What Makes OECHSLERhealth an Expert in Toolmaking for Medical Devices?

Toolmaking for medical devices is one of the most demanding disciplines in manufacturing technology. The highest precision and compliance with strict regulatory requirements are essential to ensure that the manufactured medical devices can be used reliably and safely in the medical field. In this context, special materials, innovative manufacturing technologies, and certified quality management systems are crucial.

Medical products such as injection systems or diagnostic devices require specialized tools that must be manufactured under the highest hygienic conditions. Certifications such as ISO 13485 are particularly important, as they ensure that all processes comply with medical device regulations.

In the following interview, Andreas Kastner, Head of New Tooling at OECHSLERhealth, provides insight into the specific requirements of toolmaking in the medical device sector and explains how OECHSLERhealth applies its expertise in this field.

Mr. Kastner, What Makes Toolmaking in the Healthcare Sector Particularly Special?

Toolmaking for medical devices places particularly high demands on materials and processing. To meet GMP requirements, we place great importance on the biocompatibility of our toolmaking materials. We achieve this, among other things, through the use of special coatings, lubricants, and stainless steels. These high medical standards in toolmaking are ensured at all our locations.

What Are Biocompatible Materials, and Why Are They Relevant for OECHSLERhealth’s Toolmaking?

Biocompatible materials can come into contact with living tissue or biological systems without causing harmful reactions. They must ensure that no toxic, allergic, or inflammatory reactions occur when used on patients. These materials are often used in medical technology, for example, for surgical instruments or injection systems.

For OECHSLERhealth's toolmaking, they are significant because all materials, coatings, and lubricants used must meet the strict requirements of medical technology. The increasing use of 3D printing also requires biocompatible steels to ensure the highest safety and quality standards.

Biocompatibility plays a crucial role in ensuring patient safety and complying with regulatory requirements.

How do you ensure that the tools meet the high precision requirements in the healthcare sector?

In healthcare toolmaking, tight tolerances and the highest precision are essential, as even the smallest deviations can impact the quality and functionality of a medical product. We rely on modern manufacturing techniques such as micro injection molding and produce tools with extremely small dimensions and precise surface structures. These processes enable us to manufacture components with micrometer-level tolerances, which are necessary for use in medical technology. Additionally, we use advanced measurement techniques such as 3D scanning and coordinate measuring machines to ensure that each tool meets the required precision tolerances.

What Specialized Manufacturing Techniques Do You Use in Toolmaking for Medical Devices, and Why Are They Particularly Important?

In toolmaking for medical devices, we employ a variety of specialized manufacturing techniques necessary to meet the high standards of this industry. Micro-machining allows us to produce the smallest, highly precise components with very fine details, essential for micro-surgical instruments or injection systems. Electrical discharge machining (EDM) enables us to precisely process even very hard materials, making it ideal for tools designed for complex geometries or very high tolerances. Additionally, we use laser processing to achieve precise cutting edges and surface treatments required in medical technology to ensure high cleanliness and precise functionality.

What Are the Biggest Challenges in Toolmaking for Medical Devices?

One of the biggest challenges in toolmaking for medical devices is designing the tools in terms of shot numbers and tool availability, especially regarding maintenance and cleaning. Specialized cleaning procedures and the selection of appropriate lubricants and coatings are crucial. Additionally, special cleanrooms and ultrasonic baths are required to meet the highest cleanliness standards.

What Strengths of OECHSLERhealth Are Particularly Important for Toolmaking in Medical Devices?

One of our greatest strengths in toolmaking for medical devices is our ability to quickly adapt to changing requirements. This flexibility enables us to develop innovative solutions tailored precisely to our customers' needs, even in an ever-evolving market.

What Challenges Arise When Implementing Specific Customer Requirements?

Our goal is to understand our customers' requirements in detail and implement them through our outstanding expertise in toolmaking. This means acting as problem solvers and consultants, particularly for complex components up to multi-component micro-injection molded parts. Multi-component micro-injection molded parts are particularly relevant in medical technology as they enable the production of highly precise, complex, and functional components. In this process, two or more materials are combined in a single injection molding process, creating seamless connections without additional assembly steps. A growing trend is increasingly large tool packages from a single source, with the highest quality and short lead times. An example is our 24-cavity molds for series production of high-precision plastic components used in various applications.

What Certifications Are Important in Toolmaking for Medical Devices?

In toolmaking, we work according to GMP guidelines and ISO 13485. These standards ensure that our production processes meet the highest quality requirements and that the manufacturing of medical devices complies with international standards.

By implementing GMP, we ensure that all production steps are carried out under controlled conditions, allowing for complete traceability and quality assurance. ISO 13485 guarantees that our tools and processes are optimally designed for the quality, safety, and efficiency of medical device manufacturing.

Thanks to these certifications and the continuous training of our employees, we offer tools that meet the highest standards and consistently deliver reliable and precise results to our customers.

How Do You Guarantee Seamless Documentation and Traceability in Your Production?

Documentation and traceability are particularly crucial in the healthcare sector to ensure the quality and safety of medical devices. We implement a certified quality management system according to ISO 13485, which ensures that all processes, materials, and manufacturing steps are thoroughly documented. Each component and tool is equipped with a tracking system that allows us to trace the entire production history—from manufacturing and validation to delivery. Additionally, we conduct regular validations to ensure that all production processes comply with regulatory requirements.

Conclusion

OECHSLERhealth focuses on the highest precision, innovation, and flexibility in toolmaking for medical devices. The strict requirements of the healthcare industry demand customized solutions that guarantee biocompatibility, cleanliness, and compliance with all relevant certifications. With its expertise and rapid adaptability, OECHSLERhealth remains a reliable partner for the development and production of medical devices that meet the highest standards.

Further information on toolmaking can be found here: Technology.