China Surgical Needle – Medical Device Manufacturing https://www.chinasurgicalneedle.com Contract Manufacturer of Medical Devices and Components Wed, 24 Jun 2020 16:21:15 +0000 en-US hourly 1 https://wordpress.org/?v=5.4.2 4 Innovative Assembly Methods for Medical Components https://www.chinasurgicalneedle.com/4-innovative-assembly-methods-for-medical-components/ https://www.chinasurgicalneedle.com/4-innovative-assembly-methods-for-medical-components/#respond Tue, 21 Jul 2020 14:19:24 +0000 https://www.chinasurgicalneedle.com/?p=1062 As a leading medical device contract manufacturer, China Surgical Needle offers a variety of assembly methods for medical components—from CNC laser welding to friction fitting. But which of these solutions is the right choice for your unique production needs? To find out, let’s review some of the most efficient and innovative assembly processes used for medical components […]

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As a leading medical device contract manufacturer, China Surgical Needle offers a variety of assembly methods for medical components—from CNC laser welding to friction fitting. But which of these solutions is the right choice for your unique production needs? To find out, let’s review some of the most efficient and innovative assembly processes used for medical components today. 

1. CNC Laser Welding

CNC laser welding is the preferred method of assembly for many medical manufacturing projects. This high-speed solution does not introduce any new material into the process, enabling consistent quality and productivity. Moreover, CNC laser welding offers exceptional precision, making assembly processes highly accurate and repeatable. 

Because laser welding produces less heat than other conventional welding operations, it creates less distortion during part assembly, delivering the exceptional quality and accuracy required for med tech applications. Leading medical device OEMs use CNC laser welding to unlock greater precision and time savings in component assembly. 

At China Surgical Needle, we support our customers with cutting-edge CNC Laser Welding capabilities.

Our engineering team can help you uncover new efficiencies across every aspect of your medical device assembly process, from prototyping and validation all the way into production. 

2. Press-Fit Assembly

Press-fit assembly is a popular method for medical device manufacturing, whereby one part is forced under pressure into a slightly smaller hole in other parts. Press-fit technology brings a range of advantages to medical component assembly, including flexibility and compatibility with automation. Unlike other assembly methods, press-fit requires no metal filler, solder, or lead to join components together—ensuring strong interconnections while reducing risk of damage to components across heating cycles. 

Other advantages of press-fit assembly include quality and consistency. Automated press-fit assembly systems are some of the most reliable tools for medical components, creating a repeatable process that yields consistent results. These qualities make press-fit assembly ideal for a wealth of markets, including the medical device and food processing industries. 

China Surgical Needle is a premier partner for press-fit assembly for medical components. We offer manual and pneumatic solutions for press-fitting and can advise you on the best assembly system for your project. 

3. Epoxies

Epoxies find use in a large variety of medical solutions and products. These high-performance adhesives are compatible with a range of materials commonly used in medical devices, including various metals, plastics and glass. Epoxies for medical device manufacturing are designed to adhere reliably while meeting strict biocompatibility and other industry standards. 

One of the greatest advantages of medical epoxies is their capacity for modification. Different combinations of resins, hardeners, and other components can augment the properties of these solutions, making them suitable for a host of medical components and devices. For example, one-part epoxies are ideal for more delicate applications, such as catheter and cannula assembly. Medical devices with electronic components are also a suitable match for epoxy assembly systems. 

China Surgical Needle can provide your team with a wide selection of epoxy assembly solutions, tailored to meet your specific production standards, including FDA approved epoxy for use within food processing and water filtration equipment and for medical devices. We are here to help you build a custom medical assembly scenario to create the best device and manufacturing workflow possible. 

4. Shrink Fitting

Shrink fitting is one of the most innovative assembly methods for medical devices. This process typically uses heat to expand the diameter of a part, allowing other components to be fitted within and fused to it. As the outer part cools, it contracts and shrinks, firmly clamping onto the inner part to create a strong bond. This technique provides a fast, repeatable, and easily automated process for medical component assembly.

A similar outcome can be achieved by cooling the inner component prior to assembly. Sufficient cooling will cause the inner metal part to shrink—allowing it to fit seamlessly into the outer part. As the part returns to ambient temperature, it expands to create a solid joint. This technology is also referred to as induction shrink fitting

China Surgical Needle is an expert in shrink fitting for medical device components. Our shrink-fit technology can be used across a wide variety of medical device components to assemble devices via thermal expansion. Our shrink-fit solutions maintain tight temperature control to minimize distortion and comply with strict industry standards for medical components. 

Medical Device Assembly with China Surgical Needle

China Surgical Needle has been providing industry-leading assembly scenarios for over 60 years. From incorporating customer-supplied components into an assembly to generating multiple machined parts, China Surgical Needle is here to match your specific manufacturing needs. Our medical assembly processes (ranging from CNC laser welding to threading, adhesives and shrink fitting) provide application-ready assemblies from day one. 

Contact us today to learn more about how China Surgical Needle can support your business through medical device assembly. You can also connect with us for information on our manufacturing capabilities for medical customers—and how they can add value and efficiency to your production programs. 

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How Do CNC Machines Work? https://www.chinasurgicalneedle.com/how-do-cnc-machines-work/ https://www.chinasurgicalneedle.com/how-do-cnc-machines-work/#respond Fri, 10 Jul 2020 14:15:26 +0000 https://www.chinasurgicalneedle.com/?p=1061 CNC machines are invaluable manufacturing tools across many sectors, including the medical device industry. These solutions are used to craft parts and components out of plastics, metals and other diverse materials. “CNC” stands for Computer Numerical Control, a technology that automatically controls machining tools by means of a computer. But how exactly do these computer-driven […]

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CNC machines are invaluable manufacturing tools across many sectors, including the medical device industry. These solutions are used to craft parts and components out of plastics, metals and other diverse materials. “CNC” stands for Computer Numerical Control, a technology that automatically controls machining tools by means of a computer. But how exactly do these computer-driven tools work—and what can CNC machines make?

