The Benefits of the New Medical Device Ecosystem:
In this Galen Data report part II on Sensor Platforms, Cloud Connectivity, and the New Medical Device Ecosystem, we continue to explore the transformation of medical devices and medical sensor platforms that’s changing traditional definitions and creating new opportunities.
Part I – Medical Device Ecosystem looked at the role of sensor platforms and hardware appliances in expanding medical device functionality.
Part II – Here, we’ll explore cloud connectivity in the medical device ecosystem and how collaborative partnerships can help medical device makers be successful in today’s Internet of Medical Things (IoMT).
In addition to sensor platforms and hardware appliances, the third component in the connected device ecosystem is the cloud platform.
Mobile devices, base station or docking station house a cloud platform’s API. An API (Application Programming Interface) is proprietary software that allows two applications to talk to each other.
Through a secure Wi-Fi or cell connection, encrypted data can be sent to the cloud where it can be collected, stored, shared, accessed and analyzed. In the Galen Cloud, data display can be customized and workflows for data easily created to allow for post processing. Manufacturers, providers, and patients can access this data and receive defined push notifications.
As Galen Data CEO Chris DuPont likes to point out, “Unlike automotive dashboards, medical devices don’t have a check engine light that alerts when the device is not working properly.”
The ability to leverage the cloud to collect and analyze diagnostic data characterizing the performance and status of the device provides that check engine light.
The cloud platform allows manufacturers to monitor devices remotely and transmit software updates directly to the device without medical intervention by a provider — which is considerably more convenient, safer, and less expensive to perform.
Keys to a Successful Medical Device Ecosystem
Collaborative, Turnkey Solutions
As stated in the outset, cloud-connected medical devices pose challenges and opportunities. For those who lack the resources, internal expertise, and regulatory knowledge, their best option may be to collaborate with experienced partners who can help develop, launch, and scale their solution.
Partnering requires a different mindset for engineers who view solving problems on their own as a source of great pride. (As engineers ourselves, we can appreciate your mindset.)
But increasingly, traditional medical device companies who recognize the value of cloud connectivity are turning to companies like Galen Data and sensor platform manufacturer BraveHeart to optimize resources. Their turnkey solutions minimize software customization. They enable firms to reduce design costs and avoid delays to important product lifecycle milestones such as clinical trials, FDA clearance, and eventual market implementation.
As BraveHeart Wireless’ vice president of business development Ted McAleer states, “Historical software platforms that have resided in traditional medical devices are not ‘purpose built’ for data sharing; In an IoMT world, that’s no longer a viable option. Medical device manufacturers need sensor platform designers who are equipped to handle the demands of a cloud-connected environment and data interoperability.”
Quality Systems and Security and Privacy Protocols
Collaboration starts with nimble, quality-centric partners who understand the hardware and software architecture associated with cloud connectivity.
Look for firms who adhere to quality systems and best-in-class protocols for security and privacy and safeguard against vulnerabilities that can compromise data integrity and undermine patient health. Regulatory requirements and industry standards for medical device connectivity can be overwhelming and the classification guidelines confusing for companies unfamiliar with the process.
The Galen Cloud, for example, certified under ISO 13485:2016 (Medical Devices – Quality Management Systems). Additionally, the Galen Cloud:
- Is compliant to FDA, European MDR, and Health Canada regulations.
- Adheres to HIPAA, EU General Data Protection Regulations (GDPR), and the California Consumer Privacy Act (CCPA).
- Is developed per FDA Design Controls (21 CFR Part 820), IEC 62304 (Medical Device Software – Software Lifecycle Processes), and ISO 14971 (Application of Risk Management to Medical Devices).
The medical device ecosystem requires manufacturers to see their business in whole new light.
Their market potential is far more than the patient-focused functionality of their instruments alone; it also exists in the data their devices generate. And its currency will only increase in a value-based system of care driven by analytics and software-based services and solutions.
As we discussed in Opportunities and Pitfalls for Connected Medical Devices, “Because data is collected centrally in the cloud, engineers and researchers can improve diagnostic algorithms over time. Machine learning techniques can be used to comb through this data and identify new patterns that can lead to new products or services. Connected medical devices can also provide portable diagnostics devices that can be used for in-home collection and diagnosis.”
The connected medical device ecosystem makes data’s impact possible.
Conclusion – Benefits of the New Medical Device Ecosystem
Manufacturers will benefit from an exciting new era where their medical device technology is now an ecosystem of hardware, sensor platforms, web applications, and cloud connectivity.
Today’s connected medical devices will open lucrative markets for new and existing companies including remote monitoring, data analytics, and machine learning. It will allow devices to interoperate with EHR systems to track patient health and wellness.
Success will require new ways of viewing medical devices themselves – what they can do and how they are built. Given devices’ growing complexity, companies will need to embrace an approach that is:
- Collaborative – based on partnerships that take advantage of outside expertise in cloud connectivity, regulatory compliance issues, and quality control measures.
- Data Focused — understanding the value of a device is increasingly derived from the data it generates.
The most successful collaborations result when partners can combine the incentive for profit with a shared vision of innovation and a commitment to improving patient health, reducing the cost of care, and providing easier access.