OEM Development
Services

Your idea is strong!
We develop it into a
production ready product.

Tell us more about your project!

You may be asking yourself: Who develops the electronics? Who knows about approval? How can I get everything into series production safely?
This is exactly where DITABIS comes in. We are your partner when it comes to turning an idea into a finished product – quickly, safely and without detours.

Our Solution:

  • Everything from a single source: mechanics, electronics, firmware, software and UI – developed in an interdisciplinary manner, without interface losses.
  • Early clarity: We check technical feasibility and regulatory requirements (e.g. MDR, CE, FDA, etc.) as early as the concept phase.
  • Seamless transition to series production: From development straight to production – without detours, with clear responsibilities.
  • Partnership instead of supplier: We think along with you, provide impetus and develop together with you – flexibly, agile, at eye level.

Our Experts At DITABIS

Mechanical Design

Mechanical solutions that work – design that fits.
Our device engineering combines function, ergonomics and modern housing design – from the initial idea to series production. Whether prototype construction or complex mechanical development: we consider manufacturing processes right from the start, reduce risks and create products that are technically and visually impressive.

Electronics

Intelligent electronics for reliable devices.
Our Electronics Development covers the entire process – from circuit development and printed circuit board (PCB) design to integration into prototypes and series production. We develop robust hardware that meets regulatory requirements, can be produced safely and forms the basis for high-performance medical and industrial devices.
Services In Detail
  • Housing & product design (functional, ergonomic, CI-compliant, bio compatible materials)
  • Mechanical & CAD design of components, modules and assemblies
  • Material selection & production-oriented design (plastic, metal, injection moulding, 3D printing)
  • Integration of electronics & displays into housings and user interfaces
  • Design of moving components (e.g. hinges, slides, drives, actuators)
  • Ergonomics & operating concepts for safe and intuitive user guidance
  • Design in accordance with standard requirements (e.g. ISO 13485, IEC 60601)
  • Prototype construction and CAD simulation for functional and stress testing
  • Mechanical testing and validation (e.g. cycle testing, stability, IP protection)
  • Development and design of production equipment, fixtures and QA-relevant components
  • Documentation and production documents for series transfer and certification
Services In Detail
  • Circuit development & PCB design (including layout, simulation and EMC-compliant design)
  • Development of embedded systems for control, signal processing and sensor evaluation
  • Integration of sensors and actuators (e.g. temperature, pressure, optical sensors)
  • Selection of suitable components & supplier management from a regulatory perspective
  • Development of safety-related hardware (e.g. redundancy, fail-safe concepts, standards such as IEC 60601)
  • Firmware integration & interface development (e.g. UART, USB, Ethernet, Bluetooth, WLAN)
  • Power management & energy efficiency (power supplies, battery operation, charging electronics)
  • Verification of electronics through testing in accordance with MedTech standards
  • Preparation of technical documentation for approvals (e.g. CE, MDR, FDA)
  • Preparation of manufacturing documents (Gerber data, BOM, etc.)
  • Cooperation with mechanical and software teams for seamless system integration

Firm- & Software

Software that brings devices to life.
Our Firm- & Software development encompasses embedded solutions, graphical user interfaces (UI/UX) as well as desktop and cloud applications. From controlling individual functions to complete system integration, we develop secure, intuitive and future-proof software – tailored to the needs of our customers.

Prototyping

From idea to tangible result.
We combine state-of-the-art manufacturing technologies with our development expertise to quickly and cost-effectively produce functional prototypes and pre-series devices. Through precise testing, validation and verification, we ensure that your devices not only look good on paper, but also pass practical tests – thus laying the foundation for a smooth transition to series production in medical technology, life sciences and other industries.
Services In Detail
  • Firmware development for embedded systems (control, signal processing, sensor integration)
  • C | C++ | C# | Python | Java | Assembler | PHP | .NET | …
  • Driver & interface programming (e.g. UART, USB, Ethernet, Bluetooth, WLAN)
  • Development of graphical user interfaces (UI/UX) for touch displays and desktop software
  • Software architecture & system integration for complex device platforms
  • Cloud & connectivity solutions (e.g. data management, remote updates, IoT connectivity)
  • Data management & security concepts (encryption, access controls, data protection according to MDR/GDPR)
  • Test automation & unit tests for high software quality and regulatory compliance
  • Validation & verification according to standards (e.g. IEC 62304, ISO 13485)
  • Creation of regulatory documentation (e.g. software development files, risk analyses)
  • Close cooperation with electronics & mechanics for optimal device integration
Services In Detail
  • Rapid prototyping with 3D printing, CNC, injection moulding and additive processes
  • Construction of functional models and pre-series devices for early validation
  • Integration of electronics, mechanics and software in real test devices
  • Test planning and test execution in accordance with regulatory requirements (ISO 13485, IEC 60601, IEC 62304)
  • Verification and validation of functions, safety and reliability
  • Long-term and stress tests (e.g. service life, temperature, vibration, IP protection)
  • Usability testing and human factors engineering for safe and intuitive operation
  • Iterative optimisation of design, materials and manufacturing processes
  • Preparation of test reports and documentation for approvals (CE, FDA)
  • Seamless transfer to series production through close coordination with production and QM

