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Elevating Healthcare Innovation: York's Impact on a Medical Device Digital Health Initiative

Medical Device

A global leader in the medical device industry faced a complex challenge in advancing its Digital Health Initiative and obtaining approval for its cutting-edge medical devices, navigating the intricacies of the highly regulated and technically demanding medical device industry. Seeking a partner with expertise in Digital Health and Medical device domains, the medical device company turned to York for technical assistance and services.


Amazon Healthlake, Amazon Cognito


Aid global medical device leader in advancing its Digital Health Initiative, obtaining approval for innovative medical devices, navigating regulatory complexities.

Empowering Success: York’s Dual Application Solutions

York met the organization’s needs with two vital applications: a web-based clinical study administration tool for clinicians and administrators, and a mobile app for patient engagement. The latter gathered clinical data through user interactions, sensor inputs, and Bluetooth connections with medical devices. Ensuring the utmost security for health information, all data, treated as Highly Personal Information (HPI), was encrypted in transit and at rest. FHIR protocols and APIs were utilized, storing device and clinical data in Amazon HealthLake. Authentication was handled by Amazon Cognito, while York implemented a custom role-based permissions system for safeguarding sensitive data and accommodating diverse user roles.


Driving innovation: York’s Impact on Reusable Components

The business outcome was marked by the successful rollout of the new medical devices, meeting all requirements and garnering high user satisfaction. The reusable components developed by York significantly reduced overall costs and time-to-market for new applications. The project established new standards for Digital Health applications and addressed regulatory concerns.

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