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In the dynamic realm of medical device manufacturing, pushing the boundaries of innovation, quality and precision is crucial to success in the market. The hyper-competitive environment requires medical device companies to:
- Rapidly turn their innovative ideas into reality and reduce product launch cycles
- Maintain high quality standards as defined by regulatory bodies
- Improve device precision as device geometries become more intricate
These challenges are further compounded by the increased use of precious metals in modern-day medical devices. For example, platinum and iridium are becoming more popular in cardiac rhythm management, cochlear, electrophysiology and neuromodulation devices. The durability of platinum iridium alloys makes them ideal for medical device applications. These precious metals, however, add additional complexity to the device manufacturing process.
Precious Metal Machining Challenges
Iridium is known for its exceptional resistance to corrosion and high-temperature stability. However, machining iridium is challenging due to its extreme hardness and brittleness. Similarly, platinum is a highly desirable material in medical device manufacturing due to its excellent biocompatibility, corrosion resistance, and electrical conductivity. However, it also presents significant machining challenges due to its high melting point and hardness. Achieving intricate geometries and holding tight tolerances on precious metals like platinum and iridium requires significant depth of expertise.
So, how can medical device companies navigate the above challenges and accelerate product launch lead-times? Start by selecting the right contract manufacturing partner with advanced machining capabilities and expertise in machining precious metals.
Navigating Precision Machining Partnerships: The Challenge of Choosing the Right Contract Manufacturer
Finding the right contract manufacturing partner for precision machining in the realm of medical devices poses a formidable challenge. The criticality of precision and quality in medical device manufacturing demands a meticulous selection process. Below are some of the factors that a medical device company should evaluate while selecting the right contract manufacturing partner for precision machining:
Advanced Machining Capabilities
The contract manufacturing partner’s advanced machining capabilities should encompass a wide range of machining techniques such as CNC machining, EDM, laser machining, and more. The partner should have invested in state-of-art equipment and be committed to continuously updating their technology to ensure they remain on pace with industry enhancements.
Material Expertise
When selecting a contract manufacturing partner for precision machining, evaluate them to see if they understand the unique challenges associated with machining precious metals like platinum and iridium. Do they understand how to overcome material-specific complexities to deliver products that meet stringent design and quality requirements?
Design Collaboration/DFM Expertise:
A seamless new product launch requires design collaboration between the medical device company and the contract manufacturer. The right contract manufacturing partner can offer valuable Design for Manufacturability (DFM) insights that help with component design optimization, reducing costs and shortening lead-times for product launch.
When selecting your contract manufacturer, evaluate their DFM expertise. Points to consider include:
- Do they have an in-house R&D team that can work with your product development team at early stages to identify issues?
- Can they evaluate opportunities for potential part simplification?
- Do they understand manufacturing process/operating conditions and the impact on critical tolerances that need to be adhered to?
Commitment to Quality
A quality first approach and an unwavering commitment to maintaining quality are must-have attributes for any medical device contract manufacturing partner. Compliance with the FDA’s 21 CFR 820 and ISO 13485 requirements is mandatory. The contract manufacturer’s team must be well versed with continuous improvement and root cause analysis tools. They should apply advanced inspection techniques to ensure that the product being manufactured meets stringent quality and design standards.
The Pulse Technologies Difference: Unparalleled Expertise in Precious Metal Machining
With several decades of expertise in the medical device industry, Pulse Technologies has established itself as a leading contract manufacturer, specializing in advanced machining capabilities. Why choose Pulse Technologies?
Versatility in Component Complexity
Our highly skilled engineers and technicians have extensive knowledge and experience in machining complex components for medical devices.
Whether the challenges involve intricate geometries, micro-sized features, or tight tolerances, Pulse Technologies excels in machining components of varying complexities. Our capabilities extend across a wide range of medical device applications, including cardiac rhythm management, cochlear, electrophysiology and neuromodulation devices.
Experienced at Decoding Material Challenges
We understand the complexities associated with different material types. With a particular focus on working with challenging materials like platinum and iridium, Pulse Technologies empowers medical device companies to turn their innovative ideas into reality.
We have mastered the art of machining precious metals, employing state-of-the-art equipment and innovative techniques to achieve precise and intricate features. Our advanced machining capabilities enable us to overcome any challenges that these materials present and ensure the production of high-quality components with exceptional dimensional accuracy.
Investments in Cutting-Edge Technology and Equipment
Pulse Technologies invests heavily in technology and advanced equipment to deliver superior machining services. Our state-of-the-art CNC (Computer Numerical Control) machining centers, EDM capabilities, and laser machining systems enable us to meet the most demanding requirements of medical device manufacturers. We continually update our machining capabilities to keep pace with the rapidly evolving needs of the industry. Our capabilities include:
- Up to 13-axis micromachining on CNC Swiss Screw machining
- High-capacity multi-pallet mill and mill-turn machines up to 7-axis
- Multi-spindle machines for high volume production
- EDM capability to create tight tolerances, small wire diameters and scratch-free surface finishes
- Laser cutting, welding, surface treatment
- Industry leading metrology, including CMM and CT Scanning
In-House R&D and Design for Manufacturability (DFM) Expertise
Unlike most contract manufacturers, we have an in-house design support team that can collaborate with medical device companies from the early stages of product development. Our team of DFM experts works closely with clients to:
- Optimize component designs for manufacturability
- Ensure seamless integration with our machining processes
- Reduce manufacturing costs and shorten lead times
- Enhance overall product performance.
Robust Quality Standards with a Quality First Culture
Our culture revolves around quality and our processes are compliant with all governing quality standards for medical devices (such as the FDA’s 21 CFR 820 and ISO 13485 requirements). Our team is well versed with continuous improvement and root-cause-analysis tools like FMEA, CAPA, Poka-yoke and Value Stream Mapping.
Our team also performs meticulous inspections throughout the manufacturing process, utilizing advanced measurement tools and inspection techniques. This unwavering commitment to quality ensures that every component we produce meets the highest standards of excellence.
Collaborative Approach
As a company, we firmly believe in establishing long-term collaborative partnerships with our clients. We understand the importance of open communication, responsiveness, and flexibility in meeting unique project requirements.
By working closely with medical device companies, we ensure seamless integration of our machining capabilities into their overall manufacturing process, resulting in faster product launches.
Pulse Technologies stands as a trusted partner for medical device manufacturers seeking precision machining solutions. Our expertise in working with challenging materials like platinum and iridium, coupled with our cutting-edge technology and commitment to quality, enables us to deliver exceptional results. By choosing Pulse Technologies, medical device companies gain a competitive advantage, unlocking new possibilities in product innovation and manufacturing excellence.
At Pulse Technologies, we offer:
- 25+ years of medical device manufacturing experience.
- Industry-leading in-house metrology and testing capabilities
- 70,000 sq.ft facility.
- 100+ CNC machine tools.
- Data conveniently formatted for DHFs/DHRs, and much more.
Want to learn more about precision precious metals machining for medical devices? Contact us today.
