Japan Medical Device Corporation
The Future of Cardiac Research and Patient Care

Representing the pinnacle of cardiac care innovation, UT-Heart stands as a cutting-edge technology in heart simulation. Developed by the University of Tokyo and UT-Heart Inc., the simulator can accurately replicate all crucial aspects of a beating heart, from the precise contraction to the complex relaxation process.

The advancement of this technology has persisted since the era of the “K computer”, Japan’s foremost supercomputer. Consequently, this technological research has made possible the successful prediction of cardiac resynchronization therapy (CRT), congenital heart disease (CHD) prognosis, and operative decision support, both of which are known unmet medical needs.

However, translating the research findings into practical medical applications is easier said than done as hurdles concerning processing speed and the medical device’s functional quality must be overcome.

On a mission to shift this paradigm, Japan Medical Device Corporation (JMD) has assembled a team of world-class experts spanning diverse domains to streamline calculations without the need for supercomputers. In November 2020, it took over manufacturing and distribution from PIA with an aim to position UT-Heart globally.

Shuichi Chiba leads the company and is a key figure in enhancing processing efficiency and functional excellence. In addition to CRT and CHD applications, Chiba actively engages in cutting-edge research at UT-Heart, spearheading simulation acceleration and ultra-large-scale experiments on the “Fugaku” supercomputer. Additionally, there is ongoing work on designing a system for disseminating and applying the latest research, known as the In-silico Cardiac Disease Database. Another crucial member is Takafumi Okano, chief operations officer, responsible for obtaining medical approvals for leading-edge cardiac technologies.

Above all, JMD is on a mission to reshape the future of cardiac research and patient care by making cutting-edge heart simulations accessible across all care settings.

Delivering Accurate Cardiac Simulations

The UT-Heart simulator employs a multiscale, multiphysics approach to faithfully replicate the intricate molecular level dynamics of the heart. JMD’s most recent research has culminated in the development of an In-silico Cardiac Disease Database that stores virtual heart models as mentioned above.

Within the library realized by the power of “Fugaku”, diverse cardiac variations are recreated in detail, accounting for factors such as cardiomyocyte ion channels and other physiological factors related to heart disease. Physicians can utilize individual ECG data to search virtual heart models within the database.

The archive also employs neural networks to extract critical features from ECGs and simplify them with detailed waveform patterns. This innovative approach facilitates precision medicine by providing doctors with accurate feedback based on virtual heart factors identified during the matching process.

For instance, it can assess the conductance levels of various ion channels within a virtual heart, allowing for early detection of heart failure including myocardial ischemia, arrhythmia and long QT syndrome. An additional advantage is the diagnostic test’s simplicity and minimally invasive nature, which makes it accessible to a broader range of patients.

JMD is now crafting AI models to diagnose various heart conditions based on a vast dataset of different virtual heart models. These efforts aim to integrate heart disease risk assessment into the In-silico Cardiac Disease Database by comparing ECG data associated with a virtual heart model.

“While enhancing the effectiveness and success rate of cardiac surgery is crucial, the ultimate goal is to predict risks associated with the disease and maintain health without having to resort to surgery. JMD’s mission is to unlock the potential of cardiac simulation and consistently offer this technology to society,” says Chiba, CEO and CTO of JMD.

Principles and Values

At the heart of JMD’s mission is strict adherence to data management protocols that ensure a clear separation between the image data used for simulations and the personal information of patients. It segregates datasets through its proprietary anonymization features, which are automatically applied when information is collected from medical facilities. This level of automation enhances efficiency and minimizes the risk of data breaches, setting a new standard for data security in healthcare simulations.

In Japan, JMD’s system leverages a government-approved cloud service compliant with the Information System Security Management and Assessment Program (ISMAP), which extends beyond borders, adhering to international regulations such as HIPAA for overseas data. Its dedication to legal and ethical data handling practices demonstrates an unwavering attention to protecting and securing personal information.

JMD is aligning its development process with Japan’s Medical Information System Security Management Guidelines. This proactive approach involves informing patients about the services and seeking their consent, which exemplifies the company’s focus on transparency and maintaining ethical practices in every aspect of its operations.

