PBF is the most popular of the metal additive manufacturing technologies and excels in producing complex, high performance components. The technology utilizes high-energy sources, lasers or electron beams, and has transformed the manufacturing industry by offering greater design freedom, efficient use of materials, and the ability to produce highly customized components.

Material Capabilities and Applications

The expanding landscape for PBF enables manufacturers to precisely match materials with application requirements across various industries, with each alloy category offering unique advantages.

Stainless Steels

Among stainless steels, 316L SS has become a foundational material in PBF manufacturing, due to its excellent corrosion resistance, strength and robust mechanical properties. As a surgical grade steel, it is often used for medical instrumentation applications while its corrosion resistance makes it well-suited for fluid transfer applications. Additionally, 17-4 PH stainless steel offers high strength and hardness, making it an ideal material for medical instrumentation as well.

Titanium Alloys

Processing titanium alloys through Powder Bed Fusion has revolutionized high-performance applications, notably with Ti6Al4V. This alloy’s outstanding strength-to-weight ratio and low density make it invaluable in aerospace applications. Its medical-grade variant, Ti6Al4V ELI, features stricter purity levels and lower oxygen content, alongside trusted biocompatibility and superior fatigue properties, making it the preferred choice for orthopedic implants.

Aluminum Alloys

Aluminum alloys represent one of the fastest-growing material families for PBF, with ongoing development of new feedstock that combines printability with trusted alloys from traditional manufacturing. AlSi10Mg and F357 lead this evolution, offering excellent thermal properties and strength characteristics while maintaining superior processability. These alloys excel in heat transfer applications, where their unique properties can be fully utilized. These properties combined with their lightweighting advantages make them especially useful for applications in the aerospace, automotive and industrial industries.

Nickel Superalloys

Nickel superalloys, particularly Inconel 625 and 718, demonstrate exceptional performance at high temperatures, making them essential in aerospace applications. While their mechanical performance may exceed requirements for less demanding industrial uses, they remain cost-effective options for many cases. These alloys often prove easier to process through PBF than traditional machining methods, offering an attractive alternative for complex components. The Inconel family leads this category, with ongoing development of next-generation nickel superalloys promising even better performance characteristics.

Industries Transforming through PBF

Powder Bed Fusion technology is enabling the production of highly complex, optimized components that traditional manufacturing methods cannot achieve. Its precision and ability to work with advanced materials are enhancing performance, reducing weight, and improving design flexibility across various sectors.

Aerospace Innovation

The aerospace industry has embraced PBF technology for its ability to create organic shapes that optimize component designs for environmental loads while significantly reducing mass. Engineers now routinely develop topology-optimized components that achieve weight reductions while maintaining or improving performance for the aerospace industry. Complex engine parts, turbine blades, fuel injector nozzles, and integrated turbine assemblies, showcase PBF’s capability to create features impossible through traditional manufacturing methods.

Medical Advancement

In the medical industry, PBF has revolutionized healthcare solutions through the production of highly complex, customized orthopedic implants. The technology enables the creation of joint replacements, ranging from large joints (hip and knee) to small joints (shoulder, foot, and ankle). Spinal implants with optimized osseointegration demonstrate the ability to enhance biological integration.

Automotive Evolution

The automotive industry leverages PBF technology across both performance applications and prototyping. Manufacturers utilize the technology to create optimized cooling systems with conformal channels, lightweight structural components, and integrated fluid handling systems that enhance vehicle performance. The prototyping capabilities accelerate development cycles, enabling rapid design iteration and validation before production commitment.

Manufacturing and Tooling Advancement

In the tooling sector, PBF has transformed traditional manufacturing through innovations in mold and die production. Injection molds with conformal cooling channels, die casting tools with optimized thermal management, and hybrid molds combining conventional and additive features demonstrate how PBF enhances manufacturing efficiency and part quality.

Future of PBF Implementation

Successfully implementing Powder Bed Fusion technology requires more than just acquiring a machine—it demands a strategic and comprehensive approach. Key steps include detailed process planning, material selection tailored to application needs, and rigorous quality control measures. Ensuring compliance with industry standards and regulations is critical for delivering consistent, high-quality parts.

As PBF technology evolves, advancements such as improved mechanical properties, larger build volumes, and optimized production workflows are set to drive significant gains in manufacturing efficiency. However, navigating this rapidly changing landscape can be daunting for manufacturers exploring additive manufacturing for the first time.
This is where AddUp can help. With our LevelUp offering, we guide customers through every stage of their additive journey. From application development and selecting the right additive technology to AM training, facility evaluation, and process optimization, our experts work alongside your team to ensure a smooth and successful transition to additive manufacturing. Whether you’re laying the foundation for your first AM operation or optimizing an existing setup, AddUp’s tailored services empower you to achieve your production goals with confidence

The post What is Powder Bed Fusion? Exploring PBF in Metal Additive Manufacturing appeared first on AddUp.

