The medical device industry, like others, has felt the impact of the COVID-19 pandemic. Medical device companies rely on healthcare facilities and clinical trials to obtain certification. In this era, they are sometimes finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations.
But it is from the medical demands of this moment in time where we may witness major innovations. We’re still months away from something resembling a return to normalcy for the greater economy. However, medical innovation can help us not only during a pandemic but make the lives of patients easier and the role of medical providers smoother.
In this article, we will take a deeper dive into one facet of medical design innovation that has the potential to provide economical and reliable monitoring solutions for patients anytime, anywhere. Let’s look further at multi-parameter monitoring.
The Importance of Multi-Parameter Monitoring
Multiparameter monitors are designed to condense a large amount of patient data and present that data to the caregiver, which provides the data needed to understand a patient’s immediate or trending condition.
These monitors provide readings including heart rate, central venous pressure, non-invasive blood pressure, ECG, SpO2, PaCO2 and invasive blood pressure and temperature. Typically, the monitors will sound an alarm if a parameter deviates or passes a set threshold, so caregivers know when there is a change beyond the set parameters for the patient.
What’s Driving this Technology
The primary drivers of the technology getting it to the point where we can have multi-parameter monitors are battery-powered, low-cost and highly integrated silicon solutions that implement multiple parameters into a low-power, low-cost integrated solution.
For instance, single-chip silicon solutions are emerging that contain integrated ECG, pulse oximetry, respiration in an integrated solution, as well as silicon that implements a single or multiple processing elements and a Bluetooth Low Energy radio on a single integrated circuit. These two chips combined to create a full multiparameter solution at a low cost, small volume and low power solution.
The Power of Packaging
The packaging of the device is key to the ease of deployment on the patient. Devices can be packaged as integrated with electronics and electrodes with a “foam patch” adhesive solution for rapid deployment. Or, the device can be separated from detachable electronics assembly, allowing for replacement without having to dispose of the main system.
The Importance of Biocompatibility
Biocompatibility is an important aspect of longer-term monitoring systems. Additionally, comfort has to be designed into the system so patients can achieve high compliance of wearing the device when requested, or constantly without discomfort.
If the device is deployed as a separate device and electrode system, care has to be taken to ensure the device itself is cleanable and robust enough to support cleaning and disinfection during the use of the device or potentially during the deployment of the same device on multiple patients.
Ideally, in a triage situation with infectious agents such as COVID, the device can be disposed of on a per-patient basis and environmentally conscious manner, avoiding reinfection during the reuse of the product.
If the device is intended for re-use, it’s important to develop and validate a reasonable cleaning solution because the device needs to be able to withstand that process over many cleaning cycles.
Making Data Transfers Easier
The communication mechanisms for transferring data from the patient to a central monitoring station has also been reduced in size and power consumption. This adds the possibility of multiple radio protocols to be utilized, depending on the environment the system is being deployed in.
For instance, personal monitoring systems can utilize Bluetooth Low Energy to a mobile device, with that mobile device connected to a cloud service for use in small clinics, or even homes. By using Bluetooth to network gateways, BLE can be used in multiple bed and room environments.
Devices can also utilize low power Wi-Fi solutions for deployment in larger-scale clinics or triage sites for many patients, provided the software can implement easy and rapid device provisioning.
Innovations in the use of mobile devices for accomplishing device provisioning and pairing can make the process of associating devices with patient and cloud-based electronic medical records or indications on centralized monitoring stations easier to set up.
Display of Data Needs to be Well Thought Out
The display of patient data is critical to the use of these systems in a triage situation. The caregiver needs to be notified of any patient parameters going outside of the expected range, such as drops in respiration rate, heart rate, oxygen saturation, an increase in heart rate, and so forth. It’s crucial to be able to identify if a patient is going through a rapid change and needs immediate care. Systems need to alert caregivers in real-time that a patient might be deployed in a triage situation so they can be located and identified, and caregivers or medical providers can provide immediate care to that patient.
The addition of localized monitoring or nurses’ stations into a system in a dynamically changing physical environment such as a stadium or conference hall requires the system to support multiple connections to monitoring “sensors,” and potentially even moving those sensors without user intervention.
The actual display of data on a per-patient basis needs to be well thought out from a human factor perspective to ensure key data is being communicated to caregivers and they can rapidly associate data with specific patients.
Managing Energy Draw
One of the key concerns when implementing a monitoring system utilizing multi-parameter data acquisition is the management of energy draw from the power source which drives design decisions and battery selection along with how often devices are used and parameters are reported.
Decisions between primary and rechargeable power sources are a key decision in the use of the device and will drive clinical use-cases the device will support.
For instance, acquiring all parameters and streaming data in real-time would drive energy requirements higher, requiring large coin cells, primary cell(s), or rechargeable lithium-ion solutions, which complicates things. You would need to use a charger or charging device while deployed on the patient or be able to replace the device with a charged device in the clinical environment. Ideally, a primary battery source can support the use case without the caregiver having to recharge or exchange the device.
Multi-Parameter Monitoring at Home and Senior Care Facilities
In addition to clinics and hospitals, multi-parameter monitoring is also increasingly important in-home environments. Here is one home monitoring use case: A patient would pair their device to a mobile device, sign into it and enroll in a cloud service that would collect the data from them. The patient would need to be reminded to monitor the state of their device and connection or be alerted if the device connected to the cloud has been interrupted for some reason.
Home care and senior care are becoming extremely important to a lower cost of care. Multi-parameter monitoring solutions can more easily determine the status of patients prior to transport to the hospital. They can also monitor compliance of patient activities prescribed by caregivers. Additionally, they can help with position monitoring, sleep monitoring and fall monitoring — there is a lot that’s possible for an out-of-hospital population and in senior care facilities.
In situations such as COVID, it’s very important to monitor respiration rate and oxygen saturation to determine if lung tissue is being compromised, necessitating transport from the home to a care facility for further treatment.
In conclusion, the key areas of system design for multi-parameter monitoring are the parameters to be measured, the energy requirements, biocompatibility, packaging and the human factors required to efficiently monitor and establish patient status and post-use disposal of the device.
About the Author:
Michael Garrett, CEO of Garrett Technologies, Inc., helps companies bring medical devices to market, through a rigorous product development process and technical expertise. Garrett has over 25 years of experience in the development of products, including medical devices class I, II, III, consumer and industrial.