Forget typical cycle times. We’re pushing the boundaries of conformal cooling.  While traditional approaches deliver reductions, at SyBridge, we see further.  By combining our expertise in 3D printing, mold tooling design, and in-house manufacturing, we engineer conformal cooling solutions that unlock the true potential of this transformative technology. Our unique synergy allows us to not just achieve impressive results, but to truly test the limits of what conformal cooling can accomplish for your product.   

Conformal cooling improves throughput 

SyBridge uses conformal cooling designs–either in retrofitting older tooling or as an initial design element–to enhance cooling efficiency, reduce cycle times, and increase productivity (Figure 1).  

In one redesign, after a mold flow simulation revealed hot spots on the tips of the parts, SyBridge experts engineered precision water channels to enhance cooling efficiency. Their unique design focused on cooling the front tip of the part, which enhanced the cooling of the rest of the part. This design change substantially reduced mold-open time. Figure 2 dives deeper into the results of these conformal cooling design enhancements. 

It takes experience to design effective conformal cooling 

Additive manufacturing (AM or 3D printing) is an excellent avenue for designing conformal cooling. AM enables intricate and complex structures that closely conform to every shape of the part in a way that–depending on the part geometry and complexity–is not always possible with subtractive manufacturing. During the design phase, long before the part is molded, SyBridge engineers use mold flow simulation, virtual testing, and digital integration to configure and test the conformal cooling capacities.  

Can we help you reduce cycle times? 

As conformal cooling experts, SyBridge engineers know how to help you get the cycle times and efficiencies your product needs. Contact our team to explore how solutions like conformal cooling can improve your injection molding process.

The post Conformal Cooling: Impact By the Numbers appeared first on SyBridge Technologies.

Forget typical cycle times. We’re pushing the boundaries of conformal cooling.  While traditional approaches deliver reductions, at SyBridge, we see further.  By combining our expertise in 3D printing, mold tooling design, and in-house manufacturing, we engineer conformal cooling solutions that unlock the true potential of this transformative technology. Our unique synergy allows us to not just achieve impressive results, but to truly test the limits of what conformal cooling can accomplish for your product.   

Conformal cooling improves throughput 

SyBridge uses conformal cooling designs–either in retrofitting older tooling or as an initial design element–to enhance cooling efficiency, reduce cycle times, and increase productivity (Figure 1).  

In one redesign, after a mold flow simulation revealed hot spots on the tips of the parts, SyBridge experts engineered precision water channels to enhance cooling efficiency. Their unique design focused on cooling the front tip of the part, which enhanced the cooling of the rest of the part. This design change substantially reduced mold-open time. Figure 2 dives deeper into the results of these conformal cooling design enhancements. 

It takes experience to design effective conformal cooling 

Additive manufacturing (AM or 3D printing) is an excellent avenue for designing conformal cooling. AM enables intricate and complex structures that closely conform to every shape of the part in a way that–depending on the part geometry and complexity–is not always possible with subtractive manufacturing. During the design phase, long before the part is molded, SyBridge engineers use mold flow simulation, virtual testing, and digital integration to configure and test the conformal cooling capacities.  

Can we help you reduce cycle times? 

As conformal cooling experts, SyBridge engineers know how to help you get the cycle times and efficiencies your product needs. Contact our team to explore how solutions like conformal cooling can improve your injection molding process.

The post Conformal Cooling: Impact By the Numbers appeared first on SyBridge Technologies.

–Leverages Proprietary Artificial Intelligence (AI) Algorithms–

ITASCA, Ill., June 10, 2024 /PRNewswire/ — SyBridge Technologies, a global leader in design and manufacturing solutions, today announced the launch of SyBridge Studio, a state-of-the-art manufacturing insights application, now available on the PTC Onshape® App Store.

This advanced tool integrates a comprehensive suite of design for manufacturability (DFM) features, drawing upon SyBridge’s extensive expertise in injection mold tooling and production-grade additive manufacturing. Leveraging state-of-the-art logic and data-driven artificial intelligence (AI) algorithms built on a vast database of manufactured parts and tools, the application provides users with unparalleled insights to optimize designs early, assess production tradeoffs, and achieve superior results in cost, speed, and quality.

SyBridge is a portfolio company of Crestview Partners, a leading private equity firm with approximately $10 billion of aggregate capital commitments.

SyBridge’s new application integrates directly into Onshape, the industry’s foremost cloud-native CAD software, providing a powerful extension to the existing toolset available to Onshape users. The app’s user-friendly interface and robust features offer a significant enhancement to the design process, enabling engineers to produce high-quality, manufacturable designs efficiently.

Key Features of the SyBridge Studio include:

• Automated Design for Manufacturability (DFM) Checks: Quickly understand manufacturing issues and how to mitigate them with 80+ Design for Manufacturability (DFM) checks across manufacturing processes: injection molding, CNC machining, and multiple 3D printing technologies.
• Injection Mold Action & Insert Identification: Visualize parting directions and automatically identify various common tooling actions like slides, pins, inserts, lifters, bosses, and strippers.
• Part Thickness Analysis: Visualize material distribution with a full-field colored heatmap on your part CAD to easily identify thin, thick, or non-uniform walls that could cause manufacturing quality issues like warpage or sink marks.

