From dental to orthopedic applications, implant reliability begins long before a device reaches the clinic. Behind each successful product is a network of specialized suppliers ensuring the materials, coatings, and surfaces meet the highest possible standards. Himed is one such supplier. As a biomaterials manufacturer with more than three decades of experience in advanced implant surface treatments, we support the medical device industry by combining material science expertise with a disciplined approach to process validation and quality assurance.

Although Himed is not a finished device manufacturer and therefore does not perform sterilization, our company operates under Good Manufacturing Practices (GMP) and a certified ISO 13485:2016 Quality Management System (QMS). These systems ensure that every material and process output achieves consistent cleanliness, repeatability, and regulatory integrity.

Integrating GMP and ISO 13485 for Process Control

Within the framework of ISO 13485, Himed manufactures biomaterials and provides surface treatment services that support the design, development, and production of Class I, II, and III medical devices manufactured by our customers. Himed’s processes are always an important component of the product journey, but do not result in finished medical devices as they must still undergo final sterilization and packaging elsewhere. Nevertheless, Himed’s QMS is structured to meet all relevant clauses of ISO 13485 related to process validation for critical cleaning operations, contamination control, environmental monitoring, material traceability, and supplier management.

These controls align with both FDA Quality System Regulation (21 CFR 820) and ISO 13485:2016 expectations for medical device suppliers. Himed’s surface treatment cleaning validation and surface treatment processes are designed to control contamination at the elemental level and ensure that every implant surface retains its integrity throughout downstream processing.

All our cleaning validations are periodically revalidated under worst-case conditions, such as using end-of-life chemicals near the end of their defined lifecycle. This approach tests the robustness and repeatability of cleaning processes and confirms their reliability under real-world manufacturing scenarios. In-process monitoring between validation cycles provides further assurance of stability and control, minimizing variability and risk for our customers.

Rigorous Cleaning Validations for Implant Surfaces

Himed’s cleaning validation program is designed not simply to meet regulatory expectations, but to exceed them. For surface-treated implants, revalidations incorporate multiple layers of testing and inspection, including:

• Cytotoxicity testing (per ISO 10993): Verifies biological safety.


• Bioburden testing: Confirms microbial control prior to sterilization by the final device manufacturer.


• Visual inspection: Evaluates overall cleanliness and surface consistency.


• SEM/EDS analysis: Detects and characterizes potential residues at the elemental level.


By combining biological, microbial, and elemental assessments, Himed ensures that all treated implant surfaces meet strict cleanliness standards before they reach sterilization. These activities demonstrate a proactive commitment to validation, patient safety, and regulatory readiness, which are core principles of our operations.

Comprehensive documentation supports each of these processes. Controlled acceptance, handling, and storage of raw materials prevent cross-contamination, and full traceability is maintained from incoming inspection through final product release. This level of process discipline not only satisfies GMP requirements but also strengthens our customers’ own validation and biocompatibility submissions.

Streamlining Regulatory Submissions and Supporting Quality Teams

Himed’s cleaning validation data and process documentation help device manufacturers streamline their regulatory submissions, particularly for biocompatibility and cleaning verification. By maintaining detailed records of process parameters, validation protocols, and performance data, Himed provides manufacturers with a dependable foundation for FDA and ISO documentation packages.

Himed’s goal is to serve as a true partner in manufacturing and compliance by supporting customers with the technical rigor and data integrity required to bring safe, effective implants to market.

A Culture of Continuous Compliance and Improvement

At Himed, compliance is not viewed as a static achievement but as an evolving commitment to quality and precision. Our integrated GMP and ISO 13485 systems are built around repeatability, traceability, and risk control, with ongoing monitoring and revalidation ensuring sustained process performance.

Every validation, inspection, and analysis reflects a unified purpose: to offer reliability, facilitate downstream sterilization and biocompatibility testing, and ultimately support the safe integration of implants into clinical use.

The strength of a surface treatment lies in the systems and quality standards that support it. A good system should yield consistent, high-quality results while also being transparent, reliable, flexible, and fast. For decades, Himed has met these criteria through custom robotics—this week, we're pleased to announce the newest addition to our blasting fleet, xFAB.

Short for "fully automated blaster," xFAB was wholly designed and built by the Himed engineering team to support the surface treatment of dental and orthopedic implants using our MATRIX MCD® and MATRIX Dual® processes. This new system has the same capabilities as our more complex production cells but in a simplified and more accessible format. It was developed to increase efficiency, reduce setup time, and improve day-to-day usability for both operators and engineers.

Built for usability

We created xFAB with ease of use as a central priority. When the blasting process is less complex, it supports consistency between operators while improving overall productivity on the floor, which in turn shortens lead times and ensures good results. 

xFAB's compact layout, intuitive interface, and streamlined mechanics make it simple to operate, even for team members new to automated systems. Training time is minimal, and daily operation requires fewer manual adjustments or troubleshooting steps.

Controlled, validated, and built in-house

Because xFAB was designed and built entirely by Himed, we have control over every detail. Our team engineered the system from the beginning with long-term reliability in mind, meaning we can service it ourselves and implement any improvements or updates quickly—avoiding the delays that can arise when third-party vendors are involved.

Before going live, xFAB underwent a full in-house validation process using a variety of implant designs. From threaded dental fixtures to porous orthopedic components, each test confirmed that xFAB would consistently deliver our MATRIX MCD® and MATRIX Dual® surface treatments to specification.

Designed to support what comes next

We invest in tools that support long-term growth. As implant designs become more specialized and production volumes shift, our focus is delivering the flexibility and responsiveness our customers rely on. 

That flexibility extends beyond manufacturing—xFAB is also a powerful asset in iterative research and development. Our team can make precise parameter adjustments, quickly shift between projects, and keep detailed process protocols for repeatability and documentation. These abilities are especially valuable in early-stage validation, where turnaround speed, consistency, and traceability are vital to meeting regulatory expectations.

Whether for rapid process validation or large-lot surface treatments, xFAB allows our team to stay efficient, consistent, and aligned with the evolving needs of the dental and orthopedic industries.

How can we help?

If you're advancing a new medical device, preparing for a regulatory submission that includes calcium phosphate materials, or seeking high quality implant surface treatments, our team can support you with proven materials, rigorous quality systems, validated processes, and a steadfast commitment to partnership.

🇰🇷 한국어 번역

OLD BETHPAGE, NY, May 22, 2025 — Since its founding in 1991, Himed has grown into an internationally recognized supplier of high-quality calcium phosphate bioceramic materials and surfacing solutions. In South Korea, that growth has been significantly accelerated thanks to I&H Global—a private company that has served as Himed’s exclusive sales representative in the region since 2010.

I&H Global was founded to raise awareness in South Korea about the benefits of biomaterials like hydroxyapatite in medical implants. It initially approached Himed with the idea of partnering to serve the country’s rapidly expanding dental implant and abutment market. Himed co-founder and then-President Ed Garofalo traveled to South Korea to explore the opportunity. There, he met I&H Global co-founder Inchang Song, and together they visited with several leading dental implant manufacturers to discuss how Himed’s bioresorbable apatitic abrasive and customized hydroxyapatite coatings could improve clinical outcomes while also offering a market advantage over competitors not yet leveraging the regenerative potential of calcium phosphate materials.

“Engaging with I&H Global was a pivotal moment for Himed,” says current President Craig Rosenblum. “Up until 2010, our growth was largely organic—driven by the quality of our materials, personalized client service, and strong academic ties. I&H Global changed that. Their proactive approach helped us build new relationships and contributed significantly to our expansion in East Asia.”

Over the past 15 years, global demand for both dental and orthopedic implants has continued to rise. South Korea, the fastest-growing dental implant market in the Asia-Pacific region, is projected to experience a compound annual growth rate of 11.2% by 2030. Innovations in medical manufacturing, such as 3D printing, have further increased the need for advanced materials, analytics, and R&D. In response, Himed opened its Bioceramics Center of Excellence™ in 2024 to advance the integration of calcium phosphate-based materials in additive manufacturing. I&H Global is poised to connect Korean companies exploring 3D-printing with Himed’s cutting-edge expertise.

“Many more companies in Korea could benefit from partnering with Himed,” says I&H Global President Inchang Song. “They offer quality, integrity, and deep expertise in bioceramic materials. It’s an honor to help connect innovative Korean manufacturers with Himed’s technical teams.”

Inchang Song will represent Himed at the upcoming Seoul International Dental Exhibition & Scientific Congress (SIDEX) from May 30–June 1, 2025. He’ll be meeting with current customers and introducing new companies to the value of bioceramic materials and implant surface treatments. To schedule a meeting with Mr. Song at SIDEX, please email: info@himed.com

ABOUT HIMED: Since 1991, Himed has been on the vanguard of biomaterial coating characterization. With an all-in-one research and production facility in New York, Himed supplies raw calcium phosphate biomaterials for a wide array of uses and provides tailorable, biocompatible coating and texturing solutions with their MATRIX® line of surface treatments. Himed is FDA registered and ISO 13485:2016 certified.

For those seeking an alternative to fluoride toothpaste, there’s good news: it’s possible to maintain strong, cavity-resistant teeth without giving up effective protection. Hydroxyapatite—a naturally occurring mineral—has been gaining popularity as a toothpaste ingredient due to its ability to remineralize tooth enamel and help prevent cavities. In fact, a recently updated review and meta-analysis of research on hydroxyapatite indicates that an increasing number of clinical studies confirm hydroxyapatite’s benefits (1).

However, many people just learning about hydroxyapatite naturally have some key questions:

• What exactly is it?

• How does it work?

• Is it safe?

As a biomaterials company, Himed has worked with hydroxyapatite for nearly 35 years. In this article, we’ll offer a clear overview of this compound and explain why it’s becoming a promising ingredient in modern oral care products.

What is hydroxyapatite?

Hydroxyapatite (HA) is a naturally occurring calcium phosphate and the primary mineral component of human bones and teeth. In the mouth, it makes up over 90% of tooth enamel—the hard, protective outer layer—and about 70% of dentin—the softer supportive layer underneath (2).

HA has been used for decades in both medical and dental applications, including bone grafts and implant coatings. It can be harvested from sources like animal bones or eggshells, or it can be synthesized in a lab. At Himed, we manufacture synthetic HA specifically for biomedical uses because these forms can be engineered to very closely mimic the mineral structures found in hard tissues like dental enamel and human bone.

Hydroxyapatite also happens to be bioactive—meaning it has properties that allow it to interact successfully with surrounding cells to support the body’s natural healing and regenerative processes (3).

How does hydroxyapatite in toothpaste work?

To understand how hydroxyapatite toothpaste protects your teeth, it helps to know how tooth damage occurs in the first place. Two common types of damage are dental caries, also known as cavities, and erosive tooth wear. Though they may look similar at first, they have different causes.

• Erosive tooth wear is typically caused by exposure to acids from non-bacterial sources, such as citrus fruits, carbonated drinks, or gastric acid from a condition like acid reflux (4).

• Cavities, on the other hand, are caused by acids produced by bacteria in the mouth (5). When oral bacteria digest sugars and carbohydrates in dental plaque, they create an acidic environment that strips calcium and phosphate from tooth enamel—a process known as demineralization (6).

If demineralization progresses without intervention, it can lead to sensitivity, discoloration, infections, or even tooth loss. Since enamel cannot regenerate organically, restoring lost minerals requires outside support. This is where ingredients like fluoride and hydroxyapatite play a critical role (6).

