For a medical device to enter the market, it must pass through various levels of regulation, including product development, licensing, and reimbursement. The medical field is evidence-based, and it is costly and time-consuming to build sufficient medical evidence. This is why it is difficult for new medical devices to succeed in the market, and the Korean government provides various support to help this process.
One such program is the ‘Integrated Review of Innovative Medical Devices,’ which started in 2022. As the name suggests, it is a system that supports rapid entry into the medical field by jointly examining three processes: 1) designating innovative medical devices, 2) checking existing technologies, and 3) evaluating innovative medical technologies. It is a fast track that can shorten the registration period from more than one year to 80 days.
An innovative medical device is one that has significantly improved or is expected to improve safety and efficacy compared to existing medical devices or therapies through the application of advanced technology with high technology intensity and a rapid innovation rate or improvement of usage methods. Once designated as innovative, a medical device receives benefits such as streamlined licensing processes and participation in government-supported projects.
Medical technology refers to medical practices carried out through the use of medical devices or therapeutic materials, and innovative medical technology is one that has been confirmed to be safe, despite not yet proving effective but having potential. They are evaluated and designated by the Ministry of Health and Welfare and the National Institute of Health and Medical Research (NECA). The biggest benefit is the opportunity to enter the medical market. It can be used in the medical field for 3 to 5 years as a non-salary or salary (selective salary) option. During this time, the clinical evidence of the innovative technology is accumulated, and the new medical technology is reevaluated.
Medical devices using artificial intelligence are also subject to the review process for innovative medical devices. For hospitals, receiving insurance reimbursement will reduce the cost burden for introducing AI into the medical field, which will accelerate its adoption. For companies, it is a good opportunity to accumulate medical evidence.
AI Innovative Medical Devices
My company has taken advantage of this scheme, and as of 2024, we have three products that have been designated as innovative medical devices and are beginning to enter the medical field. All three are targeted at serious emergency conditions where a delayed or missed diagnosis can lead to a poor prognosis for the patient. They are artificial intelligence software designed to assist in the diagnosis of cerebral hemorrhage, aortic dissection, and pulmonary embolism, respectively.
I believe that artificial intelligence, which assists medical staff in diagnosis, is most helpful in environments where there are no specialists available for interpreting medical images. Moreover, the value of AI rises in cases of severe diseases whose outcomes are highly dependent on the accuracy of diagnosis or the timeliness of treatment. For this reason, my company is focusing on emergency room environments, where the prevalence of severe diseases is high and it is challenging for radiologists to be available 24/7.
Artificial intelligence software installed in the ER can automatically analyze a patient's images and instantly communicate the results to medical staff, preventing diagnostic errors or delays in a complex environment like the ER. This technology can be used to benefit real patients. AVIEW NeuroCAD, which has been designated as the first innovative medical device by our company, has been in clinical use since April this year. Medical staff have reported that it has been helpful in actual patient care by immediately informing them whether a patient has a brain hemorrhage, and providing details on the location and extent of the bleeding.
Expected Effects of Introducing AI in the Emergency Room Environment
Although the use of advanced tests such as CT is rapidly increasing in emergency departments, fewer than 50 hospitals offer round-the-clock readings, including during on-call hours. According to a study by Seoul National University Hospital in 2021, there is about a 2% discrepancy between specialists’ preliminary readings and final readings, which can result in changes to diagnosis or treatment plans. More than 70% of false negatives are due to the failure to recognize important findings, and the discrepancy rate almost doubles between 2 am and 4 am compared to other times of the day. Tests performed during these on-call hours are typically read during regular business hours the next day, often not by a live imaging specialist. Additionally, emergency departments are frequently overcrowded and critically busy, leading to delays in imaging confirmation and difficulties in obtaining second opinions on ambiguous findings.
I believe artificial intelligence can play a significant role in improving this environment. In critical emergencies, where time to treatment is crucial, AI can identify and prioritize the most urgent patients for diagnosis. By reducing the time taken to treat a patient and deciding whether to admit or discharge them, we can improve patient outcomes and alleviate ED overcrowding. Due to the shortage of imaging specialists, there are inevitably disparities in healthcare across time and geography. AI can help reduce false negative errors and improve diagnostic accuracy by providing highly sensitive results.
Starting with the three innovative medical technologies described above, my company is also developing additional AI solutions for emergency departments, such as those for coronary artery disease and trauma. It is expected that these can be quickly applied to emergency departments through the integrated review system for innovative medical devices. In the future, if administrative procedures such as obtaining consent are improved to suit the emergency room environment, it will help create a safer medical environment for both patients and medical staff.
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