Academic Day Presentations on 18.10.2025 at 8.00 AM by Department of Technology and Quality Management
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Item Chemical characterisation of medical device materials in a risk management process as per ISO 10993-18(SCTIMST, 2025-10-18) Renjith, SThe demand for medical devices in India is steadily increasing. The National Medical Device Policy 2023 was introduced with the goal of capturing a 10-12% share of the global medical device market within the next 25 years. Achieving this objective requires strengthening medical device development and testing capabilities. Each medical device must undergo rigorous biological evaluations in accordance with international standards to ensure patient safety and prevent health risks. ISO 10993-18 provides a framework for the chemical characterization of medical device materials, crucial for toxicological risk assessment. Chemical characterization involves several steps, including the identification of material components, analysis of their composition, and estimation of extractable, leachable, and degradation products released from the device under ambient or accelerated conditions. This process also helps establish the equivalence of a new material or device with existing ones. Combining chemical characterization with toxicological risk assessment enables the screening of potential materials or devices for clinical use and ensures the biological safety of new or reprocessed medical devices. The presentation will focus on the step-by-step methodology for chemical characterization of medical devices according to ISO 10993-18.Item Internet of Things (IoT) based platform for technical infrastructure management(SCTIMST, 2025-10-18) Sajithlal, MKAt the Biomedical Technology Wing, the Division of Engineering Services manages various technical infrastructures, including IT systems, networks, air conditioning, electrical systems, and many sophisticated instruments. To enhance efficiency, a proactive monitoring and management approach is desirable over the traditional “firefighting” approach, as it helps reduce both operational costs and equipment downtime. Under the DST-TRC funded project titled “Development of Connected Platform for Infrastructure Management,” an Internet of Things (IoT)-based platform was developed for real-time monitoring of environmental parameters (temperature, humidity, light, air pressure, etc.), as well as the vital parameters of electrical and mechanical equipment (voltage, current, surface temperature, vibration, etc.). The system also tracks water levels in various overhead tanks. The platform automatically sends alerts (via SMS, email, or mobile notifications) to the concerned facility custodians whenever anomalies are detected in the monitored parameters. In addition, automation based on human movement has been implemented for controlling lights and exhaust fans. The entire system was developed using open-source software and hardware platforms. This platform is scalable and can be extended for real-time monitoring of patient vitals—such as heart rate, SpO₂, and blood pressure using wearable sensors (like wristbands or rings). The initiative was launched in collaboration with the Centre for Development of Advanced Computing (C-DAC), Trivandrum, as part of the Digital Health program.