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Deviceology - The USA Market Access People

Deviceology is well-equipped to guide clients through the dynamic and expansive U.S. Medical Devices market. Utilizing our deep expertise in international regulations and ISO standards, such as ISO 13485 for quality management systems, we offer a comprehensive array of services to facilitate smooth market entry.

Our team of experts provides essential guidance on navigating the complex regulatory landscape overseen by the U.S. Food and Drug Administration (FDA). We also offer insights into the Medical Device Single Audit Program (MDSAP), which allows for a more streamlined approval process for manufacturers from MDSAP-recognized countries.

The U.S. market is particularly noteworthy for its size and growth potential. Revenue in the Medical Devices market in the United States is projected to reach $164.10 billion in 2023, with an expected annual growth rate of 4.71% from 2023 to 2028, resulting in a market volume of $206.60 billion by 2028. The largest market segment is Cardiology Devices, projected to have a market volume of $23.29 billion in 2023.

Our end-to-end solutions, from initial market research to product launch, are designed to meet both international and U.S.-specific standards. This includes a nuanced understanding of the U.S. healthcare system, reimbursement policies, and the complexities of operating across various states.

By partnering with Deviceology, clients can anticipate a streamlined, compliant, and strategically advantageous entry into the highly lucrative U.S. Medical Devices market.

Market Data

Medical Devices Market Valuation

2022: valued at $184.61 billion

2023: projected to reach $192.78 billion

2030: projected to reach $291.04 billion

Key Market Segmentation

  • Minimally invasive surgeries

  • Monitoring and Therapeutic Devices

  • Personal Mobility Devices

  • Cardiovascular Devices

  • In-Vitro Diagnostics

  • Radiology and Imaging

  • Telemedicine and Virtual Care

  • Mental Health Monitoring

Healthcare Expenditure

  • In 2021 National Health Expenditure (NHE) increased by 2.7%, reaching a staggering $4.3 trillion, or $12,914 per person.

  • This accounted for 18.3% of the country's Gross Domestic Product (GDP).

  • Over the period from 2022 to 2031, the average growth in NHE is projected to be 5.4%, outpacing the average GDP growth of 4.6%.

  • This is expected to result in an increase in the health spending share of GDP from 18.3% in 2021 to 19.6% in 2031.



  • Advanced Diagnostic Testing: Accelerated development of point-of-care devices and innovations in genomics and molecular diagnostics.

  • Wearable Medical Technology: The wearable technology industry is expected to reach $54 billion in 2023.

  • AI and Machine Learning: Significant market growth expected; opportunities for integrating AI into existing or new products.

  • Cybersecurity: Increasing need for robust security measures for both new and legacy medical devices.

  • Virtual and Augmented Reality: VR and AR technologies are primarily used for training healthcare professionals but are gaining momentum in treatment settings.

Market Dynamics

Technological Growth: Advances in AI, Machine Learning, and minimally invasive surgeries are driving the market, which is expected to grow at a CAGR of over 9.5% from 2023 to 2030.


Aging Population: An increase in heart-related conditions among the aging population is fuelling demand for medical devices like aortic valve replacements.


Segment Dominance: Minimally invasive surgeries and the transcatheter aortic valve segment are key revenue drivers, with hospitals being the leading end-users.

Contact us to discuss your access requirements for the United State's Medical Devices market

Deviceology - The Market Access People

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