An Examination of 3D Printing and Business Model Disruption in Medical Devices

With our latest study of medical 3D printing markets, SmarTech has chose to focus on a set of interesting medical device applications which, while on the surface appear to be quite different from one another, all share one important thing in common –they can teach us very important lessons about 3D printing’s ability to potentially alter the underlying structure and supply chains of a market. Other major medical applications in 3D printing are focused specifically on surgical care. Of course, 3D printing can also effectively target medical devices which have a much greater degree of consumer interaction in the value chain, and this is where things get interesting, especially in the case of hearing aids, orthotic insoles, orthotic braces, and prosthetic devices. It’s these aforementioned devices which we’ve decided to focus on in the report.

To begin a quick comparison of 3D printing’s potential to disrupt these particular markets, let’s look into the world of hearing aids.

Hearing Aids – Minor Disruption from Underutilization of Print Technologies

Christian Sandstrom, an associate of the Ratio Institute in Sweden, produced a study of the implications of adoption of 3D printing within the hearing aid industry in late 2015 which arrived at some interesting conclusions. He proposed that, because 3D printers and related solutions were widely available at their time of adoption, and because the hearing aid industry was highly consolidated already, 3D printing had relatively little total disruptive effect on the hearing aid industry. Major players were all able to transition to producing custom hearing aid shells with printers, and because the design of the actual products stayed more or less the same, relatively little competencies were destroyed as a result.

What is interesting to note, however, is that Sandstrom also makes sure to include the feedback from leaders in the audiology industry that 3D printing technology still has quite a lot of untapped potential to offer in terms of optimizing hearing aids. Since the study’s publication, there may be mounting evidence to point to in this regard. First, Phonak has recently utilized metal additive manufacturing for the first time in commercial production of a new hearing aid shell, which allows them to make their smallest hearing aid ever with additively manufactured titanium. Though customers predominantly desire a custom hearing aid, today the majority end up with non-custom products pushed by the industry because they are higher margin. Meanwhile, more and more companies are now utilizing 3D printing to produce other elements of non-custom hearing aids, which is leading to an increased overall penetration of the technology in production as the industry as a whole has shifted to non-custom products over the last decade. The greater degree to which additive technologies can be used to produce the end product, the greater the disruptive potential to an industry.

With relatively little disruption through the adoption of 3D printing in the hearing aid industry today, but some argument to suggest it may increase in the future, let’s compare two other medical device areas which are providing significantly greater chances for major changes through use of 3D printing.

Orthotics – Major Potential for Disruption Thanks to Total Digital Solution

In the area of 3D printed orthotic insoles, another excellent study was produced in late 2016 by Dr. Simon Spooner of Peninsula Podiatry in the United Kingdom and published in Podiatry Today which compared the potential cost effectiveness and overall disruptive potential of 3D printing in the foot orthosis industry. The study suggested that there were few advantages to utilizing 3D printing for orthosis production at industrial scale compared to other digital subtractive CADCAM (milling) technologies. However, the study itself relied on previously published works from 2011 and 2012 which were based on the capabilities and cost profiles of older technology, and also acknowledged that the existing body of academic study in this regard was lacking in direct comparability. The study did however conclude that 3D printing had an interesting potential to impact the existing business model of orthotic insoles.

Today, operations such as Wiiv provide consumers with a fully digitized solution for custom orthotic insoles, allowing the consumer to utilize their own smartphone to capture key anatomical data which is then automatically converted into the necessary design for the insole, matched to the shape of the foot. The insole base is produced via powder bed fusion and shipped to the consumer for $99 a pair. Compared to existing “custom” orthotic products and how these are ultimately dispensed to consumers, what 3D printing and a fully digital solution can provide is astounding. Most truly custom orthotic insole products dispensed by podiatrists cost several hundred dollars, and require multiple visits to a podiatrist. Clearly, there is some potential for disruption not only on the basis of cost (assuming quality is comparable to traditionally made products), but also in the underlying acquisition process. Dr. Spooner begins to recognize this potential at the end of his study, noting that the role of an orthotic laboratory and podiatrist could change significantly in the future.

Prosthetics – Enormous Disruptive Potential from Radical Redesign Potential

Finally, in the area of prosthetics, 3D printing has already been shown to have the potential to be barrier-busting, with thousands of functional upper extremity prosthetic hands already having been produced and now in use with children and adults. In a video recorded by e-Nable contributor Jeremy Simon in 2014, an amputee gives his thoughts on the ~$500 3D printed prosthetic he had recently been provided with his existing solution (which, by the way, cost around $40,000). The printed device clearly provides improved functional elements with fully articulating fingers, and while most would agree that today’s printed hand prosthetics can be challenging in robust durability and continued long term function, existing prosthetics costing tens of thousands of dollars are generally accepted to only have a useful life of three to five years before they need to be replaced as well.

