How to Choose Right Metal for Medical Device
Selecting the right metal for medical devices is essential for ensuring their effectiveness and safety.
Whether it's sturdy aço inoxidável or noble platinum, each metal plays a unique role in healthcare applications, requiring a delicate balance of durability and compatibility for implants and surgical tools.
The selection process involves considering factors like availability, flexibility, and cost per unit, influencing the reliability and functionality of the medical device.
Let this blog post help you choose the suitable metal for your project!
How Does Metal Work in Medical Devices?
Metal has long been used in medical device and instrument production, whether for implants, prostheses, surgical tools, or other equipment.
Metals must meet stringent requirements concerning durability, strength, corrosion resistance, and biocompatibility to ensure they are safe for use within the body or on medical instruments that come into contact with bodily fluids.
There are different types of metal to choose from, each offering particular qualities depending on their intended purpose, such as wear resistance and antimicrobial protection.
Temperature range requirements also need consideration when utilizing a metal. Read on to find out more about metal options for medical devices!
Choosing the Right Metal for Medical Devices
When selecting metal for medical device fabrication, there are a range of considerations that must be taken into account.
From performance properties to regulatory requirements, the type of metal chosen can have far-reaching implications on its efficacy and provide valuable insights into design specifications.
Availability
A wide range of metals like stainless steel, titanium, copper, and others are available, each offering unique properties for different needs in medical device design.
Design Flexibility
Engineers have the opportunity to select materials based on performance, cost, safety, compliance, aesthetics, manufacturability, and sustainability to tailor devices for optimal function.
Cost Per Unit
Quality materials meeting medical standards might increase manufacturing costs, potentially compromising quality and affordability.
Other factors such as labor costs related to production, part complexity in engineering design, and material's chemical properties can also affect cost per unit during the manufacturing process.
Performance Properties
The selected metal's properties significantly impact a device's reliability and function, with considerations like corrosion resistance, strength, and durability being crucial.
Stainless steel is one of the most commonly used materials in medical devices due to its corrosion resistance, availability, low cost per unit, strength/durability, ability to maintain shape under duress or extreme temperatures, and its non-toxic status that meets regulatory requirements.
Specialty metals such as Nitinol exhibit memory effect characteristics, which make them ideal for applications that require shape change upon exposure to heat or force.
Cobre also has unique antibacterial qualities, which can help with sterilization processes while remaining cost-effective compared to other metals like gold alloys and platinum alloys that may come at higher premiums.
Regulatory Compliance
Adhering to FDA and ISO regulations is pivotal for approval, necessitating careful material selection, validation, biocompatibility testing, and adherence to standards.
Biocompatibilidade
Metals used in medical implants must undergo rigorous testing to ensure safety and compatibility with body tissues and fluids.
Aesthetics and Usability
Beyond material strength, aesthetics and user-friendly design elements are essential in product success, aligning with marketing objectives and user experiences.
Manufacturing Efficiency
The choice of metal affects production processes, with certain metals offering benefits like heat resistance, reducing machining needs, and improving overall efficiency.
Other metals like Titanium also feature outstanding thermal characteristics, including excellent oxidation stability at higher temperatures while providing optimal mechanical properties.
Moreover, when sourced sustainably, titanium allows manufacturers to reduce their overall costs by providing lightweight yet strong components they can easily integrate into full medical assemblies without significantly increasing the device's weight profile.
Sterilization and Cleaning
The type of sterilization used depends on the materials employed in device construction, ensuring safety without compromising device function.
While steam autoclaves are commonly used for hardy materials like stainless steel, ethylene oxide (EO) must be adopted when dealing with heat-sensitive components such as plastics.
For handpieces that cannot be heat sterilized, high-level disinfection through a chemical process may be required after each patient's use so it does not become contaminated and can also reduce cross-contamination risk.
Sustentabilidade
Environmental impact, waste reduction, resource availability, and end-of-life disposal considerations are increasingly vital in medical device design and production.
The 11 Most Common Types of Metal Used in Medical Devices
From stainless steel to gold and iridium, learn about the different alloys often used in medical devices and their applications.
Check this list now for an insightful look at modern healthcare.
Aço inoxidável
Stainless steel is the most widely used type of metal for medical devices due to its combination of properties, cost-effectiveness, and strength.
It has excellent corrosion resistance and a high resistance against acid attack, making it very durable in biomedical applications such as fracture fixation plates, rods, and screws.
Austenitic stainless steels are the most commonly utilized grades in instruments and implants due to their unique balance between formability and strength.
In addition, stainless steel has good biocompatibility, reducing sensitization risk when implanted into human tissues.
In recent years, there have been developments in nickel-free austenitic stainless steels that can reduce potential allergies caused by nickel content found in traditional types of stainless steel.
Cobre
Copper has a range of features that make it well suited for producing medical devices, such as electrical conductivity and excellent malleability, allowing for high-precision manufacturing on complex geometries.
Additionally, copper also provides antimicrobial properties, which makes it ideal for use as a surface coating and can even help to inhibit bacterial infection during implantation surgery.
Copper’s visible sleeving feature makes it particularly helpful in producing medical device parts, where its aesthetic appeal can contribute to better product usability.
Copper must be carefully managed when used in medical devices; however, specific oxidation processes could cause the performance of these parts to deteriorate if not treated correctly during manufacture.
Titânio
Titânio is a popular metal used in the manufacture of medical devices due to its impressive strength-to-weight ratio, durability, and superior resistance to corrosion and heat, water, and salt.
Its superior properties make it an ideal choice for implantable medical devices such as orthopedic surgical implants and prosthetics.
