Cloud connectivity is set to become a core feature of all Medtech devices. Technological advancements have led to innovative medical devices for diagnosing, tracking, and managing patient conditions. Due to these advancements, modern medical devices have become smaller, more portable, and widely accessible. Manufacturers must adapt swiftly to these changes to stay competitive, increase market penetration, and avoid falling behind.
According to a recent study, the global healthcare cloud computing market is set to expand from USD 39.4 billion in 2022 to USD 89.4 billion by 2027, with a compound annual growth rate (CAGR) of 17.8%. This growth is fueled by increased demand for enhanced patient care, improved efficiency, cost savings, and the rising need for telehealth, wearables, and remote monitoring services.
The medical device industry is continually influenced by changing guidelines and regulatory requirements. Recently, there have been significant updates in the AAMI guidance on cloud change control, also known as TIR15 and the new FDA cybersecurity guidance. These updates are crucial for organizations creating medical devices and developing and managing cloud technology systems.
As advancements in cloud connectivity transform the medical device industry, staying ahead of regulatory changes and best practices is crucial. In this blog, we will provide actionable insights on leveraging these updates to enhance your cloud-powered medical devices. We’ll dive into the practical benefits of cloud-connected design, compliance strategies, and effective mechanisms to help one make strategic decisions and ensure regulatory adherence to your products and business strategy.
Before discussing cloud-powered medical devices in detail, it is essential to understand how they differ from connected devices.
Connected Medical Devices: These devices primarily focus on securely transmitting patient and device data to third-party systems, such as remote patient monitoring tools or electronic health records (EHRs). In this setup, the cloud plays a role in secure data storage and transfer.
Cloud-Powered Medical Devices: These devices integrate the cloud more deeply and can be categorized into two layers.
By leveraging the cloud, medical devices can offload significant processing and data management tasks, allowing the physical device to focus on patient interaction and therapeutic functions. The cloud handles device activation, authentication, data storage and analysis, device management, and collaboration with ecosystem players. It also supports integration with EHRs, EDCs, QMSs, and more.
Integrating cloud technology into medical devices offers many benefits, including cost optimization, enhanced functionality, and an innovative business model. Here, we'll explore some benefits and provide supporting examples of how cloud-powered devices can transform the medical industry.
1. Cost Optimization and Offloading Capabilities
One key advantage of cloud-powered medical devices is cost efficiency. Devices can be simplified by offloading processing and data management tasks to the cloud, reducing hardware costs and operational expenses. Let's look at some examples.
Neteera: The company developed a radar-based sensor that monitors vital signs like heart and respiration rates. Instead of performing complex algorithms on the device, Neteera sends raw data to the cloud, where these computations are performed. This approach not only lowers the cost of the device but also makes it easier to manage and upgrade. Additional features and capabilities can be added by updating the algorithms in the cloud rather than redesigning the hardware.
[Also read: How Neteera Deployed its Proprietary AI on BioT’s Distributed Medical Device Platform to Improve Patient Care]
Zilia: Zilia is a health technology company based in Canada. It is famous for developing a breakthrough platform to measure biomarkers in the eye and specializes in retinal image analysis. Since medical images can be large and complex, Zilia offloads the heavy processing tasks to the cloud, utilizing GPUs from providers like Nvidia. This strategy reduces costs associated with high-performance on-device computing and simplifies device development and maintenance.
2. Innovative Business Models
Cloud technology also enables new business models to generate additional revenue streams and offer flexible pricing options.
BloomLife: This award-winning women’s health company based in the U.S. developed a pregnancy monitoring system for high-risk pregnancies. Their approach involves utilizing remote patient monitoring CPT codes and implementing a revenue model that partners with clinics. By enabling clinics to monitor their patients remotely, Bloomlife supports better patient care and introduces an additional revenue stream for these clinics.
Sofwave: This company, specializing in dermatology devices, transitioned from a traditional capital equipment sales model to a more flexible subscription-based approach. They introduced a website where customers can purchase device pulses in quantities such as 5,000 or 10,000. These pulses are then loaded into the device through an online purchasing process. By shifting from a one-time capital expense to a subscription or package model, Sofwave has created a new revenue stream and offered customers a more adaptable payment option. This model improves cash flow and aligns with contemporary consumer preferences for flexible purchasing.
3. Better Patient Outcomes
Cloud-powered devices can significantly impact patient care by enabling more personalized and effective treatments through data analysis.
Theranica Nerivio: Offers a migraine therapy and neuromodulation treatment that leverages cloud technology to enhance patient care. Through the cloud, Nerivio engages with patients by collecting feedback on their experiences before and after treatment. This data collection has led to the creation of one of the largest migraine databases globally, providing deep insights into the causes and patterns of migraines. By analyzing this extensive dataset, Nerivio can introduce new, tailored features and capabilities, optimize treatments for individual patients, and significantly improve patient outcomes. This example highlights how cloud-based data sharing and analysis can drive advancements in personalized medicine and treatment efficacy.