In addition to these powerful features, SyBridge is actively developing future enhancements to the application’s capabilities with a comprehensive roadmap including cost insights and analysis tools, a material recommendation engine, and the ability to purchase parts directly from Onshape via SyBridge On-Demand.

“Going from an industrial design to physical parts is a time consuming processes, typically requiring multiple iterations between different technical domains. With the launch of SyBride Studio, we are excited to provide designers and engineers with a tool that not only makes this process easier and more efficient, but works directly in their CAD environment,” said Byron J. Paul, CEO of SyBridge Technologies. “Our application’s integration with Onshape underscores our commitment to delivering innovative solutions that seamlessly integrate into our customers’ existing workflows to help simplify and accelerate the design and manufacturing process.”

“We are thrilled to welcome this app to the Onshape App Store,” said Jon Hirschtick, Co-Founder and Chief Evangelist of Onshape. “This app provides our users with invaluable tools to get feedback as they are designing, ultimately helping them to achieve their business goals more effectively.”

Onshape users can easily access and install the new application directly from the Onshape App Store, enabling them to quickly take advantage of its powerful features. For more information about SyBridge Studio and to download it, please visit the Onshape App Store.

About SyBridge Technologies

SyBridge Technologies is the global leader in technology-enabled design, prototyping and manufacturing solutions for complex, high-precision parts. Its mission is to use technology to simplify and accelerate how parts are designed and manufactured. SyBridge is one of North America’s largest injection molding tooling platforms and the largest private on-demand digital manufacturer. Our AI/ML technology platform is supported by an industry-leading team of software engineers, computational geometry experts and data scientists.  SyBridge Technologies is backed by Crestview Partners and comprises 15 acquisitions that bring together different products, services, and technologies into a unified technology-enabled platform. SyBridge is headquartered in Itasca, Illinois and operates through 18 locations across North America, Europe, and Asia. For more information, please visit www.SyBridge.com.

About PTC (NASDAQ: PTC)

PTC (NASDAQ: PTC) is a global software company that enables industrial and manufacturing companies to digitally transform how they engineer, manufacture, and service the physical products that the world relies on. Headquartered in Boston, Massachusetts, PTC employs over 7,000 people and supports more than 25,000 customers globally. For more information, please visit www.ptc.com.
PTC.com            @PTC            Blogs

PTC, Onshape, and the PTC logo are trademarks or registered trademarks of PTC Inc. or its subsidiaries in the United States and other countries.

SyBridge Media Contact:
Jeffrey Taufield or Jennings Brooks
Kekst CNC
(212) 521-4800
jeffrey.taufield@kekstcnc.com / jennings.brooks@kekstcnc.com

PTC Media Contact:
Greg Payne
Corporate Communications
gpayne@ptc.com

The post SyBridge Technologies Launches SyBridge Studio, an Innovative Application, on the PTC Onshape App Store appeared first on SyBridge Technologies.

Designing a product is just the beginning. The real challenge lies in ensuring your design is manufacturable, cost-effective, and meets your quality standards. Waiting for design feedback, navigating last-minute design changes, and dealing with manufacturing issues can make this journey feel like an uphill battle. But there’s a solution to make this process smoother and more efficient. 

We’re excited to introduce the SyBridge Studio App, a powerful new tool now available in the Onshape App Store. Developed by leading global manufacturer SyBridge Technologies, the app brings the existing features of SyBridge Studio directly into Onshape. Leveraging insights from millions of parts and tools made combined with the power of artificial intelligence, it codifies a century of manufacturing knowledge to provide you with expert guidance at your fingertips. Easily confirm manufacturability, understand trade-offs, and optimize your design, all while meeting your goals for cost, speed, and quality. 

Manufacturing insights at your fingertips 

After subscribing to the app, you’ll instantly get access to the following features: 

Automated Design Feedback – Quickly find ways to improve part design and reduce costs with manufacturing recommendations. Get feedback on draft angles, non-standard holes, supported surfaces, surface imperfections, and more. Understand how to mitigate potential manufacturing risks with a collective 80+ Design for Manufacturability (DFM) checks available across six manufacturing processes: injection molding, CNC machining, and four 3D printing processes (DLS, FDM, MJF and SLA). 

Injection Mold Action & Insert Identification – See where your tooling requires actions such as slides, pins, inserts, lifters, bosses, or strippers. Use this to make informed design modifications that minimize witness marks and enhance the aesthetic quality of your part. Identify opportunities to reduce tooling complexity and costs, streamlining the manufacturing process and improving overall efficiency. 

Part Thickness Analysis – Visualize the material distribution in your part with a full-field colored heatmap to easily identify thin or thick wall issues. Maintaining consistent wall thickness ensures uniform cooling, minimizes warping, and enhances part strength, durability, and aesthetic quality. Use this analysis to make informed design modifications that improve part quality and reduce costs by normalizing wall thickness throughout your design, resulting in a more efficient and effective manufacturing process. 

