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DeviceLab Digital Health Wireless Medical Device Expertise
Digital Health is a growing field incorporating biometric and behavior measurements with data communications and artificial intelligence (AI). The figure above illustrates the landscape of Digital Health, with patients, practitioners, and administrators communicating directly through a variety of commercial and specialized devices over a mix of open and closed networks. This is DeviceLab’s Digital Health Wireless Medical expertise domain.
This interconnected healthcare system aims to improve caregiver/patient connection, evidence-based procedure outcome, deep-learning technologies and analysis. Devicelab provides technologies and techniques to aid healthcare professionals and patients manage illness and health risks while promoting wellbeing. The discipline holds the promise to enhance the efficiency of healthcare delivery and make treatment more personalize and precise. This includes post-surgical recovery, management of chronic diseases, medication compliance, early diagnosis and the reduction of clinical visits.
The Internet of (Medical) Things
The integration of digital communication into modern medical devices allows connecting the patient to a care network in real-time and medical instruments to electronic medical record systems. Whether wireless or wired, medical devices performing simple tasks like taking temperatures or a complex task like LASIK surgery are now connected to a network. While connected devices offer improved capabilities, remote monitoring and diagnosis they also have the onus of achieving higher standards for reliability and secure internet connection than most other connected devices. Fault-tolerant applications and protocol stacks are critical for meeting these higher standards.
Insights with Telemedicine
Real-time 2-way communications for diagnostic or surgical procedures is finally becoming a reality as providers seek to use their resources efficiently and provide a superior patient experience through a reduction of in-office or clinic visits. Patient data can be reviewed by remote practitioners at any time, improving outcomes in surgical recovery and chronic disease management. Specialist consultation can be done rapidly and remotely, with full access to all patient data. Successful telemedicine requires reliable data connections, clear data presentations, and intuitive software applications. The technical requirements can be simple or daunting, depending on whether the goal is patient interviews or remotely operated surgical robots.
Enabling Technologies for Digital Health
Realizing the promises of Digital Health means incorporating key technologies seamlessly and with reliable operation. DeviceLab is proficient in the implementation of these key technologies. Enabling technologies include:
Sensors: Medical practitioners require the measurement of many biometrics. Effective sensors applied to the patient are required to measure vital signs (heart rate, blood pressure, temperature, respiration rate, pO2) or detailed data such as ECG. Sensors must be comfortably worn, easy to apply and provide verifiably accurate data throughout the intended use period.
- Vital Signs sensors use mechanical, electrical, thermal, or optical means to monitor dynamic body functions that are traditionally measured manually and intermittently – heart rate, respiration rate, blood pressure, and temperature.
- Blood characteristics such as glucose and oxygen levels can be measured transdermally, reducing the need for finger sticks and blood draws. Sensors can also perform diagnostics based on perspiration chemistry.
- Some implants have active components that need to communicate with other system components. In this case, a radio “sensor” may need to be worn to receive the data the implant is transmitting.
- Health outcomes depend on activity levels, which can be monitored with accelerometers and GPS sensors. Physical therapy and exercise can be monitored with sensors that measure angles, distances, and forces.
Battery-Powered Systems: Battery-operated point-of-care (POC) devices that reduce delays and cost of lab work by bringing the test to the patient are becoming more predominate. DeviceLab has successfully designed many battery-powered devices. We well versed in all the latest battery technologies even in with rapidly evolving technologies. Our designs have maximized battery efficiency to achieve impressive and predictable run times.
DeviceLab is experienced in the design of wired and wireless chargers that preserve battery life and recharge rapidly to minimize device downtime regardless of the size and form of the device.
Wearable Devices: DeviceLab has a proven successful track record designing devices adhered to, worn on, or applied to various parts of the body, for patients of all types. Many additional regulations apply to wearable devices, including human factors of use, patient contact materials, and limits on the delivery of energy to the body (active medical devices). Wearable devices present other unique challenges such as:
- Accommodating a wide variety of anatomy differences while maintaining required accuracy.
- Electronic miniaturization and tight packaging
- Excellent ingress protection from dirt, liquids and other compounds.
- Durability from environment and outdoor exposure.
- Immunity to altitude changes and electromagnetic interference.
DeviceLab has the experience and expertise to develop reliable wearable devices that overcome these challenges and meet the higher standards.
Wireless Communications: Wireless technology is needed for the digital health but is especially suited to wearable devices, allowing for data to be easily transferred between small sensors and smartphones and other clients on cellular or local area networks. DeviceLab is well-versed in all of the popular software protocols used today and their medical applications:
- 4G Cellular
- Wi-Fi (IEEE 802.11)
- Bluetooth 5, BLE, Bluetooth Mesh
- Zigbee (IEEE 802.15)
- Near Field Communications (ISO/IEC 18092 / 21481)
- Body Area Network (IEEE 802.15.6)
We have the wireless hardware expertise required to implement these protocols. Our implementations of wireless links are fault-tolerant, reliable, and exploit the full bandwidth of the protocol. The devices we develop readily connect, stay connected, and reconnect easily after interruptions of service.
Application Software for Digital Health: Users participate in digital health mostly through application software. Running on consumer devices like iPhones or custom-built medical devices, software provides data display, archiving, interpretation, and manages the communications that are key to digital health, Medical apps, unlike general software applications on consumer devices, must be completely secure, fault-tolerant, and error-free to preserve patient privacy and preclude medical errors. Some digital healthcare products are software only (e.g. an app on an Apple Watch), but are still regulated by the FDA, requiring expertise the average software developer does not possess. DeviceLab’s team of Engineers have the skills and experience to create compliant software and regulatory documentation to ensure a smooth submission process.
Cloud Software for Digital Health: It is now possible to connect multiple sites and devices for the sharing of medical data with the advent of secure and reliable cloud services. Cloud services include online access, visualization of data and data processing in the cloud. The benefits derived include the security of a distributed, broadly accessible databank and the ability to perform sophisticated analyses of very large datasets. DeviceLab has the know-how to deliver software solutions that securely connect your system to a cloud server to offer extended services including remote diagnostics, data collection for analytics and patient/practitioner data sharing.
Many applications require data exchange with an existing Hospital Data System and interoperability with a variety of connected instruments. DeviceLab has years of experience with these systems with several successfully deployed devices.
Cybersecurity & HIPPA – Protection of Data
In any setting, protection of patient data is paramount and legally required under HIPPA. Systems must be able to ensure that data is shielded from unauthorized access and protected from tampering. Cybersecurity techniques such as encrypted transmission protocols are employed, and validation testing must demonstrate that the system is secure.