A form of hydroxyapatite called nano-hydroxyapatite, or nHA, is commonly used in toothpaste. While there is currently no single standard for what qualifies as “nano” HA, the dental industry broadly identifies it as a type of synthetic HA with a micro-crystalline structure. It not only helps prevent plaque but also fills in tiny areas of mineral loss on the tooth surface. In doing so, it restores strength to enamel and helps reverse early signs of decay. Several studies comparing nano-hydroxyapatite and fluoride have shown that nHA can remineralize teeth just as effectively—and in some cases, even more thoroughly—than fluoride-based products (6).

Hydroxyapatite vs. fluoride

Most of us are more familiar with fluoride, which has long been an effective staple in anticavity toothpastes. Like hydroxyapatite, fluoride helps remineralize enamel and reduce decay. However, there are some key differences worth noting.

Fluoride doesn’t contain calcium or phosphate itself. Instead, it works by drawing these minerals from saliva and forming a protective substance called fluorapatite, which bonds to weakened areas of enamel. This process has been proven effective, but it depends on the availability of minerals in the mouth and doesn't always lead to deep remineralization.

Hydroxyapatite, by contrast, supplies calcium and phosphate directly. Because its composition mimics that of natural enamel, it can easily integrate into the tooth’s structure. In some recent studies, HA-based toothpaste has shown the ability to remineralize a bit more thoroughly than fluoride, reaching deeper layers of damaged enamel rather than only rebuilding the surface (1,7), however more testing would be necessary to fully understand the conditions impacting the remineralization effects of HA vs. fluoride.

What other benefits does hydroxyapatite toothpaste offer?

In addition to remineralization, hydroxyapatite may offer several other oral health benefits. Research from the University of Toronto in 2021 found that HA toothpaste produced noticeable whitening effects, something fluoride alone does not offer (8). It also appeared to reduce symptoms of dentin hypersensitivity, which is a common issue for many adults.

Other studies have shown that hydroxyapatite may help reduce bad breath by limiting the growth of certain bacteria, especially when combined with complementary ingredients like zinc or silver (9). This is why you’ll often see zinc citrate or nano-silver listed in HA toothpaste formulations. These additions help improve oral health without the need for strong antibacterial agents that might disrupt the natural balance of the mouth.

Is hydroxyapatite toothpaste safer than fluoride toothpaste?

While fluoride remains a safe and effective ingredient when used as directed, its safety profile has some limitations—especially for young children who are more likely to ingest it. Ingesting too much fluoride can cause intestinal discomfort, and over time, contribute to conditions like dental fluorosis, which causes white or brown discoloration of teeth, or skeletal fluorosis, which can lead to stiffness and pain in bones and joints (10).

Hydroxyapatite, on the other hand, has not been associated with any concerning side effects (11); in fact, one of its admirable properties is its high level of biocompatibility (12). This means that it’s non-toxic to the human body overall, does not harm cells in the mouth, and causes minimal inflammatory responses.

Another often-overlooked distinction is that fluoride’s antimicrobial action can affect both harmful and helpful bacteria in the mouth. While reducing decay-causing bacteria is beneficial, fluoride’s broad action may unintentionally disrupt the balance of oral microbiota, which play an important role in digestion and immune defense.

One of hydroxyapatite’s benefits, fortunately, is its lack of antimicrobial properties (12). Especially when paired with zinc, hydroxyapatite has shown the ability to prevent the formation of plaque while protecting helpful mouth bacteria. It also has been shown to reduce symptoms of gum diseases like periodontitis and gingivitis, such as bleeding and inflammation. This is thought to be because it hinders bacteria from sticking to the enamel and other surfaces in the mouth.

Can I buy hydroxyapatite toothpaste?

While it may be tougher to find in retail stores, you can easily buy hydroxyapatite toothpaste online. There are many popular brands now which have been well-reviewed. Hydroxyapatite is also appearing in mouthwashes, tooth gels, and even tube-free tooth powders and tablets. However, before using any product containing hydroxyapatite, you should always consult an oral care professional to determine whether hydroxyapatite is a good fit for you. 

At Himed, we’ve supplied biomaterials like hydroxyapatite for more than three decades. We’re excited to see this safe, effective compound being used to support healthier, more resilient smiles—and to give people more options when it comes to their daily oral care.

References

1. Clinical evidence of caries prevention by hydroxyapatite: An updated systematic review and meta-analysis

2. Human Tooth: Wikipedia

3. Hydroxyapatite: A journey from biomaterials to advanced functional materials

4. Dental erosion (Erosive tooth wear)

5. Cavities and tooth decay

6. Advanced non-fluoride approaches to dental enamel remineralization: The next level in enamel repair management

7. The use of hydroxyapatite toothpaste to prevent dental caries

8. University of Toronto researchers show effectiveness of fluoride-free hydroxyapatite toothpaste

9. Hydroxyapatite in Oral Care Products—A Review

10. Fluorosis

11. Nano-hydroxyapatite in oral care cosmetics: characterization and cytotoxicity assessment

12. Hydroxyapatite in Oral Biofilm Management

NOTE: Every effort has been made to ensure the accuracy of the information shared in this post at the time of publication. This content is not intended as medical advice and should not be used in place of consultation with a qualified healthcare provider. If you believe any part of this post is inaccurate or could benefit from an update, please contact us.

OLD BETHPAGE, NY, and VIENNA, AT | May 29, 2024 – Himed (www.himed.com), a leading manufacturer of bioceramic materials, and Lithoz (www.lithoz.com), a pioneer in ceramic 3D printing equipment, are pleased to announce the launch of a new Bioceramics Center of Excellence™ (BCoE) at Himed's New York headquarters. The BCoE will offer a holistic approach to R&D using bioceramics for medical device manufacturers, integrating various analytical services to support the rapid prototyping process.

The launch is timely: increased global life expectancy has spawned a larger demand for bioceramic materials in healthcare and dental care—primarily in the form of implants—and the global bioceramic industry is expected to reach USD 10.2 billion by 2028. Bioceramic materials are the next frontier of regenerative therapies that promote osseointegration, the body’s natural process for healing hard tissues and developing healthy new bone.

With the launch of the BCoE, Himed is extending its capabilities into rapid prototyping and expanding its offerings for medical device manufacturers. The center will provide a comprehensive suite of services, including design support and optimization, SEM imaging, material analysis and characterization, biomaterial customization, and bioceramic 3D printing using a Lithoz CeraFab S65 Medical printer. The company aims to promote the development of innovative manufacturing processes for bioceramic materials and help customers explore new compositions and manufacturing techniques that may have been previously out of reach for some companies.

The BCoE will particularly benefit medtech startups and other businesses looking to cost-effectively prototype and optimize designs that use bioceramics. Himed's President, Craig Rosenblum, explains: "Before investing in a medical 3D printer, companies can effectively lease time on one, along with the support and materials expertise of Himed's engineers and scientists. They'll pay a fraction of the cost of either purchasing a printer or coordinating research and analysis through multiple vendors. Himed will support them from concept through optimization, and at the end of the R&D process, they'll have a clear path for scaling up production."

This milestone follows the strategic partnership announced last year between Lithoz and Himed. The partnership, a testament to the companies' shared vision and commitment to innovation, outlined plans for an R&D collaboration to design new bioinks for use in Lithoz's ceramic medical-grade 3D printers using Himed’s materials, setting the stage for the BCoE's future success. 

"Lithoz's technology is unlike anything else out there—they've solved some meaningful challenges in this field, and their printers can take you from concept all the way through production. That's going to open up new avenues for invention in implant design," says Dana Barnard, CEO of Himed. “Both companies also recognize that while developments in imaging and printer technology are critical to moving the additive bioceramic industry forward, materials knowledge is an essential piece of success, and that's where Himed fits in. We want the BCoE to be a platform where medical device manufacturers can easily access the latest bioceramic technologies and analytical services to develop visionary products that improve patient outcomes." 

Says Johannes Homa, CEO of Lithoz: “This new Bioceramics Center of Excellence will open up a new chapter in 3D-printed medical applications for North America—with the combination of Himed’s experience and Lithoz’s technology, new applications will certainly be enabled which are currently unthinkable.”

About Himed: Since 1991, Himed has been on the vanguard of bioceramics characterization. With an all-in-one research and production facility in New York, Himed supplies raw calcium phosphate biomaterials for a wide array of uses and provides tailorable, biocompatible coating and texturing solutions with their MATRIX® line of surface treatments. Himed is FDA registered and ISO 13485:2016 certified.

Contact: Kaelie Barnard | Dir. Marketing, Barson Corp.
press@barson.group | +1 (516) 712–6050

About Lithoz: Lithoz is the world and technology leader for high-performance ceramic materials and 3D printers. Founded in 2011, Lithoz is committed to breaking the boundaries of ceramic production and supporting customers in expanding the manufacturing opportunities for the ceramic industry. The company has an export share of almost 100%, nearly 150 employees, and 4 different sites worldwide. Since 2016, Lithoz has also been ISO 9001-2015 certified.

Contact: Alice Elt | PR Manager, Lithoz
aelt@lithoz.com | +43 660 1563

Old Bethpage, NY – Himed, a biomaterials manufacturer and pioneer in surface enhancements for medical implants in the dental and orthopedic markets, today announced a strategic leadership transition effective January 1, 2024.



Craig Rosenblum has been appointed as the new President of Himed. He succeeds Ed Garofalo, who will be transitioning into the advisory position of President Emeritus. 



Rosenblum’s guidance has helped propel Himed to achieve remarkable milestones and solidified its position as an industry leader in biomaterials for medical devices, leading to his promotion. Having joined the company in 2015, he has seamlessly transitioned through three distinct roles, culminating in his current position as Vice President and General Manager. Rosenblum holds a B.S. and M.S. in Materials Science & Engineering with a Biomaterials concentration from The Johns Hopkins University. His visionary leadership and deep understanding of biomaterials will undoubtedly drive Himed to new heights in the biomedical engineering field.  

After more than three decades at the helm, Himed’s esteemed co-founder Ed Garofalo will 
continue providing invaluable support to the company as it enters its next phase of growth. This transition reflects Garofalo's dedication to Himed's ongoing success. Says Garofalo, “It’s very gratifying to see innovations we made decades ago positively impacting the efficacy of various medical devices around the world. In the early 1990's calcium phosphates like hydroxyapatite were not being widely used, but now they factor significantly into all kinds of implants. I’m grateful that I can continue to contribute meaningfully to Himed’s future development, even as I pass along the responsibilities of daily leadership.”

Himed's ongoing success is a reflection of a customer-centric culture that Ed Garofalo championed from the beginning. Rosenblum states, “Ed has always focused the company on meeting specific customer needs. To this day, we listen deeply to the biomaterial problems our customers face and are committed to finding tailored materials solutions to support their goals.”

Rosenblum sees 2024 as a year for focusing on Himed’s newly formed research partnerships and enhancing analytical service offerings through expanded on-site testing and prototyping capabilities. “As we embrace the possibilities of technology and innovation, we recognize the pivotal role that biomaterials play in shaping healthcare. Himed is committed to producing high-quality solutions that help the body heal,” he says. “I intend to foster an environment that encourages groundbreaking research and collaboration. Ed has proven that if we stay focused on the needs of our customers, they will stay committed to Himed for decades.”

About Himed: Since 1991, Himed has been on the vanguard of biomaterial coating characterization. With an all-in-one research and production facility in New York, Himed supplies raw calcium phosphate biomaterials for a wide array of uses and provides tailorable, biocompatible coating and texturing solutions with their MATRIX® line of surface treatments. Himed is FDA registered and ISO 13485:2016 certified.

