J.Jpn. Surg. Soc.
ISSN 1880-1129

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J.Jpn. Surg. Soc.. 126(5): 427-434, 2025

Feature topic

IMPLEMENTING THE DESIGN APPROACH IN THE JAPANESE CONTEXT

1) Experience Design and Alliance Section: EDAS, Tohoku University Hospital, Sendai, Japan
2) Department of Neurosurgery, Tohoku University Graduate School of Medicine, Sendai, Japan
3) Future Medicine Design, Tohoku University Hospital, Sendai, Japan
4) Department of Biodesign, Center for Research Innovation and Education, Tohoku University Hospital, Sendai, Japan
5) Department of Anesthesiology and Perioperative Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan
6) Department of Cardiology, Tohoku University Graduate School of Medicine, Sendai, Japan
7) Department of Diagnostic Radiology, Tohoku University Hospital, Sendai, Japan
8) Department of Biomedical Engineering, Stanford University, Palo Alto, CA, USA
9) Department of Breast and Endocrine Surgical Oncology, Tohoku University Graduate School of Medicine, Sendai, Japan
10) Massachusetts General Hospital, Boston, MA, USA
11) Harvard Medical School, Boston, MA, USA

Atsuhiro Nakagawa1)2)3)4), Takuya Shiga1)5), Tomohiko Shindo6), Aoi Sakurai3), Ayaka Harigai7), Harrison Banks8), Narumi Harada1)9), Masaya Higuchi2)10)11), Hidenori Endo2)

In Japan, the working-age population is rapidly declining due to the low birth rate and superaging society, while the older population is increasing and the era of 100-year life expectancy approaches. As a result, the roles expected of healthcare professionals are diversifying, and workloads are growing. Resolving this huge mismatch between rising demand and limited resources is an urgent challenge.
In a society where material needs are largely met, medical device development and commercialization will not succeed unless they offer solutions and value that prompt users and decision-makers to say, “This is exactly what we needed!” For healthcare providers, addressing this mismatch, creating scalable industries with economic impact, and expanding them globally is becoming a key mission for sustaining high-quality healthcare. To that end, design approaches as problem-solving processes for identifying new opportunities are regarded as effective tools and social skills developed through training. In Japan, supportive environments have been steadily developed, including innovation programs such as biodesign, infrastructure that enables industry access to clinical settings, and training of specialized personnel.
This article outlines the significance and implementation of design approaches in medical device development, highlighting biodesign in Japan, leading examples from the USA, and local initiatives at Tohoku University Hospital.

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