Options
Overview

Contact us
We ensure that your vision becomes reality. If required, we are happy to collaborate with renowned design agencies from our network or with your partner. In doing so, we always keep an eye on quantity-oriented manufacturing processes, the necessary materials and the desired look and feel.

Housing

  • customised design or
  • catalogue housing
  • use of existing parts
  • plastic, metal
  • bio compatible
  • quantity-optimised

Control Elements

  • touch displays
  • switches
  • buttons
  • soft touch elements
  • haptic elements
  • mechanical elements

Displays

  • with touch and without
  • colour or black and white
  • various different technologies such as LCD/OLED
  • UI/graphics/menu a.s.o. as specified

Your Advantages With DITABIS

1. Everything from a single source

At DITABIS, mechanics, electronics, firmware, software and UI design all work under one roof. For you, this means no interface losses, short communication channels and clear responsibilities – from the initial idea to the finished product.

2. Safety & Regulatory Affairs

We develop in accordance with ISO 13485 and consider approvals such as CE or FDA right from the start. This gives you security, saves time in the approval phase and significantly reduces your project risk.

3. Quick results, early decisions

With prototypes and functional models, we provide you with early clarity on feasibility, design and operating concepts. This enables you to convince investors, accelerate internal decisions and shorten your time to market.

4. Partnership

DITABIS sees itself not only as a developer, but also as a strategic partner. We contribute our own ideas, remain flexible to changes and accompany your product throughout its entire life cycle – from prototype to series production and beyond.

Project Samples

DITABIS is your partner for a wide variety of devices in the fields of medical and laboratory technology. A selection of project examples, as well as special areas of focus and expertise gained from 30 years of development experience, are summarised here.

Further development of existing device generations

Your device works fine – but compared to the competition, it’s no longer up to date? This is exactly what we see with many customers, for example in the field of laboratory equipment. The technology is great and reliable, but modern features such as touch displays or wireless communication are missing.

We retain the proven basis and continue to develop the device in a targeted manner. The result is a new generation of devices that combines solid technology with modern functions, for example:

  • Modern housing design with improved ergonomics and durable materials
  • Touch display for intuitive and safe operation
  • New electronics platform with energy-efficient power management and future-proof interfaces
  • Connectivity functions such as Bluetooth and Wi-Fi for data transfer and service access
  • IoT functions for monitoring, predictive maintenance, analysis and remote updates
  • We document all changes in accordance with DIN EN ISO 13485 and prepare the device for approval.

The result: proven technology is used to create a new generation of devices that remain reliable but are once again at the forefront of the market thanks to the latest functions. A clear competitive advantage for our customers.

Handheld Devices

A customer has a vision for a compact handheld device that enables rapid analysis directly at the point of care or in the field. The challenge: high functionality in a small space, intuitive operation, robust design and regulatory compliance.

Various Device Types

  • Point-of-care diagnostic devices (e.g. for blood tests, PCR or antigen analyses)
  • Lab-on-a-chip systems for portable research and life science applications
  • Therapy devices (e.g. for physiotherapy or dermatology)
  • Measuring and monitoring devices (e.g. vital signs, temperature, gas sensors)

We take care of the entire development process, from the initial idea to series production:

Design & Ergonomics

  • Compact housing design (plastic or metal, injection moulded or hybrid solutions)
  • Ergonomic design for one-handed operation
  • Biocompatible materials, robust construction (IP protection classes, shock resistance)

 

Electronics & Hardware

  • PCB design for highly integrated electronics
  • Integration of sensors and actuators (optical, electrical, thermal, biological)
  • Power supply via lithium-ion batteries, with charging and power management
  • Wireless connectivity such as WLAN, Bluetooth, LTE or IoT connection

 

Firmware & Software

  • Embedded firmware for fast signal processing
  • User-friendly UI/UX on touch displays (LCD or OLED)
  • Cloud connection for data storage, evaluation and remote updates
  • Integration of security mechanisms (data encryption, access control)
  • Prototype construction & testing
  • Rapid prototyping for early functional models
  • Verification & validation according to IEC 60601 (medical technology) or industry-specific standards
  • Usability tests and human factors engineering

The finished handheld device combines reliability, intuitive operation and modern networking. It is regulatory compliant, scalable for series production and can be flexibly adapted to future generations.