More features in an expanded view – SyBridge Studio’s Onshape extension currently houses the most important features, but even more are available on the SyBridge Digital Platform, including instant quoting, parts ordering, and additional analysis tools. Log in here using the same email used to sign in to the SyBridge Studio Onshape app to continue working in a more immersive, full-screen view. 

And more coming soon

More advanced features to help you design more effectively and bridge the gaps between design and manufacturing are on the way, including: 

Instant pricing and cost insights – Receive estimated part and tool pricing at various quantities, access cost-saving design recommendations, understand cost breakdowns, and view other key cost drivers (e.g., cycle time) for 6 manufacturing processes. 

Purchase parts – Easily place an order for your part when you’re ready to check out, directly inside Onshape.  

Recommended and customizable manufacturing orientation – Use our recommended manufacturing direction or adjust it based on aesthetic requirements. Easily visualize and understand the impact on design recommendations and tooling requirements. 

Injection molding tool visualization – View a mock-up of the mold core and cavity to get a sneak peek at how your tool will be made. 

Additional insights – Intelligent systems meet intelligent design. Stay tuned for more insights coming your way: material insights, more advanced DFM checks, and additional injection molding guidance. 

Assembly support – The SyBridge Studio app currently analyzes individual components that you select. Next up is support for full BOMs/assemblies. 

Elevate your design process today 

The SyBridge Studio App is here to change the way you approach design and manufacturing. By integrating advanced manufacturability analysis and optimization tools directly into your Onshape workflow, this app aims to help you overcome common challenges and achieve your design goals more efficiently. 

Ready to take your design process to the next level? Head to the Onshape App Store and subscribe to the app today to experience firsthand how this powerful tool can transform your workflow and bring your designs to life with greater ease and precision. 

The post AI-Powered DFM Analysis by SyBridge, Now Available in the Onshape App Store  appeared first on SyBridge Technologies.

Get the full article at MoldMaking Technology

The post How to Make Data Work for Mold Productivity and Performance appeared first on SyBridge Technologies.

In this fast-paced market, where consumers crave both luxury and sustainability, staying ahead of the curve is crucial. This article delves into the key trends transforming the industry, from captivating design elements to eco-conscious solutions, empowering you to create packaging that not only looks good but resonates with today’s savvy consumers. 

Product differentiation drives sales 

In an increasingly crowded marketplace, creating a unique style for cosmetic packaging is key to catching the eye of consumers and building brand loyalty. Consumers look for details in the design, such as embossed logos on caps, custom colors, unique materials like copper and aluminum, and exclusive shapes (Figure 1). 

Figure 1. Distinctive shapes and mixed materials help products stand out in the beauty market.  

Consumers also expect a luxe feel when purchasing a beauty product with a high price point. Using substantial materials in packaging gives even miniature products a high-end feel.  

Additive manufacturing supports new product development  

Developing products with novel designs requires expertise and options for scaling if products become popular. Since the cosmetics industry moves quickly, bringing a new product from conception to design to reveal is essential for its relevance. And because customer preferences can pivot rapidly, manufacturing a limited number of new products using cost-effective techniques to test the market is also important.  

Additive manufacturing processes like 3D printing meet both requirements—they can produce parts quickly and don’t require huge upfront costs (Figure 2). 

Figure 2. Carbon® Digital Light Synthesis™ is one of SyBridge’s many 3D printing techniques 

Companies can scale production with high cavitation injection molds or other production techniques if the product is commercially viable. Although specialty tooling capabilities may have a higher upfront cost, their ability to support higher production runs and longer lifetime cycles ensures they remain cost-effective. The ability to start small and scale ultimately results in the lowest overall cost of ownership for brand owners.  

Using sustainable materials and designs to appeal to consumers  

Sustainability continues to be a trend for consumer products in 2024, including cosmetic packaging. However, most consumers are unwilling to compromise on increased prices for more sustainable products. Manufacturers must find a way to produce sustainable packaging that is also cost-effective.  

Toward more sustainable cosmetic packaging  

Refillable and reusable packaging is emerging as a more environmentally friendly alternative to single-use packaging. Other sustainability trends include using either post-consumer recycled (PCR) plastic or aluminum for manufacturing or creating products made of single, recyclable plastics (mono-material) instead of a mixture of plastic and metal (Figure 3).  

Figure 3. Material selection simplifies sustainability for consumers 

Mono-material packaging simplifies recycling but does come with challenges, such as finding plastic alternatives to metal springs and other traditional metal components. Manufacturers are also limited in design by choosing mono-material packaging because they can’t use decorative metal coatings.  

A simple way to meet the demand for sustainable packaging without making consumers pay more for beauty products is by choosing a minimalist design (Figure 4). Sleek designs without added decorative features can reduce production complexity and material usage. The challenge to choosing minimalist designs is standing out in a market that relies so much on eye-catching products.  

Figure 4. Minimalist designs can reduce material usage and simplify production  

Design services help meet manufacturing challenges  

Producing flawless cosmetic packaging with the luxe feel consumers expect using sustainable materials is a serious challenge. That’s where working with companies with design services and a range of manufacturing capabilities becomes essential. SyBridge experts can complete design for manufacturability (DFM) checks and simulation analysis to identify production issues before production begins, reducing design iterations and saving on production costs (Figure 4). 

