IoT Platform for Connected Medical Device

Value Proposition:

There are basically four reasons why you would consider connecting your Medical Device

  • Enable Cloud Monitoring of the status or position of your Medical Device
  • Use the Cloud as Data Collection for usability or performance analysis of your Medical Device
  • Take advantage of Azure IoT Edge Management of your Medical Device configuration
  • Design using Cloud Integration to address the intended use of the Medical Device

Challenge:

Where Cloud Monitoring, Data Collection and Azure IoT Edge Management solutions for Medical Devices are similar to use cases in e.g. Connected Products and Smart Production, the Cloud Integration into the core architecture of the design, that addresses the intended use of the Medical Device, poses special advantages and challenges for Medical Devices.

  • What are best practices of Medical Device Architecture with Cloud Integration?
  • How is 62304/82304-1 compliance ensured in a Medical Device with Cloud Integration?
  • How is Design Control and Change Control handled in a Medical Device with Cloud Integration?

How Beacon Tower fits:

The Beacon Tower architecture is based on many years of experience building IoT platforms. It makes use of well-tested Azure services that ensure a stable, scalable, and high-performance solution.

By using Beacon Tower you can focus on the unique features of your product development, while we ensure that Beacon Tower supports the resources defined in the architectural design of the Medical Device.

Best Practices

There are the following typical examples of Cloud Integration into a Medical Device.

1. Utilisation of the unlimited cloud resources, supplementing the limited resources in the Medical Device:

The Medical Device, is the main controller of the system. Measured data is send to the Cloud for analysing and extraction of visualized data, vital markers, or bio markers, which are sent back for presentation.

2. Using the Cloud resources as the main controller of the Medical Device:

The Cloud controls the functionality of the system. The Medical Device delivers data to the Cloud. A Smartphone or Desktop App act as User Interface for the system.

3. Using Cloud Data Management as interface to Hospital/Laboratory Information Systems (HIS/LIS)

Vital markers or bio markers are sent to the Cloud that handles the transfer of these to external systems.

4. Using Cloud System as copy protection:

Each single use item has to be approved by the Cloud system, based on the Single Use Items Unique ID (RFID, Barcode or similar).

5. Using Cloud Data as your business model:

The business model is based on pay per use. Medical Device usage is reported to the business system.

62304/82304-1 compliance:

As Beacon Tower components are developed outside the use of your QMS (Quality Management System), they are considered SOUP (software of unknown provenance) in 62304 terms.

Using Beacon Tower, you will find that the components used have well defined functionality and interfaces. This provides a good baseline for 62304/82304 Class A and Class B Software Systems compliance.

Design Control and Change Control:

In any Medical Device project, establishing and controlling a stable configuration of well proven components is vital. Verification and validation according to 62304 and 82304-1 is time-consuming.

Using Beacon Tower Accelerator, you have full control over the configuration. Beacon Tower gives the details needed for planning the changes. But the planning of changes are controlled by your QMS.

​Key Beacon Tower functionalities  that enable Connected Medical Devices

 

No vendor lock-in
Hardware or electronics vendor lock-in in a Medical Device is nothing new. In the early stages of development of a new Medical Device, the platform architecture is chosen. In this process, key components, critical components, like the CPU, the Display and the Power Supply are identified.
Of particular interest in this selection is the identification of second source components. If a critical component is discontinued, it is important to have a plan B – a second source.
Software vendor lock-in is something new, that you must consider when you allow Cloud Integration in your Medical Device. As you would do for your Critical Components, you should identify a second source for your Cloud software. Using Beacon Tower from Glaze, you may choose to have full access and control over the application and the environment. This makes it possible to discontinue Glaze and proceed with your second source – any company, that has experience with Microsoft Azure IoT, worldwide.
Virtual Signals
Extract vital signs from your signals and combine them or use them for alarm detection.
Beacon Tower provides a platform for controlled data analysis, extraction, and aggregation – virtual signals.
Virtual signals allow you to create new signals by applying algorithms to existing signals, or by combining multiple signals into a new one. The virtual signal is then sent the same route as all other signals, meaning both it and the source signal will be stored as telemetry and you can apply rules and alarms to it.
Access Control
A typical use case is to store trend data in the cloud. Establish full control of the access to trend data to your system actors – users, organisations or external system components.
Through Beacon Tower’s flexible access control, you can not only model your own organisation, but also your customers. You can allow them directly into the system and define exactly what assets they can see and what they can do. Access can be set either to single devices or groups with a granularity to only read data or control physical devices.
Rules & Alarms
Create rules that are applied directly on streaming real-time data. The rules can either be simple thresholds that triggers alarms when sensor values, virtual signals or vital signs go outside them, or complex rules based on multiple different sensor values or vital signs.
The rules can either start actions or trigger alarms. The alarms can be of varying severity to notify different groups of users.
Real Time Telemetry

