The Growing Business Cases for Additive Manufacturing of Orthopedic Implants

Additive Manufacturing of Orthopedic Implants

This new blog that examines additive manufacturing of orthopedic implants is drawn from new report, Additive Manufacturing In Orthopedics: Markets for 3D Printed Medical Implants 2019

Looking at market opportunities for additive manufacturing and 3D printing technology, it’s common in today’s world to focus on what’s just on the horizon –those areas where AM/3DP is just beginning to have an impact and shaking up product design, supply chains, business models, and manufacturing implementations. However, it’s also necessary to look at those areas where AM is already a more mature technology (relatively speaking). The areas that often ‘pay the bills’ for stakeholders in the broader AM ecosystem.

One such area is in the additive manufacturing of orthopedic implants. For the sake of exploration, let’s use a more specific definition –in the additive manufacturing of implants for orthopedic applications, defined as those medical devices which are otherwise permanently implanted into the body to correct deformities of bone or muscle. At SmarTech, we like to call this particular segment ‘additive orthopedics.’

In the additive orthopedic market today, AM/3DP technologies have advanced into a new evolution of use, where the focus and industry conversations and related conferences have shifted from those of ‘what is theoretically possible in the future’ to ‘what is economically feasible today with the current solutions and supply chain.’ This shift is the hallmark of a technology moving into a new stage of mainstream relevance, and if one examines headlines and articles in popular trade press outlets for orthopedic business, it’s clear that AM/3DP is, indeed, a mainstream concept.

A necessary step in becoming a mainstream force in any industry that AM might disrupt is developing key business cases for application of printed components or parts –in essence, not just talking about AM’s possibilities, nor just producing pre-production parts that are not yet subject to economic constraints. Real rubber-meets-the-road business cases for real parts that will be fielded and used in the real world. Along these lines, the business cases in additive orthopedics continue to expand, and now cover the entirety of the traditional orthopedics industry structure ranging from major joint replacement to trauma solutions. The graphic below provides a visualization of business cases across the industry today.

Source: SmarTech Analysis

Over the last two years, there has been some very compelling movement forward in the orthopedic industry in two important ways. First, within established business cases, such as the printing of lumbar spinal fusion cages using titanium alloys, there has been significant market uptake from a huge number of device OEMs in both internal production and outsourced contract manufacturing. Secondly, and equally important, has been efforts to demonstrate the viability of new business cases for the use of AM to produce devices. In some cases, these cases have been ‘validated’ previously, but now with much wider competitive support and global presence, they have become a more universally recognized business case across the industry.

We would call particular attention to a couple of potentially very interesting market examples in the expansion of the business cases for additive orthopedic implants which could significantly push the overall industry forward.

The first is in the emerging sector of additively produced off-the-shelf shoulder arthroplasty systems with components produced via metal additive technologies. At least two leading innovators in the world of AM implants have are preparing full market availability of such devices this year, to include Lima Corporate’s SMR TT Hybrid Glenoid, and ExacTech’s Equinoxe Stemless Shoulder systems. These devices address the fastest growing segment of the shoulder arthroplasty market, which in itself is expected to under exceptionally rapid growth as an underserved joint replacement opportunity in the future. These systems feature titanium printed cage glenoid structures with known porous printed features for biologic fixation, drawing on existing market acceptance of similar structures applied across spine, hip, and knee segments over the last several years.

Second, is the continued establishment of patient-matched knee solutions with directly printed implant components. Although there are existing solutions from BodyCAD and ConforMIS that have utilized 3D printed surgical guides and casting molds, at least one company in Italy known as Rejoint is now preparing for full availability of a directly printed implant system drawn from patient imaging data.

Finally, although first announced almost two years prior from today, American company SI-Bone has demonstrated how additive manufacturing can also be successfully clinically applied to specialty areas of orthopedics with its iFude3D sacroiliac joint stabilization implant. The device somewhat mimics printed spinal cages in appearance and design but is tailored to addressing sacroiliac dysfunction in the pelvic region.

