Virtual symposium “3rd BID Workshop: “Role of Clinical Validation & Calibration Testing in Bringing Medical Devices to the Markets” successfully concludes at PGIMER
The Biomedical Instruments and Devices Hub: A Centre for Innovation, Design, and Clinical Validation BID-HUB established at Postgraduate Institute of Medical Education and Research PGIMER, Chandigarh, with the support of the Department of Science and Technology DST, Government of India to promote indigenous development of biomedical instruments and their testing & clinical validation. The center is also working towards the mission of ‘Make in India’ by promoting the indigenous development of high-quality medical devices through innovation, design, and clinical validation steps. The hub has already delivered indigenous medical devices prototypes, patented and commercialized novel medical devices.
A one-day virtual symposium “3rd BID Workshop: “Role of Clinical Validation & Calibration Testing in Bringing Medical Devices to the Markets” specially designed to decipher the role of Calibration Testing and Clinical Validation of medical equipment in getting approval to market in the country was conducted today on 23rd of July 2021. The seminar was inaugurated by Prof. Rajeev Ahuja, Director IIT Ropar. The seminar highlighted the common issues faced by the medical device R&D, Industry etc., followed by the discussions on how to address those challenges?
Prof. Jagat Ram, Director PGIMER, Chandigarh explained that the Innovation is indeed a challenge, and 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. The need to bring them altogether was felt by PGI, and a team of doctors led by Prof. G. D. Puri and Prof. Mathews made a proposal to the department of Sciences and Technology for sanction of Biomedical Instrument and Devices Hub A centre for Innovation, design and clinical validation in 2015 resulting in a functional Biomedical Instruments and Devices Hub 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 settings. Notably, the newly procured medical devices are also being subjected to the in-house calibration testing center at BID-Hub 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.
Prof. Rajeev Ahuja, Director IIT Ropar shared his journey as a successful innovator briefly and appretiated such a multidisciplinary activity. He further explained the dire need of collaborations among the two institutes.
Prof. GD Puri, Dean (A), PGIMER, Chandigarh explained that BID-Hub at PGIMER is not only testing the new prototypes and devices made locally but also testing and validating the devices which are being used by clinician in different part of the hospital. The calibration testing lab at Biomedical Instruments and Devices Hub aims to make the medical devices safer by calibration-testing of all medical devices. The center is equipped with the calibrated analyzers to perform most medical devices. The fully functional lab is currently doing in-house testing of different medical equipment types already in-use at PGIMER settings. Notably, the newly procured medical devices are also being subjected to the in-house calibration testing center at BID-Hub 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.
Prof. Joseph L Mathew, Department of Paedriatics, PGIMER explained briefly the activities of the Biomedical Instruments and Devices Hub (BID-Hub) and highlighted the clinical expertise at BID-Hub, PGIMER, Chandigarh. He emphasized upon the clinical expertise at the Hub which can act critically in the success of most medical devices. Being the end-user of the medical devices, clinicians can be the better judge of how well a device performs in clinical settings.
Mrs. Rama Venugopal, Executive Director, Value Added Corporate Services Pvt Ltd, Chennai, was one of the key speaker of the event. She demonstrated the various standards that applies to the medical device as a product, and manufacturing of medical devices process certifications. Also, the rules and regulations applicable to different kind of medical equipment.
Dr. Suresh Nair, Chief Technology Advisor to Foundation for Innovation and Social Entrepreneurship, an initiative of Tata Trust, presented the concept of making a product from beginning. He emphasized upon the significance of design thinking in the success of any medical device giving real examples.
Dr Rubina Bose, Deputy Drug Controller of India, CDSCO, Government of India provided her meaningful insights over the regulatory aspects of medical devices. She explained how the COVID related medical equipment is screened at the earliest to expediate the products reaching the market.
The event was attended by Dr. Anita Agarwal, Scientist “F,” Department of Science and Technology DST, Govt. of India. She informed about the various schemes of DST to support the biomedical research and development.
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 center is also working towards the mission of ‘Make in India’ by promoting the indigenous development of high-quality medical devices through innovation, design, and clinical validation steps. The hub has already delivered indigenous medical devices prototypes, patented and commercialized novel medical devices.
The BID-Hub Lab is a state-of-art facility with the potential to become an official medical device testing centre in the northern region. The calibration testing lab at Biomedical Instruments and Devices Hub aims to make the medical devices safer by 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.