Currently, the most common healthcare use cases for additive manufacturing are developing anatomical models to help patients understand their upcoming procedures and customizing surgical instrumentation.

All signs point to a future in which healthcare organizations will be manufacturing devices at the point of care (POC). That means that hospitals will soon be the newest members of the medical device manufacturing (MDM) industry, a proposition with real institutional and infrastructure challenges. “After all, this is not what healthcare facilities are really set up for,” says Severine Valdant, chief commercial officer for QuesTek Innovations, a leading materials engineering firm, and a founding member of the AddUp medical advisory board. “It takes a different way of thinking for a hospital.”

The AddUp Medical Advisory Board was established in 2023 in order to provide the company with nonbiased, holistic perspectives on the application of metal 3D printing technologies for healthcare. Severine Valdant provides her unique perspective as a leader in the development of medical devices and 3D printing. Before joining QuesTek, she led the transformation of Oxford Performance Materials into an additive manufacturing leader, helping it become the first company to receive FDA approvals for 3D printed polymeric implants.

Key stakeholders recognize value of 3D printing

Even with the challenges that additive manufacturing brings for healthcare organizations hoping to leverage 3D printing at the point of care, the concept is gaining widespread acceptance among healthcare executives and other key stakeholders.

• OEMs are making big advances. “If printer manufacturers can deliver an all-in-one solution, it makes it much less difficult to implement AM at the point of care and we’re not that far away,” says Valdant. The good news is that companies like AddUp are bringing new printers to the marketplace that can be easily integrated with other established systems and processes.

• The FDA is on board. “In fact, they see a lot of value in POC manufacturing and they’re working with players on the healthcare and OEM side to figure out what regulations or guidelines are needed to make it happen.”

• Surgeons are enthusiastic about the possibilities. “I’ve talked to a lot of them and they’re pretty excited about the etools, but we need to be careful that they don’t stop being doctors and become engineers,” Valdant continues.
• Administrators play a key role. “They’re the big decision makers. If we bring AM to the point of care, they need to see a good ROI.”

Future Applications

The future of healthcare is personalized medicine and POC manufacturing will play an important role. We expect that there are many new uses cases on the horizon that will push the boundaries of the technology and broaden its possibilities. These include advances in the just-in-time manufacture of single-use, procedure- and patient-specific instrumentation to replace traditional systems at affordable costs.

The sweet spot for future applications of POC AM will be procedures for which there is not a convenient or effective off-the-shelf implant option—including complex surgeries for knee, hip, and pelvis reconstructions; spine surgeries; and tumor modeling for cancer patients.

In addition, AI and machine learning will soon enable the automation of workflows and speed production of patient-specific implants, improving development times from as long as 18 months to a matter of days. This is expected to improve patient outcomes exponentially, while also reducing operative times and the need for additional corrective surgeries.

The Right OEM

POC manufacturing will need to be an effective partnership between healthcare facility and OEM. “I think we’re a lot further ahead than we were 10 years ago, because collaboration between the two is happening,” Valdant continues. “With our deep knowledge of the medical market and a solution that is very efficient and integrated, AddUp will be a great partner on the OEM side.”

The post Metal Additive Manufacturing is Getting Closer to the Point of Care appeared first on AddUp.

In recent years, 3D printing has solved some of the biggest challenges in the field of orthopedics. Before it was possible to quickly produce custom implants, surgeons often needed to modify standard implants to fit some patients by conforming the patient’s body to match the implant. Today, we are getting closer to producing implants that match the patient before going into surgery.

Now, AM is making it possible for surgeons to accomplish tasks that were previously impossible. After creating digital print files from patient x-rays, CT or MRI scans, production of a complex, patient-specific metal implant can be completed, often in less than 24 hours.

Throughout the history of AM, there have been many commercial and clinical successes. In 2012, researchers at the BIOMED Research Institute in Belgium implanted a 3D-printed titanium mandibular prosthesis in an 83-year-old patient. 2013 saw the first successful implantation of a 3D-printed polyetherketoneketone (PEKK) skull implant. Fast-forward to 2024: AddUp Solutions and Anatomic Implants are collaborating on the first 3D printed toe joint replacement. 

With all the benefits it offers for the future of personalized healthcare and improved patient outcomes, the application of AM in orthopedics promises to be a game-changing development. 

From subtractive to additive manufacturing

Traditional subtractive manufacturing methods have always had limitations in the geometries they can produce. They also require significant amounts of time for machining, particularly when working with materials like titanium. 

By enabling the layering of materials to manufacture objects from 3D model data, AM makes it possible to create complex shapes and structures not possible before. It has provided a cost-effective new approach to producing medical implants tailored to the unique anatomy of individual patients, providing significantly greater design freedom and control without the need for tooling or molds.

“With traditional processes, there is a need for post-production surface treatments with porous sprays, whereas 3D printing makes the production of implants with highly porous structures possible,”  says Tyler Antesberger, medical application engineer at AddUp Solutions. “So, it’s definitely a value-add that with AM, you have complete control of the device down to the micron—not just applying something to the surface and hoping that it works.” 

From metals to biocompatible materials

The use of metal-based AM for producing medical implants has been on the rise for many years. Materials used in manufacturing medical implants must meet many requirements, including high strength for functioning for long periods, corrosion and wear resistance, and biocompatibility and biodegradability.

“There’s a lot of talk around biocompatibility,” says Antesberger. “There are a lot of studies about cell scaffolds and things like that—how does bone actually grow into these devices and become part of the body?” AM makes it possible to design highly complex, customized designs that match a patient’s anatomy—and to create lattice structures that are needed to create the porous surface needed to improve bone integration in the human body. AddUp’s roller coater technology makes it possible to create an implant with a smooth surface finish with fine features and lattice resolutions.

While many advances have been made in the use of 3D-printed metallic biomaterials for use in implants, there are currently only a few metals that can be used. Today, about 75% of medical implants are made from stainless steel, titanium alloys, cobalt-chromium alloys, niobium, nitinol and tantalum—with the use of magnesium, zinc, iron, and calcium on the rise.^[1]

“The primary material used now for medical implants is Grade 23 titanium,” Antesberger says. “It has a lower oxygen content than other titanium on the market and good biocompatibility. A few other materials used in 3D printing are stainless steel alloys.”

Expanding what’s possible

The promise of 3D-printed implants for the future of personalized medicine is bright. Healthcare institutions like the Mayo Clinic already have launched large-scale 3D printing labs where they produce patient-specific 3D-printed orthopedic braces and surgical tools. And we may soon see a future in which hospitals are producing 3D-printed, patient-specific medical devices on-site at the point of care.

“Hopefully, in the future, additive manufacturing in healthcare will allow us to create a customized design for every individual—to help reduce the time in the hospital, reduce recovery time, and increase the life of the implant,” Antesberger concludes.

^[1] https://www.sciencedirect.com/science/article/pii/S266652392300096X

The post 3D-Printed Patient-Specific Implants: Where We’ve Been and Where We’re going appeared first on AddUp.

Metal powder in it’s raw form is a hazard to the touch and through the air. Some particles are fine enough that human skin does not serve as a barrier, so the powder acts as a vessel for heavy metals to work their way inside the body. Finer particles also hang in the air for longer, where it becomes possible to enter through the lungs. With employee and customer safety always being front-of-mind at AddUp, the design of any 3D Printer being used in their facilities had to mitigate these health risks for their employees.

The question shifts to How can you minimize operator exposure to powder without sacrificing any functionality on the machine? AddUp’s answer is the Autonomous Powder Module, the powder handling system on the Form Up 350. The main components in the APM are the Glovebox, Hopper, Sieve Unit, and Feeding System, all of which are kept inert. Powder is loaded through the glovebox of the APM and is transferred via vacuum suction to the Hopper, which has a capacity of 59L. Prior to a build, powder will move from the Hopper and through the Sieve, with the Feeding System providing the sieved powder to the interior of the Form Up’s build chamber.

After the build completes the operator vacuums the remaining powder with an interior nozzle, sending that material back to the Hopper where it can be used for the next build. The APM contributes to maintaining a safe environment by separating the operator from the powder and keeping the powder away from oxygen at all times.

The single most dangerous product of Powder Bed Fusion is the condensate formed during the melting process. Condensate is flammable, an explosion risk, and readily reacts with oxygen – with the worst case scenario being when Titanium is the base material. A common solution is paper filters, but those must be serviced and replaced by a human. These filter changes are a source of many of the safety incidents. That risk inspired AddUp to move away from paper filters and partner with Herding Filtration. With the Herding system, fumes are collected in the Fluid Module and dispensed into a metal dust bin (both of which are kept inert). In addition to the condensate, Calcium Carbonate is used to passivate the hazardous substance and inhibit any sort of reaction. Swapping out the dust bin is a simple process that takes 1-2 minutes, and is much safer than changing a filter. Dust bins are replaced about twice a month, depending on machine usage, and the remainder of the Fluid Module can go multiple years without being serviced.

Powder management may be the most important aspect of safety in Metal AM, but other machine features can encourage a safe workplace as well. As the industry grew and expert users arose, their feedback was used to incorporate ideas that addressed their pain points. AddUp made cleaning the interior of the build chamber easier by incorporating multiple access doors. This allows for the entirety of the inside to be wiped down and thoroughly cleaned without uncomfortably stretching for the back corners. Similarly, the laser lenses are removable so that they can be cleaned outside the machine. From a software perspective, oxygen setpoints and alarms are set during creation of the build file so that they can be customized to alert the operator of any potential issue, or shut down if it becomes a safety issue.

