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Comprehensive Medical Device Finishing Services for the Healthcare Industry

Why Plate Medical Device Components?

Medical device surface coatings are a critical part of the manufacturing process. Plating helps to enhance overall part performance, reliability and safety, which benefits both the patient and the provider. 
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The plating process and materials used will depend on the specific requirements of the application. However, the benefits of all medical device plating are extensive and include corrosion resistance, electrical and thermal conductivity, antimicrobial properties that improve sanitation, radiopacity to prevent radiation passing through during x-ray procedures, strength and durability, biocompatibility (especially for implants) and improved aesthetics.

The best way to achieve these outcomes will depend on the application itself. Whether it's the conductivity of gold, the durability and biocompatibility of titanium or the antimicrobial properties of silver, the choice of plating material plays a crucial role in the functionality and longevity of medical devices.

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Types of Metals Used for Medical Device Plating

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Au

gold

gold

With exceptional conductivity and corrosion resistance, gold is a top choice for electrical contacts in medical devices. It also has high biocompatibility, which makes it suitable for implants and other components that come into direct contact, like heart stents, pacemakers and dental crowns

This list is not exhaustive, and the selection of the appropriate metal for medical device plating depends on various factors, including the intended application, required properties and regulatory considerations.

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Ag

silver

silver

Known for its antimicrobial properties, silver is often used in applications where preventing the growth of bacteria and infections is a priority such as with catheters. It also offers high electrical and thermal conductivity, making it a lower-cost alternative to gold for electrical components.

This list is not exhaustive, and the selection of the appropriate metal for medical device plating depends on various factors, including the intended application, required properties and regulatory considerations.

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Ti

titanium

titanium

Thanks to its remarkable strength, durability and biocompatibility, titanium is frequently used for orthopedic and other long-term implants.

This list is not exhaustive, and the selection of the appropriate metal for medical device plating depends on various factors, including the intended application, required properties and regulatory considerations.

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Pt

platinum

platinum

In applications where exceptional resistance is required, platinum is a great choice. It’s often used in pacemakers and other implants.

This list is not exhaustive, and the selection of the appropriate metal for medical device plating depends on various factors, including the intended application, required properties and regulatory considerations.

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Cu

copper

copper

As a highly conductive material that’s also resistant to bacteria, copper is sometimes used for electrical and thermal applications.

This list is not exhaustive, and the selection of the appropriate metal for medical device plating depends on various factors, including the intended application, required properties and regulatory considerations.

Stainless Steel

Stainless Steel

A go-to in the medical device industry thanks to its affordability, strength and resistance to corrosion. Stainless steel is used in everything from device housings to surgical instruments.

This list is not exhaustive, and the selection of the appropriate metal for medical device plating depends on various factors, including the intended application, required properties and regulatory considerations.

Medical Plating Processes

The plating of medical devices involves several specialized processes tailored to meet stringent performance and regulatory requirements. Among the most common plating processes are:

Anodizing Medical Parts

Anodizing is commonly used in the finishing of medical parts to enhance their surface properties and overall performance, as well as aesthetics. This electrochemical process involves the formation of a durable oxide layer on the surface of a metal substrate, usually aluminum or titanium, through controlled oxidation.

Why anodize a medical part? There are several reasons:
  • Corrosion resistance: Anodizing creates a protective barrier on the surface of the metal, shielding it from corrosion. 
  • Biocompatibility: The oxide layer formed during anodizing is inert and biocompatible, making it safe for use in patient contact.
  • Surface Durability: The anodized surface is harder and more wear-resistant than the base metal, enhancing durability and longevity.
  • Color Coding and Identification: Anodizing can be performed in a variety of colors, allowing for easy identification and differentiation of medical components based on their intended use, size, or other relevant parameters.
  • Improved Aesthetics: Anodized surfaces often have a visually appealing, uniform appearance, contributing to the overall aesthetics of medical devices and instruments

Titanium anodized parts, in particular, are used in many leading dental and medical devices or implants.

Pickling for the Medical Device Industry

Pickling and passivation are critical processes in the finishing of stainless steel components for the medical device industry. In a nutshell, these processes help remove contaminants, impurities, and other imperfections from the metal’s surface – usually stainless steel surfaces in medical uses.

This is important to prevent rust and reduce reactivity to other parts, while also preparing the surface for other finishing like priming or painting. For the manufacturing of medical devices and equipment, pickling and passivation are key.

Pickling is the first step in the process and involves the removal of impurities such as oxides, scales, rust and other contaminants from the stainless steel surface. It involves immersing the components in a pickling solution, which usually contains nitric acid or a combination of nitric and hydrofluoric acids that dissolve impurities.

Passivation for the Medical Device Industry

Passivation is a critical part of manufacturing medical devices and equipment. The process involves making the metal surface non-reactive – or “passive” – by altering the surface layer or coating to improve the metal’s resistance to corrosion or contamination.

Passivation is most commonly used for ferrous parts like stainless steel to prevent rust formation, reduce reactivity to other parts and prepare the surface for any additional finishing.

One of the most effective ways of achieving passivation is through electropolishing.

Electropolishing

Electropolishing is a highly effective process of preventing corrosion in metals used for medical devices. It involves immersing the metal part in an electrolyte solution while applying an electrical current to the bath. Doing so dissolves surface imperfections, contaminants and roughness – creating an ultra-smooth, clean surface.

