The Problem:
IoMT and Medical Devices companies are breaking the ground for revolutionary healthcare with continuous monitoring and remote monitoring capabilities. For what was mere a $24.4 billion global IoMT in 2019, due to its increased dependency is expected to grow to $285.5 billion by 2029 at a CAGR of 28.0%!
Most of the IoMT device companies have created innovative and novel MedTech devices that are not only FDA-approved but have also garnered amazing adaptation from patients and providers. While IoMT devices have successfully managed to commercialize healthcare data and applications amongst users, they are still limited to certain users and consumer sections are struggling to increase the demand for their products.
For instance, 25% of MedTech leaders are investing in R&D to increase demand for their products and the majority of IoMT medical devices are focusing of making optimum use of their data! This can be corroborated by the finding in a survey that said, out of all the MedTech companies that utilize IoMT as their offering,
- 43% are using data to drive business decisions
- 39% are incorporating data as an added value to justify the pricing
- 31% are offering data distribution channels as a service
So, while IoMT organizations are actively trying to increase the meaningful use of their medical data, they have been facing the problem of making their data accessible and available for life science organizations! Medical data is not just required by patients and providers, that can also be useful for clinical trials, clinical research organizations, pharmaceutical companies, and insurance companies!
With the increasing accuracy of medical data tracking using IoMT devices, there has been a large demand for collected patient data through IoMT devices as its real-time and continuous monitoring capabilities provide unique insights and analytical abilities for Life Science organizations which were unchartered territory for them before.
The actual challenge – Data Structuring and Data Relevance!
A commonly cited estimate in a survey found that in the Life Science industry, 80% of company data are unstructured. It was also found that incomplete and inaccurate data is the biggest challenge faced by 74% of the companies that were surveyed. [Source]
Thus, if Medical Devices companies that use the IoMT ecosystem can provide secure and real-time access to relevant, accurate, and use-case-specific data with the Life Science industry which can deliver actionable insights supporting their thesis, they become more likely to connect with such organizations and create a larger market for their data as DaaS and Clinical Intelligence providers!
To put this in perspective, here is the potential of IoMT devices in the Life Science division as DaaS and Clinical Intelligence providers:
The Potential:
Healthcare and its increasing need for medical data
MedTech and Medical Wearable Devices have been transforming healthcare and patient care. With healthcare moving towards connected and continuous care, IoMT or the Internet of Medical Things has been growing exponentially because of 3 major benefits- data, statistics, and real-time analytics!
Not only are patients and healthcare providers opting for IoMT devices, with the growing compliance and regulatory policies around data accessibility and connectivity, increasing demand for cost-effective and accelerated clinical trials, and the ability of IoMT devices to deliver informed decision-making in the payers’ ecosystem, but IoMT devices or Smart Medical Devices capable of continuous and remote monitoring have also been in high demand across the industry.
Statistics to prove the growing need for continuous monitoring and connected medical devices across the healthcare ecosystem:
Clinical Trials:
For instance, when we search for the keyword “sensor” in all the listed studies which are completed, active, and recruiting, 1,452 studies were identified. This means that clinical trial organizations are relying on sensor-based wearables or implanted devices to remotely collect data and collect supportive evidence for their study in a non-invasive manner!
This shows that clinical trials that are run using Sensor based medical devices for continuous monitoring delivery can derive effective, real-time, and accurate insights. IoMT devices deliver quality data programs up front and the ability to analyze data intermittently lowers the risk to a minimum in clinical trials.
Provider and Patient Ecosystem:
A recent study found that more than seven million patients are using remote monitoring and connected healthcare devices! [source] and the use of remote monitoring is expected to continue to expand, and opportunities abound for innovations, including general platforms that can be adapted to a wide variety of cases specific to therapeutic areas.
Data Donation Need for Clinical Research:
In a study, it was found that many patients want to donate their data for medical research. According to various surveys, nine-out-of-ten patients with access to their health data are willing to share that data to support research. But the hindrances that patients face while sharing this data are a lack of electronic medical information interoperability and a lack of trust in the privacy of patient medical information.
Government initiatives that mandate providing access to medical data:
- MyHealthEData from Trump Administration
- The Interoperability and Patient Access final rule (CMS-9115-F)
IoMT devices and their data are at the center of this ecosystem! Making their data accessible to all with the consent of patients can make them the anchor for interoperable and secure medical information generation, classification, and distribution.
Medical Devices and IoMT manufacturers cannot only deliver continuous care and remote health monitoring capabilities, but they can become a DaaS and clinical intelligence platform that can share relevant information with all whiles adhering to the compliance and regulatory requirements. To make it possible, seamless, and continuous sharing, here is our proposition to the IoMT companies!
The Proposition:
AIMDek MedTech data interoperability architecture that effectively makes IoMT companies a DaaS and clinical intelligence platform!
Brief about the architecture:
While the world is gaga over integrating data points, to ensure data interoperability HL7 FHIR compliance in Medical Devices, consumer Wearable Devices, and IoMT devices, they would rather have to focus on data segregation!
To ensure effective data governance, and regulatory compliance and to become a DaaS that only transmits relevant data to the respective consumers, we have created this HIPAA and HL7 FHIR-compliant data architecture that ensures effective data management, filtration, easy access and pairing of data on-demand from respective consumers.
The architecture consists of:
IoMT streaming devices: This architecture is defined to transmit any sort of data from edge devices to the cloud.
Data Management Architecture: We ensure that your data is stored securely and that it is HIPAA compliant.
Data Storage: For cost-effective data storage of bulk and streaming data we have established a multi-layer storage facility that helps in cost-optimization for short-term associations and long-term storage.
HL7 FHIR compliant processing:
With a state-of-art data syntactic and semantic parser, classifier, and distribution model, we decouple the data from sources and filter it into a completely dynamic data set that can be paired and connected on demand.
Post-processing HIPAA-compliant storage:
To ensure that the data is stored in a secure and meaningful manner post-processing, we have created an elegant database that is completely secure, dynamic, scalable, and HIPAA compliant.
ONC mandate friendly distribution APIs infrastructure:
Once the data is processed, it can be delivered in bulk or in near-time streaming to CROs, Clinical Trials, Healthcare Payors, Healthcare Providers, and any other potential target customers in the form of APIs that are built as per the guidelines set by the Interoperability and Patient Access final rule (CMS-9115-F).
Use cases of Architecture:
- Medical Device and IoMT companies planning to become a DaaS and Cloud-intelligence platform that serves a larger set of customer bases while adhering to the HL7 FHIR compliance.
- Consumer wearable and device companies looking to transform towards a medical-grade device. This architecture not only provides them with data interoperability but also ensures data governance, HIPAA compliance, the ability to stream data to various parties apart from device users, and an opportunity to become a DaaS device that exhibits the optimum value of their data.
Data Standardization and Cloud-security at its best for smarter, continuous, connected, and remote care:
With government bodies and the healthcare industry at large embracing continuous and remote care with increased adaptation of IoMT devices, AIMDek work towards a better healthcare future where we help IoMT and Medical Device companies in making their data accessible for all their consumers.
