program medical devices'', and ``strengthening of the system for early practical application''.
In addition, as an image of the future of medical care, the Ministry of Economy, Trade and Industry has announced "anywhere medical access" as an image to aim for in 2040.
"The development of AI medical devices (software medical devices) requires three perspectives: 'Between medical sites and the medical industry,' 'Medical device system,' and 'Software development.' The development of AI medical devices requires co-creation with appropriate stakeholders.” (Mr. Kato)
Three Perspectives for AI Medical Device Development
Wearable devices could unlock hypertension
Next, let's look at technology for continuous monitoring of vital data, especially blood pressure monitoring. At Arblet, we are developing 24-hour continuous blood pressure monitoring using devices as our core technology.
“The difference from general wearables is the technology that makes good use of the data that was previously discarded from the data measured by wearables. Many wearable devices have a green You can see the light, and this is the light sensor, which irradiates the skin with LED light and detects changes in the amount of light reflected by the photodiode,” says Konobu Shimizu, Board Director of Arblet.
Hemoglobin in blood has the property of absorbing green light, and this property is used to monitor blood volume. The measurement data contains a variety of information such as hand movement and respiratory components.By filtering this data, heart beats called "pulse waves" can be obtained.
"Pulse wave" obtained by Arblet technology
Wearable devices are life's best companions
Takuya Kishi, chairman of the Next Generation Hypertension Committee of the Japanese Society of Hypertension and professor of cardiovascular medicine at the Graduate School of Medicine, International University of Health and Welfare, said, , There is not enough information to determine this with a single blood pressure measurement, and there is a limit to quantification.For this reason, wearable devices are effective.With this, you can accumulate data without being conscious of it. In other words, wearable devices can be said to be the best partner in life that enables 'relaxed monitoring'."
By measuring with a wearable device, we can know more about the state of the heart. This will allow us to know in more detail whether you really have high blood pressure, whether the medication you are taking is appropriate, and how to treat it. If DX in the medical field progresses and data from wearable devices can be used, it may be possible to solve this problem.
“Aggressive digitalization” accelerates in the medical and pharmaceutical fields
He also mentions the use of data in the medical and health field and the potential of Braintech from the perspective of pharmaceutical companies.
It takes an extremely long time and money to bring a new drug to market, and the probability of success is extremely low at 1 in 25,000. On the other hand, it is highly valued as a key industry in Japan, and the Japan Pharmaceutical Manufacturers Association (JPMA) has set DX as one of the ways to realize its industrial vision.
In the pharmaceutical industry, AI drug discovery, virtual clinical trials, and RPA are being introduced as part of digitalization aimed at improving operational efficiency. Kotomo), disease management apps to provide customers with new experience value, and digital biomarker development.
Takayuki Sasaki, Head of the Digital Promotion Group, Corporate Planning Department, Meiji Seika Pharma, said, “Until now, the pharmaceutical industry has operated within the framework of public medical insurance, but as the paradigm shift in medicine and healthcare progresses, An increasing number of companies are working on prevention, food, clothing, housing, etc. with the aim of extending lifespans.This movement is called 'Beyond the Pill.'"
Utilization of IT makes it possible to provide new experiences and value to customers
What are the possibilities Braintech brings to the pharmaceutical industry?
In addition, Mr. Sasaki also mentions "Brain Tech" which combines "Brain" and "Technology".
“Braintech is also highly anticipated in the medical and healthcare field, particularly in the two fields of 'disappearance of activity barriers' (human augmentation and BMI) and 'self-regulation of brain activity' (behavior modification). We have great expectations.” (Mr. Sasaki)
So how can the pharmaceutical industry contribute to Braintech?
“Since it is directly related to human health, it is important to first understand and comply with laws and regulations related to medical and pharmaceutical affairs, and to create high-quality evidence. Provision of evidence-based software for interventions, and provision of programs to manage and treat medical disorders and diseases, require regulatory approval as medical device programs, which require clinical trials to prove efficacy. We need to do that,” explains Sasaki.
Digital health, on the other hand, is defined as “improving medical and health outcomes,” but is not subject to regulatory approval. From the perspective of the pharmaceutical industry, psychological follow-up, such as increasing patient motivation in compliance with medication and treatment continuation, has an affinity with Braintech.
DTx solutions appearing one after another
The DTx market is expected to expand rapidly in the future, and is expected to exceed 1 trillion yen in the latter half of the 2020s. On the other hand, DTx has also evolved over the past 10 years, from the initial text communication and numerical report-based DTx to the recent use of gamification for treatment and prevention in a “natural” and “non-intrusive” way. There are more cases that are going to help you.
“In Japan, the Ministry of Health, Labor and Welfare has announced a package strategy to promote the practical application of programmed medical devices, and is working to create an environment that facilitates business. In addition, since some of the data handled by Braintech is highly sensitive, various considerations are being made around the world from the perspectives of personal information protection and ethics regarding its use in research, diagnosis, and treatment. .
In order to solve these problems, people who understand the medical domain, people who know information science, digital devices, human psychology and emotions, and those who understand these things need to work together. is needed. This makes it possible to create new value.” (Mr. Sasaki)
▼People caption
Iris Co., Ltd. Board Director Vice President CSO Doctor
Mr. Hiroaki Kato
Chairman of the Next Generation Hypertension Committee, Japanese Society of Hypertension
Professor, Department of Cardiovascular Medicine, Graduate School of Medicine, International University of Health and Welfare
Mr. Takuya Kishi
Arblet Co., Ltd. Representative Board Director
Mr. Akira Shimizu
Macnica New Business Headquarters Healthcare Business Promotion Office Manager
Mr. Takeo Nishimura
Meiji Seika Head of Digital Promotion Group, Corporate Planning Department, Pharma Co., Ltd.
Mr. Takayuki Sasaki
Macnica New Business Headquarters Medical Business Promotion Office Assistant Manager
Mr. Yasuhiko Hayashi