Considerations regarding the development of SaMD required in healthcare and clinical fields

On October 6, 2023, we held the 3rd Academia Clinical Development Seminar online, inviting Prof. Hiroyuki Tanishiro from Division of Regulatory Science Instruction and Consultation, Translational Research Institute for Medical Innovation (TRIMI), Osaka Dental University.
After working on medical device regulatory affairs at the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare, (MHLW) he is currently engaged in development support and academic consultation related to regulations at Osaka Dental University.
In this seminar, he spoke about considerations regarding the development of SaMD required in healthcare and clinical fields based on his extensive experience.

First of all, he explained the basics of medical device regulations regarding SaMD (Software as Medical Device), key points of the approval application procedure, and QMS.

Second of all, regarding the clinical evaluation method of SaMD, one of the simplest methods is to compare the performance of SaMD in reading images against doctor readings, but there is an issue that if the clinical data sufficiently reliable for evaluation is not secured when comparing SaMD with the golden standard, evaluation will not be possible, and this issue needs to be discussed in the future, he said.

Next, he stated that when the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices was revised in 2019, the accelerated review systems have been introduced based on the characteristics of medical devices, and the key is to take them into account when developing SaMD.

Regarding expectations for SaMD useful for health and medicine, he said that there is a need for SaMD that can treat and diagnose in a way that has never been done before, and that it would be useful for patients and medical professionals if treatment and diagnosis can be performed using information that has not yet been used in clinical practice, or using existing information that has been combined.

In this seminar, he gave a useful lecture on the development of SaMD. The seminar ended successfully with a lively Q&A session and many participants.

The next seminar will be held on Friday, December 8, 2023, inviting Associate Professor Masaya Tachibana from United Graduate School of Child Development, Osaka University.
We look forward to seeing you at the next meeting.