Overall, the building of new business cases is critical for the expansion of AM in the world of orthopedics, as is the continued acceptance of otherwise proven business cases among a wider swath of device companies over time. For more insights on the current state of additive manufacturing technologies in the orthopedic industry,

SmarTech Analysis has just released its latest study on additive orthopedics, available for order.

Metal Powder Bed Fusion Marathon Winners and Losers

Metal Powder Bed Fusion

This article is a preview from SmarTech Analysis’ report, Powder Bed Fusion Markets, A Metal Additive Manufacturing Market Analysis

Despite what headlines, technologists, and marketing executives would have you believe, the metal 3D printing “race” is a marathon, not a sprint. To continue with the metaphor, we’re probably in about mile 10 of the race today –certainly not at the beginning anymore, but also quite a long way from the end. We are now about twenty three years since the first commercial metal powder bed fusion (PBF) systems came into view.  The race has gotten exciting in the last few years, with a lot of competitors now fully invested and looking for victory –or at least to be relevant twenty years from now.

With so many closely comparable suppliers of metal powder bed fusion equipment now vying for market share, this begs the question, who has what it takes to make it? Everyone in the race today is working toward similar visions of an “Industry 4.0” future that hinges on metalworking going fully digital and highly automated from end to end, from prototyping all the way up to scaled production, with varying levels of customization capabilities based on industry needs along the way.

Before we answer the question posed in the previous paragraph, we note that metal PBF isn’t the only viable metal AM process. But for now, metal PBF has major standout traits. First, PBF now has a slew of suppliers all operating with relatively similar processes who are now searching to some degree for elements to differentiate themselves from the pack; second it accounts for about 80 percent of all installed metal additive technology in the world today; and third; it has the greatest potential to be a “jack of all trades” metals manufacturing process that excels in many aspects and can fulfill the stated vision of the broader industry.

Here’s our current predictions on how the metal AM powder bed fusion race will shake out, and what elements will keep the players relevant a decade from now; as well as who might fall to the back of the pack to be eventually acquired or even become a competitive casualty. There are plenty of companies not mentioned in this piece.  Also, just about every competitor has some elements we applaud and some we find troubling. Those that are mentioned below are the exceptional, while those that aren’t mentioned, couldn’t readily be identified as a long-term leader or potential die-out.

 

Powder Bed Fusion Market Share

Source: SmarTech Analysis 2019 Metal Powder Bed Fusion Market Deep Dive Report

The Winners

 EOS

As of the end of the first quarter of 2019, EOS still controls the largest number of metal PBF machines installed worldwide, by about 400 systems compared to its next closest competitor. If there were any single factor that could aid in a company’s longevity in the space, this would probably be the most important one. Any developer of a third-party technology or solution to aid in the PBF workflow is going to make sure its solution works with EOS machines, simply because they’re the most common. That gives EOS a certain “market pull” that nobody else can claim.

However, it’s not just about the numbers. EOS has a diverse product lineup of metal machines that range from capable entry-level systems, to workhorse single-laser systems of medium and large sizes, to modular multi-laser systems that can operate in parallel architectures for continuous use and automated factory-like implementations. This in itself isn’t unique in the marketplace anymore. But when combined with the consulting prowess of Additive Minds (EOS’ customer consulting division), EOS’ technology for quality assurance and process monitoring, and its proven ability to innovate on the technology side, it establishes EOS’ prowess.  EOS isn’t going anywhere for a long time.

The next big thing from EOS might be an adaptation of its Laser Pro Fusion concept, which utilizes many smaller, less expensive diode lasers, for metal PBF. Even though EOS is more specialized in one metal additive process, if any firm has the capability to totally reimagine the nature of the process and commercialize it into a manufacturing tool, it’s EOS.

GE Additive

GE has had its share of corporate problems in the recent past, and some in the industry have speculated that there’s no guarantee that GE’s additive division won’t be divested if GE decides to shed holdings to focus down on (what GE might consider) core businesses. However, not only is this purely speculation, it’s actually probably not at all likely to happen, because additive is increasingly at the core of GE.

