Step-by-Step Guide to Developing IoT Wearable Healthcare Devices

Healthcare wearable IoT development aims to address new global healthcare challenges. For instance, the triumph of medical advancements in vaccination, antibiotics, and surgical tools has led to an increased lifespan. Therefore, the healthcare industry faces a new array of challenges brought by an aging population. Logically, more technological advancements, especially in IoT wearable devices, can help support people with increased longevity.  

As an example, an aging population means a higher demand for caregivers. This is where IoT medical devices can step in and provide high-quality reliable monitoring. It is more cost-efficient than manual monitoring and deals with a shortage of medical personnel.

A few other healthcare challenges where IoT wearable healthcare devices can be a game-changer are:

• Increasing spread of chronic conditions and illnesses; 
• The growing importance of preventative health;
• Health issues brought on by climate change, e.g. heat stress in the workplace.   

Resorting to traditional medicine driven largely by manual labor is not sufficient. The superiority of healthcare IoT development lies in its ability to generate enough precise data for early diagnostics, disease prevention, and as a part of a healing process. Most importantly, healthcare wearable IoT development helps to deliver cost-efficient and scalable care in comparison with traditional healthcare.

Data fact: According to NIH, each extra day of heat in the summer increases the risk of death by .07 per 100,00 adults. This translates into 1,373 extra deaths annually which are preventable. Wouldn’t it be reasonable to have an employee wear an IoT device that can monitor body and environment indications for early signs of heat stress? In terms of custom healthcare app development, it can be a B2B solution for an employer rather than individual use. Read on for steps to implement wearable IoT development.

Step 1 Conceptualizing your wearable device in healthcare wearable IoT development

The first step is making sure your device addresses a particular use case. There is a growing number of devices that are disrupting the healthcare landscape already. They are: 

• Continuous glucose monitors for people with diabetes;
• Wearable defibrillator for patients at risk of sudden cardiac death;
• Wearable concussion protection neck device for athletes and people involved in combat;
• EMG sensors for patients after stroke or undergoing rehabilitation with prosthetics;

And also, there are devices for monitoring adherence to prescribed medication, depression monitoring, and an ambitious field of smart contact lenses. All in all, the uses of medical wearable IoT development show signs of both: expanding domains and narrowing expertise. This makes healthcare wearable IoT development a profitable avenue with great possibilities of making a difference. 

Case-in-point: healthcare wearable IoT development with Continuous Glucose Monitors (CGMs)

Traditionally, CGM’s primary target audience is people with diabetes. In the US, 11.3% of the entire population is diagnosed with diabetes which is 38.4 million people. In addition, 3.4% of the US population is undiagnosed but meets clinical requirements for diabetes. This is 11.55 million people more affected by diabetes. With such a growing and spreading problem, the CGMs as a wearable IoT solution comes as an effective and accessible solution. They can be employed to provide better health management, improved quality of life, and empowerment to control this condition. 

Moreover, there have been trends in the use of CGMs for people without diabetes. It is said that adjusting blood sugar levels  and their fluctuations primarily can improve:

• quality of sleep, 
• mood, 
• ability to focus, and 
• energy levels among other things. 

These are all sought-after benefits when it comes to the use case of wellness and preventative health. 

Of course, the wider use of CGMs is not without its controversy. For instance, Harvard Health Publishing posted their review that there is no evidence to suggest positive tangible effects of CGMs for healthy people. However, Harvard Medical does have a stained credibility. Their researchers were paid to downplay the risks of sugary foods by the sugar industry. 

Lastly, there are other conditions that CGMs can track such as prediabetes, low blood sugar, and other metabolic disorders. For instance, CGMs for detecting prediabetes might seem like an extra expense. However, they make the onset of Type 2 diabetes preventable and reversible with simple lifestyle changes. Looking at the economic costs of Type 2 diabetes, these are staggering 412.9 billion US dollars in 2022. It makes a strong case for the use of CGMs for every use case of Custom IoT Development. 

Use Cases and Target User of healthcare wearable IoT development

Overall, there are four major use cases for healthcare IoT development:

• Chronic disease management;
• Wellness and preventative health;
• Rehabilitation support;
• Remote patient monitoring.

Within those, you can target the following groups of users:

• individual users, 
• medical institutions, or 
• solving a narrower problem like with athletes or heat stress for workers. 

For this purpose, it is advisable to employ methods of lean project discovery. You can read more about it in Lean Project Discovery Phase: Definition, Process, Benefits

Market Trends and Unmet Needs

Whatever use case and target user you choose, manufacturing IoT devices requires reliable data for forecasting in most cases. If you’re developing IoT solutions for hospital use, you’ll need to research:

• Hospital sizes and capacities;
• Frequencies of procedures for the target use case;
• Consider adoption rates by hospitals and hospital spending patterns;
• Lifespan of your IoT device;
• Other relevant data.

Bear in mind that these estimates are likely to change after pilot programs. 

Case-in-point: research for IoT devices for nursing homes

For example, here is a case study where wearable IoT development attempted to address the issue of the ageing population and the emerging need for patient monitoring in nursing homes. The traditional approach involves a nurse checking the vitals of 10 patients at a cost of 3,000 euros per month in Europe. Accordingly, the more patients a nursing home has, the more nurses are required. This presents a problem of limited scalability. To replace one nurse, a set of sensors will come at a price of 1,000 euros, and their lifespan is set at 36 months due to battery specifications. As we can see from the chart, this solution cannot only be easily scaled but also provide immense operational savings. 

Let’s take France and assume there are potentially 7,500 nursing homes for the older population. Then, the research within your healthcare IoT development must focus on their technological readiness, budget availability, and government programs that could sponsor these initiatives. 

