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A Tribute To Prof. M S
Valiathan
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The Pioneer Of Medical
Devices Development In India
(Courtesy : Balram Sankaran, Scientist, Sree Chitra
Tirunal Institute for Medical Sciences
& Technology, Trivandrum ) |
• As founder Director of Sree
Chitra Tirunal Institute for Medical Sciences &
Technology (SCTIMST), Trivandrum, he identified the
need and took unprecedented efforts to develop high
quality medical devices and implants meeting
international standards.
• Had a vision of establishing a
world class Biomedical Technology Wing campus in the
country along with a hospital (SCTIMST).
• Eventhough trained as a cardiac
surgeon, he had the mind of an inquisitive scientist,
practical wisdom of an engineer and enthusiasm of an
entrepreneur.
• As a cardiac surgeon, his dream
was to develop an artificial heart valve prosthesis to
replace diseased valves and make it affordable to his
large number of patients.
• He had the foresight to set up a
Technology Transfer Cell in house to protect the
intellectual property (IPR) and file patents for the
inventions made in the Institute.
• Committed to ensure that the
results of the research reached the patients in the
form of commercially available and competitive devices
and implants.
• Indian medical devices industry
will always gratefully remember his contributions to
the growth of indigenous medical device development in
the country. |
Professor Marthanda Varma Sankaran Valiathan (24 May
1934–17 July 2024), was a distinguished cardiac surgeon
who is considered as the pioneer of medical devices
development in the country. As early as the 1970s, he
identified the need and took unprecedented efforts to
develop high quality medical devices and implants
meeting international standards. He was founder Director
of Sree Chitra Tirunal Institute for Medical Sciences &
Technology (SCTIMST), Trivandrum, a unique Institution
in the country that combines a medical hospital with a
biomedical technology wing. The Institute was
strategically placed under the Department of Science and
Technology, Government of India through an Act of
Parliament in 1980, to support his vision of
establishing a world class Biomedical Technology Wing
campus in the country along with a hospital. The
hospital wing set up by him, stood out for excellence as
a tertiary care cardiac and neuro hospital and became
synonymous with high quality patient care.
As a cardiac surgeon, his dream was to develop an
artificial heart valve prosthesis to replace diseased
valves and make it affordable to his large number of
patients. As he embarked on this mission, he realised
that developing biomedical devices, especially high risk
implants requires a multi disciplinary approach and
dedicated infrastructure for both research as well as
testing which was lacking in the country. He therefore
took upon himself, the task of setting up a
multidisciplinary team of engineers, polymer scientists,
biologists, toxicologists and veterinery surgeons to
work on biomedical projects. Under his leadership,
engineering laboratories for design, development &
testing, precision tool room for fabrication and polymer
processing labs were soon set up with best of
facilities.
A polymer analysis lab which was much advanced for the
time, with equipment such as DSC, TGA, FTIR, HPLC, UV
Vis spectrophotometers and UTM was set up with expert
faculty for screening and characterisation of
biomaterials. For the first time in the country, a
laboratory to study blood material interaction and
conduct thrombosis research was set up in SCTIMST. A
toxicology division was established to assess material
safety and identify biocompatible materials as per ISO
standards. An animal facility for breeding and care of
experimental animals comprising rabbits, mice and guinea
pigs was also established as a logical step to
facilitate smooth conduct of toxicological evaluations.
To cap it all, a large animal evaluation facility
consisting of a modern operation theatre, pre and post
operative care for animals such as sheep, pig and dogs
was established. An unmatched facility and expertise for
conducting surgical procedures in large animals was
established within the Biomedical Technology wing campus
which played a crucial role in subsequent product
development. All these facilities were conceived and
implemented with deep thought that even after four
decades, they still remain relevant, functional and
continue to be part of safety and performance evaluation
of a large number of devices and implants. These
facilities have also been utilised by several medtech
industries on a chargeable basis. In addition to these,
a gamma radiation facility for sterilisation of medical
devices was set up in the campus with the help of Bhabha
Atomic Research Centre.
Much before it became mandatory, he set up an
Institutional Ethics committee which was chaired by a
retired high court judge to review proposals for
human clinical trials. A library with huge repository of
books and journals provided access to latest research
information at that time. Under his guidance, a nation
wide market survey to estimate the market demand and
identify the medical devices to be developed was carried
out.
He encouraged international collaborations and many
faculty of Institute were given an opportunity to get
trained abroad. Under an active Indo- UK program,
several visits of experts from leading biomedical
institutions in UK to Institute and vice versa took
place.
Prof. Valiathan was committed to ensure that the results
of the research reached the patients in the form of
commercially available and competitive devices and
implants. He had the foresight to set up a Technology
Transfer Cell in house to protect the intellectual
property (IPR) and file patents for the inventions made
in the Institute. He was actively involved in scouting
for appropriate industry partners to license the know-hows
and IPR developed by the institute. He constituted a
Technology Transfer committee with experts from academia
and industry to develop policies and guidelines to
facilitate transfer of technology from Institute to
industry. It became evident to him that the technologies
developed in the laboratory needed to be scaled up for
mass production to be commercially successful. To
facilitate a scale up of production and to ensure a
smooth technology transfer to industry, a unique Technoprove facility was established in the Institute.
This facility, in which the industry and institute
personnel jointly worked towards solving the problems in
scaling up and producing a large number of clinically
usable devices became a catalyst for successful transfer
of technology and commercialisation. The clinically
usable devices were utilised for the conduct of
unicentric or multicentric clinical trials as well as
market seeding.
The tilting disc mechanical heart valve prosthesis
launched as TTK Chitra Heart valve with M/s TTK Pharma
(now TTK Healthcare) as the industry partner became a
blockbuster success and is a testimony of the tireless
efforts and commitment of Prof. Valiathan in overcoming
the various scientific and technical challenges that
came in the way. From selecting appropriate materials to
its sourcing and processing, from design to testing and
manufacturing, each step had several challenges as a
heart valve has to beat over 40 million times in an year
without any minute wear and tear inside the body. The
heart valve finally launched was after a decade of
sustained research and development efforts. It is
implanted in over 200,000 patients successfully without
any failures and continues to be the most
affordable mechanical heart valve and widely used. The
blood transfusion bags developed by the Institute was
transferred to Peninsula Polymers (now Terumo Penpol) in
the 1980s and subsequently to Hindustan Latex Ltd (now
HLL Lifecare) both of which even today produce over 50
million bags annually and are extensively used for blood
transfusion all over the world. The blood oxygenator and
cardiotomy reservoir was commercialised as SPICTRA brand
through South India Drugs and Devices Pvt Ltd (SIDD).
Several disposables such as chest drainage system,
urinary bags, custom packs, humidifiers etc were
developed as spin off projects. Development of
hydrocephalus shunt system, dental materials,
embolisation materials, vascular graft etc were taken up
during his tenure, some of which were later
commercialised.
Eventhough trained as a cardiac surgeon, he had the mind
of an inquisitive scientist, practical wisdom of an
engineer and enthusiasm of an entrepreneur. It is no
wonder then, that the high risk medical devices that he
undertook to develop, achieved highest standard in
performance and commercial success. Apart from medical
device development, his contributions in patient care,
medical and higher education, public health research,
scientific administration, ayurveda etc were equally
significant. Professor Valiathan received many coveted
honours and was bestowed with the prestigious Padma
Vibhushan.
The generations to come associated with the Indian
medical devices industry in the country will always
gratefully remember his contributions to the growth of
indigenous medical device development in the country. |
