BID 3rd Workshop: Role of Clinical Validation & Calibration Testing in Bringing Medical Devices to the Markets

Friday, 23 July 2021

Biomedical Instruments and Devices Hub, PGIMER Chandigarh (BID-Hub)

BID-Hub 3rd annual workshop in the form of a virtual symposium focused on the “Role of Clinical Validation & Calibration Testing in Bringing Medical Devices to the Markets”. The invited experts Dr Rubina Bose (Deputy Drug Controller of India, CDSCO); Dr Suresh Nair (Product Innovation Guru, Founder Design Alpha and Biophoton Technologies); Mrs Rama Venugopal (Management Consultancy Expert, (Founder:Value Added Corporate Services); Prof Rajeev Ahuja (Director IIT-Ropar) shared their views on the role of Calibration Testing and Clinical Validation of medical equipment in getting approval to market. Prof. Jagat Ram, Director PGIMER, Chandigarh highlighted the importance of Innovations in the medical device industry and explained that India is well poised to achieve success in developing biomedical devices if all the stakeholders like industry, doctors, Engineers, and technicians come together at a single platform to do the much-needed brainstorming. PGI felt the need to bring them all together, and a team of doctors led by Prof. G. D. Puri and Prof. J L Mathew proposed the Department of Sciences and Technology for sanction of Biomedical Hub in 2015, resulting in a functional Biomedical Instruments and Devices Hub: A centre for Innovation, design and clinical validation in 2018.

The fully functional lab at the Hub is currently doing in-house testing of different medical equipment types already in use at PGIMER clinics. Notably, the newly procured medical devices are also being subjected to BID-Hub’s in-house calibration testing centre for their performance and safety evaluation. This practice of testing the equipment before the procurement or installation in the hospitals ensures critical analysis of the medical equipment regarding its accuracy and defined standards, thereby improving patient care at PGIMER and saving the cost.

The multidisciplinary center is facilitating device development by acting as a bridge between the engineers and clinicians. The Hub acts as a node for CRIKC institutes IIT-Ropar, IIT Mandi, Panjab University, IMTECH, IISER, CSIO, INST, etc., in the region for a diverse range of medical devices research & development. The BID-Hub Lab is a state-of-art facility with the potential to become an official medical device testing center in the northern region. The calibration testing lab at Biomedical Instruments and Devices Hub aims to make the medical devices safer by performing the calibration-testing of all medical devices. The center is equipped with the calibrated analyzers to perform most medical devices. With clinicians’ experience and expertise at PGIMER, the center is moving ahead towards becoming a certifying body for validating and testing medical devices in the coming time, thereby solving the greatest challenge of clinical validation faced by Indian Medical Devices Research and Industry.