Herein lies GE’s biggest market advantage –it has been the biggest user of its own technologies (and others) for a long time. In its power generation division, GE has begun to demonstrate what leveraging additive manufacturing in a major way can accomplish. GE has demonstrated this with the Additive Manufacturing Performance upgrade to its GT13E2 gas turbine announced a year ago –the production and installation of additively manufactured heat shields and turbine vanes which, through design innovation and AM, increase efficiency of an existing turbine. This is one of the best demonstrations of advanced additive innovation in the world. Now, whether or not GE Additive can sell machines and services to customers to help them achieve the same level of innovative implementation in their additive strategies is still up for debate.

But to alleviate any remaining concerns about GE Additive’s prospects, we would point to their second-to-none diversification of offering in the metal AM market. Its laser powder bed fusion segment has the broadest product portfolio in the industry, so that no opportunity within the scope of PBF is left on the table. This will be expanded even further with the commercialization of GE’s ATLAS extra-large format offering in the coming years. GE also still has a stranglehold on the electron beam powder bed fusion market, and its subsidiary Arcam’s performance in the last quarter was stellar. Add in the in-house metal powder offering, and the soon to be commercialized industrial metal binder jetting technology, and GE Additive is definitely looking to not only be around at “Mile 26” of the race.  It is clearly hoping to win. And by most metrics it is well positioned to do so.

Perhaps GE’s only weakness relative to its competition is that it’s part of a mega-corporation. Although this certainly has its advantages in terms of resources and building internal expertise, smaller specialist competitors can be nimble and flexible, capturing market attention with the full weight of corporate focus on one mission.

Trumpf

Trumpf’s advantages in the laser PBF  market are numerous, suggesting the potential to thrive over the long term in the market, but they just aren’t there yet in 2019 compared to the other companies in the “winners” category. However, when taking their entire business into consideration (of which additive is only a portion), Trumpf’s prospects look very good.

As an expert in the development and implementation of laser-based manufacturing technology, Trumpf makes and develops its own laser technology. It works in close collaboration with the most influential research institute in the metal AM market, Fraunhofer ILT (though many of its competitors do as well to varying degrees). Examples of the level of innovation in laser technology and development that can quickly be applied to AM by Trumpf and its partners at Fraunhofer include the green laser technology announced for the TruPrint 1000 system in processing copper or precious metals in 2018, or the high speed laser metal deposition process developed in conjunction with Fraunhofer and commercialized in late 2017.

In fact, a consistent customer sentiment on Trumpf’s additive technologies is that having the laser itself made by the machine manufacturer creates an excellent synergy for parameter developments, and potential replacements as optical systems wear out.

The list of elements that Trumpf lacks today compared to the powder bed industry leaders is rapidly shrinking as well. Though it has only two primary systems today which are widely supported in the market, its 5000 series system is now fully commercially available and expands Trumpf’s offerings into the realm of highly industrialized powder bed fusion with multi-laser capability. More recently Trumpf’s additive division has also begun offering powder distribution and parameter development services to its customers, as well as a connected series of ancillary handling products for powder and part management.

Compared to close competitors, Trumpf has broader company resources and manufacturing implementation experience, but remains exceptionally dedicated to industrializing metal additive manufacturing as the future of the company.

Powder Bed Fusion Revenues

Source: SmarTech Analysis 2019 Metal Powder Bed Fusion Market Deep Dive Report

The Losers

SLM Solutions

It’s no secret that SLM Solutions has been struggling during the recent period of market slowdown in metal PBF, with financial results falling, despite the fact that an excellent rebound seemed on the way after a dramatic failed GE acquisition bid in 2016. Taking into consideration the GE debacle, slumping performance, and leadership turmoil, SLM Solutions’ issues are at least in part due to consistent failures in leadership. By most accounts, SLM’s core technology is solid, and the company has a reputation for selling machines which are stable and productive.

