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The year 2025 is shaping up to be a pivotal one for the medical technology industry. With political shifts, evolving regulations, and dynamic investment landscapes, MedTech players will need to navigate a rapidly changing environment.
Here’s an overview of the key trends that will define 2025 and drive the ongoing transformation of global healthcare.
More AI-Enabled Medical Devices
The first AI-enabled device approved by the FDA was introduced in 1995. Since then, the number of approvals has risen sharply: from just six in 2015 to 221 in 2021, and nearly a thousand by the end of 2024, according to MedTech Dive. Health Canada has also authorized several hundred AI-enabled devices, reflecting a similar trend.
According to FDA data, the great majority of medical devices incorporating AI are used in radiology. These include improving image quality, helping to position patients for examination, optimizing radiation dosage, and detecting potential health issues.
According to a report by the Business Research Company, the market for AI in medical devices is growing at a rapid pace, increasing from $15.42 billion in 2023 to an estimated $97.07 billion by 2028, with an annual growth rate of 44.6%.
In December 2024, the FDA issued new recommendations to streamline the approval process for software changes in AI- and machine learning-based medical devices. These guidelines aim to foster innovation that improves healthcare services and patient outcomes while ensuring safety and efficiency.
Steady Growth in Investments
Despite an uncertain economic environment in 2024, capital investment in the MedTech industry remained strong. According to a report by Zapyrus, investments surged by 88% compared to 2023, reaching $34 billion. The third quarter of 2024 even saw the largest increase in capital invested since the peak of the COVID-19 pandemic.
Looking ahead to 2025, certain areas are expected to attract particular attention from investors, notably women’s health, cardiovascular health, and urology. These segments dominated investment in 2024 due to targeted innovations and increasing demand.
From a technological perspective, the majority of investments are anticipated to focus on software as a medical device (SaMD) and connected devices, with a growing emphasis on artificial intelligence.
The Trump Administration's Impact on Industry in North America
Donald Trump’s return to the White House is expected to reshape healthcare policy and regulatory priorities in the United States, with consequences for the industry.
A deregulation-focused approach, including a review of FDA procedures, could speed up approval processes for medical devices, especially those leveraging innovative technologies such as AI.
Furthermore, policies favoring research and development (R&D), such as corporate tax cuts, are likely to drive increased investment in advanced medical technologies across the U.S.
Analysts also anticipate that the Trump administration will facilitate mergers and acquisitions (M&A) by making regulatory controls less stringent. According to a Zapyrus report, M&A activity has already been on the rise in 2024: a trend particularly advantageous for service providers operating in commercial phases, such as contract manufacturers and regulatory service providers.
However, increased tariffs on imports, including a 60% hike for products from China and the imposition of 25% tariffs on imports from Mexico and Canada, could impact medical device companies that rely on imported components. These changes may result in additional costs and force manufacturers to reorganize their supply chains.
The year 2025 promises to be a transformative period for the MedTech industry, driven by significant technological advancements, strengthened investment dynamics, and potentially transformative political changes. Companies will face a complex landscape where innovation presents both opportunities and challenges.
At CLEIO, we are committed to supporting our clients through this dynamic environment, helping them achieve success in their medical device development.
