（Seminar Report) 4th Academia Clinical Development Seminar
“Things to consider in practicalizing medical devices”
The 4th Academia Clinical Development Seminar in 2018 FY was held on Friday October 26th at the multi-media hall, Osaka University Hospital. As a lecture, we invited Dr. Koji IKEDA from Clinical Research, Innovation and Education Center, Tohoku University Hospital.
Dr. IKEDA lectured with a title of "Things to consider in practicalizing medical devices", based on his abundant experience in Pharmaceuticals and Medical Devices Agency (PMDA), and research and development in academia. He explained and focused on difference more in detail in research and development between drugs and medical devices through his experiences.
The lecture started with an introduction of Dr. Ikeda himself, saying "I’ve been away from Kansai a while yet I still speak in the Kansai dialect pretty much" since he spent a childhood in Toyonaka, Osaka. That definitely made the entire audience relaxed. He shared his childhood memory in Osaka with us a little. Then he introduced the todays’ main topic about the differences in pharmaceutical law to get regulatory approval including process of research and development between medical device and drugs. Apart from drugs, there are no established guidance or regulation for developing medical devices, because usage, shape, performance and aim of medical devices are not uniform. Therefore, research and development of medical devices are usually conducted through discussion between investigators and regulatory authorities, he said. We impressed that he used to visit to where the devices are required repeatedly to feel and understand the medical needs on his review process when he worked at PMDA. We learned about how medical devices have been developed with repeated revision of them through clinical trials that are different from the process to get regulatory approval for drugs.
He mentioned that there are few medical devices that have been developed in Japan, leading to a device lag in clinical use, being similar to circumstances for drug development, and that there are issues of excess medical devices that have been imported outside from the country. As for these concerns, he emphasized an importance from the view point of patients how investigators provide novelty for patients rather than an exploration of advanced technology that investigators from academia would try to. He also pointed out that there is a paucity regarding driving forces and experiences in companies that have responsibility for medical devices.
In the later part of the lecture, he told adverse effects of drugs and health issues resulting from their effects. It suggests that regulatory authority, PMDA, reviews through not only scientific rationale, but also comprehensive responsibility to avoid the issues. Therefore investigators need to recognize them with a consideration that there are differences in risk and benefit between society and individuals, when they are trying to perform research and development, according to his experiences. There is insufficient experiences in risk in Japan, requiring an importance on regulatory science in order to get approval with optimal and relevant products for new drugs and devices. He ended his lecture saying what is most important is balance between accelerator and break without any adverse events when we perform research and development. After the lecture, he kindly responded to questions one by one from the audience, and it ended in great success.