Reducing costs and risk through modular medical device development

Modular components make work easier for developers when it comes to fine-tuning hardware and software and implementing European regulations like MDR and IVDR.

The introduction of MDR and IVDR has further complicated the development of medical devices. For companies placing them on the market they result in more effort, especially regarding documentation and certification of even previously existing systems. Because of this, Solectrix is using a system development approach based on modular individual systems for current projects.


Developing medical products using modular design

In any case, meticulous analysis of commonalities and variances is the first step: For instance, a look at the lab device market shows that many devices have the same technical requirements for the processing of a sample. The evaluation method varies, but then many devices share a clear control interface for the user and the connectivity to the cloud or some hospital infrastructure. Implementing these using modular design can thus generate significant positive effects.

Each building block of a modular system needs to be completely and thoroughly specified, developed and, most of all, verified. For this, Solectrix uses the application lifecycle management (ALM) system “codebeamer X” by Intland Software, which makes it possible to transfer the necessary information into a subsequent development project almost in a copy-and-paste manner. It provides safety and control mechanisms and also ensures the required traceability.

Defining interfaces and configuration options with foresight

To enable broad use of modular sub-systems, interfaces for communication, control signals and the power supply must be designed with great care to make them as universal and future-proof as possible. The well-conceived use of similar components and the early definition of configuration options for possible hardware setups have positive effects not only on development time, but also on procurement and production. A broad use of modular components further enables central handling of all topics related to obsolescence of third-party components and also has positive effects on product software maintenance, for example when it comes to continuous security updates and the quick closing of security loopholes.

Example: SX Mobile Device Kit

A successful example for the modular approach at Solectrix is the SX Mobile Device Kit, a development platform for mobile medical devices. The kit consists of perfectly matched and verified hardware, software and mechanics. The focus on mobile applications means that the special requirements of mobile devices regarding battery operation and wireless communications are covered by default. On the software side, all components come with fully developed and documented implementations within the framework of a Board Support Package for Linux or Android. This way, development can begin on a very advanced level. From the start of the project, planning and design security is a given and so is a shortened time-to-market.

Expanded and combined with a suitable, specific sensor or detection module, the kit has already served as a platform base for lateral flow test devices, mobile IPL (intense pulsed light) devices and other universally usable medical tablets.

Your reliable partner for development and production

As an experienced service provider for development and production, Solectrix generates reliable solutions that meet its customers’ technical requirements while taking into account and satisfying the strict regulatory policies of the medical market.

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