Medical devices have proliferated in recent years, and the rapid pace of development is anticipated to continue.
Traditional devices are designed to work alone, requiring manual entry of generated data into electronic health records.
Medical device integration (MDI) enables sharing of data between devices and healthcare information systems, providing patients and healthcare workers with access to their comprehensive health data in a centralized location.
MDI supports faster, more efficient, more data-driven decision-making and better patient outcomes and the potential to significantly reduce healthcare costs.
MDI systems must comply with a myriad of regulations and standards, normalization of data from many different devices/device manufacturers with different formats and proprietary protocols can be complex, and ensuring data integrity and security can be challenging.
Choosing the right MDI system/services provider is essential to overcoming all of these potential roadblocks.
What Is Medical Device Integration?
Medical devices have proliferated in recent years, and the rapid pace of development is anticipated to continue as patients seek to use advanced technologies to help monitor, control, and improve their health. The best results can’t be realized if each device works only on its own and does not communicate its results to users and their physicians.
Medical device integration (MDI) addresses this interoperability issue by allowing individual devices to connect to one another and the overall healthcare network in a safe and secure manner. It enables automatic sharing of data between all types of devices (e.g., wearables, heart and other monitors, Internet of Things (IoT) sensors, infusion pumps, ventilators) and healthcare information system, such as electronic medical records (EMRs), as well as artificial intelligence (AI) models and other analytics software using standard communication protocols and data formats.
Why Is Medical Device Integration Important?
Thousands of medical devices have been approved, and more are reaching the market every year, exhibiting a nearly 7% compound annual growth rate with the value projected to surpass $1 trillion globally by 2031. This growth is occurring at a time when medical equipment and communications technology is quickly evolving, preventative care is becoming more prevalent, and hospitals are facing ever-rising cost and resource pressures.
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Without effective MDI, data collected by different devices are fragmented across different formats that require labor-intensive management, creating challenges to providing high-quality care in a timely manner.6 MDI is crucial to supporting the use of data by connecting individual devices with information technology (IT) infrastructure so that data can be combined to generate a more comprehensive view of a patient’s current and past health.2,7,8
MDI therefore supports more informed healthcare decisions without the need for manual transposition and data entry. Interoperability enables connection of bedside and diagnostic equipment and various monitoring systems to support real-time data exchange, reduce the administrative burden on healthcare providers, and facilitate faster, more efficient, more data-driven decision-making and better patient outcomes. MDI could potentially save the U.S. healthcare system as much as $30 billion annually.1
What Does Medical Device Integration Enable?
MDI provides numerous benefits for patients and healthcare providers.1,3,7 By streamlining the flow of data between devices and healthcare systems, MDI helps ensure that essential patient data is captured and incorporated into EHRs. Administrative burden and the risk of errors are reduced by eliminating the need for data transcription, while access to comprehensive patient data is maximized. Because all data are available in a consistent format, analysis is easier, allowing for identification of trends and patterns that would not be identified otherwise. The availability for remote monitoring and generation and sharing of real-time data also supports tracking of patient conditions over time.
All of these benefits contribute to improved patient care and ultimately better health outcomes. In addition, with MDI facilitating communication between many types of devices, clinical studies can leverage more types of data, and device developers have more freedom to innovate.
What Are the Key Features of Effective Medical Device Integration?
Effective medical device integration solutions should contain an number of specific features.1,2,7 In addition to supporting data among between multiple device types that use multiple data formats, an MDI solution should offer plug-and-play connectivity, leverage standardized data formats (which requires data normalization) and protocols (Bluetooth Low Energy, WIFI, USB, MQTT (standard for IoT messaging), REST APIs (representational state transfer application programming interfaces, specific for healthcare system integration)), comply with relevant interoperability standards, and support real-time data streaming. Options for real-time data integration or integration in batches on a less frequent basis should be available. Inclusion of solutions for handling connection interruptions and ensuring data security (encryption), authentication, and traceability are also important. Finally, the user interface should be intuitive and sufficiently flexible to enable easy operations my patients, caregivers, and healthcare professionals.
With respect to hosting location, some MDI solutions use middleware located on cloud platforms for aggregating data. Alternatively, edge middleware can be installed on local hardware.7 The former is appropriate for remote monitoring and ideal for collection of large-quantities of data for aggregation, analysis, and trending, such as on a population-level. The latter is preferred when the data must be processed immediately and for security reasons would be kept locally. In many cases, a hybrid approach is beneficial.
Are There Recommended Strategies for Medical Device Integration?
The specific approach taken for achieving medical device integration depends on several factors, including data security requirements, applicable regulations, and specific interoperability needs.1,2 The type of data to be collected and how frequently, what format(s) they are in, their quality and level of detail, and the intended clinical application must all be well understood. A plan should then be established for building an effective MDI solution that takes this information into account and addresses the specific needs of the user(s).
First, it is highly recommended that regulatory and quality assurance teams be included from the outset to ensure that the MDI solution design complies with the numerous regulations that apply to medical devices and MDI.2 Including at least one healthcare professional on the design team is important to ensure the developed solution supports anticipated clinical workflows.
