Launching Internet of Medical Things Products the Right Way

The Internet of Medical Things represents a network of connected devices that generate, collect, process, and send data and software applications to deliver wireless health quickly, easily, and securely. IoMT ecosystem can also fall under various names, such as wireless health, MedTech, Healthcare as a Service, and so on. 

Key drivers of the rapid development of the IoMT industry include:

• developments in wireless technology (5G, Bluetooth Low Energy), miniaturisation (thanks to advances in microfabrication and nanotechnology), computing power (Edge Computing, AI integration).
• a wide adoption level of healthcare wearables among both clinicians and patients.
• The healthcare system shifts from a product-based view to value-based medicine.

According to the Deloitte report:

“Provided medtech companies can convince clinicians and patients of the value and benefits of connected medical devices, the pace and scale of health care transformation will be exponential.”

While growth is clearly happening, the challenges remain. For instance, IoMT devices are at the heart of dealing with personal health data. As such, Internet of Medical Things security is a key challenge. 

In this article, we’ll outline key moments that will help you launch your IoMT product the right way. After all, pursuing an IoMT product requires more than simply understanding the tech. It requires an understanding of clinical use cases and how your product fits within the larger IoMT ecosystem. You must be well-aware of its core elements and how it differs from general-purpose IoT systems. Whether you are a founder with tech know-how or medical expertise, this article will offer insight into critical moments on the journey to launching your IoMT product.

What is the Internet of Medical Things (IoMT)?

In short, IoMT is the medical devices plus software to work with data, interfaces for clinicians and patients, and its underlying infrastructure. The variety of devices is huge: smart medical devices range from bandages and syringes, to glucose monitors and pregnancy or DNA kits, to surgical tools, pacemakers, and CT and MRI machines.

Definition and Scope of Internet of Medical Things

IoMT is a connected healthcare system that consists of medical devices and software for processing and storing the generated data. The flow of data can go either from the device to a healthcare app or system, or devices can communicate with each other, or both. For instance, a continuous glucose monitor collects patient glucose level data and transmits it to the app. The app, in its turn, can analyze the levels and send the signal to the insulin pump. Or, there can be direct communication between CGM and an insulin pump using Bluetooth.  

IoMT often includes multiple stakeholders such as device manufacturers, insurance representatives, regulatory institutions, as well as patients, doctors, and hospitals. 

The scope of IoMT includes any medical device or sensor, from personal health monitoring to remote healthcare, hospital automation, and chronic disease management. The list of most common IoMT devices is shown in the table below. 

Familiarizing yourself deeply with these different categories of IoMT devices helps to correctly define your product launch strategy. Each category of these devices bears different requirements for data management, regulatory compliance, integration types, and user interaction. For example, a physiologic device always requires FDA clearance in a medical setting, while ambient sensors require much fewer regulatory hurdles. Treatment devices like infusion pumps or smart capsules bear distinct integration requirements with the workflows of care, fail-safe mechanisms, and stringent clinical testing. 

IoT vs IoMT (Internet of Medical Things)

IoT, or Internet of Things, is an umbrella term that generally defines connected devices that create systems that operate with little to no human intervention and can become a part of autonomous systems. In terms of use, IoT is often utilized to augment decision-making, such as to alert a human that a certain action or attention is required. For instance, in an industrial IoT, a sensor will alert a technician that there is a need for maintenance. 

IoT has developed specialized niches based on unique requirements for the devices and systems involved. For instance, a smart home IoT system has comparatively relaxed requirements for data security, accuracy, and reliability compared to medical IoT. After all, in medical IoT, sensors, devices, and software directly impact the quality of healthcare and treatments. In contrast, in a warehouse, an RFID tag might tolerate mid-level latency, location accuracy within meters, and such. For a patient coming into the ER who can possibly fall unconscious or is unstable, the RFID band requires much higher locational precision and real-time latency due to the possibility of critical emergencies.

Understanding the difference between IoT and IoMT contexts helps to avoid costly mistakes when launching your Internet of Medical Things product. Real-world deployment of IoMT devices usually leads to specific requirements such as integration with hospital protocols (HL7/FHIR), enhanced fail-safe mechanisms, clinical testing, compliance with industry standards (IEC 60601, ISO 13485), etc. This is especially important when building a device from general-purpose IoT modules. You will see below how even selecting a regular RFID module is a big security vulnerability for Internet of Medical Things security compared to the AES-enhanced RFID module.

