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Regulatory Science for Medical Device Development Lab
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A lab that studies the development of medical devices for brain diseases and the regulatory science that supports it.
AboutAbout the lab
Bringing new medical devices to society through regulatory science.
The Regulatory Science for Medical Device Development Lab studies "regulatory science," which, when research and development results are put to practical use, predicts, evaluates, and judges quality, efficacy, and safety appropriately and quickly on the basis of scientific knowledge.
Building on regulatory science, the lab aims to contribute to the development of new drugs and medical devices, to create an environment where people can learn about regulation, and to train specialists in this field.
Working with affiliated hospitals that have extensive clinical experience, the lab advances the real-world implementation of developed products based on regulatory science.
Key terms
- Regulatory science
- The discipline of scientifically predicting, evaluating, and judging the quality, efficacy, and safety of medical products
- Regenerative medicine
- Medicine that uses stem cells and other methods to restore the function of lost organs or tissues
- Neurodegenerative disease of the brain
- A disease in which nerve cells in the brain are gradually lost
ResearchResearch themes
The lab conducts research on the development and practical application of medical devices and other products for brain diseases, as well as research on the regulatory science that supports them.
*Illustrative imageDevelopment Research on Medical Devices for Brain Diseases
The lab conducts basic research that starts from clarifying the mechanisms of diseases such as cerebrovascular disease, brain tumors, and neurodegenerative diseases of the brain, and leads to the development of new medical devices, drugs, and regenerative medicine.
*Illustrative imagePractical Application Research on Medical Devices for Brain Diseases
The lab conducts clinical research focused on improving prognosis, covering the practical application of new medical devices, drugs, regenerative medicine, and other approaches for brain diseases.
*Illustrative imageRegulatory Science Supporting Medical Device Development
The lab conducts regulatory science research on predicting, evaluating, and judging the quality, efficacy, and safety of research on the development and practical application of medical devices and other products, appropriately and quickly, on the basis of scientific knowledge.
MembersFaculty
- Program-Specific Associate ProfessorChiaki Sakai
- Program-Specific Assistant ProfessorShigeki Takada
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Report an errorAbout the images
The top and research theme images are illustrative and were not taken at the lab. They are cropped from Wikimedia Commons images. Cropped CC BY-SA images are provided under the same CC BY-SA license as the original (version shown on each line).
- Top image: “US Navy 080607-N-9689V-011 Cmdr. Kenneth Kubis, director of surgical services aboard the Military Sealift Command hospital ship USNS Mercy (T-AH 19), uses an operating microscope” U.S. Navy photo by Mass Communication Specialist 3rd Class Joshua Valcarcel / Public domain (cropped)
- Development Research on Medical Devices for Brain Diseases: “CHAPEA Mission 2 Crew Members Test Specialized Medical Monitoring Device (jsc2026e409154)” NASA Johnson Space Center / Public domain (cropped)
- Practical Application Research on Medical Devices for Brain Diseases: “National Hospital for Neurology and Neurosurgery - geograph.org.uk - 1025529” Stephen McKay / CC BY-SA 2.0 (cropped)
- Regulatory Science Supporting Medical Device Development: “Respiratory pressure meter device example” Mdd2018 / CC BY-SA 4.0 (cropped)
- Related lab (Pharmacometrics and Systems Pharmacology Lab): “Infusion pump 2” Senior Airman Andrea Posey/U.S. Air Force / Public domain (cropped)
- Related lab (Educational Neuroscience Lab): “Hitane Elementary School classroom 3” Douglas P Perkins / CC BY 3.0 (cropped)
- Related lab (Social Impact Evaluation Lab): “First Minister John Swinney addressed the Social Enterprise Scotland Conference on 7 November 2024 - 6” Scottish Government / CC BY 2.0 (cropped)
- Related lab (Neonatology Lab): “MODULAR NICU WITH HEPAFILTERS” Kaveri appala / CC BY-SA 4.0 (cropped)
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