A few things to keep in mind when deciding whether to use cloud-connected medical devices for data-gathering are the following:
Cloud technology in healthcare
Definition of a medical device that is connected
As a starting point, how do we define a “connected medical device?” A medical device is an electromechanical gadget worn or implanted by a patient that can monitor physiological data or administer therapy (such as a neurotransmitter).
A medical device can have data input or data output, depending on the function it serves. CPAP machines and other “near-patient” equipment can also be included.
Health data can be transferred, managed, stored, and analyzed using connected devices.
Information pertaining to medical devices
Medical device data can be broken down into four categories:
1. Physiological data from the user. An example of “output data” is a person’s vital signs, which include things like blood pressure, body temperature, and even brain waves.
2. Incorporating therapeutic data This is “input data” to the medical device, which includes any information that sets the therapeutic parameters for the patient.
3. Information about the demographics of the users. Height, age, sleep patterns, and weight are all examples of “output data” that isn’t directly measured by the medical device.
4. Information on the device’s current state. “Output data” is used to gauge the health of a specific device. It could, for example, include information on the health of the battery. When it comes to medical devices that aren’t connected, there is no “check engine” light. Device monitoring can benefit from cloud connectivity in healthcare, which can provide the missing link.
Your medical device’s purpose is to help people.
When developing medical devices, many companies place a high priority on the device’s core functionality in the early stages of development. Design controls, device verification, and clinical trial validation take a lot of time.
As a matter of course, the company aims to secure market clearance by demonstrating to regulators that their medical device is safe and effective. Preoccupation with regulatory and quality standards is understandable at this early stage of a product’s development.
In our opinion, bringing a product to market is not the ultimate goal. The real goal should be market acceptance, where the device proves to be highly usable. Typically, the market is looking for connectivity and the additional benefits it provides. The opportunity to connect to the internet is no longer a “nice to have” in today’s market; rather, it is a need. Because this is the case, you should begin planning for it early on.
Factors influencing the market’s acceptance
The three most important factors for market acceptance are: Each of them complements and overlaps with each other:
1. Regulatory: Regulators play a huge role in the process of bringing a medical device to market. In the absence of a regulatory expert on your team, we strongly recommend either hiring one in or enlisting the help of a consultant to guide you through the process.
2. Quality: There should be a robust quality management system in place for every medical device (QMS). This is a well-structured system that encompasses all of your device development processes and procedures. Manufacturing and supply chain management are just a few examples of design controls.
3. Connectivity: As previously stated, there is a high demand for medical devices that can store, share, or process data. Having this feature allows for a wide range of new patient care options.
For device manufacturers, there are three key design questions to consider.
When it comes to connectivity, medical device companies should ask themselves three questions:
#1. Is it necessary for my device to be linked at all?
Medical device manufacturers frequently cite risk as an issue when discussing connectivity. Connectivity does come with some downsides. Those are primarily related to breaches of privacy or cybersecurity
However, it is feasible to mitigate this risk. Either risk can be avoided if best practices are followed, such as security monitoring, regular updates, or adhering to HIPAA guidelines.
Cloud computing healthcare security
In our opinion, there is a greater risk in not connecting a medical device than there is in connecting it. In the case of an epileptic child, for example, a connected device can alert the parents if their child has a seizure while out with friends. They are able to take action immediately. However, if they didn’t have a connected device, the parent might not be notified until much later in the day or night.
Another example is the use of medical devices that can track a patient’s medication dosage and the circumstances surrounding it. The ability to analyze data and be alerted when underdosing may be occurring is one benefit of connectivity. For months, the patient may be unaware that they have been underdosing and are once again in a disease state before they see their next doctor.
We at Mirat.ai have designed a platform that includes leading access restrictions and core security design features in order to minimize the risks of cloud computing in healthcare.
#2. What are my choices for the platform’s design?
There are numerous methods for creating devices that are interconnected. Start with the device’s components, such as whether it’s intended to be worn on the body or implanted. The greatest approach might be to use an app on a smartphone.
Do you think the device will only gather data and send it to a third-party processor? Or will it be able to do its own data analysis? How will it spread the word? In addition to MICS and Bluetooth, other options include WiFi and WiFi. In the early 2000s, a service called MICS (Medical Implant Communication Service) emerged. We’ve found that most of the companies we’ve worked with prefer Bluetooth).
Additionally, software operations and data storage & patient data security are other important considerations. The medical equipment itself doesn’t have a lot of storage capacity. The potential storage capacity of the cloud is virtually limitless. As a final point, the ability to analyze and use data stored on the device or patient is a critical consideration. The heart pumps as an example. It is possible to analyze data from multiple patients and pumps using predictive analytics. Instead of predicting when a catastrophic failure will occur, manufacturers would be able to pinpoint specific equipment.
#3. Consider whether or not there’s a demand for my product or service.
In today’s world, it is possible for patients and doctors to benefit greatly from being connected. Because of the current novel coronavirus pandemic, some inefficiencies have been brought to light, such as the long wait time for test results, which connectivity can alleviate.
The regulatory environment and how it might change in order to accommodate more of the cloud adoption in healthcare are the areas of opportunity.
Several examples are provided.
Use cases for connected devices include the following:
1. Reimbursements: Treatment or monitoring with a device is often required in these cases. Using a connected device makes this much easier to demonstrate, as usage data is automatically collected and displayed!
2. Compliance: Trial devices must be able to show that they were used in accordance with specific protocols. With a connected device, it is much easier to demonstrate this.
3. Diagnostics for the device: Connectivity makes it much easier to monitor and diagnose the health of the device. Patients, providers, and the device manufacturer can all be alerted to battery levels and other performance issues via real-time data collection and analysis.
In closing, here are our final thoughts.
What’s next? Take into account how your medical device is connected to the cloud. What are your technical and design concerns? Why don’t we talk about sensors?
Connectivity has evolved into a “must-have” feature for new medical devices seeking market adoption. Competitive advantage and new market opportunities may arise if you connect your device.
Contact us at Mirat.ai to learn more about how Mirat’s Cloud connectivity platform, which is fully operational and compliant, can assist you.
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