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How Should RPM Vendors Choose Remote Patient Monitoring Device Suppliers?

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Update time : 2022-07-27 11:36:45
Great thanks to Healthcare IT Today CEO John and HealthcareITToday.com for inviting and sharing our understanding about RPM devices. AOJ Medical has kept trying understand the RPM industry and vendors' requirements deeply, and deliver valuable devices for our customers, including total hardware solutions for chronic disease management.
 
The following is the article by Jack Wang, the Vice President of AOJ Medical.
 

RPM service and Telehealth are not new topics In the current health care market, and many RPM and Telehealth vendors have already set up services, systems, and applications for specified diseases or target patients. These kinds of vendors also treat remote monitoring devices as a key part of the services, such as different kinds of vital signs monitoring and chronic disease monitoring devices.

The benefit of continually monitoring the conditions of the patients provides health care vendors an ongoing status from a technical and data-oriented view so that they can evaluate the patients' state and optimize the care solutions more effectively.

Vendors need various monitoring devices and these devices also need to be integrated into the entire health care system.  How to choose these kinds of device partners and suppliers is a little bit complicated for heath care vendors and many vendors have no hardware design and manufacturing background. During our three years of working side by side with RPM vendors, our experts at AOJ Medical summarized a few principles as good practices to help RPM vendors make more efficient decisions.

Principle 1: Evaluate the technical competence of the suppliers.

Due to the global supply chain division and cooperation, most hardware devices are from some manufacturing countries like China. Normally, there are no big differences in basic manufacturing competence among different suppliers in China. Most of them have their own manufacturing plants with high-cost materials and labor.

Despite the mature supply chain system, many factories have no self-owned R&D capabilities or only few engineering people. They purchase the technical solutions such as algorithms and software licenses with no R&D or engineering capabilities on staff. This approach has a very high-cost performance for traditional retail markets, because there will be no any continuous support for later online health care monitoring service after selling the devices.

For RPM services, the remote monitoring must be accurate, easy to use, good design, and with flexible software interfaces for integration. The traditional manufacturing type of suppliers will not be competent enough for RPM vendors. The key to dealing with this is to carefully evaluate the R&D competence of the device suppliers.  For example, do they have a cross-functional R&D team which includes algorithm engineers, software engineers, hardware engineers, mechanism engineers, ID designers, and related laboratory and devices? During the evaluation process, requesting a questionnaire is a good start, and an on-site interview is also helpful to find the truth.  That questionnaire can include things like  how many engineers they have, the engineers background and education, etc.

Principle 2: Evaluate the regulation competence of the suppliers.

RPM devices work as medical devices which are governed by the FDA and related departments. When evaluating medical device suppliers, you should also evaluate their entire medical device quality system and regulation status.

First, the ISO 13485 and related quality system must be correctly built and executed during the daily work. According to the administration rules, all the procedure and records should be clearly documented and can be traced, and all the risk has been recognized and under proper control solutions.

Second, FDA cleared status should be well checked, not only the 510K, but also new issues with RPM devices, like whether cybersecurity principles and rules are fully performed, and all the security risks were tested by protocols, API and SDK.

And last, normally the traditional monitoring manufacturers only focus on manufacturing, even outsourcing the regulation jobs to others and they do not have capable teams in house. You need to check whether they have an independent regulation department or teams that are responsible for building, training, and applying medical devices quality system and certifications.

Principle 3: Evaluate the software competence of the suppliers.

In the past, before the present RPM services, only a few devices had embedded software installed inside the independent monitoring devices. There were not any outside connections. But for RPM devices today, the connection capability is a key function of the devices. When you integrate new devices from monitoring device factories, you should carefully check the software capabilities.

When you have your own software development teams and you can solve the basic transition functions, you only need to check if the device protocols are fully defined and implemented, and with clearly described documentation.  The will help your engineers to develop your own interfaces and modules.

When you want to fast track your delivery and integration of new devices, a good approach is to get the SDK or API from the suppliers. The supplier SDK and API should have already implemented basic functions like connection management, device management, data management, and security management. Your engineers do not need to develop these functions again, and can instead just invoke and test the interfaces. Once the device is upgraded to new versions, all the interfaces should be forward compatible for your existing users.

Even you just start a trial market, you do not need to develop your own applications yet. Get early demo applications to verify your business model with nearly zero investment.  If the suppliers can provide similar products, this is helpful to accelerate your business verification.



Principle 4: Evaluate the service competence of the suppliers.

Most hardware device providers have traditional hardware product delivery services, including the entire ODM/OEM process.  But for RPM devices providers, how they understand the RPM vendor's requirements is a key issue. Suppliers need to understand the market and the diseases. Take chronic cardiovascular diseases as an example. If the RPM device providers do not know about the health care insurance system and the treatment of remote patients, it will be very hard for the supplier to provide high value functions and services.

On this point, you should not only check how they are professional in hardware manufacturing, but also check how they understand the medical details associated with chronic diseases. Normally you can evaluate this important factor with a face to face interview, a check of the features they’ve developed, and understanding their customized requirements capability.

Further, how the supplier integrates the hardware, software, and services as solutions will be key for choosing the right RPM device suppliers.  For example, at AOJ Medical we work to align the RPM customers requirements and needs into comprehensive solutions. This kind of alignment will satisfy different kinds of customers and requirements.

We believe RPM and telehealth will keep changing the pattern of the health care industry, and choosing a good supplier will help you to be an outstanding company in changing times.
 
About Jack Wang
Jack Wang is the Vice President of AOJ Medical, a RPM device provider. Jack has over 10 years of experience in developing and delivering complex core network system for global telecom vendors and over 5 years of delivery experience on complex internet system and medical devices, and later joined AOJ Medical to be responsible for serving RPM customers cooperation. Reach out to Jack with any RPM supplier questions.
 
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