Core Components of an Internet of Medical Things Ecosystem

Below is the schema for the remote patient monitoring health system. It combines a variety of smart physiological devices: blood pressure monitor, thermometer, blood glucose monitor, weighing scale, and a range of wearables. On top of this, there are communication protocols and an integration layer (an IoMT hub) that ties together all these devices. Then, there is a cloud/edge layer that processes, stores, and analyzes the data. The clinicians and hospitals interact with the application layer interfaces with an added layer of security and compliance throughout the entire IoMT system. Optionally, the system can incorporate advanced AI and analytics capabilities. 

Let’s look into each core component in a greater detail. 

Device Layer

The basis for any IoMT system is the devices that collect data. The detailed categorization and list of the devices  was provided in the table above.

Communication Layer

On top of that, the IoMT ecosystem utilizes a variety of connectivity protocols for transmitting data for local processing or the cloud. Based on the needs of a particular IoMT system, several different connectivity technologies can be utilized. They are wireless (BLE, Wi-Fi, Zigbee), cellular (4G, 5G), wired, and edge gateways. For launching in the IoMT context, Wi-Fi will not be a desirable choice, especially for critical hospital systems. A better choice today is a wired connection, while the future is likely to favor 5G technology.

Data Integration & Management Layer

Next, the data must be received, integrated, normalized, and stored. Data integration & Management layer is where different APIs, middlewares like Kafka, MQTT, and  FHIR (Fast Healthcare Interoperability Resources) interact to ensure reliable and fast data reception and convert it from raw data into the desired format.

Cloud & Edge Computing Layer

Once the data is collected and standardized, there is a layer of computational activities such as preparing for long-term storage, processing, and analyzing. This layer largely relies on cloud & edge computing. Cloud computing is for real-time analytics and long-term data storage in compliance with regulations. In addition, AI/ML capabilities also use cloud capacity to process and learn from medical data. Lastly, IoMT system designers adopt edge computing for ICU monitoring, where IoMT devices and sensors need to support time-sensitive decision-making.

Application & Interfaces Layer

All of these layers finally lead to the Application layer, where patients, clinicians, and other stakeholders can meaningfully engage with the data. Here, interfaces might take a variety of forms, such as:

•  An application with dashboards for clinicians, either for ICU or RPM (Remote Patient Monitoring) portals. 
• Applications can be mobile apps for caregivers or parents who monitor their child’s condition. 
• a telehealth platform with IoMT integrations.
• minimal applications for a sole purpose of alerting or notifying. 

Compared to launching a regular app, launching an IoMT application requires going beyond aesthetics and smoothing out user flows. Your team should consider DTx (Digital Therapeutics) standards and definitions. Moreover, considering the IoMT concept should also be matched against regulations and definitions for specific countries, such as outlined in the Digital Therapeutics Alliance guidelines. Overall, applications and interfaces include a whole spectrum of patient/clinician-specific needs dictated by the demands of their conditions and environments.

Internet of Medical Things Security & Compliance Layer

While the Application layer focuses on user interactions, any healthcare app development requires a Security & Compliance layer. Internet of Medical Things security, in particular, utilizes available IoT protocols. These are more generic in nature and ado not adhere to specific requirements of medical settings. 

For instance, Infrared (IR) communications are no longer made for use in both broader IoT applications and IoMT due to a lack of any security and authentication protocols. Yet, older IoMT devices, which remain in use, still continue using this technology. They are older glucose monitors, heart rate and pulse oximeters, and smart bedside monitors. The main way to increase security is to physically restrict access. 

In contrast, RFID tags, which are more frequent in use than IR ones, present even more challenges. Primarily, standard implementation of RFID tags has no security or authentication protocols, just like IR communications. While scanning does require close proximity, RFID-tagged items or individuals are mobile, and restricting access to tags defeats the purpose. As such, security vulnerabilities of RFID tags include:

1. attacks on data integrity, 
2. cloning of tags, 
3. anyone having a comparable scanner can scan confidential data, as there is no authorization protocol, 
4. unauthorized tracking of tagged items or individuals, 
5. RFID data may be stolen and reused, and 
6. Denial of Service attacks where tags can be jammed or overwhelmed and rendered unavailable. 