Contact: Kaelie Barnard | Dir. Marketing, Barson Corp. 
press@barson.group | +1 (516) 712–6050

ASK A BIOMATERIALS SCIENTIST offers real-world insights into questions about medical biomaterials like hydroxyapatite, β-TCP, and other calcium phosphates. Have a question you’d like answered in a future post? CONTACT US

There is no single form of hydroxyapatite (HA, or HAp) that is used universally for all applications, so the short answer is no.

But that doesn’t mean that you can’t find a suitable equivalent, or even a better form, based on your intended application. With so many uses now for hydroxyapatite across a wide range of industries, it’s safe to assume that every company has unique needs and requirements that must be met when sourcing a new vendor.

If you’re considering a change in biomaterials suppliers, the steps below offer a logical methodology for identifying the key qualities of the material you’re trying to match. With that information, you’ll be able to more clearly convey your needs and get the results you want from a new provider.

STEP 1: Understand the Composition of What You’re Trying to Match

COMPOSITION

When sourcing a raw biomaterial, you’re going to begin by looking at the composition of what you’ve been using. Is it 100% HA? Well, that probably means >95% HA, with the other approximately 5% being composed of other calcium phosphate phases and trace elements. Maybe you’ve been using a mixture of HA and β-TCP (beta tricalcium phosphate, or b-TCP)? That’s a mixture we see a lot for bone repair applications due to the bioresorbable nature of β-TCP. The composition of your current material should be documented clearly on a product specification sheet provided by the manufacturer.

At Himed, we have detailed specification sheets for all of our raw biomaterials, and this is often the first request a company makes when exploring whether they want to work with us, because they want to compare compositions.

PARTICLE SIZE & DISTRIBUTION

Particle size is another important property to identify when trying to match a biomaterial like hydroxyapatite. You may already have a very specific use for this material and be applying it in a very specific manner—a dramatic change in particle size can wreak havoc on the systems you’ve carefully calibrated, so it cannot be disregarded as a factor. That being said, comparing particle size isn’t always apples to apples:

Let’s say the powder you’re using is indicated as 100-300 microns. But in reality, it’s not going to be 100% 100-300 microns—there’s a distribution. Characterizing that distribution might be key to getting good results from another supplier’s powder of a similar particle size. The closer you can get that distribution to match, the less likely you are to run into performance problems and surprises when applying powder from a new supplier within your current systems.

SHAPE & SURFACE AREA

The final composition factor that can be helpful to understand is the actual shape of the particle you’re trying to match. Most people can’t immediately discern huge differences in the qualities of powders milled to equivalent sizes when looking at them with the naked eye. So if you look at something under a microscope, is it a gravel-shaped particle? That means it has hard edges. Or maybe the particles are lumpy with lots of tiny voids? That’s a material that has a much higher surface area.

Those differences in shape can have a big impact on factors like osteoconductivity or the in vivo dissolution rate of a material. The surface area of the powder can be measured using BET Nitrogen sorption. However, to visualize the particle shape requires viewing physical powder samples with a scanning electron microscope (SEM). That can be an involved process, which is why we’ve opted to put SEM images of our biomaterials directly on our specification sheets so that anyone who requests them can immediately see the shape and surface structure on the particles for each material.

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Just imagine that you’re a cell, and you want to attach to a surface. Cells usually like things with surface roughness and texture. It gives them more places to attach by providing little crevices where they prefer to grow. Materials with this type of surface have an overall higher surface area.

Consider this too: a different surface area will change how a material mixes. For example, if you’re mixing a biocompatible powder with a polymer to make a bone putty, that surface area of the powder will change the mixing behavior, uniformity, and the particle retention of the biocompatible phase in the biocomposite. The biocompatible powder particles exposed on the surface encourage cell attachment and osteointegration.

Hydroxyapatite is similar to the mineral component in natural bone, and its ability to promote osteointegration is one of the biggest reasons it’s being used so much in dental and orthopedic implants, but there’s a lot of variety across hydroxyapatites (see the above image), and those variations have real effects on cellular adhesion and bone integration.

In short, conducting a basic analysis of the physical properties of the biomaterial you want to match is a good starting point when sourcing a new supplier. The next step is to try and understand how that biomaterial is manufactured.

STEP 2: Clarify the Method of Manufacture

How hydroxyapatite and other calcium phosphates are manufactured has a direct impact on their physical properties and potential applications. Knowing whether a powder you’re trying to match was manufactured using a high-temperature sintering process or a precipitation process could help eliminate another variable, and it could speed up the testing process for a replacement material.

If the specification sheet you have from your current supplier doesn’t provide the method of manufacture, take a look at any past Certificates of Analysis that you may have received for the material. Sometimes that information can be found there.

Many suppliers aren’t particularly open about their method of manufacture. At Himed, we’ve opted to put that information front and center on our specification sheets, but other companies can treat it like a trade secret. Thankfully, there are some observable properties and basic tests that can be conducted by companies like ours which help reveal this bit of information if you can’t find it elsewhere.

STEP 3: Communicate Directly with the Technical Team of a Potential Supplier

As a matter of efficiency, nothing beats having a direct conversation with a member of the potential supplier’s technical team or leadership. In some cases, it’s hard to even get specification sheets by which to compare materials without taking this step. Frankly, it’s just a good thing to do early on in the process of evaluating another supplier. The company you select might end up being a business partner for decades, and you want to get a sense of who they are, what they value, and how they behave right away to see if they’ll be a good fit.

Be candid about the product you’ve been using and what specific performance parameters you’re seeking from a replacement. Share as much about the composition of the biomaterial as possible so that the potential supplier can quickly determine whether or not they could even match it. The more information provided, the more forthcoming they can be about what is similar, or different, about their material. If you require an NDA before discussing anything in detail, just say so and provide it so that the dialogue can move forward with clear understandings.

At the end of the day, there’s an important human element to any business relationship—if you’re seeking a material that’s critical to your success, then clear communication, reliability, and trustworthiness cannot be overstated. If a supplier can deliver on those things, that has a real financial value that should factor into any cost analysis you do.

STEP 4: Test Samples Within Your Existing Systems

If you reach a point where you believe a supplier could provide a good equivalent—or better alternative—to the material you’re currently using, then it’s time to begin testing. Order a small quantity and test it in your process. Then do that again many times, ideally using different batches of the sample material from the potential vendor each time so that you can compare results.

You’ve likely already optimized the system that will be using that material to produce a specific product or outcome—testing allows you to identify how good a fit the replacement material might be. The more it performs like what you’ve used before, the less you’ll have to adjust a process that already works. Testing samples from different lots/batches of the same material, and assessing the consistency of the results, can reveal how uniform the quality of the material actually is from the potential supplier. Consistency of performance is key!

Speaking from experience, powders can be really tricky. Even slight changes in composition are capable of creating significant disruptions in pre-existing systems. It’s critical to find a new supplier that is willing to understand your production methodologies and intended outcomes. They should be able to offer material solutions that match the scale at which you’re operating—adjusting powders for optimum flowability if your production volumes are high, for example. They should be able to identify the differences that might be needed according to your final objective: after all, a hydroxyapatite powder for a plasma spray coating is very different from the hydroxyapatite that will be part of the bioink used to 3D-print a spinal implant.

Seeking Help with Biomaterial Characterization

At this point, you might be wondering whether it’d just be easier to have a sample of the current material professionally analyzed before beginning the process of sourcing other potential suppliers.

For companies with large in-house scientific teams and the right equipment, perhaps not. But at Himed, we receive many such requests from start-ups to midsize companies precisely because we have a lab space specifically designed for such material characterization—not to mention a 30+ year focus on customizing biomaterials.

We understand the various outcomes people are seeking from these materials because we manufacture and customize them for companies around the world. If you’d like to explore having Himed’s help, just contact our technical team:

Without question, adding a new materials supplier requires time and effort if it's done correctly. Clearly understanding the qualities of the material you want to source, and the outcomes that material is intended to elicit, are the most important pieces of data you’ll need. If a potential supplier isn’t interested in those details, talk to someone else!

Himed has entered a new realm of research this month with the formalizing of a research and development agreement with Santa Fe, NM-based Mercury Bio.

As a global supplier of calcium phosphate materials and implant surface treatments that support bone repair, Himed wishes to explore the frontiers of organic CaP integrations at the molecular level, and was seeking a partner with promising IP for small particle delivery. We were fortunate to find that partner in Mercury Bio, which has developed a novel advanced drug delivery system that could prove effective at also loading and targeting CaP compounds.

For more information, please see the entire press release below.

SANTA FE, N.M., July 13, 2023 - Mercury Bio, (www.mercurybio.com) a Santa Fe, NM-based biotech company working in the area of drug delivery, has entered into a joint research, development, and licensing agreement with Old Bethpage, NY-based Himed (www.himed.com), a leading producer of bioceramics and biocompatible surface treatments for medical and dental implants. The two companies aim to develop a unique osteogenic material to be used in applications like bone cements, coatings for implantable devices, and many more.

Mercury Bio’s new yEV technology harnesses natural extracellular vesicles (EVs) and engineers them to carry specific RNAs and small-molecule drugs, such as the protein BMP-9, to targeted cells. These allogeneic particles, when loaded into an organic calcium phosphate (CaP)-based scaffold created by Himed, will elute at desired rates into the surrounding tissue to promote bone healing and growth.

Himed, which also announced a partnership this week with medical 3D printer manufacturer Lithoz, is looking to strategic collaborations to design new approaches to healing using calcium phosphates. CEO Dana Barnard says, “These are exciting times—this agreement marks Himed’s debut into organic materials, building on our long history of supplying top-level bioceramic materials and services to device manufacturers. Mercury Bio’s technology is completely innovative—we think this collaboration has great potential and could chart new directions in bone repair.”

Calcium phosphates, particularly hydroxyapatite (HA) and tricalcium phosphate (TCP), are natural minerals that compose about 70% of bone. While they’ve been utilized in bone repair since the 1920s, their use in implantable devices and bone putties has grown rapidly over the last few decades as a way to accelerate hard tissue healing at implantation sites. Owing largely to the world’s aging population, orthopedic surgery is now one of the fastest-growing surgical categories—thus, improving surgical outcomes and shortening recovery times is critically important for patients and their providers.

Mercury Bio’s CEO, Bruce McCormick, believes that layering these technologies will yield dramatic benefits for device implants and other bone surgeries: “Loading yEVs with BMP-9 and infusing them into bioactive coatings will provide a highly targeted, controlled release of bone morphogenic protein, which may dramatically speed up healing and reduce the risks of complications from long recoveries after surgery. We’re excited to work with a world leader in calcium phosphates to bring the potential of advanced yEV drug delivery to the orthopedic field.”

About Mercury Bio: Sparked by scientific breakthroughs in genomic research, Mercury Bio is developing a next-generation biomolecular drug delivery platform. Using a novel system for drug encapsulation in natural nanoparticles, their technology enhances drug potency while simultaneously reducing side effects and employing cell-specific targeting not feasible in artificial drug encapsulation systems. The result is a next-generation drug delivery system in a scalable, low-cost production platform that will unlock the potential of new therapies and shift the paradigm in drug delivery. For those interested in learning more, Mercury Bio’s Chief Scientific Officer, Dr. Richard Sayre, will be delivering a review of the company’s new technology at the mRNA-Based Therapeutics Summit in Boston on July 27th.