 

Imaging

A customer wants to develop a new imaging device that delivers high-resolution images for diagnostics and research. The challenge: maximum image quality, fast data processing and intuitive user guidance – compact, robust and regulatory compliant.

We develop the device holistically – from optics and electronics to software – and combine proven technologies with state-of-the-art imaging solutions, for example:

  • High-precision optical modules (e.g. lenses, filters, laser sources) for accurate imaging
  • High-resolution camera sensors with optimised signal processing
  • Motion systems & mechanics for precise positioning and stability (e.g. in microscopes or scanners)
  • Powerful electronics & data processing for fast image calculation and analysis
  • Intuitive user interface on touch display with live preview and image processing tools
  • Connectivity and cloud functions for storing, analysing and securely sharing image data
  • Hygienic, ergonomic housing design for use in medical environments

All developments are carried out in accordance with the necessary regulatory standards and take into account the requirements for successful certification of the device as early as the concept phase.

The result: an imaging device that combines clinical precision with modern ease of use and opens up completely new possibilities for users in laboratories, clinics and research.

Start-up Wearable

A young start-up approaches us with an innovative idea: a wearable device that can deliver results in just a few minutes. The founders have the core technology, but lack the resources to develop it into an certified, marketable product.

DITABIS takes on the role of development partner and accompanies the start-up step by step:

  • Feasibility study & prototyping for rapid validation of the idea
  • Design of housing and mounting system with a view to ergonomics and series production
  • Development of electronics including sensor integration and power supply
  • Firmware & software development with intuitive user interface
  • Regulatory consulting in accordance with ISO 13485 and preparation for CE marking
  • Pilot production & test series to convince investors and partners

The result is a functioning pre-production device that the founders can successfully present within a reasonable time frame. With our support, the start-up not only gains technological certainty, but also the confidence of investors – laying the foundation for a successful market launch.

In-Vitro-Diagnostics

A customer is planning a new in-vitro-diagnostic device that shall deliver fast and reliable results directly at the point of care. The challenge: to reliably map complex analysis processes in a compact, user-friendly device – while meeting all regulatory requirements.

We take on the entire development process and contribute our interdisciplinary expertise. The result is a device that combines performance with easy use, e.g. through:

  • Highly integrated electronics platform for precise signal processing and control
  • Optical modules for detection (e.g. fluorescence)
  • Automated sample handling for safe and reproducible processes
  • Touch display with intuitive UI/UX, optimised for laboratory and POC applications
  • Connectivity functions such as Wi-Fi, Ethernet or cloud connection for result transfer and remote monitoring
  • Compact, hygienic housing design for easy cleaning and safe handling
  • Test kits, e.g. for calibration or quality assurance of the device

All development work is carried out in accordance with ISO 13485 and takes into account the requirements of the IVDR from the outset.

The result: a market-ready IVD device that delivers precise measurement results, is regulatory compliant and opens up new application possibilities thanks to modern features.

Privacy

An important component for cooperation

Unfortunately, we are unable to show most of our exciting projects, and there is a good reason for this. Discretion and confidentiality are a matter of course for us. Many of our customers entrust us with highly sensitive developments that are subject to strict non-disclosure agreements (NDAs) and do not want us to appear as a partner. At DITABIS, your ideas and technologies are in safe hands.

Dr. Daniel Marcato

One Point of Contact
Clear Communication

At DITABIS, you will have a dedicated project manager as your personal point of contact throughout the entire collaboration. They will be familiar with your project in detail, coordinate the team and ensure that development, production and regulatory affairs work together smoothly.

For you, this means:

  • Clear communication without detours
  • Planning reliability through coordinated processes
  • Quick decisions thanks to direct responsibility
  • Transparency regarding progress, costs and schedules

This is how we ensure that your project is in safe hands – from the initial idea to series production.

 

 

Contact us

You have a good idea,
but no partner for technical implementation?

Our Solution:

Get in Contact with us!

