6 steps to release a medical IoT device

Once a device has measured the patient’s vitals, it can alert the doctor or healthcare team as well as the patient. This makes it easier to identify events or changes in the patient’s condition that require attention. This approach extends medical monitoring outside the hospital, making it easier to manage chronic diseases.

Smart medical IoT devices are primarily used to track medical issues, but they can also be used to administer medications and support rehabilitation measures. They are also useful for preventing health issues in high-risk individuals. By integrating these devices into a larger health system, medical professionals can instantly leverage data from multiple devices.

6 key steps to release a medical IoT device

Here’s an overview of the process of approving an IoMT device for release to the market.

1. Market research

Market research is essential for identifying the level of demand for the IoT solution, providing the justification for investing in the development of a medical IoT project. One way to assess the potential success of a device is to compare it to the offerings of competitors. If the device is unique or offers improved functionality over the existing competition, it has a good chance of being profitable.

Another important consideration is the potential size of the market for a specific device. If the product is too niche, the return on investment might be too low, especially if the market is already saturated with similar products. Factors such as convenience and cultural acceptance can also be useful to consider.

The findings of the market research phase should be summarized in a report that helps stakeholders understand the market dynamics surrounding the project. This includes an overview of the existing market, the potential target market, the research literature related to the relevant medical condition, and any alternative approaches to treatment.

2. Regulatory planning

Once there is a working concept, it’s important to incorporate compliance with regulations into the business plan. Obtaining regulatory approval can be time-consuming, delaying the product’s release to market. Preparing in advance by understanding the relevant laws and regulations can help save time.

For example, to achieve regulatory compliance in the European Union, it’s necessary to understand the European Medical Device Regulation (EU MDR, 2017/745) and the European In Vitro Diagnostics Regulation (EU IVDR, 2017/746). If the target market is in the US, the device creator must be familiar with the Medical Device Regulation 21 (CFR Part 800) from the US Food and Drug Administration (FDA).

This stage involves defining the intended use for the proposed device, including its purpose and the target population. The definitions must be carefully thought out to ensure accuracy and avoid issues with legally charged terms such as “diagnostic,” which will be used to assess the device’s efficacy and compliance. The definition also informs the device classification, which takes into account the risk-level, function, and invasiveness of the product.

3. Design controls

The device development process should incorporate design controls to ensure the quality of the product. It’s important to document these controls throughout development and ensure the documentation is complete and accurate.

Standards like the ISO 13485 require design controls to be traceable, with all design changes documented. Using a traceability matrix allows auditors to review the device and its development process.

The design controls should cover the planning and review phases, changes to the design, and the validation process. The documentation should consider the user’s needs and outline the history of the device’s design.

4. Quality Management System (QMS)

The QMS must be tailored to the device creator and comply with the relevant regulations. For example, a small company might only require a minimal QMS system, while a larger company would need a system that can handle a more complex manufacturing process and distribution chain.

The quality management system should address design controls, document management, risk assessment and management, and supply chain management. Additional considerations include post-release surveillance and procedures to prevent and fix issues with the device, including how to address feedback and complaints.

The QMS should reflect the relevant standards based on the intended market for the IoMT device. For example, a globally marketed product would need to comply with ISO 13485, while compliance with 21 CFR Part 820 is enough for products sold exclusively within the US.

5. Clinical evaluation

Clinical evaluation is an essential part of the product’s technical documentation because it demonstrates the safety and efficacy of the device. This report provides a summary of all the evidence obtained during clinical trials, showing the risks and benefits of the device.

There are different processes for clinical evaluation depending on the phase of development. Clinical and preclinical tests are the main sources informing the evaluation before the device is released to the market. In some cases, clinical trials might not be necessary or available, in which case the main source for evaluation would be the scientific literature.

6. Postmarket surveillance

Device manufacturers must continue to monitor the performance of medical products after their release to the market. This is typically a requirement of the regulations on medical devices. The objective is to ensure that the device remains safe and effective in the long term, and to identify issues that may not have been evident in the testing and development phases.

Medical device designers in the US can use the FDA’s MedWatch portal to submit risk reports and track the performance of devices. The FDA conducts postmarket surveillance independently, but it also requires manufacturers to surveille Class II and Class III devices. These devices are classified as those that pose a potential health risk if they fail, are used on children, are long-term implants, or are intended for use outside of a medical facility.

The European requirements for postmarket clinical followup are more stringent than in the US and apply to all medical devices, including those classified as low-risk. These requirements are governed by the EU MDR. Refer to this detailed blog post for more background on postmarket surveillance.

How edge computing benefits medical IoT devices

Edge computing is especially useful for medical IoT devices because it decentralizes the processing of data. It enables data to be analyzed at various physical locations, close to the source that generated it, whether this is the IoT device or a local network. This is more efficient than sending the data from geographically distributed devices to a centralized system, which can delay analysis.

When it comes to healthcare applications, the closer the data processing occurs, the faster the analysis results can be accessed to make decisions related to patient care. For example, a patient can wear a health monitoring device and receive instant alerts thanks to edge computing.

This speed is essential for emergency medical situations where time is critical in reducing the negative impacts. For example, if an elderly patient falls, or a diabetic experiences a spike in blood glucose, having immediate alerts allows the patient to receive treatment on time.

Another advantage of processing data at the edge is that it reduces the system’s reliance on Internet connectivity. This means that if there is an outage, or a patient is in a remote location with limited connectivity, the IoT device will still function.

Technical Considerations for Edge Computing Integration

Designers and manufacturers of IoMT devices need to carefully consider several key elements when integrating edge computing into their products.

Firstly, the hardware requirements of the device must be capable of processing data locally, which necessitates sufficient computing power. To support edge computing, the device might require a more powerful processor along with greater storage and memory than a standard IoT device. Other important considerations include ensuring robust connectivity and maintaining adequate battery life.

Data security and privacy are paramount. The device must be equipped to protect patient privacy and prevent unauthorized access to sensitive healthcare information. While edge computing reduces exposure to the Internet by processing data locally, it still necessitates strong access control and encryption measures to guard against device hacking.

Despite edge computing’s reduced reliance on continuous Internet connectivity, IoMT devices still require an Internet connection to function effectively. These devices must handle intermittent connectivity and outages because they need to communicate with a central system eventually. This communication is crucial for synchronizing data and enabling deeper analysis.

Interoperability is another critical factor. IoMT devices must integrate seamlessly with other devices and medical systems. In some instances, a device should support multiple systems, offering users flexibility in choosing the software for analyzing health data and sending alerts. Adopting a standard data format and communication protocol can enhance interoperability, ensuring that data is shareable across different healthcare platforms.

Lastly, data processing speed is vital. The response time for healthcare monitoring and analysis often impacts life-saving decisions. Therefore, medical IoT devices should use a real-time operating system (RTOS) with algorithms optimized for fast processing to ensure timely and accurate responses.

Final thought

The Internet of Medical Things is an exciting and fast-growing field in healthcare. New devices are constantly emerging to provide more personalized and detailed medical treatment outside the hospital. In addition to improving outcomes for patients, these devices have the potential to be highly profitable and make it easier for healthcare professionals to monitor medical conditions and implement treatments.

However, the process of developing and releasing an IoMT device is long and complex, as it is necessary to obtain the approval of authorities like the FDA and comply with medical and data privacy regulations. Edge computing can help make devices more efficient and resilient by processing health data locally. It can also make it easier to ensure that devices comply with IoMT regulations.

About the author

Gilad David Maayan is a technology writer who has worked with over 150 technology companies including SAP, Imperva, Samsung NEXT, NetApp and Check Point, producing technical and thought leadership content that elucidates technical solutions for developers and IT leadership. Today he heads Agile SEO, the leading marketing agency in the technology industry.

Article Topics

data  |  edge computing  |  IoMT  |  IoT  |  medical IoT devices