Download the full 2026 Medical Device Trends Report here.

This free industry report outlines industry perspectives and expert advice from our team of life sciences consultants. You can view an excerpt of the report below, and if you’d like to discuss any of the above trends or other challenges in the medical device space, connect with our team today.

Key Medical Device Industry Trends

Medical devices companies continue to embrace digital technologies, allowing patients and healthcare providers to make informed decisions regarding patient care. Continuous monitoring and AI-driven insights are giving patients and providers greater visibility into health trends and potential risks, helping shift care beyond isolated clinical encounters. 

As these technologies become more embedded in everyday care, the responsibility to balance innovation with trust grows. Staying aligned with evolving regulatory expectations, and treating data security and patient safety as foundational requirements rather than afterthoughts, will be critical as companies continue to bring new, connected devices to market.  

Clarkston’s life sciences consultants have highlighted the top medical device industry trends that businesses should consider and keep top-of-mind throughout the year:

1. Evolving FDA Oversight of Consumer Health and Diagnostic Device
2. Expansion of Remote Patient Monitoring Elevates Cybersecurity Requirements
3. Continued Growth of AI-enabled Medical Devices 
4. Tariffs Impacting Pricing and Medical Device Supply Chains

Trend 1:

Evolving FDA Oversight of Consumer Health and Diagnostic Devices

In the last few years, wearable fitness trackers have added novel functionality to providing health and wellness metrics at patients’ fingertips. Users can track more than just steps on a watch or hours slept. Wearable devices like the Apple Watch enable continuous heart rate monitoring, track sleep apnea, and capture other critical health metrics. The newest Apple Watch even includes features that allows users to track blood pressure and identify cases of hypertension, which is significant given that almost 1 billion people worldwide live with high blood pressure, often without a diagnosis.  

These new monitoring and diagnostic features have the potential to be lifesaving, especially for undiagnosed conditions. However, as patients receive this health information almost instantaneously, it’s imperative that the data and collection methods are accurate.  

Apple has worked closely with the FDA on its health-enabled features on the Apple Watch, including sleep apnea monitoring irregular heart rhythm notifications, and the hypertension notification, which has received FDA approval. Moving forward, companies must invest in regulatory expertise and continue to collaborate with the FDA in such a rapidly evolving regulatory environment. 

Over the last several years, consumer electronics have also increasingly implemented health tools that blur the line between wellness products and medical devices. Now, the convergence has extended in the opposite direction, as medical device companies like Dexcom introduce innovations such as the first over-the-counter continuous glucose monitor, Stelo.  

Marketed to adults who aren’t taking insulin, Stelo allows individuals to proactively track their blood sugar levels and identify potential risks earlier. For individuals with limited access to care or inadequate health insurance, tools like Stelo can also offer valuable diagnostic insight and increased visibility into their health. According to the Stelo website, the product is marketed toward adults who aren’t taking insulin and can be purchased by anyone seeking additional information on their glucose levels. 

However, while these technologies can enhance awareness and detection, they’re intended to complement, not replace, guidance from a healthcare provider. 

Trend 2:

Expansion of Remote Patient Monitoring Elevates Cybersecurity Requirements

Wearable devices such as wellness trackers and continuous glucose monitors can now collect and analyze health data 24 hours a day, expanding what’s possible with remote patient monitoring: a practice in which patient data is collected at home with healthcare providers accessing the data, providing a fuller view of patient health as opposed to traditional, episodic care. 

When health and wellness features are embedded into devices people already use, patients are more likely to stay engaged and actively participate in their own care. Software-enabled devices, including the Apple Watch and Dexcom’s Stelo, enable data sharing with healthcare providers, making it easier for patients and clinicians to view trends over time, supporting earlier detection and leading to more informed medical decisions. 

However, this also raises important questions about how that data is shared and protected. As remote patient monitoring becomes more common, it’s increasingly important that these systems are capable of safely handling and protecting sensitive health information. While greater access to real-time patient data has its benefits, it cannot be implemented without considering risks, including security breaches.  

In response to this growing risk, the FDA has issued new guidance on ensuring cybersecurity in medical devices prior to marketing the device. Adhering to this guidance is essential for companies developing connected health technologies, helping ensure that sensitive patient identifying information and patient health information is kept secure.

Continue reading by downloading the full report below.

Download the Full 2026 Medical Device Industry Trends Report Here

Read last year’s Medical Device Industry Trends Report here.