As with any promising new technology, Metal Additive Technology has extremely enticing benefits. The industry is constantly trying to extract all they can from these machines without putting anyone at risk. Machines and processes should all be designed with safety in mind, but even advanced safeguards don’t replace responsible operators, proper PPE, and an appropriate facility setup. Watch the video below to see how we’ve integrated safety into the AddUp Solution Center in Cincinnati, Ohio.

Features of the FormUp 350

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Tooling has an important purpose: to create high-quality end use parts. While the GD&T minutia of the final part may be pored over for months, less attention is paid to the tools themselves, as long as they can get the job done. In an industry where technology and workflow has been stable, Additive Manufacturing has to showcase clear-cut advantages to disrupt the tooling space. Whereas traditional manufacturing has handled toolmaking with relative ease, designers using AM will need to examine each application with a fine-toothed comb to best exhibit how AM can push the boundaries of tool performance. This is made more challenging by the limited material portfolios of Powder Bed Fusion (which are expanding!), meaning we aren’t always replacing an existing tool with a matching material. Improving molds via the design freedoms awarded by 3D Printing is not enough, the new tools must be optimized for surface finish as well.

Why care about surface finish?

Surface finish plays a key role in wear performance of the tool and reducing the post-processing burdens of the part and/or tool. Let’s dive into what this means for the Aluminum Die Casting industry:

Wear Performance: One of the most basic metrics for tools – how long do they last before they need to be retouched or replaced? Tool life can be measured in number of shots, total parts produced, time spent on an active production line, or in various other ways. Clearly, it is advantageous for molds and tools to last longer, as the manufacturer would like to spend as little time making tools and instead make the revenue-producing parts. Surface finish is critical for achieving best possible wear performance, as wear failures often start as small imperfections on the surface of the tool itself. Better surface finish means the part-mold interaction takes place at a smoother area with smaller stress concentrators, and therefore working for longer before needing to be replaced.

Sometimes it is acceptable to use an as-printed surface in a tool, but some applications require a finish that can’t be achieved with 3D Printing. In Die Casting, for example, molds are normally shot-peened or bathed in chemicals before use. The better the surface finish these molds can start with, the less time they spend being processed before use. By achieving a better out-of-the-box surface, you’re saving on time and resources needed to create a final product.

Surface finish is a key area of focus for Powder Bed Fusion, and more opportunities will present themselves to the industry once strides are made in this field. AddUp is leading this pursuit by implementing a combination of a Roller Recoater and fine powder in the FormUp 350. Only a roller is capable of handling fine powders (ie 5-25um) without them clumping together. The finer media paired with a compacted powder bed creates a consistent, better controlled melt, leaving behind as-printed surface finishes as smooth as 3um Ra. Attaining these finishes without sacrificing productivity is a huge step towards more widespread comprehension of Powder Bed Fusion as a viable production tool, including the tooling industry.

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The post Surface Finish for 3D Printed Tooling: Advancing PBF Technology as a Production Tool | Blog appeared first on AddUp.

Additive manufacturing (AM) is a revolutionary manufacturing technique that will reshape the future manufacturing sector. Design freedom, waste reduction and mass customization are some of the benefits of AM. Although AM technology may not be used by all manufacturers today, the potential ahead is massive. Development of new materials to be utilized with AM technology is a key step in fully realizing the potential AM has to offer.

In the AM technology evolution process, it is necessary to develop melting parameters for existing standard alloys and newly designed alloys so that the material properties meet or exceed conventional manufacturing techniques such as casting, forging, rolling and machining, etc.

In addition to material development, appropriate qualification is necessary to fabricate critical components for medical, aerospace and tooling applications.  Material qualification can be very time-consuming and expensive depending on the application or industry. The first step in this process is establishing baseline melting parameters in which sufficient data needs to be collected to demonstrate that the material will function as required.

Material development for metal AM is a complex process that requires a thorough understanding of melting and re-solidification temperatures and corresponding microstructures. Melting strategies can have several specific focuses, such as part quality, productivity, and feature specifics, so a “one-size-fits-all” approach is not feasible.  For application-specific product development the customer’s use case must be kept in mind for material development from start to finish.

The addition of new materials to the existing catalog requires rigorous testing and analysis to ensure that the printed part meets the quality requirements.  This requires an immense amount of work in defining and executing the printing, testing and analysis protocols. This blog will explore some of the important considerations in melting parameters development.

Feedstock Properties

Feedstock material selection is the first and foremost important step in the metal AM process. Key attributes of metal powder such as shape, size, flowability and chemical composition contribute to achieving high-quality parts. So, it is important to choose the correct powder depending on the required functionality of the part.

Melt Pool Dimensions

This aspect of development measures the physical characteristics of a single bead pass, as well as the melt pool dimensions of each bead. A statistically driven experimental approach combined with simulation analyses can be utilized in identifying the primary melting parameters to obtain the appropriate melt pool dimensions to achieve the required solid densities.

