Reducing Costs and Risk Through Modular Medical Device Development

Modular components make developers' work easier when coordinating hardware and software and implementing European regulations such as MDR and IVDR.

With the introduction of Regulations (EU) 2017/745 [MDR] and (EU) 2017/746 [IVDR], the development of medical devices has become even more complex. This means even more work for distributors, particularly for documentation and product certification, including for existing systems. Solectrix therefore relies on system development based on modular individual components.

Developing Medical Devices According to the Modular Principle

A careful analysis of similarities and variances always comes first: For example, laboratory devices often have the same technical requirements for processing a sample. The method of evaluation varies, but what many devices have in common is a neat user interface and connectivity to the cloud or hospital infrastructure. Implementation in the form of a modular system can therefore generate significant positive effects.

Each “building block” of a modular system must be fully and consistently specified, developed and, above all, verified. Solectrix uses the “codebeamer” Application Lifecycle Management system (ALM) from PTC, which allows the necessary information to be transferred to a subsequent development project almost in a copy-and-paste manner. It includes protection and control mechanisms and also guarantees the necessary traceability.

Defining Interfaces and Assembly Options with Foresight

To ensure the widest possible use of modular subsystems, interfaces for communication, control signals, and power supply must be designed with great care to be as universal and future-proof as possible. The well thought-out use of similar components and the early definition of assembly options for possible hardware configurations not only have a positive effect on development time, but also on procurement and production. The widespread use of modular components also enables all obsolescence issues relating to purchased components to be dealt with centrally and also has positive effects on the maintenance of product software, for example when it comes to security updates and the rapid closing of emerging security loopholes.

Your Reliable Partner for Development and Production

As an experienced, DIN EN ISO 13485-certified service provider for development and production, Solectrix generates reliable solutions that meet the necessary technical requirements of its customers while complying with strict regulatory requirements worldwide, thus ensuring global market access.

By integrating the ASSDEV Group into the Solectrix Group in 2024, we are strengthening our commitment to in-house production.  By combining competencies, the development and design expertise of Solectrix and AST-X in the field of innovative embedded systems is bundled with the manufacturing know-how of ASSDEV and Solectrix Systems for the production and distribution of complex electronic assemblies and systems.

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