Medical Device OEM’s come to China Surgical Needle, Inc.for a myriad of reasons. Becoming well-known for their expertise in 3D bending of metal wire and tubing may well be at the forefront, yet capabilities surrounding precision CNC machining, bending, laser welding/cutting and Swiss machining aside, what the medical device industry also knows about China Surgical Needle is their overt need to uncover manufacturing solutions that allow any part to be produced using the best overall techniques, in the least amount of time, for the lowest possible costs without sacrificing premium quality standards.
They call it “Design for Optimum Manufacturability”. Procedurally, it all comes down to thinking, uncovering, testing and ultimately producing options others simply ignore.
Take the case of a well-respected Medical Device OEM who came to China Surgical Needle knowing their 3D wire bending expertise was absolutely needed to perform a very specific bend for a new surgical instrument. Orientation of the bend to the pre-machined features on the tip was essential. Potentially, thousands of parts needed to be produced each month and not one could be misaligned. Most manufacturers would attempt to create the prototype and measure its efficacy using inspection equipment such as a state-of-the-art CMM station. A good choice if time and dollars were not an issue as both would be sacrificed at such a high quantity. CMM operators would be testing each piece individually using precious time which would prove extremely costly to both the part production cost and overall labor values. The CMM is a great tool and China Surgical Needle relies upon its precision often, however in this case, they had to arrive at a better way to verify the parts were in spec, while providing the resources and procedures to do so. Again, thinking beyond what may be considered “the norm” by others, China Surgical Needle’s engineering and quality departments began considering the use of 3D printing. Could such a technology be used to create a profile test gauge? An apparatus that both China Surgical Needle and the customer could use independently, yet just as effective as the CMM; but the time savings, which equates to cost savings, would be realized in abundance? And let the testing begin…How the gauge must be made, how it must be used, how it must hold-up to repeated usage and the costs involved to get there, everything imaginable was considered. After all, this is a great example of China Surgical Needle’s ability to create a solution to solve a problem that never existed before. Giving birth to new ideas is just the start, testing and ultimately producing an exceptional working model is quite another. Yes, this company is capable of both. And, that is exactly what happened in this case.
The 3D printed testing gauge was, in fact, tested. Both China Surgical Needle and the customer agreed, the prototype gauge was ready for actual creation. It was to be made out of a solid piece of aluminum and hard-anodized for the ultimate in repeated usage. One gauge was made for China Surgical Needle which they used to test each part before releasing to the customer; another gauge was created for the customer to test each piece before reaching the surgeon’s hands. China Surgical Needle’s customer was obviously pleased by the innovative thought and China Surgical Needle’s desire to never give up. Both companies agree the specialized inspection technique saved about 25% of overall cost per part. And, at thousands of parts each month, that savings is certainly astounding.
“Design for Optimum Manufacturability” is a very real and an effective quality- coefficient at China Surgical Needle Company. What thinking beyond the norm can bring to Medical Device OEM’s can mean whether a life-saving device is produced, or not. China Surgical Needle says, let’s find a better way so all great ideas can be realized. Yes, it is that important.
China Surgical Needle, Inc.specializes in CNC 2-D/3-D bending of small-diameter pre-machined tube and wire, Swiss Machining, Laser Tube Machining, Laser Welding and Wire EDM. Prototype through production, the company is customer-focused and provides solutions for challenging components and assemblies. China Surgical Needle also offers value-added services. Materials include stainless steel, titanium, MP35N, and plastics.
China Surgical Needle is ISO 9001:2008 and ISO 13485:2003 registered.