In addition to its natural biocompatibility with human tissue - meaning no allergic reactions or toxicity implications resulting from use - titanium provides high-performance elements for many demanding device applications requiring strength while remaining light in weight.
If you want to learn more about titanium, feel free to read este blogue.
Cromo-cobalto
Cobalt Chrome's popularity is primarily due to its balance of mechanical and biocompatible properties.
With high strength, wear resistance, and corrosion resistance, Cobalt Chrome alloys are excellent for harsh operating conditions in healthcare settings.
Furthermore, non-oxidizing properties can ensure long-term success for implanted applications, making it approved by the FDA to be used as medical devices or implants.
Not only do hospitals make use of this material, but its unique combination of mechanical and bio-comprehensive characteristics makes it commonly utilized in dentistry applications as well.
All these benefits explain why Cobalt Chrome has become one of the most common metals chosen when designing complex medical instruments such as implantable defibrillators or orthopedic joint replacements.
Alumínio
Aluminum is a strong, lightweight, corrosion-resistant, and malleable metal used in many medical devices such as wheelchairs, walkers, crutches, and other supporting equipment.
It also withstands high temperatures, which makes it useful for sterilization during production.
Aluminum can also be anodized, which provides added protection against wear and increases the longevity of medical equipment while offering precise calibration in specific instruments.
It is one of the most important metals used for medical instruments due to its biocompatibility properties that have proven over time not to harm patients when coming into contact with them routinely or occasionally.
Magnésio
Magnésio is a lightweight, corrosion-resistant metal that has excellent biocompatibility with human tissues, making it a promising material for temporary implants such as bone screws and plates.
It is the eighth most common element in the Earth's crust and can be found within mineral deposits located around the world.
Magnesium is also relatively easy to manufacture into complex shapes using traditional machining techniques like casting and stamping.
Its unique properties include a superior strength-to-weight ratio to other metals and low toxicity levels when released as dust or vapor.
These increased electrical conductivities may improve device performance, longer life span due to less wear on components during use, and enhanced patient comfort from its lighter weight designs.
Ouro
Gold is an incredibly versatile, durable, and biocompatible metal that has seen rising popularity in medical device applications.
This precious metal has been used for centuries in surgical tools and implants due to its toughness and responsiveness to the body’s varying acidity levels.
Popularly employed today as a coating for medical devices, gold helps reduce postoperative infections while protecting against corrosion and abrasion.
For dental prostheses such as bridges, crowns, periodontal splints, and inlays, gold is often chosen over other metals because it does not cause adverse reactions when contacting human tissue.
Gold is also ideal for electroplating medical instruments where aesthetics are essential—the bright shine created by the metal layer can provide visual feedback or confirmation that a tool has performed accurately or thoroughly.
Platina
Platinum is a rare and noble metal widely used in medical applications. Its unique physical and chemical properties make it an ideal material for medical devices, such as pacemakers, implantable defibrillators, catheters, stents, and cancer treatments.
Not only does platinum offer superior durability compared to many other metals - meaning its components tend to be longer lasting - but it also boasts heightened biocompatibility when interacting with the human body.
Moreover, platinum-based alloys are easier to sterilize after manufacturing, which minimizes the risk of contamination during surgeries.
In addition to this impressive performance profile, platinum has the ability to slow or stop the division of living cells, making it especially useful for chemotherapy drugs administered via drug delivery systems or MIGS (minimally invasive glaucoma surgery).
Prata
Silver has antimicrobial properties, reducing infection caused by contact with bacteria and other microorganisms from non-sterile surfaces.
Its combination of strength, formability, and durability makes it an excellent choice for long-term implants or orthopedic applications where longevity is essential.
Additionally, this metal exhibits high biocompatibility with human tissue when prepared correctly, making silver suitable for cardiovascular stents and other complex medical devices that come into contact with bodily fluids or tissue.
Currently, silver is primarily used as part of composite materials such as alloys to give specific properties to medical device components.
Its receptiveness to sterilization procedures at temperatures well under boiling points allows silver parts and tools to be easily cleaned without compromising their integrity or performance quality over time.
Iridium
Iridium is a chemical element with the symbol Ir and atomic number 77, found in the Earth's crust and not radioactive.
It is renowned for its superior corrosion resistance compared to other metals. This highly durable metal also has a bright luster that makes it aesthetically pleasing within any medical application.
It's commonly used in platinum-iridium wires on pacemakers. It boasts properties like durability against wear, low electrical resistance for high frequencies, and excellent biocompatibility, making it a top choice in medical materials due to its safety and effectiveness in implants.
Tântalo
Tantalum is an important metal option for medical device manufacturers as it offers excellent biocompatibility, high corrosion resistance, and the potential to promote osseointegration.
Combined with other elements such as iron or niobium, tantalum can be made into a strong alloy that is both lightweight and highly flexible.
These features make tantalum a perfect choice for creating intricate yet durable components of biomedical devices such as pacemakers, orthopedic implants, scissors, stents, and more.
Besides these advantages, its nonmagnetic nature makes it ideal for use in MRI-compatible medical equipment like scanning catheters or laser probes, which need to maneuver safely through tight spaces within the body without incurring any risks from magnetic field interference.
Conclusão
Medical device manufacturers face critical decisions when selecting metals and alloys for their products, considering factors like safety, performance, regulations, manufacturing efficiency, and cost.
Specialty metals, such as stainless steel, titanium, cobalt chrome alloys, niobium, or nitinol, offer advantages like strength, lightweight qualities, corrosion resistance, and unique properties for intricate medical applications.
Understanding the benefits, costs, and limitations of each material helps in making informed choices for specific medical device applications.
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