The emergence of Internet of Things (IoT) devices is arguably one of the most impactful events of the 21st century. It has propelled monstrous growth in both high-tech industries and the use of data analytics. For years now, the presence of IoT devices has become embedded in people’s everyday lives, with applications ranging from retail and transportation to manufacturing and healthcare. When it comes to IoT design for the healthcare and medical industries, strict regulatory hurdles must be cleared and required certifications must be obtained before a new device can be introduced into the market. These restrictions may tempt designers to follow the path of least resistance, which can lead to shortsighted and faulty designs. Therefore, it’s important to consider a variety of factors when designing IoT medical devices.
What is the Internet of Things?
Before elaborating on the factors to consider when designing IoT medical devices, it helps to review what exactly is the Internet of Things. IoT refers to equipment, machinery, products, and devices that collect and exchange data with one another via the internet without the need for human interference. This allows for immediate information transfer that can be used to optimize processes and reduce costs. For example, in the medical field, heart rate monitors embedded into smartwatches or standalone glucose monitors transmit health data to software that doctors and/or patients can use to view the data. This enables them to make appropriate adjustments to treatment plans to ensure optimal health.
Design considerations for IoT medical devices
IoT solutions consist of physical devices (like sensors and actuators) to collect data, networks to exchange data, and software to analyze data. These components work together to create meaningful user experiences. The presence of multiple physical and digital components can present unique challenges when designing IoT systems. Many designers are accustomed to designing systems for industrial or practical purposes. However, special attention must also be paid to user experience (UX) and user interface (UI) design when designing IoT solutions. This can add special challenges, but if designers consider the following five factors, IoT design for medical devices can be a less arduous process from start to finish.
- Focus on the big picture
Successful IoT solutions require multiple devices and software to work together to deliver valuable information. It is important to take a systems approach and consider the scope of the application being fulfilled. Focusing only on components can lead to great components that can't work together as a system. A systems approach is crucial for the success of medical IoT devices. Components must be designed to work seamlessly with each other. By considering the entire scope of the IoT solution, a designer cannot only ensure that the system functions as intended, but also that the UX and UI features work effectively for the end-user.
- Concentrate on value
Since the rapid adoption of IoT systems into the medical industry, users have been collecting and using data to improve their organizations’ processes and patient treatment plans and outcomes. With so many IoT solutions out in the market today, it’s important to dig deep into user needs and expectations to make a product people want to purchase. Successful new medical IoT solutions can be created by concentrating on the value a solution can offer and understanding the challenges that a majority of users currently face with their processes or treatments.
- Reusable versus single-use
When designing any medical device or instrument, designers must consider whether their product will be reusable or single-use only. It’s no different when designing medical IoT solutions. Depending on their expected use, medical devices must satisfy stringent regulations to ensure that they stay functional during use and can withstand rigorous cleaning and sanitation. Reusable devices are held to higher standards due to repeated cleaning and prolonged exposure to the environment. While single-use devices can provide significant savings when it comes to development and unit costs, designers must still develop solutions that adhere to medical standards and requirements.
- Required software and security
IoT medical devices measure and record patient health data. When such information is stored and exchanged via the internet, it is subject to the standards outlined in the Health Insurance Portability and Accountability Act, or HIPAA. Data security must be built into a medical IoT device from the start, as it is much harder to alter a design to add security features once it is further along in the design process. IoT medical devices are designed such that their connection to the internet is secure and the data they transmit and store are safe.
A good rule of thumb to follow is that patient information collected by IoT devices should be stripped of personal information before being transmitted to the appropriate doctors and nurses. For example, John Smith’s glucose levels as measured by an IoT monitoring device are transmitted to the doctor, but John is only referred to as “Patient 1234” to ensure confidentiality. Not doing so can be a huge liability risk for hospitals and manufacturers, so it’s important to consider device security from the start of the design process.
- Certification requirements
To ensure the health and safety of patients, the United States Food and Drug Administration (FDA) uses Ingress Protection (IP) ratings and classification terminology to distinguish between different medical devices. Certification tests for medical devices include testing for sensitivity to shock and vibration, as well as testing the device’s durability. IP ratings are used to establish the level of protection an electronic device has against foreign debris and liquids. Classifications for medical devices are used to describe the levels of control needed to ensure the safety and effectiveness of the device. Three classes (I, II, and III) are used - the higher the class, the stricter the safety standards for the device. Before medical products are released to the market, the FDA assigns a classification to a device based on the potential risk it poses to the user based on the device’s intended use. For example, a scalpel used during surgery would face stricter regulation than a wearable heart-rate monitor.
Additionally, medical devices must fulfill a host of other certification requirements. For example, IoT devices that plug into a wall must utilize a power supply certified for medical use and may even require a battery backup. Therefore, it’s important to consider IP ratings and FDA medical device classifications, as well as any other medical device certifications, when designing medical IoT solutions.
Final thoughts
IoT solutions are the future of healthcare, so it’s important to consider these five factors when designing IoT medical devices to guarantee proper function and a high-quality user experience. Design of IoT medical devices can be difficult, but by paying attention to each component and considering the function of each within the entire system, rest assured the developed solution will be the best. Contact an ACHB representative today to discuss how we can assist with your IoT medical device needs.
