A Proposed Design of an Universal Electrochemical Reader Based on a Collated Medical Device Innovation Framework and Systems Thinking

Glucometers are the most common electrochemical readers that people are using frequently, but, similar readers can be used for analyzing many other tests like HbA1c, Hemoglobin, Serum Albumin, Urine ACR, etc. However, at this moment most of the tests are conducted using proprietary readers, which add on to a lot of energy being consumed (with sustainability in focus, we consider energy consumed in form of all resources that is utilized for development, manufacturing, handling and disposal of the product) and also leads to increase in cost of tests and thereby raises the question on cost effectiveness of these tests. There are multiple other parameters which probably at the moment are not even considered while design of these products, thus, directly raising questions on sustainability of these products. In this paper we propose a design of a universal electrochemical reader which is generic in nature and can be adapted to any tests which can be measured or analyzed using an electrochemical measurement process and requires a small quantity of liquid samples like blood or urine. The proposed design is the result of following a Medical Device Innovation framework that was collated by the authors through reviews of existing frameworks and interviews. Systems Thinking was also used as a tool to understand the problem at a systems level with the help of cross-impact simulation models in the current solutions available across the market. The aim of this study was to optimize the design of electrochemical reader, especially considering the case of glucometers with the focus being on study of Sustainability. With the help of the Medical Device Innovation framework model an optimized design for electrochemical readers was conceived.