Functional Requirements and Quality Assurance Necessary for Successful Incorporation of Electroporation-Based Therapies Into Clinical Practice

Abstract

Electroporation-based therapies have a huge potential for implementation into clinical practice in socioeconomically disadvantaged populations. Currently, the price of electroporators and electrodes is relatively high, but custom low budget devices can be developed. In the paper, we describe three most established applications in medicine, with the focus on the basic mechanisms, which should be taken into account during the development process of a clinical electroporator. Also, typical pulse parameters used in each of the described applications are defined. In the second part of the paper, we describe technical functional requirements for a clinical electroporator and safety guidelines, with the focus on medical device standard. At the end of the paper, the focus moves to a more general problematic, such as quality assurance and the importance of measurement during the pulse delivery, which we firmly believe is necessary for successful electroporation.