John CK Hui, Zhen-Sheng Zheng. The four stages of development: a historical prospective of external counterpulsation. J Geriatr Cardiol 2010; 7(2): 74-78.
Citation:
John CK Hui, Zhen-Sheng Zheng. The four stages of development: a historical prospective of external counterpulsation. J Geriatr Cardiol 2010; 7(2): 74-78.
John CK Hui, Zhen-Sheng Zheng. The four stages of development: a historical prospective of external counterpulsation. J Geriatr Cardiol 2010; 7(2): 74-78.
Citation:
John CK Hui, Zhen-Sheng Zheng. The four stages of development: a historical prospective of external counterpulsation. J Geriatr Cardiol 2010; 7(2): 74-78.
Cardiology Dept, State University of New York, Stony Brook, New York, and Vasomedical Inc, Westbury, New York, USA,
The Key Laboratory of Assisted Circulation, Health Ministry of China and Cardiology Dept, The First Affiliated Hospital, Sun Yet-sen University, Guangzhou, China.
There are four stages in medical device development. The beginning starts with some new understanding of physiological concepts which evolve into the formation of an innovative idea. The second stage is the technical development tphase, from idea to the development of a design to technical reality. At this stage, capital funding and patent applications for the development are necessary but they are not considered here. The third stage is experimental and clinical studies, a data gathering phase to provide evidence of safety and effectiveness of the applications of the device. The final stage is society adaptation and acceptance. These four stages do not occur in series but constantly interact and feedback on each other, evolving on their way to maturity.
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