Figure 5. DFM checks help determine how to manufacture the highest-quality part at the lowest possible cost per unit. 

Design services are essential not only for testing novel ideas but also for optimizing current production. SyBridge experts can use product data and analytic tools to create a digital thread — a centralized source of truth for the part. We use the digital thread to gain insights about a part’s lifecycle (design to final production) and see opportunities for increased efficiency and improved quality (Figure 5).  

Novel dispensing methods make for more hygienic products  

A carryover from the COVID-19 pandemic continuing to influence health and beauty products is an emphasis on hygiene. Where many skincare and makeup products require brushes or even a fingertip for application, consumers are now choosing contactless options like droppers, misters, products with internal applicators, and airless pumps.  

Airless pumps reduce the chance of harmful bacteria getting into beauty products during use or illnesses spreading between people sharing the product (Figure 6). Pump dispensers also give customers precise control over how much product they use because each pump produces an exact volume. Companies can use pumps as an opportunity to provide instant brand recognition through contoured pump heads and other unique details.  

Figure 6. Airless pumps help reduce the spread of microbes and regulate dosing. 

In addition to enhanced hygiene and dosing control, the airless packaging used in pumps and sprays can preserve the chemical composition of the formula by not introducing oxygen during use. This extends the product’s shelf life. Airless packaging can help reduce waste, and it is often made from mono-material, making it 100% recyclable.  

Manufacturing for optimal user experience and safe shipping 

A challenge for manufacturing novel dispensing methods is ensuring function. Consumers can easily become frustrated and dissatisfied when features such as pumps malfunction, ultimately costing brands the loyalty they have worked hard to gain. Precise manufacturing is essential to avoid warpages, stress cracks, and other flaws that can cause packaging to malfunction. 

E-commerce companies selling cosmetics also need packaging that meets shipping standards. Products must have the strength to withstand rough handling during transportation, sortation, and distribution.  

SyBridge helps companies manufacture uniform, strong products by incorporating quality inspection services and advanced designs, such as conformal cooling, in our manufacturing technology. Our precision manufacturing can help companies achieve high-feature, aesthetic parts that are also functional. 

Partnering with SyBridge  

Manufacturing partnerships help cosmetics companies maintain a competitive edge in the fast-paced industry. Since needs vary by product, partners with multiple capabilities are especially valuable and critical to support reduced overall tooling costs. SyBridge experts can help cosmetics packaging manufacturers wherever they are—whether seeing if a novel design is achievable or choosing the best manufacturing technology for a proven product.  

Staying ahead of 2024 beauty trends is possible with the right partners. Connect with a SyBridge expert today to learn how our comprehensive services can help you meet your goals this year.  

The post 2024 Trends in Cosmetic Packaging appeared first on SyBridge Technologies.

by Charlie Wood, Ph.D.
VP of Innovation, Research & Development

As a part of the SyBridge team, I’ve witnessed the remarkable evolution of design and engineering tools over the past decade. These digital advancements have revolutionized our approach to manufacturing, allowing for more data-driven processes and insights. But it can be difficult to know where to start, or even to understand where there are opportunities to implement.

At the heart of our approach lies the concept of the “Digital Thread,” a framework that interconnects data across the entire lifecycle. This concept enables us to leverage the wealth of design and operational data across our data lake that is generated in the manufacturing process, from CAD designs to inspection results. While the industry is still moving towards seamless integration, we’ve made significant strides in creating workflows that prioritize data-driven decision-making.

Streamlining Injection Mold Design Workflows

One key area where data is contributing to efficiencies within manufacturing is that of injection mold tooling design. By utilizing virtual component libraries for mold designs, we’ve been able to streamline the complex process of coordinating and collaborating on intricate assemblies for mold making. In these libraries, we have standard blocks, system approaches and components stored in a way that allows us to quickly identify and digitally pull components. This approach offers lots of flexibility when it comes to customer requests and needs, all while keeping standard practices built right into our tools. Over the course of many years, we’ve built software-driven processes to design new builds based off of these standard components, allowing us to quickly handle new requests from customers and build a learning feedback loop to avoid costly mistakes.

Additionally, through the use of parametric component libraries, we’ve been able to significantly reduce design complexity and incorporate our own manufacturing intelligence into these components, allowing us to directly check for design issues and integrate manufacturing information into CAD files. This process creates a flow of information from the conceptual stage of the design through manufacturing and approval, extending our Digital Thread from end to end. This information flow can also go backwards, tying quoting, estimation assumptions and specifications directly to tool designs. These advancements in our design approach have not only made the job of a tool designer a bit easier, but have improved quality by creating
more explicit feedback loops in our design processes.

Innovations in Conformal Cooling

As many know, 3D printing has unlocked incredible design freedom for manufacturing engineers around the world. However, what can be overlooked is how impactful it has been for system designers, like toolmakers, who can utilize that design freedom and low cost of complexity to create components that radically improve performance. In the case of toolmaking, 3D printing has unlocked new cooling channel designs simply not possible before.