Solid Part Density

Solid part density is a measure of porosity inside of a printed part and builds off dialing in single beads by changing how they are printed next to each other. Layer thickness and laser scanning rotation angles significantly impact how these melting passes interact with each other. This directly impacts the density and microstructures of the printed parts. Solid part density can be tested with techniques such as metallography or MicroCT scan.

Material Performance

Printed material performance must be tested extensively when developing new melting parameters.  This includes physical and mechanical data collection from various tests. In addition, checking for warpage and any other dimensional deviation of the printed part before and after post-thermal conditions is necessary. This helps in understanding the byproducts of internal stresses and the efficacy of post-thermal conditions on part geometry.

This preliminary dimensional, density, surface finish and tensile data validate the quality of the melting strategy before moving to an expensive application specific qualification process.

Specific Use-Case Optimization

While optimized baseline melting parameters are necessary to print most parts, if there are specific quality requirements extra measures need to be taken.  It is critical to incorporate part production/quality requirements such as surface finish, productivity, and feature resolution, etc. from the inception of the development.

The AddUp Difference

AddUp’s catalog of materials includes a diverse mix of different alloys of steel, titanium, aluminum, Inconel, and more. We continuously work on developing and optimizing melting parameters for new materials to fit the needs of the industry. AddUp utilizes a fully data-driven approach and application specific inputs in developing new materials or changes to the existing melting strategies. With our expert materials engineering team combined with in-house testing capabilities, we can produce melting strategies for new or existing materials quickly and efficiently. In this process we are open to collaborating with industry partners and academic researchers.

Check out this video showcasing some of our material development process for Zeda in 17-4 PH Stainless Steel at our AddUp Solution Center in Cincinnati, OH.

Learn more about the capabilities of the FormUp 350. 

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The post Important Considerations for Material Development in Additive Manufacturing | Blog appeared first on AddUp.

Introduction

Acetabular cups, essential components of total hip replacements, have traditionally been manufactured through casting and forging. Although effective, this method was cumbersome and costly, necessitating long lead times and complex validations. However, AddUp’s groundbreaking FormUp 350 has transformed this narrative, showcasing how additive manufacturing technologies can revolutionize the field.

Traditional Manufacturing Process

Historically, the production of acetabular cups relied on the lost wax method, a labor-intensive process resulting in slow turnaround times and additional, costly processing stages. The final product required a porous structure that was both expensive to manufacture and challenging to validate, posing a significant hurdle to progress in the field.

The Advent of Additive Manufacturing and the Limitations of Electron Beam Technology 

Additive manufacturing brought a significant shift in acetabular cup production, with Electron Beam Technology (EBM) offering a promising alternative to traditional methods. However, EBM presented challenges, such as unpredictable failures and complex validation processes, which could escalate the overall time and cost of production.

The Game-Changing Impact of AddUp’s FormUp 350: A Superior Leap in Acetabular Cup Manufacturing

In the pursuit of more efficient and precise manufacturing methods, AddUp’s FormUp 350 has emerged as a superior alternative to EBM. This innovative machine, operating on Laser Powder Bed Fusion (LPBF) technology, delivers closer net shape parts with no supports needed, dramatically reducing post-processing and lead times. It offers a larger build plate and more lasers than EBM printers, potentially doubling the throughput and optimizing production processes.

Notably, the FormUp 350 features a fine feature resolution and a roller recoater, enabling the printing of a lattice structure within the implant. This key feature significantly enhances osseointegration, leading to longer-lasting implants and improved patient outcomes.

Revolutionizing the Medical Device Industry: The Impact of FormUp 350 

AddUp’s FormUp 350 has profoundly impacted the medical device industry. By shortening lead times and enhancing precision, this machine enables manufacturers to respond swiftly to market demands and deliver superior quality products. The capability to print lattice structures not only enhances the performance of the implants but also improves patient outcomes. This development leads to fewer revision surgeries, resulting in cost savings for both patients and healthcare providers.

Conclusion

The FormUp 350 from AddUp delivers throughput capabilities currently unchallenged on the market. This can be seen in the below Hip Cup Productivity Study. Parts shown were printed with a compression roller technology in 30um layers of Ti6Al4V ELI. Compared to EBM technology, the AddUp 350 has a shorter run time of 12:41 compared to 15:23 (EBM) which leads to an improved annual throughput of 9,309 (16,403 LPBF, 7,094 EBM). As the medical device industry continues to evolve, this concrete evidence of the FormUp 350’s superiority underscores its transformative potential in the future of hip replacement surgeries and beyond.

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The post Innovative Advancements in Acetabular Cup Manufacturing: The Revolutionary Impact of AddUp’s FormUp 350 appeared first on AddUp.

