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Implants Forge Ahead



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Forging can help manufacturers produce enhanced parts while saving time and reducing costs.

Tibia tray forgings are removed from the furnace for their final forging blow.
A customer recently asked for advice about a product that was being manufacturing in-house. The customer was machining a tibia tray knee implant from raw bar stock and had been spending too much time machining the parts. Demand for the product had increased, and the company couldn’t keep up with the orders. The customer had heard of using forging for this part but needed to know what differentiated the process from machining.
 
This implant was a perfect application for forging. In the end, the process not only saved the customer time in machining the part, but overall costs were reduced. Using forging, the customer achieved 75% savings in machine time, reduced input weight of material by 60%, and realized an estimated overall cost savings of more than $100 per part. This article discusses forging and how the process enables manufacturers to produce implants in an efficient and cost-effective manner. 
 
Forging 101
So what is forging anyway? If you know anything about history, you may be imagining a smithy with a hammer and an anvil, pounding away on a piece of hot metal. Forging has been used for centuries—ever since humans started working with metals. Although a lot has changed since those days, the basic characteristics remain the same today.
 
Forging is the plastic deformation of material into the desired shape. See the sidebar “Materials in Forging” for examples of what materials are used in forging in orthopaedics. Today, this deformation of material usually involves heat and force via a furnace and a press. Although this article won’t discuss the types of furnaces and presses available, it is important to know that they are varied and are used to control the different process variables of forging. 
 
Forging also involves a set of dies or impressions in which the raw material billet (a small piece cut from bar stock) is formed into a part. They are usually made from high-strength steel and are either CNC machined or milled out using an electronic discharge machine. Once you have the dies, billet, press, and a furnace, you are ready to make a forged part. 
The following are four main instances when it makes sense to use forging:
  • When a product requires a lot of machining. Products like this often experience long cycle times, limited resources, and increased costs.
  • When a raw material is very expensive. Titanium and cobalt chrome aren’t as expensive as gold, but it can be quite expensive to make chips from titanium and cobalt chrome while machining a part.
  • When the overall shape of the part is complicated. Large, curving surfaces lend themselves well for forging versus sculpture milling of parts.
  • When there is a need for enhancing or maintaining the physical properties of the material. Forging is always better than casting in terms of improving physical properties. 
A robotic arm feeds a heated billet into a rotary forging press. 
Design Considerations
A number of considerations must be addressed when using a forged part for an implant. Most of these issues are fairly simple to review but are important because they can affect the outcome of the finished product. The first consideration is the desired shape of the product. Forgings can be grouped into three shape categories—gross, near-net, and net.
 
Gross. Gross-shaped forging usually has a lot of excess stock on a part and requires all surfaces to be machined. Sometimes the forging doesn’t even remotely resemble the end product. This shape is chosen when there are many part codes and relatively low volume for each code. It allows the benefit of the volume of all the codes into one forging part number. For example, there may be 10 different part codes in a part family. Some of these sizes can be grouped together so that one forging can be used for multiple sizes. Other benefits include allowing one type of machining fixture and setup, as well as inventorying only one forging part code.
 
Near-Net. Near-net forgings have minimal stock on a part and closely resemble the final product. Operations such as machining, grinding, and polishing usually follow forging, but for the most part, the process removes less than 0.01 in. of material per surface. In this scenario, there are multiple part codes with a forged part for each code. Higher volumes make more sense for this case, such as greater than 100 pieces per part code, because the manufacturer can amortize the cost of the tooling over a greater number of parts.
 
Net-Shaped. In the case of net-shaped forging, there are typically some surfaces on the part that are already at the final surface dimension. And in some cases, minimal machining is required. This is the ideal situation to save time when machining and finishing a product.
 
