The future of medical devices: smarter, connected, and continuous

The medical device market is undergoing a major shift driven by emerging technologies and new applications. The shift is propelling the future of medical devices from hardware-focused, standalone products towards AI-enabled, software-integrated solutions. Adopting these new devices will push healthcare towards a more personalized, predictive, and precise future.

We see evidence that these emerging devices, and the technology which underpins them, are already impacting the global medical device industry. The market is robust and projected to grow substantially in value in the next five years. In fact, in 2025 the market was valued at $572 billion and is expected to rise from $605 billion in 2026 to $1 trillion by 2034.

The next generation of medical devices will increasingly combine smart hardware and software-as-medical-devices (SaMD). This equipment will evolve a patient’s healthcare journey from one that is episodic and determined by clinic-based measurements to one of continuous real-world monitoring that will bring care into the homes of patients.

AI is a core component in the future of medical devices

AI is already embedded in medical devices used for diagnostics, imaging, cardiovascular care, neurology, and other specialties. Even now in the United States, the Food and Drug Administration (FDA) maintains a continuously updated AI-Enabled Medical Device List.

A review of the list offers insight into the types of applications where AI is most used today. Radiology devices are most prevalent, showing that AI is most commercially active in devices that involve high-volume data, image inputs, and relatively well-defined tasks.

AI will likely enable more personalized treatment, streamlined clinical workflows, improved diagnosis, and a more predictive continuum of care. However, the technology is not without its challenges because technology capability alone is not enough.

According to an American Medical Association (AMA) survey, 78% of physicians want clear explanations of how AI systems make decisions. At the same time, 60% of adults said they would feel uncomfortable with providers relying on AI for diagnosis or treatment recommendations. Taken together, we see that AI-enabled devices face a dual adoption challenge: clinicians need greater transparency to trust them, while patients need more confidence to accept their use.

These market adoption challenges make market research critical to medical device innovation.

Medical device market research methods

There are multiple stakeholders whose inputs must be understood if a medical device is to be successful in the marketplace. Often, the users of the device, such as physicians and nurses, the device’s purchaser, and the patient who ultimately experiences the device may all see different effects.

Qualitative market research methods for medical devices include:

Physician interviews can help manufacturers determine clinical utility, workflow fit, unmet needs, and the evidence needed to support adoption. These face-to-face interviews are helpful in healthcare where respondents may feel more comfortable discussing sensitive subjects one-on-one.

In-depth interviews with hospital purchasing agents and administrators reveal a different set of priorities. They can uncover evidence around acquisition cost, reimbursement, service requirements, training needs, and interoperability.

Nurse interviews can help identify practical issues that may be less visible to physicians, such as ease of setup, cleaning, patient positioning, and day-to-day usability.

Why consumer research is necessary

Consumer (patient) research will be vital in the future of medical devices. Accounting for the consumerization of healthcare technology, shifting from devices utilized only by medical professionals to devices that are designed for at-home use and continuous remote monitoring, we understand why.

Consider devices like the Empatica Embrace, an FDA-cleared, prescription (Rx) smart wearable designed for epilepsy patients to detect and alert caregivers to potential seizures. Given that the device is primarily for consumer use, be that patient or caregiver, it is difficult to imagine a scenario where understanding the consumer audience would not be critical. Moreover, for prescription wearables like this, user research is not just a marketing exercise—it is a core component of Human Factors Engineering (HFE) and is mandated by regulatory bodies around the world.

While this is only one scenario of many, it illustrates the importance of quantitative consumer research. In this case, researchers can explore consumers’ experiences through interviews and focus groups. Focus groups and face-to-face interviews reveal insights that other methods miss—capturing body language, pauses, facial expressions, and nuanced details that only strategic follow-up questions can uncover.

Regional differences in medical device markets

Manufacturers of medical devices must understand important regional distinctions around the world to compete effectively.

North America, for example, combines an advanced healthcare infrastructure with high adoption of digital technology. In 2025, it accounted for 38.1% of the global medical device market. Both Europe and North America are large, established markets. But device manufacturers in these regions face complex, evolving regulatory environments and increasing downward pressure as governments work aggressively to reduce healthcare costs.

Meanwhile, Asia Pacific is expected to grow faster than the mature western economies. The smartest brands understand that China, Japan, and other Asian markets can not be treated interchangeably. For example, Japan’ s Pharmaceuticals and Medical Devices Agency (PMDA) have dedicated programs for SaMDs, generative AI in medicine, and medical device development using real-world data.

In contrast, conditions in developing regions such as Latin America, India, and Africa present different barriers to growth. From reduced purchasing power for high-cost devices to limited reimbursement options, manufacturers need to understand that what may be a successful device in developed economies may not translate directly to low- and middle-income markets.

Legal and regulatory aspects of medical device testing

Legal requirements for medical device testing depend on the level of risk a product poses to patients. This will likely vary significantly by region. In the United States, testing generally requires both FDA approval under an Investigational Device Exemption and approval by an Institutional Review Board before testing can begin.

Naturally, anytime testing involves humans, ethical considerations such as Informed Consent and Good Clinical Practices, comes into play. At the same time, AI-enabled and connected devices raise new questions about software updates, cybersecurity, transparency, and reliability.

Future trends

One area where we can see a future trend in medical devices is in Orthopedics. Robotic-assisted surgery already helps surgeons plan and execute joint replacements and spinal procedures with sub-millimeter accuracy. The trend is the reliance on robotics and automation before, during, and after operations. We are likely to see this trend expand in many other categories of care.

In cardiac medical procedures and devices, we see the transition from traditional open-chest operations to minimally invasive techniques like keyhole incisions and catheter routing. We also find robotics at work here with technology like haptic feedback allowing surgeons to “feel” the strength of heart tissue during suturing. Other trends include transient or dissolvable devices that power themselves with body fluids and, of course, AI integration.

Conclusion and recommendations

The future of medical devices won’t be defined by one breakthrough technology but rather the convergence of AI, software, robotics, connectivity, sensors, and continuous data. Devices will not only get smarter, but they will also move patient care out of hospitals and into patients’ homes, and integrate more deeply into their lives. Yet success for medical device companies will require more than technical performance. Physicians need to trust them, patients must be comfortable with them, and regulators must be satisfied.

Business leaders will require the right market research to distinguish themselves in the marketplace. At SIS, we have spent over 40 years helping medical device companies address their strategic questions through qualitative and quantitative research with physicians, nurses, hospital decision-makers, patients, and consumers.