Dr. Manoj Komath Scientist G & HoD, Dept. of Biomaterials Science and Technology Sree Chitra Tirunal Institute for Medical Sciences and Technology, Poojappura, Trivandrum

ABOUT THE SPEAKER Dr. Manoj Komath is working as G-level Scientist with the Biomedical Technology Wing of Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum. Currently holding the position of the Head of the Department of Biomaterials Science and Technology, which is known for developing and translating biomaterials based products in orthopedics and dentistry. Dr. Manoj studied M.Sc. Physics in Calicut University, and is an alumnus of IISc, Bangalore. His early research carrier was focused on thin film technology of diamond-like carbon and titanium nitride. He joined as a Scientist in SCTIMST in the year 2000, and started working on the research and development of ceramic coatings and bioactive bone fillers, which earned 16 patents in his credit. Special interests are design and validation of biomaterials for tissue regeneration. Several products he worked upon have got commercialised. Awards : MRSI Best Paper Prize in 2004, Young Investigators’ Award in the Asian Bioceramics Conference 2007, Osaka, Japan. He is a communicating author in the Best Paper/Poster Awards in IUMRS-ICA 2013 held in Bangalore in BioMET 2018 held in Vellore and in ICMT-23 held in Annamalai. Also received the Science Literature Award of Kerala Govt in 2012 for the best science book in Malayalam.

 

Abstract:

 

Medical Device Translation – Aspects of Compliance and Commercialisation
Dr. Manoj Komath
Scientist G, Biomedical Technology Wing
Sree Chitra Tirunal Institute for Medical Sciences and Technology,
Trivandrum – 695012
E-mail : manoj@sctimst.ac.in

 

Given the compelling need of indigenous development of medical devices, understanding the modalities of medical device translation is imperative. The initial part of translation takes different steps like ideation from an unmet clinical need, proof-of-concept build-up, prototype development, materials characterization and biological validation. In the post-development stage, packaging and sterilization and checklist of regulatory compliance are to be finalised. The translation process will be completed only with pre-clinical animal studies and human clinical trials. The whole activity is intensive in skill sets, manpower, time and funds, and hence demands a meticulous planning. The progress of activity and maturity of technology are assessed using Technology Readiness Level (TRL) scale. Medical device translation is inclusive of regulatory compliance, and viability in production and marketing. This presentation deals with the compliance and commercialisation aspects of medical device translation. The regulatory compliance is needed to ensure the safety of the device whereas commercialisation should be viable ensuring affordable level of production. An optimised translational plan in needed for each device, so as to minimise the manufacturing complexities and regulatory burden.