Hip stems undergo an electropolishing process to remove the oxidized layer before further processing.
Draft angles and corner radii are also critical design features that need to be addressed in the part design. As material fills the die cavity during the forging process, material flows and moves throughout the impression. To prevent folding of a material, the radius (0.02 in. minimum) on the corners must be large enough to allow for good flow. Smaller radii have been forged, but to maximize the benefits of forging, it helps to use a generous radius. 
 
As a general rule, the larger the radius, the easier it is to forge. The draft angles are also important because they allow the part to be easily removed from the die cavity. A preferred draft angle of 2˚ (included) yields a good removal. Again, the same principle applies as with radii—the larger the draft angle, the easier it is to remove the part from the die. Parts cannot have negative draft, because once forged, the part will not be able to be removed from the die.
 
When deciding whether a part needs to be forged, additional design considerations include the following:
 
  • Are there large, curved surfaces that must be machined? These surfaces are ideal for forging, because they are easily formed compared with sculpture milling, which is more expensive.
  • How expensive is the material being used? Forging can minimize the use of expensive materials.
  • What are the finishing processes that need to be done to the part? Laser marking, passivation, blasting, anodizing, coating, etc., can be affected by the design of the forging.
  • Are there fine details on the part that would be better to forge than to machine?  
Material Characteristics
One of the many reasons to use forging for implantable medical devices is the enhancement of physical properties of the material that the process produces. Properties of a forged product, such as tensile strength, yield strength, elongation, reduction, and hardness, are as good as or better than the properties of the raw material. This result is due to the nature of forging—the movement of a material between dies through heat and pressure.
 
A rotary blaster removed the oxidized layer on hip stem forgings that still need the excess flash removed. 
Metallurgical characteristics need to be understood because temperature and pressure must be controlled in the process to ensure acceptable results in the material properties. Strict controls are put in place to ensure that the part is forged at the right temperature, and the appropriate reduction (amount of material moved in forging blow) and pressure are monitored throughout the process. If these variables become out of control, it could affect the grain size, flow, or type; or tensile, yield, reduction, elongation, or hardness. In addition to establishing and maintaining proper process controls, at least one piece from each lot should be destructively tested to ensure that desired properties are maintained.
 
Chemical properties are usually unaffected but because forging is conducted in an unprotected atmosphere, an oxygen-rich layer can form on the outside of the part. This layer should be removed via chemical etching, electropolishing, blasting, or machining. The thickness of this oxidized layer should be reviewed and determined during validation activities to ensure proper removal.
 
Lastly, the material condition needs to be considered because, depending on the raw material used, an annealment or heat treat may be required after the forging process to relieve stress or enhance physical properties. ASTM International has many established standards for these conditions as well as information on material characteristics.
 
Process Control Considerations
The basic forging process for a titanium part with two blows is shown in Figure 1. Raw material is cut into small billets on a saw or lathe and is then heated. Then the press is loaded with dies that are lubed to prevent the parts from sticking to the impression of the die. The first forging blow occurs, and the parts are trimmed and air cooled. During surface preparation, the parts are blasted, chemically milled to remove the oxidized surface, and inspected for any defects. Upon the completion of inspection, the parts continue back to the forging press for the final blow. Surface prep is repeated, and the parts are heat-treat annealed. Upon completion, the excess flash must be removed via mechanical trimming or milling. The final step is a nondestructive test—100% fluorescent penetrant inspection (FPI)—along with any required dimensional or mechanical tests. For example, the FPI test is an industry standard for net and near-net shaped forgings. Some customer specifications require this type of inspection. Other mechnical tests, such as tensile, elongation, or hardness, are conducted because the material’s physical properties have been changed during the heating and forging process. Depending on the part being forged, there are always some dimensional checks that are conducted to ensure that the product meets the customer’s requirements. 
 
