Connected device SaMD is software as a medical device that works across an ecosystem of connected devices, linking measurement, analysis, and action rather than serving a single isolated function. The healthcare industry is in the midst of a profound shift, from siloed, single-purpose devices to intelligent, interconnected ecosystems. The Internet of Medical Things (IoMT), once considered a buzzword, is now reshaping care delivery.
The market for IoMT is projected to grow from USD 230.7 billion in 2024 to USD 658.6 billion by 2030, at a robust 18.2% CAGR. In parallel, the Software as a Medical Device (SaMD) market is forecast to grow from USD 1.58 billion in 2024 to USD 6.87 billion by 2032, at more than 20% annually.
At the heart of this transformation are biosensors, the foundational technologies that convert physiological signals into actionable insights. From continuous glucose monitors to cardiac patches and fertility trackers, biosensors drive the collection of real-time data, enabling earlier diagnosis, more precise interventions, and better outcomes. Patients, providers, and payers alike now demand solutions that are secure, interoperable, and seamlessly integrated into everyday life.
The Connected Device SaMD Landscape
The ecosystem of connected health technologies is expanding rapidly. IoMT growth is fueled by increasing adoption of wearables, home diagnostics, and telehealth. Regionally, North America leads the market, while the Asia-Pacific region is the fastest-growing, where connected solutions are filling gaps in access to care.
Biosensors are scaling just as quickly. The global biosensors market was valued at roughly USD 30 billion in 2024 and is expected to reach USD 48.6 billion by 2030, at an 8.6% CAGR. Electrochemical biosensors dominate, representing over 70% of market share, thanks to their affordability and broad applicability. These technologies form the backbone of SaMD solutions, powering ecosystems where devices feed rich data into applications that provide diagnostics, alerts, and interventions.
The direction is clear: connected device SaMD is no longer about measuring isolated metrics. It is about interlinking measurement, analysis, and action across devices, platforms, and care settings.
Key Development Considerations for Connected Device SaMD
Interoperability
Cross-platform compatibility is now a baseline expectation. HL7 FHIR has shifted from experimental to the standard of choice for health data exchange, with most surveyed countries reporting active use in at least some clinical use cases. Major EHR vendors now offer FHIR APIs alongside legacy HL7 v2 feeds, reflecting a clear expectation that data should move easily across platforms.
In the U.S., ONC and CMS rules explicitly require FHIR APIs for key workflows such as patient access and prior authorization, while FDA guidance on interoperable, cybersecure medical devices stresses secure communication and well‑documented interfaces. Vendors that ignore standards‑based interoperability increasingly face commercial and regulatory risk, from integration headaches and information‑blocking concerns to skepticism from health systems that now treat FHIR support as table stakes.
Regulators reinforce this push: the FDA’s guidance on interoperable medical devices emphasizes secure protocols and well-documented interface specifications. Companies that fail to design for interoperability risk market rejection and regulatory delays.
User Experience
Even the most advanced system will fail if users cannot or will not adopt it. Patients and providers now expect connected health apps to mirror consumer-grade experiences: seamless, intuitive, and cross-platform. For chronic disease management, where adherence is vital, ease of use is directly tied to outcomes. In a crowded market, UX is a decisive differentiator.
Data Integrity and Quality
The sheer volume of real-world biosensor data brings challenges. Signals are often noisy or incomplete, with artifacts caused by movement or the environment. In diabetes care, minor inaccuracies in continuous glucose monitoring can mean the difference between effective therapy and dangerous misdosing, a clear example of why accurate data matters across the entire connected device industry. Regulators increasingly expect transparent documentation of how developers ensure data integrity throughout the lifecycle.
Cybersecurity and Privacy
Healthcare continues to be among the most expensive sectors for data breaches. Industry analyses of data breaches consistently rank healthcare at the top for incident cost, with IBM’s 2025 Cost of a Data Breach data putting the average healthcare breach at about USD 7.42 million, the highest of any sector. At the same time, multiple cybersecurity assessments have flagged large numbers of internet‑connected medical imaging devices and PACS/DICOM servers as misconfigured or weakly secured, exposing sensitive images and patient data to unauthorized access and malware.
For connected device developers, embedding end-to-end encryption, secure boot processes, and alignment with HIPAA and GDPR is not optional.
AI and Machine Learning
AI and machine learning are enabling predictive, adaptive, and personalized healthcare. They also raise concerns around transparency, bias, and regulatory acceptance. Regulators are still shaping frameworks for adaptive algorithms, and dataset diversity remains a core requirement. Companies that treat AI not just as a technical tool but as a trust enabler will be best positioned to succeed.
Navigating Regulatory and Market Complexities
Estimates of the connected device SaMD market vary widely by research firm, because each defines the category differently. One frequently cited forecast puts the connected medical device market at roughly USD 76 billion in 2025, rising toward USD 153 billion by 2030. Whichever definition is used, the direction is the same: rapid growth, and rising regulatory complexity alongside it. The medical device regulatory affairs market is itself projected to reach USD 13.7 billion by 2032, underscoring the growing cost of compliance.
For leaders, the lesson is clear: success in connected device SaMD requires precise regulatory planning, realistic budgeting, and global launch readiness.
Building the Future of Connected Health
The evolution of connected device SaMD is creating unprecedented opportunities for personalized and preventive care. It also introduces risks, including interoperability breakdowns, cybersecurity vulnerabilities, inconsistent data, and regulatory uncertainty. Organizations that address these challenges early will not only avoid setbacks but will help define the future of digital health.
Doing so requires more than internal resources. It requires an experienced partner who knows connected device SaMD inside and out. Sequenex brings deep expertise across biosensors, cloud and mobile integration, interoperability standards, and global SaMD regulatory pathways. From developing SDKs and APIs for multi-vendor ecosystems to guiding regulatory submissions and payer alignment, Sequenex acts as a strategic ally. Our work in diabetes, one of the most advanced connected health markets, demonstrates our ability to deliver interoperable, secure, and user-centric systems, and we extend that expertise to the broader connected health landscape.
For executives leading the next wave of innovation, the question is not whether connected devices will transform healthcare; it is whether your organization will be ready to seize the opportunity.
Read our full white paper, Connected Device SaMD: Important Considerations for Developing Successful Interoperable Solutions, to explore these trends, risks, and strategies in greater depth.
Frequently Asked Questions
What is connected device SaMD?
Connected device SaMD is Software as a Medical Device that operates across an ecosystem of connected devices rather than performing a single isolated function. It links measurement, analysis, and action, for example, taking data from a biosensor, analyzing it in the cloud, and delivering alerts or interventions to patients and clinicians.
What is the Internet of Medical Things (IoMT)?
The Internet of Medical Things is the network of connected medical devices, wearables, and applications that collect, transmit, and sometimes analyze health data over the internet. IoMT is the broader ecosystem in which connected device SaMD operates.
Why is interoperability important for connected device SaMD?
Interoperability lets devices, apps, and health systems exchange data reliably. Standards such as FHIR are widely adopted across EHR systems, and the FDA’s guidance on interoperable medical devices expects secure protocols and documented interface specifications. Without interoperability, a connected device SaMD product struggles to integrate into clinical workflows.
What are the main development challenges for connected device SaMD?
The main challenges are interoperability, user experience, data integrity, cybersecurity and privacy, and the regulatory treatment of AI and machine learning. Each must be addressed early, because retrofitting them later drives cost overruns and delays.