The Real Time Telemetry processing is the core of Beacon Tower’s signal processing. It allows you to create rules that triggers alarms or actions within milliseconds from receiving the signal.

Visualisation
Use the data visualisation functionality of Beacon Tower to get insight to establish the prognosis of your patient.
Visualisation of telemetry in graphs allows you to see trends, compare signals and understand your assets.

How do we get started with Connected Medical Devices?

01

​Inception

So, you have an idea of your System Software Architecture and you have started looking for commercially available solutions that may fit in. You will find that you have two general options:

  1. Find a turn-key solution that plugs into your architecture and fulfils all requirements.
    If this is possible, it is by far the best solution – it is fast and easy.
    Beacon Tower SaaS is one of many options that can deliver this.
  2. Find a baseline that can be integrated into your architecture and adjusted to implement your requirements.
    This is a more realistic approach and will give a strong and robust architectural baseline for the Software Life Cycle (SLC) of your product.

Beacon Tower is uniquely positioned to offer transition between the A) SaaS and the B) Accelerator solution with minimal effort.

 

01

How we can help with the regulatory approach

We can help you to establish the right system architecture and regulatory approach to achieve 62304/82304 compliance of your software systems. This is one of the most important decisions in your project as it will have major impact on the project and the device lifecycle in the years to come. The decisions are based on an analysis of intended use, important features, patient risk, project risk and available software components. We have many years of experience with this and can help you find the best solution.

02

Pilot & Initial Launch

When running the first Proof-of-Concept and Pilot you want to address technical or patient risks. If you have an initial Patient, Usability, Software or Cyber Risk Assessment, this is a good starting point. You will want to establish a baseline system, that
A) Fulfils your intended use
These are often based on quite simple algorithms and are easy to plug-in using standard Beacon Tower configuration
B) Addresses unacceptable risks from your initial risk analysis
You may have to implement redundant data or algorithms, important user interfaces or special access control or encryption. If this is not available in the standard Beacon Tower SaaS solution, it may be a configurational option.

Above all, Beacon Tower offers customization. Well documented API’s and self-managed flexible components with an open platform approach makes Pilots and PoC’s relatively easy to implement.

02

How Beacon Tower secures an effective baseline

Regulatory compliance is obligatory. But all too often technology ends up being the critical path of the new Medical Device. With Beacon Tower, you have technology that works, and you can build a PoC quickly. Integration with your system and necessary adaptions is easy and we will always have regulatory compliance as a prerequisite in our work.

03

Design Control and Compliance


As Beacon Tower components are developed outside the use of your QMS (Quality Management System), they are considered SOUP (software of unknown provenance) in 62304 terms.
Beacon Tower components have well defined functionality and interfaces. They are self-contained testable services with full version control. Based on your Patient, Usability, Software and Cyber Risk assessment, this makes it relatively straight forward to evaluate the Beacon Tower SOUP components within the Risk Process and thus provide 62304/82304 Class A and Class B Software Systems compliance.

03

How Beacon Tower helps you scale

Beacon Tower’s architecture, features and infrastructure are designed to be able to scale from a few devices to several thousands. Not only from a capacity standpoint, but also by providing functionality that you might first need with a large-scale roll-out. We have a vast set of automated tests that verifies functionality. We monitor all components and make use of Microsoft Azure’s features to maintain quality when scaling. All this enables Beacon Tower to follow you through your whole Medical Device lifecycle.