The Benefits of Medical Device Electropolishing

For medical device manufacturing, electropolishing brings a number of benefits including:
improved

Improved Surface Finish

Electropolishing is a highly effective process of preventing corrosion in metals used for medical devices. It involves immersing the metal part in an electrolyte solution while applying an electrical current to the bath. Doing so dissolves surface imperfections, contaminants and roughness – creating an ultra-smooth, clean surface.
enhanced-cleanability

Enhanced Cleanability

The non-porous surface produced by electropolishing makes medical devices easier to clean and sterilize, critical in a healthcare setting.
corrosion-resistance

Corrosion Resistance

Electropolishing removes surface contaminants and impurities that compromise the corrosion resistance of stainless steel components. This prolongs the lifespan of medical devices and reduces the risk of malfunction.
biocompatibility

Biocompatibility

The smooth surface produced by electropolishing is biocompatible, making it suitable for devices and implants that come into direct contact with the body – minimizing the risk of adverse reactions or complications.
regulatory-compliance

Regulatory Compliance

Electropolishing is a well-established finishing process that is widely accepted and recognized within the medical device industry, meaning that manufacturers can ensure compliance with regulatory standards and requirements.

Working With a Medical Device Finishing Partner

Working with a dedicated finishing partner brings numerous benefits and is particularly advantageous for medical device manufacturers.

For one, finishing processes for medical devices often require specialized knowledge, equipment and techniques that adhere to strict regulatory requirements. By partnering with a finishing specialist, you gain access to a team of experts with deep expertise in healthcare finishing, ensuring components are processed using the most effective, efficient, and compliant methods.

Outsourcing finishing to a trusted partner allows your team to focus on core competencies such as design, engineering, and manufacturing, while leaving the finishing tasks to specialists who can execute them with precision and efficiency. This can streamline your operations and bolster overall productivity, improving your bottom line and offerings for your customers.

Plus, it provides flexibility and scalability to meet fluctuating demand and production requirements so you can easily scale up or down your finishing capacity as needed without the constraints of in-house resources and infrastructure.

Why Choose AOTCO for Your Medical Device Finishing Needs

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Choosing AOTCO for your medical device finishing needs means partnering with a leader in the industry, renowned for our decades of technical expertise and successful partnerships with medical manufacturers.

Our in-house capabilities enable us to handle the unique challenges presented by the complex geometries of medical devices, with ISO-certified finishing for biocompatible parts and a broad range of finishing technologies including:

A range of anodizing technologies is available to meet your unique needs, as are more than 20 plating processes on more than 25 substrates to the standards of more than 60 finishing specs. AOTCO Labs’ dedicated team of in-house engineers specializes in problem-solving and collaborates closely with clients to develop innovative solutions for new product development. 

Plus, plating processes are coupled with other services such as laser marking and engraving capabilities for a complete set of solutions for your needs.

Quality Assurance in Medical Device Finishing

At AOTCO, quality control is embedded in every step of our finishing processes. Our in-house capabilities allow for rigorous testing and validation of finishing techniques, ensuring that each medical part meets the stringent requirements and demands of the medical device industry. 

Our commitment to quality is reflected in our adherence to industry standards and certifications, exceeding expectations, and our reputation as a trusted partner across medical, dental, and orthopedic fields.

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Frequently Asked Questions (FAQs) About Medical Device Finishing Services

What is medical device finishing?

Medical device finishing refers to the process of applying various treatments and coatings to the surface of medical parts and equipment. These processes can include cleaning, polishing, passivation and coating to enhance the device's performance, durability and safety. Finishing is crucial for ensuring that devices meet the stringent standards required in the medical industry.

Why is surface finishing important for medical equipment?

Surface finishing is essential for these devices because it improves part functionality, longevity and biocompatibility. Proper finishing can reduce wear and friction, prevent corrosion, improve resistance to infection and ensure smooth surfaces. It also plays a role in the aesthetic appeal of devices.

How does passivation protect medical devices?

Passivation is a chemical process that removes impurities from the surface of parts, usually stainless steel, enhancing corrosion resistance. The process forms a thin oxide layer that protects the device from rust and degradation, which is especially important for devices that come into contact with a patient or are used in harsh environments. Passivation helps to maintain the integrity and cleanliness of the devices over time.

What measures are taken to ensure quality control?

Quality control involves several measures, including adherence to industry standards and regulations, such as certifications like ISO 13485. Finishing facilities conduct rigorous in-house testing to ensure that finishing processes meet specific criteria for cleanliness, corrosion resistance and surface smoothness, among other requirements. Regular audits, process validations and employee training are also crucial components of a comprehensive quality control program.

What is ISO 13485-certified?

ISO 13485 is an internationally recognized standard for quality management systems in the medical device industry. It outlines requirements for ensuring product safety, efficacy and regulatory compliance throughout the entire product lifecycle. All AOTCO medical device finishings are ISO 13485-certified.

Can complex geometries of medical parts be effectively finished?

Yes, modern finishing techniques and equipment are highly capable of handling complex geometries of medical parts. Techniques such as electropolishing and precision coating applications are designed to reach even the most intricate areas, ensuring that every surface is treated without compromising a part's functionality or integrity.

Why work with a finishing partner?

Working with a finishing partner provides medical device manufacturers access to specialized expertise, advanced technologies, and cost-effective solutions, ensuring optimal surface finishing for their products while allowing them to focus on core competencies in the medical industry.
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