Knowledge is the key to success

seleon medical engineering has a clear goal: to turn your ideas into products that represent the very pinnacle of development. We use our experience for the benefit of our customers to develop housings, equipment holders, control units, sensors, valves, compressors, fans, pumps and much more.

The specialist knowledge of our interdisciplinary development teams is at your disposal throughout the development process, from concept design to series production. By outsourcing all stages of the project to a single service provider you can cut costs, gain time and ultimately achieve the best possible outcome for market success.

Development process

Research/concepts

We carry out careful feasibility studies to identify a realistic project outcome and ascertain how quickly the project can be completed and with what resources. We analyse the situation, produce and compare technical concepts, evaluate the availability of special components and estimate the costs.

Feasibility studies

To demonstrate the practical feasibility of a concept we build prototypes and demo models. After all, your customers will always be more impressed by something they can see in action.

During this phase we also carry out patent research to help you evaluate industrial property rights and develop patentable solutions.

Design drafts/studies

During the design phase we attach a lot of importance to the visual and tactile aspects of the product. This is a key component of our service. The look, material and finish are all experienced by the senses and convey something of the product’s characteristics. It goes without saying that in medical engineering, ergonomics, comfort and safety are just as important as performance.


Depending on the scope of the task we either use our own designers or collaborate with external design studios.

Specifications/requirements catalogues

Any development process needs a wish list and building instructions.

The first step is to define the product, establish the market requirements and specify the required product features. This information is summarised in the specification. The specification forms the basis for development work. If the customer comes to us with simply an idea, we will work with them to produce the specification.

How these defined product requirements are to be implemented, within what time frame and with what financial resources is set out in the requirements catalogue. This document is essential to a successful development outcome. We strive to make sure it is well structured and no important details are missing. The requirements catalogue includes a discussion of possible solutions, the complete project plan and an initial risk analysis to allow you to plan with confidence.

Functional samples

Functional samples reduce development risk and therefore costs. Depending on requirements a functional sample may be a simple lab mock-up which only demonstrates the most critical functions or an advanced model with an almost complete set of features. Where appropriate we also produce functional samples at different stages of development.
 

Prototypes

Prototypes are very similar to the final product. To manufacture prototypes we use the process known as rapid prototyping, a method of converting CAD data quickly and efficiently into actual workpieces. Our prototypes are generally advanced enough to receive a CE label and a licence for use as a medical product (with limited period of use).

Transition to series production

The development phase is only complete once the product can be series-produced. In order to transition to series production, we provide support with the necessary documentation (such as structural parts lists or manufacturing and testing instructions), production and supervision of the zero series, and the provision of production equipment or special test equipment. We also assist suppliers with the tool and mould concept, mould testing and fine adjustment of machinery.

Areas of development

Mechanics/mechatronics/design

One of our core competencies is the interplay of mechanical, electronic and IT modules in mechatronic systems.

We design plastic and metal components in ProEngineer and SolidWorks and also organise the manufacturing of series production tools and moulds.

Electronics

We provide a full range of development services for the type of electronics used in medical engineering. For example, we develop 2-layer to multi-layer PCBs, analogue and digital measuring circuits, microcontroller systems, control systems, measurement recording and processing systems, and much more. We design both the circuit and the PCB layout. EMC factors are taken into consideration throughout the development process.

Software/Firmware

We offer a complete software and firmware development service, from concept design and programming to testing and documentation. We develop programs not only for PCs but also for embedded systems and microcontrollers. We work with many different types of systems, from simple device control to multi-processor systems for life-supporting or safety-related processes, including wireless interfaces and PC interaction.

Process technology

Our process engineers are specialists in fluid handling and the heating, cooling and thermostatic monitoring of body fluids in medical equipment. This includes sensor technology for monitoring pressure, flow rate, temperature and concentration, actuating components such as valves, pumps, fans and compressors, and control technology with model-based process management.

Product testing/product documentation

On the basis of a structured test plan in line with the V-model, our products are tested at each stage of development:

  • FMEA, hazard analysis, risk analysis, safety analysis
  • Long-term test runs
  • Service life calculations
  • Function tests
  • Software module tests
  • Component tests
  • System tests

To perform complex testing we collaborate with certified laboratories. We produce complete documentation for every stage of the project we are responsible for. This documentation is an important part of the subsequent license application process.

Project management

The project manager has a high degree of responsibility for the customer’s time and financial budgets. That’s why our projects are managed by trained and experienced project managers who put the customer’s interests first and who uphold the values of teamwork and transparency.

Quality management

Quality assurance in the development process

By making quality management an integral part of the development process, we make sure your product is developed on time, within budget and in line with the necessary requirements.

One essential component is risk management, which we apply throughout the entire product lifecycle. We pay particular attention to the associated documentation, which we draw up in accordance with the relevant standards and the customer’s requirements. Early risk detection means efficient development and safe products.