Surface finish is crucial in additive manufacturing of medical devices and implants, as it must meet or exceed the standards set by traditional subtractive manufacturing methods, ensuring better patient outcomes and reducing contamination risks.

Due to the novelty of additive manufacturing, surface finish will always be compared back to subtractive manufacturing. This is even reflected in ASTM standards for additive manufacturing. ASTM F3001 which is the standard for Ti6Al4V ELI (Extra Low Interstitial) used with Powder Bed Fusion constantly references ASTM F136 which is the standard for Wrought Ti6Al4V ELI Alloy for Surgical Implant Applications. This sets the bar for the additive manufacturing industry that the final finished good must be equivalent or better than products manufactured from bar stock.

Medical Implants: Better Surface Finish for Better Patient Outcomes

On the implant side of the medical industry, additive manufacturing has been innovative. No longer are product development engineers looking to spray their parts with plasma porous spray to gain osteointegrative benefits, they are intentionally designing complex structures that mimic bone. These complex structures cannot be traditionally manufactured and can be more easily validated unlike plasma porous spray.

Industrial metal 3D printers are steadily improving their surface finish to be closer to wrought directly from the printing process. Advances are being made in recoating systems, melt-monitoring systems, and powder handling to produce the best as-printed surfaces as possible. As additional post-printing surface treatments are developed for the additive manufacturing industry, differently manufactured parts will be indistinguishable from each other.

Surface finish is imperative for implantable medical devices for several reasons. A few are pathogen spread, implant rejection, part corrosion, surface contamination, reduced lifespan, and biocompatibility. Most of these reasons are directly related to patient well-being. The inherent process of additive manufacturing (layer by layer) creates voids in the material that can be difficult to clean and sterilize. This creates plentiful spaces for bacteria to hide in. It is of utmost importance that the implant can be thoroughly cleaned before it is in a surgical setting. Then there is always the aesthetic of the implant itself. A cosmetically good-looking implant intuitively portrays itself as clean, functional, and well manufactured.

Minimize Finishing Treatments to Reduce Cost and Lead Time

Some common surface finishing treatments for additively manufactured implants include blasting, vibratory finishing, and chemical passivation. Both blasting and vibratory finishing aim to give the implant a uniform finish. They can help to blend between manufactured and printed surfaces while helping to remove any burrs or sharp edges. Blasting is typically completed with a glass bead whereas vibratory is done with some type of ceramic media. Chemical passivation is done as a cleaning step to ensure that the implant is free of any in-process materials from manufacturing before going to . As the additive manufacturing process improves, there is optimism that secondary surface finishing operations can be minimized. This can help reduce costs and potential avenues for contamination.

Surface Finish for Surgical Instruments

Surgical instruments and trauma devices must be even closer to wrought surface finish specifications. These devices do not want any type of osteointegrative features like complex structures. Reusable instruments must be able to be cleaned between surgeries and retain their sharpness. Trauma devices like plates and screws must be able to be removed once the injury has healed. These requirements tend to lead to these types of devices being made from 316L, 17-4 PH, and 420. Technology advances are allowing these industrial 3D printers to utilize fine powders and resolve a better surface finish closer to a traditionally manufactured device.

AddUp’s Solution

Achieving parts directly off the printer with optimal surface finish is a priority for AddUp. That’s because industry-leading surface finish means less post processing and therefore cost reduction for our customers. The FormUp 350 provides advanced technology with a roller recoating system that allows many parts to meet surface finish requirements as printed.

Controlling the penetration of the melt into the lower layers is a key factor in the surface quality of a 3D metal-printed part. Poorly managed, it leads to high variations in Ra index, with high sensitivity to surface angle. Using AddUp’s roller spreading system, the homogeneity of the powder bed is greatly enhanced, limiting this type of variation and allowing for a smoother surface finish as printed. Parts printed on the FormUp 350 achieve an Ra value as low as 3µm.

In addition, AddUp uses finer powder (PSD 5-25µm) instead of the widely-used industry standard medium powders (PSD 15-45µm or 20-63 µm). This makes it possible to considerably reduce the size of the voids between particles therefore improving the permeability of the powder bed, reducing erratic bath penetration and lowering laser power. The use of these fine powders not only enhances the surface finish for parts printed on the FormUp 350, but it also greatly reduces the need for support structures.

Learn more about AddUp’s FormUp 350 for medical applications here.

Driving Innovation and Advancement

Manufacturers are continuously encouraged to improve their processes and technologies. In the case of AM, certifications push for research and development in areas such as material science, process optimization, and design guidelines. By setting stringent criteria for certification, manufacturers are motivated to innovate and refine their practices. This drive for innovation not only benefits the individual companies but also contributes to the overall advancement of the manufacturing industry.

The post Surface Finish – Why it Matters for Medical appeared first on AddUp.

