Domico Med-Device Updates

7 Common Mistakes to Avoid in Medical Device Tool Design and Build

Written by Domico Med-Device | November 18, 2024

In the world of medical device manufacturing, precision and quality are paramount. Tool design and build play a crucial role in ensuring that medical devices meet stringent standards and perform reliably. However, several common mistakes can compromise the quality and effectiveness of these tools. In this blog post, we will explore seven common mistakes in machining, tool design, and build, and discuss how outsourcing to a contract manufacturer like Domico Med-Device can help you avoid these pitfalls.

Mistake 1: Inadequate Material Selection

Choosing the wrong material for your tool can lead to a host of problems, including premature wear, failure under stress, and incompatibility with medical standards. When designing and building tools for medical devices, it is essential to select materials that are durable, biocompatible, and suitable for the specific application. Domico Med-Device excels in this area by offering expertise in material selection, ensuring that the chosen materials meet the highest standards of performance and safety.

Mistake 2: Poor Design for Manufacturability

A common mistake in tool design is not considering the manufacturability of the tool. Complex designs that are difficult to machine or assemble can lead to increased production costs and longer lead times. By working with a contract manufacturer like Domico Med-Device, you can benefit from their extensive experience in designing tools that are both functional and manufacturable. Their design team uses advanced CAM software to convert CAD designs into efficient cutting programs, ensuring that tools are optimized for production.

Mistake 3: Ignoring Tolerances and Fits

Precision is critical in medical device manufacturing. Ignoring tolerances and fits can result in tools that do not function as intended, leading to potential failures and safety issues. Domico Med-Device's robust machining and turning centers are equipped to handle tight tolerances and precise fits, ensuring that every tool meets the required specifications. Their in-house equipment includes state-of-the-art CNC milling centers and lathes that deliver high-quality, precise machining.

Mistake 4: Overlooking Surface Treatments

Surface treatments are essential for enhancing the durability and performance of tools. Common treatments include anodizing, plating, and powder coating, which protect against corrosion and wear. Overlooking these treatments can shorten the lifespan of the tool and compromise its performance. Domico Med-Device's in-house coating facilities can provide a range of metal treatments, ensuring that every tool is built to last and performs reliably under various conditions. 

Mistake 5: Inadequate Testing and Validation

Skipping or inadequately performing testing and validation can lead to tools that fail to meet medical standards and regulatory requirements. Proper testing ensures that tools function correctly and safely. Domico Med-Device is ISO 13485 certified and adheres to all FDA regulations, guaranteeing that every tool undergoes rigorous testing and validation processes. This commitment to quality ensures that all products meet the highest standards of safety and efficacy.

Mistake 6: Inefficient Production Processes

Inefficient production processes can lead to increased costs, longer lead times, and inconsistent quality. Optimizing production processes is essential for achieving high-quality tools in a cost-effective and timely manner. Domico Med-Device utilizes advanced CNC milling and turning centers to streamline production and ensure efficiency. Their equipment includes a Breton 3-axis CNC milling center, Hardinge 3-axis CNC milling center, YCM large format 3-axis CNC milling center, Hurco 5-axis CNC milling center, Quintax 5-axis CNC router with dual vacuum tables, and Miltronics CNC lathe.

Mistake 7: Lack of Collaboration and Communication

Successful tool design and building require close collaboration and communication between the design team, engineers, and manufacturers. A lack of communication can lead to misunderstandings, errors, and delays. By outsourcing to a contract manufacturer like Domico Med-Device, you gain a partner who values collaboration and open communication. Their team works closely with clients to understand their needs and ensure that every tool is designed and built to meet those requirements.

Benefits of Outsourcing Tool Design and Build

Expertise and Experience

Outsourcing to a contract manufacturer like Domico Med-Device provides access to a team of experts with extensive experience in tool design and build. Their knowledge and skills ensure that every tool is designed and manufactured to the highest standards, avoiding common mistakes and delivering reliable, high-quality products.

Advanced Equipment and Technology

Contract manufacturers invest in state-of-the-art equipment and technology to deliver precise and efficient machining. Domico Med-Device's advanced CNC milling and turning centers ensure that every tool is manufactured with the highest level of accuracy and quality. Their equipment includes advanced machines capable of handling a variety of materials, from steel and aluminum to carbon fiber and plastic.

Cost-Effective Solutions

Outsourcing tool design and build to a contract manufacturer can be more cost-effective than handling it in-house. Contract manufacturers can leverage their expertise, equipment, and economies of scale to deliver high-quality tools at a lower cost. Domico Med-Device's efficient production processes and advanced equipment ensure that clients receive cost-effective solutions without compromising on quality.

Regulatory Compliance

Ensuring compliance with regulatory standards is critical in the medical device industry. Contract manufacturers like Domico Med-Device are ISO 13485 certified and adhere to all FDA regulations, providing peace of mind that every tool meets the required standards for safety and efficacy. Their commitment to quality and compliance ensures that clients receive reliable and regulatory-compliant products.

Domico Med-Device: A Leader in Tool Design and Build

Domico Med-Device stands out as a leader in the tool design and build industry, offering advanced capabilities, extensive experience, and a commitment to quality. Their machining, tool design, and build services ensure precision and quality in every detail. With a wide range of in-house equipment, including advanced CNC milling centers and lathes, Domico Med-Device delivers high-quality, reliable tools for the medical device industry.

Whether you need a one-time custom tool or repeat production runs, Domico Med-Device ensures precision and quality are cut into every machined detail, tool, and assembly. They use CAM software to efficiently convert CAD to cutting programs and have robust machining and turning centers to handle various materials, including steel, aluminum, titanium, carbon fiber, foam, and plastic. By working with local sources for metal treatments, Domico Med-Device ensures that every tool is built to last and performs reliably under various conditions.

Domico Med-Device's commitment to quality is demonstrated by its ISO 13485 certification and adherence to all FDA regulations. Their rigorous testing and validation processes ensure that every tool meets the highest standards of safety and efficacy. By outsourcing your tool design and build needs to Domico Med-Device, you can avoid common mistakes and benefit from their expertise, advanced equipment, and commitment to quality.

Conclusion

Tool design and build are critical components of medical device manufacturing, requiring precision, quality, and compliance with regulatory standards. By avoiding common mistakes and outsourcing to a contract manufacturer like Domico Med-Device, you can ensure that every tool meets the highest standards of performance and safety. Domico Med-Device's advanced capabilities, extensive experience, and commitment to quality make them an ideal partner for your tool design and build needs.

Want to learn more? Check out these blogs to read more about contract manufacturing: