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.

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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.

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Medical devices are challenging products to manufacture. The combination of regulatory requirements and life critical components make the development expensive and technically difficult.

Stage 1: Ideation and Conceptualization

The first step to developing a medical device is identifying a user need in the target market. Minimizing the gap between the user’s needs and the designer’s perception of those needs is critical to creating a successful product.

Needs in the medical community primarily fall into two categories — “vitamins” and “painkillers.” “Vitamins” are not healthcare solutions, but they do support or improve patients’ quality of life. “Painkillers” are devices that directly address a medical problem.

To assess user needs, start with these seven key questions:

1. What will the device do?
2. Who is going to use it?
3. When will it be used?
4. What are the most important features to consider?
5. How will the user use this device?
6. What are the clinical indications/applications for the device?
7. Is the device single-use or multi-use?

A strong development team is critical here — think experts in engineering and design, usability engineering, medicine, compliance, quality assurance, and intellectual property law. These partners will help answer these questions, ensure the concept is promising enough to pursue, and mitigate risk.

This stage is also the time to lay the groundwork for the rest of the medical device design, development and manufacturing process. This includes coming up with timelines for the project at large as well as its individual stages, calculating potential revenue, gathering an understanding of the regulatory pathway ahead, assessing risk, and budgeting. Budgeting considerations can include funds for labor, materials, consulting, product testing, clinical trials, biocompatibility testing, and licenses and fees if the product will be released internationally.

Stage 2: Regulation and Compliance

The second stage of medical device manufacturing is very involved, but is critical to ensuring only the safest products make it to market. Every medical device must pass regional and international compliance standards that ensure the quality and usability of biomedical tools, materials, and equipment.

For example, all product designers must heed the International Electrotechnical Commission (IEC) standard 60601-1 — it sets out the general requirements for medical electrical equipment and guidelines for health and safety.

However, compliance requirements are not all-encompassing. If a device is compliant with all IEC and International Standard for Organization (ISO) standards, that doesn’t necessarily mean that the Food and Drug Administration will approve it. The FDA has its own parameters for compliance that are derived from regional and international standards, to which engineers will also have to adhere. Finally, engineers must also consider design control regulations set out by the FDA. Design controls are the parameters an engineer uses to prove their product is safe, effective, and able to meet the needs of its target market.

Stage 3: Product Development and Design

Design is the most important stage of the medical device manufacturing process. Even if it makes it through regulatory compliances, a loosely defined or designed device can’t make it to market and deliver the functionality it promises.

The product development stage is oriented around design inputs and design outputs. Design inputs are the physical and performance characteristics that are used as the basis for the device’s design. Good design inputs are clear, objective, and written as provable or disprovable statements. Design outputs are any drawings, specifications, and manufacturing instructions that are associated with the device.

Engineers should keep copies of design inputs and outputs, plus the design plan — which includes a description of all development activities, who is responsible for said activities, and when design reviews will take place — and update them as needed.  In conformance with regulations and good design principles, dated signatures need to be gathered by all responsible engineers during the design process.

As the technical capabilities of the device are being proven out in laboratory settings, product and industrial designers can begin to build the form of the device. Here, rapid prototyping will help engineers and designers move through several concepts. Once the technical aspects of the device begin showing repeatable results, a functional prototype can be built. This will start the process of replicating the scientific breakthrough seen in a laboratory setting in a less controlled environment.

Some considerations to discuss as the device moves out of the laboratory are:

1. Precision — How will precision be measured? How will the device remain precise over time?
2. Lifespan — How long will the device last? What happens when it must be fixed and how will that affect patient health?
3. Travel limits — Will the device include any sensors or switches that limit mobility?
4. Mechanical safety — Are there any pinching or crushing hazards?
5. Debris — Will any debris from the device compromise user safety or biocompatibility?
6. Fringe cases — What happens during worst-case scenarios?

Additive manufacturing is a quick and cost-effective way to develop medical device prototypes, as no tooling is required. An experienced manufacturing partner can help product designers decide what material and manufacturing processes are best suited for a given part.

Stage 4: Testing

The testing stage is all about verification and validation (V&V). Verification is an internal process that evaluates whether or not the device meets the specified requirements, and confirms whether or not design outputs have met inputs.

Validation is an internal-external process that evaluates whether or not the device delivers on its promised benefits. The development team will need to enlist a medical technology expert to help create the tests used for V&V to ensure the tests are as comprehensive as needed.

Since no device turns out perfect on the first try, the testing stage can quickly put product teams over-budget. A strong test strategy can optimize costs and help engineers get their products to market at speed.

Get Started With SyBridge

The medical device manufacturing process is like a waterfall, not a step ladder. Engineers should expect to progress from one stage to the next as well as frequently cycle back through previous stages based on ongoing feedback. In every stage of medical device design and manufacturing, product teams can benefit from the advisory of a trusted manufacturing partner.

At SyBridge, we’re passionate about creating a better world by helping product teams of all shapes and sizes create products that improve the health, safety, connectivity, and sustainability of our world. Now more than ever, high-quality medical devices are a large part of that. Our dedicated team of designers and engineers can provide end-to-end support on product design, material selection, manufacturing method, finishing and post-production, and more. We’re dedicated to helping product teams like yours make new things possible. Contact us today.

The post Key Considerations for Medical Device Manufacturing 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.

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