Apr 30, 2025
medtech series | author
Weronika Michaluk
MedTech Practice Lead at HTD Health
The market of global medical device connectivity is, to put it lightly, exploding. Projections indicate an increase from $2.35 billion in 2023 to $8.84 billion by 2029. This equates to an annual growth rate of approximately 24.7%. This surge highlights a significant shift in the healthcare landscape towards a more connected, efficient, and patient-centric model, driven by advancements in medical device connectivity. This momentum is driven not only by technical advancements but also by increasingly complex regulatory frameworks–like the FDA’s guidance on cybersecurity and the EU MDR–that developers must navigate.
Medical device connectivity, which facilitates seamless data transmission to electronic health records (EHRs), real-time alerts for clinicians, and remote patient monitoring, has become a cornerstone of contemporary healthcare, moving away from its previous niche status. At the same time, adoption hinges on the clinical value proposition: Can a device demonstrably improve outcomes, reduce costs, or enhance care delivery?
Striking the right balance between innovation and practical implementation is key. Solutions must not only be cutting-edge but also realistic to deploy within existing healthcare systems. For developers working in this space, understanding the forces driving this growth is key to building solutions that meet the needs of healthcare providers and patients alike. Let’s explore 10 major trends that are shaping the future of medical device connectivity and what they mean for developers.
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10 trends to watch in Medical Device Connectivity space
1. Wireless connectivity is leading the charge
Gone are the days when hospitals relied solely on wired connections to keep devices talking to each other. Wireless technology has taken center stage, offering greater flexibility, scalability, and convenience. Hospitals and clinics are moving toward wireless solutions that can quickly transmit real-time data from devices to EHRs without the hassle of cables and complicated setups.
Why does this matter? Wireless systems allow for easier device mobility and reduce the need for constant hardware upgrades. This is especially important in fast-paced environments where real-time data can mean the difference between timely intervention and a missed opportunity. For example, Wi-Fi-enabled infusion pumps can send dosage updates directly to the EHR, giving clinicians a full picture of a patient’s medication history without manual entry.
How do wireless Medical Devices stay compliant?
Alongside Wi-Fi, Bluetooth and Bluetooth Low Energy (BLE) are playing a critical role in enabling secure, short-range communication between medical devices and host systems. BLE, in particular, is designed for low-power use cases—making it ideal for wearables and portable health devices that need to transmit data reliably without draining battery life. If you’re weighing the pros and cons of classic Bluetooth vs. BLE for your device – this article offers a helpful breakdown of how each performs in different medical scenarios.
However, wireless medical devices must meet stringent regulatory requirements. In the U.S., the FDA requires premarket submissions to include wireless coexistence testing, while international standards like ISO/IEC 80001-1 focus on risk management for wireless networks in healthcare environments. Certification through programs such as ANSI/AAMI/IEC 60601-1-2 ensures electromagnetic compatibility (EMC) and safety for wireless medical equipment.
Real-world examples:
- OxiWear System: An ear-worn device for non-invasive SpO2 and pulse rate monitoring. It uses Bluetooth to communicate with a mobile app, enabling real-time data transfer, continuous health monitoring, and access to historical trends. NSULCLOCK® v2.0 PRO by Insulcloud: A reusable transmitter for insulin pens, using Bluetooth to track and transfer dose data to smartphones, improving diabetes management and enabling remote monitoring by healthcare providers. Nalu Neurostimulation System by Nalu Medical: An implantable device for managing chronic pain from peripheral nerves in adults. It uses Bluetooth Low Energy (BLE) for wireless control via a Therapy Disc, secure data transmission, and remote management by healthcare providers through a Clinician Programmer Application.
- NSULCLOCK® v2.0 PRO by Insulcloud: A reusable transmitter for insulin pens, using Bluetooth to track and transfer dose data to smartphones, improving diabetes management and enabling remote monitoring by healthcare providers.