Tell us more about your project. We will listen to your idea, give you an initial assessment and let you know how DITABIS can contribute tangible added value to the project. All of this is completely non-binding for you. Even at such an early stage, we are happy to secure the discussion with a confidentiality agreement if you wish. Your ideas are in safe hands with us!

Meeting in Person

In a follow-up meeting, which can also be held in person, we will present your project to our team. We will work with you to develop ideas and discuss the steps necessary to turn your product into reality. We will also clarify any initial regulatory issues and ensure that nothing stands in the way of a successful project.

Project Kick-Off

Based on the information available and the agreements made, we prepare a quotation estimate. We would also be happy to conduct a workshop with you, at the end of which we will draw up a specification sheet for your product. This then forms the basis of our work and serves as a common thread throughout the development project. Now nothing stands in the way of starting the project!
AI-Beispiel für branchenübergreifende Projekte

Cross-Industry Know-How

Our focus is on medical technology, life sciences and laboratory technology – but our expertise does not end there. We also apply our know-how across industries.
Whether in Robotics, Automation, Consumer Electronics or Defence – wherever precision, quality, regulatory thinking and reliable series production are required, we contribute our experience. This results in cross-industry products that benefit from our approach.

FAQ – Area

1. What services does a development at DITABIS specifically cover?

We offer the entire development process from a single source: housing and mechanical design, electronics design, firmware and software development, prototyping, testing and technical documentation. This ensures that your idea is seamlessly brought to series production.

2. How do you ensure that my product complies with regulatory requirements (MDR, CE, FDA)?

Our development processes are DIN EN ISO 13485 certified and geared towards approval right from the start. We prepare the necessary documentation, handle communication with laboratories and testing centres, carry out risk analyses and assist you with applications – securely, compliant and efficiently.

3. How long does a development project typically take – from the idea to the prototype or series production?

That depends on the complexity and desired certification of your device. We can often produce initial functional prototypes within a few months, while complete and complex series projects can sometimes take 2-3 years. The important thing is that we work efficiently, in a structured and transparent manner, so that you always have a clear overview and can plan accordingly.

4. What sets DITABIS apart from other development service providers in the industry?

We offer you more than just development expertise: we combine technical know-how with regulatory competence and our own production facilities. For you, this means short communication channels, clear responsibilities and a partner who accompanies your project from the initial idea to series production – quickly, reliably and seamlessly.

5. Can DITABIS also update and modernise old product generations?

Yes. We preserve proven technology and upgrade it with modern features such as touch displays, connectivity and cloud integration. This allows us to extend the life cycle of your products and make them fit for current market requirements.

6. Do you also offer reverse engineering services?

Yes, this is one of the common tasks of our development departments. We support you in reverse engineering existing devices or components – for example, if current design or manufacturing documents are not available anymore. In doing so, we record geometries, materials and functions, document the results and, if necessary, develop upgrades for components. In this way, we ensure the availability of spare parts, extend the product life cycle and create the basis for further developments.

7. Do you also provide solutions for start-ups?

Yes! Our services focus on start-ups, SMEs (small and medium-sized enterprises) and large corporations. Many of our customers are start-ups, which often face the challenge of having to develop market-ready products quickly and reliably with limited resources. We support them with flexible project models, rapid prototyping, regulatory advice and lean, efficient collaboration. This gives start-ups early certainty and enables them to convince investors or partners with tangible results. The next pitch? No problem!

8. Is it possible to collaborate with DITABIS without using production services?

Yes, we do not exclude this. Upon request, we can also take care of the development exclusively and then hand over the complete documentation to you for your own production. However, customers appreciate the advantages of seamless series transition at DITABIS, our efficient supplier network and the reliability of production. We are therefore delighted when customers consider production at DITABIS from the outset.

9. We have developed our own core technology – can you turn it into a complete product?

Yes. Many of our customers bring an innovative core element with them, such as a sensor, an optical unit or a special algorithm. Based on this, they are looking for a partner who can develop a functional, approved complete product. This is where we are strong:

We take care of the mechanics, electronics, firmware, software, housing design and approval processes and integrate your technology into a product. This turns your innovation into a market-ready device – quickly, reliably and in compliance with regulatory requirements.

Klementina Nagy-Kanasz

Interested?

Let’s get in contact with each other!

We look forward to getting to know you and your idea! Please contact our sales team:

 

Klementina Nagy-Kanasz
Sales & Marketing

Tel.: +49 (0) 176 / 1298 6337
E-Mail.: K.Nagy-Kanasz@ditabis.de