# Medical devices: Follow one offering through the chain Syringes, implants, scanners, monitors and diagnostic tests for hospitals and clinics Source page: https://www.materialinsights.org/industries/medical_devices/story/ #### Follow one offering through the chain **4** Example story · 8 steps · India ### A drug-eluting heart stent made in India Follow a coronary stent from cobalt mine to cath lab, and the price cap in between. 1 / 8 · Materials and components #### A cobalt-chromium tube, laser cut **74%**DR Congo's cobalt share, 2025 (calculated) A modern stent begins as a fine cobalt-chromium alloy tube, laser cut into a mesh that expands inside an artery, and the tube must be implant grade with tightly controlled purity and wall thickness. The cobalt itself is highly concentrated: DR Congo mined about 230,000 of the world's 310,000 tonnes in 2025, roughly 74% (calculated).^[1](https://pubs.usgs.gov/periodicals/mcs2026/mcs2026-cobalt.pdf) **Constraint** Cobalt comes overwhelmingly from one country, and switching an implant-grade tube supplier needs fresh biocompatibility and validation data. [Co Cobalt](https://www.materialinsights.org/commodities/cobalt/)[Cr Chromium](https://www.materialinsights.org/commodities/chromium/)[Ni Nickel](https://www.materialinsights.org/commodities/nickel/)[W Tungsten](https://www.materialinsights.org/commodities/tungsten/)[Ar Argon](https://www.materialinsights.org/chemicals/argon/)[Metal products](https://www.materialinsights.org/industries/metal_products/) 2 / 8 · Materials and components #### A drug in a thin polymer coat **99.81%**cases using drug-eluting stents The metal mesh is coated with a drug such as everolimus or sirolimus, held in a thin polymer that releases it over weeks to stop the artery narrowing again, then crimped onto a nylon balloon catheter. Drug-eluting stents have all but replaced bare metal ones in India: a 2026 report on national registry data put their share at 99.81% of cases.^[2](https://www.onmanorama.com/news/kerala/2026/10/06/kerala-3rd-in-stent-use-10-000-implanted-every-month.html) **Constraint** Each polymer and drug grade is validated into each stent, so changing a supplier means months of testing and fresh regulatory filings. [PTFE Fluoropolymers (PTFE, PVDF)](https://www.materialinsights.org/chemicals/fluoropolymers/)[PA Nylon (PA6, PA66)](https://www.materialinsights.org/chemicals/nylon/)[API Small-molecule APIs](https://www.materialinsights.org/chemicals/apis/)[Plastic and rubber products](https://www.materialinsights.org/industries/plastic_rubber/)[Pharmaceuticals](https://www.materialinsights.org/industries/pharmaceuticals/) 3 / 8 · Device design and approval #### Indian makers take on global brands **70%**India's devices imported, by value Companies such as Meril in Vapi, Sahajanand Medical Technologies in Surat and Translumina design, test and make stents in India, competing with Abbott, Boston Scientific and Medtronic. Stents are a bright spot in a sector that, the government told Parliament in July 2025, still imports about 70% of its devices, including US$5.3 billion of electromedical equipment in 2024-25.^[3](https://medicaldialogues.in/news/industry/medical-devices/medical-device-imports-still-at-70-india-spent-over-usd-25-billion-in-5-years-parliament-informed-152802) **Constraint** New stent designs need clinical trials and years of follow-up data before doctors and regulators accept them. [Rgt Reagents and high-purity lab chemicals](https://www.materialinsights.org/chemicals/lab_reagents/)[HVAC AC transmission](https://www.materialinsights.org/energy/e_hvac/)[Education and research](https://www.materialinsights.org/industries/education_research/)[Software and IT services](https://www.materialinsights.org/industries/software_it/) 4 / 8 · Device design and approval #### Class D: the strictest licence **Oct 2023**all Class C and D licensed A coronary stent sits in Class D, the highest-risk group under India's Medical Devices Rules, 2017, and the Central Drugs Standard Control Organisation must license its manufacture or import. From 1 October 2023 licensing was extended to every Class C and D device, so factory audits, testing and clinical evidence now apply across high-risk products.^[4](https://ssrana.in/articles/class-c-and-d-non-notified-medical-devices-to-require-licensing-under-medical-devices-rules-2017-from-october-1-2023/) **Constraint** No stent can be sold without a CDSCO licence, and any change of material, coating or plant needs approval first. [Public administration, defence and security](https://www.materialinsights.org/industries/public_admin/)[Professional services](https://www.materialinsights.org/industries/professional_services/) 5 / 8 · Manufacturing and sterilisation #### Sterilised with ethylene oxide gas **~50%**US sterile devices using EtO, 2019 Packed stents and catheters are sterilised before shipment, usually with ethylene oxide gas, which passes through packaging without the heat or radiation that could harm a drug coating or polymer. The method is a quiet chokepoint: an FDA official said in 2019 that it accounted for roughly half of all devices supplied sterile in the US.^[5](https://www.fda.gov/media/130169/download?attachment) **Constraint** Ethylene oxide is toxic and carcinogenic; the FDA warned in 2019 that more plant closures over emissions could severely cut device availability. [EO Ethylene oxide](https://www.materialinsights.org/chemicals/ethylene_oxide/)[CO2 Carbon dioxide](https://www.materialinsights.org/chemicals/carbon_dioxide/)[H2O2 Hydrogen peroxide](https://www.materialinsights.org/chemicals/hydrogen_peroxide/)[Waste and recycling](https://www.materialinsights.org/industries/waste_recycling/) 6 / 8 · Distribution and purchasing #### Distributors stock every size **₹16,000**top guidewire price, uncapped Distributors keep many lengths and diameters of stents, balloons and guidewires at hospitals, because the cardiologist picks the size mid-procedure. Unlike the stent, these accessories carry no ceiling price: prices reported in Kerala in 2026 ran from ₹3,000 to ₹7,000 for a balloon and ₹4,000 to ₹16,000 for a guidewire, so angioplasty bills vary widely.