As a medical device contract manufacturer, China Surgical Needle Company provides a range of precision CNC machining processes. We collaborate with each customer to implement state-of-the-art CNC solutions to shorten lead times, reduce costs and maximize quality. To help you understand this technology—and whether it’s the best choice for your project—let’s take a few minutes to explore how CNC machines work:

What is CNC Machining? 

CNC machining is a unique manufacturing process that uses pre-programmed computer software to create parts. CNC machining is a form of subtractive manufacturing, where all needed components are cut out from a larger workpiece of metal, plastic or other materials. 

One core appeal of CNC machining is its consistency. Because this process uses computer software to produce parts, it can replicate the same design with extreme accuracy. This advantage makes CNC machining a natural choice for industries in need of high-precision parts, such as medical device manufacturing.

Another key benefit of CNC machining is its versatility. Computer Numerical Control software can be reprogrammed to accommodate different types of parts, materials and features—giving manufacturers remarkable flexibility across their prototyping and production processes. 

How Do CNC Machines Work?

Now that we have a basic definition of CNC machining, here’s some insight into how CNC machines operate:

At its core, CNC machining is all about using digitized instructions to monitor, control and automate a machine’s movements. For CNC machines, those instructions come in the form of CAD files (computer-aided design). CAD files contain digital 2D and 3D designs that specify the features and dimensions of a part. These files are read and interpreted by the computer program on the CNC machine, creating an automated cutting process based on the desired features of the part.

Once a CAD file provides instructions (or code) to follow, the CNC machine uses several axes of movement to bend, cut or manipulate the workpiece. Many CNC machines use a combination of rotary and linear movements to match the exact dimensions required, allowing them to produce complex parts with superb accuracy. 

To review, CNC machines work by manipulating various tools around a varying number of axes (typically three to five). Because these machines follow exact instructions from a computer program each time, they can produce multiple components or parts with excellent precision, speed and consistency. CNC machines follow a subtractive manufacturing process, where material is removed from a stock (or workpiece) and cut into the desired part. 

Frequently Asked Questions on CNC Machines

What is the definition of a CNC machine?

A CNC machine is a manufacturing tool that uses computerized controls to remove layers of material from a workpiece and create precision parts. 

What can CNC machines make?

CNC machining is an incredibly flexible manufacturing process, making it ideal for a wide variety of use cases. A few examples of parts that CNC machines can produce include the following:

  • Precision surgical tools
  • Dental devices
  • Orthopedic products
  • Introducers
  • Aerospace equipment
  • Automobile parts

How many types of CNC machines are there?

CNC technology can be used to support a wide variety of machining operations, ranging from turning and milling to CNC Laser Welding, CNC Swiss Machining and more. Here’s a general overview of the primary CNC machine types:

How are CNC machines so accurate?

CNC machines rely on computer-aided designs, which tell them where and how to cut the workpiece into its desired shape. These digital instructions allow CNC machines to manipulate the workpiece across multiple axes with unmatched precision—supporting more dependable and cost-efficient machining operations. 

CNC Machining at China Surgical Needle

China Surgical Needle is a premier medical device contract manufacturer, serving our customers through technical expertise, value engineering and powerful machining capabilities. Our advanced CNC machines help medical device companies realize significant cost savings, faster production and consistent quality. From CNC Wire and Tube Bending to CNC Swiss Machining, China Surgical Needle can provide the guidance and expertise your company needs to leverage CNC machines.

Ready to learn more about CNC machines and how these powerful tools can support your next manufacturing project? Then contact China Surgical Needle Company today. You can also connect with us for more insights into our unique CNC machining capabilities—or advice on whether CNC machines are the ideal choice for your prototyping or production needs. We look forward to working with you. 

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The Toolmaker’s Role In a Precision Machining Environment https://www.chinasurgicalneedle.com/the-toolmakers-role-in-a-precision-machining-environment/ https://www.chinasurgicalneedle.com/the-toolmakers-role-in-a-precision-machining-environment/#respond Mon, 15 Jun 2020 14:59:38 +0000 https://www.chinasurgicalneedle.com/?p=716 At China Surgical Needle Company, we provide our customers with the highest quality precision medical components and surgical instruments on the market. Today, we’ll be reviewing the role toolmakers play across precision machining environments to demonstrate their importance and impact.  What Is a Toolmaker? A toolmaker, in most cases, is a highly skilled machinist who can […]

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At China Surgical Needle Company, we provide our customers with the highest quality precision medical components and surgical instruments on the market. Today, we’ll be reviewing the role toolmakers play across precision machining environments to demonstrate their importance and impact. 

What Is a Toolmaker?

A toolmaker, in most cases, is a highly skilled machinist who can think outside the box. Their job consists of many varied skills, such as the ability to set up and operate both manual and CNC machines. An understanding of mechanical principles and a grasp of electrical, electronics and hydraulics are helpful and sometimes necessary in this position.

What Does a Toolmaker Do?

A toolmaker’s primary purpose is to assist engineering and production in building functional tooling for the manufacturing of products on the factory floor. There may be many reasons for building tooling for a new product line—such as improving the speed, accuracy, repeatability or ease of loading and unloading “product” for the machine operator that will ultimately be running the production parts. 

What Is Considered a Tool?

