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Industry Landscape
The medical imaging equipment aftermarket is characterized by a strong demand for cost-effective solutions for equipment maintenance, repair, and training. It's driven by healthcare providers seeking to extend the lifespan of existing assets and reduce operational costs, especially in the face of rising healthcare expenditures. Technological advancements in imaging modalities continue to fuel the need for skilled technicians and accessible, reliable parts. The industry sees increasing consolidation and global expansion as companies aim to offer comprehensive services.
Total Assets Under Management (AUM)
Medical Imaging Equipment Market Size in United States
~Approximately 20-25 billion USD in 2023 (for overall medical imaging equipment market, aftermarket is a segment of this)
(5-7% CAGR)
- Driven by increasing prevalence of chronic diseases. - Growing elderly population. - Technological advancements in imaging.
Total Addressable Market
10-15 billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
Predictive Maintenance & AI
Utilizing AI and machine learning to analyze equipment data for anticipating failures and scheduling proactive maintenance, minimizing downtime.
3D Printing of Medical Parts
Additive manufacturing of complex or rare medical imaging equipment parts, enabling on-demand production and reducing reliance on traditional supply chains.
Remote Diagnostics & IoT
Integration of Internet of Things sensors and remote connectivity for real-time monitoring and diagnosis of medical imaging equipment issues without on-site presence.
Impactful Policy Frameworks
Medical Device Regulation (MDR) 2017/745 (EU - relevant for global companies selling into EU)
While an EU regulation, the MDR 2017/745, fully enforced since May 26, 2021, significantly tightens requirements for medical device manufacturers and distributors regarding product safety, performance, clinical evidence, and post-market surveillance.
This policy increases the scrutiny on the quality and documentation of aftermarket medical imaging parts, requiring companies like DirectMed Imaging to ensure their refurbished or manufactured components meet stringent safety and performance standards when distributed globally.
FDA's Quality System Regulation (QSR) 21 CFR Part 820 (US)
The FDA's QSR (21 CFR Part 820) outlines current good manufacturing practice (cGMP) requirements for finished medical devices, including design controls, production and process controls, and quality system documentation, to ensure devices are safe and effective.
DirectMed Imaging, as a provider of refurbished parts and potentially remanufactured components, must adhere to these stringent quality standards to ensure compliance and maintain customer trust in the safety and efficacy of their offerings within the US market.
Right to Repair Legislation (Various US States, evolving)
Increasingly, various US states are introducing or passing 'Right to Repair' legislation that mandates manufacturers provide access to diagnostic tools, parts, and manuals for independent repair shops and consumers.
This emerging policy trend could significantly broaden the market for independent service organizations and aftermarket parts providers like DirectMed Imaging by legally ensuring access to critical information and components previously restricted by OEMs.
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