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Behind the Scenes: Medres’ In-House Fixture Engineering

At Medres, we prioritize quality, precision and efficiency in manufacturing. The manufacturing of medical devices presents various challenges, however custom-designed tools, known as fixtures, play a crucial role in overcoming these obstacles and enhancing the efficacy of the medical device assembly process. Since our manufacturing engineering team is dedicated to the design of these fixtures in-house, we asked Mr. Benett Karsai, our Senior Process Engineer, to share his insights into this exciting field.


The Definition of Fixtures

Fixtures are custom-designed tools that support specific manufacturing operations, often performing stabilizing or positioning tasks. In the realm of medical device assembly, fixtures play a pivotal role in ensuring the rapid, accurate, and repeatable assembly of components. This, in turn, contributes to the uniformity, reliability, and compliance of the final products with regulatory standards.


Key Considerations in Medical Device Fixture Design

By considering these factors, fixtures can effectively support the manufacturing of medical devices, ensuring a precise, safe, and efficient production process:

  1. Safety: Ensuring that fixtures do not pose risks to user safety is paramount.
  2. Repeatability: Critical for maintaining consistency in the produced items.
  3. Accuracy: Products must meet specifications, including customer requirements and industry standards.
  4. Material Selection: Choosing materials compatible with cleanroom is essential. Easy-to-clean materials resistant to common cleaning agents such as isopropyl alcohol are recommended.
  5. Durability and Reliability: Fixtures must provide long-lasting and reliable performance throughout the medical device manufacturing process.
  6. Ergonomics & Usability: Designing fixtures with user-friendly features minimizes physical strain on manufacturing line workers, improving overall efficiency.
  7. Cost-effectiveness: Striking a balance between functionality and simplicity to manage costs effectively.
  8. Compliance with Quality Standards: Adhering to quality standards, notably ISO-13485, is essential. This process includes understanding regulations, meticulous design, testing, and comprehensive documentation. Decision-making regarding fixture compliance is a collaborative effort between engineering and quality assurance teams.


A Step-by-Step Guide to Fixture Design

Data Collection & Requirement Definition

Understanding the task, identifying the problem, determining the fixture requirements, our expectations, the final output characteristics, and the functionality of the tool.

Brainstorming & Conceptual Design

Collaborating with relevant stakeholders and developing concepts aligned with defined requirements.

3D Design and Modeling

Utilizing dedicated software for detailed design and visualization.

3D Design Analysis

Assessing aspects like usability and potential impact on cycle time, expected functionality, and considering redesign if necessary.

Specification Creation

Generating specifications with input from quality assurance and customer approval.

Fixture Manufacturing

Building the fixture prototype based on the approved specifications.


Rigorous testing with quality assurance approval to ensure compliance with requirements. Re-design if necessary.

Implementation of Final Version

Documenting the final version for production use and providing training.


Challenges in Fixture Design and Solutions

The primary challenge is meeting various requirements, requiring a comprehensive approach. This involves implementing advanced safety features, precision engineering, stringent quality control, careful material selection, rigorous testing and ergonomic design.

Balancing cost-effectiveness involves streamlined design without compromising quality, and compliance with standards requires a thorough understanding of regulations.

In custom projects, flexibility and meticulous planning are crucial to address additional complexities. Close collaboration with teams, especially quality control, is essential, ensuring seamless communication throughout the design process. Operator feedback is invaluable, leading to adjustments improving performance, optimizing functionality, enhancing ergonomics, and increasing safety.



It can be stated that at Medres, our commitment to excellence in medical device manufacturing is also evident in the meticulous design and implementation of fixtures. Through careful consideration of key factors, they can contribute significantly to the production of high-quality medical devices.