Figure 1. The basic process for forging titanium parts with two blows.
Critical factors must be controlled to ensure the desired outcome. These factors include the following:Appropriate controls must be in place to ensure that parts are processed according to predetermined plans established in the validation protocol. The cycle as indicated in Figure 1 can be repeated depending on the complexity of the forging. A net-shaped forging may require multiple blows to achieve the desired shape. Simpler designs may only require one or two blows.
  • Billet temperature. Each material has a critical temperature range in which a part can be forged. If not controlled, the result can be a deficient product. Furnaces with regularly calibrated controllers are required to ensure that the temperature is maintained throughout the forging process.
  • Die temperature. To ensure proper die life, the dies themselves must be heated to a controlled temperature.
  • Lubing of the die impression. To facilitate part removal from the die, a die-release material such as lube is evenly applied to the impression surface.
  • Amount of die closure. This ensures the proper amount of flash is on the part and creates the proper grain flow and size.
  • Amount of material reduction. To maintain required physical properties, a controlled amount of material must be moved at each forging blow. 
Quality and Regulatory Requirements
Forging in an FDA-regulated industry requires companies to be well versed in quality and regulatory requirements, especially FDA validation requirements. However, the company should also be ISO 13485 certified. The installation qualification, operational qualification, and process qualification are important aspects of the process and should be a regular part of the manufacturing process.
 
Many medical device forgings have been submitted through the 510(k) and premarket approval (PMA) processes. In general, FDA does not require notification when changing to a forging process from machining from bar stock for an existing Class I or II device. However, controls such as validation, testing, and risk assessment must be in place to ensure that the changes produce a substantially equivalent product. For Class III devices or new products, FDA must be notified. 
 
Commercialization
The last, but certainly not least, point to discuss is the commercialization of forgings in the medical industry. It is important to understand how forging can be used in a complex and changing environment such as the medical device industry. Before starting a forging project, some inputs are required and some important considerations must be addressed.
 
Early in the process, discussions regarding the design and development of the product should include the proposed method of manufacturing. It is best to discuss the design of the forging before the product design has been finalized. In addition, items such as forging prints and models, inspection criteria, condition of supply, potential volumes, and tooling can begin to be developed. The key to the success of a forging project is having a project manager, a well-defined new project plan, 3-D modeling capabilities, in-house tooling capabilities, the ability to test the validity of the dies via computerized simulation software, and clearly assigned engineering resources in the areas of process, quality, and design.
 
Surface defects on a forged hip are examined under a black light during routine fluorescent penetrant inspection.
It is also important to address tooling for forging, because it can become an impediment if costs are too high. Tooling charges can consist of the raw material for the dies, electrodes and cutters, engineering development time (models, prints, and simulations), and machine time to create the impressions in the die. Costs for this can range from $4000 per part code (for simple parts) to as much as $10,000 per part code (for more complex parts). Typically, this is a one-time charge, and the refreshing of the dies when the impression wears out is included in the initial cost. 
 
In high-volume jobs, return on investment in tooling can be realized quickly. By contrast, using forging with low volumes can have expensive up-front costs. However, through advances in technology, the creation of generic tooling, and the use of lean principles, it has become much more cost-effective to use forging for volumes of less than 100 pieces per year. 
Lean manufacturing has had a significant effect on forging in the orthopaedics industry. Lean principles have allowed lead times to drop to as little as two weeks for some forged products. Other programs such as vendor-managed inventory and Kanbans (efficient pull systems) can allow for even shorter lead times (days instead of weeks). Other benefits of these programs include having a small amount of controlled inventory, an increase in product quality, and a decrease in the risk associated with running products through traditional manufacturing programs. Working with customers to remove waste from the product value stream can allow for overall decreased costs. Forging is ideally suited for the application of lean manufacturing principles and these types of programs.
 
Conclusion
Forging can be highly effective in the medical device industry. Advantages include reduced use of raw material, reduced cutter wear and machine time, increased throughput, and enhanced material properties. The value of the process—providing a lower cost and increasing the customer’s capacity—can be achieved using the same amount of capital equipment versus bar stock while also producing a substantially better product.
 
Joe Zuzula is director of sales and marketing at Orchid Orthopedic Solutions (Holt, MI). 
 

 

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