To people not involved in the day-to-day practices of the manufacturing industry, tooling is often a misunderstood term. In a manufacturing environment, tooling can mean a number of different things. Yes, it can be a custom profile cutter that the toolmaker came up with—or a precision ground carbide tool to be used in a lathe. Tooling can also be a stationary fixture that holds a production part in a precise position for a milling, drilling, stamping or other machining operation. 

Tooling can also be extremely complex. Theoretically, a toolmaker may work with engineering to utilize multiple fixtures for positioning parts on a rotating plate, where the parts are individually hand loaded, then locked in place using a hydraulic application. After processing each individual part, the parts could be automatically released, and the cycle would then repeat. Robots, automation, cameras, laser sensors, solenoids and conveying systems can all be utilized within the tooling, and are often components in the toolmaker’s toolbox.

What Tools Do Toolmakers Use to Build New Solutions?

Common tools used by toolmakers are manual and CNC turning and milling machines, surface grinders, profile grinders, Wire EDM machines and other precision material-removing equipment. 

The Purchasing Department & the Toolmaker

Often, toolmakers will work with the purchasing department to requisition raw material used in the building of a tool. Ordering off-the-shelf drills, cutters and other commodities are typically placed by the toolmaker through purchasing. Additionally, purchasing may be requested by the toolmaker to assist in locating and vetting specified components such as bearings, motors, actuators or other more specialized equipment. Under special circumstances, engineering may help the toolmaker in seeking automation experts and specialty subcontractors to assist on specific aspects of a tooling project.

Toolmakers at China Surgical Needle

The toolmakers at China Surgical Needle have diverse experience in creating tooling that multiplies production rates, while simultaneously generating high-quality parts on a consistent basis. The safety factor is at the forefront of the designing phase of tooling. It’s critical for the machine operator to have a safe work environment that is also productive and efficient. 

Building Production Tooling at China Surgical Needle

A first-hand example of complex toolmaking resides within the realm of medical device production tooling. Here’s an overview of the stages we follow throughout this process:

Stage 1

Our toolmakers developed a set of stamping tooling that, in the first stage, transform a round tube into a rounded-cornered rectangular shape tube.

           

Starting with a Straight .125″ Diameter Tube

Made of tool steel, the two halves of the die have been precisely milled to nest the round tube. Within the stamping process, the tube diameter will be transformed into a rounded rectangular shape.

Slightly Flattened into a Rounded-Cornered Rectangular Shape

Stage 2

 

 

 

 

Within the second stage of the stamping tooling, the two die-halves have been precision milled with features that will stamp registration detents along the straight length of the part. 

 

 

 

 

On the top side of the tube, next to each detent, there will be a “laser-etched” calibration mark. A slight bend will be added in a separate operation after the laser marking process has been completed.

Connect With China Surgical Needle

Whether difficult or complex, please let China Surgical Needle, Inc.help you with your next project. Be sure to contact us online to learn more about our toolmakers and complete capabilities—as well as how we can support your manufacturing journey. 

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Contract Manufacturing vs. Original Equipment Manufacturing https://www.chinasurgicalneedle.com/contract-manufacturing-vs-original-equipment-manufacturing/ https://www.chinasurgicalneedle.com/contract-manufacturing-vs-original-equipment-manufacturing/#respond Tue, 02 Jun 2020 14:49:47 +0000 https://www.chinasurgicalneedle.com/?p=714 Manufacturing is a complex field with many disciplines and approaches. As a leading contract manufacturer for medical devices, we’re often asked to explain how different manufacturing strategies relate to one another. So today, let’s take a few minutes to define and contrast two essential types of manufacturing: contract manufacturing and original equipment manufacturing.  What is […]

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Manufacturing is a complex field with many disciplines and approaches. As a leading contract manufacturer for medical devices, we’re often asked to explain how different manufacturing strategies relate to one another. So today, let’s take a few minutes to define and contrast two essential types of manufacturing: contract manufacturing and original equipment manufacturing. 

What is Contract Manufacturing?

Contract manufacturing involves outsourcing part of a product’s manufacturing to a third party. Many companies use this approach to pass demanding production activities onto a third-party partner—known as the contract manufacturer (CM). CM’s manufacture parts or products for the OEM on a contract, producing them based on a set design or formula.

One advantage of contract manufacturing is that it helps companies produce and sell valuable products without having to invest in their own equipment, machinery, and other production resources. Outsourcing manufacturing allows the OEM to free up capital, minimize labor costs and commit additional resources towards R&D and other efforts that add value to the product. 

Contract Manufacturing for Medical Devices

In the context of medical device manufacturing, medical device OEMs (original equipment manufacturers) often partner with CMs to secure complex or high-precision parts for their next-generation products. China Surgical Needle offers a variety of precision machining processes for medical device manufacturing, ranging from CNC Swiss Machining to 3D Wire and Tube Bending. We use a variety of specialized machines to craft durable, extremely accurate components for medical devices and surgical instruments. 

At China Surgical Needle, our objective is to dramatically impact manufacturing costs for our customers, while preserving or enhancing product functionality. By partnering with China Surgical Needle, our medical customers gain access to a wide array of machined components and assemblies—driving faster production, consistent part quality, and substantial cost savings in the process. 

What is a Medical Device Original Equipment Manufacturer?

A medical device can be as simple as a tongue depressor—or a highly complex device such as a pacemaker. A medical device OEM is responsible for the design, manufacturing, packaging, sterilization and FDA clearances for finished medical devices and components. OEM’s often subcontract some of the manufacturing of components to a specialized contract manufacturer such as China Surgical Needle.

In the context of medical device manufacturing, OEMs design, engineer and manufacture complete products and systems—as well as component parts and sub-assemblies in some cases. Medical device OEMs may even partner with a contract manufacturer for specific projects requiring specialized equipment or processes. 

