TY - JOUR
T1 - Preliminary study on the development of a system dynamics model
T2 - The case of EVAHEART
AU - Kato, Tsugiko
AU - Umezu, Mitsuo
AU - Iwasaki, Kiyotaka
AU - Kasanuki, Hiroshi
AU - Takahashi, Yutaka
N1 - Funding Information:
This work was funded by the “Biomedical Engineering Research For Advanced Medical Treatment Using Nonclinical Study” project of the Research Institute for Science and Engineering (08L01) at Waseda University.
PY - 2013/6
Y1 - 2013/6
N2 - The Japanese medical device industry's stagnation over the years can be attributed to the uncertainty related to device development. The purpose of this study is to identify the major factors that impact development. We studied the ventricular assist device EVAHEART through interviews with the persons involved and created a development model using system dynamics. There are at least six stages in the device development process, including interactions with academia and the government. Through a simulation and comparison to Novacor, it was determined that the satisfaction of academia leads to government action in the subsequent measures. Our trial simulation of EVAHEART suggests that it has the potential to clarify unclear relationships in the development of devices.
AB - The Japanese medical device industry's stagnation over the years can be attributed to the uncertainty related to device development. The purpose of this study is to identify the major factors that impact development. We studied the ventricular assist device EVAHEART through interviews with the persons involved and created a development model using system dynamics. There are at least six stages in the device development process, including interactions with academia and the government. Through a simulation and comparison to Novacor, it was determined that the satisfaction of academia leads to government action in the subsequent measures. Our trial simulation of EVAHEART suggests that it has the potential to clarify unclear relationships in the development of devices.
KW - EVAHEART
KW - Entire observation system
KW - Regulatory science
KW - System dynamics (SD)
KW - Ventricular assist device (VAD)
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U2 - 10.1007/s10047-013-0693-5
DO - 10.1007/s10047-013-0693-5
M3 - Article
C2 - 23420496
AN - SCOPUS:84879422925
SN - 1434-7229
VL - 16
SP - 242
EP - 247
JO - Journal of Artificial Organs
JF - Journal of Artificial Organs
IS - 2
ER -