Syringes shouldn’t leak. Hospital beds shouldn’t creak. Scalpels shouldn’t struggle, and implants shouldn’t shift. Across every part of the medical industry, it’s easy to see why precision should never be a matter of question. Both patients and care providers expect high quality, consistency, and reliability from medical devices of all kinds, and for good reason– just one small slip up could result in dire consequences.
With that in mind, it’s up to medical device OEMs to make precision a top priority in everything they do. By taking every step to ensure infallible performance of all their parts, OEMs can maximize the comfort and safety of every patient that comes into contact with their products. Achieving such a high level of precision is much easier said than done, though.
One of the most critical steps to guaranteeing patient safety is to select the right material for the job: one that can meet both the performance and precision needs of a product’s intended use.
Material Selection in OEM Med Device Manufacturing
In medical device design and manufacturing, numerous factors must all be carefully considered when choosing which materials will be used in a component or assembly. Where will the product be used? What is its intended life cycle? What kind of external factors will it be exposed to? Is it meant to mimic an organic material? The answers to these questions will help determine what properties to look for when selecting the right material for a component or finished product. Some of the properties that matter most in medical device manufacturing include:
- Biocompatibility
- Absorption
- Impact resistance
- Corrosion resistance
- Fatigue strength
- Antimicrobial properties
That’s just to name a few. With so many factors to balance, med device materials must be chosen carefully to achieve the desired properties in the final product. Yet across all types of medical devices, precision remains as a feature that can universally make or break a product.
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How Precision Is Built Into OEM Medical Devices
This precision is achieved in a variety of ways depending on the material itself. For some products, it might be achieved through careful design and machining of an injection mold tool. For others, it may be achieved through a 3D print with high dimensional integrity. For others still, the material may need to be ground, faced, trimmed, or milled to reach its final shape within specified tolerance limits. Let’s take a look at some of the more common precision materials that can be found in OEM medical devices.
Common Precision Materials in Medical Devices
Materials for OEM medical devices can be largely divided into 3 categories: metals, polymers (or plastics), and ceramics. In this blog we will be focusing on metals and plastics.
Medical Grade Metals
For metals, titanium and stainless steel are two of the most commonly used in medical applications.
Medical grade titanium is exceptionally suited to precision medical device manufacturing. Unlike many other metals, titanium is biocompatible, meaning it can safely interact with the human body without causing adverse reactions. Additionally, titanium is known for possessing great fatigue strength despite its light weight, along with corrosion resistance and durability. These properties make titanium an ideal choice for a broad range of medical applications, from orthopedic implants to ergonomic surgical instruments. Its ability to be precisely machined allows for the creation of components that meet stringent tolerance requirements, ensuring the safety and effectiveness of medical devices. However, it's worth noting that titanium can be quite costly compared to other metals.
Another critical metal for medical device manufacturing is stainless steel. It is known for its excellent corrosion resistance, strength, and biocompatibility, making it suitable for a wide range of applications. While many other metals require a special coating to protect them from corrosion, stainless steel's ability to withstand sterilization processes without degrading ensures that it maintains its integrity and safety for patient use. In addition, stainless steel is relatively affordable when compared to the likes of titanium. Incorporating medical grade stainless steel into device designs can help provide the durability and reliability needed for patient safety and effective medical treatment at a lower price point.
Medical Grade Plastics
Plastics are commonly used in not just comfort care and pharmaceutical delivery devices, but also in implantable orthopedic devices as well. Naturally, these plastics must be formed to precise tolerances in order to meet the fit and function needs of the patient for long term use and comfort. These medical device materials are often selected for implants that are customized to an individual patient, as they can be more efficiently adjusted for a one-of-one fit compared to metal parts.
Mirroring titanium, polyether ether ketone (PEEK) is a polymer which is lauded in OEM medical device applications for its biocompatibility. This material is known to not trigger allergic reactions in patients, making it an invaluable option for flexible yet robust orthopedic implants. In many ways, from shock absorption to thermal expansion, it has been observed to behave similarly to human bone– all the more reason to consider it as a strong contender for precise medical implants.
One last material to consider is polytetrafluoroethylene, more commonly known by its trade name: Teflon. While rarely used on its own, Teflon is a popular choice for durable, lightweight coatings for medical devices. It displays some unique advantages that make it an extremely versatile coating material for countless applications, such as antistatic and hydrophilic properties. This can help make other materials, including other polymers and metals, more viable choices for OEM medical device applications.
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Medical Tools That Use Precision Materials
So, where do these precision materials shine? There are a myriad of medical applications which require the use of corrosion resistant metals, lightweight polymers, or a mix of both. Some tools which are made possible with precision materials include:
- Biopsy tools
- Torque screwdrivers
- Medical screws
- Surgical drill bits
Supporting A Circular Economy
Many medical tools are discarded after just one use, simply due to the nature of the item. Surgical tools, for example, are often prepared for a single use and discarded after the procedure has been completed. However, many medical devices used in other settings, such as laboratories, testing facilities, or patient rooms can be mostly or entirely recycled. As supply chain challenges loom larger than ever, it is important for medical device manufacturers to recognize the value of sterilized, recycled materials in their designs.