From a lab type to a product: a retrospective view on Impella's assist technology.
A lab type is best described by its value as a result of its handcrafted uniqueness in small numbers. Logically, there is not one lab type like another, and the fact that it has been realized does not mean that this special effort can be easily reproduced. Furthermore, most lab types have undergone stand alone test runs revealing fingerprints rather than universal results at a 20% effort to 80% effect ratio. A product development, on the other hand, is best described by an 80% effort to 20% effect ratio in terms of measurable results. Products are producible and cost effective goods which are well documented and have undergone numerous test runs and test procedures assuring safety and quality, a basic requirement for market approval and cost effective marking. Based on the intravascular pump technology, comprising a sensorized axial flow pump with an integrated micromotor, the iterative dependence of the product development on lab types is demonstrated showing in particular the importance of having highly developed lab types before initiating the product development. By example, we demonstrated that high product quality has a greater impact on the reduction of blood damage than numerous redesigns. Reengineering issues are addressed, which are part of the product development process. Furthermore, the previously mentioned technology serves as a platform leading directly from the perioperative biventricular system to a 7 day pump as well as a miniaturized 12 Fr version.
Siess
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T
Impella Cardiotechnik AG, Aachen, Germany.
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Menzler
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D000818:Animals; D017076:Computer-Aided Design; D006353:Heart-Assist Devices / Q000009:adverse effects; D006461:Hemolysis; D066298:In Vitro Techniques; D011474:Prosthesis Design; D013552:Swine