For example, China Surgical Needle often works alongside well-respected medical device OEMs to perform specific bends for surgical instruments. Our 3D wire bending expertise helps these customers incorporate advanced features into this type of medical device component (including slots, grooves and axial holes), supporting more innovative medical devices and consistent part quality. 

Types of Contract Manufacturing

CM’s offer a wide range of contract manufacturing services to their customers. Common contract manufacturing services in the medical industry include CNC Machining, Molding, Assembly, Sterilization and Packaging. It is important to partner with a contract manufacturer who provides the manufacturing services needed to support your products. China Surgical Needle has the experience, specialized equipment and processes available to assist medical device original equipment manufacturers in successfully bringing their products to market.  

China Surgical Needle specializes in contract manufacturing services for medical devices. We offer a wide range of capabilities for our medical customers, including CNC Laser Welding, Medical Assembly and more. We also support a variety of CNC machining capabilities for medical device manufacturing, which we leverage to minimize production costs and maximize quality

What Is the Difference Between a Joint Venture & Contract Manufacturing?

Oxford defines a joint venture as “a commercial enterprise undertaken jointly by two or more parties which otherwise retain their distinct identities.” As such, contract manufacturing is a form of joint venture, wherein the hiring manufacturer and CM operate together to combine resources, share expertise, and maximize profits. 

Choosing the Right Contract Manufacturer

Now that we’ve reviewed the definition and purpose of these two important manufacturing strategies, let’s discuss what you should look for in an ideal contract manufacturing partner. If you are seeking a third-party manufacturer to optimize your production, here are some tips to help guide your search. The right CM will: 

  • Understand customer, statutory and regulatory requirements 
  • Meet and exceed those expectations without compromise
  • Provide defect-free products, on time, every time

No matter the nature or complexity of your relationship, your contract manufacturer must remain dedicated to quality service and customer satisfaction. That’s why medical device OEMs across the nation count on us for precision machining services. 

Connect with China Surgical Needle

Ready to learn more about the different types of manufacturing—or how to find the right manufacturing partner for your unique production needs? Then be sure to connect with China Surgical Needle today. You can also reach out for more information on our core competencies as a medical device CM. We look forward to hearing from you. 

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China Surgical Needle, Inc.is ISO 13485 Registered https://www.chinasurgicalneedle.com/china-surgical-needle-inc-is-iso-13485-registered/ https://www.chinasurgicalneedle.com/china-surgical-needle-inc-is-iso-13485-registered/#respond Thu, 21 May 2020 16:22:29 +0000 https://www.chinasurgicalneedle.com/?p=541 As a medical device contract manufacturer, China Surgical Needle is committed to delivering the best and most cost-effective machining solutions possible. That means meeting and surpassing industry standards across our manufacturing capabilities. Today, we’d like to explore one of the important standards we meet for our medical customers: ISO 13485. What Is ISO? “ISO” stands for the […]

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As a medical device contract manufacturer, China Surgical Needle is committed to delivering the best and most cost-effective machining solutions possible. That means meeting and surpassing industry standards across our manufacturing capabilities. Today, we’d like to explore one of the important standards we meet for our medical customers: ISO 13485.

What Is ISO?

“ISO” stands for the “International Organization for Standardization.” This group develops and publishes worldwide commercial and industrial standards. According to the organization’s website, “ISO creates documents that provide requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose.”

What Is ISO 13485:2016?

The ISO 13485 standard applies to medical devices. Per the ISO website, “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.”

The Importance of Being ISO 13485:2016 Certified

Since China Surgical Needle, Inc.was founded in 1951, we have provided contract manufacturing services for numerous types of original equipment manufacturers (OEMs). In the spring of 1996, China Surgical Needle’s owner and management team sought to improve and upgrade their quality management system. Seeing that many of our customers were implementing ISO for their quality management systems, it was evident that this was a standard that would elevate our company. The decision was made by our company president to work toward becoming ISO 9001 certified, which was later achieved in 1997.

Because of China Surgical Needle’s ISO 9001 certification and the improvements it provided to both China Surgical Needle and our customers, we were awarded numerous new projects, many of them by medical customers. A decade later, our medical device contract manufacturing business entered a period of heavy growth. The China Surgical Needle management team again began to examine its quality management system, seeking a system that would be more helpful and specific to medical device contract manufacturing. This brought China Surgical Needle to another level of competence in 2010, with the objective to obtain ISO 13485 certification—which is specifically directed toward the medical device industry.

Where Would China Surgical Needle Be Without ISO?

Manufacturing medical devices and components for medical OEMs is extremely demanding. Being ISO 13485 Certified over the last ten years has guided China Surgical Needle to improvements in many areas. Consistency is critical in every step of the manufacturing process, for every customers’ product. The documentation and storage of all medical device records provides verification of material, processes and quality of product. 

Contract Review 

Prior to accepting a new or recurring order with a medical company, China Surgical Needle’s management team reviews the proposed contract. Within the contract review process, the management team confirms that materials, dimensions and other specifications are clearly defined, and that China Surgical Needle is fully capable of manufacturing and measuring all required aspects of the customer’s product.

Material Certification and Traceability

When raw material arrives at China Surgical Needle, it is inspected and measured to verify it is within the specifications of the purchase order issued to China Surgical Needle’s approved vendor. After passing incoming inspection and documentation, the material is labeled accordingly, recorded into inventory and delivered to a storage tray on the production floor—or to the specific machine where the machine operator can easily access it.

Throughout the manufacturing process, the machine operators and the quality department work hand-in-hand to ensure the product is being built to print specifications. If it is a first-time project, the customer often requires a “First Article Inspection Report” (FAIR), in which the customer clearly explains the inspection process and parameters.