Internet of Medical Things Security

Overall, Internet of Medical Things security requires more sophisticated approaches than general IoT provides. In case of RFID tags, there are ones specifically for the environments that require compliance with enhanced security protocols. For instance, the schema of an AES-enhanced RFID tag is shown below. AES and EEPROM modules provide cryptographic enhancements to ensure encrypted communication. EEPROM module stores a unique ID and a cryptographic key, while AES computes strong cryptographic authentication. AES-enhanced RFID tags mitigate vulnerabilities numbers 1,2,3, and 5 from the list above.

Similar specifics exist across the board for IoT protocols and technologies used in medical settings. In addition, the Security & Compliance layer includes components such as audit trails and compliance logs.

Therefore, the requirements of this layer are crucial for the market launch of your IoMT product. Your team, in cooperation with the development agency, must clearly work out a security and compliance strategy. This will help avoid launch delays, certification failures, or rejections from healthcare providers.

AI & Analytics Layer

This layer is optional, and not every IoMT system might have it. Though it is getting increasingly common to include it as a competitive advantage point for your IoMT product. AI & Analytics layers provide the IoMT system with advanced capabilities, such as:

• Predictive analytics;
• Pattern recognition;
• Machine Learning (ML);
• Clinical decision support;
• Risk scoring;
• Analyzing trends;
• Visualizations.

Key Applications & Use Cases of Internet of Medical Things

Remote Patient Monitoring

• Focuses on the monitoring of patients’ vitals and transferring these to clinicians. Examples are wireless blood pressure monitors, thermometers, ECG monitors, and others. Already existing solutions include  Philips Extended Holter – ePatch or Withings BPM Connect;
• Home diagnostics, which can be molecular diagnostics (Cue Health Monitoring system) or a smart glucometer such asiHealth Gluco+ Wireless Smart Gluco-Monitoring System;

Smart Inhalers, Insulin Pumps & Other Wearables and Implantables

• Smart implanted devices, such as Micra leadless pacemakers for bradycardia orConfirm Rx insertable cardiac monitor from Abbott;

People & Asset Tracking in Hospitals

• Hospital asset tracking, like ThingMagic® Embedded RFID Modules that is utilized across different healthcare units, from surgical instruments and IV pumps to carts and larger inventory items.;
• Tracking newly admitted patients with a wearable sensor or RFID wristband, for instance, AeroScout RTLS;

Automated Medication Dispensers

• IoMT devices that are responsible for storing and dispensing medicine according to the schedule. At the same time, they store data about the usage and transmit it to the overseeing party, be it a clinician, caregiver, or a health platform. 
• These can be used by people individually at home, or by healthcare personnel at hospital settings or in pharmacies. For instance, there is Hero Smart dispenser for home use and XT Automated Dispensing Cabinet for pharmacies. 
• One can also attribute here smart syringes for instance. As an example, there is YpsoMate autoingector that enables precision medicine. Overall, such syringes are quite handy for injecting insulins, biologics, or pain management, all of which falls mostly under chronic disease management. 

Telehealth & Tele ICU: Virtual Care Integration

• Tele ICU, a solution likeMural™ Virtual Care Solution, which collects data from bedside devices from remote ICUs;
• Integrations for telehealth to ensure the receipt of high-quality patient data during a telehealth consultation. For instance, there is a home exam kit “The Home Smart Clinic”, from Tytocare.

Conclusion

Considering the distinctiveness of Internet of Medical Things compared to general-purpose IoT, launching a successful product requires a complex approach. Accounting for increased costs connected to Internet of Medical Things security and compliance, it is of paramount importance to clearly define the initial scope and costs of IoMT product development. The best approach, time- and cost-wise, is to opt for MVP development. Partnering with a professional MVP development company will ensure you get your basics covered, all the while developing a selected functionality to deliver the core value to your target users.

Read “What the Heck Is Custom MVP App Development?” to learn more about MVP development methodology.

FAQ: Launching Internet of Medical Things Products