Making all the parts for tools and devices in the medical industry is hard because you must master two critical things: precision and quality.
As the field of life sciences has grown, metal stamping has become essential for medical devices for treating diseases and illnesses through active stimulation or surgery.
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Metal Stamping can Be Made More Quickly
It can take a long time to get a new Class III medical device on the market, so time is of the essence. Manufacturers are looking for suppliers who can give prototypes faster than ever when making a new product.
Because metal-stamped parts are so complicated, prototyping usually takes two to four weeks. Now, original equipment manufacturers are looking for stampers who can make prototypes in a few days. Metal stampers should have a dedicated prototype and research and development unit to deliver.
At the same time, OEM engineers need layouts of the prototype’s critical dimensions to see if it differs from the production part. Clinicians need a reliable working prototype of the device to test it and see how it looks, feels and works.
DFM with Software for Simulation
Design for Manufacturability is a process that goes hand in hand with prototyping (DFM). When their engineers work on the part design with the OEM’s team early in the design process, metal stamping companies can add significant value.
As the size of devices that can be put in the body gets smaller, metal stampings are getting smaller and more complicated. At the same time, some speciality metals like titanium used in implantable devices can be hard to shape with stamping. Engineers from the metal stamper should be consulted before the design of a metal stamped part is finalized. The engineers usually have good ideas for improving the stamping production process so that unnecessary stages are removed or the number of expensive metals used is reduced.
Finite Element Analysis (FEA) simulation software is used by metal stamping part suppliers that make new designs to determine how a part will work in production. For a new part design that might push the limits of metal stamping, engineers can run a simulation that shows how a tool will shape a part and if the metal chosen will work within those limits. This feature can also speed up prototyping by eliminating multiple versions of prototype parts in favour of the ones most likely to work.
Precision Metal Stamping and the Ability to Make Tools In-house
Precision metal stampers should be able to build and take care of their custom tools to show they know what they are doing. In the past, it took anywhere from 8 to 14 weeks to design and build the tool, depending on the project. OEMs might need a prototype tool that works in less than a week.
Even though this is only sometimes possible with complex metal stampings that need a progressive die, many metal stampings can now be made with a single-stage die set thanks to new technologies like 3D tool design and laser jet, water jet, and EDM blanks.
Implantable and Surgical Devices have their Quality Systems
The implantable and surgical medical device industry has to deal with the strictest government rules in the world. Since this is so important to the medical device producer, the metal stamper should be ISO 13485 certified and have a quality system tailored to their demands. They should also know about FDA 21 CRF820.3 and the definitions of regulations for quality systems.
A company that stamps metal should use strict validation protocols that follow the OQ/IQ/PQ process to ensure that the new part’s critical-to-function dimensions are kept. Modern metal stampers use in-die sensor technology and digital inspection equipment to check the quality of their products in real-time while they are being made.
For uptime, it’s also essential to have backup presses with the same tonnage and manufacturer. Metal stampers can use the same die to validate two or more of the same presses. If a press breaks down, they don’t have to validate a new press. Having more than one press is essential for reducing risk and ensuring that parts will always be available without needing a change order.
No matter the application, the metal parts are made with the proper cleanliness, tools, and surface finish to make them easy to use and maintain. Deep-drawn metal stamping makes it possible for medical needs to be met with total accuracy and precision, thanks to customized designs and special modifications. This helps the industry move forward even when things are hard.