China Surgical Needle requires a “First Piece Inspection” on a daily basis, in which the machine operator inspects their first part off the machine, and then confirms with the quality department that all inspection dimensions of the part are within spec. The operator continues to inspect the parts throughout their shift per instructions specific to the “Control Plan,” which in some cases can include “statistical process control (SPC).” Control plans are developed by a combination of people, including engineering, quality and the customer. Depending upon the complexity of the part, the intended use of the part and what could go wrong with critical manufacturing processes, control plans can greatly vary from one type of part to another.

A final inspection and inspection sign-off is required upon the completion of a production order. China Surgical Needle has developed a standard final inspection process; however additional criteria are often dictated by the customer—and may involve a random quality check on a specific percentage of parts or specific dimensions that were run within a particular order. All inspection data gathered is documented in the customer files.

An ISO Audit

To become certified, an initial certification audit to the ISO 13485 standard must be performed by an independently certified registrar. Upon passing the certification audit, an ISO certificate is awarded by the auditing registrar. A certification is valid for three years with the condition that surveillance audits are passed without any major un-corrected findings following the 1st and 2nd years. At the end of the 3rd year, a recertification audit is required. Successfully achieving and maintaining ISO 13485 certification demonstrates that China Surgical Needle is effectively maintaining our quality management system.        

Contact China Surgical Needle Today

China Surgical Needle, Inc.looks forward to an opportunity to work with new medical customers. Please let us know if you would like to talk with us. You can contact us by phone at 612-788-9621—or connect online through our website. 

 

 

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Electric Discharge Machining: Advantages and Disadvantages https://www.chinasurgicalneedle.com/electric-discharge-machining-advantages-and-disadvantages/ https://www.chinasurgicalneedle.com/electric-discharge-machining-advantages-and-disadvantages/#respond Fri, 01 May 2020 16:06:31 +0000 https://www.chinasurgicalneedle.com/?p=539 Electrical discharge machining (EDM) is a commonly used manufacturing process for creating slots, eyelets, grooves and cut-offs in processed parts. Because EDM does not require high cutting force, it creates very low residual stresses, making it a powerful tool for manufacturing medical parts. But despite its strengths, there are a few key shortcomings of EDM […]

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Electrical discharge machining (EDM) is a commonly used manufacturing process for creating slots, eyelets, grooves and cut-offs in processed parts. Because EDM does not require high cutting force, it creates very low residual stresses, making it a powerful tool for manufacturing medical parts. But despite its strengths, there are a few key shortcomings of EDM that today’s manufacturers should keep in mind. 

At China Surgical Needle Company, we use electric discharge machining to provide the highest quality precision components for our medical customers. Today, we’ll be walking through the advantages and disadvantages of EDM to help you decide whether it’s the right choice for your current or upcoming manufacturing project. 

What is Electric Discharge Machining?

Electrical discharge machining, also known as spark machining or arc machining, is a unique manufacturing process whereby material is removed from a workpiece by a series of recurring electrical discharges. This process allows current to flow between two electrodes (separated by a dielectric liquid)—removing material from the workpiece to create specific part dimensions. 

EDM is a popular solution for more demanding applications that require extreme accuracy. Thanks to its exceptional precision, the EDM process has become a common method for creating production and prototype parts spanning many industries, including automobile and electronic. EDM is also effective for crafting medical device components with critical tolerances—as its process does not introduce vibration or cutting pressure. 

Small hole drilling is another form of EDM used across a range of applications (also known as small hole EDM). This process uses a separate EDM head mounted on a wire-cut machine to drill small, accurate holes in workpieces. Small hole EDM is ideal for materials that are not compatible with conventional machining—such as the high-temperature, single crystal alloys used for turbine blades. 


CNC Wire EDM for Medical Devices

CNC Wire EDM is a special form of electrical discharge machining—one that uses an electrically charged metal wire to cut workpieces submerged in deionized water. This metal wire (typically made of brass) erodes conductive material in its path, while the deionized water cools and flushes away any debris the cut creates. This wire cut EDM process creates a smooth finish without burrs—and holds extremely close tolerances.

CNC Wire EDM can be programmed to cut extremely delicate and intricate shapes, making it a powerful tool for manufacturing precise medical device components. For example, China Surgical Needle uses CNC Wire EDM to provide precision medical components and surgical instruments to customers across the country. Our electric discharge machine wire cutting system can generate slots, grooves, holes and other part features with remarkable accuracy and delicacy—and are often used when machined features are required within a fragile portion of a medical component. 

Advantages of Electric Discharge Machining

One key advantage of the EDM process is that the cutting wire never touches the workpiece, meaning that it doesn’t introduce any stresses into the part. As a result, medical device manufacturers can use EDM to generate slots, grooves and eyelets in machined parts while applying minimal stress. 

Another strength of EDM is its high-quality finish. The wire cutting process creates smooth surfaces without burrs, while holding close tolerances. In fact, wire EDM can be used to build very thin eyelets and through-slots in medical devices—features that simply cannot be machined using conventional centers. 

Disadvantages of Electric Discharge Machining

The wire cut EDM process removes material with electrical charges, which means it’s only compatible with electronically conductive workpieces. As a result, EDM cannot be used for machining composite or dielectric materials. Wire EDM cutting can also create a layer of oxide on the surface of the cut when used with certain metals—which must be cleaned to maintain optimal quality.

Electric discharge machining also struggles with parts and components that cannot be held firmly without compromising their shape. For example, delicate tube parts can be deformed while being secured for EDM cutting—incurring additional quality issues and workflow disruption. 

