A new ‘In vivo Evaluation facility’ has been established at Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum, an autonomous institute under the Department of Science and Technology, to test medical devices on animals.
Dr. V.K. Saraswath, President, SCTIMST, inaugurated the facility on March 12th, 2020. The establishment of this new ‘In vivo Evaluation facility’ will augment the exiting efforts for indigenous development of medical devices in our country through supporting in-house development of such devices as well as by providing additional capacity to the Indian medical device industry and academia for their medical device development process.
The In vivo Evaluation Facility under the Division of In vivo Models & Testing is a state-of-the-art facility for housing large experimental animals having a capacity to house 40 adult pigs and 70 adult sheep in compliance with the recommendations and requirements of the regulatory agency. There is also space for minor medical procedures and acute pre and post-operative management of experimental animals.
All the animal enclosures have automatic stainless steel drinkers for animals, and the sheep facility is installed with durable and impact-resistant polypropylene slatted floor. The building is designed to ensure the safe housing of animals, their management and movement, species segregation, and paddocks for grazing and exercise of sheep. The entire facility is pest and rodent-proof and also has an efficient system for managing the animal waste and effluent treatment facility to ensure least impact on the environment.
SCTIMST is a forefront runner National Institution in the field of medical device development using indigenous technology since the inception of laboratories in the Biomedical Technology (BMT) Wing in 1978 at the Satelmond Palace campus, Poojappura.
Animal evaluation of medical devices is an integral part of medical device development to establish functional safety prior to its clinical use in patients. The division of In vivo models and Testing in the BMT wing accomplishes this important task. Numerous high-risk medical devices such as the mechanical heart valve, oxygenator, vascular graft, hydrocephalus shunt, bone substitutes, dental materials, etc. have undergone animal studies in this facility to prove its safety and performance before it reached patients.
Currently, there is a resurgence of medical device development activities at SCTIMST under the Technical Research center (TRC), a programme funded by the Department of Science and Technology, Government of India. SCTIMST has recently launched nearly 40 research projects for the development of indigenous biomedical devices and biomaterials under TRC as part of the efforts by the Department of Science and Technology (DST) to fast-track work on indigenous medical devices development. In this program, dedicated teams are working on mission mode to develop technologies ready to be transferred to industry partners. The development of these medical devices requires animal studies to establish preclinical safety/performance.
Apart from its own activities, SCTIMST helps the domestic medical device industry in the development of indigenous medical devices by undertaking preclinical animal evaluations for their products since 2000. More than 15 Good Laboratory Practice (GLP)-compliant studies were performed for several Indian medical device companies. As SCTIMST is a significant center in India for doing such studies, there is a pressing demand for pre-clinical animal testing from Indian medical device manufacturers.
This new facility will enable SCTIMST to go for GLP certification by the Government of India, thereby enhancing the global acceptance of animal study data generated here.