About Himed: Since 1991, Himed has been on the vanguard of biomaterial coating characterization. With an all-in-one research and production facility in New York, Himed supplies raw calcium phosphate biomaterials for a wide array of uses and provides tailorable, biocompatible coating and texturing solutions with their MATRIX® line of surface treatments. Himed is FDA registered and ISO 13485:2016 certified.

Companies seek to enhance medical-grade bioceramics for implants using biocompatible calcium phosphates.

OLD BETHPAGE, NY, July 11, 2023 - Advancing 3D-printed medical implants depends on the steady progress of leading-edge printer technologies, as well as the skillful development of the raw materials used in those technologies. Appreciating that these crucial factors must work together, Himed (www.himed.com), a New York-based biomaterials manufacturer serving dental and orthopedic implant markets worldwide, and Lithoz (www.lithoz.com), a global market leader in 3D printing based in Austria, have teamed up to develop new bioceramic feedstocks. They’ve begun a long-term strategic Materials Research Partnership Agreement to explore novel integrations of Himed’s calcium phosphate (CaP) biomaterials with Lithoz’s proprietary ceramic binder used in their innovative CeraFab S65 medical 3D printer.

Over the last thirty years, calcium phosphates like hydroxyapatite have gained widespread use in implantable devices, bone putties, and grafting materials for their similarity to natural bone, and can aid the organic regrowth of hard tissue at the implantation site. Since 1991, Himed has collaborated with different medical implant manufacturers to develop and optimize various CaP powders and surface treatments for osseointegration. The partnership with Lithoz, however, allows new opportunities for Himed in the medical additive manufacturing market beyond bioactive surface treatments and post-processing of implants. Himed’s CEO, Dana Barnard, explains:

“Himed understands CaP optimization and how to scale it for a growing market. We’ve refined many calcium phosphates to strengthen their healing potential, but most of these were targeted toward surface coatings on traditionally manufactured titanium implants. Lithoz’s remarkable 3D printing technology allows a whole new direction for our products, in which we can use CaP to its greatest advantage—as a biomimetic material within the implant structure itself that can be replaced by a person’s own natural bone over time.”

For Lithoz, this partnership grants opportunities to build upon the success of their LithaBone product line—a printable bioceramic that leverages the resorbable and osteoconductive qualities of hydroxyapatite (HA) and tricalcium phosphate (TCP) for medical applications. Collaborating with Himed is the next logical point in the large-scale commercialization of this highly specific technology, and together the two companies form a powerful international pool of researchers capable of advancing the functional benefits of osteoconductive bioceramics. The partnership also allows the two groups to explore how other CaP formulations might enhance the highly sophisticated biomimetic forms Lithoz printers can produce. Dr. Johannes Homa, Lithoz’s CEO, says: “This is definitely a big milestone for our partnership, and just a first starting point for a mutually beneficial collaboration for additive manufacturing of bone replacement.”

Initial research will occur at Lithoz’s U.S. location in Troy, NY this summer by a joint team of materials scientists. In early fall, Himed will install a new Lithoz CeraFab S65 printer at their 25,000 sq. ft. facility in Long Island, allowing for swift on-site experimenting and analytical testing. It will also broaden their R&D services to include rapid prototyping of different forms for Himed’s clients to conduct unique biomaterials research. 

Ultimately, both companies believe there’s still much to discover about developing CaP materials to augment the performance of 3D-printed implantable forms. This strategic partnership represents a first step in expanding the range of biocompatible materials suitable for a future of highly customized, patient-specific medical solutions that can be printed on demand.

_____

About Himed: Since 1991, Himed has been on the vanguard of biomaterial coating characterization. With an all-in-one research and production facility in New York, Himed supplies raw calcium phosphate biomaterials for a wide array of uses and provides tailorable, biocompatible coating and texturing solutions with their MATRIX® line of surface treatments. Himed is FDA registered and ISO 13485:2016 certified.
Contact: Kaelie Barnard | Dir. Marketing, Barson Corp.
press@barson.group | +1 (516) 712–6050

About Lithoz: Lithoz is the world and technology leader for high-performance ceramic materials and 3D printers. Founded in 2011, Lithoz is committed to breaking the boundaries of ceramic production and supporting customers in expanding the manufacturing opportunities for the ceramic industry. The company has an export share of almost 100%, almost 150 employees and 4 different sites worldwide. Since 2016, Lithoz has also been ISO 9001-2015 certified.
Contact: Alice Elt | PR Manager, Lithoz
aelt@lithoz.com | +43 660 1563

In particular, additive manufactured implants benefit from post-processing to remove residual beads present on the implant as a result of the 3d printing process. If left untouched, these beads can potentially become dislodged upon packaging, or after implantation.

In the scanning electron microscope (SEM) image above of a lattice matrix on a 3D-printed Ti64 spinal spacer, the presence of these loosely adherent residual beads is obvious. They can even be seen on the surfaces of the internal cavities. Other imperfections, in the form of flattened areas on the exterior surface, are likely points at which the implant contacted the printer’s build plate.

While titanium is specifically employed in the design of many medical implants because of its biocompatibility, a detailed understanding of the physiological effects from dislodged Ti particles has yet to be comprehensively studied. Until such research is conducted the logical solution is to apply a safe and effective post-processing methodology to remove the residual beads. Doing so yields aesthetic improvements as well, like eradicating visible layer lines and the surface abnormalities which can result from contact with the build surface. However, there are limited options for such post-processing, and only one that can consistently provide a uniform surface texture to Ti and Ti-alloy implants without introducing different residual contaminants to the surface in the process.

Adding Benefit, Not Residue, When Post-Processing Additive Manufactured Implants

Abrasive grit blasting has long been a staple of industrial manufacturing applications, with aluminum oxide (or alumina) of differing particle sizes commonly employed on a variety of metals and metal-alloy surfaces because of its extreme hardness (9 on the Mohs scale). However, while conventional grit blasting via aluminum oxide may effectively remove residual beads, these abrasives are notoriously brittle. During application, small pieces or shards will become embedded in the surface of the softer titanium. The embedded particles are insoluble in acids, so removing AI2O3 contamination via ultrasonic bath immersion is not possible.

ALUMINUM OXIDE ABRASIVE BLASTING

This raises the question: are embedded grains of aluminum oxide any more, or less likely, to shed in vivo as the loosely adherent titanium beads they removed? Further study would be necessary to make an accurate assessment of that possibility.

As the SEM images above show, a significant amount of new residual material results from aluminum oxide blasting, and an EDX spot analysis confirms that the implant’s surface can no longer be classified as purely Ti in composition.

A more recent abrasive blasting option are glass beads. These contain less aluminum oxide overall, but are effective at removing surface abnormalities from a 3d-printed Ti or Ti-alloy implant, even with a much lower Mohs rating of approximately 5.5.

GLASS BEAD ABRASIVE BLASTING

Nevertheless, like conventional aluminum oxide abrasives, the glass beads can shatter upon contact with the implant surface—thereby introducing new particulates into the Ti which cannot be fully eradicated through passivation. Spot test analysis via EDX of these particles predictably reveal less aluminum but more silicon. And the reduction of pure Ti surface area due to the addition of glass bead fragments.

Fortunately, Himed developed a micro-abrasive material nearly 30 years ago that is ideally suited to post-processing the 3d-printed implants of today. It is completely soluble, and leaves behind no trace residue following ASTM F86 passivation. Originally conceived to provide a uniformly textured surface to Ti dental implants prior to a coating of hydroxyapatite, this apatitic abrasive offers an ideal solution for the post-processing of 3d-printed implants of all shapes and sizes.

Biocompatible Post-Processing That Adds an Optimized Surface Texture for Osseointegration

MCD Apatitic Abrasive is a calcium phosphate abrasive, principally composed of hydroxyapatite and tricalcium phosphate. It is formulated to be as hard as possible, and can obtain a Mohs hardness rating of up to 5. Available in a wide variety of sizes ranging from 425 μm, the appropriate granular size may be chosen so that media can effectively reach internal porous surface cavities to create a uniform surface roughness (Ra). While notably less hard than aluminum oxide, it is only slightly softer than many commercially available glass beads. Nevertheless, it is still capable of refining Ti and Ti-alloy within a Ra range of 1.0μm–3.2μm through adjustments in particle size, blast pressure, duration, and distance. Furthermore, its gentler contact with the implant surface means that critical tolerances and shape details within the original design are preserved.

APATITIC ABRASIVE BLASTING

As evidenced in the SEM sequence above, the implant surface following micro-abrasive blasting with MCD apatitic abrasive presents a textured Ti topography on both the external and internal implant surfaces. Unlike with aluminum oxide grit or glass beads, there is no evidence of any residual contaminant after passivation that might inhibit biological fixation or shed in vivo.

Over three decades, Himed has refined the application of MCD apatitic abrasive to meet the exacting standards of a wide variety of orthopedic and dental implant designs. Comprehensive analysis of the post-processing results possible via MCD apatitic abrasive are available as free white paper downloads via the button below.

There is no question that the emergence of additive manufacturing technologies into the medical and orthopedic fields has been transformative, advancing device intricacy and performance while offering patient-specific solutions. Himed is pleased to offer a solution to the complex challenges of post-processing this new generation of intricate 3d printed devices…even if we arrived at that solution a quarter-century before 3d printing was a viable technology!

Last Updated: 04/18/2023

There are many industry events in the medical device sector, and Himed makes it a point to attend a number of these annually to connect with clients in both the dental, and orthopedic, markets.

Sometimes our scientific teams simply attend the events to keep up-to-date on technology impacting medical device manufacturing, but more often we exhibit at these events so that we can show samples, share our white papers, and listen to the needs of those working to optimize implantable healing technologies.

This past week we put together an EVENTS page on our website that gives a quick glance of all the places Himed will be in 2023. On that page you can also see past events we participated in, including industry webinars where Himed presented. We’ll be updating this new EVENTS page regularly as we commit to more trade shows and presentations during the year.

Want to schedule an in-person meeting with Himed at a 2023 event? Or perhaps a visit at your business near one of the cities an event takes place? Just fill out the quick meeting request form via the button link below:

Himed’s Confirmed 2023 Trade Show Event Details

EXHIBITOR - American Academy of Orthopedic Surgeons Annual Meeting (AAOS 2023)

The very first trade show Himed will be attending in 2023 is the American Academy of Orthopaedic Surgeons (AAOS) 2023 Annual Meeting in Las Vegas, Nevada from March 8–10.

Having never exhibited at an AAOS event before, we are especially excited to share more with the members there about the implant surface customizations Himed has developed over the past decades as part of our MATRIX® line. We’ll be exhibiting at Booth 3906, showing samples of both surface treatments and various biomaterials, including our proprietary bioresorbable apatitic abrasive, which creates a highly-textured surface topography on titanium (and Ti-alloy) implants, without the potential for residual contaminants that can occur with conventional sandblasting and acid etching methodologies.

EXHIBITOR - Society for Biomaterials (SFB 2023)

Our team really appreciated the in-depth materials questions that were raised and discussed during our time exhibiting at SFB2022, so we’re very excited to return in 2023 (and to visit beautiful San Diego, CA). The scale and focus of this event make it an excellent place to connect directly with other biomaterials researchers. We encourage anyone new to the SFB event to chat with us at Booth 503—we’ll have copies of our white papers, and some other great gifts, to share with you.

PRESENTATION - CRAIG ROSENBLUM LECTURE AT RAPID+TCT

RAPID+TCT is the largest additive manufacturing event in North America, and Craig Rosenblum, Himed’s VP & General Manager, has been invited to deliver a presentation about the post-processing of 3d-printed titanium medical devices using MCD apatitic abrasive. The presentation occurs on May 3, at 3:00pm CST in Room W178a. Registration to RAPID+TCT is required.