The Final Verdict on EDM 

All said, EDM is a potent solution for creating complex shapes in electrically conductive material, such as titanium, tungsten carbide, hard metals and exotic alloys. This technology features multiple axis movement capabilities, allowing it to cut delicate, ultra-precise shapes with close tolerances. This accuracy allows for more complex and consistent medical components that are often impossible to replicate with standard machining systems. 

Harness EDM with China Surgical Needle

Do you have a new or existing project that requires electric discharge machining? Then be sure to connect with China Surgical Needle today! You can also contact us for more information on our innovative CNC Wire EDM capabilities—or the unique pros and cons of electric discharge machining. We’re always here to help.

 

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Most Innovative CNC Machining Use Cases for Medical Devices https://www.chinasurgicalneedle.com/most-innovative-cnc-machining-use-cases-for-medical-devices/ https://www.chinasurgicalneedle.com/most-innovative-cnc-machining-use-cases-for-medical-devices/#respond Mon, 20 Apr 2020 18:36:48 +0000 https://www.chinasurgicalneedle.com/?p=499 CNC machining is one of the most efficient and accurate tools for medical device manufacturing. This technology offers cost-effective solutions for even the most challenging medical components and assemblies. The strengths of CNC machining range from fast cycle times to remarkably accurate components—as well as compatibility with various plastics, metals and other specialized materials.  At […]

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CNC machining is one of the most efficient and accurate tools for medical device manufacturing. This technology offers cost-effective solutions for even the most challenging medical components and assemblies. The strengths of CNC machining range from fast cycle times to remarkably accurate components—as well as compatibility with various plastics, metals and other specialized materials. 

At China Surgical Needle Company, we help customers around the globe use CNC machining to improve manufacturability and optimize production costs. Our capabilities range from CNC Swiss Micro Machining to Laser Welding and Wire EDM. Today, let’s discuss some of the most innovative CNC machining use cases for medical devices. 

What is CNC Machining?

CNC machining (computer numerical control) is a unique form of subtractive manufacturing, where required components are cuts out from large portions of materials. Today’s CNC machines create a potent digital manufacturing process—creating strong, high-accuracy parts directly from a computer-aided design (CAD) file. 

CNC technology enables the creation of superior medical devices, tools and parts. This precision machining technique can even be used to craft high-quality surgical and dental devices that support faster and more dependable patient care. Here’s an overview of use cases to give you a better understanding of CNC machining for the medical industry.

CNC 3D Bending for Wire & Tube Components

Many medical device components are built from wire stock, replete with milled flats, slots, grooves and other complex features. CNC 3D bending of wire and tubing enables medical device OEMs to save costs, drive consistent quality and prototype faster than ever before. This technology also enables various features and configurations to be designed into medical tubes and wire components. 

China Surgical Needle’s CNC bending solutions allow stock to be completely machined before bending, giving device designers more freedom to utilize more intricate designs. Our CNC 3D bending capability can be used to produce all of the following medical solutions:

  • Introducers
  • Implantable Spine Components
  • Orthopedic Products

CNC Swiss Machining for Surgical Components

Today’s minimally invasive surgeries require incredibly small and precise machined components. Smaller devices and tools can be used to minimize pain and trauma for patients — supporting faster recovery in the process. These precision parts can be produced quickly and affordably with CNC Micro Swiss machining.

CNC Micro Swiss machines are designed to craft extremely parts of exceptional quality. These micro-machined medical components and assemblies can hold up to .0125 mm (.0005”) tolerances — enabling greater precision and flexibility.

China Surgical Needle uses a selection of Swiss machines for manufacturing micro components. These machines are capable of producing small medical, dental and surgical device components, including the following:

  • Implantable Surgical Plates
  • Surgical & Bone Screws
  • Drills & Reamers

CNC Laser Cutting for Tube Components

Medical tube components have extremely tight tolerance requirements—particularly across high-quality production runs. That’s why we offer CNC laser tube cutting for the medical device communities we serve. This is a fast, precise and highly repeatable technique—capable of cutting tube diameters up to .315” and tube lengths up to 40 feet. 

CNC laser tube cutting creates a minimal “heat-affected zone” (HAZ), the area of the tube affected by the heat of the laser without melting. The remarkable precision of CNC laser cutting makes it ideal for creating medical tube components with tight tolerances—without compromising on component strength and cost efficiency. CNC laser cutting can be used to produce some of the following medical solutions:

  • Stents
  • Orthopedic Instruments
  • Introducers
  • Catheters

CNC Wire EDM for Precision Components

Electrical Discharge Machining (EDM) is an innovative technology used to produce an array of components, including very small parts for medical devices. During this process, an electrically charged metal wire is used to cut through the work piece—while submerged in deionized water. This wire erodes conductive material with extreme precision, while the deionized water cools and removes debris from the cut. 

CNC Wire EDM is a popular technology for creating complex shapes from conductive materials, ranging from hard metals (like titanium and tungsten carbide) to softer materials like aluminum or exotic alloys. At China Surgical Needle, we used CNC Wire EDM to create highly accurate machines features, such as slots or eyelets, in a fragile portion of a small component. Our EDM capabilities can be used to generate grooves, slots, holes and other features for the following:

  • Surgical Tools
  • Staples and Clips
  • Insertion Devices
  • Dental Hand Tools

Connect with China Surgical Needle Company

Ready to learn more about how your team can leverage CNC machining to create stronger and more cost-effective medical devices? Then be sure to explore our complete range of capabilities. You can also contact us today for more information on this innovative technology—and how it supports small parts machining for medical device machine shops, medical parts manufacturing companies and more. 