However, poor leadership isn’t the only problem –after all plenty of companies in the 3D printing industry at large have had their share of leadership failings. The company’s product offering is comparable to much of the pack of competitors, but does not quite measure up to industry leaders, with the vast majority of its revenues coming from just two hardware products.

SLM Solutions also may be significantly lacking in close links to customers, something which all of the winners in this industry share in common. There is no significant or unified application consulting group, no marketed or known offering for machine customization for customer specific solutions,  no opportunities to build customer relationships by offering parts printing as a service while customers grow to purchase machines in-house, preferring to leave it up to customers to develop solutions on their own through an open and accessible machine architecture. While this of course offers some advantages to those customers who are dedicated to doing a lot of the total process development, strategy, application business cases, themselves, this is a lot to ask of customers who ultimately want to fully utilize machines to be making parts and seeing return on their investments. To be clear, successful entities don’t have to have parts printing services, operating customer consulting groups, or a customized machines offering. But those that want to survive should probably have some business elements that link them more collaboratively to customers without requiring them to do all the heavy lifting.

But perhaps the most glaring difference between SLM Solutions and it’s three closest competitors appears to be a lack of long term technical vision for powder bed fusion technologies demonstrated by future pipeline projects. EOS was first to market with its parallelized architecture concept, with GE Additive’s Concept Laser very close behind. Today these companies have visions for extreme large format powder bed fusion based on moving exposure zones, or highly productive powder bed fusion concepts based on alternative laser types and laser control (like Laser Pro Fusion from EOS). SLM Solutions is less innovative in its vision, with its most potentially disruptive project underway being a sixteen-laser system which seems unimaginative compared to what others are developing.

Renishaw

Renishaw is a company that has made good strides in the last three years building up its powder bed fusion business from close to nothing into something that resembles a legitimate challenger to some of the German powerhouses, especially with its latest AM 500Q quadruple laser system.

However, out of all of the players in laser powder bed fusion who are worth mentioning today as challengers to the historical leaders, Renishaw still probably has the most limited product portfolio in the market. The company sells three standalone system configurations, all of which are roughly the same build size. Legacy Renishaw printers in its now retired AM250 platform are widely deployed in research institutes, and its AM 400 printer it now sells is clearly a slightly more robust version of that system, with design elements mainly a call-back to the standalone R&D and prototyping systems of the early 2000s, but with some modernizations in the material handling and filtration.

Meanwhile, it’s 500 platform comes in a single laser and quadruple laser configuration. It’s 500Q quad laser system appears to be quite capable, and Renishaw should be applauded for designing its own optical galvo components made via additive manufactured aluminum. The build volume of its quad laser system is the same as it’s other two systems at 250x250x350mm (well not exactly, the AM400 is 250x250x300), which is a fairly modest size for a four laser system, but this in part allows all four lasers to track the entire build chamber, and also gives it some distinction amongst other quad laser systems which tend to have larger build chambers.

As far as hardware goes, however, that’s it. More recently Renishaw has begun offering a range of ancillary supplies, as well as distribution of metal powders under what appears to be a ‘white label’ style agreement. To its credit, Renishaw does have some in-house developed process monitoring components, and also operates ‘Solution Centers’ which provide customers access to machines and experts to help develop applications and build business cases, though these are clearly not production centers in the traditional ‘parts printing services’ sense.

Overall, Renishaw looks like a company that can succeed in the industry, but it really needs to expand the scope of its AM efforts quickly if it wants to continue to gain share and remain relevant well into the future. The AM business is only a small portion of corporate Renishaw, which is also involved in the global metrology and healthcare solutions markets (among other things), so we could easily see Renishaw’s additive business unit getting spun off at some point in the future should growth become difficult in a crowded marketplace.