Although increasing numbers of toolmakers are using these advanced manufacturing techniques today, the new design space is so complex it can be hard to probe. In the past, conformal cooling channels were fairly straight, in-plane paths driven by tool access limitations in machining. With metal 3D printing, the limits are far less restrictive and allow designers to pursue more creative and complicated structures.

Using advanced data-driven methods with virtual design and testing capabilities, we’ve been able to uncover non-obvious opportunity areas in the design space. Through these novel design and
manufacturing workflows, we’re optimizing cooling performance and achieving remarkable improvements in tool performance as measured through cycle time. Through our approach, we’re seeing cycle time reductions as high as 50%. These successes have inspired us to further integrate and enhance these workflows, driving continued innovation.

AI Tools for Manufacturing

The Fast Radius Portal’s AI-powered DFM checks

Looking ahead, we’re enthusiastic about the possibilities that emerging technologies like machine learning (ML) and artificial intelligence (AI) offer. These novel data modeling approaches have shown incredible potential, and the pace of technological advancement is rapidly accelerating. We’ve been able to use ML models to build data models faster than through simple bottom-up logic, particularly for complex problems that contain many correlating factors.

The critical ingredient in implementing AI for manufacturing are large data sets that provide a source of truth for model training and validation. By leveraging our existing datasets, we aim to predict defects, optimize designs in real-time and ultimately revolutionize quality control processes. These technologies are not a distant vision; they’re an integral part of our current digital platform, with features like instant quoting and DFM checks based on captured manufacturing data. And this is just the beginning of what’s possible.

Unlocking Manufacturing Innovation via the Digital Thread

Our journey in harnessing digital workflows for injection molding design has seen remarkable progress and tangible results. The end-to-end integration of data into the Digital Thread, combined with the power of ML and AI, holds the key to unlocking even greater innovation. As we continue to push boundaries and explore new frontiers, we’re excited about the advancements at the interface between the physical and digital worlds.

Are you ready to harness the power of the Digital Thread for your organization? Contact us today to get started.

The post The Digital Thread: End-to-End Data-Driven Manufacturing appeared first on SyBridge Technologies.

Restrictions around specific materials will vary by region. This means that a device that is approved for use in the United States might not meet the European Union’s standards.

While not every medical device requires biocompatible materials, many do. If the device is intended for internal use it will face stricter scrutiny than devices that might aid in a surgery or are in contact with the skin momentarily. Common examples of medical devices intended for internal use include pacemakers, prosthetics, stents, artificial hips, and other joint replacements.

It’s important that product development teams know which biocompatible materials are best-suited for their specific requirements in order to protect the patient’s health and wellbeing, achieve ongoing compliance with stringent regulations, and mitigate risk and liability. Here are some key guidelines and grounding principles for medical device material selection.

Regulatory Standards for Biocompatible Materials for Medical Devices

The materials and components used by medical device manufacturers must meet the stringent quality and performance requirements of the international regulation ISO 10993, which deals specifically with biocompatibility. ISO 10993 lays out an approach for how to perform risk mitigation and performance testing for device materials in a consistent and uniform manner.

ISO guidelines have the backing of the FDA. In September 2020, the agency released a guidance document offering suggestions for how to implement ISO regulations and ensure that FDA-approved materials for medical devices are in alignment with international standards.

Biocompatibility is a complex and evolving subject with few simple definitions, and the latest update to ISO 10993 guidelines (10993-1:2018; updated from 10993-1:2009) reflects the latest developments in the field. Perhaps the most significant change in the latest edition of ISO 10993 involves how biocompatibility is tested.

Whereas the previous version provided specific tests for assessing the biocompatibility of different device types, the current standard seeks to better address the many variables involved in medical device manufacturing through a comprehensive process of risk assessment, mitigation, and management. This allows the standard to be applied in a wider range of dynamic medical and manufacturing contexts.

The ISO 10993 update also includes additional or updated information about contact and non-contact medical devices, as well methods for evaluating the biocompatibility of nanotechnology, gas pathways, and absorbable materials.

Demonstrating biocompatibility is generally done through a three-stage process:

1. Product teams develop a Biological Evaluation Plan (BEP), which outlines known risks and strategies to test or mitigate these concerns. This document fulfills ISO 10993-1’s requirement for an initial risk assessment.
2. The device’s materials and components are tested to address these outlined risks, which can include evaluating factors such as how the device wears over time, material toxicity, or how the device operates when it comes in contact with fluids. Often, a variety of test types and design controls for medical devices are necessary to ensure the device functions as intended.
3. Product teams consolidate test results and analyses of the data into a Biological Evaluation Report (BER), which they then submit to the FDA for approval.

Additional Biocompatibility Challenges

In addition to achieving compliance with ISO and FDA regulations, biocompatible medical device design can lead to additional challenges for product teams. Medical device product development teams often have specific functional or design-related requirements by which they must adhere, and reconciling these requirements with material restrictions can be a time-consuming and intensive process. In fact, it’s not unheard of for customer requirements to necessitate a contradictory or mutually exclusive set of material properties — and it’s up to product teams to do the research that leads to an acceptable compromise.