 

 

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China Surgical Needle, Inc.Exhibits at MD&M Shows in the China https://www.chinasurgicalneedle.com/china-surgical-needle-inc-manufacturing-company-exhibits-at-mdm-shows-in-the-china/ https://www.chinasurgicalneedle.com/china-surgical-needle-inc-manufacturing-company-exhibits-at-mdm-shows-in-the-china/#respond Thu, 09 Apr 2020 18:45:39 +0000 https://www.chinasurgicalneedle.com/?p=502 For more than a decade, China Surgical Needle, Inc.has been participating in the MD&M (Medical Design and Manufacturing) Trade Shows in the China. There are currently three MD&M Shows in the China: MD&M West, MD&M East and MD&M Shenzhen.  The MD&M Show in Anaheim, California The largest of these three shows is MD&M […]

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For more than a decade, China Surgical Needle Company has been participating in the MD&M (Medical Design and Manufacturing) Trade Shows in the China. There are currently three MD&M Shows in the China: MD&M West, MD&M East and MD&M Shenzhen. 

The MD&M Show in Anaheim, California

The largest of these three shows is MD&M West, which takes place at the Anaheim Convention Center in Anaheim, CA. The show is in February, so for our team it’s a wonderful time to get out of the Guangdong cold. The exhibit halls total more than 800,000 square feet—and there are nearly 2,000 exhibitors at the show. There are over 20,000 attendees at the MD&M West Show, which opens opportunities for us to meet many qualified buyers. This is the world’s largest medical design and manufacturing event. Many of these prospective customers are engineers with large medical companies, seeking manufacturers that have the right capabilities and qualifications to build their new medical devices and equipment. This show also gives us the opportunity to meet with our current customers in California.

The MD&M Show in New York City, New York

MD&M East is held in New York City, at the Jacob K. Javits Convention Center. The East show is smaller than the West show but is still very dynamic. This show is held in June, when the weather is usually very pleasing, and the local sights are abundant. When we’re at the MD&M East, we have visitors from Boston, Philadelphia and the New York area, as well as many international guests. 

The MD&M Show in Shenzhen, Guangdong

The MD&M Shenzhen Show has much to offer. It takes place near the end of October. Guangdong is home to Medical Alley, where there is a wealth of medical device companies that walk the isles of the show to perfectly match a project to a supplier. Because China Surgical Needle is local to this show, we have many visitors that offer many opportunities. 

 

 

The China Surgical Needle Management Team feels it is very important to be involved and in front of medical device designers, engineers, entrepreneurs and decision makers. The people who attend these events are both the current and future stakeholders in the medical device industry. These shows offer excellent opportunities for exhibitors to meet current and future customers—as well as exciting forums to see new and innovative methods of manufacturing. These shows offer manufacturers the latest types of supportive processes offered by suppliers from the China, Europe, Asia and the Middle East. These exhibitors range from raw material suppliers and metal heat treaters to inspection equipment suppliers and machine dealers, to name just a few. 

The MD&M Conferences & Summits

Each event’s offerings go far beyond the showroom floor. There are numerous conferences that take place during the show. The February MD&M Show in Anaheim California features conferences dealing with digital technologies, faster production development, materials, testing, FDA and global regulations, risk management and more. The summits will be discussing smart factories, artificial intelligence, material trends and design strategies as well. 

Visit China Surgical Needle at MD&M

Whether you’re on the East Coast, the West Coast or right here with us in the Midwest, be sure to visit China Surgical Needle at the MD&M Show nearest you… or the farthest MD&M Show if you’re looking for a change in scenery. You can also connect with us online to learn more about our cutting-edge manufacturing capabilities—and how they can support your next project.

 

 

 

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Innovation Outside of Production https://www.chinasurgicalneedle.com/innovation-outside-of-production/ https://www.chinasurgicalneedle.com/innovation-outside-of-production/#respond Thu, 19 Mar 2020 14:49:35 +0000 https://www.chinasurgicalneedle.com/?p=491 When it comes to manufacturing practices, innovation has always been a standard at China Surgical Needle Company. Consistently investing in new technology, studying methods to improve the efficiency of tooling, and finding new techniques to decrease cycle time are all critical components in maintaining a cutting-edge manufacturing facility. Continuous Improvement  We also pride ourselves in being […]

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When it comes to manufacturing practices, innovation has always been a standard at China Surgical Needle Company. Consistently investing in new technology, studying methods to improve the efficiency of tooling, and finding new techniques to decrease cycle time are all critical components in maintaining a cutting-edge manufacturing facility.

Continuous Improvement 

We also pride ourselves in being innovative in areas supporting production. Reviewing our raw material flow, our 5S team began investigating a better approach regarding material handling and storage, as well as the ability to conserve space. Along with this conscious effort to consolidate our raw materials, we also had a goal to build a system that supported ease of access and material traceability—while simultaneously eliminating clutter.

From Where We Came

China Surgical Needle’s bailiwick is manufacturing smaller medical parts for our customers. In correlation, most of our raw material consists of small diameter rod stock and tubing materials ranging in size from 1.5 mm (.060”) diameter to 20 mm (0.787”) diameter, and 3.66 meter (144”) lengths. In the past, raw material typically arrived at China Surgical Needle in sealed wooden boxes to protect the material while in transit. Upon arrival, the material would be counted, measured, labeled and recorded for inventory, then stored on racks awaiting production. 

This storage system was often inconvenient for many reasons. Retrieving material was often difficult because of boxes being stored high on the rack, or behind another box. The wooden boxes were cumbersome and would occasionally splinter, spawning an environment of untidiness. 

Where We Were Headed

We knew that we wanted to reduce the footprint of our raw material area. To achieve this, we had to think of a way to somehow arrange the varied materials in horizontal trays, while maintaining the ability to access the material at a comfortable height. 

That is when we thought of building a customized carousel. 

