IVD & Medtech industry – My two pence

Our expectations from the IVD and the Medtech devices industry are consequent to our expectations from the healthcare delivery system that we envisage for the future. The contemporary hospital-driven model has failed globally, and there is a need to revert to a decentralized domiciliary-based healthcare. Only a miniscule part of the current hospitalization – those needing surgical interventions, acute emergencies, and serious ailments should be handled in the hospital, and mere need for intravenous medications or oxygen and terminal socio-nursing care should fall under the purview of domiciliary care.

The industry should innovate and manufacture customized products, aligned to the needs of a geographical society, sourcing even their supply chains locally to the extent possible. The devices should encourage and promote healthy behavior, and should be simple to use, so that an unskilled individual can operate them at home. We need reusable and recyclable products, and use-and-throw products should become a taboo. Needless to say, they must be affordable, accessible, available, and easily employable. Moreover, the devices should be enabled for internet synchro­nization for easy transmission of data.

However, achieving these goals pose major chal­lenges – grossly deficient and dysfunctional infra­structure; dearth of skilled manpower; corrupt, in­efficient, and deficient regulatory mechanism; and lack of innovation and quality standards so that substandard products, albeit marginally cheap, rule the roost. To top them all, our colonial mentality and obsession for foreign-made goods make a heady mix with our lack of commitment and faith in our own capabilities, and all that is Indian.

Sunny flipside, however, just as we have a plethora of challenges, there are an equally exhaustive panoply of opportunities. The government should take lead, and which it has already taken in certain matters like PLI schemes, 100 percent FDI sans preapproval, and establishment of dedicated parks for Medtech devices. The cost of finance must reduce for manufacturing of such products, including appropriate subsidies from the government and they should be prescribable and eligible for insurance reimbursements. For better regulation and synchronization, and as also recommended by the parliamentary panel recently, the Department of Pharmaceuticals, which controls devices also, should be transferred to the Ministry of Health from the Ministry of Chemicals and Fertilizers. In fact, the recommendations also include creation of a separate department of medical devices, which should be tasked with the jobs of production, development, control, promotion, education, training, and research in the field. Even the ideation of a Medical Device Promotion Council is a welcome step.

Pari passu, the device industry must also rise to the occasion by addressing the concerns of the society and, therefore, they must innovate products for remote monitoring and sensing and point-of-care testing of commonly prevalent diseases in a par­ticular area. If steps are taken in the right earnest, India’s dependency on import of the medical devices can be reduced from the current 75–80 percent to 25–30 percent within the next decade. There is an opportunity in better regulation too, as high­lighted by the Parliamentary Board. Regulators themselves must be properly qualified and trained for effective implementation of the guidelines. For this, quality institutions like the IITs and NITs can be roped in. There should be more coordination between the bench and the bedside, viz., the manu­facturers, the innovators, and the medical frater­nity. Intellectual property rights protection and marketing too provide potential arenas for gains.

The domain of metaverse, including artificial intelligence (AI), virtual and augmented reality, internet of things (IoT), machine learning, biodata analytics, etc., is a virgin area waiting to be explored and violated for the good of the humanity. In the absence of big funding, collaboration, and translational research, picking up low-hanging fruits, should be the mantra.

Indeed exciting times ahead!