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Liza Dzhezhora

FDA Compliance

Top Five Challenges for Medical Device Integration

How to ensure the integration of IoMT devices in your practice

Published: Thursday, February 9, 2023 - 12:03

Having appeared in the early 2000s, connected health technologies have gradually become a game changer in the healthcare industry. Healthcare providers that have embraced smart medical IoT solutions reduce costs, improve patient experience, and ensure preventive care.

The trend is not fading away. According to Research and Markets, the global health and wellness device market will grow threefold and reach around $152 billion in 2027.

The internet of medical things (IoMT) includes many tools, from blood pressure monitors and pulse oximeters to smart pill dispensers. Nevertheless, implementing medical devices and related software has specific challenges.

How do you ensure the integration of IoMT devices in your practice? We consider the four barriers and see how developers can help to overcome them.

Challenge 1: Device connectivity

In the healthcare industry, connecting a medical device and a healthcare system is about creating a digital environment that leverages the medical facility systems. Medical device connectivity helps healthcare providers offer alternative care delivery models patients have sought for a long time, such as at-home hospitals.

Thus, Kaiser Permanente, headquartered in Oakland, California, offers acute care services at home. The hospital provides selected patients with a tablet for video visits and an emergency response bracelet seamlessly connected with the care team 24/7. Such a tech set allows doctors to deliver hospital-level care at home. In addition, the program supports both virtual and in-person visits. The program helped the provider reduce the rate of readmissions from 13 percent to 8 percent of cases. In addition, at-home care resulted in a reduced rate of hospital-acquired infections and a higher patient satisfaction rate.

Challenge 2: IoMT interoperability

IoMT interoperability is another crucial medical device integration challenge where data sharing comes into the spotlight. It allows clinicians to access, process, and exchange the collected IoMT data. Interoperability helps medical professionals make timely and effective healthcare decisions and ensure preventive care. Unfortunately, different healthcare organizations and even a single provider’s clinics often lack seamless interoperability.

In the latter case, providers can enable interoperability by activating API in their EHR independently or with their vendor’s help. For example, at UAB Hospital in Birmingham, Alabama, Cerner and the hospital’s health IT provider teamed up to create a unique data integration solution enabling health records’ API. The chosen strategy helped the hospital improve patient medical records, safety, clinical workflows, and data accuracy.

Different clinics can go for supporting open data standards and platforms to enable cross-provider interoperability.

Challenge 3: Data security

IoMT devices store and transmit sensitive data. That is not only confidential medical data but also home address, family data, finances, and other personal information. These data travel across wireless networks of varying security. Logically, they can fall victim to cybercriminals. According to the 2022 Insecurity of Connected Devices: A report by Ponemon Institute and Cynerio, 88 percent of those interviewed stated cyberattacks on their facilities involved connected devices.

To prevent such situations, IoMT developers need to take up several measures, either independently or in cooperation with reputable vendors:

1. Regular security testing, including penetration testing and vulnerability scanning, and patching the identified vulnerabilities

It makes sense to cooperate with information security experts to stay up to speed with security threats for connected devices. Besides, in Nov. 2022, the U.S. Food and Drug Administration published a playbookon medical device cybersecurity. The playbook highlights the need to ensure diverse teams participate in mock cyberattacks. It helps polish the adequate response in case an attack occurs.

2. Compliance with the HIPAA security rule

The rule aims at protecting personal health information (PHI): Vendors must ensure PHI access according to a user’s position in the healthcare facility. It helps provide the minimal information a hospital employee needs to perform their daily activities and prevent excessive exposure of patients’ personal data.

What’s more, the rule requires establishing user authentication procedures. For this matter, three-factor authentication serves well. It provides access relying on three components—knowledge (user ID and password), possession (a one-time OTP token), and inherence (e.g., a fingerprint). The authentication method helps ensure a person’s validity at three sides, which upscales PHI security.

Challenge 4: Regulatory compliance and licensing

Medical devices enable continuous monitoring, screening, diagnostics, and condition management affecting patients’ health. These functions call for regulatory compliance with 21 CFR 820.30 or design control guidance for medical device manufacturers by the FDA.

However, the task is challenging. According to the 2022 Recall Index by Sedgewick, medical device recalls reached a record number for the past three years in Q2 2022. Safety and software issues were the top two reasons for the recall.

To comply with the regulation, medical device developers need to:
• Formulate and explain the purpose of the device or its intended use.
• Ensure that the device covers the users’ needs.
• Run risk analysis and make sure the product is safe for users relying on ISO 14971: ”Medical devices—Application of risk management to medical devices.”
• Perform quality assurance (QA) and prove that the chosen implementation ensures that the device will cover users’ needs.

The FDA approval is a complex process that needs time. Some teams prepare the required documentation at the project kickoff to speed up the process. Nevertheless, such a hurry may be useless. Experienced medical device developers say it’s better to set off with ensuring FDA approval at the final stages of the project’s implementation. In that case, it will require less rework.

It’s important to note that the FDA doesn’t issue certificates. It only grants approval or a clearance, depending on the medical device’s class. The approval allows the manufacturer to sell its device in the U.S.

If you aim at a larger market, you can go for the Medical Device Single Audit Program (MDSAP). An MDSAP certificate confirms that a manufacturer meets the requirements of the regulatory bodies recognized internationally, including the FDA. An MDSAP certificate allows a manufacturer to sell the device in five countries: Japan, Brazil, Canada, Australia, and the U.S.

Challenge 5: Device mobility

Connected medical devices, such as remote patient monitoring tools and other wearables, are mobile, posing another challenge. The connection can be interrupted due to network instability, insufficient bandwidth, and shifts in network connections.

These interruptions may be high-risk for patients using real-time monitoring or therapeutic devices—for instance, auto-injectors, infusion pumps, and asthma inhalers. In those cases, an interruption can lead to a life-threatening event if not mitigated properly.

Therefore, it is essential to enable a safe network switch for mobile, Wi-Fi, LTE, 5G, and other supported networks in the medical device. It allows providers to continue monitoring and treating their patients even when they are on the move.

On a final note

Integration of medical devices is a promising field not only for healthcare but also for health IT. However, it presents several major challenges. IoMT solution vendors can help you solve those challenges and facilitate medical device integration.

Software service providers can set up cross-system communication via APIs and enable seamless network switches to ensure flawless medical device operation. In addition, IT security experts can perform quality penetration testing and vulnerability scanning, ensuring the solution complies with HIPAA standards and FDA regulations.


About The Author

Liza Dzhezhora’s picture

Liza Dzhezhora

Liza Dzhezhora is a healthcare IT analyst at Itransition, a custom software development company headquartered in Denver. She looks into the ways IT technologies can streamline healthcare processes and explores how medical IoT, AI, robotics, and healthcare analytics help solve industry challenges.