Wearable Medical Devices: Challenges in Design

By Software & Firmware Teams @ CLEIO

IoMT (Internet of Medical Things) devices are revolutionizing the MedTech industry. With their advanced technology and connectivity, they are transforming how we approach our health and well-being.

In this category of medical devices we find wearables. These small electronic objects, worn on the body like a bracelet or clothing, collect, process, and transmit data in real-time. Once analyzed, the data can give important information about the user’s overall health.

While they are not a substitute for a doctor, they are a valuable tool in health monitoring, prevention and disease detection.
So, what are the challenges in designing IoMT devices to ensure their effectiveness in healthcare?

User Experience

A user-centered design is crucial for the wearability, safety and adoption of these devices. A device that is user-friendly is more likely to be embraced by patients and healthcare professionals.

Here are a few points to keep in mind:

Accessibility and Ease of Use

An intuitive, accessible design is likely to be more widely adopted. If the device is difficult to use, it won’t be worn regularly. As a result, its effectiveness could be significantly reduced. Conducting tests in real-world context to comprehend and integrate feedback from targeted users is crucial.

Comfort and Portability

A comfortable, discreet device that doesn’t interfere with daily activities encourages continuous use, which is vital for real-time health monitoring.
Developing a test protocol that allows the user some time to adapt to the new device helps prevent biases which might initially lead people to think it is disruptive or uncomfortable.

Personalization and Adaptability

Effective customization enhances user engagement. Thus, it’s important to tailor the device to meet the unique needs of various users, offering them options to personalize features and alerts.


The aesthetic appeal of a product can aid its adoption. Sometimes it’s necessary to change its narrative, or its appearance, to prevent user stigma. For instance, designing a medical device to look like jewelry can significantly enhance the chances of it being worn continuously.


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Health Data Processing and Analysis

The data collected by IoMT devices is sensitive and is linked directly to patient health, requiring appropriate processing to have a positive impact on it.
Here are three key points to consider:

Data Accuracy and Reliability

Inaccurate or misunderstood data can lead to incorrect diagnoses or treatment. For this reason, the collected health data must be precise, clear and reliable for safe medical use.

Likewise, real-time data analysis is vital to ensure timely triggering of alerts if the patient’s health status suddenly worsens.

Data Integration with Healthcare Systems

Smooth integration of data with electronic medical records is crucial to provide a comprehensive view of patient health.
In many cases, data is integrated with the patient’s electronic medical record, giving healthcare professionals a comprehensive view of the patient’s overall health status. It’s vital to ensure this data integration is flawless to prevent the loss of critical information and to guarantee effective care. Given the volume of data gathered by healthcare professionals through various channels, the importance of this cannot be overstated.

Health Data Confidentiality

To maintain user trust in wearable devices, transparency is key. Users feel more comfortable knowing what data is collected, how it’s used, and who it’s shared with. Being fully informed, they are more inclined to give their consent for its use.
Furthermore, strict regulations exist such as the RGPD (General Data Protection Regulation) in Europe and the HIPAA (Health Insurance Portability and Accountability Act) in the United States. Non-compliance with these regulations can lead to significant penalties.


Since it gathers confidential health data, a wearable medical device must be impeccable in its cybersecurity measures. Mitigating intrusion risks is crucial to prevent the severe repercussions that could result from a data breach affecting patients.
Key challenges to consider in ensuring the confidentiality of personal data include:

Authentication and Authorization

IoMT devices are susceptible to targeted attacks that could disrupt their function or expose patients’ personal data. Therefore, it’s important to restrict data access exclusively to authorized users, employing a strong authentication system.

Data Transmission Security

In order to be used, the collected data must be transmitted to servers or applications over the Internet or Bluetooth. Securing the transmission of personal data is essential to prevent interception. Data encryption ensures its confidentiality in case it is falling into the hands of unauthorized parties.

Security Updates and Maintenance

Failing to regularly update an IoMT device can leave it vulnerable to cyberattacks. Consistent updates are essential to address and rectify potential security vulnerabilities.

Exposure to Electromagnetic Waves

Like all electronic devices, wearable devices emit electromagnetic waves. This leads to questions about their potential effects on both the health and the safety of users, and about the operation of other devices in the same environment.

Minimizing Long-Term Health Effects

Wearable devices use wireless technologies such as Bluetooth or WiFi for data transmission. Consequently, a patient wearing such a device continuously is constantly exposed to electromagnetic waves.
Concerns over long-term health effects are valid. Therefore, it’s important for manufacturers to minimize exposure to these waves as much as possible, while still maintaining the device’s operation.

Standards to Prevent Interference

The design of electromedical devices is regulated by strict standards, which are more stringent than those in other sectors. An example is IEC 60601, which sets limits on electromagnetic emissions for manufacturers.
Specifically, it seeks to ensure that, in a clinical environment, the functioning of these devices is not disrupted by electromagnetic waves, and that they do not emit waves that could impact the operation of other equipment. Ultimately, this is a matter of ensuring patient safety.

Wearable medical devices are more than just a trend: they represent the future of preventive and personalized medicine. By focusing on all these aspects, we can gain the trust of patients and healthcare professionals, thereby ensuring the long-term success of these devices.

At CLEIO, we’re actively contributing to this revolution, applying our design and engineering expertise to these innovative solutions that are propelling healthcare forward.

Author & collaborators

Written by
Software & Firmware Teams @ CLEIO

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