Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, is a statutory body and an Autonomous Institute of National Importance under the Department of Science and Technology, with a unique mission to develop biomedical technologies, provide and demonstrate high standards of patient care and participate in public health initiatives. Having the status of a University, SCTIMST conducts post graduate training programs of the highest quality. This institute stands apart from other National Institutes in its structure and function. The missions are executed by the three wings: a tertiary referral super specialty hospital in Cardiac and Neurosciences, the Achutha Menon Centre for Health Science Studies (AMCHSS) and a Biomedical Technology (BMT) Wing established in two campuses about 8 km apart. The strength of the institute is the multi-domain team of engineers, scientists, clinicians, nursing staff, public health experts and specially trained technical and supporting staff.
SCTIMST focuses on high quality, advanced treatment of cardiac and neurological disorders, indigenous development of technologies for biomedical devices and materials and public health training and research. The institute has a total faculty strength of 135 (Medical 83, Scientist 52) along with 917 staff members in the three campuses.
The Hospital Wing offers advanced treatment using modern technologies in several specialized areas such as interventional radiology, cardiac electrophysiology, deep brain stimulation for movement disorders, epilepsy surgery, pediatric cardiac surgery, skull base and vascular surgeries, to name a few. Various departments including Anesthesia (for heart and brain surgeries), Biochemistry, Cardiology (adult, pediatric and electrophysiology), Cardiovascular and Thoracic Surgery, Cellular and Molecular Cardiology, Imaging Sciences and Interventional Radiology, Microbiology, Neurology (Cognition & Behavioral Neurology; Comprehensive Care Centre for Movement Disorders; Comprehensive Center for Sleep Disorders; Comprehensive Stroke Care Center; Multiple Sclerosis and related disorders Division; Neuromuscular Division; Pediatric Neurology & Neurodevelopmental Disorders; R Madhavan Nayar Center for Comprehensive Epilepsy Care), Pathology, Neurosurgery, Nursing, Physical Rehabilitation, Transfusion Medicine and Clinical Engineering Departments work in concert to provide best patient care services. The Cardiology department has the Center for Advanced Research and Excellence in Heart Failure of ICMR, one of the ten National Centres established by ICMR. The AMCHSS takes up research and training in medical and public health areas of social relevance. The Centre focuses on research in the areas of non-communicable diseases, gender and health, health policy and management. The BMT Wing has excellent facilities and teams of professionals dedicated to the development of innovative biomedical devices and products, and evaluation of medical devices to global specifications.
TECHNOLOGY DEVELOPMENT
The tradition of developing appropriate and affordable technologies and establishing its market presence through industrial partnership is the inimitable imprint of this institution, and its impact upon the growth of the Indian medical device industry is well recognized. The Biomedical Technology Wing of the institute was established with the objective of promotion of biomedical science and technology in the country. Through the successful development and commercialization of various indigenous biomedical products, it has played a pivotal role in establishing a medical device industry base in India. The institute has also won many awards including the prestigious National Technology Award (2002) and three National Research Development Corporation (NRDC) awards from the Government of India for biomedical technology translation work in recent years.
The activities of the BMT Wing diverged into four streams — applied research activities, medical device development, devices and materials evaluation and human resource development. The campus includes various highly specialized, multidisciplinary state-of-art research and development labs led by experienced faculty, working in different areas of biomedical sciences and technology.
The BMT Wing has an organized milieu for the evaluation of medical devices and biomaterials. The test labs are engaged in in-silico studies, physicochemical characterization and biological characterization along with preclinical and product release studies. The labs are working on a quality platform and accredited by international agencies. The institute is also taking care of human resource development in this area, including in-house training programs and regular training for uplifting students belonging to SC/ST categories.
As of now, the Intellectual Property Rights (IPR) Cell of SCTIMST proudly speaks about the unparalleled experience of 45 years in biomedical product translation, among other public sector institutions in the country. The institute holds about 150 sealed patents, (130 Indian and 20 international). As many as 70 patent applications are in process, with 160 design registrations. The patent-to-commercialisation ratio is >30%, among the highest in the country.
A total of 50 technologies have been transferred, out of which 16 products are a commercial success.
The medical device testing services are working on the ISO17025 platform and accredited by the French agency COFRAC. Over 15 international and 100 Indian biomedical research teams have availed this facility.
SUCCESS STORIES AND FLAGSHIP PRODUCTS
The SCTIMST team developed disposable blood bags for the first time in India, in the early 1980s that changed the blood transfusion practice in the country. The first technology partner is now the largest producer of blood bags in Asia. All industrial partners who took the blood bag technology together are making about 50 million bags annually and the item is being exported to several countries.
The Chitra Heart Valve, conceived by stalwarts of SCTIMST, a noble vision, paved the foundation of ‘Make in India’ even in the Nineties. The journey was not easy; it was the greatest challenge faced by the team in the development of the Mechanical Heart Valve at that time. This device saves the patient from detrimental health issues arising due to defective natural valves of their heart. The first generation valve was made of a chrome cobalt alloy (frame), Ultra High Molecular Weight PolyEthylene (tilting disc) and polyester (sewing ring). Superior haemodynamics, structural integrity, low profile and silent operation were built into the design. The know-how was transferred to TTK Healthcare Ltd, and the product attracted worldwide attention for its quality and affordability. The Chitra-TTK valve model has the history of three decades of clinical existence, used across 400 centres in India and abroad, without any major in vivo failure. Now more than 1,80,000 valves have been installed inside patients, adding decades of longevity to their life. The second generation model of TTK Chitra Heart Valve TC2 has been re-designed for MRI compatibility, better minor orifice flow and enhanced thrombo-resistance.