Introduction

Spinal fusion devices play a crucial role in the medical field, providing essential support and stability in spinal surgeries. Traditionally, large spinal fusion devices were produced using small format Powder Bed Fusion (PBF) machines or machined out of poly bar stock. While these methods were effective, they presented several challenges, including high costs and lengthy production times. However, the advent of advanced manufacturing technologies, such as the FormUp 350 PBF machine, has revolutionized the production process, offering enhanced efficiency, precision, and improved patient outcomes.

Traditional Manufacturing Methods: PBF and PEEK

The conventional manufacturing process of large spinal fusion devices relied on PBF or machining out of PEEK bar stock. These methods, while effective, were not without their drawbacks. The production process was slow and costly, leading to increased prices for the finished implant. Additionally, when produced using PEEK, these types of implants lacked ideal Osseo integrative features, which are crucial for the success of the implant. Moreover, the unstable material supply chain for PEEK presented further challenges in the manufacturing process.

The Advent of Additive Manufacturing

The introduction of additive manufacturing marked a significant shift in the production of large spinal fusion devices. However, the manufacturing of these devices on smaller platforms with 1-2 lasers increased the cost of the finished implant. These implants were tall in Z, leading to increased build times that were further increased with a small number of lasers. Furthermore, the use of a scraper/brush recoating process and the need for wire electrical discharge machining (EDM) to remove the LLIFs from the build plate added to the overall time and cost of production.

The FormUp 350: A Leap Forward in Spinal Fusion Device Manufacturing

The FormUp 350 PBF machine has emerged as a superior alternative to smaller platforms with 1-2 lasers. Thanks to a 350 millimeter squared build plate, the FormUp 350 can hold 1.5 times the amount of large spinal implants compared to smaller platforms. The use of 4 lasers allows for 152 large spinal implants to be printed in just 32 hours, significantly reducing production time and increasing output.

The FormUp 350 utilizes a powder roller technology which allows for geometric complexity using minimal supports and results in optimal surface finish. This technology enables the realization of intently designed complex structures and surface roughness that contributes to better patient outcomes. There is no longer a need for a plasma porous spray or sheet-based trabecular surface, and the surface roughness is not a byproduct of the process. This helps to decrease the manufacturing processes required to complete a finished product, reducing costs along all parts of the supply chain and supporting more efficient patient outcomes.

The Impact of the FormUp 350 on the Medical Device Industry

The adoption of the FormUp 350 in the manufacturing of large spinal fusion devices has far-reaching implications for the medical device industry. By reducing lead times and increasing precision, the FormUp 350 allows manufacturers to respond more quickly to market demands and produce higher quality products. Moreover, the ability to print complex structures and achieve optimal surface roughness improves the performance of the implants, leading to better patient outcomes. This is a significant advancement, as it not only enhances the quality of life for patients but also reduces the need for revision surgeries, leading to cost savings for both patients and healthcare providers.

Results

Large spinal implants produced using small build capacity, low number of lasers, and traditional recoating systems cost more than when produced using the FormUp 350.
The FormUp 350 machine is ideal for medical applications because it provides an improved and cost-effective process to mass-manufacture highly complex and/or customized medical parts.

Parts built per laser on the FormUp 350:

• 2 Laser – 76
• 4 Laser – 38

Time to build on the FormUp 350:

• 2 laser – 52.95
• 4 laser – 32.35

Annual throughput on the FormUp 350:

• running 1 shift per day for 52 weeks per year
• 1 – 1.5 from laser off to laser on (build flip)

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The post Innovations in the Manufacturing of Spinal Fusion Devices appeared first on AddUp.

Author: Mark Huffman, Aerospace and Defense , AddUp

Promoting Safety

Safety is paramount in any industry, and manufacturing is no exception. Certifications help manufacturers ensure that their processes and products meet rigorous safety standards. In AM, certifications provide assurance that the production methods, materials, and equipment used adhere to safety protocols. By complying with safety certifications, manufacturers can mitigate risks associated with potential hazards, such as material integrity, structural strength, and part failure.

Ensuring Quality and Reliability

Certifications act as a benchmark for quality and reliability in the manufacturing industry. They establish standards and best practices that manufacturers must adhere to, ensuring that products meet specific requirements. For AM, certifications are crucial in maintaining consistent and predictable outcomes due to the unique nature of the technology. With certifications, manufacturers can demonstrate their ability to produce reliable and high-quality parts, fostering trust among clients and consumers.

Compliance with Regulations

Certifications in the manufacturing industry, including AM, often involve compliance with specific regulations and standards set by governing bodies. These regulations encompass various aspects, such as material properties, process control, and environmental impact. Adhering to certifications ensures that manufacturers operate within legal frameworks, avoiding penalties and liabilities. Additionally, certifications help manufacturers stay up to date with evolving regulations, contributing to the overall compliance and sustainability of the industry.

