The advancing digitalization of medical technology is revolutionizing our healthcare system. It offers enormous market opportunities for innovative companies. While facing the technical challenges, it is also important to focus on the steadily increasing legal framework and regulations throughout development.
As an experienced development service provider, we offer you reliable solutions that meet the necessary technical requirements while taking into account and fulfilling the strict regulatory guidelines of the medical market.
Many years of experience in medical technology, extensive know-how about processes, methodology, product development and production make us a strong partner in the development of tailor-made solutions for innovative medical and IVD products. For you and with you we develop electronic components and software, but also complete medical devices and systems, in a standard-compliant, efficient and individual manner.
Our customers, whether they are start-ups, medium-sized companies or large corporations, particularly benefit from our cross-sector expertise and our skills in high-speed electronics, embedded software, FPGA design, image processing and the development of mobile devices.
Our service portfolio for medical technology is broad. We develop system solutions for IVD devices and point-of-care technologies (POCT). In the development of diagnostic, treatment and monitoring devices, we are specialists for projects with a focus on mobile devices, taking into account the specific requirements for battery and charging operation, wireless communication and security. In addition, we convince with innovative and highly precise temperature control solutions for handling samples in laboratory devices in clinical use. Innovative solutions such as a 3D camera monitor system for sophisticated digital microscopy with high demands on image quality and latency complete our portfolio.
The latest development in this area is the SX Mobile Device Kit (MDK). As a platform for the entry into the development of a mobile ARM-based embedded system it provides an elaborate device design, comprising both hard- and software and a flexible housing concept that can be adapted according to the customer’s needs.
Using intelligent temperature control without an expensive Peltier element, combined with contactless measurement data acquisition via RFID, we have developed an LED-heated measuring chamber for moving liquid samples. The temperature of the liquid is regulated by individually controlled infrared LEDs, which can achieve a much more constant temperature level in the sample than conventional heating systems, resulting in a temperature accuracy of ± 0.35 ° C at 7500 rpm. One of numerous possible areas of application for the measuring chamber: temperature control and analysis of blood samples.
Temperature control solutions
As a cooperation partner in the development of a highly sensitive, two-dimensional detection system for molecular diagnostics, we have developed a technology for particularly precise temperature control of a large number of analysis samples. The innovation of the system is the ability to individually control and optimize each of the existing heating and cooling elements. With our temperature control solution, we managed to achieve homogeneity of less than 0.5 °C across all vessels in all phases of the heating and cooling ramps in a PCR unit for 96 samples using a heating and cooling system with 6 Peltier elements.
3D camera monitor systems
We develop digital 3D camera monitor systems that use sophisticated high-performance data processing to produce an exact 3D image in 4K UHD resolution with low latency. By employing a 3D screen that can be used without glasses, we have created a compact system that meets the highest quality standards and can be used entirely glasses-free as an upgrade for optical stereo microscopes or as a complete digital system. Our camera heads deliver up to 60 frames per second in 4K UHD resolution. The image sensor system records the image data and forwards it for image processing and 3D processing. Our in-house “real 3D” concept ensures the synchronous recording of the two image data streams, guaranteeing uniform image properties through simultaneous processing within a single FPGA. The stereo image is processed in real time for the viewer and output on a 3D monitor. Areas of application: from demanding diagnostic work in the laboratory or industrial production to use in medical microscopy.
Our actions always focus on your needs. We use state-of-the-art technology to implement your vision an efficient and high-quality manner. Our partnership-based cooperation is grounded on professional project and process management with agile development methods, always taking into account your time-to-market factor. Transparency and openness are just as important to us as reliability regarding deadlines and flexibility.
We are at your side with advice and assistance for the entire product life cycle of your innovation. We take on exactly the tasks for which you need us. Because for us, a collaborative partnership is designed in a modular way.
We offer you software, hardware and mechanics from a single source, perfectly coordinated and optimally tailored to your needs. Our solutions include highly integrated electronics and high-speed microprocessor assemblies with complex user interfaces and programmable logic. We provide you with the appropriate firmware and take care of the connection to the operating system of your choice.
- Circuit diagram and layout creation (tools: Altium Designer®, Siemens/Mentor PADS® & Expedition™, Pulsonix)
- Circuit simulation
- Complete EMC-compliant design
- Design and implementation of analog circuits
- Evidence and testing of conformity (CE, UL, ROHS)
- Development for FPGAs / SoCs of all common manufacturers
- Reliable controls for real-time critical and safety-relevant applications
- High-speed data processing, e.g., for use in image processing (ISP)
- Ensuring update capability in the market
- Software development for medical devices according to IEC 62304
- Consideration of safety and security aspects during the initial phase of the architectural design process
- Expertise for all common processor architectures
- Implementation of complex controls and regulation of sensors / actuators
- Realization and deployment of board support packages (BSPs)
- Implementation of device drivers and hardware abstraction layers
- Application development based on real-time operating systems (RTOS), embedded Linux® or Android™
Certifications & standards
Our systems are designed, developed and documented in accordance with the MDR, IVDR and FDA standards. We also follow guidelines and standards such as:
- IEC 60601-1: „Medical electrical device safety”
- IEC 62366: „Usability applications for medical devices”
- IEC 62304: „Medical Device Software – Software Life Cycle Processes”
- EN ISO 14971: „Medical devices – application of risk management”
- EN ISO 13485: „Medical devices – Quality management systems – Requirements for regulatory purposes”
Explain your idea to us! If we understand the area of application and the requirements for your product, we can use our expertise and creativity to show you solution options that are optimally tailored to your needs.
In close consultation with you, we create a system concept for your medical or IVD product. We select suitable system components, optimized according to technical, systemic and cost aspects.
Whether for a complete medical system or a programmable electronic subsystem for integration into your overall system – we align the electronics, mechanics and software design with your environmental factors and develop in a custom-tailored and time-to-market-oriented manner. We work according to our own development process or integrate ourselves into your company’s existing processes.
We support you during the construction and further development of test set-ups, prototypes and system integration. Additionally, we conduct tests during the development, thus ensuring the eventual verification and its documentation early on.
Our in-house production company Solectrix Systems enables us to offer you professional manufacturing services up to small-batch production. Individual test concepts ensure product quality and documentation requirements. Or we accompany you up to the switch to your own series production.
In addition to production, we provide you with service and support over the entire product lifecycle of our development. We work self-reliantly on topics such as the obsolescence of components to ensure long-term producibility. We are happy to reliably handle the maintenance and further development of your device software.
All trademarks are the property of their respective owners.