HW/SW Leadership in Digital Health
Challenges in building full-stack digital health solutions
- HW/SW Engineering, Embedded Systems, Cloud Software Development, Mobile Application Development
- Ypsomed AG
- 2022 - 2024
Abstract
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.
Challenge
Key Challenges in medical device development and focused insights into Digital Health Solutions of the project include:
- Organizational Challenges: Organizational challenges include ensuring collaboration across hardware, software, and healthcare teams, balancing budgets and timelines while maintaining quality, and establishing effective decision-making protocols among stakeholders.
- Team Expertise: Team expertise challenges revolve around acquiring healthcare domain knowledge for IoT devices and workflows, keeping pace with advancements in technology and cybersecurity, and bridging gaps between technical and medical expertise.
- Regulatory Challenges: Regulatory challenges include navigating complex approval processes to meet standards such as FDA and EMA certifications, ensuring compliance with privacy laws like GDPR and HIPAA, and addressing variations in regulatory requirements across regions to enable global deployment.
- Testing: Testing challenges encompass validating performance under diverse patient conditions, simulating edge cases and rare usage scenarios, and conducting iterative testing for reliable outcomes.
- Mobile App Integration: Mobile app integration challenges focus on designing user-friendly applications for diverse patient demographics, achieving real-time synchronization between the device and app, and ensuring compatibility across various operating systems. As Ypsomed’s digital health solution is highly customizable, mobile app integration requires the strict specification of protocols and APIs.
- Cybersecurity: Cybersecurity challenges include encrypting sensitive patient data to prevent breaches, ensuring IoT security for hardware-software integration, and complying with standards like ISO 27001.
Solution
At sensaco we had the opportunity to contribute with consulting services and interim positions in development.
Consulting services always apply to specific work packages tailor-made for the project during specific phases.
Interim leadership positions assumed come with a broader scope and additional challenge of serving programs with multiple projects. In addition, strategy changes, an evolving process landscape and market dynamics need to be accounted for.
Result
Contributions to specific project challenges were implemented as follows:
- Organizational: collaboration across hardware, software, and healthcare teams was largely improved by setting up strategic initiatives with their respective integration into project budgeting to rely on synergies.
- Team expertise was improved by acquiring healthcare domain knowledge for IoT devices (medical IoT) and perfectioning an already high-standard software development process according to ISO/IEC 62304.
- Testing: both verification and validation activities were improved, automation was added to them and processes rewritten where necessary, e.g. around CSV (computer system validation) and CSA (computer software assurance) activities. The latter was mainly driven by the increasing complexity of build pipelines and tool-chains.
- Major contributions to Mobile App Integration were provided by collaborating with newly set-up internal and existing external teams. Applying the latest technology on iOS and Android software-stacks was crucial for the project’s success.
- Cybersecurity: as consultants a secure product development framework (SPDF) was implemented with Ypsomed’s experts. After a thorough strategy evaluation the FDA recommendation for using the JSP 2.0 and ISO/IEC 81001-5-1 standards was followed. Close integration to the existing risk management processes according to ISO 14971, ANSI/AAMI SW96 and IEC 81001-5-2 was required.
We can conclude that above results did contribute to the project’s completion. However, the product’s success will rely on future market launches of pharmaceuticals, suitable medications delivered through the autoinjectors, and approvals in the respective countries.