DMG Mori

It almost seems inappropriate to put DMG Mori on this list because of the lack of impact this company has had in the powder bed fusion market. But because of DMG Mori’s status in traditional manufacturing, there exists potential for the company to build a significant additive business with PBF, but not any time soon.  In the hybrid directed energy deposition metal additive manufacturing, DMG Mori has been quite successful and holds a very good reputation, and its overall prospects remain quite good. In fact, the company would very likely find itself on a list of ‘Winners’ for directed energy deposition additive outlooks

DMG Mori’s PBF technology was lacking in capability when the company acquired the rights to develop it further and sell systems from Realizer GmbH, and since then, some progress has been made. However, we think that there is likely little hope for DMG Mori to grow its PBF business beyond a niche offering that exists almost solely as a compliment to a broader metalworking technology portfolio that is based on laser deposition welding and machining.

Another Hat in the Ring: Will Xerox Shake up the 3D Printing Market?

xerox

At Xerox’s recent Investor Day 2019, a company that has been indirectly involved in the 3D printing industry for many years, announced its acquisition of metal additive manufacturing systems company Vader Systems and the company’s plans to develop a direct role in the market for 3D printing technologies.

Is Xerox entering 3D printing in this way, at this time, like a big fish leaping into a small, yet crowded pond?  In the last two years, there are quite a few big fish which have jumped into the proverbial 3D printing ‘pond,’ and while said pond keeps getting bigger, it’s certainly becoming more and more crowded.

Statements from Xerox regarding their plans for 3D printing are very reminiscent of other major companies which have done the same in recent years, with the most direct comparison likely to be HP.

Will Xerox shake up the 3D printing market?

The company’s biggest and most direct influence for now appears will occur via its acquisition of Vader Systems. Vader, in SmarTech’s opinion, is an “aging startup” and a developer of what is claimed to be an innovative metal additive manufacturing technology based at some level on inkjet technology. While Xerox has also made some claims on its intent to bring solutions into the polymer 3D printing market including materials, printing systems, and software, we do not have concrete details as of now so we will focus on Vader and metal additive manufacturing.

What impact might Xerox have on metal AM?

From a technical perspective, Xerox’s acquisition makes some sense. The company has a longstanding history in inkjet technology, and has been a long time supplier of various elements of this technology to other 3D printer manufacturers who use it in their own printers. Vader’s technology is based on some of the same tenants of inkjet printing, with the inherent (theoretical) scalability that comes with it. With that in mind, a lot of my thoughts on how to answer the question of “will Xerox shake up the metal additive manufacturing market” end up circling back to “what are the reasonable expectations for inkjet-oriented technologies to compete against fusion or extrusion based technologies?”

There’s no easy way to answer or opine on that in a blog post, but for now, I’ve made a few observations and formed some opinions that have started to shape my thoughts on Xerox’s potential impact (keeping in mind that more concrete details are still to come).

First, the primary statements regarding Xerox’s own motives for the Vader acquisition (and apparently it’s overall upcoming 3D printing activities that will be revealed in more detail), are based on the perception that, “manufacturing customers want to use 3D printing, but the current offerings only serve the prototyping market well, not broad manufacturing.

I consider this a very risky statement to put forth as the bases for a large investment and business strategy as this this perception is becoming rapidly outdated.   I would argue that manufacturing customers are using current 3D printing technologies and they want to use them more as they are able to overcome production challenges.  Suppliers and customers are increasingly messaging parts production in their AM efforts.

Xerox is also staking its position in metal AM on a technology that is decidedly not impacting the broader AM market as of yet. While there is an argument to be made for going with an outsider whose technology matches up closely with your own expertise, at this time I believe that the manufacturing community at large is ready to buy into a specific metal AM manufacturing process and work at fine tuning their processes and technologies to advance. To this end, technologies like powder bed fusion, and metal binder jetting have exponentially greater support in terms of end-to-end solutions.

There also comes a point where switching and experimenting with other metal AM methods provides diminishing returns for manufacturing customers. Xerox will have to sell the most influential users of metal AM today on a new process and at a time when we’re seeing such strong momentum behind some of the existing and more widely adopted methods.