Enhancing Market Competitiveness

Manufacturers can gain a significant competitive advantage through certifications in the manufacturing industry. They demonstrate a manufacturer’s commitment to quality, safety, and compliance, distinguishing them from competitors who lack the same certifications. In an increasingly competitive market, certified manufacturers have an edge when attracting clients, securing partnerships, and bidding on projects. Certifications also serve as a marketing tool, assuring potential customers of a manufacturer’s capability to deliver superior products and services.

Driving Innovation and Advancement

Manufacturers are continuously encouraged to improve their processes and technologies. In the case of AM, certifications push for research and development in areas such as material science, process optimization, and design guidelines. By setting stringent criteria for certification, manufacturers are motivated to innovate and refine their practices. This drive for innovation not only benefits the individual companies but also contributes to the overall advancement of the manufacturing industry.

Environmental Responsibility and Sustainability

Environmental stewardship is becoming increasingly important in the manufacturing industry, including AM. Manufacturers using AM technology including OEMs are encouraged to adhere to environmental management standards and practices, reducing their environmental impact and promoting sustainability.

AddUp’s Certification Focus

AddUp operates with a strong focus on quality, efficiency and customer-centricity. AddUp’s processes and systems have been reviewed and validated for compliance to applicable ISO standards. This means that independent third parties have qualified AddUp’s systems and processes in accordance with the defined requirements. We believe our certifications enhance our reputation and credibility, an important aspect to earning the trust of our customers.

The certifications of ISO 9001, ISO 13485, International Traffic in Arms Regulations (ITAR), and Cybersecurity Maturity Model Certification (CMMC) play a significant role in assisting AddUp in making Proof of Concept (POC) parts for customers to demonstrate the capabilities of FormUp 350 LPBF technology. Here’s how each certification can contribute to a successful deployment of the technology:

ISO 9001:

ISO 9001 certification showcases the AddUp’s commitment to quality management principles and customer satisfaction. When producing POC parts, this certification assures potential buyers that AddUp’s LPBF technology follows robust quality control processes, resulting in consistent and reliable outcomes. It indicates that AddUp has implemented effective quality management systems, enabling them to meet specific requirements and deliver high-quality parts that showcase the capabilities of AddUp’s LPBF technology.

ISO 13485:

By holding ISO 13485 certification, AddUp demonstrates its adherence to stringent quality management systems specifically tailored for the medical device industry. When producing POC parts for potential buyers in the healthcare sector, this certification instills confidence in AddUp’s ability to meet regulatory requirements, ensure traceability, and deliver reliable and safe medical devices. It provides assurance that AddUp’s LPBF technology can be used for manufacturing medical devices with consistent quality, meeting the unique demands of the healthcare industry.

ISO 14001:

Also known as the Environmental Management System (EMS) certification, ISO 14001 focuses on environmental responsibility and sustainability. By obtaining ISO 14001 certification, AddUp demonstrates a commitment to environmental responsibility and ecologically friendly manufacturing practices. This certification ensures that AddUp’s technology operates in an environmentally conscious manner, reducing the impact on the ecosystem, complying with environmental regulations, and promoting resource efficiency and waste management. By integrating environmental considerations into operations and technology, AddUp encourages end users of AM technology to remain environmentally conscious and contribute to the overall sustainability of the AM industry.

ITAR:

For AddUp to participate in to support the defense and aerospace sectors in the USA, ITAR compliance and certification is vital. With ITAR registration and certification, AddUp can demonstrate that we adhere to strict regulations concerning the export and import of defense-related articles and services. This certification ensures that POC parts manufactured by AddUp are produced within a secure environment, safeguarding sensitive information and intellectual property. Potential buyers in the defense sector can trust that AddUp can handle sensitive projects in accordance with ITAR requirements, reinforcing confidentiality and security.

CMMC:

CMMC certification addresses the crucial aspect of cybersecurity within the USA. When producing POC parts, AddUp must protect sensitive data and ensure the integrity of critical information. With CMMC certification, AddUp can demonstrate to potential buyers that they have implemented appropriate cybersecurity measures to safeguard information related to defense contracts or other controlled unclassified information (CUI). This certification instills confidence in AddUp’s ability to protect buyers’ proprietary designs, ensuring the security and confidentiality of projects.

Supporting our Customers Through the Qualification Process

By holding these certifications, AddUp can effectively demonstrate to potential buyers the capabilities of our technology through POC parts. Once the POC application development is complete, these certifications allow AddUp to guide customers in qualifying their processes to meet the necessary standards. AddUp’s expertise, supported by these certifications, ensures a smooth qualification process by providing guidance on process control, risk management, traceability, documentation, and continuous improvement. Whether customers are producing medical parts in an ISO 13485 environment or flight-worthy hardware under AS9100, this partnership between AddUp and the customer fosters a collaborative environment that promotes adherence to industry standards, regulatory compliance, and the production of high-quality, certified parts.

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The post The Importance of Certifications in the Additive Manufacturing (AM) Industry appeared first on AddUp.