- Nalu Neurostimulation System by Nalu Medical: An implantable device for managing chronic pain from peripheral nerves in adults. It uses Bluetooth Low Energy (BLE) for wireless control via a Therapy Disc, secure data transmission, and remote management by healthcare providers through a Clinician Programmer Application.
2. Home Healthcare is Growing at Lightning Speed
While hospitals still hold the largest market share in medical device connectivity, home healthcare is catching up—and fast. The pandemic accelerated the push toward home-based care, and now, more patients are opting to be monitored from the comfort of their homes. This shift has created a surge in demand for connected devices that allow clinicians to monitor vital signs remotely and intervene when necessary.
Companies like Butterfly Network and Vave Health are leading the way in bringing advanced diagnostic tools into non-traditional care settings. Both offer compact, connected ultrasound devices that enable clinicians to capture high-quality imaging at the point of care—whether in a patient’s home, a rural clinic, or an urgent care setting—and wirelessly transmit results for review. These devices are helping expand access to diagnostic imaging beyond the hospital walls and are setting a new standard for flexibility in care delivery.
Think about this: A patient recovering from heart surgery can wear a connected ECG monitor that transmits data to their cardiologist, allowing them to identify irregularities without requiring the patient to travel for follow-up visits. Not only does this improve patient comfort, but it also reduces strain on hospital resources.
3. Remote Patient Monitoring is Changing the Game
Remote patient monitoring (RPM) has gone from being a “nice-to-have” to an essential part of modern healthcare. The ability to track a patient’s condition in real time and catch potential issues early has been a game-changer—especially for managing chronic conditions and post-acute care. Effective RPM also depends on sustained patient engagement. Studies show that tailored user interfaces and reminder systems have shown positive impacts on self-management behaviors and treatment adherence.
The numbers back this up: The global RPM market was valued at approximately $24.39 billion in 2023 and is projected to reach $56.94 billion by 2030, growing at a compound annual growth rate (CAGR) of 12.7%. This rapid growth reflects the increasing demand for solutions that support aging populations, chronic disease management, and the ongoing shift toward decentralized care.
Why is this so important? RPM reduces hospital readmissions, improves patient outcomes, and gives clinicians a clearer view of what’s happening between office visits. Wearable devices, such as continuous glucose monitors (CGMs) and blood pressure cuffs, can transmit data directly to providers, alerting them to changes that might require intervention.
How can developers build more inclusive RPM devices?
For developers, the challenge lies in ensuring that RPM devices remain reliable, accurate, and secure. It’s not just about collecting data—it’s about making that data actionable and accessible in real time. Developers must also account for diverse user needs–from mobile-first interfaces for younger populations to simplified onboarding for older adults. Inclusive design principles can boost adoption and ensure equitable access across demographics.
4. EHR integration is becoming non-negotiable
As healthcare systems continue to move toward full digitization, the importance of seamless EHR integration cannot be overstated. Connected devices that can automatically sync data to a patient’s record not only save time but also reduce the risk of human error. The rise of standards like HL7 FHIR (Fast Healthcare Interoperability Resources) is helping to simplify integration efforts. FHIR provides a modern, web-based approach to sharing healthcare data, and its adoption is accelerating globally.
When this kind of integration fails or is absent, the consequences can be significant. A study published in JACC Journals found that hospitals with poor interoperability had 13% higher 30-day readmission rates for heart failure patients. Another report from the West Health Institute estimated that the U.S. healthcare system wastes over $30 billion annually due to lack of medical device interoperability—stemming from errors, redundant testing, and inefficiencies in care delivery.
Why is interoperability still a challenge in connected devices?
Many devices use proprietary protocols, which creates obstacles to achieving true interoperability. Developers often find themselves creating custom APIs or middleware to ensure that devices can “talk” to different EHR systems.
Integration also plays a critical role in reducing clinician workload. According to a study published in ACP Journals, physicians spend nearly half of their time on electronic health records and desk work. Automating device data entry can significantly reduce this burden.