Another notable one is the hormone releasing Intrauterine System (IUS) jointly developed with HLL Lifecare Ltd. and launched under the brand name EMILY. This is India’s first (and the world’s second) product in this category, used for contraception and to control abnormal uterine bleeding.
These were followed by a large number of commercialized products — Hydrocephalus shunt, Bubble oxygenator, Cardiotomy reservoir, Concentric needle electrode, Haemoconcentrator, Membrane oxygenator, Vascular graft, Dental composites, Glass ionomer cement, Single solution bonding agent, Chemo-mechanical caries removal agent, ECG electrodes, Calcium phosphate bone cement, Field kit for detecting antibiotic sensitivity of mastitic milk, Rapid diagnostic kit for Urinary Tract Infections, Vein viewer, Bioceramic bone fillers, Injectable hydrogel for cartilage repair, PT/INR monitoring device, Device for Tuberculosis diagnosis, Lint-free absorbent wound dressing, Calcium phosphor-silicate composite, Bioactive bone cement, Blood flowmeter, External pneumatic compression equipment, Flow diverter stent, Infant warming wrapper and bassinet, Automatic smart trash bin for disinfection using UV enabled microwave and Drug eluting bioactive beads.
TIMeD, TECHNOLOGY BUSINESS INCUBATOR OF SCTIMST
The Technology Business Incubator for Medical Devices and Biomaterials (SCTIMST-TiMed) was started in 2015 and aimed to ‘incubate’ and ‘promote’ startup companies and to provide a niche for innovative medical devices and technology. TIMed nurtured the enthusiastic entrepreneurs, scientists, students and clinicians to take an entrepreneurial role in the medical devices sector. It is also open to industry that may want to launch a new product to market with the support of the incubator. Incubatees are selected after a review of the proposed business plan. TIMed provides a strong mentoring in scientific, technical and business domains to its incubatees with the help of its network of mentors both from within SCTIMST and experts from other institutions and industry. In less than a decade of existence of TIMed, the start-ups have successfully proven their mantle including Sascan Meditech Pvt Ltd that received the National Technology Award 2023.
TECHNICAL RESEARCH CENTRE
The BMT Wing was identified as a Technical Research Centre (TRC), the nodal research centre for development of biomedical devices in the country by the Department of Science and Technology, Government of India, in 2015. The centre worked on a mandate of developing about 40 medical device technologies in five identified segments, viz., cardiovascular, neuroprosthetics, hard tissue devices, biologics and in vitro diagnostics (IVD). A Medical Device Regulatory Compliance Facility (MDRCF) for supporting the Indian medical device industry and an Industry-Institute Partnership Cell (IIPC) for training human resources are also functional as part of TRC.
The outcome of the first phase marked a large number of proof-of-concepts of devices, some of which progressed to the technology transfer stage. Industrial partners are identified for Para-corporeal left ventricular assist device, Endovascular stent graft, Atrial Septal Defect (ASD) Closure Device, Deep Brain Stimulator, Radiopaque liquid embolization device, Bioactive material platform for drug delivery in bone, and wound healing matrix from porcine-cholecystic-extracellular matrix. Other products which completed the course of validation are — Bioprosthetic heart valve, TiN coated stent, Aortic stent Graft, Bioink for 3D printing, Point of care detection of HPV and Blood derived products.
During the pandemic outbreak, the research team at SCTIMST remained at work, developing related products in fast-track mode. As many as 14 fast-track projects were done for Covid-19 management. Out of them, the following know-how were transferred to the industry: RNA isolation kit, Covid-19 test kits, Swabs and viral transport media, Isolation pods, Examination booths, Swab collection booths, UV based disinfection system, Disinfection walkways, Super absorbent gels, AirBridge EBAS (Emergency Breathing Assistance System) and Deployable emergency isolation wards/ hospitals. The World Health Organisation has also accepted some of these products for widespread international dissemination.
Many of the proof-of-concept works are further taken to a higher level of technology readiness. A total of 37 new developmental projects and four facility projects are being taken up in the second phase of TRC. Two of the products, a porcine gallbladder dressing and TB kit have got CDSCO approval for commercialisation.
In the arena of training, for the first time in India, a unique DM-PhD and MCh-PhD program has been started. Besides this, PhD, MPh, and MTech degrees are being awarded. Postdoctoral certification courses and postdoctoral fellowship in various sub-specialties of medicine are also being given.
FUTURE DIRECTIONS
With the addition of a 170-bed hospital under the Pradhan Mantri Swasthya Suraksha Yojna (PMSYY), SCTIMST will soon be in league with the largest setup in Cardiac & Neurosciences tertiary healthcare in India. With the growing size of the Indian medical devices market from estimated Rs 90,000 crore (US$ 11 billion) to US$ 50 billion by 2030 with a CAGR of 16.4 % (as per a report by the India Brand Equity Foundation, 2022), the Indian market share in the global market is estimated to be 1.65%. In this sector, the BMT Wing has always been a trailblazer, a model to emulate for the biomedical technology development and translation, in line with the National Medical Devices Policy, 2023 to facilitate an orderly growth of the medical device sector to meet the public health objectives of access, affordability, quality, and innovation.
*Dr Komath is Scientist G; Head, Department of Biomaterial Science and Technology, while Dr Gulia is Scientist G; Head, Division of Sleep Research, BMT wing, SCTIMST & Chief Editor of Chitra Dhwani, the e-magazine of SCTIMST.
