Healthcare professionals have access to vast amounts of drug and clinical information, but identifying what is relevant to an individual patient can be challenging. Patient-specific decision support brings the most relevant information into the clinical workflow at the point where it is needed.

Medbase CDS (Clinical Decision Support) is a CE-marked medical device designed for the European market. It brings patient-specific medication decision support into everyday clinical practice. The solution combines structured patient data, including medication, demographic and clinical information, with Medbase’s validated drug information to generate clinically relevant notifications, alerts and reminders.

Medbase is responsible for the product’s clinical expertise and medical content. Monad has contributed to the development of the technical foundation, integration capabilities and development model for Medbase CDS as a regulated medical device. As a result of the collaboration, Medbase has a scalable and traceable product platform that can be developed in a controlled manner in accordance with the requirements of a regulated environment.

The challenge: turning clinical decision support into a regulated software product

Medbase’s goal was to develop a product that brings medication decision support directly into the environments where healthcare professionals already work. The support can be triggered, for example, when prescribing medication, reviewing a patient’s medication list or when new relevant information becomes available, such as a laboratory result or diagnosis.

The product needed to be clinically useful, easy to integrate and adaptable to different organisational workflows. At the same time, its development had to meet the requirements applicable to medical devices.

This required more than building functional software. Development had to be traceable from requirements through implementation and testing to acceptance criteria. It needed to be possible to demonstrate what was being built, why it was being built, how the correctness of the implementation was verified and how risks were managed.

The solution combined software development, quality management and traceability

Monad participated in the design and development of Medbase CDS in close collaboration with Medbase’s experts.

Medbase provided the clinical expertise, quality and regulatory know-how, as well as business and market understanding. Monad contributed software engineering, architecture expertise and the technical capabilities required to develop a regulated software product.

The work combined software development, architecture design, preparation for integrations and the design of a development model suitable for a regulated product. Monad helped build an approach in which product requirements, software implementation, automated testing, code reviews and acceptance criteria are linked to one another.

This is essential in medical device development. The development process must demonstrate that the software meets its defined requirements and that changes can be traced in a controlled manner from requirements through implementation and testing.

In practice, the work strengthened the processes for testing, code review and traceability. Software test coverage was assessed against product requirements and acceptance criteria. Automated testing, code reviews and a documented development model were not treated as isolated quality measures, but as an integral part of demonstrating product conformity and creating a sustainable foundation for further development. Risk-based development and risk management, both central to medical device development, were also embedded in the practical work.

Medbase CDS was designed as an API-based service that can be integrated with electronic health record systems, pharmacy systems and other healthcare IT environments. This integration model enables decision support to become part of existing clinical systems and workflows, rather than requiring healthcare professionals to switch to a separate service to search for information.

The solution is built on Medbase’s modernised Kubernetes-based technical environment. This supports the addition of new services, scalability and deployment across different operating environments.

A controlled foundation for product approval and lifecycle management

Medbase CDS is a CE-marked medical device that helps healthcare professionals identify patient-specific risks related to medication therapy.

“Monad’s value is particularly evident in their strong technical expertise and their ability to apply it to medical device development. Their contribution has been instrumental in building a sustainable technical foundation and development model, enabling the product to be developed in a controlled manner, integrated with different healthcare systems and scaled across different operating environments.”
Markus Jansén – Software Products and Development

The collaboration also resulted in a development model that supports the product throughout its lifecycle. It helps ensure that new features, databases and services can be added while maintaining traceability, testing and quality management as an integral part of day-to-day development.

Development of the next version of the product continued during the approval process related to CE marking. In practice, this included adding new databases and additional areas of decision support on top of the existing product foundation. The development model also supports the controlled introduction of future product versions in accordance with medical device requirements.