Design and development strategy for the rotary blood pump.

Development of an antitraumatic antithrombogenic and durable blood pump is a very difficult task. Based upon this author's experience of over 35 years in the development of various types of cardiac prostheses, development strategies for a rotary blood pump are described. A step-by-step development strategy is thus proposed. Initially, the development of a 2 day antitraumatic pump (Phase 1) would be made. Then, conversion of this pump to a 2 week antithrombogenic pump (Phase 2) should be attempted. After the successful development of the Phase 2 pump, the conversion of this device to a durable, implantable, and long-term blood pump (Phase 3) should be established. Based upon this development strategy, 2 rotary blood pumps, namely, the axial flow blood pump and the centrifugal blood pump, have been developed in less than 6 years with modest development costs.