The devices are equipped with certificates from the SwissPKI^TM solution during the production process. In later use, the relevant certificate processes are managed continuously and automatically across the intended lifecycle. This makes it possible to use certificates with a limited validity period wherever this makes sense. It supports the security of the overall system without additional manual effort for patients.

mylife’s systems are connected to SwissPKI^TM certificate management through its registration interface (Registration Authority API). The CA keys of the private PKI are stored on dedicated hardware security modules (HSMs). Ownership of the certificate chains and their use remains with mylife. The specific technical expertise required for secure and stable PKI operation is provided by libC. A binding service level agreement, together with the manufacturer’s ongoing development of the solution, allows mylife to focus on its core competencies.

Challenge

Internationally distributed production sites in one central PKI

mylife operates several internationally distributed production sites that need to be integrated seamlessly into the central PKI solution. Certificates are to be loaded onto the individual medical devices automatically and reliably during the production process, without additional manual intervention.

At the same time, integrating the PKI solution into mylife’s existing service and system landscape places high demands on stability, scalability, and process reliability. The various use cases must be implemented in a way that supports safe and reliable use of the devices by patients over the long term.

Automated certificate processes across the entire device lifecycle

This requires largely automated certificate processes across the entire intended lifecycle, from initial issuance through to the renewals needed after several years. Patients should be able to concentrate solely on the medical use of the devices. For mylife, the focus is therefore on technical, organizational, and operational challenges.

Solution

Managed PKI based on SwissPKI^TM

mylife Diabetes Care AG chose the managed PKI solution from libC Technologies, based on the “SwissPKI^TM” product. The PKI is offered as a managed service on various cloud platforms.

The implementation concept for the various requirements was developed in joint workshops. This ensured that requirements were correctly identified and interpreted, while also enabling a continuous transfer of know-how from libC to mylife. The project team was made up of experienced staff who have already delivered a range of projects successfully and who bring many years of experience in their respective fields.

Fully automated certificate lifecycle management

The “SwissPKI^TM Managed Service” is hosted in Switzerland and operated by libC as the manufacturer together with its partners. The service is quickly available, cost-efficient, and easy to use. Even the entry-level version offers the option of securing keys in hardware security modules.

Certificate lifecycle management was given high priority. At the same time, it was ensured that the solution is fully integrated into mylife’s service management system. The certificates of the medical devices are renewed fully automatically within the intended cycle, without users having to take any action. SwissPKI^TM is designed for high performance and can process simultaneous certificate renewals for thousands of devices.

Benefits

• The managed service approach allows mylife to focus on its own core competencies in developing and delivering diabetes care solutions, without having to build and maintain all of the specific PKI operating knowledge in-house.
• In joint workshops, customer requirements are translated in a structured way into a viable solution concept, supporting a targeted transfer of know-how and reducing unnecessary complexity and avoidable cost drivers at an early stage.
• Many years of experience and pre-built solution components guarantee efficient integration and rapid deployment.
• The complete PKI service is provided with a defined service level agreement, establishing clear operational and support responsibilities for mylife.
• Ownership of the keys of the trust chains remains with the customer. The CA keys are stored securely in a hardware security module (HSM).
• Defined approval and issuance processes support controlled and traceable use of certificates.
• Integrated lifecycle management enables the automated issuance and renewal of certificates and reduces manual operating effort for mylife.
• The standardized solution and the clear division of responsibilities contribute to predictable operating costs and a solution that remains maintainable over the long term.

About mylife Diabetes Care

mylife Diabetes Care AG is a Swiss medical technology company specializing in diabetes management solutions. Headquartered in Burgdorf, the company aims to improve the lives of people with diabetes through innovative medical devices and digital technologies, and to simplify diabetes therapy.

The portfolio comprises automated insulin delivery (AID) systems, insulin pumps, infusion sets, and digital solutions for therapy management. The smartphone-based myLoop system connects compatible devices, supports automated insulin delivery, and makes it easier for people with diabetes to manage their therapy day to day.

With around 850 employees, 15 local subsidiaries, and a presence in more than 20 markets, mylife Diabetes Care combines over 40 years of experience with a strong focus on innovation, quality, and patient-centered care. The company is guided by four core values: Patients, Belonging, Performance, and Ownership.

Further information about mylife Diabetes Care is available at www.mylife-diabetescare.com.

Note: The SwissPKI^TM production environment described in this case study is live. The associated medical device use cases are, at the time of publication, being prepared for commercial use and are not yet available on the market.