ATTENDING - Orthopedic Manufacturing and Technology Exposition & Conference (OMTEC 2023)

One of the best annual events to target orthopedic medical device design and production, OMTEC offers a comprehensive view of current innovations and trends in a market that is estimated to grow to approximately $57.7 billion globally by 2030. This year the event is being held in Chicago, IL. Members of our research team will be attending as part of their annual professional development program, and are available to connect with current and prospective clients who are also in attendance.

EXHIBITOR - BIOMEDevice 2023

With a diverse range of exhibitors and presenters from the biomedical device market, BIOMEDevice can be a key show for OEMs who are seeking to broaden (or update) their pool of contract manufacturers for critical materials, processes, or components. As a company that offers a variety of post-processing services suitable for both 3d-printed and conventionally milled/cast implantable devices, BIOMEDevice helps us share how we can reduce an OEM’s supply chain through multi-step in-house post-processing that easily scales as product demand increases. Curious to learn more? Then come and visit us in Boston, MA at Booth 1030, or request a private meeting via the form above.

You actively maintain the information on our website, so you can check back here, or at our EVENTS page, throughout 2023 to see new events we’ll be attending and webinars we’ll be offering.

Here at Himed, we just added a new member to our team of robots. We call it iFAB (short for “fully automated blaster”). It’s a highly-dexterous, automated industrial robot with six-axes of motion, that is contained within a new production cell. The iFAB has been specifically designed to deliver our biocompatible MATRIX MCD® treatment to medical devices, dental implants, and orthopedic implants.

The automated cell has a significantly larger chamber than we’ve created in the past, a more agile articulated arm, and is a key addition to our capabilities. It means we’ve not only upped our capacity for post-processing medical devices and implants for our customers, it also means we can more quickly handle surface optimization for larger orthopedic devices.

Meeting the needs of medical device designers — through rigorous validation

With our growing customer base, plus the expanding market for implants in general (and 3D-printed implants in particular), our team needed a way to handle the finishing processes for a wider variety of implantable medical devices. But we couldn’t just pick a robot out of a catalog and plug it in. 

First, our engineers selected an ABB industrial robot that could be customized to become our newest blaster. After designing, fabricating, and implementing the necessary modifications, our work was only half done…next came validation. 

For over thirty years, our validation process has been a critical step in everything we do. We take it seriously and are proud of the fact that we are FDA registered and ISO 13485:2016 certified for the "design of surface texturing/coating for dental and orthopedic implants and biomaterials manufacturing, including special processes." Each time a new customer approaches us with a customized request, we have a rigorous validation process to ensure every specification can be met.

To confirm the new automated cell was up to our standards, we began the process of testing the machine on a variety of parts representative of implant designs that commonly receive our MATRIX MCD® and MATRIX Dual® apatitic abrasive blasting processes. Everything from surface screw threads to the inner chambers of porous 3d-printed matrices were blasted with our soluble MCD using a variety of parameters. We verified the results, then did it all over again. Through a months-long process of blasting, analyzing, and recalibrating we’ve finally ensured iFAB’s results are consistent and reproducible. As of December, iFAB is online and ready to fulfill customer requests.

More complex implant designs at larger scales

Modern implants — especially those created via additive manufacturing — are far more nuanced than they used to be. The specialization and complexity of the devices have changed everything from device size to lot size. With iFAB, our entire apatitic abrasive blasting system is now more flexible. A more agile applicator arm means we can tailor our surface finishing process to the minute differences of the part.

The larger blast chamber and chamber door mean we can handle larger orthopedic parts, such as spinal implants, hip components, and more. With most orthopedic devices averaging many times the dimensional parameters of a dental implant, this additional space within the blasting cell is critical to allowing the ABB robot the necessary range of motion. 

And on a very practical level, more space enables the consistent processing of larger quantities of devices without sacrificing quality. When a company is cleared to take a product to market we can rapidly scale up production to meet that additional demand while retaining all the customized input parameters specific to their design.

Keeping lead times short without sacrificing quality

What does our new robot mean for our customers? Not only have we increased our ability to handle larger, more complex, and more customized implant surface finishing, we’re improving on our lead times. We know that over the past few years supply chains and lead times have increased dramatically across the board. But even before the pandemic hit, Himed has always tried to maintain a futuristic viewpoint, upgrading and optimizing in anticipation of our customers’ and the market’s future needs. That viewpoint helped us come out the other end of lockdowns with an expanded customer base and minimal additional lead times. 

Our iFAB is one more way we’re keeping up with growth — while maintaining our uncompromising commitment to quality. If you’d like to hear more about the advanced capabilities of iFAB, we invite you to schedule a call with one of our engineers. 

Bone grafting is a dental, spinal, or orthopedic surgical procedure in which a bone replacement material is physically added to the area of missing bone. The goal of bone grafting is to have the patient’s own bone cells grow into the replacement material over time, eventually creating strong, healthy bone.

What is a synthetic bone graft?  

Bone grafting material comes in many forms and from different sources. Natural sources include the patient’s own body, bone tissue from another human body (usually cadavers), or tissue from an animal. Synthetic bone graft material is manufactured in a lab setting and includes polymers, ceramics, metals, and composites. The most successful synthetic bone graft materials are those substances that mimic and closely resemble human bone scaffolding. These biomaterials are often porous, calcium-based substances such as calcium phosphates. Hydroxyapatite (HA) is a calcium phosphate that’s particularly suited to synthetic bone grafts thanks to its biocompatibility and osseointegration abilities.

Defining common bone graft terminology

Bone graft materials from different sources have specific terminology. Further bone grafting terms refer to the desired biological interaction between bone grafts and the patient’s native bones.  

• Autograft: As the prefix “auto” suggests, an autograft is derived from the self, or the patient’s own body. Typically, a small portion of bone is surgically removed from an area of the body. This area is often the top of the pelvic bone, or iliac crest, but can also come from leg bones (often the fibula), spine, the jaw, and the ribs. 

• Allograft: Since “allo” means other, it makes sense that an allograft comes from another human. Generally this is bone material harvested from living donors, such as patients undergoing a hip replacement, or from cadavers.

• Xenograft: The third natural source of bone graft material comes from animals, quite often from bovines.   

• Calcium Phosphate: A porous, naturally occurring mineral, made up of the same mineral components as bone. As a synthetic bone grafting material, calcium phosphate, is highly biocompatible due to its porosity and compatibility with bone.

• Hydroxyapatite: A highly crystalline calcium phosphate compound that’s well suited to bone grafts and cements. 

• Osseointegration: The root word “osseo” refers to bone. Osseointegration happens when living bone tissue fuses and assimilates with another element, such as an osseointegrated implant. In the case of bone grafts, osseointegration refers to the integration of the grafting material with native bone. 

• Osteogenesis: The formation of bone, which is necessary for bone replacement treatments. 

• Osteoinduction: A process that inspires osteogenesis. Generally, the human body naturally undergoes osteoinduction to repair a damaged bone. In the case of bone grafting, if the grafting materials are osteoinductive they will induce the body to generate new bone tissue. 

• Osteoconduction: A situation in which native bone grows on the surface of another material, such as around an implant. In bone grafting, osteoconduction happens when the bone graft acts as a scaffolding across which new bone cells form, eventually replacing the graft material.
  
  

Autograft vs allograft vs synthetic bone graft material

There are benefits and drawbacks to both natural and synthetic bone grafts. Autografts have the benefit of coming from the patient's own body. Factors such as biocompatibility and osseointegration are greatly improved as the material is not seen as foreign and the chance of disease or pathogen transference from another source is eliminated. However, autografting requires the removal of bone, which can be painful, takes time to heal, and subjects the patient to complications of a second surgery (in addition to the bone graft surgery). The amount of healthy bone tissue that can be removed from the patient’s own body is, obviously, limited. 

Allografts solves most of the drawbacks of an autograft, but comes with its own set of considerations. Allograft material can come from fresh-frozen cadavers or in the form of freeze dried bone matrix. If the tissue comes from a cadaver, the amount that may be harvested is far less limited. A second surgery is also not required.  Compatibility and immunogenic rejection issues can sometimes arise when using bone graft material harvested from another person. Allografts have also resulted in slower osseointegration. 

Like allografts, synthetic bone grafts eliminate the risks of an additional operation on the patient. As a completely sterile material, the risk of introducing human pathogens is completely eliminated, which is a small risk with allografts. Like human bone material, synthetic bone graft material has osseointegration and osteoconduction properties. Bioactive synthetic bone graft materials have been shown to have osteoinduction properties on par with autografts, especially when chemical composition and particle structure are optimized.

Osteoinductive vs osteoconductive 

The end goal for all bone grafting procedures is the regeneration of healthy bone where there had previously been a void, damage, or disease. Both osteoinduction and osteoconduction play a role in this desired outcome, but the terms have slightly different meanings and play different roles in the bone grafting process. 

In the simplest terms, you can think of osteoinduction as the process by which osteoconduction occurs. As mentioned above, complete osteoconduction in bone grafts occurs when the patient’s own bone cells have fully replaced the grafting material with living bone tissue. That can’t happen if the cells surrounding the bone graft material are not inspired to create osteogenic (or bone-forming) cells. Osteoinduction happens because the grafting material, in contact with nearby cells, induces them to create bone cells (as opposed to other tissue) and begin the process of regenerating bone.

As osteoconduction is the goal, it’s extremely important that the bone graft material be capable of osteoinduction. Autograft bone has the benefit of supplying its own osteogenic cells, from the patient’s own body, that lead to osteoinduction. Allograft materials also contribute to osteoinduction as they still contain bone morphogenetic proteins to stimulate bone growth.

Osteoinductive synthetic bone graft materials

Synthetic bone graft materials can be made from a wide variety of materials, including polymers, ceramics, bioglasses, metals, and composites. Critically for osteoinduction, bone graft materials made from calcium phosphate ceramics are bioactive and have the ability to induce cellular responses in nearby tissue. Factors such as porosity, surface chemistry, and surface morphology all have an effect on nearby cells and encourage osteroinduciton and eventual osteoconduction.

As manufacturers of pure, bioactive calcium phosphates, Himed works with members of the orthopedic and dental industries to produce effective bone graft materials to nearly any specification.

1. Excess Material: The existence of loosely adhered beads or excess build material from the printing process 

2. Surface Texture: The necessity to create a uniformly textured surface, either for aesthetic reasons or to support specific biological functions in vivo, such as osseointegration

3. Maintaining Design Parameters: Using post-processing methodologies that avoid damage to the intended final shape of the device

In 2020, Himed published a white paper which addressed how Himed’s proprietary finishing process, MATRIX MCD® could address each of the above issues. MATRIX MCD®, which utilizes a unique apatitic abrasive, has the added benefit of never introducing bio-incompatible materials to the device. 

Below is a synopsis of the white paper which uses data from three case studies to demonstrate how Himed has helped device manufacturers to improve their 3D-printed end product with post-processing. The complete white paper can be downloaded using the request form at the bottom of this post.

The importance of using a biocompatible blast medium 

Decades ago, Himed pioneered the concept of a biocompatible, resorbable blast medium (RBM) when engineers utilized a specially hardened form of hydroxyapatite to finish the surfaces of titanium implants and devices. 

Himed evolved that discovery into its MATRIX MCD® finishing process, which utilizes a granular, multi-phase calcium phosphate abrasive that is engineered to be as hard as possible. Combining the abrasive with an automated blasting system, the process creates complex, highly uniform macro and micro surface texturing on both cast and 3D-printed titanium alloy implants. 

