To provide NFL and D1 players with enhanced protection with greater comfort, VICIS collaborated with the advanced manufacturing team at SyBridge, 3D printer/materials manufacturer Carbon and the digital customization experts at Toolkit3D to create player-specific 3D printed pads for ZERO2 MATRIX football helmets.

SNAPSHOT

Challenge

The team at VICIS was seeking a way to manufacture football helmet pads that offer greater comfort, safety and durability to provide players with improved protection against head injuries.

Solution

Drawing upon the expertise of the teams at SyBridge and Carbon, VICIS 3D printed these advanced new helmet pads with Digital Light Synthesis™ (DLS) technology, utilizing lattice structures made from a new energy-damping, strain-rate-sensitive elastomer (EPU 45). To achieve a truly custom fit, VICIS turned to sports body equipment customization specialists Toolkit3D to perform 3D head scans of individual players. With SyBridge’s digital manufacturing capabilities and expertise in 3D printing, VICIS was able to create pads that conform to each player’s unique head shape, providing custom-fit comfort, enhanced protection and greater durability.

Outcome

Worn by some of the world’s best football players, VICIS helmets featuring these individually-customized 3D printed pads are now the top rated helmets for safety according to the NFL and NFLPA.*

*Data and rankings as of April 2023

“Just as in football, precision, speed and agility were key components when selecting a manufacturing partner for the 3D printed pads used in the Zero2 Matrix helmet. With SyBridge’s engineering expertise and advanced manufacturing technologies like Carbon® DLS™ and the Fast Radius Portal, we were able to incorporate feedback from the field to develop this helmet with player-specific customization in mind, bringing next-level design, protection and performance to the D1 and professional players of this sport we love.”

— Cord Santiago, Senior Design Engineer, VICIS

In the world of professional football, player safety is of utmost importance. With a growing concern about head injuries and the long-term effects they can have on athletes, leading helmet manufacturer VICIS set out to create an improved football helmet that would reduce impact force during head collisions.

To make this possible, the team at VICIS turned to SyBridge and Carbon in order to design and manufacture protective helmet pads, leveraging the digitization and customization expertise of Toolkit3D to achieve a custom fit for each player’s unique head shape.

The Challenge

REPLACING FOAM AROUND THE DOME

With traditional football helmets, including many of those used by professional and D1 athletes, foam is used as the primary material for padding and impact absorption. However, there are several key issues with foam pads that prevent them from being ideal for this application.

Foam pads:

• Offer little ability to fine-tune for specific impacts, limiting performance and safety
• Lack durability and require frequent reconditioning
• Cannot be customized without machining or other labor or material-intensive processes
• Trap heat and moisture

Recognizing the limitations of traditional foam pads, VICIS aimed to create helmet pads that not only remain structurally intact over time but also prioritize player comfort and offer unparalleled safety against head impacts. This required an innovative manufacturing approach, along with expertise in material science and engineering, leading VICIS to the advanced manufacturing experts at SyBridge and Carbon, and the sports body equipment customization specialists at Toolkit3D.

About EPU 45

EPU 45 is a new energy-damping elastomer developed by the material science engineers at Carbon. It prints four times faster than traditional elastomeric polyurethanes and is a strain-rate sensitive material that stiffens to absorb energy at higher impact rates, enabling the design of highly breathable lattice structures tuned for comfort at low-impact speeds and energy absorption at high-impact speeds.

Advantages of Lattice Structures

In addition to enhanced breathability, the lattice structures of the 3D printed helmet pads allow for optimal energy distribution upon impact. Combining this structural design with the unique properties of EPU 45 makes these advanced helmet pads a superior alternative to foam padding traditionally used in football helmets, as they offer greater durability with superior impact absorption.

The Solution

CRAFTING A NEW PLAYBOOK FOR IMPROVED CRANIAL PROTECTION

Working closely with the designers and materials scientists at Carbon and manufacturing engineers at SyBridge, VICIS determined that Digital Light Synthesis™ (DLS) was the right technology to manufacture these advanced helmet pads due to material compatibility and a focus on customization. With a lattice-structure design consisting of the new EPU 45 material, the 3D printed helmet pads would offer an ideal combination of enhanced protection and greater durability.