A connected ventilator that transmits real-time respiratory data to the EHR allows clinicians to make faster, more informed decisions without having to manually input data. This reduces administrative burden while ensuring that the most up-to-date information is available for patient care.
5. North America is leading, but Asia pacific is on the rise
It’s no surprise that North America currently dominates the medical device connectivity market. The region benefits from:
- high healthcare spending,
- a well-established digital health ecosystem,
- and favorable government policies supporting healthcare IT.
But reports show Asia Pacific is quickly becoming the fastest-growing region in this space. Countries like China and India are making significant investments in healthcare digitization and AI-powered solutions, which is driving increased adoption of connected devices.
For instance: China’s push toward building smart hospitals and incorporating AI in healthcare workflows is fueling demand for medical devices that can integrate with these technologies. As these investments continue to grow, Asia Pacific is expected to reshape the global landscape of medical device connectivity.
How do global regulations impact Medical Device development?
However, regional regulatory requirements differ widely. The U.S. FDA’s 510(k) process contrasts with the EU MDR’s risk-based classification and post-market surveillance rules. In Asia, markets like Japan and South Korea have their own device certification frameworks, often requiring local clinical trials. These variations can significantly impact development timelines and go-to-market strategies.
6. 5G and IoT are unlocking new possibilities
5G and IoT technologies are transforming how medical devices communicate. With faster speeds, lower latency, and greater capacity, 5G is making real-time data transfer between devices more reliable and instantaneous. When paired with IoT, 5G can create a truly connected healthcare environment where devices not only collect data but also communicate with one another to create a more comprehensive view of a patient’s health.
Imagine this: A 5G-enabled ambulance that streams high-definition video and transmits a patient’s vitals to the ER while en route. This gives emergency teams a head start, allowing them to prepare for the patient’s arrival with critical information already in hand.
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7. The market is crowded, but key players stand out
The medical device connectivity market is highly fragmented, with numerous players vying for market share. Major companies like Philips, GE Healthcare, and Medtronic are leading the way through strategic acquisitions and partnerships designed to expand their capabilities.
Take Philips, for example: Its acquisition of Capsule Technologies enhanced its ability to offer device integration solutions, making it easier for healthcare organizations to manage data from multiple devices. These kinds of moves signal that the market will continue to consolidate as companies look to broaden their offerings.
8. Interoperability remains a persistent challenge
Despite all the advancements, true interoperability between medical devices remains a stubborn hurdle, studies show. Many devices still operate on proprietary protocols, making it difficult for different systems to share data effectively. This creates inefficiencies that undermine the potential of connected healthcare.
The stakes are high: a study found that poor interoperability is still rampant in our healthcare system with fewer than one in three hospitals able to electronically find, send, receive, and integrate patient information from another provider.
What role do standards like FHIR and SMART play in interoperability?
A familiar scenario: A hospital using devices from multiple manufacturers may need to implement costly middleware to ensure that data from those devices can be properly integrated into the EHR. While middleware can help bridge the gap, it’s not the only solution. Industry-wide efforts to establish common standards (like HL7 FHIR) and the growth of Health Information Networks (HINs) are also playing a key role in improving interoperability. These networks are increasingly evolving beyond simple data exchange and offering more flexible, patient-centered approaches to integration. Learn more about how Health Information Networks are changing the game.
Standards organizations like IHE (Integrating the Healthcare Enterprise), HL7, and IEEE are leading efforts to align protocols and enable consistent, secure data exchange across platforms. Frameworks like SMART on FHIR are gaining traction for enabling plug-and-play app development in healthcare environments.
This complexity highlights the ongoing need for developers to prioritize interoperability when designing new solutions—and to stay informed about the evolving infrastructure supporting it. Discover how HTD can help with interoperability.
9. Cybersecurity is connected Medical Devices is more important than ever
With more connected devices comes an increased risk of cyber threats. As medical device connectivity expands, ensuring the security of patient data is a top concern. Healthcare organizations face constant threats from hackers who target sensitive information, making cybersecurity an unavoidable priority.
