Raj Shah
CEO & Founder · Coherent Market Insights
Pune, Maharashtra, India
Medical Devices
Data that powers smarter decisions in medical devices
Global Market Size: USD 1,203.81 Bn (2033)
Medical devices are becoming more connected, intelligent, personalized, and accessible. By January 2025, the FDA had authorized more than 1,000 AI-enabled medical devices, with…
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USD 1,203.81 BnGLOBAL MARKET SIZE (2033)
850+MEDICAL DEVICES REPORTS TRACKED
200+PRIMARY INTERVIEWS / QUARTER
85–92%FORECAST ACCURACY
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Our Advantage
Why CMI for Medical Devices
01
Device-level market intelligence
We interview 200+ clinical, engineering, regulatory, procurement, and commercial leaders per quarter across leading medical device manufacturers, hospitals, distributors, and service providers. Our forecasts are built from device utilization, average selling prices, and consumables demand not headline-based assumptions.
02
Regulatory, quality, & reimbursement depth
Our research evaluates FDA, De Novo, and PMA pathways, EU MDR requirements, EUDAMED registration, ISO 13485, quality-management systems, reimbursement policies, and health-technology assessments. This helps clients anticipate approval, compliance, coverage, and market-access risks.
03
Workflow and adoption economics
We benchmark procedure time, clinical outcomes, throughput, training requirements, capital investment, maintenance costs, consumables pull-through, reimbursement, and total cost of ownership. This helps clients distinguish technical innovation from commercially scalable adoption.
Industry Briefing
Inside CMI’s Medical Devices Research Engine
An 8-minute walkthrough of how we track device portfolios, procedure volumes, installed equipment, regulatory approvals, reimbursement changes, procurement activity, product launches, recalls, and competitive developments across medical device sub-segments.
Industry Overview
Market Landscape
Medical devices are becoming more connected, intelligent, personalized, and accessible. By January 2025, the FDA had authorized more than 1,000 AI-enabled medical devices, with applications expanding across radiology, cardiovascular care, neurology, gastroenterology, and patient monitoring. The FDA continues to update its AI-enabled device list as new products enter the U.S. market.
Care delivery is simultaneously moving beyond hospitals. CMS broadly covers remote patient monitoring involving physiologic data collected through connected devices for chronic and acute conditions. The FDA’s Home as a Health Care Hub initiative is also encouraging devices designed for safe, convenient, and person-centred use in home environments.
Our medical devices practice tracks commercially relevant products, installed bases, clinical procedures, regulatory pathways, hospital procurement, pricing, reimbursement, distribution networks, service requirements, and competitive strategies. Clients use this intelligence to size addressable markets, prioritize product categories, benchmark competitors, plan launches, evaluate acquisitions, and assess market-entry opportunities.
Industry Trends
- Artificial intelligence expanding across medical imaging, patient monitoring, clinical decision support, and software-based devices
- Minimally invasive and robotic procedures reducing recovery time and changing surgical workflows
- Wearable, implantable, and connected devices supporting continuous and remote patient monitoring
- Home-use medical devices bringing chronic-disease management and rehabilitation closer to patients
- Smart sensors and interoperable platforms enabling real-time data collection and clinical connectivity
- FDA QMSR, EU MDR, EUDAMED, cybersecurity, and post-market requirements increasing lifecycle compliance obligations
- Reimbursement and health-technology assessment frameworks evolving to evaluate digital and connected medical devices
- Sustainable manufacturing, repairability, reprocessing, and supply-chain decarbonization gaining importance in device procurement
Trusted By
Our Clients in Medical Devices
Leadership
Industry Experts
Common Questions
Frequently Asked Questions
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