Another key challenge involves production timelines. The testing required for toxicology and biocompatibility assessment do not produce simple pass or fail results; rather, these evaluations collectively create a demonstration of compliance or a recommendation for further research and evaluation. Because this requires a thorough and well-documented approach, the certification and approval process for medical devices cannot be rushed. Successful product teams are those with the skill and expertise to meet customers’ requirements while operating in accordance with ISO and FDA regulations.

Key Considerations for Selecting the Right Biocompatible Material

There are numerous variables and factors to take into account when designing and manufacturing biocompatible medical devices, and the specific details will of course vary based on the application.However, choosing the right material is paramount, as researchers have found that 30-40% of device recalls are caused by improper material choice. Here are three key considerations for product teams:

• Material availability: If the design of a medical device includes materials that are scarce or hard to come by, an alternative solution may be necessary. This helps to keep per-unit costs low and to ensure that the device can reach the market on schedule.
• Manufacturing process: The material requirements of a medical device or its components will help determine the optimal production method or methods. Injection molding, for instance, is a rapid and cost-effective means by which to create large quantities of precise plastic components with good surface finishes, but can be extremely expensive for low-volume production. CNC machining, on the other hand, has very few material restrictions but some significant geometric ones. Likewise, developments in additive manufacturing technologies are enabling faster production and greater customization — an especially valuable quality considering the medical sector’s large-scale shift toward patient-centric care —  though it’s worth noting that both CNC machining and additive manufacturing are compatible with a comparatively limited range of materials.
• Sterilization needs:Some medical devices and tools, such as hypodermic needles and IV tubing, must be sterilized before they can be circulated back into use. In design terms, this means the device must have a material resistance to the sterilization process. Knowing early on whether a device will have a sterilization requirement — in addition to the sterilization method that will be used — is key to avoiding expensive revisions and tests.

Maintaining an Efficient Design Process During Medical Device Product Development

Given that biocompatibility testing and approval require ongoing evaluation, product development teams will likely need to adapt or rethink their design processes based on their findings.

There are a couple of structural ways in which teams can streamline their design processes. Maintaining an accurate database of materials that includes information related to test results, material toxicology or carcinogenicity, and other characteristics laid out by the ISO 10993, is the first step to creating an archive of historical data that can be referred back to in future design efforts. Doing so not only helps to improve the efficiency of modifications during the design process, but also helps to keep the design team acquainted with the various materials that are relevant to a device’s biocompatibility and functionality requirements.

If component materials have been selected but part geometry has yet to be finalized, plaque testing is a technique that allows teams to stay productive and efficient. This technique involves producing multiple small plaques via the manufacturing method that will be used to create the final product. The plaques are then subjected to biocompatibility testing — including chemical testing and determining how the material breaks down over time — while product developers finalize the part design. This helps to establish the foundation for subsequent evaluation and can speed the regulatory approval process.

Choosing the Right Manufacturing Partner for the Job

The updated processes contained in the latest ISO 10993 seek to minimize unnecessary testing while still guaranteeing that product teams are able to account for how relevant factors like the device design, physical and chemical characteristics of the device materials, and even the manufacturing process can influence the quality of devices and how well they are able to meet patients’ needs. The strenuous design, development, and regulatory processes required for effective medical device manufacturing can present significant challenges for product teams, which is why it’s beneficial to partner with a tried-and-true manufacturer like SyBridge.

SyBridge is an innovative, on-demand digital manufacturing platform with significant experience working with medical device design teams to bring safe, reliable products to market. Our skills and techniques have been used to create cutting edge prosthetics, highly precise surgical models, and more, and our team is prepared to provide 360-degree advisory and support services from the design and prototyping stages to production and fulfillment. Ready to get started? Contact our team today.

The post Medical Device Manufacturing and Biocompatible Materials appeared first on SyBridge Technologies.

Additive manufacturing, also known as 3D printing, has become an increasingly popular manufacturing method across many industries, from the automotive industry to the medical industry. Over the last few years, there have been several advancements in 3D printing technology, allowing manufacturers to create increasingly complex and durable components that are on par with those made via CNC machining or injection molding.

Additive manufacturing has also had a significant impact on the food industry, which has strict requirements to ensure that the materials which come in contact with food are safe for people.

Is Additive Manufacturing Food-Safe?

3D printed parts can be food-safe and meet Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) regulations, as long as specific steps and precautions are taken. To ensure your parts are safe for use with food, you’ll want to follow 3-A Sanitary Standards and review your part’s design, your materials, and the additive manufacturing process itself. To help you get started, follow these best practices when it comes to designing 3D printed food-safe products:

Eliminate Crevices and Voids

Make sure that any section of your part or product that can come into contact with food (product contact surfaces) is free of crevices and voids. These features are difficult to clean and can allow bacteria to thrive. If your part requires voids or crevices, ensure that those areas can be easily accessed for cleaning when your product is disassembled.

Round any Sharp Corners

Sharp corners are difficult to clean, and like crevices and voids, can potentially harbor bacteria. With this in mind, you should round any corners within your design, and instead incorporate fillets with large radii when possible.

