The implantable medical device market is growing at a rapid pace globally. As manufacturers develop amazing new therapeutic technologies for orthopedic, cardiovascular and other conditions, metal stamping firms must be equipped to support that innovation and to help OEMs speed time to market for new devices.
This article highlights six of the advanced capabilities that metal stampers must have to serve manufacturers of short-term or long-term implantable medical and surgical devices.
“Metal stampings for implantable devices, surgical devices and drug delivery devices, all must meet critical FDA Class III regulations and be manufactured in a process that controls for risk and quality,” observes Steve Fischer, president of Peterson Enterprises, which represents a variety of manufacturers, including Kenmode. “With the rapid innovation by manufacturers in developing new endoscopic and laparoscopic surgical tools and improved implantable devices such as pacemakers, defibrillators, and neuro-stimulators, metal stampers have to be just as quick to innovate their practices. Because metal stamping tooling is inherently a time-consuming process, the premier metal stamping firms are finding new ways to speed up part design, tooling and production to accommodate the emerging need.”
1. Faster rapid prototyping of metal stampings
The process of getting a new Class III medical device to market can be arduous, so speed is of the essence. When developing a new product, manufacturers are looking for suppliers who can provide prototypes faster than ever before.
Due to the complexity of metal stamped parts, prototyping has typically taken anywhere from two to four weeks in the past. Now, OEMs are looking for stampers who can produce a prototype in a matter of days. In order to deliver, metal stampers should have a dedicated prototype and R&D unit.
At the same time, OEM engineers want layouts of the critical dimensions of the prototype to know if it differs from the expected production part. A reliable working prototype of the device is important so that clinicians can test it with a realistic look, feel and function.
2. DFM with simulation software
Hand in hand with prototyping is Design For Manufacturability (DFM). Metal stamping firms can add tremendous value when their engineers are involved early on in the design phase by working with the OEM’s team on part design.
With the move toward miniaturization of implantable devices, metal stampings are becoming smaller and more complex. At the same time, some of the specialty metals used in implantable devices, such as titanium, can be difficult to form in a stamping. Before the design of a metal stamped part is finalized, the metal stamper’s engineers should be consulted. The engineers often can suggest improvements to the stamping design that can eliminate secondary operations or reduce the use of precious metals and related costs.
Metal stamping firms that work with innovative product designs rely on Finite Element Analysis (FEA) simulation software to determine how a part design will perform in production. For a new part design that may test the limits of metal stamping, engineers may run any number of different iterations of a simulation, showing how a tool will form a part and whether the metal specified will work within those limits. This capability can also speed prototyping by eliminating multiple iterations of prototype parts in favor of those most likely to succeed.
For more information, see the Kenmode blog article, “How Metal Stamping Simulation Software Saves Money.”
3. In-house tooling capacity and precision metal stamping capabilities
Metal stampers should demonstrate their expertise in precision stamping by their ability to build and maintain the customized tool in-house. In the past, the process of designing and building the tool has taken anywhere from 8 to 14 weeks, depending on the project. Now, OEMs may require a working prototype tool in less than a week.
While that compressed timeframe is not always possible to achieve with a complex metal stamping that requires a progressive die, new technologies such as 3D tool design and laser jet, water jet and EDM blanks allow many metal stampings to be formed with a single-stage die set.
4. Specialized quality systems for implantable and surgical devices
The implantable and surgical medical device industry has to navigate the toughest government regulations in the world with the U.S. Food and Drug Administration (FDA). For that reason, the metal stamper should have ISO 13485 certification and a quality system that matches the specialized needs of the medical device manufacturer. They should also be aware of FDA 21 CRF820.3 and definitions of quality systems regulations.
A metal stamping firm should work with stringent validation protocols that follow the IQ/OQ/PQ process to ensure critical-to-function dimensions are held for the new part. During production, advanced metal stampers rely on in-die sensor technology and digital inspection equipment for real-time quality control.
Redundant presses of the same tonnage and manufacturer parameters are also important to ensure uptime. To avoid having to revalidate a new press in the event of a mechanical failure, metal stampers can validate two or more of the same presses with the die. Having multiple presses is an important factor in risk mitigation and ensuring a steady supply of parts, without the need for a change order.
5. Experience with noble and medical-grade metals for implantable devices
More implantable devices are incorporating expensive noble metals such as Titanium 9 and 23, because of their compatibility for patients who must undergo MRI exams. These materials can be difficult to stamp, due to their unique properties. In addition, the materials are often not available in the typical coiled lengths used in metal stamping, so the stamper must have the capability to rework the material’s dimensions and hand feed it into the press, if required.
Specialty materials commonly used in medical devices include:
- Stainless steel
- Platinum iridium
6. Medical-grade cleaning, handling and packaging
Metal stampers with implantable medical device experience will understand how to best clean, handle and package precision metal stampings, particularly micro-miniature stampings that go into such devices as pacemakers that continue to get smaller.
Medical-grade metals are certified to be free of contaminants, but the metal stamping process uses lubrication that must be removed safely prior to shipping. The state-of-the-art equipment for ensuring part cleanliness is a non-chlorinated closed loop system for vapor degreasing.
The metal stamper also must know how to handle and package precision parts without damaging them or introducing contaminants.