Traditional grit blasting methods utilize media such as aluminum oxide, which can leave behind embedded residue, even after acid bathing or other passivation methods. Unlike traditional grit blasting methods, surface finishing with Himed’s MCD Apatitic Abrasive leaves behind virtually no residue after passivation. And, if for some reason any MCD residue were to remain, it would be entirely biocompatible due to its composition of naturally occurring hydroxyapatite and other calcium phosphates.

In each of the studies below, all test devices were passivated per ASTM F86. This dissolved the soluble MCD Apatitic Abrasive and yielded a virtually residue-free, contaminant- free finish.

CASE STUDY #1

Removing excess beads on the additive build surface 

This first case study focuses on the removal of residual beads from a 3D-printed titanium alloy acetabular cup: a component in an artificial hip replacement system. The cup is additively manufactured with a porous surface that provides initial mechanical fixation and long term biologic fixation. 

In the creation of this porous surface, loosely adherent residual beads remain on the surface as a by-product of the additive manufacturing process. If the beads were to remain on the surface, researchers expressed concern that the titanium beads could become detached from the surface of the cup in vivo, potentially causing complications. 

Himed’s study revealed that grit-blasting with MATRIX MCD® dislodged the beads, while providing the added benefit of further increasing the surface texture to create a more complex surface that could encourage osseointegration.    

CASE STUDY #2

Removing surface abnormalities and defects on the additive build surface 

In additive manufacturing, many devices are printed with a critical surface in direct contact with the additive build platform. Temporary support structures may also be required for more complex printing alignment. Both scenarios are likely to create surface abnormalities, or leave behind trace amounts of build material.

This case study analyzed additive-manufactured titanium alloy spinal spacers. Immediately following manufacture, the face of the implant that was in contact with the additive build platform showed pronounced surface irregularities when viewed under magnification. 

The study subjected the spinal spacers to MCD grit-blasting, analyzing the surface after increasing intervals of time. With increased exposure to the grit-blast process, the surface defects and imperfections were eliminated. The overall surface of the device then showed an optimized, uniform texture, rendering the device ideal for implantation. 

CASE STUDY #3

Maintaining surface profile in post-processing

One of the benefits of additive manufacturing is the ability to produce highly detailed and accurate device shapes. Therefore, it’s important that post-processing methods don’t alter the overall shape of the product.  

The third case study quantitatively characterized surface profiles after MATRIX MCD® grit-blasting by analyzing roughness, height, shape, and high spot count parameters using laser profilometry.  

The study involved additive manufactured, flat, non-porous surfaces, and divided the surfaces into four different test groups. The first was a control group, with the subsequent three groups subjected to increasing intervals of grit-blasting time. Process factors such as blast distance and pressure were maintained for each of the three grit-blasted groups.  

After blasting and evaluation, the control surface showed the highest degree of roughness and surface variation. Each of the grit-blast-treated surfaces showed increased micro-texture and a more uniform macro-textured surface. 

Measuring kurtosis, or sharpness of the roughness profile, revealed that the blast was effective in creating a uniform surface, but it did not overly blunt the peaks beyond a gaussian shape. Minimal change was also shown for the skewness, or the degree of symmetry of the surface peaks and valleys. The high spot count values, which measure the largest peaks and surface irregularities, were reduced by 50 percent, even with the shortest blast time interval. 

This study revealed that the blasting process removed minimal material while preserving the dimensional accuracy that’s critical for device performance. For complex designs that seek to preserve original surface features, custom masking can be used to selectively treat specific regions of the device.

Optimizing additive-manufactured devices while maintaining shape and biocompatibility  

Additive manufacturing offers rapid prototyping technologies and mass production of implantable devices, all with a low cost and quicker lead time. Finding the right post-processing is critical for the best end-patient outcome. Himed’s MATRIX MCD® finishing process has been demonstrated to offer optimal surface texture while eliminating common concerns resulting from the 3D printing process. 

To see more imagery and detailed data from these studies, use the form below to request a copy of the Finishing 3D Printed Devices with MATRIX MCD® Apatitic Abrasive white paper. Or call our engineers today to discuss post-processing options for your additive manufactured devices. 

I’d like to request a copy of the white paper via email…

You know that saying, “If it’s not broken, why fix it?” Well, what if something isn’t necessarily broken but could be made better with a few simple changes? That’s exactly the way we saw our address system. 

Himed was founded 30 years ago within the facilities of an aerospace coating provider called Hitemco. We’ve since expanded into our own nearby facilities and our business has grown to become a leader in the biomaterials industry. 

Yet, through all these years, we’ve been using Hitemco’s shipping and receiving. That setup certainly wasn't broken but we realized we could streamline the process by implementing our own address.

HIMED’S NEW ADDRESS & PHONE NUMBER

148 Sweet Hollow Road, Old Bethpage, NY 11804 USA
Phone: 516-586-5700

Why now?

If the pandemic has taught us anything, it’s to focus on what we can actually control. Practically every industry has been hit with delays, shortages, supply chain snafus, and other things that are out of their hands. The biomaterials and medical implant sector is no different. 

So we took a laser-focused look at each step of our operations. We examined every process to see where we can improve and what we can optimize. While we can’t control shipping delays and material availability, we can make small improvements each day that ensure we keep our turnaround times tight and competitive for all of our clients. 

Getting our own address is just one of the many things we’re doing to keep improving. 

In 2019 we made deep investments in production equipment for our MCD apatitic abrasive to ramp up output. In 2020 we worked on outreach, developing our relationships with customers and seeking out new partnerships. Both efforts paid off and business has grown rapidly. 

Now as we close out 2021, we’re looking back on a year that saw us streamlining and improving the efficiency of our business. A new address is just part of that process. We can’t wait to see what advancements 2022 may bring.

WHITE PAPER | MATRIX Dual® Expands Micro-Scale Morphology Potential of Orthopedic Implants, By Craig Rosenblum

As the medical industry continues to explore the conditions for successful implant integration with the human body, closer attention is being paid to the surface morphology of a given device. That “closer attention” is taken quite literally in our latest white paper. In it, four case studies are reviewed that use advanced scanning technology to characterize—at the submicron and nanoscale level—surfaces treated with our two-step MATRIX Dual® process.

The studies reveal the positive benefits delivered by MATRIX Dual®, including highly complex micro and macro pitting, freedom from contamination, and fidelity to the size, shape, and function of the original device after treatment. 

Like our first white paper on finishing 3D printed devices with our MCD Apatitic Abrasive, this white paper was published by BONEZONE. The findings support the efficacy of MATRIX Dual® surface treatment through documentation that includes:

• Scanning electron microscopy (SEM) and energy dispersive x-ray spectroscopy (EDS) to characterize the textured surface of joint screws

• Surface metrology analysis to quantify the change imparted between the two steps of our dual process

• Computed tomography (CT) and OGP Smartscope Flash Microscopy to quantify the insignificant reduction in volume and thread diameter of bone screws after treatment

Get a copy of the MATRIX Dual® white paper in your inbox…

Here at Himed, we are gearing up for the BIOMEDevice and the NASS trade shows in Boston. So we started asking ourselves what we were most excited about in orthopedic advancements in general, and spinal health in particular. The answer—perhaps not surprisingly for a surface treatment company—are the benefits that patients experience when spinal implants undergo optimizing surface treatments after manufacture.   

In order to create the best possible spinal implants, the surface must be free of contaminants and textured in a way that creates an ideal environment for integration with the surrounding bone. That most often requires a post-processing surface treatment. And that's something Himed has spent decades pioneering and perfecting. 

The market for spinal devices is growing

It’s a vital time for the world of spinal devices, as there’s been a broad expansion of the spinal sector in modern orthopedics. In 2019 and 2020, the FDA issued 1,555 orthopedic 510(k)s and 41% of them were for spine devices. When two out of five premarket notifications for orthopedic devices are for the spine, that’s a remarkable trend. 

An increase in the ageing population, along with improved surgical procedures that are encouraging doctors and patients to explore spinal surgeries, are creating an increased demand for spinal procedures and the accompanying spinal devices. 

As more device companies enter or expand their offerings in the spinal sector, many of them are looking for ways to set themselves apart from the competition. Turning to Himed for surface treatment is helping companies across the globe bring better spinal devices to market. Himed’s proprietary processes help improve surfaces for better osseointegration while removing contaminants to create the best possible version of an implant. 

Despite recent and continued advancements, there is still room for improvements in the spinal device marketplace. Himed aims to work with device manufacturers to bring those advancements to life. After all, fully optimized spinal devices lead to better patient outcomes. And that’s always the primary goal for everyone in the biomedical industry.

The key to improving spinal implant success

Plates, pedicle screws, cages, rods and other spinal devices each have their specific function. And while the structure and mechanics of an implant is obviously important, no implant will be successful if the body rejects it. Titanium has proven itself over the years as being particularly conducive to integration with the body. Data shows that titanium and bone create a chemical reaction responsible for osseointegration at the chemical level.

Yet, all titanium implants do not share the same level of success. 

What makes the difference when it comes to optimizing osseointegration? Often it is the surface of the implant itself. Two factors affect osseointegration: the presence of an ideal texture and the absence of residue. 

Roughed titanium has been shown to better stimulate cells to create bone- and blood vessel-forming microenvironments than a smooth titanium surface. Residual contaminants left behind after additive manufacturing or after traditional finishing can be released into the body, creating an inflammatory response which can lead to implant failure. 

To create a properly textured surface, while also removing potential contaminants, grit blasting is an ideal method. Traditionally, orthopedic devices were blasted with aluminum oxide or other metallic media. Unfortunately, even with thorough cleaning processes, traditional grit blasting leaves behind residue.   

Blasting with hydroxyapatite 

Decades ago, Himed pioneered grit-blasting for implant surfaces using a specially hardened form of hydroxyapatite (HA). The proprietary blasting media is fired through a micro-grit blaster nozzle using pressurized air. The accelerated particles are forcefully directed against the surface of the implant, where it can deburr, remove surface abnormalities, and add texture. We call our proprietary finishing technique MATRIX MCD™ and it represents a superior method for optimizing orthopedic implants. 

One objective when subjecting a device to a surface-finishing process is to remove the possibility of potential contamination in the patient’s body—in the case of titanium additive manufacturing, the contaminants appear in the form of titanium beads that are a known byproduct of 3D-printed parts. If left unchecked, there’s a danger of the beads breaking off and being released into the body as a foreign object. 

When removing that potential contaminant, it only makes sense to ensure that further contamination is not created. Unlike traditional grit blasting which leaves behind residue (even after cleaning processes), MATRIX MCD™ leaves nothing behind. After passivation, virtually none of the grit-blasting media remains. And because the HA grit blasting medium is a biocompatible and resorbable substance, if trace amounts were ever left behind, the HA would harmlessly assimilate into the patient’s body. 

Unique and controllable surface morphology

Another key objective for surface treatments is optimizing the device for osseointegration. Studies have shown, and the practical consensus is, that surface roughness increases the responsiveness of bone-forming cells. The limiting factor in additive manufacturing of spinal implants is the surface texture. With current technology, 3D printed devices have a hard time producing submicron scale surfaces. 

That’s where finishing with MATRIX MCD™ comes in. 

MATRIX MCD™ grit-blast applications result in highly textured surfaces, which can be minutely controlled. Thanks to Himed’s Fully Automated Blasting System (FABS), we can fine-tune the texture on a device surface. We have the ability to adjust the particle size of the hydroxyapatite, the blast pressure, and the blast duration. Our engineers are also able to create custom masking so that the textured surface is properly targeted. Tailored to virtually any surface specification, a completely customizable output can be achieved.  