To create a truly custom fit for each player, VICIS leaned on the expertise of Toolkit3D, specialists in digitizing and automating the customization of high-performance medical and sports body equipment, to create a digital model of each player’s unique head shape. Then, collaborating with the engineers at SyBridge and Carbon, VICIS was able to optimize each pad’s design for manufacturability and cost-effectively 3D print the custom elastomeric helmet padding.
For additional customization and traceability, each pad is printed with the player’s name, pad set, print date and serialization, ensuring that players use the correct pads for their specific cranial geometries.

In the event a replacement pad is needed, utilizing the design flexibility that 3D printing provides combined with the on-demand digital manufacturing capabilities of SyBridge’s Fast Radius Portal, players can receive new pads that match their original head scans in as fast as 2 days, ideal for reconditioning equipment during bye weeks.

The Outcome

LEADING THE LEAGUE IN HELMET SAFETY

The agility of digital manufacturing and the rapid production times that 3D printing offers have allowed VICIS to manufacture these new pads for their Zero2 Matrix helmets with mass customization in mind. When it comes to comfort, one size doesn’t fit all, and sacrificing safety for an improved fit should never be a consideration.

Worn by some of the world’s best football players, VICIS helmets featuring these individually-customized 3D printed pads are now the top rated helmets for safety according to the NFL and NFLPA.*

With these helmets, players get enhanced safety without the impediment of additional size or weight, and a truly customized fit for improved security and performance.

*Data and rankings as of April 2023

The NFL in collaboration with the NFLPA, through their respective appointed biomechanical experts, annually coordinate extensive laboratory research to evaluate which helmets best reduce head impact severity. The results of those tests, which are supported by on-field performance, are set forth on this poster.

The helmet models are listed in order of their performance, with a shorter bar representing better performance. The rankings are based exclusively on the ability of the helmet to reduce head impact severity measures in laboratory testing. Performance variation related to helmet fit, retention, temperature-dependence, and long-term durability are not addressed in these rankings.

All helmets in green are recommended for use by NFL players. Based on a statistical grouping analysis, helmets in the Top-Performing group have been further distinguished into two green categories. The darker green group represents those that performed similarly to this year’s top-ranked helmets, while the light green group performed similarly to the lowest ranked dark green helmet. Helmets with poorer laboratory performance were placed in the yellow or prohibited groups. Yellow and newly prohibited red helmets are not permitted for new players and players who did not wear them during the 2022 NFL season. Newly prohibited helmets will be prohibited for all players in 2024.

The laboratory test conditions were intended to represent potentially concussive head impacts in the NFL. The results of this study should not be extrapolated to collegiate, high school, or youth football.

The post Tackling Football Head Injuries With Manufacturing Innovation 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.

Injection molding involves melting and injecting plastic into a mold, cooling it, and ejecting the finished product. Injection molding is used across various industries, but it’s particularly instrumental in the medical supply and device industry, as it can produce large quantities of accurate, high-quality parts and is compatible with many medical-grade plastics.

Common Medical Applications of Injection Molding

Injection molding offers high levels of accuracy, compatibility with FDA-approved materials, the ability to achieve ISO 13485 compliance, and a low cost-per-part, making it ideal for many medical applications. Medical injection molding can be used to create components for dental X-ray equipment, catheter locks, diagnostic testing kit components, personal protection equipment, microfluidic devices, and surgical and drug delivery equipment.

Other medical plastic injection molding applications include orthopedics, syringes, Petri dishes, and pipettes, as well as parts, housings, and casings for medical devices, electronic devices, and computerized medical equipment. Injection molding is ideal for situations that require high volumes of durable, accurate, and sterilization-friendly parts.

The Benefits of Using Injection Molding in the Medical Industry

Injection molding has plenty to offer the medical industry, including:

Cost Efficiency

While creating tooling requires a significant amount of time and money upfront, injection molding is extremely cost-effective at high volumes. Bulk injection molding will spread the tooling cost across thousands of parts, lowering the overall cost-per-part.

High Levels of Accuracy

Injection molding is known for its accuracy and repeatability, making it perfect for the medical industry, where the slightest mistake can cause a part or device to fail. Injection molding allows companies to quickly create hundreds or thousands of identical parts while providing exceptional accuracy and adhering to tight tolerances.

A Wide Range of Compatible Materials

Compared to all other manufacturing processes, injection molding has one of the widest material selections. While some materials aren’t suitable for use in the medical industry, there are still many materials capable of meeting the industry’s various requirements and regulations.