While Enhancing The Effectiveness and Success Rate of Cardiac Surgery is Crucial, The Ultimate Goal is to Predict Risks Associated with the Disease and Maintain Health Without Having to Resort to Surgery. Jmd’s Mission is to Unlock The Potential of Cardiac Simulation and Consistently Offer This Technology to Society

Even when offering educational materials, JMD leverages its heart models without using patient data, ensuring privacy while opening new avenues for medical education and training. JMD’s pledge to security, ethics and innovation positions it as a frontrunner in the quest to revolutionize cardiac care without compromising patient confidentiality.

Transforming Cardiac Care with a Digital Twin

JMD’s UT-Heart simulation is the only tool offering comprehensive predictions for heart structure, motion and circulation.

“To virtually recreate an individual’s heart, skilled CG creators utilize references such as CT, echo and X-ray images, along with electrocardiograms and blood pressure data, which contribute to the precise simulation of the heart’s movement with cloud computers. This empowers doctors to anticipate surgical and therapeutic outcomes in advance, enabling them to make more informed treatment choices,” states Okano, COO at JMD.

The solution is reinforced by validation efforts that demonstrate a strong correlation between real patient ECGs and the company’s simulated models. This alignment includes critical parameters such as blood flow, pressure and oxygen saturation, all mirroring real-world diagnostic measurements.

A total of 47 retrospective CRT clinical studies have been conducted. Also, 7 retrospective and 16 prospective research endeavors were performed to enhance surgical decision-making and prognostic predictions for CHD. These studies consistently produce highly favorable results, emphasizing the substantial impact of JMD’s cardiac simulation technology in advancing patient care and medical research.

To ensure predictive reliability, the simulated hearts also undergo rigorous assessments by physicians throughout the trials.

In a recent CHD case with a single ventricle, while hepatic venous blood flow should ideally be distributed evenly to both lungs, this patient presented with an uneven ratio of blood flow, leading to progressive cyanosis.

The simulation indicated that opting for the initially contemplated surgical procedure in this patient would not have corrected the uneven ratio of hepatic venous blood flow to both lungs; and if it had been conducted, it could have resulted in the patient’s death.

After simulating various surgical procedures proposed by the physician, a specific intervention was identified, predicting to improve cyanosis by achieving an equal ratio of hepatic venous blood flow to both lungs. Subsequently, the surgeon chose and successfully performed this procedure, defying the odds and improving the patient’s outlook.

This success highlights JMD’s dedication to revolutionizing healthcare through computer simulations. Engineers at JMD led by Chiba are focused on enhancing calculation speed. CHD and CRT services, currently in the research and development phase, are specifically designed to be implemented using existing computers, eliminating the necessity of a supercomputer.

The Team behind the Technology

JMD’s team comprises professionals with backgrounds in computer science, physics and medical device development. These experts have successfully translated the pioneering technology of UT-Heart’s heart simulation into a tool substantially benefiting the field of medicine. The team is also brimming with elite computer scientists who have made instrumental contributions to shaping JMD’s innovative market trajectory.

Chiba’s outstanding contributions have earned him renowned acclaim for enhancing UT-Heart’s processing efficiency and elevating its functional excellence to new heights. In parallel, Okano’s expertise in navigating the intricate landscape of medical device approvals and astute leadership is indispensable in ensuring the seamless integration of JMD’s pioneering technology into clinical practice.

Another leader supporting and spearheading JMD’s global operations is Simon Downes, an MD candidate from the International University of the Health Sciences in New York City. He guides collaboration and navigates the nuances of diverse regulations and medical practices. With him overseeing FDA-related affairs, JMD effectively bridges the gap between international and Japanese medical standards.

Ushering in an Era of Next-Gen Cardiac Care

Japan’s regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), plays a crucial role in the approval process for groundbreaking drugs and medical devices developed within Japan. Certain drugs and medical devices demonstrating exceptional promise in early clinical trials often receive priority evaluation within this system, and JMD’s CRT technology is the beneficiary of this prioritized approach.

Further positioning it on a global scale is a strategic partnership with the esteemed National Cerebral and Cardiovascular Research Center, a global leader in cardiovascular disease research. JDM has inhouse cardiovascular internal medicine experts complementing this collaboration and playing a key role in the project. As it continues to work on securing medical device approvals, JMD’s mission to streamline calculations without supercomputers draws closer to reality, promising a brighter future for patients worldwide.