IoT is trending. Companies invest in new tech...
But First: Getting a Connected Insulin Pump CertifiedThough often neglected, getting a certification is probably the main concern of healthtech companies before launching their product on the market.
Every new insulin pump should fulfil standards of precision, for example, International Electrotechnical Commission (IEC) standard 60601-2-24 for infusion pumps in the US.In the US, the Food and Drug Administration (FDA) classifies insulin pumps as Class II (moderate risk) devices. However, when a pump is classified as an integrated system, enhanced with a CGM, it os classified as Class III (higher risk) devices. Here hides the key difference between the two types of devices:
- Class II devices are not required to pass clinical studied for getting marketing authorization. However, manufacturers are generally required to perform small ‘human factors’ studies to prove that potential users can understand and properly use a device.
- Class III devices must pass a Premarket Approval process, including extensive clinical studies and regulatory review, to prove their safety and effectiveness.
Building the Connected Insulin Pump Architecture: Cost Breakdown of Each PartThe market of connected diabetes solutions is moving towards closed loop insulin pumps, where a system of interconnected elements acts as an artificial pancreas. Connected insulin pumps mimic the way the human pancreas works by delivering small doses of short acting insulin continuously (basal rate) and variable amounts of insulin when a meal is eaten (bolus). As any IoT-driven technology, it includes basic elements which can be enhanced by additional features and functions.
Insulin Pump Hardware SystemA classical firmware part of the connected medical solution consists of several components:
- Insulin pump. With advances in the medtech area, today tethered insulin pump, i.e. insulin pumps connected to the body via tubing, are massively replaced by patched pumps, attached to the skin with an adhesive. Both types are aimed at delivering a set of the hormone to the body throughout the day. Insulin pumps are equipped with a remote control device, featuring a display, buttons and circuit board, connected with the pump wirelessly.
- Glucose sensor. Placed under the skin, it performs Continuous Glucose Monitoring (CGM) by constantly tracking blood sugar levels. It can be integrated into a patched insulin part or be a standalone device, worn in addition to the pump. The sensor monitors a user’s status, changes settings, and updates the device’s firmware.
- Transmitter. It is usually clipped onto the sensor, and is usually connected to it via Bluetooth. When receiving sugar levels from the sensor, it transmits them to a user’s smartphone or smartwatch.
For the simplicity reasons, users prefer sensor-augmented insulin pumps, automatically delivering the right amount of insulin without requiring instructions from the wearer and sending glucose data wirelessly to the on-screen display.More advanced versions of such pumps can not just keep a user updated on their glucose level, but send alerts to the insulin pump when a user is reaching or has reached personally preset glucose target limits.
Insulin System Development CostsAs there are different types of connected insulin systems present on the market today, their development costs can be assessed only on a case-by-case basis. However, engineering and designing a pump, equipped with sensors, on-screen display and required transmitters, and integrated with the medical platforms, used by a company, will take a period of 6 up to 9 months of intensive development. Add to this no less than 10,000 hours needed for the system’s thorough testing – and you will see that it is a long-lasting cycle.
Pavel Shylenok, R-Style Lab’s CTO, estimates approximate costs of the insulin pump development to be around $400,000-500,000.
Building Infrastructure Behind a Connected Insulin PumpFunctioning of any successful insulin pump is based upon a thought-through and properly tested back-end server part, built in accordance with the business logic of a platform. It will be responsible for data storage and processing, that’s why security and scalability become developers’ major concerns. From the point of view of data collection and data analysis, the system should feature the following functionality:
- Tracking glucose rates.
- Setting customizable reminders.
- Sending alerts for missed glucose measurement, when a user is hitting a preset low glucose level or reaching it.
- Providing alarms in the event of a blockage preventing continuous insulin infusion through the pump.
Using the Cloud in Smart Insulin Pumping SystemThe collected data is sent to the cloud server for further processing, storage, and visualization. The cloud uses its advanced tools (AI, ML, etc.) to use the obtained data:
- Doing analysis, both in real time and later.
- Sending commands to a specific insulin pump.
- Monitoring of the Insulin pump state and actions.
Taken into account a sensitive nature of the stored and processed data, as well as life importance of commands sent from the cloud to end-devices, developers at R-Style Lab pay utmost attention to security issues to make such products compliant with internationally acknowledged standards.
Connectivity in Insulin Pumps: Concerns & ChallengesToday, when most customers want to control their insulin pumps via their smartphones or smartwatches, developers are working on providing Bluetooth connectivity and phone access to their products. While perfectly in line with the development of other products in the IoT world, getting an insulin pump wirelessly connected with the other elements of the system opens up new potential vulnerabilities and security concerns.
An unauthorized third-party can interfere with pump communication, which can result in changing wireless pump commands, generating new ones, or denying communication with the pump device.
To get a connected diabetes device certified and the whole system properly protected, address wearable software development companies with a vast portfolio of project in the healthtech industry.
Infrastructure Cost BreakdownThe back-end part of the connected insulin part solution will consume no less than 2,000 hours of the development team work. That is, developing the cloud-based server part will cost no less than $60,000. It is a very rough number, greatly influenced by such factors as:
- Compliance with security standards. Within a connected insulin pump system, mere ciphering and hashing are not enough, and developers need to follow the security requirements set by the area where a device will be used.
- Integration with third-party solutions and APIs. They typically integrate an insulin pump with an advanced analytics system, visualization tools, and role-access platforms, where clinicians and researchers can make use of the obtained data. And while integrating with systems via public APIs would give developers more freedom in system’s settings, integration with ready-made products can result in longer development hours due to less integration flexibility.
Smartphone as a Controlling Center of the Connected Pump SystemIn the case of connected insulin pumps, a mobile app can serve multiple purposes:
- Controlling the pump.
- Remote monitoring, presenting obtained glucose level data in a form of customized graphs and reports.
- Text notifications and sound alerts, once any alteration is detected.
- Emergency call for a clinician.
Today’s mobile app for a connected insulin pump would not just provide real-time sensor glucose reading with high and low limits. It will indicate sensor life, reservoir volume, pump battery, system connectivity – that is, interconnect with every element of the insulin pump ecosystem.