Ensure Toughness

When you’re manufacturing food-safe products, make sure that your parts are robust enough for their applications. If they crack, corrode, or break down, bacteria can grow, putting users at risk. Additionally, if a part breaks, small pieces may contaminate the food, posing a danger to consumers and often requiring a recall of the product.

Smooth Surface Finishes

A part’s surface finish can be problematic, as rough surfaces have small pockets that enable bacteria to grow. However, creating food-safe 3D printed products with smooth, non-porous surfaces can be challenging, as 3D printers build parts layer by layer, resulting in microscopic crevices. To achieve surface smoothness, you can use:

• Mechanical finishing: Mechanical finishing techniques, such as sanding, bead blasting, and polishing, can help smooth a part’s surface while also improving clarity.
• Vapor smoothing: Compatible with certain plastics, vapor smoothing involves exposing 3D printed plastic parts to vaporized solvent. Your part’s external features and edges will melt and re-seal, creating a smoother, glossier surface without voids or crevices.
• Surface coatings: In situations where mechanical finishing isn’t a viable or cost-effective option, you might be able to use a food-safe coating, such as food-grade epoxy or polyurethane. Make sure your coating is compatible with any cleaning products and other chemicals your part will come into contact with to avoid pitting, delamination, and blistering.

The additive manufacturing process you choose also plays a role in the amount of post-processing you’ll need to do. Technologies like stereolithography (SLA), HP Multi Jet Fusion (MJF), and Carbon® Digital Light Synthesis™ (DLS) produce parts with smoother surface finishes than fused deposition modeling (FDM), and typically require less post-processing. However, regardless of technology, even if a part is printed with food-safe materials, it might not be considered food-safe if the printer isn’t itself deemed food-safe. Something as small as an FDM printer’s nozzle containing lubricant can cause the resulting parts to be considered non-food-safe, so every detail counts.

How is Additive Manufacturing Used in the Food Industry?

Additive manufacturing, unlike injection molding, doesn’t involve machining expensive tooling to mold plastic parts. By eliminating the cost and lead time associated with machining injection mold tooling, companies can save a great deal of time and money when making parts and maintenance tools for their factories, such as spacers, grippers, and assembly tools. Additionally, additive manufacturing — particularly when combined with digital part storage and factories with cloud-based manufacturing capabilities — is an ideal process for producing spare parts, keeping equipment up and running and avoiding expensive, unplanned downtime.

What Materials are Used in Food-Safe Additive Manufacturing?

When creating products that will come into contact with food, choosing the right material is essential. You’ll want to choose a non-toxic, non-contaminating, corrosion-resistant base material, and you’ll need to make sure any added coatings or dyes are also food safe.

Specific food-grade plastics that are compatible with the additive manufacturing process include:

• Polyetheretherketone (PEEK): PEEK has high resistance to heat and dimensional stability, so it can be used in the microwave and dishwasher. It’s lightweight yet strong and can be manufactured with colorants, giving it plenty of design flexibility. PEEK can be found in coffee machine nozzles, mixing scrapers, blenders, kneaders, food packaging, and more.
• ULTEM 1010: ULTEM 1010 is a strong, high-performance thermoplastic compatible with the FDM 3D printing process. In addition to being mechanically suitable for many applications, it has been certified to NSF 51, meeting the FDA’s minimum public health and sanitation requirements for materials used in the construction of commercial food equipment.

What are Some Sterilizable Additive Materials That Meet Food Safety Standards?

Manufacturers often use sterilizable additive materials, as the last thing they want is for bacteria to grow unchecked within a product that comes into contact with food. However, it’s important to know that not all sterilizable materials are necessarily food-safe materials.

Creating Food-Safe Products With SyBridge

The introduction of additive manufacturing to the food industry has changed the game. Thanks to 3D printing, companies can create food-safe products from a wide variety of materials quickly, cost-effectively, and on demand. However, creating food-safe products via additive manufacturing isn’t as simple as selecting appropriate materials. You’ll also need to pay attention to your printer, your part’s design, and your part’s surface finish.

There’s a lot to remember when trying to meet regulations and create food-safe products, so using an experienced manufacturing partner can put your mind at ease and ensure your customers aren’t put at risk by unsafe products. When you work with SyBridge, our engineering team can help you choose an FDA-approved plastic that will meet your needs and ensure your design is ready for printing. You can also upload your part files to get an instant DFM analysis of your design, explore material options, and order your parts online — even using a purchase order (PO). Contact us to discuss the requirements for your next food-safe additive manufacturing project.

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Over the last few years, companies around the globe have experienced supply chain problems, showing that the global pandemic has had consequences for businesses large and small. On top of the surge in consumer demand, there was a shortage of shipping containers and dockworkers, a decline in air freight capacity, and a lack of truck drivers, leading to port congestion. Ships were left idling off shore for days, or even weeks — and the problem is ongoing. At the tail end of 2021 and the start of 2022, container ships spent an average of seven days at American ports.

These supply chain disruptions have also caused manufacturing delays. All industries experienced record-long lead times for raw materials in October of 2021, and things haven’t improved much. For example, chipmakers must wait 18 months for critical equipment, such as electronic modules, lenses, valves, and pumps.