[Recommended reading: How Theranica Leveraged Connectivity to Harness Big Data to Build the World’s Largest Migraine Registry]
These examples illustrate how cloud integration can transform medical devices' operational and business aspects and improve patient care. Leveraging cloud data enables innovative business models, such as subscription services and flexible purchasing options, and enhances patient care through personalized treatment and real-time feedback.
Cloud integration offers many possibilities. Balancing connectivity with a device's core functions is crucial, but it's also important to consider how these advancements impact the device's platform, hardware, and software architecture. Medical device manufacturers can create devices that leverage cloud benefits and deliver reliable, high-performance solutions by considering the following.
1. Balancing Simplicity and Functionality: Start with a minimum viable product (MVP)
Simplicity is key when designing medical devices, especially those with cloud capabilities. Starting with a minimum viable product (MVP) allows focusing on core functionalities while keeping the design manageable. The architecture should be adaptable, allowing for future expansions.
Decide what data processing should occur on the device versus in the cloud. On-device processing can simplify connectivity requirements and enhance performance, particularly when offline. Cloud processing can handle complex algorithms and larger datasets, but it adds complexity and potential latency.
2. Processing and Connectivity Decisions
Historically, all processing was done on the device to maintain simplicity and minimize device connectivity requirements. For mobile or portable devices, such as those not always connected to power or Wi-Fi, performing data compression and initial processing locally before sending summarized data to the cloud can be advantageous. This approach ensures quick responses and reduces reliance on constant connectivity, critical in clinical settings where delays can impact patient care.
3. User Experience and Data Management
Actionable and timely information is critical for clinicians. Medical device connectivity should enhance its functionality without overwhelming users with unnecessary data. The goal is to streamline user interfaces and minimize alert fatigue by communicating only essential data. While it enables real-time monitoring, remote diagnostics, and advanced analytics, it also adds layers of complexity. This includes handling various types of connectivity like Bluetooth, Wi-Fi, and cellular, each with its trade-offs in terms of power consumption and configuration needs. Balancing these factors is crucial, especially for battery-operated devices, where connectivity is often the largest power drain.
4. Battery Life and Connectivity
When designing connected medical devices, especially those that are portable or implantable, striking the right balance between battery life and connectivity options is paramount. Wi-Fi offers a cost-effective solution suitable for environments with stable access but demands initial configuration and isn't always reliable for mobile scenarios. Cellular connectivity provides broader coverage and a simpler setup, making it ideal for devices operating in diverse locations without consistent Wi-Fi; however, it incurs ongoing subscription costs and can be power-intensive.
Bluetooth Low Energy (BLE) emerges as an energy-efficient alternative, leveraging a mobile phone as a gateway. This approach reduces the need for dedicated hardware and cuts costs, though it requires initial setup and stable BLE connectivity. Recognizing the varying demands of these connectivity options, designing devices capable of both connected and offline modes becomes essential. Such devices can continue to function and collect data even when intermittent connectivity exists, efficiently synchronizing information once a stable connection is re-established. This strategy not only conserves battery life by minimizing reliance on power-hungry connectivity options but also ensures reliable performance across different usage scenarios.
6. Design for Future Adaptability
Design your architecture with adaptability in mind. While starting with an MVP is practical, plan for scalability to accommodate future features and changing requirements. Ensure that the system can evolve without requiring a complete redesign. Keep the end goals in sight when making architectural decisions. Building a scalable and adaptable system from the beginning can prevent costly redesigns and facilitate smoother growth as new needs arise.
7. Monitoring and Compliance
Connected devices can improve compliance monitoring and data collection. They can utilize connectivity to track device usage and patient interactions, aiding clinical and usability studies. Devices must be designed to protect sensitive patient data and comply with regulatory standards. Initial skepticism about cloud integration due to security concerns is common, but addressing these concerns through robust encryption and security practices can mitigate risks.
Adhering to the following key considerations can help medical device manufacturers ensure compliance with FDA requirements and other regulations such as ISO 27001, SOC 2, and HITRUST, maintain robust cybersecurity measures, and protect patient privacy. Leveraging cloud technology and implementing best practices in cybersecurity will facilitate the development of secure, compliant, and effective medical devices.
1. Adhere to Cybersecurity and Privacy Guidelines for Cyber Devices
To ensure compliance with FDA requirements and other regulations for cyber devices, it is essential to understand what a cyber device is. According to the latest FDA guidance, a cyber device is any device that includes software or firmware with communication interfaces, such as serial or USB. These devices are considered cyber devices and must be protected. As part of your FDA submission, you must provide a plan addressing vulnerabilities and conducting threat assessments. This definition applies regardless of whether the device uses cloud services. Understanding this, the cloud becomes a significant tool for complying with regulations and effectively managing cyber devices. This involves monitoring for vulnerabilities, updating the device as needed, and ensuring proper protection measures are in place.