While for now I retain a healthy amount of skepticism about Xerox’ potential success in metal additive manufacturing. I look forward to learning more about the specific solutions Xerox will bring in 2019 and beyond.

By Scott Dunham – Vice President, SmarTech Publishing

 

 

Henkel European hub for 3D printing technology opens in Dublin, as company eyes production

As we reported late last year, adhesive and materials giant Henkel was working on a multi-million dollar 3D printing research facility. The company has now finished and officially opened the Henkel European hub for 3D printing and Innovation and Interaction Center (IIC) at its Tallaght site near Dublin, Ireland.

The IIC, which is the first in a new generation of global industrial customer centers, is set to become Henkel’s European regional hub for technical presentations, demonstrations, training, testing as well as customer service for 3D printing solutions. During the official inauguration Henkel welcomed the Irish Minister of State for Housing and Urban Renewal, Damien English, representatives from governmental organizations in Ireland as well as customers and senior management of its ecosystem partners Carbon and HP.

As demonstrated by its close collaboration with two of the 3D printing hardware companies that are most focused on AM for final part production, Henkel is looking to use its expertise in transforming industrial manufacturing processes to drive adoption in the rapidly growing market for additive manufacturing, beyond prototyping to final parts production.

Based on strategic partnerships with technology leaders, the Adhesive Technologies business unit offers end-to-end solutions for 3D printing to its customers, including novel materials, specialized equipment and a broad portfolio of customized post-processing solutions.

Henkel European hub for 3D printing
Henkel 3D printing Display, Dublin.
Picture Colm Mahady / Fennells – Copyright© Fennell Photography 2018.

Expanding AM R&D

To further expand its R&D and application capabilities globally the company is investing into new regional innovation and customer centers. The IIC in Dublin, which is in proximity to the existing R&D and production facility for 3D printing Loctite resins, comprises laboratories, customer service offices, meeting rooms and 3D Printing facilities. It is equipped with Carbon and HP printers in addition to specialized Henkel equipment, technology and devices.

As the European hub for the technology, the IIC has been designed to excite and engage Henkel’s customers across various industries such as medical devices, automotive, consumer goods and manufacturing to discover and use Henkel´s high-impact solutions for transforming final parts production.

“The opening of our first Innovation and Interaction Center in Ireland will further strengthen our expertise and capabilities to bring 3D Printing solutions into manufacturing processes of our broad customer base,” explained Michael Todd, Global Head of Innovation at Henkel Adhesive Technologies, during the event.

“The close connection to our scientists and engineers as well as to the production will enable us to accelerate the development of new solutions for our customers and will foster the identification and realization of tailor-made 3D Printing applications across industries,” Philipp Loosen, Head of 3D Printing at Henkel Adhesive Technologies, added.

This appears to be only the beginning, as later this year Henkel is expected to open two more regional centers for 3D printing, one in Rocky Hill for North America and another one in Shanghai for Asia.

EU commits to fast-tracking additive manufacturing industrialization at AMEC 2018

Bigger fiscal and R&D incentives, bolder standardization efforts and caution before legislating are needed to speed up additive manufacturing deployment in Europe. This was the main message emerging from the AMEC 2018, the Additive Manufacturing European Conference, which took place in Brussels and was co-hosted by Members of European Parliament (MEPs) from some of the …

The post EU commits to fast-tracking additive manufacturing industrialization at AMEC 2018 appeared first on 3D Printing Media Network.

Concorci and Leitat build Catalonia advanced manufacturing hub for 3D printing

The Consorci de la Zona Franca de Barcelona, Leitat and Fundación INCYDE have revealed the launch of a High-Tech 3D Incubator Project to be housed in the Barcelona Free Trade Zone and financed with European Regional Development Funds. The bid has been provisionally approved by the INCYDE Operations Selection Committee. According to State Delegate in …

The post Concorci and Leitat build Catalonia advanced manufacturing hub for 3D printing appeared first on 3D Printing Media Network.