Additionally, moving on to health benefits, connecting the sensors to Machine Learning algorithms allows for improved health outcomes. In healthcare IoT development, ML can detect patterns to aid early diagnosis and more precise disease detection. The study underscores the presence of human clinicians for ultimate diagnostics. However, the point of the study is to emphasize the focus of market research for IoT wearable devices for hospital use. 

When it comes to IoT devices for personal use, the focus is rather on aligning with user lifestyle, demographics, trends in terms of health goals, and competitors.

Step 2 Hardware Selection for healthcare wearable IoT development

After conceptualizing your wearable IoT device, selecting the right hardware is the next step in healthcare IoT development. In most cases, hardware will be the major cost factor and also a determinant of your product’s performance and functionality. Therefore, this step is crucial to get right.

Research done during the previous step must already indicate the requirements for your hardware:

• Is it for personal wellness use or for hospital use?
• What metrics should it track? What is the required functionality?
• Are there requirements for data transmission and power consumption?
• What are budgetary constraints?

Devices for personal use put certain characteristics as a priority. For instance, stylish looks, lightweight, and compact are central to this kind of healthcare IoT development. After all, it is likely to be for everyday use. The device must fit into a user’s lifestyle and look aesthetically pleasing.  

In contrast, an IoT healthcare device for hospital use must be much sturdier. The device should factor in extensive use, sterilization procedures, and rigorous use. Appearances are likely to be not even on the list of priorities. However, compliance with the regulation will certainly be another top consideration. 

With all that in mind, there are two major paths to take for selecting hardware. They are pre-made sensors and custom manufacturing. Both options have their advantages and disadvantages. 

Power consumption and data transmission

Power consumption and data transmission protocols and range are often the major considerations in healthcare IoT development regardless of the use case. Below are the results of the study of existing devices and their power consumption. And right after the bar chart, there are specifications for the studied wearable devices, the sensors that go into them, and communication protocols.

As a result of this study, researchers have developed a chart of communication protocols in terms of range to data rate & power consumption and also reflecting the cost. The research data for wearables was relevant for the years 2020-2021.  

Additionally, with every manufacturer or supplier, you have to conduct a check on their track record. Will they be a strong partner? What about transparency? Do they provide technical support and so on?

Pre-made sensors

If your wearable IoT development relies on pre-made hardware, you will benefit from:

• Cheaper components;
• Hardware testing has already been completed;
• Quick to assemble and deploy.

However, there are certain limitations to the use of these devices:

• They might not meet the exact functional requirements;
• They might end up not as stylish or compact as desired;
• Even though they have been tested, it still might not be enough for compliance with medical regulations if it is for hospital use.

Custom sensors

This option comes after considering available pre-made hardware. If the existing solutions are not able to meet the required specs, you must get into developing custom hardware. This option is substantially more costly. After all, you need to start from scratch: designing, prototyping, testing, materials sourcing, setting up manufacturing, and so on. But, with this option, you can develop a unique product and get it just right for your target user. With this option, you’ll get the precision and flexibility to meet the market needs and unique demands of the users.

Step 3 Software Integration

Depending on the intended use defined in the device conceptualization, the software requirements will be extremely different. For a personal use device, software must prioritize:

• Real-time monitoring;

• Intuitive interface;
• Dashboards with the selected data;
• Engagement features to encourage the daily use;
• Personalization features to deliver actionable advice.

As such, the healthcare wearable IoT development in this case is more focused on usability and engagement. 

The healthcare wearable IoT development for hospital use is drastically different. It prioritizes:

• Compliance with regulations;
• Accuracy of data display;
• Data accessibility with no distractions;
• Multi-user access and integration with patient records;
• Requires rigorous testing as there is zero tolerance for errors.

Consequently, in software for hospital use, appearances and any sort of personalization are secondary considerations if even mentioned. 

Wearable IoT development of software for personal use devices is likely to be quite fast and driven by user feedback. In contrast, healthcare wearable IoT development of software for personal use should undergo rigorous testing and validation, and meet regulatory requirements for security, reliability, and accuracy.  

Step 4 Data Security and Compliance

Let’s examine the case of CGMs – continuous glucose monitors. You can conceptualize CGMs for medical purposes and for personal use. So your CGMs can be marketed as a therapeutic tool vs a wellness tool. Depending on that, it may or may not require FDA approval. The regulations are changing, but FDA approval is mainly needed for FSA/HSA eligibility. The latter allows patients to save money by referring CGMs to their medical expenses. 

At present, consumer devices without FDA approval dominate the market of wearable healthcare devices. This is not a surprise as of 2024, the FDA has approved only 950 medical devices that use AI and ML. However, the situation has been considerably improving with FDA approvals as shown in the figure below. 

As such, although non-FDA-approved wearable devices take up the largest revenue share of 77% in 2024, for FDA-approved wearables the Compound Annual Growth Rate (CAGR) is forecasted to skyrocket.

Final Words

These are general considerations regarding healthcare wearable IoT development. Within the outlined steps there are some more intricacies that must be accounted for. A successful wearable IoT development depends on a strong commitment to a few areas. For instance, getting a medical professional on board or a person with a medical background is vital. This will ensure that your healthcare IoT development aligns with clinical realities and that all research efforts are on point. User interviews are often essential to learn about the pains, concerns, and hurdles in using wearable IoT devices. Moreover, you always have to stay focused on ensuring tangible health benefits. After all, products that genuinely help people are the only way to make a meaningful impact. 

FAQ: IoT Wearable Healthcare Device Development