Creating better spinal implants through optimized surfaces

The first few weeks after implant are the most critical for successful bone healing. Immediately after implant, the device interacts with the blood and serum coating the surface. EIther that biological environment begins to help differentiate stem cells, encouraging them to create osteoblasts and other bone-building cells. Or else the body begins to create an inflammatory response, which can lead to undesirable outcomes. That initial interaction is essential to the success of a spinal implant. 

For the greatest potential of osseointegration and lowest risk of foreign contaminants—whether for additive manufactured devices or traditional subtractive manufacture—a device should ideally undergo a proper finishing process. 

Spinal implants that undergo finishing with Himed’s MATRIX MCD™ apatitic abrasive set themselves apart from other devices on the market, simply because a fully optimized surface leads to a better patient outcome. 

A distinguished final product

As the market for spinal implants widens, and the number of new devices entering the marketplace increases, many device manufacturers are feeling the pressure to improve their spinal offerings to stay competitive. What better way to distinguish a final product than through a cleaner, more bone-friendly surface? Free of contaminants and ideally textured to promote osseointegration, a spinal device that undergoes Himed’s MATRIX MCD™ process is destined for unparalleled success. 

Call today to speak to an engineer about setting your spinal implants apart from the crowd.

If you ever went searching for your car keys but found a $100 bill instead, you might feel a little like Dr. Per-Ingvar Brånemark. He was looking into how blood flow affects bone healing—and he ended up discovering osseointegration. 

Better osseointegration is one of our primary goals at Himed. When we develop surface treatments and coatings, we do it with the aim of improving the integration of implants with a patient’s bones. The very phrase “osseointegration” was coined by Dr. Brånemark, who is now considered the father of the modern dental implant. Before his work, the medical community was pretty sure that such a thing wasn’t even possible. 

Rabbit legs 

Swedish physician, anatomy professor, and medical researcher Dr. Per-Ingvar Brånemark was working with rabbits in 1952, attempting to study blood flow as it relates to bone healing. By implanting a specially modified microscope into the leg bones of rabbits, Brånemark and his team were able to see how microcirculation in bone tissue aided healing—from the inside out. 

After collecting the data they needed, it was time for Brånemark and his team to remove the optical devices from the rabbits’ leg bones. Except they couldn’t. The bones had fused to the casing surrounding the optical devices. 

The material for the casing? Titanium. 

A hard road towards acceptance

Up to that point, the common belief in the medical community was that the body would eventually reject any implanted foreign object. The idea that bone would actually fuse and grow into an implant was unheard of, and frankly disbelieved. 

Brånemark knew what he had discovered was groundbreaking, with wide-ranging potential. He quickly switched his focus to dive deeper into the possibilities of the process he termed osseointegration. 

But the medical community wasn’t as enthusiastic about his discovery. Despite first discovering osseointegration in the early 1950s, it wasn’t until years later, after numerous rejections, that he finally received funding in the form of a grant from the United States National Institutes of Health. 

Not that lack of support or major funding dampened his efforts. 

A wildly successful test case

By 1965, Brånemark had verified that titanium was indeed compatible within the human body—by testing it on his own lab students. About 20 medical students working in his lab had a small piece of titanium inserted into their upper arms—with no ill effects. 

So in 1965, Brånemark performed an operation using titanium dental implants he and his team developed. The patient receiving the implants suffered from a cleft palate and jaw deformities that left him with no teeth in his lower jaw. The operation fixed four implants into the patient’s jaw, allowing for the use of compatible dentures. The implants developed no complications and stayed in place for four decades, proving effective up to the point of the patient’s death.

Yet another serendipitous discovery

As part of his research into oral titanium implants, Brånemark and his team needed to verify that implants were actually integrated into the bone, and not just mechanically anchored. They tested the osseointegration by applying a high-frequency vibration to a patient’s implant. 

One particular patient happened to suffer from hearing loss, yet he was able to hear the high-frequency of the vibrations. Brånemark concluded that the patient’s bones were conducting sound. 

A member of Brånemark’s research team, PhD student Anders Tjellström, followed Brånemark’s suggestion that a titanium implant in the bone behind the ear could act as a kind of hearing aid. Tjellström went on to perform the first bone conduction implant surgery, restoring hearing to a patient who had struggled with hearing loss for thirty years.  

From skepticism to millions of implants

Thanks to Brånemark’s tireless work, continuing with his research even when the majority of the medical community did not believe in his discoveries, osseointegration of implants is now commonplace. 

Finally in 1970, Sweden’s National Board of Health and Welfare approved Brånemark’s dental implants. Brånemark received European and US patents for his system of titanium implants. And today, the biomedical company he formed in Sweden in 1981 still markets and sells the Brånemark System®. 

Of course titanium implants are now used in implants throughout the body, helping patients throughout the world. Here at Himed, our processes and surface treatments for implants build on Brånemark’s discovery nearly 70 years ago. Without Dr. Brånemark and his unexpected discovery, titanium’s ability to bond with our bones may never have been known. It’s a pretty great narrative to keep in mind when you’re looking for one thing, but find something else entirely.

Researchers at the University of New South Wales in Sydney have created a novel ink for 3D printing—one with major advantages for doctors and patients. The idea of 3D printing implants using biocompatible materials is not new. Here at Himed, we’ve been working to improve biocompatible calcium phosphate scaffolding agents for ten years, both to help patients today and in preparation for on-demand implant printing. 

As reported in the World Economic Forum, this new material and technique not only mimics bone structure, it contains living cells. Additionally, the ink hardens when placed in aqueous environments such as body fluids. When the ink is combined with substances containing living cells, it is able to fabricate bone-like tissues that incorporate the living cells into its structure. 

The red hot promises of room temperature

In addition to the biocompatible advantages of integrating living cells into the implant structure, the newly-developed ink and printing technique can be performed at room temperature. While this may seem like a fairly basic achievement, the implications are huge. 

With current technology, the vast majority of implant fabrication requires the use of high-temperature furnaces. Production must happen at off-site labs where such facilities exist. If bone-like implants can be fabricated without the use of specialized furnaces, they can be created far closer to the site of implantation—namely the surgery suite where the patient is receiving the procedure.  

Made to order, and printed at the site

As the technology for 3D printing improves, it opens up the possibility that bone-like implants can one day be printed directly in the cavity of the patient. Using this novel ink, which would incorporate the patient's own cells, pieces of bone that are removed during surgery could be replaced via printing directly in the cavity. 

The implant would be created to the exact specifications required. It would be uniquely compatible with the surrounding tissue to speed healing. And it would include all of the benefits 3D printing offers—less wasted material, instant turn-around times, and a more efficient supply chain. All of which results in a better outcome for the patient. 

Getting to know COBICS

The findings were published by the UNSW scientists this January in a paper in Advanced Functional Materials. They call the new technique “ceramic omnidirectional bioprinting in cell-suspensions” (COBICS). The ink they developed hardens in minutes when exposed to water. Though it’s referred to as an ink, it’s actually a dry material that technicians in the operating theater would “wash,” then mix with the patient’s living cells. The ink would then be extruded (ie, 3D printed) directly into the place where the implant is needed. 

The possible applications are vast. In addition to bone-tissue replacement, the researchers noted COBICS’s possible use in disease modelling and drug screenings. The technique will prove particularly useful in treatments where large amounts of tissue is removed or damaged, such as in trauma situations and cancerous tissue removal. 

A remarkable materials conversion

In a news release from the UNSW in Sydney, Dr Iman Roohani from UNSW’s School of Chemistry, a scientist behind the discovery and an author of the paper, describes the way the ink forms such a unique bone-like structure, saying:

“The ink takes advantage of a setting mechanism through the local nanocrystallization of its components in aqueous environments, converting the inorganic ink to mechanically interlocked bone apatite nanocrystals.” 

The material converts to a structure that’s similar to bone, and only begins the conversion when it’s exposed to body fluids. That leaves the surgeon or researcher using the ink the important ability to work with the substance easily without it setting before he or she is ready. 

The next step for the scientists behind the discovery is in vivo animal testing to find out whether the living cells in the COBICS technique will continue to grow after implantation in a living body. 

If the tests prove successful, this remarkable technique could help better care for patients in need of bone replacement. One day, a surgery for bone implants will potentially require fewer steps, fewer resources, and result in quicker healing with living-cell implants directly printed in the body. 

An exciting time to be in the biomaterials industry

For three decades now, Himed has provided biomaterials aimed at bone restoration. Seeing such a unique and promising breakthrough not only energizes us to continue with our own research, it makes us excited to be a part of such a dynamic and innovative field—one that will only continue to improve the lives of patients everywhere.  

As President of Himed, Ed Garofalo oversees a business that’s now a leading global provider of cutting-edge biomaterials and surface treatments for the dental and orthopedic industries. Yet thirty years ago, if you went looking for Ed, you’d find him working with metal coatings for engine turbines at a family-owned business in New York called Hitemco.

Of course, engine turbine parts and a hip implant don’t have much in common on paper, but it’s safe to say that the finish on both had better be unquestionably precise before they’re put to use.

From engine turbines to medical implants

In the late ‘80s, the medical implant industry looked very different than it does today. Medical advancements were coming at a respectable pace but a flexible, adaptable supply chain simply wasn’t in place the way it is now. That’s why Ed would get calls from members of the medical industry asking if Hitemco could provide finishes on orthopedic implants.

One major issue with implants back then was the cement used to bond the implants to bone. The cement would heat up, degrade or even crack the bone, and sometimes break off completely over time. Terrible scenarios, all of them, which often required additional corrective surgeries. The solution didn’t come in the form of better cement, but a different approach entirely.

That approach was to create a rough, beaded surface on a metal implant that was then pressure-fit into the bone. The body would naturally develop tissue around the implant, using the textured surface as a scaffold. Hitemco was uniquely suited to create those finishes on cobalt-chrome implants.

What’s hydroxyapatite, anyway?

Once members of the medical community got wind of Hitemco’s plasma spray coatings, Ed started getting more calls. Could Hitemco perhaps put hydroxyapatite (HA) on implants? Ed was pretty sure they could…if they knew what the heck hydroxyapatite was. Curious and inspired, Ed hit the phones (remember, Google didn’t exist back then). He searched for suppliers and gathered up any information he could. He soon learned that HA is a naturally occurring calcium phosphate which can be found, albeit in modified forms, in both human bones and teeth.

Unlike metals and alloys, Ed didn’t have a ready idea of where to acquire HA, so he put in the hours to figure it out. After all, this wasn’t the first time a client request came from out of left field—and it was far from being the last.

Back then, the market for this type of calcium phosphate wasn’t especially large—and consistent supply of the material was largely unavailable. One day Ed came across the NYU College of Dentistry and their Calcium Phosphate Research Lab. If anyone knew about HA, it would be the researchers at a lab that was practically named for the stuff.

Finding exactly the right people

On a visit to the NYU lab, Ed had a fortuitous meeting with Dr. Raquel Le Geros. She was at the forefront of research around the use of hydroxyapatite in dental applications and traveled the world giving talks on the subject. Few people knew more about HA than Dr. Le Geros.

Her husband, John, was also a medical researcher and after several discussions between the Le Geroses, Ed, and the founder of Hitemco, Richard Barnard, the four realized the singular opportunity they had on their hands. Hitemco knew surface coatings. The Le Geroses knew HA. The medical community was in great need of HA coatings and products. Teaming up just made sense.