Additive manufacturing may offer some much-needed relief to supply chain issues. It can provide several benefits when it comes to low-volume production runs, quality control, and material cost, making it a viable alternative to the traditional supply chain and a more predictable asset during turbulent times.

Why additive manufacturing?

Additive manufacturing, commonly known as 3D printing, involves manufacturing or printing a part directly layer by layer, as opposed to subtractive methods like machining. It’s an accurate, highly digitized process that requires much less tooling and setup, eliminating the need for molds, forms, and specialized cutting tools.

Compared to traditional manufacturing methods, additive manufacturing technology offers several advantages, including:

Faster lead times

Additive manufacturing allows for faster prototyping and low volume production, helping companies accelerate the design iteration and product validation processes to get their products to market faster.

Plus, since there’s no need for tooling, you can print end-use parts within a few hours or days instead of spending weeks or months for setup associated with designing and fabricating tooling, like a mold, as you would when injection molding. Essentially, you can start the production run as soon as the final design is complete and a printer is available.

Increased flexibility and agility

3D printers enable companies to print parts on demand, offering incredible flexibility and agility. Not only can companies quickly and cheaply create custom products with 3D printing technology, but they can also easily produce more or less of a product as demand shifts.

While ramping up production with injection molding, design changes after release can mean waiting weeks or months for another tool to be created. With the elimination of tooling, 3D printing enables companies to shift gears quickly. For example, during the early stages of the pandemic, HP printed over 2.3 million medical components, including nasal swabs, personal protective equipment, and ventilator parts when the demand was dynamically growing. Had they used injection molding, they would have needed to design and manufacture a mold, which could have taken months.

Decentralized production

Using 3D printing technology will also enable companies to decentralize production. Instead of producing goods in a single location and shipping them worldwide, companies can manufacture goods close to or at their point of use. Distributed production can drastically shorten the supply chain, eliminating many potential bottlenecks and accelerating a product’s time to market, so it’s hardly surprising that 52% of companies were considering localized production in 2021.

Shifting towards additive technology and a decentralized production system can also help companies get products in consumers’ hands faster, avoid the cost of long-haul shipping, and cut back on transportation-related greenhouse gas emissions.

Reduced warehousing costs

3D printers allow companies to manufacture goods on-demand, meaning you can produce the exact number of parts you need and then ship them directly to your customers, more perfectly matching supply and demand. Instead of buying or renting a warehouse, you can rely on digital inventories and produce parts whenever a customer submits an order.

Since warehouse vacancy is at just 3.6% and demand will likely only increase as more companies reshore manufacturing and diversify their supply chains, printing on demand and shifting to a digital warehouse rather than storing physical inventory can help save a significant amount of capital.

Can building additive manufacturing into production cycles avoid future disruptions?

While most companies believe it’s time to take action to avoid future supply chain disruptions, it can be difficult to identify which measures to take. For those that have shifted tactics, many are relying on short-term measures. In fact, less than half of the 3,000 chief executives surveyed by AlixPartners have taken action to alleviate supply chain disruptions in the long term.

Building additive manufacturing into the production cycle can help companies mitigate or avoid future supply chain disruptions. After all, additive manufacturing supports decentralized manufacturing and allows for a simpler supply chain and increased flexibility and agility. Companies can produce products closer to their destination, potentially avoiding supply chain bottlenecks like severe port congestion. Additive allows companies to produce the exact quantity required, reducing excess shipments to warehouses before distribution to customers.

What are the risks of replacing the traditional supply chain with an additive manufacturing supply chain?

Given the many benefits of additive manufacturing, it’s hardly surprising that the global market for 3D printing products and services was around $12.6 billion in 2020 and will continue to grow in the coming years as more companies rebuild shorter or more flexible additive supply chains. However, people who have spent their careers designing for or working with injection molding or CNC machining may have difficulty shifting to these newer disruptive processes.

Common problems people run into while 3D printing include warping, cracks, poor layer-to-layer adhesion, and part failures. Thankfully, technological advancements in the manufacturing equipment and materials worlds have made these problems smaller and less frequent, as well as engineers working across the life cycle from design to manufacturing. For example, in fused deposition modeling (FDM), layer shifting, stringing, under-extrusion, and over-extrusion are possible, but experienced engineers and manufacturing technicians are continually developing solutions to improve part quality. Similar process advancements in other additive technologies (SLA, SLS, etc.) have been made to make more applications possible. However, these advancements require a 3D printing partner that has the knowledge and expertise to develop and employ these novel processes.

If you work with SyBridge, our experienced engineers will be able to review and refine your design, helping you manufacture parts quickly and cost-effectively without making difficult quality sacrifices. Our domestic factories and distributed production capabilities will help you avoid the delays and headaches associated with overseas logistics, and our suite of digital tools can automatically detect design issues before your part or product goes into production. You can also explore various materials and manufacturing methods before initiating a quote. To learn more about how our additive capabilities can help resolve your supply chain issues, accelerate production, and ensure maximum cost-per-part efficiency, create an account or contact us today.

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