|
|
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.
|
|