Outsourcing machining services to capable, qualified contract manufacturers can offer a variety of advantages. Chuck Platt, general manager, Orchid Orthopedic Solutions (Holt, MI) discusses the ins and outs of contract machining services for orthopedic device manufacturers.
MPMN: What areas of expertise, equipment, and capabilities should orthopedic device manufacturers look for in a contract machining partner?
Platt: When selecting a contract machining partner, medical device manufacturers should examine the vendor's ability (core competence alignment) to competitively produce a quality product within certain promised lead times. Next, they should ask for evidence of an established measurement system (scorecard) of overall business performance. With that comes a clear commitment from the manufacturing partner to relentlessly pursue improvement in their business. Also, OEMs should pay specific attention to the partner's quality system and its ability to consistently produce a very high level of quality product. Identify the strength and level of expertise of the team that will be supporting your business needs as well. Lastly, it is necessary to determine your comfort level with the partnering company. Information sharing must stem from a path of trust, which will lead to the highest level of success for the relationship.
MPMN: What new machining challenges have advances in orthopedic implant materials and design presented and how have suppliers such as your company had to adapt?
Platt: Orchid has experienced a greater increase of new types of materials coming from the orthopedics industry, but our machinability is similar to existing materials in which we have already achieved a high level of success. Thus, the transition to working with these new materials has not been a major challenge for us. However, the changes in the design features have increased at a much faster rate in both complexity and tolerances. To ensure that products are produced to the new feature specs, Orchid has optimized the use of our production equipment, added better inspection equipment, and automated the inspection process, where necessary, to meet these new requirements. In parallel, many of our operators and inspectors have completed advanced specialized training programs. We continually train our operators to enhance their skill level to stay current and ahead of new design challenges.
MPMN: What are the most common mistakes medical device OEMs make when designing a product in relation to machining?
Platt: The most common mistakes OEMs make when designing a product are a culmination of a few things. Often, issues arise from the combination of stacking tolerances in components that result in interference at the assembly, releasing drawings before they are fully vetted, and adding features that may not be required for the functionally of the part that may add undue cost to the project.
CNC machining of small parts
A specialist in precision laser-machining of tubular metal components for medical devices, including endovascular stents, Pulse Systems offers CNC machining as part of its contract manufacturing services for the fabrication of small custom device components. The company is equipped to perform CNC milling, turning, boring, and drilling to produce very small features on parts machined from a range of biocompatible materials. In addition to machining solid materials such as stainless steel, nitinol, and titanium supplied in bars up to 0.787 in. in diameter, the equipment can handle tubular or cannulated starting materials in sizes as small as 0.032 in. OD. The company can deliver turnkey machining and subassembly services compliant with ISO 13485 and ISO 9001 quality systems. Capabilities include laser welding, electropolishing, nitinol shape-setting, microblasting, and cleanroom assembly.
Laser micromachining services
Using a high-resolution laser process capable of machining extremely small features with high levels of precision and accuracy, Gateway Laser Services provides medical device manufacturers with laser micromachining services. The company employs excimer and YAG laser technologies to perform laser ablation with single-micron precision. Capabilities include ultraviolet machining, a cold process that leaves a clean edge without heat-affected zones and thus does not diminish the integrity of the material. Laser micromachining promises high levels of consistency and repeatability and very tight tolerances. The service provider can machine most metals and alloys, ceramics, nitinol, silicon, and such plastic materials as polyimides, polyurethanes, PEEK, nylon, PET, silicones, polypropylene, PEBA, PMMA, ABS, and others in thin-film form. Applications include implants, biomedical filters, tubes, orifices for gas flow, medical electronics, and catheters, among others.
Gateway Laser Services
MARYLAND HEIGHTS, MO
Machining of precision medical components
The manufacturer's representative RepExact LLC sources custom precision medical device components made by such domestic and European principals as Tectri S.A. of Switzerland, which offers turning, milling, gun-drilling, tapping, and thread whirling. The Swiss company is available through the representative to produce medical components for implantation and instrumentation, precision micromotor components, and difficult-to-machine parts from titanium, stainless steel, and other materials. Tolerances can be held to a few microns, and components are delivered fully machined and burr free from the machine with surface finishes as good as 8 µin. Ra. A recently added seven-axis machining center is entirely computer numerically controlled and allows the company to accommodate parts with highly complex geometries.
Plastic and metal component machining
A contract manufacturer serving the medical device industry machines device components from metal and plastic materials. The company also offers tooling and fixtures, assembly jigs, and special machines. In addition, the company can mark components by means of laser engraving and via pad-printing with medical-grade inks. Among the common materials it processes are titanium and stainless steel, polycarbonates, PEEK, and other high-temperature engineered plastics. The vendor's operations are certified to ISO 9001:2008 standards.
Plastic & Metal Center Inc.
LAGUNA HILLS, CA
Surgical and orthopedic component machining
Orchid Orthopedic Solutions is a contract manufacturer of small, ultraprecision orthopedic devices and implants, surgical instruments, and accessories. The company is equipped to perform Swiss-style and conventional turning and milling, grinding, EDM, and special processes such as color-coding; welding, cutting, and etching with lasers; diamond coating; gun-drilling; and microdeburring. Capabilities also include material selection, prototyping, performance enhancement, and design for manufacturing, along with custom sterile and nonsterile packaging and labeling and inventory stocking.
Orchid Orthopedic Solutions