Equipment maintenance emerges as the next hurdle in the growth plan

Republished by Newlife - MIM. All rights belong to the original publisher; see Source below.

Medical device maintenance, not manufacturing alone, will determine India’s growth trajectory.

India’s medical device sector has spent the past several years chasing manufacturing milestones, from production-linked incentives to import substitution targets. A study released by FICCI and DUA Consulting on August 8, 2026, at the ninth edition of India Medical Device 2026, argues that manufacturing capacity alone will not sustain the sector’s growth ambitions, and that how equipment is serviced after it reaches a hospital matters just as much as how it was built.

The scale of what is at stake gives that argument weight. The domestic medical device sector, currently valued at around USD 14 billion, is projected to reach USD 30 to 50 billion within this decade and as much as USD 250 billion by 2047, an eighteen-fold expansion from current levels. As equipment increasingly underpins diagnostics, emergency care, and advanced treatment, the analysis contends that servicing, calibration, and lifecycle management must be treated as core infrastructure for that growth rather than an afterthought handled at the facility level.

The maintenance gap the whitepaper documents is wide. Between 30 and 40 percent of medical device maintenance across India is currently carried out by unregulated service providers, and among Tier-II and Tier-III hospitals surveyed, the figure rises to 45 percent. No national certification pathway exists for medical equipment service engineers, and no central registry lets hospitals verify a technician’s credentials before letting them work on critical equipment. The consequences are not hypothetical – the assessment cites documented cases in which misdiagnosis and intra-operative equipment failures have been traced back to uncertified servicing and the use of counterfeit components. Poorly maintained equipment, it notes, translates directly into downtime, financial losses and patient safety risk, an outcome that runs counter to everything the sector’s manufacturing push is meant to achieve.

For hospitals and diagnostic centers, that gap has largely been an invisible cost, absorbed as unplanned downtime, shortened equipment life or ad hoc repairs rather than tracked as a distinct line item. For device manufacturers and distributors, it has meant competing on service quality without an external standard to certify against; for procurement teams, it has meant vetting service vendors with little more than a company’s own claims and a hospital’s word-of-mouth experience.

The recommendations aim squarely at closing that gap through regulation rather than voluntary best practice. The centerpiece is a risk-tiered maintenance framework aligned with the Central Drugs Standard Control Organisation’s existing device classification system, under which maintenance protocols would scale with the risk category of the equipment rather than apply a single uniform standard across everything from infusion pumps to imaging systems. Alongside that framework, the assessment calls for a national certification architecture for service engineers, built around stronger technical training and a verifiable credentialing mechanism that hospitals and regulators could both rely on. It also pushes for wider adoption of predictive maintenance, digital monitoring and lifecycle-management systems, technologies that flag equipment problems before they cause failures rather than waiting for a breakdown to trigger a service call.

A less technical but equally central recommendation concerns money. The document calls for commercial models that make compliant servicing economically viable, along with a more rational fiscal framework to support them, an acknowledgment that unregulated servicing persists partly because it is cheaper, not only because oversight is absent. Without addressing the cost gap between certified and uncertified servicing, tighter standards on paper risk pushing informal providers further underground rather than out of the market.

The timing connects this maintenance push directly to the manufacturing incentives already in motion, and the scale of those incentives shows how far policy attention has run ahead on the production side. The production-linked incentive scheme for medical devices carries a financial outlay of ₹3,420 crore running from FY2022-23 through FY2026-27, offering approved manufacturers a 5 percent incentive on incremental sales for five years across four target segments – cancer care and radiotherapy equipment, radiology and imaging systems, anaesthetics and cardio-respiratory and renal care devices, and implants. Of 27 approved applications, 14 belong to MSMEs, and actual investment against the scheme has reached ₹1,153 crore, with ₹266.64 crore in incentives released through FY2024-25. Nineteen greenfield projects were operational as of September 2024, producing 44 categories of medical devices, including MRI systems, CT scanners, linear accelerators and ultrasound machines that India previously imported in full, and cumulative sales under the scheme had reached ₹8,039.63 crore, of which ₹3,844.01 crore came from exports. A parallel medical device parks scheme has released ₹209.80 crore in central assistance and allotted 210 manufacturing plots across three sites, in Noida, Ujjain and Kancheepuram, while total foreign direct investment into the sector reached ₹17,201 crore between FY2021-22 and FY2025-26.

The Scheme for Strengthening of Medical Devices Industry, carrying its own outlay of ₹500 crore through FY2027-28, is where the maintenance argument finds its closest existing policy lever. The scheme runs across five components – common infrastructure for device clusters, a marginal investment scheme aimed at reducing import dependence, a medical device clinical studies support scheme, an international promotion scheme, and a capacity building and skill development component. Twenty-four projects have been approved under the import-dependence component, drawing ₹101.50 crore in grants, alongside 13 cluster projects worth ₹88.67 crore and seven MSME and startup projects. The skill development component is the natural home for the national certification architecture the maintenance assessment calls for, since it already funds workforce training for the sector, but its current design targets manufacturing-side skills rather than the biomedical service engineers who maintain equipment after installation. Extending it, or building a parallel certification track alongside it, would let India’s medical device policy address production and upkeep through connected programs rather than treating manufacturing incentives and maintenance standards as separate problems.

Capacity to build devices only translates into a reliable healthcare system if there is equally reliable capacity to keep those devices running once installed, and right now the money has moved much faster on the first half of that equation than the second. For an equipment and device buyer, that gap suggests service and maintenance credentials are likely to become a more formal part of procurement evaluation over time, alongside price and specification, particularly if a certification architecture along the lines proposed here eventually takes shape under an existing scheme rather than a new one.

Hospitals and diagnostic chains that get ahead of that shift, by favoring certified service arrangements and tracking maintenance costs as a distinct budget line rather than an absorbed operational expense, stand to be better positioned than those waiting for regulation to force the change.

Source

- medicalbuyer.co.in (2026-09-27) - Original article: Equipment maintenance emerges as the next hurdle in the growth plan - Medical Buyer - https://medicalbuyer.co.in/equipment-maintenance-emerges-as-the-next-hurdle-in-the-growth-plan