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MEDICAL DEVICES

Innovation partner for future-proof medical technology solutions

Medical technology is the backbone of modern healthcare. Innovative technologies and processes are key drivers of progress in prevention, diagnosis and therapy. These improvements require modular, mechatronic architectures, intelligent digitalization strategies, modern update concepts and comprehensive integration of cybersecurity measures. Companies face significant challenges in this regard: Regulatory requirements such as the Medical Device Regulation (MDR), the EU Artificial Intelligence Regulation (AI-ACT) and FDA guidelines demand precise technical solutions, seamless documentation and uncompromising quality. At the same time, there is a growing demand for sustainable, resource-efficient products that combine ecological advantages with economic goals such as reduced costs and positive brand perception.

Regulatory requirements such as the Medical Device Regulation (MDR), the EU Artificial Intelligence Regulation (AI-ACT) and FDA guidelines demand precise technical solutions, seamless documentation and uncompromising quality. At the same time, there is a growing demand for sustainable, resource-efficient products that combine ecological advantages with economic goals such as reduced costs and positive brand perception.

 

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Topic overview


EDAG Group:
Excellence in quality meets efficiency

As an experienced development partner, the EDAG Group combines the highest quality with time and cost efficiency – even under demanding conditions. We have been successfully applying this expertise in medical technology for years, supporting companies of all sizes – from start-ups and small and medium-sized enterprises to corporations.

We ensure verified functionality and develop aesthetic, cost-optimized and future-proof medical products. Our solutions are intuitive to use, scalable and sustainable over their life cycle. Together, we are shaping the medical technology of tomorrow – innovatively and reliably.

Our core competencies in the medical industry

  • Products and design:
    From the concept to the prototype to series development, including virtual and test-based validation, release and documentation
  • Electronic and software development:
    Customized electronic and software solutions – from the requirements to the system release
  • Verification and validation:
    From functional validation to a safe, market-ready and verified medical device
  • Production solutions:
    From vision to realization: scalable, efficient and future-proof
  • Regulatory standards:
    From analysis to release recommendation

Services in the field of medical technology

As a medical device manufacturer, you need comprehensive development services that go beyond technical implementation and production planning. Regulatory and market-related requirements play a major role here. The EDAG Group is here to support you:

  • Product development and design
      • Fully digital development:
        Implementation of a product idea from the initial concept to the production-ready product – including requirements management, styling, design and simulation.
      • Verification and validation:
        Ensuring functionality through comprehensive tests and inspections.
      • Concept and design:
        Development of user-friendly and functional medical devices using CAD models, individually tailored to your requirements.
      • Functional development:
        Analysis and development of functional requirements such as kinematics of components and mechanical systems for optimal product performance.
      • Ergonomics and user-friendliness:
        Taking into account user needs for easy handling.
      • Producibility and material selection:
        Efficient production and selection of optimal materials that ensure performance, biocompatibility and durability.
      • Detailed design:
        Precise CAD models and technical drawings ensure flawless implementation of your products.
      • Data management and documentation:
        Structured management of your data to meet the highest regulatory requirements.
      • Integration and interfaces:
        Seamless connection of all components and systems for smooth functionality.
      • Dimensional management: 
        Precise tolerance analyses to calculate and optimize manufacturing accuracy, ensuring precisely fitting components and the highest product quality.
      • Surface creation:
        Designing functional, aesthetic and hygienic surfaces that meet the highest requirements for ergonomics and safety.
  • Electronic and software development
      • Use case-oriented creation of product specifications and concepts
      • Development and validation of embedded hardware and software
      • Creation of frontend and backend solutions for user-friendly digital ecosystems with added value
      • Integration of IoT components and sensors
      • Development of cloud-based solutions and data management systems
      • Implementation of security and data protection measures
      • Prototyping and testing of hardware and software solutions
      • Maintenance and continuous improvement of existing systems
  • Regulatory expertise
      • Consultancy on MDR, FDA and other standards
      • Creation of the required documentation
      • Tests for certifications (ISO 13485, CE)
      • Risk analysis and concepts for ensuring safety and reliability
      • Process consultancy for management and development processes
  • Prototyping and testing
      • Development and validation of functional prototypes
      • Development of standardized or customer-specific test equipment
      • Conducting verification, validation and usability tests (e.g. according to IEC 62366)
  • Product optimization and specification
      • Refinement of product specifications, failure analysis and product improvements
  • Manufacturing and scaling
      • Production planning and optimization, support in production preparation, supplier management and process optimization
  • Post-market-surveillance and lifecycle management
      • Post-market surveillance and ensuring regulatory compliance
  • Project management and coordination
      • Project management and monitoring:
        Maximum transparency ensures timely and high-quality implementation of all project phases.
      • Finding solutions when goals are missed:
        Fast and targeted measures ensure project success when faced with unplanned challenges.
      • Timing, weight and cost tracking: 
        Precise monitoring of schedules, weight and costs ensures that your project stays on track and that resources are used efficiently.
      • Status reports:
        Regular updates keep you constantly informed about the progress and current status of the project.
      • Supplier management:
        Reliable coordination of suppliers and partners guarantees a smooth supply chain and on-time delivery.
  • Training and documentation
      • Creation of technical documentation and training for safe use.
  • Technology and innovation consulting
      • Consultancy on IoT, AI, sensor technology and other technologies.
      • Development of innovative product ideas and identification of new market opportunities.