2. Conduct Regular Vulnerability Assessments and Management via Threat Modeling
Regular vulnerability assessments and threat modeling are critical to maintaining cybersecurity in medical devices. These processes involve identifying potential security threats, appropriate tests to uncover security gaps, and performing code scans to ensure robust protection. Threat modeling helps understand and mitigate risks, while vulnerability management ensures that identified vulnerabilities are promptly addressed and resolved.
Scalability is another essential factor—utilize the cloud’s auto-scaling capabilities to adjust your resources based on demand, ensuring cost efficiency. Implement high-availability architecture for non-critical devices; standard infrastructure should suffice for non-critical devices. Interoperability with Electronic Health Record (EHR) systems and other operational considerations also play a role in regulatory compliance, highlighting the importance of keeping the device's primary purpose and regulatory requirements in focus.
3. Perform Penetration Testing to Identify and Address Security Gaps
Penetration testing is a proactive approach to identifying security gaps within a medical device. By simulating cyber-attacks, penetration testing helps uncover weaknesses that malicious elements could exploit. Addressing these security gaps promptly ensures the device remains secure and compliant with regulatory requirements. This testing should be conducted regularly to stay ahead of potential threats.
Over-the-air (OTA) updates are essential for keeping medical devices secure and compliant. OTA updates allow for the timely application of security patches and feature enhancements, ensuring that devices remain protected against new vulnerabilities. A robust update mechanism ensures that updates can be deployed seamlessly without disrupting the device's functionality, maintaining compliance with regulatory standards.
4. Maintain Cybersecurity Measures Like Single Sign-On, Two-Way Authentication, and Firewalls
Implementing robust cybersecurity measures is crucial for protecting medical devices. This includes single sign-on for streamlined access control, two-way authentication for verifying user identities, and application firewalls for monitoring and controlling incoming and outgoing traffic. Data encryption in transit and at rest is vital to prevent unauthorized access and ensure data integrity. You need to demonstrate that your architecture is robust and meets the requirements.
5. Ensure Effective Management of SBOM to Track and Address Vulnerabilities
Vulnerabilities will inevitably arise, and it’s crucial to manage your Software Bill of Materials (SBOM) and update the plan effectively. A Software Bill of Materials (SBOM) is a critical tool for tracking and managing the software components within a medical device. It provides detailed information about the software used, enabling effective vulnerability management. Regularly updating and maintaining the SBOM ensures that any vulnerabilities in the software components are promptly identified and addressed, keeping the device secure and compliant. The cloud is an enabler in this process, allowing for continuous monitoring and rapid deployment of updates.
6. Understand Geographical Deployment Requirements
Compliance aspects vary depending on geography and the specific requirements of care providers. In Europe, ISO 27001 is often required for security compliance, while in the U.S., SOC 2 and HITRUST are standard. Additionally, the deployment location of your cloud solution matters; for instance, Amazon Web Services (AWS) has nearly 30 physical locations globally. Some countries mandate that patient information be stored within their physical boundaries. Therefore, if you operate in China, you should deploy in AWS Beijing; in the U.S., options include North Carolina and Virginia; in Europe, Ireland and Frankfurt are available.
7. Ensure Device Privacy by Using the Right Tools and Infrastructure
When addressing privacy, it is essential to consider region-specific regulations such as HIPAA in the US and GDPR in the UK. From our experience, treating a broad range of data types and attributes as potentially sensitive personal healthcare information (PHI) is crucial. This includes obvious identifiers like patient names and birth dates and indirect identifiers such as device serial numbers that can be linked to individuals.
To protect PHI, you must use infrastructure that supports de-identification and anonymization of relevant data types and attributes. Regulations vary by region (e.g., China, Canada, the US), so it's important to adapt your approach accordingly.
In addition to your primary cloud infrastructure, ensure that any third-party tools you use comply with PHI protection standards. For example, when exchanging operational data (like bug reports that may contain PHI), ensure it transits only through secure, compliant channels. Be cautious with tools like Slack unless you are sure they provide the necessary PHI protections. Moreover, when integrating cloud connectivity into your medical device, remember that the FDA regulates the safety and efficacy of medical devices under a risk reduction framework.
By adhering to the above strategies and maintaining a disciplined approach, medical device companies can effectively balance innovation with regulatory compliance, ensure their devices' successful deployment and operation, and strategically position their product and company in the competitive market.
For in-depth insights and valuable guidance, register for the on-demand webinar featuring expert speakers Daniel Adler, Co-Founder & CEO of BioT, Adam Jacobs, Chief Technology Officer at Sunrise Labs, Inc., and John Miller, VP of Americas at BioT. They will share best practices for designing and developing advanced medical devices and systems that maximize the benefits of cloud technology.
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https://go.biot-med.com/best-practices-for-developing-end-to-end-cloud-powered-medical-devices
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Last updated on:
August 1st , 2024 VER .17