^[2](https://www.onmanorama.com/news/kerala/2026/10/06/kerala-3rd-in-stent-use-10-000-implanted-every-month.html) **Constraint** Demand data is patchy: Kerala distributors estimate 16,203 stents a month against 9,722 in registry data, complicating stock planning. [Bld Energy in buildings](https://www.materialinsights.org/energy/e_buildings/)[ICV Combustion road vehicles](https://www.materialinsights.org/energy/e_road_ice/)[Transport and logistics](https://www.materialinsights.org/industries/transport_logistics/)[Wholesale and retail trade](https://www.materialinsights.org/industries/wholesale_retail/) 7 / 8 · Use, payment and service #### A price ceiling of ₹39,186 **₹39,186**drug-eluting stent ceiling, April 2026 India's National Pharmaceutical Pricing Authority caps the price of coronary stents. Under its notification of 25 March 2026, from 1 April a drug-eluting stent may be sold for no more than ₹39,186 and a bare metal one for ₹10,762, before GST, after a 0.65% rise for wholesale inflation. The same ceiling applies in any hospital, public or private.^[6](https://teamleaseregtech.com/updates/article/54962/nppa-notified-regarding-the-revision-of-ceiling-prices-for-coronary-stents/) **Constraint** One national ceiling binds every stent sold, so makers' prices move only with a yearly inflation adjustment, 0.65% for 2026. [Finance: banking, insurance, markets](https://www.materialinsights.org/industries/finance/)[Public administration, defence and security](https://www.materialinsights.org/industries/public_admin/) 8 / 8 · Use, payment and service #### Eleven lakh stents a year **11.3 lakh**stents used in a year Finally the stent reaches a catheterisation lab, where a cardiologist threads it to a blocked artery. Labs reporting to the National Interventional Council used 11.28 lakh stents in 7.92 lakh patients last year, as reported in October 2026, about 1.4 per patient (calculated). Coverage is partial: 1,130 labs report, while the atomic energy regulator lists 1,994.^[2](https://www.onmanorama.com/news/kerala/2026/10/06/kerala-3rd-in-stent-use-10-000-implanted-every-month.html) **Constraint** Registry data covers 1,130 of about 1,994 labs, so true use is higher, and cath labs cluster in cities and private hospitals. [W Tungsten](https://www.materialinsights.org/commodities/tungsten/)[Bld Energy in buildings](https://www.materialinsights.org/energy/e_buildings/)[HVAC AC transmission](https://www.materialinsights.org/energy/e_hvac/)[Healthcare services](https://www.materialinsights.org/industries/healthcare/)[Finance: banking, insurance, markets](https://www.materialinsights.org/industries/finance/)[Waste and recycling](https://www.materialinsights.org/industries/waste_recycling/) #### What the chain shows India makes and caps the stent, but its alloy tube, coating chemistry and sterilant still come through a few suppliers, many abroad. Sources 1. [Mineral Commodity Summaries 2026: Cobalt](https://pubs.usgs.gov/periodicals/mcs2026/mcs2026-cobalt.pdf) US Geological Survey, 2026 2. [God's Own Country lives on stents; Kerala 3rd in India for cardiac implants (National Interventional Council data)](https://www.onmanorama.com/news/kerala/2026/10/06/kerala-3rd-in-stent-use-10-000-implanted-every-month.html) Onmanorama, 2026 3. [Medical device imports still at 70%, India spent over USD 25 billion in 5 years: Parliament informed (Rajya Sabha reply, 29 July 2025)](https://medicaldialogues.in/news/industry/medical-devices/medical-device-imports-still-at-70-india-spent-over-usd-25-billion-in-5-years-parliament-informed-152802) Medical Dialogues, 2025 4. [Class C and D non-notified medical devices to require licensing under Medical Devices Rules, 2017 from October 1, 2023](https://ssrana.in/articles/class-c-and-d-non-notified-medical-devices-to-require-licensing-under-medical-devices-rules-2017-from-october-1-2023/) S.S. Rana & Co., 2023 5. [FDA Innovation Challenges webinar on sterilisation alternatives and ethylene oxide emissions (transcript)](https://www.fda.gov/media/130169/download?attachment) US Food and Drug Administration, CDRH, 2019 6. [NPPA notification S.O. 1587(E), 25 March 2026: revision of ceiling prices for coronary stents (reproduced)](https://teamleaseregtech.com/updates/article/54962/nppa-notified-regarding-the-revision-of-ceiling-prices-for-coronary-stents/) National Pharmaceutical Pricing Authority, via TeamLease RegTech, 2026 ## Other sections - [Overview](https://www.materialinsights.org/industries/medical_devices/index.md) - [Where ₹100 goes](https://www.materialinsights.org/industries/medical_devices/cost-mix/index.md) - [Price links with suppliers](https://www.materialinsights.org/industries/medical_devices/price-links/index.md) - [Linked industries](https://www.materialinsights.org/industries/medical_devices/linked-industries/index.md) - [Value chain](https://www.materialinsights.org/industries/medical_devices/value-chain/index.md) - [Materials drawn on](https://www.materialinsights.org/industries/medical_devices/materials/index.md) - [Chokepoints and risks](https://www.materialinsights.org/industries/medical_devices/risks/index.md) - [Sources](https://www.materialinsights.org/industries/medical_devices/sources/index.md)