Developers must align with FDA pre-market cybersecurity guidance, which outlines requirements like threat modeling, software bill of materials (SBOM), and lifecycle management plans. Internationally, the NIST Cybersecurity Framework and IEC 81001-5-1 also set standards for secure development of connected medical technologies.
How can you build security into Medical Devices from day one?
Building security into the design from the ground up. Implementing encryption, two-factor authentication, and continuous monitoring can help safeguard sensitive patient data and ensure compliance with regulations like HIPAA and GDPR.
At HTD, we take a proactive approach to security by regularly collaborating with experienced penetration testers, like Penester, to identify vulnerabilities before they become risks. By incorporating pen testing as part of our development lifecycle, we help ensure the digital products we build are resilient, secure, and aligned with industry best practices from day one.
Adopting a security by design approach–embedding encryption, role-based access control, and automated software updates from the start–can mitigate vulnerabilities before they reach patients.
10. AI and advanced analytics are powering smarter care
AI and advanced analytics are becoming everyday essentials in connected healthcare—not just buzzwords or future ambitions. As more data is generated from connected devices, the ability to turn that information into actionable insights is transforming how care is delivered.
From predictive maintenance of medical equipment to early detection of patient deterioration, AI algorithms can help healthcare providers spot patterns that might go unnoticed in traditional workflows. For example, AI-powered platforms can analyze real-time vitals from multiple sources to predict the onset of sepsis—potentially hours before symptoms become critical.
Developers now have the opportunity to build solutions that don’t just transmit data, but also interpret and prioritize it. By combining machine learning models with data from connected devices, developers can support clinicians in making faster, more informed decisions—and ultimately improve patient outcomes.
What Drives Success in Connected Health?
Clinical Workflow Transformation
- Connected medical devices don’t just collect data–they actively reshape clinical workflows. For example, continuous glucose monitors have reduced the need for frequent in-clinic visits for endocrinology patients, allowing more proactive, data-driven treatment plans. Similarly, connected cardiac monitors enable cardiologists to intervene earlier, improving outcomes and reducing hospitalizations.
ROI Considerations
- Developers must also consider financial incentives. Value-based care models and reimbursement changes–such as CMS coverage for RPM and CPT codes for remote physiologic monitoring–are making ROI a key factor in adoption. Demonstrating cost-effectiveness and clinical benefit is increasingly essential for market success.
Patient-Centric Design
- Patients are becoming active participants in their care, and design must reflect that shift. Accessibility, personalization, and clarity are crucial–espeically for populations with limited digital literacy or language barriers. Metrics like Net Promoter Score (NPS), app engagement rates, and time-to-intervention can help gauge the effectiveness of UX. Issues of data privacy and ownership are also rising in prominence, as patients seek more control over their health information.
What this means for developers?
For developers working in medical device connectivity, these trends offer a roadmap for where the industry is headed. Whether it’s ensuring seamless EHR integration, enhancing cybersecurity, or leveraging 5G to improve device communication, staying ahead of these trends will be key to building solutions that are both innovative and impactful.
As healthcare continues to evolve, the role of connected devices will only become more central to delivering better patient outcomes and streamlining clinical workflows. Developers who understand this shifting landscape and build solutions that align with these trends will be well-positioned to make a lasting impact in the world of connected healthcare.
To succeed in this evolving space, developers need more than coding skills. A deep understanding of clinical workflows, regulatory requirements, and end-user behavior is vital. Collaborating with clinicians and patients through the product lifecycle can surface design improvements and reduce costly iterations post-launch.
HTD: Driving innovation in Medical Device connectivity
At HTD, we’re not just observing the transformation of medical device connectivity—we’re actively shaping it. Whether you’re developing solutions to streamline EHR integration, enhance remote patient monitoring, or harness the power of 5G and IoT, our team brings the technical expertise, regulatory knowledge, and human-centered design needed to turn your ideas into reality.
Join us in redefining the future of connected healthcare in 2025 and beyond!