Use Cases


Development of digital products for medical devices
Development of front- and backend solutions as medical devices

 

  • Task:
      • Feature extension through digital solutions: Development of intuitive front-end solutions and scalable and future-proof back-end systems.
      • Securing update capability: Concept design and implementation of over-the-air update-capable systems.
      • Cybersecurity analyses and concepts: Identification of threat scenarios, risk assessments, development and implementation of robust security concepts.
  • Challenges:
      • Requirements and specifications: Precise, clear and testable description of requirements.
      • Future-proof concepts: Integration of devices and digital products while ensuring seamless compatibility.
      • Regulatory requirements: Complete and standards-compliant documentation, as well as compliance with all relevant standards.
      • Project management: Close interdisciplinary collaboration, combined with agility and reliability.
      • Data protection and cybersecurity: Protection of sensitive patient data through robust access management and security solutions.
      • Time and costs: Efficient budget planning and short time to market.
  • Solution:
      • Early involvement: Development of proof of concepts or minimum viable products to ensure successful implementation.
      • Clear project management: Structured milestone planning with reference to agile feature development.
      • Iterative testing: Continuous security and usability testing during all development phases.

Virtual development (CAE) – medical devices – structural integrity
Numerical simulation

  • Task:
      • Requirements analysis: Use of modern simulation tools to evaluate:
      • Structure (strength, durability, vibrations, acoustics, impact loads)
      • Media flows (mixing processes, pressure losses, temperature management, ...)
      • Wide range of applications: Can be used for medical products as well as for their production tools and equipment.
  • Challenges:
      • Avoiding cost-intensive and unreliable products.
      • Minimizing risks and shortening development times.
  • Solution:
      • Use of the latest numerical optimization tools for maximum functionality with minimum material usage.
      • Early integration of simulation tools ensures that all requirements are met and costly hardware tests are avoided.

Validation of production processes – endoscopy device
Validation and quality assurance with a focus on production

  • Task:
      • Process validation: Review of production drawings, specifications and work instructions. Performance and documentation of process analyses and validations.
      • Validation of test methods: Development and specification of the required test equipment and optimization of processes. Ensuring the quality of product properties and specifications through validated end tests.
      • Design transfer/series production: Feeding quality improvements back into production and revising specifications, with a particular focus on sustainability in process and test method validation.
  • Challenges:
      • Increase in the quality level of production.
      • Securing external approvals for validation.
  • Solution:
      • Continuous integration of quality processes throughout the development process.
      • Transfer of industry know-how with lessons learned.
      • Ensuring transparent and continuous reporting to those in charge from a quality perspective.

Design development of surgical robots
Design and development of a support arm structure for a 5-arm surgical robot

  • Task:
      • Conceptual design: development of the upper articulated arms with design and concept validation, including cross-section design of the profiles based on force requirements. Kinematic design of the articulated arms according to specifications for travel distances.
      • Material selection: Evaluation of suitable materials considering stiffness requirements, processability, functional integration, quantity, finish, media and aging resistance, weight, and certification according to medical standards.
      • Design and creation of drawings: Detailed design based on the concepts. Integration of servomotors, circuit boards, cable routing, lighting and end stops. Creation of single-part and assembly drawings.
      • Dimensional management: Precise tolerance analyses to optimize manufacturing accuracy and ensure precise fit.
      • CAE: Calculation of the articulated arm structures, taking into account specific load cases.
  • Challenges:
      • Increasing the rigidity of the articulated arms, both in terms of individual parts and in terms of assembly.
      • Reducing the mass while at the same time reinforcing the structural measures to absorb forces during the operation and to minimize relative movements and vibrations.
      • Selecting a material that meets the requirements of the specifications and guarantees long-term usability.
  • Result:
      • Optimized component geometry and the use of high-strength materials increase the rigidity of the articulated arms while simultaneously reducing their mass.
      • Additional structural measures minimize vibrations and relative movements during the surgical procedure by effectively absorbing any forces that occur.
      • The final design of the articulated arms is highly precise, functional and robust, and meets all mechanical requirements and medical standards.
      • Carefully considered material selection and design measures ensure a long service life and excellent performance in a medical environment.

Let's talk about your use case now!

Peter WeismüllerSenior Sales Manager Medical