Second, it is recommended not to send data directly to the final target software.2 The best strategy is to develop bridging software that collects and normalizes the data from different devices and manufacturers, validates the data and ensures it meets business rules, and enables traceability and auditing. This approach also enhances data security and ensures system scalability, as it makes it easier to add additional devices and accommodate device upgrades. The use of open APIs, meanwhile, provides flexibility and agility.
Once an MDI solution has been launched, it is imperative to conduct regular performance evaluations using established perveance indicators to ensure it is still meeting the evolving needs of the users. Training should also be an ongoing exercise with specifics customized to address the aspects important for different user groups.
Specific steps a healthcare facility/group should take to ensure successful MDI solution development include assessment of requirements, evaluation of MDI solution vendors, development of the solution by the vendor, confirmation of regulatory compliance obligations, data standardization, actual connection of devices in the appropriate configuration, mapping of the standardized data to the right fields in the target software, testing to ensure the data is properly transferred to the EHR, and, ultimately, implementation across the organization.7
Finally, it should be noted that choosing medical devices designed for use in a connected environment can facilitate MDI.9 Traditional devices were designed to operate individually, Devices designed to communicate with other devices and clinical systems follow relevant standards and have more flexible data interfaces, making them more readily integrated. They also proactively address cybersecurity and patient data privacy issues,
What Regulations and Standards Govern Medical Device Integration?
Multiple regulations and standards apply to medical device integration solutions or to medical devices that leverage MDI solutions to transmit patient data across multiple devices and clinical systems.1-3,5,7 The U.S. Food and Drug Administration (FDA) may require 510(k) clearance or premarket approval (PMA) for integrated devices, depending on the level of risk data sharing poses.3,11 Devices must also meet the requirements of the Quality System Regulation (QSR) established 21 CFR Part 820. Of course, medical devices must also be clinically validated through clinical studies.
Depending on the integration layer within the MDI solution, it may be considered a data consumer or software as a medical device (SaMD). Data consumers use but do not change medical device data, while SaMD actually performs medical functions separate from the device itself, such as analyses or data curation. The latter are covered by a wider set of regulations. Such MDI solutions must ensure the privacy and integrity of patient data according to the Health Insurance Portability and Accountability Act (HIPAA). The National Institute for Standards and Technology (NIST) cybersecurity framework, which outlines best practice for cybersecurity and data protection (in alignment with the General Data Protection Regulation (GDPR)) must also be followed. Patients must be informed of how their data will be used, be educated on privacy policies, and provide consent. In the EU, these MDI solutions may require Conformité Européenne (CE) marking, clinical evaluation, and post-market surveillance
With respect to data communication, several standards have been established. The international Health Level Seven (HL7) (v3 is the latest) set of messaging formats, data exchange protocols, and terminology standards ensure seamless interoperability between different medical devices and clinical systems. The Digital Imaging and Communications in Medicine (DICOM) standard covers the sharing of medical images and associated data. The newer Fast Healthcare Interoperability Resources (FHIR), developed by the HL7 organization, leverages REST APIs to ensure interoperability and is becoming widely used for MDI solutions that support real-time data exchange and integration between medical devices and EHR systems (e.g., cloud-based platforms, mobile health solutions). The Integrating the Healthcare Enterprise (IHE) initiative, meanwhile, provide specifications and guidelines for interoperability, largely through the provisions of use cases and example workflows.
Other applicable standards including IEC 62304 for software life cycle and risk management from the international Electrotechnical Commission, ISO 13485 on the quality management of integration software from the International Organization for Standardization, and the IEEE 11073 service-oriented device connectivity (SDC) family of standards from the Institute of Electrical and Electronics Engineers.
What Are the Main Challenges to Medical Device Integration, and How are They Being Overcome?
Even when following best practices and carefully planned strategies, the implementations of integrated medical device solutions can be challenging for healthcare facilities.1,2,6,7 A recent survey conducted by the Association for the Advancement of Medical Instrumentation found that three of the top 10 medical device–related challenges for clinical engineering and biomedical departments involves integration issues, including connection of devices to one another and to information systems; ensuring proper maintenance, including managing upgrades, updates, and virus protection; and difficulties with the management of the growing number of connected devices being used in healthcare settings.10
One of the biggest hurdles relates to the difficulty integrating many different devices from many different manufacturers with different types of data in different formats and using property protocols. The need to integrate older legacy devices further complicate the job. This task is often complex and requires commitment and diligence to ensure the resulting solutions provide robust seamless communication with proper data protections and in compliance with the myriad standards and regulations that cover integrated medical devices. That also requires staying up to date with constantly evolving regulations.
Another notable challenge can arise if the existing IT infrastructure (network protocols and software applications) is not compatible with the medical devices in use at the facility. Projects can also be slowed down if industry-wide standards and protocols must be established and extensive data normalization and semantic and structural transformation of data are required. Implementing sufficiently robust integration security measurers (encryption, control of data access, etc.) can also be complex. Choosing the right MDI system/services provider is essential to overcoming all of these potential roadblocks.
