Precision is highly important across the medical industry in applications ranging from prescription dosing to surgical procedures. The human body is complex and fickle, so absolute accuracy is necessary across the care continuum to prevent negative health outcomes.
Naturally, this extends also to medical manufacturing. Medical instruments, devices, and implants must be engineered carefully within tight tolerances, as even slight defects can compromise patient safety.
As these medical technology sectors rapidly grow and evolve, manufacturers are facing increasing difficulty managing the tricky balance between exacting quality and efficient production. This problem is compounded by industry-wide spikes in healthcare costs that technology manufacturers must navigate, all while keeping pace with the latest advancements.
For instance, medical devices are currently trending towards smaller, less intrusive designs. Reducing the footprint of medical devices is a laudable goal that benefits patients, but it also poses a number of challenging production problems. Specialized machining processes can achieve the extremely tight tolerances required for these shrinking designs, but such techniques also tend to be expensive and time-consuming.
Many professionals have begun to turn to metal stamping as a rapid, consistent, and more cost-effective solution.
Medical Metal Stamping
For many engineers, machining is considered the default for complex components. However, technological advancements have made metal stamping a preferable alternative to machining for medical applications.
Modern stamping presses can produce even very small, very complicated designs by combining various dies, presses, and finishing techniques. An experienced stamping operator can use these tools to engineer everything from surgical tools to minuscule implants with great accuracy and efficiency.
Materials and Considerations
As effective as stamping can be, proper material selection is critical to ensure the safe and proper function of medical devices. Some common metals within the medical industry include, among others:
- Stainless steel
The types of materials available for a specific application are limited not only by regulatory standards, but also by the constraints of human physiology. Few materials can be used internally, and even non-surgical components might need to resist bacterial growth or be hypoallergenic. The following represent a few of the most important criteria for material selection when beginning the design process:
- Supply. A pragmatic material choice must take supply chain variables into consideration. Some metals are more difficult to obtain than others, so it’s important to vet a reliable supplier when working with less common substrates—it’s nearly impossible to guarantee consistent quality without one. You’ll also want to consider how availability might affect your timeline.
- Design flexibility. In some ways, innovation is driven by the freedom to experiment with unconventional materials. Maintaining an inventory of common materials for design experimentation may help to streamline the design process.
- Cost. No manufacturing project can proceed without a careful analysis of the financial constraints. You’ll need to consider how your material selection affects the final unit cost, keeping in mind that quality outweighs savings where human health is involved. Stamping is affordable as a process, so pricier metals may still be obtainable within budget.
- Physical characteristics. The physical qualities of a metal cannot be ignored for the sake of savings or convenience. For a device to perform as it should, the importance of factors like strength, chemical resistance, temperature resistance, and antimicrobial properties should all be carefully weighed. In many ways, this consideration can make or break the entire product—some surgical tools absolutely must have the ability to withstand high sanitization temperatures or cleaning chemicals, for example.
- Regulations. Depending on your location, you may need to consider FDA, USP Class VI, or similar international regulations when selecting your metal. Failure to do so could be a very costly mistake.
- Biocompatibility. Biocompatibility considers whether a material is compatible with human tissue within the context of a given medical application.
- Manufacturing process. Some materials are just easier to work with than others. Your choice of material can therefore affect the speed and cost of the manufacturing process, and, by extension, your bottom line.
Clearly, the design process is complicated, but a holistic consideration of these factors at the beginning of the stamping process ensures a safe and effective medical device—and one that can legally be brought to market. At American Industrial Company (AIC), our team can help you understand which materials are best suited to metal stamping and your design.
Medical Device Manufacturing Applications
Stamping can be used to great effect for a diverse set of medical applications, assuming proper design and material selection. AIC has experience stamping accurate and consistent medical products among the following applications:
Stamping produces many common surgical instruments like forceps, retractors, cannulas or drill components, but jaw housings are a particularly compelling case study for stamping’s potential in this area. Jaw housings are essential equipment for laparoscopic surgeries, which are becoming increasingly common as robotic technology advances. As such, there has been a strong incentive to innovate their manufacturing process.
The traditional method for manufacturing a jaw housing involved machining a metal tube. More recently, it has been shown that stamping can not only produce jaw housings, but it can do so at the same quality standards for half the price. We are confident that this is not an isolated occurrence. With a bit of creativity, stamping can likely produce similar savings on a broad range of surgical instruments.
Titanium is unique for medical applications because it rarely stimulates a negative reaction from human tissue. It resists corrosion from bodily fluids, and is unlikely to be rejected when used internally. This makes it one of the most useful metals in the medical industry, including for stamped components like device enclosures.
Device enclosures are designed to shield permanent implantable devices such as pacemakers, internal defibrillators, or drug pumps, making inert titanium alloys a perfect solution. With proper care during the design process, these enclosures can also be stamped efficiently and affordably.
These same implantable devices also make use of multiple tiny metal components like brackets, clips, and clamps. Some of these parts must be tiny to fit within the small enclosures, creating a significant design and manufacturing challenge. Microstamping equipment enables rapid and consistent replication of minuscule metal pieces.
Custom Stamped Parts for Critical Procedures
American Industrial Company has been a stamping specialist in the Chicago area since 1981. We’ve worked extensively with clients across North America to manufacture high-quality metal components of all shapes and sizes. We are fully committed to maintaining our established reputation for quality, and we are ISO 9001:2015-certified for precision metal stamping.
We understand that medical device needs vary depending on the product, so we hold ourselves to customer-oriented standards of flexibility and personal attention. Whether you need a small or large run using stainless steel or an obscure alloy, we’ll find a way to meet your specifications at a competitive price and within a reasonable timeline while upholding our Lean manufacturing principles.
It’s difficult to overstate the importance of a trustworthy supplier for life-saving medical equipment. With AIC, we will draw on our decades of experience to produce precise components to your exact specifications. As a provider of turnkey solutions, we will work with you at every step of the process, striving to understand and exceed your expectations from prototype to delivery.
If you’re ready to learn more about how metal stamping can drastically improve your medical device operation, request a quote so we can discuss your needs.