Superior Strength, Durability and Mechanical Properties

Injection molded parts are quite strong and durable. They may also be resistant to vibrations, impacts, and harsh environments. Some are resistant to heat, meaning they can be easily and repeatedly sterilized via an autoclave without suffering any damage.

Comparing Medical Injection Molding Materials

• Polyethylene (PE): This thermoplastic has a high molecular weight and is perfect for use in wearable medical devices. However, you can’t sterilize PE with an autoclave, as it’s less resistant to heat.
• Polypropylene (PP): PP is highly heat resistant, making it ideal for parts that will be regularly sterilized by an autoclave. PP is also tough, lightweight, affordable, and resistant to radiation, chemicals, electricity, and organic solvents.
• Polystyrene (PS): PS offers good impact resistance and dimensional stability. It’s also non-toxic, inexpensive, odorless, FDA-compliant, and lightweight, making it great for Petri dishes and test tubes.
• Polyetheretherketone (PEEK): PEEK is highly resistant to chemicals, radiation, and wear. Since PEEK is also incredibly resistant to high temperatures, it’s great for sterilization and injection molding. PEEK is often used in orthopedic devices, dental implants, healing caps, and spinal fusion devices.
• Polycarbonate (PC): This strong yet flexible engineering-grade thermoplastic offers high vibration, heat, impact, and UV light resistance. PC offers good dimensional stability and is often used in medical devices.

Determining Which Material is Best for Medical-Grade Products

There are plenty of materials suitable for medical injection molding, but each medical-grade plastic has its own advantages, and each will perform differently. In addition to opting for a contaminant-resistant material that can be sterilized, consider:

• Durability and strength: In the medical industry, using an easily breakable material isn’t very practical. In fact, it can be both inconvenient and dangerous if it breaks at a crucial moment, so make sure to opt for a material that’s resistant to shattering and breaking and offers the durability and strength needed for its intended application.
• Operating conditions: Before deciding which material to use, you’ll need to consider the application environment. For example, if the part is repeatedly sterilized and subjected to high heat, a material resistant to high temperatures is needed, such as polypropylene. On the other hand, if a part needs to be flexible and durable, use a strong material like polycarbonate, which is resistant to vibrations, abrasions, and heat.
• Ease of use: When selecting a part’s material, consider who will use the part and how. After all, a heavy, non-ergonomic surgical instrument would only hinder a surgeon from doing their job. A light, ergonomic surgical instrument that’s functional and easy to sterilize can make all the difference.

Compliance: Adhering to FDA Regulations and ISO Standards

In addition to the use-case and material-specific considerations that you need to make when manufacturing injection molded parts and products for the medical industry, there’s also the matter of compliance. The medical industry is highly regulated. This means that any parts or products that you make, whether through injection molding or another manufacturing process, must adhere to FDA regulations, as well as receive ISO certification and comply with the corresponding standards.

• FDA regulations: The FDA has strict regulations regarding the cleanliness and sterility of implantable devices, medical instruments, other medical components, as well as materials used in cleanrooms. This means that you’ll need to ensure that your chosen material is capable of meeting those standards. Plus, you’ll need to pay attention to the injection molding process itself, as you or your manufacturing partner will likely need to pass an audit to receive medical-grade approval.
• ISO certification and compliance: You’ll also need to ensure your medical components meet ISO standards. Meeting ISO 13485:2016 standards is a must, but you may also need to meet other standards. In some cases, you may need to demonstrate compliance with Class I, II, or III requirements or ISO 10993 and other biocompatibility standards.

Medical Industry Solutions From SyBridge

Injection molding is a precise, cost-efficient manufacturing method that results in high-quality parts and is capable of meeting the strict standards of the medical industry. There are countless applications for injection molding in the medical industry, but some materials are better suited for specific situations than others. To ensure you have the best design paired with the right material and can meet strict regulatory requirements, consider working with an injection molding expert.

At SyBridge, our expert engineers can help you refine your design and select the right material for your component. You can also access instant DFM analysis and more by uploading your designs to identify potential design pitfalls, reduce unnecessary production slowdowns, and lower your cost-per-part.

Create an account or contact us today to discover what SyBridge can do to help you make injection molded parts for the medical industry or other applications.

The post How Injection Molding is Used in the Medical Industry appeared first on SyBridge Technologies.

