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You have been assigned the task of selecting a new outsourcing partner to design, prototype and manufacture your company’s latest medical device or surgical instrument. After several sales pitches and dazzling promises of future market success, the big question remains: How do you choose the provider that will be the right fit for your project? Here are eight things to keep in mind as you size up a potential partner.
Evaluate the company’s capabilities and prevailing work ethic
The first thing on your checklist should be to verify the company’s capabilities and its work ethic. It is commonplace for surgical instrument manufacturers to tout the various machining processes performed at their facilities. As you search for a provider, be sure the company can service as many of your needs as possible. The best option, by the way, is a company that can provide all services in-house.
Also, you will want a provider who works well in a team environment to ensure your requirements are clearly communicated and understood throughout the entire development and manufacturing process. Projects can steer off course quickly–and costs escalate–if the entire team is not on the same page. Ask who will be involved with your project.
Ideally, the dream team will consist of:
- Experienced product design engineers
- Manufacturing and quality engineers
- Machinists/programmers
- Programme/project manager
- Customer care/sales
- And you!
Ensure design intent is well defined
The new product may be great, but you still need to do some background work to understand the wants and needs of the end user. A surgeon’s valuable input will ensure your instrument has the overall functionality, style, shape and ergonomic design that will seal its success in the marketplace. It is the product development engineer’s responsibility to work closely with you to ensure that the intent for design is clearly defined.
Ask about product development and prototyping
One of most exciting parts of product development is when the design leaps off the drawings to become a three-dimensional working model. Unfortunately, many people forget to ask about prototype development when selecting a provider. Look for a company with a 3-D solid modeling package that integrates with CAD/CAM software and finite element analysis for design optimisation. Again, a company with in-house capabilities is best.
Don’t neglect testing, verification and validation
Your new surgical instrument not only has to work in the design phase, but during the entire testing, verification and validation process. At the moment of prototype design and testing, the outsource provider should review all processes to ensure the design intent is met and he should validate the machining process before the actual product is released for production. It is extremely important to identify any potential problems at this stage to ensure a smooth, trouble-free manufacturing process. You will save time and money.
Gauge on-site manufacturing experience and capabilities
Don’t believe the sales hype: not all CNC machines are created equal. Different CNC machines offer varying levels of integrity, quality and capabilities that can directly affect the final product’s quality, functionality and accuracy. When selecting an outsource provider, make sure the company has invested in high-end brand-name machining centres from manufacturers such as Marubeni Citizen-Cincom, Mazak, Agie, Star and Fanuc. Then ask about the operators and programmers. A well-experienced team will ensure that your product meets high quality standards and that specifications are precise and accurate.
Verify quality assurance systems
No ifs, ands or buts: you must look for a partner with facilities that are certified to ISO 13485 and/or registered with US FDA. You should not rely solely on certificates, however: Investigate key indicators of quality within the company’s design process, as well.
Expect a commitment to innovative technology
Choose a company driven by a vision to continually investigate and invest in the latest technologies such as laser machining, rapid prototyping and precision investment casting. Your partner’s investment in leading-edge systems can help you stay one step ahead of your competition.
Test the staff’s expertise and experience
Even the most advanced machinery will not perform at its peak without expert staff on hand to properly program and operate it. It is the skilled journeymen, programmers and operators who will get the maximum efficiency and accuracy out of each piece of equipment. Their experience and expertise shine through every product that has been manufactured at the facility. In the right hands, precision machining—and the entire product development and design process--is an art form, not merely a metal removal process. Ask for information on the staff’s breadth of experience and knowledge, as well as experience specific to surgical instrumentation, machining and finishing.
Keep these eight items in mind as you audition an outsource provider for the development and production of your new surgical instrument. They will help you to find a reputable provider that will work with you to develop quality instruments that not only perform to specifications, but meet the approval of surgeons across the world.
This article was contributed by Teleflex Medical OEM, which engineers, prototypes and manufactures specialised instruments and devices that touch nearly every organ and system in the human body. Their portfolio of products and services includes custom extrusion, catheters, introducer systems, performance fibers, resins, sutures, instrument handles, machined and forged medical instruments, and spinal and small bone implant systems. For more information, visit www.teleflexmedicaloem.com [5] or e-mail oeminfo@teleflexmedical.com [6].