Next-gen Medical Devices

Pushing the envelope in MedTech with emerging technologies

Overview

Next-gen medical devices combine traditional medical equipment with advanced software and technologies like AI, machine learning (ML), robotics, and sophisticated sensors. These devices are becoming smarter and smaller, offering new features that support patient diagnosis, treatment, and monitoring. They aim to provide better security, safety, and integration with clinical workflows and improved data management and patient experience.

These devices can be categorized into diagnostic, treatment, and monitoring tools. Diagnostic devices use AI and other technologies for precise and early disease detection; treatment devices employ AI and robotics for personalized care and less invasive procedures; and monitoring devices use smart sensors and the Internet of Medical Things (IoMT) to track vital signs continuously.

The demand for these advanced medical devices is growing due to several factors. The increase in chronic diseases, especially among older populations, creates a need for innovative solutions. The shortage of healthcare workers drives the adoption of technologies that can enhance efficiencies. Additionally, the high cost of healthcare, particularly in the US, is encouraging the use of devices that can optimize resources and cost-effectively improve patient outcomes. However, challenges such as FDA approval processes and integration with legacy healthcare systems must be addressed.

Industry Updates

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Market Sizing

The US Next-gen Medical Devices market could reach USD 32.5 billion–42 billion by 2028

Conservative case

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Base case

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Expansion case

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Use cases


Next-gen medical devices are being deployed primarily in the healthcare sector to enable use cases like robotic-assisted surgeries, patient monitoring, diagnosis, and treatment. Software that enhances medical devices—often known as software-as-a-medical-device—has seen recurring use cases in automating laboratory workflows. 

In addition to healthcare, next-gen medical devices are being used in other industries, such as education, or in elements of the public sector, like correctional facilities to enable training and monitoring. 

We have identified key Next-gen Medical devices use cases below:

Market Mapping


The next-gen medical devices space consists of players that combine traditional medical equipment with advanced software and technologies like AI, machine learning (ML), robotics, and sophisticated sensors to develop various diagnostic, treatment, and monitoring tools. Most companies are concentrated in the surgical devices segments, along with significant focus on non-implantable surgical devices. Providers of developer tools make up the smallest segment in this space.

As of September 2024, the surgical devices segment had raised USD 7 billion—over half of the industry’s funding. The diagnostic devices segment followed, with over USD 2 billion raised as of the same date.

Big Techs such as Johnson & Johnson, GE Healthcare, and Siemens Healthineers are among the active incumbents in this space, focusing on one or a few segments.

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Implantable surgical devices
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Diagnostic devices
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Monitoring devices
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Drug delivery devices
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Other non-surgical devices
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Software as a medical device
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Developer tools
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The Disruptors


Disruptors in the next-gen medical devices space are predominantly at an go-to-market or minimum viable product stage, with around 80% established after 2010. Most players focus on developing a specific product or product range for a specific market segment.

CMR Surgical is the highest-funded disruptor, with total funding of over USD 1 billion as of September 2024, followed distantly by Asensus Surgical, with funding of ~USD 475 million. While there are relatively few listed players in the industry, some notable ones include Sonendo, Sientra, and Vicarious Surgical.

Funding History

Competitive Analysis


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Incumbents


Global companies such as Johnson & Johnson, GE Healthcare, and Siemens Healthineers are active incumbents in the Next-gen Medical Devices space. Generally, most incumbents focus on one particular industry segment rather than diversifying across various segments. Within their respective domains, many of these incumbents offer a wide range of solutions, often driven by the need to incorporate the latest technologies to keep pace with the market. Johnson & Johnson, GE Healthcare, and Insightec are some companies operating in more than one segment.

Incumbents' offerings predominantly include products designed and built in-house or through various product partnerships. However, incumbents also leverage acquisitions to fuel growth and diversification. One of the most notable acquisitions is Medtronic acquiring Covidien for USD 42.9 billion in June 2014, and more recent examples include Stryker’s acquisition of Wright Medical Group for USD 4 billion in November 2019 and GE Healthcare's acquisition of BK Medical for USD 1.5 billion in September 2021.

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Notable Investors


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Market Sizing

The TAM for Next-gen Medical Devices in the US is estimated at USD 159.6 billion.

The total addressable market (TAM) refers to the total revenue opportunity available for a product or service, while the actual market is the market size based on revenue projections.
The TAM for Next-gen Medical Devices in the US is estimated at USD 159.6 billion. Medical devices (including implantable surgical devices, non-implantable surgical devices, diagnostic devices, monitoring devices, drug delivery devices, and other non-surgical devices) account for the largest share of the TAM at USD 123.2 billion (~77% of total TAM). The TAM for Software as a medical device is estimated at USD 36.4 billion (~23%% of total TAM).
The actual market for Next-gen Medical Devices was estimated to be USD 21.2 billion in 2023 and is projected to grow at a CAGR of 11.9% to reach USD 37.2 billion by 2028, with a penetration of 23.3%.

Summary

Our expansion case projects the actual market to grow at a CAGR of 14.7% over the next five years, reaching USD 42.0 billion by 2028, implying a penetration of 26.3%. This growth is fueled by an increasing need for more cost-effective alternatives amid the rising healthcare spending in the US and the need for innovative options given the rising prevalence of chronic diseases and shortage of healthcare professionals.
In contrast, our conservative case projects slower growth in the actual market, with a CAGR of 8.9% over the next five years, reaching USD 32.5 billion by 2028 and implying a penetration of 20.3%. This could be the result of the comparatively longer time required for market entry, which may dampen innovation and development in this space, while the slow take-up may be due to lingering concerns around data breaches and privacy risks.
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