3D printing was pioneered by Charles W. “Chuck” Hull, who had the idea to use computer-aided design software to create three-dimensional objects. Hull built a machine that used a UV laser to engrave layers of acrylic into shapes before stacking the layers to build objects. He patented the “apparatus for production of three-dimensional objects by stereolithography” in 1984, marking the birth of 3D printing.

In the three decades since, 3D printing has found applications across industries, including healthcare. As 3D printing becomes more advanced and more economically accessible, its medical applications continue to broaden. 3D printing can even be credited with some of medicine’s most impressive recent advancements, including 3D printed vascular tissue, prosthetic devices, and bones, as well as a slew of medical devices, including surgical guides, pacemakers, and more.

How 3D Printing has Helped Transform Healthcare

The healthcare industry was one of the earliest adopters of 3D printing technology. As early as the late 1990s and early 2000s, 3D printing was being utilized to produce dental implants and custom prosthetics, surprising even Charles Hull, who admitted to never having anticipated 3D printing’s effect on medicine. Since then, the technology’s medical applications have evolved considerably, particular in the last half decade.

Because 3D printing is agile, allowing for rapid iterations and alterations, it’s uniquely suited to products like prosthetics and dental implants, which demand both high customization and low volume production. For example, Coapt, a Chicago-based company that produces myoelectric pattern recognition systems for upper limb prostheses, uses additive manufacturing technology to build fully responsive prosthetic arms, customized to each patient’s biology.

3D printing offers the potential to transform other fields of medicine, as well, particularly orthopedics. With 3D printing, orthopedic surgeons are able to create structures that perfectly mimic a patient’s biology, which may one day aid in eliminating the discomfort and degradation associated with “one size fits all” artificial bone implants. While 3D printed bones aren’t in regular clinical use, the success of several headline-making implants has demonstrated the technology’s progress and promise.

Where We’re Going: 3D Printed Biomaterials

While 3D printed bio-devices such as prosthetics and bones have been tried, tested, and put into practice, the next frontier in medical 3D printing, organic mimetic devices, remains on the horizon. In the early 2000s, a team of researchers at Boston Children’s Hospital successfully built replacement bladders of collagen and synthetic polymer by hand using a construction method called “scaffolding.” They layered the scaffolds with cells from the trial’s patients, allowing them to grow into functioning organs. Seven years after the organs were implanted, all of the trial patients remained in good health.

Unfortunately, building organs in this manner is not only incredibly costly, but also extremely time-intensive. Seeking a less time-consuming and more easily replicable means of producing synthetic organs, a research fellow named Dr. Anthony Atala founded the Wake Forest Institute for Regenerative Medicine (WFIRM) in 2004. Soon after, WFIRM researchers began experimenting with 3D printing synthetic human organs, eventually developing machines capable of consistently printing organs and tissues for use in clinical trials.

However, despite the relative success of synthetic bones, 3D printed organs remain far from ready for clinical use. The gap between experimental synthetic organs and clinically viable ones may lie at the cellular level; that’s why researchers are attempting to apply 3D printing to living cells, replicating human tissues. In 2019, a team of Brazilian researchers successfully bioprinted “organoids” that perform all of the functions of the human liver, including building proteins, storing vitamins, and secreting bile.

These miniature livers aren’t yet ready for transplantation, but many experts believe that, as soon as we can successfully replicate human tissue via 3D printing, the path to creating fully-functioning human organs will be cleared — and medicine will be forever changed.

The Future of Medical 3D Printing

It is difficult to overstate the potential that 3D printing has to transform healthcare. As additive manufacturing technology becomes more accessible and more affordable, meaningful medical innovation seems more achievable than ever before — and it’s increasingly clear that 3D printing services will play an important role in revolutionizing medicine in the next decade and beyond.

Primed for on-demand manufacturing, 3D printing allows medical researchers to create small volumes of parts for niche applications — and to pivot quickly when new needs arise.

However, harnessing 3D printing technology — choosing the right materials, the most effective processes, and the best workflows — can be difficult. By partnering with the experts at SyBridge, you can rest easy knowing that we’ll work with you during every phase of the design, prototyping, production, and fulfillment processes. We’ll ensure that every design is optimized for manufacturing and that your choice of materials and production method align with your specific requirements. Ready to get started? Contact us today.

The post A Brief History of 3D Printing in Medicine appeared first on SyBridge Technologies.