General protocol for ethical conforming development for non-invasive blood biomarker measurement optical device

摘要

The new Indonesian national regulation for medical device evaluation necessitates the modification of current best practices for solution development. This article describes our current protocol for medical device development and evaluation. We have combined best practices from Simplified Pressman Standard and Indonesian Technology Readiness Level and Clinical Trial Regulation as a base for our medical device development and evaluation methods. Settings. This protocol is currently evaluated by "Konsorsium Riset Alat Ukur Haemoglobin, Kadar Gula (Glukosa dan HbA1c) Non- Invasive" between IPB University, Agency for the Assessment and Application of Technology, and PT Tesena Inovindo. This article is a preposition article developed from literature research and currently evaluated in three years of research in the consortium. We have developed a three-phase protocol, consist of technology, product, and market phase. This article describes in detail for each point for this protocol, using our current non-invasive blood glucose and Haemoglobin level medical device as an example. The technology phase includes primary literature and lab review for technological units for the non-invasive medical device. The product phase describes best practices for laboratory examination for medical device development in the research stage. The market phase describes best practices for medical device development for consumer usage. We are currently evaluating our protocol. and shall report the evaluation within three years.