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The SmartPilot connected add-on accessory converts autoinjectors into digital health devices. By connecting to mobile apps and backend solutions, patients’ adherence is improved and new possibilities for health personnel become available. Developing full-stack digital health solutions like Ypsomed’s SmartPilot accessory involves addressing critical challenges in organization, expertise, regulations, testing, mobile APIs, and cybersecurity. Development lifecycles demand higher peak loads during realization and testing of the solution. In addition, getting clearance and fulfilling all regulatory requirements can lead to late changes in documentation. Sensaco contributed during some of these lifecycle phases to realize the project.
Key Challenges in medical device development and focused insights into Digital Health Solutions of the project include:
