Medical Products & Disposables
Medical Products & Disposables: Innovative solutions for the highest standards
Secure fulfillment of regulatory requirements
The market for medical products and disposables is on the verge of dynamic developments that will bring both opportunities and challenges. Disposable products such as gloves, syringes, infusion sets and bandages are essential for everyday medical care and contribute significantly to infection prevention. The increasing demand for such products is driven by factors such as an aging population, increasing health awareness and the need for improved hygiene standards.
At the same time, the industry is subject to strict regulatory requirements, for example, the Medical Device Regulation (MDR) in Europe and the requirements of the US Food and Drug Administration (FDA). These regulations ensure that medical products meet the highest quality and safety standards, but they also increase the complexity of product development and approval.
- Mastering regulatory requirements
Mastering regulatory requirements
The increasing complexity of the regulatory environment is influenced by various factors: the demanding language of regulation, the complexity of the approval process, global differences, database-related aspects and product-specific challenges.
In this challenging environment, the EDAG Group is a competent partner for companies in the field of medical products and disposables. With our extensive expertise, we support you in product development and design to create user-friendly, functional and safe solutions that meet the requirements of the medical sector and the needs of users. Our electronics and software development offers customized solutions for products with electronic components, such as modern inhalers or diagnostic tests.
In addition, we have in-depth regulatory expertise and can support you in complying with all relevant regulations, including the MDR and FDA guidelines. Our range of services includes prototyping and extensive testing to ensure the functionality and safety of your products prior to market launch. We can help you optimize existing products in terms of material selection, user-friendliness and production processes to achieve efficiency gains and cost reductions.
- Efficient development, production and market launch
Through effective project management and structured coordination, we ensure that all phases of development and production run smoothly and on schedule. After market launch, we are at your side with post-market surveillance and lifecycle management to ensure the quality and safety of your products throughout their entire lifecycle. Our training programs and the creation of complete, compliant documentation support you in the approval and distribution of your products. At the same time, our technology and innovation consulting services keep you up to date on new materials, manufacturing technologies and innovative solutions to help keep your products competitive and future-proof.
The EDAG Group is your reliable partner for operating successfully in a constantly changing market and meeting the highest quality standards.
Topic overview
Our core competencies in the area of Products & Disposables
- Development and design
Development of innovative, user-friendly and safe disposables that fulfill both medical requirements and the needs of users.
- Prototyping and validation
From the initial idea to series production: simulation, development, testing and optimization to ensure functionality, safety and efficiency.
- Regulatory requirements and quality management
Advice and support in complying with regulatory requirements and in quality management throughout the entire product life cycle.
- Production and scaling
Efficient manufacturing and scaling of disposables to ensure economical and high-quality production.
- Project management and support
Structured planning, coordination and support of all development and production phases – supplemented by training and documentation.
- Technology and innovation consulting
Strategic advice on new materials, manufacturing technologies and innovative solutions to make disposables competitive and future-proof.
Customized services in the field of medical products and disposables
- Customized solutions
EDAG Group as a provider of comprehensive solutions or as a partner in selected disciplines.
- Holistic development and support
- Support in all phases: from design and development to prototyping and testing, as well as production and digital services.
- Regulatory advice, documentation and lifecycle management for a safe and efficient market launch.
Use Cases
Optimizing the product costs of medical devices
- Requirement
A leading supplier of medical laboratory equipment needed support in reducing the product costs of a storage tank to ensure its long-term competitiveness. The aim was to create transparency regarding the manufacturing costs and to enable a well-informed decision to be made about in-house production.
- Targets
- Detailed analysis of the manufacturing costs
- Securing cost efficiency for possible in-house production
- Sustainable reduction of production costs
- Solutions
- Disassembly and detailed analysis of the product to identify potential savings
- Calculation of product costs and transparent presentation of the cost structure
- Benchmarking and cost comparison with competing products
- Determining cost drivers and optimization potential
- Development of targeted measures for sustainable cost reduction
- Your benefits
- Complete transparency of manufacturing costs and cost structure for in-house production
- Reliable “make-or-buy” decision based on sound analysis
- 22% reduction in product costs, without compromising on quality and functionality
Development of a sustainable plant and logistics concept for the production of dialysis machines
- Requirement
A leading manufacturer of dialysis machines was looking for a partner to optimize the production processes for its main product. The goal was to develop a reliable and sustainable plant and logistics concept that would enable efficient and economical production.
- Targets
- Comprehensive concept development for a new production area
- Creation of a sustainable production concept based on defined requirements
- Solutions
- Analysis and comparison of the manufacturing processes used
- Evaluation of the product design with regard to the proportion of common parts and structure
- Examination of shared production lines for efficiency potential
- Suitability test of different manufacturing, quality and logistics philosophies
- Comparison of alternative layout and manufacturing strategies
- Integration of new requirements into existing production facilities
- Estimation of the cost of the production changeover
- Creation of a detailed schedule and timetable
- Your benefits
- Efficient optimization of production and logistics processes
- In-depth assessment of automation potential to increase manufacturing performance
Let's talk about your use case now!