March 25, 1991: Himed is born

With the Le Geroses providing their expertise, Ed shifted part of his time away from Hitemco to develop Hitemco Medical Applications (doing business as Himed). He was joined by biomaterials scientist and engineer Jinlong Wang, who would later become Himed’s VP of Biomaterials. In the beginning, Himed managed just a few sales, adding up to about $6,000 the first year. While sales may have been slow, however, Himed was quite busy.

Convinced there was a way to make a plasma-sprayable HA powder, Ed and a small team led by Jinlong Wang spent the next four years researching—until their hypothesis proved correct. The substance and techniques the team developed are now used around the world and on millions of medical implants.

A fortunate discovery

While searching for the solution to a plasma-sprayable HA, Ed had a eureka moment. (You could even call it his “a-HA” moment.) Creating textured surfaces on implants was (and is) incredibly important.

Most grit blasting of implant surfaces at the time was done with aluminum oxide. While the substance is very hard and great for texturizing, there’s simply no way to get all the residue out of the implant’s surface after blasting. Brushing, ultrasound, nothing will do the trick…

And that’s a problem. If implanted into the body, that residue could create an inflammatory reaction, compromising the implant. One solution was to coat the surface to keep the residue from contact within the body. However, the grit particles from the aluminum oxide embedded beneath the coating could become what’s known as a “stress riser” which concentrates pressure, thereby weakening the mechanical strength of the whole device.

So Ed found a better solution. He realized that if Himed could make a harder form of calcium phosphate, it could be used as an abrasive for implants. At the time, there wasn’t a name for it, but now it’s known as resorbable blast medium (RBM) or soluble blast medium (SBM).

Even if this blast medium left behind trace amounts of residue, it theoretically wouldn’t matter, thanks to the mineral’s excellent biocompatibility.

Just hard enough

There is one notable limitation to abrading with calcium phosphate grit—even when it is manufactured to be as hard as possible it cannot exceed a 5 on the Mohs’ scale. Aluminum oxide? That rates near the top of the scale at a hardness of 9. So CaP couldn’t do much to the surface of hardened tool steel, and it would have zero effect on cobalt-chrome. However, most implants at that time were being designed with titanium (or titanium-alloys) and medical-grade stainless steel, which are both materials that Himed's CaP-based grit could easily impact.

The wide-spread adoption of titanium as a material was logical as it happens to be hypoallergenic, light weight, and possess a high tensile strength; making it an ideal material for both orthopedic and dental implants. What titanium lacked was a surface texture that was inherently supportive of the body's natural processes for forming new bone, which is why medical device manufacturers had been turning to conventional alumunium oxide grit and acid-etching techniques.

Ed reached out to implant manufacturers to tout the benefits of Himed’s new development: MCD apatitic abrasive. Many medical implants could now have their surfaces roughed with a soluble media, giving native bone something to grab onto, with none of the adverse side effect potentials from traditional blasting.

Taking it one step further, Himed researchers were also able to show that by using MCD apatitic abrasive just prior to the normal implant passivation step, the RBM residue would dissolve, creating a surface that was exceptionally compatible with the body.

Initially, Ed didn’t receive huge interest from the implant manufacturing market. But one company did see the potential in MCD as both a functional improvement and a market differentiator. They happened to be one of the larger implant manufacturers and once they were on board—and other companies saw the benefits—the adoption of this “resorbable blast media” (RBM) rapidly took off.

Doctors loved this new technique. Implant designs improved—as did patient outcomes. Today, RBM is the industry standard for texturizing titanium implants.

Risky business

By 1994, Ed had grown the tiny Himed team from a one-room operation at the back of Hitemco to a two-room operation. The atmospheric plasma-sprayed hydroxyapatite (APS HA) idea was now a reality, which made Himed one of the few companies possessing the ability.

Additionally, Himed’s soluble apatitic abrasive, and their corresponding blasting service using that grit, was taking off. For both the APS HA and the RBM developments, Ed had kept all of the R&D in-house. Guided by inquiries from potential clients and the team’s own creative problem solving, Himed had spent the better part of four years researching these breakthroughs—with little income stream and no guaranteed client interest once the products were developed.

It was a risky move, business-wise; a whole lot of time and resources invested in ideas that relied on possible developments in the implant industries, which may not pay off in the end.

But it did pay off. Himed is now the number one supplier of RBM globally and their plasma-sprayable HA powder and spraying capabilities are used on hundreds of thousands of implants year after year.

Not just better, but faster too

Fast-forward to 2004 and Himed’s customer base was expanding rapidly. But other suppliers were growing, too. Ed already knew Himed had excellent products. The next goal would be to deliver them faster, and with better customer service, than anyone else in the industry.

That led to a major site expansion for Himed: in addition to creating the space for resources to fulfill customer requests faster, the facility now housed on-site automation. Back when he was VP of Operations for Hitemco, Ed fueled the company’s leap into robotic spray systems, a move that cut job set-up time from a half day to a matter of minutes. The investment wasn’t small, but the payoff was worth it, allowing Hitemco to scale up the scope of their projects and expand capacity within months.

Applying the same logic, Himed invested heavily in automation for creating forms, plasma-spraying, surface treatments, and more. The result? Himed could now turn most customer orders around in rapid time, much quicker than the competition. Paired up with a more competitive price, and a customer service ethic carried over from the family-owned ethos of Hitemco, Himed was able to scale up dramatically.

Even better than cow teeth

By 2012, Himed had moved into a state-of-the-art 25,000-square foot facility adjacent to Hitemco with 5,000 square feet of laboratory clean rooms. The move only made the innovations come faster. Thanks to ongoing internal research leading to more and more discoveries, Himed decided to gather its growing variety of in-house implant surface treatments under the name MATRIX™.

The new expansion wasn’t just great for Himed’s ability to innovate, it also allowed Himed to improve their quality assurance. With enhanced analytical capacity, including new vision systems, many inspection processes could now be automated—improvements that led Himed to set its sights on seeking ISO and FDA recognitions.

All the while, customers continued to call Himed and ask, “Can you do this?” and the R&D team would eagerly figure out if there was a way to meet those needs. One customer needed a better way to test toothpaste, whiteners, and other dentifrices. The techniques for testing such products at that time included using cow or cadaver teeth. Unfortunately, those substrates have a high degree of variability which confounds the experimental results. Using sub-par materials, researchers were being denied the ability to gather valuable and reliable data.

This led to Himed developing gel-cast CaP solids in forms such as teeth that could be mounted in a position that mimicked the human mouth, allowing researchers to test the products in ways that would be found in real people. The efficacy of testing was greatly improved.

Other labs quickly saw the value in other substrates that would help with scientific research. Himed developed ways to supply everything from hydroxyapatite discs for direct experimentation, to CaP forms that could be machined into parts for implant elements. Using hydroxyapatite in implants was particularly intriguing as such parts could potentially become resorbable implant elements—with considerable patient benefits.

High purity, high performance, and lower cost

After such unparalleled successes in the dental implant market, Himed refocused its efforts on orthopedics. In 2015, Craig Rosenblum was hired as Himed’s Engineering Manager, and he immediately began to tackle different process development projects related to the MATRIX™ line of surface enhancements. Under his guidance, Himed officially launched a novel titanium coating process for hip implants that they had patented in 2013.

While other companies were already offering textured titanium coatings, they were doing so under expensive vacuum conditions. Himed’s process was unique in that it was performed in atmospheric conditions at a fraction of the cost—with zero reduction in the performance of the coating.

Himed’s process was named MATRIX Ti™. Used in combination with Himed’s MCD abrasive, implants undergoing this process received a commercially pure, porous surface ideally suited for bone regrowth. Medical implants coated with MATRIX Ti™ were approved by the FDA in 2016, and a CE mark for similar use in Europe was obtained in 2018.

The future will be in 3D

After making significant, industry-changing strides in coatings, CaP forms, and surface treatments, Himed wasn’t content to sit still. Looking to the future, they wondered what might be the next generation of medical implant innovations. What about resorbable implants created to the exact specifications of each patient

Himed sees that idea getting closer and closer to reality with advancements in 3D printing. Specialized CaP forms and mixes may soon be used as the printer’s “inks,” allowing surgeons to 3D print bone scaffolding directly: built to the exact specifications of the patient’s precise implant needs.

Himed aims to be a major contributor to these new solutions.

The promise of bespoke implants

Himed has been working for more than ten years on improving biocompatible scaffolding agents, preparing for the day that on-demand printing of implants is a reality. There’s no question that HA will play a key role in implant manufacturing via 3D printing, thanks to thirty years of strong scientific evidence for HA’s ability to support osseointegration, and broad acceptance of HA coatings in major global markets.

This technological shift will mean completely bespoke fabrication of implants on a patient-by-patient basis, yielding perfectly shaped implants that seamlessly integrate into the body. Lead times will virtually disappear and wasted material will be a thing of the past.

Doubled capacity and evolving surfaces

In 2019, with increasing demand, Craig and the engineering team doubled Himed’s production capacity of MCD apatitic abrasive by implementing two more industrial furnaces. That same year, Himed publicly launched an advanced application of its standard MATRIX MCD™ abrasive blast texturing process, naming the new iteration MATRIX Dual™.

With MATRIX Dual™, titanium implant surfaces are blasted to create smaller pores inside of larger pores. The result is a surface with exacting uniformity on even the most geometrically complex and smallest surfaces. For device manufacturers looking for the utmost control over a textured surface, MATRIX Dual™ offered resorbable blast texturizing with a much more complex surface morphology than single blast texturing.

A brand new CEO with a Himed lineage

In 2020, Dana Barnard joined Himed as CEO. Dana came to the company fresh off the sale of a tech company that had developed a unique cold-chain storage technology used in the emerging cell and gene therapy industry. He was no stranger to Himed’s dedicated focus on innovation.

In fact, he was no stranger to Himed at all. Nearly thirty years ago, Dana’s father, Richard, worked with Ed and the Le Geros team to form Himed. Dana had stayed connected to Himed over all those years, but was excited to work more closely with the company on further market expansions.

Dana could plainly see where the future of the orthopedic and dental implant markets was heading. Demand in the industry would continue to increase in response to the aging baby boomer population. That will drive innovation quickly, and Dana wanted to ensure that Himed would remain at the forefront of biomaterials innovation, offering novel solutions to those expanding markets and the patients they serve.

Looking forward to the next 30 years

Dana’s first challenge with the Himed team was ensuring the company could maintain production during the volatile first months of the COVID-19 pandemic (which it did). He then turned his attention to more actively sharing Himed’s remarkable story. New marketing and outreach efforts, including the publication of Himed’s first whitepaper about the additive finishing potentials of MATRIX MCD™, helped Himed’s outward-facing image start to look as impressive as what went on behind the scenes. Within only a few months of these efforts, Himed became much more visible.

Before, Himed had quietly grown through constant innovation and real-world results. But now, the usual word-of-mouth promotion was joined by a new group of start-ups and manufacturers—exciting new partners and clients who had found Himed on the web or in trade magazines.

Still answering the calls

It does seem improbable sometimes that one day in 1991, Ed and Jinlong started working out a way to spray HA coatings on medical implants, and thirty years later, Himed has changed the implant industry for the better. From one room at the back of a metal spray coatings company to a 25,000 square foot facility and a team of thirty-five, Himed has come a long way.

But one thing remains the same: the phone still rings. And while Ed might not always be the one taking the call, the conversation goes much the same. A customer asks, “Can you do this?” and more often than not, the Himed team answers with a resounding, “YES.”