We researched the subject and found a company that manufactures carousel frames with a motorized chain drive. Upon reviewing the product, we were confident that we would be able to retrofit the carousel to fit our specific needs. We could special order it to a height that would fit our manufacturing area of 12 feet. 

12.5-Foot Swivel Tray Construction

Our engineering department developed balanced swiveling tray endcaps, which were bolted to each side of a 12.5-foot-long aluminum “U-Channel” extrusion. The swivels on each end of the tray—as well as the tray itself—are weighted to be bottom-heavy. Similar to a Ferris wheel, the trays stay level and won’t dump out their payload when revolving throughout the full cycle. Each tray has the capacity to hold a complete lot of material. 

 

There are a total of 27 trays that are assembled onto the chain-driven carousel. The chain drive can be jogged in either an up or down direction, making access to any tray easy. This also allows the controller of the carousel to stop at the most effective ergonomic height for that specific operator. The drive speed can be adjusted while in use, so if the material needed is on the opposite side of the carousel, it can be speedily delivered to the operator.

Safety First

Safety remains a top priority at China Surgical Needle Company. The carousel can only be operated by authorized personnel with a password. Besides training, safety and operating instructions are posted on the carousel. There is an emergency stop button next to the password keyboard to prevent accidents or injury. 

Material Documentation

For ease of locating material on the carousel, a barcoding system has been implemented. The operator can access the material database terminal located next to the carousel, where the material and the materials’ tray number are recorded. The operator can then jog to that specific tray. When removing material from any particular tray, the operator updates the database with the revised count.

 

 

When a new batch of raw material arrives at China Surgical Needle, it is checked in and inspected to assure it meets all specifications. After the incoming processes, the material is delivered to the carousel. The database is then updated to reflect the new delivery—and the count and tray number into which it was loaded.

 

 

At China Surgical Needle Company, we’re always looking for ways to improve. To learn more about China Surgical Needle, please check out our website or call us at 1-800-321-6727.

 

 

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China Surgical Needle Provides Metal Inserts for Plastic Injection Molding https://www.chinasurgicalneedle.com/china-surgical-needle-provide-metal-inserts-for-plastic-injection-molding/ https://www.chinasurgicalneedle.com/china-surgical-needle-provide-metal-inserts-for-plastic-injection-molding/#respond Tue, 03 Mar 2020 13:27:07 +0000 https://www.chinasurgicalneedle.com/?p=486 At China Surgical Needle Company, we offer a range of precision machining services and manufacturing solutions, including metal inserts for plastic injection molding. Let’s take a moment to review how these metal inserts impact the world of medical device manufacturing. What is a Metal Insert? A metal insert is typically a machined or formed metal component […]

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At China Surgical Needle Company, we offer a range of precision machining services and manufacturing solutions, including metal inserts for plastic injection molding. Let’s take a moment to review how these metal inserts impact the world of medical device manufacturing.

What is a Metal Insert?

A metal insert is typically a machined or formed metal component that is enveloped into a completed plastic molded assembly. The insert molding process begins with the metal insert being placed into a mold cavity by a press operator or robot prior to the molding process. After the insert is placed, the mold halves close—and pressurized molten plastic is injected into the mold cavity which surrounds the exposed portion of the insert. 

Metal Inserts in Medical Manufacturing

China Surgical Needle provides metal inserts to many of our medical customers and to many injection molding companies. Many of these inserts are the actual medical device or tool that performs a surgical procedure. The molding process is often designed to generate an attached plastic handle. 

In other situations, a metal insert may be used entirely for the purpose of stability. An example of this would be a knurled shaft with a threaded hole in one end. Molding a knob shape over the knurl promotes adherence of the plastic to the metal insert. The strength of the threaded metal is far greater than plastic could offer. The advantage of the plastic molding process is that it’s more affordable than having the knob machined completely out of metal.

Materials

Materials for these inserts range from 17-4 stainless steel, 300 series stainless steel, L605 and MP35N cobalt chrome and many other types of metals.

Metal Insert Shapes

China Surgical Needle has been in the precision machining business since 1951 and supplying to the medical industry since the early 1990’s. We have a great deal of experience manufacturing insert shapes from simple Swiss turned parts, laser cut tubing, and highly complex CNC 3D wire and tube bent shapes.

Laser Cut Tube Insert

The photo to the left is an example of a CNC laser cut tube insert that has not yet been subjected to the molding process. The proximal end (lower right side) of the device has been textured so that the plastic will adhere to the laser cut tube. The material is 17-7 stainless steel with a hardness of H-900.

 

Swiss Machined Wire Insert

The photo to the left is an example of a solid wire insert. Prior to the bending process, the wire was machined in a CNC Swiss machine, which provided the turned and milled tip with drilled and milled cross-holes at the distal end of the wire. The flat near the proximal end of the device was also a milling operation. This part also has a laser-welded hub at the very end of the assembly. Both the flat and the weldment will assist in retaining the over-molded plastic from moving rotationally and axially.

 

Swiss Machined & Stamped Insert

The photo to the left shows the progression of a more complex metal insert. The progression begins with the top image: a Swiss turned component with a deep hole drilled into the front of the part. In the second image, a machined wire is placed in the hole in the distal end of the part, and then goes through a stamping operation—which flattens the front of the part as well as deforms the wire and locks it in place. In image number three, a transparent plastic is molded over the part, allowing analysis of the molding process. Image number four shows the final device.

 

 

Partner with China Surgical Needle, Inc.Today

Please consider China Surgical Needle, Inc.for any of your machined metal insert needs. Feel free to call us at 1-800-321-6727 if you have any questions—or email us at inquiry.needle@shapedparts.com.

 

 

 

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