With 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 Thiruvananthapuuram-based Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) has kicked off an In vivo Evaluation Facility under its Division of In vivo Models & Testing at the institute’s Biomedical Technology Wing at Poojappura in the Kerala state capital.
The state-of-the-art facility boasts numerous high risk medical devices such as the mechanical heart valve, oxygenator, vascular graft, hydrocephalus shunt, bone substitutes, and dental materials, and they have undertaken animal studies to prove their safety and performance before they reach patients.
Establishment of the new In vivo Evaluation facility will augment the existing efforts for indigenous development of medical devices in our country through supporting in-house development of medical devices as well as by providing additional capacity to Indian medical device industry and academia for their medical device development. Dr. V. K. Saraswath, President, SCTIMST, will inaugurate the facility on March 12.
This new facility will enable SCTIMST to go for GLP certification by Government of India thereby enhancing the global acceptance of animal study data generated here.
The In Vivo Evaluation facility has the capacity to house 40 adult pigs and 70 adult sheep in compliance with the recommendations and requirements of 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 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, functioning under the Department of Science and Technology, Government of India, has of late seen a resurgence of medical device development activities at its Technical Research centre (TRC), a programme funded by DST. SCTIMST had recently launched nearly 40 research projects for the development of indigenous biomedical devices and bio materials under TRC as part of the efforts by the 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. 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 evaluation for their products m since 2000.
More than 15 Good Laboratory Practice (GLP)-compliant studies were performed for several Indian medical device companies. As SCTIMST is a major centre in India for doing such studies, there is a pressing demand for pre-clinical animal testing from Indian medical device makers.