Common challenges when building a medical device on a public cloud by yourself

DiY on a Public Cloud

Rollback control, such as reverting to a previous version or configuration, relies on the Public Cloud Provider's capabilities, and they may not provide sufficient options or features for effective rollback.

Extra Horizon Medical BaaS

Extra Horizon allows customer-requested rollbacks of its services, giving control back to the manufacturer and minimizing reliance on Public Cloud Providers. This ensures greater flexibility and control over the rollback process.

DiY on a Public Cloud

Service Level Agreements (SLAs) with Public Cloud Providers may not include explicit provisions for rollback features or options, making it challenging to ensure proper rollback mechanisms.

Extra Horizon Medical BaaS

Extra Horizon understands regulatory requirements and enables customer-requested rollbacks, ensuring flexibility and control over the rollback process. This helps manufacturers meet regulatory compliance standards.

DiY on a Public Cloud

Depending on the Public Cloud Provider, there may be concerns about the reliability of the infrastructure, potential downtime, and performance issues.

Extra Horizon Medical BaaS

Extra Horizon proactively supports customers when unanticipated changes from AWS impact their medical devices, ensuring reliable performance.

DiY on a Public Cloud

Public Cloud Providers implement security measures, but there may be limitations or concerns regarding data privacy, regulatory compliance, and protection against cyber threats.

Extra Horizon Medical BaaS

Extra Horizon conducts comprehensive risk analyses and incorporates customer-identified hazardous situations, enhancing security measures and ensuring regulatory compliance in the medical domain.

DiY on a Public Cloud

Cybersecurity threats are constantly evolving, and adapting to new risks and implementing robust security measures can be challenging in a cloud environment.

Extra Horizon Medical BaaS

Extra Horizon integrates automated tests into its Continuous Integration (CI) pipeline, ensuring device security against disruptive changes and providing a proactive approach to cybersecurity threats.

DiY on a Public Cloud

Managing and deploying changes in a cloud environment can be complex, requiring specialized knowledge and time-consuming processes.

Extra Horizon Medical BaaS

Extra Horizon provides agile processes and automated test suites, allowing rapid and efficient deployment of changes while maintaining regulatory compliance. This streamlines workflows and saves time for developers and manufacturers.

DiY on a Public Cloud

The dynamic nature of Public Cloud environments can make it challenging for medical device companies to ensure consistent validation of their systems, leading to potential compliance issues.

Extra Horizon Medical BaaS

Extra Horizon monitors the underlying Public Cloud environment for unannounced changes, conducts automated re-validation, and ensures continuous compliance.

DiY on a Public Cloud

Depending on the complexity of the application or workload, the computing power provided by the cloud may not be sufficient, resulting in performance issues.

Extra Horizon Medical BaaS

Extra Horizon offers increased computing power and built-in functionalities to accelerate development and improve performance, ensuring that your application runs smoothly and efficiently.

DiY on a Public Cloud

Medical device companies may struggle with maintaining control over the Public Cloud platform and managing changes, which can affect the stability and reliability of their systems.

Extra Horizon Medical BaaS

Extra Horizon enables customers to test changes in a staging environment and incorporates failover mechanisms for seamless operations amidst unannounced changes.

DiY on a Public Cloud

Medical device companies may face difficulties in reviewing and approving changes to the Public Cloud infrastructure before they are implemented, which can impact system functionality and performance.

Extra Horizon Medical BaaS

Extra Horizon empowers customers with pre-deployment testing in a staging environment, allowing thorough verification and control.

DiY on a Public Cloud

The lack of visibility and control over changes in the Public Cloud can introduce risks that may adversely affect the safety and effectiveness of medical devices.

Extra Horizon Medical BaaS

Extra Horizon takes extensive measures to detect changes, notify customers, and re-evaluate services to reduce hazards resulting from uncontrolled changes, prioritizing safety and performance.

DiY on a Public Cloud

Public Cloud platforms may offer features and functionalities that are not relevant to medical device companies, leading to unnecessary complexity and potential security vulnerabilities.

Extra Horizon Medical BaaS

Extra Horizon offers customizable service plans, allowing customers to select only the required functionalities, reducing complexity and potential issues.

DiY on a Public Cloud

Paying for cloud resources can result in higher costs, especially if you are not utilizing them optimally or if you need to scale up quickly.

Extra Horizon Medical BaaS

Extra Horizon offers customizable service plans, ensuring cost optimization by introducing only required services into the mix.

DiY on a Public Cloud

Some Public Cloud Providers may not offer specific tools or functionalities that are essential for development, requiring additional time and effort to build and integrate them.

Extra Horizon Medical BaaS

Extra Horizon provides built-in functionalities for customers to streamline and expedite development processes.

DiY on a Public Cloud

Medical device companies may face challenges in leveraging risk controls and security measures from other software systems when using Public Cloud services, potentially compromising overall system security.

Extra Horizon Medical BaaS

Extra Horizon Horizon develops services in compliance with IEC 62304, providing customers with validated risk controls and simplified regulatory compliance.

DiY on a Public Cloud

Meeting regulatory requirements can be more complex when medical device companies rely on Public Cloud infrastructure, as they must ensure compliance with data protection and privacy regulations.

Extra Horizon Medical BaaS

Extra Horizon develops services according to medical standards, streamlining the regulatory process and facilitating compliance for customers.

DiY on a Public Cloud

Public Cloud Providers may not prioritize the specific safety requirements of medical devices, making it harder for medical device companies to ensure the safety of their products.

Extra Horizon Medical BaaS

Extra Horizon prioritizes risk controls, patient safety, and strategic planning, catering specifically to the unique needs of the medical sector.