Use of 3D printing for prosthetics is limited today commercially, with a great focus being put on compassionate use which leverages the digital nature and disruptive cost profile of printing to get functional prosthetics to those who have simply been priced out of an existing solution. But the long term implications are clear –with the right designs and technologies, printing of prosthetics can provide a solution that no other method in the industry can. It’s only a matter of time before this is leveraged in a more commercial manner to impact markets. Currently, startups like Mecuris are already getting started producing robust, fully printed foot prosthetics using high end powder bed fusion technology to produce an entire prosthetic foot in a single part.

3D-Disruption Not Always Measured in Dollars and Cents

Looking back at these three medical device areas of application, the moral of the story is clear; medical devices can be effectively redesigned to leverage digital production via 3D printing to improve functionality, access to devices through cost reduction, or some combination of both. The greater degree to which printing can produce critical components of a device or aggregate them into a new design, the greater the disruptive potential. For now, 3D printing’s impact in these areas has been either niche based on limited commercial implementations, or largely un-disruptive because the technology is only being leveraged in the scope of a traditional approach to manufacturing (such as in the case of printing hearing aid shells). But in the future, we suspect that printing will continue to upend traditional business models in many medical device markets, with implications not only to the manufacturers of such devices, but to the broader medical community involved in their dispensation and management as well.

Business Model Disruption in Medical Devices

Source: SmarTech Publishing, Opportunities for Additive Manufacturing in Medical Devices – Prosthetics, Orthotics, and Audiology

Seen above, the total market value of printed devices from the standpoint of economic impact doesn’t tell the whole story. With 3D printing providing significant cost savings in certain device applications to include prosthetics and orthotics when leveraged in an all-encompassing way through effective design, the real disruptive impacts become measured less purely by dollars and cents, and more by how the industry structure could be impacted –from manufacturing to patient-provider care.

In order to best understand and prepare for the impacts which healthcare-related 3D printing applications are having on patient care and medical device design, SmarTech is hosting its first ever conference in conjunction with 3Dprint.com called Additive Manufacturing Strategies. To learn more about the conference and how leaders from the healthcare printing industry are leveraging 3D printing, visit https://www.additivemanufacturingstrategies.com.

Primary Elements of Next Generation 3D Printing Software

The future of 3D printing software is in unified tools which encompass all of the critical features scattered throughout today’s printing software chain in highly functional software environments. Additive manufacturing build environment software has years of development and is continuing to evolve to resemble CAM for 3D printing.

Additively-intelligent design environments are being developed on the concepts of process simulation and generative design. The AM process monitoring software environment uses simulation and in-situ data collection to inform the ongoing development of the build and design environments.

Combined, these three areas of software development represent the primary elements of tomorrow’s 3D printing software.

Generation 3D Printing Software

 

3D Printing for Medical and Dental Solutions – A Major 2018 Opportunity

Everybody in the 3D printing industry knows that printing for medical and dental markets is a longstanding area of commercial application –in fact, use of printers in these industries is amongst the oldest known use cases for technologies like stereolithography and laser sintering. For two decades, there have been a relatively narrow set of high value applications commercialized across various areas of healthcare, but those have helped create the backbone of today’s 3D printing industry and have propelled a number of key industry stakeholders to their current prominent position in the industry. Materialise, 3D Systems, Stratasys, EnvisionTEC, and EOS all come to mind.

The talk of the proverbial town for the last few years, however, has been all about the transitioning of various 3D printing technologies to “manufacturing” applications. What most of these conversations really are referring to is the adaptation of printing solutions –printers, materials, and software –to produce parts to be used in real products. There’s also a general understanding during these conversations that print technology for manufacturing would be producing such end-use parts in high volumes.

This calls to mind two broad areas of potential adoption which the industry at large is now working to develop attractive solutions for –consumer products manufacturers, and various industrial equipment and product manufacturers. Because much of the value proposition is being tied to ‘high value’ parts which can benefit from redesign to bring cost and performance benefits, industrial markets are getting a lot of attention when it comes to the development and marketing of the future of 3D printing/additive manufacturing.

Such a shift in focus to the industrial markets and related manufacturing applications has left the industry in a state of flux, with overall market growth in hardware responding accordingly. Outright growth has slowed somewhat while the effects of such a change cause ripple effects. During this period, however, we would call back the attention to the healthcare segment, where growth in 3D printing appears to continue to be flourishing and advancing in an increasingly differentiated way; one that may be highly attractive to stakeholders in both the short and long term.

According to our purpose-built market models, developed individually to capture the unique intricacies of each segment of healthcare 3D printing, the combined medical and dental markets for 3D printing will be worth an estimated $3.0B by the end of this year (a large portion of this being associated with printing and engineering services across both dental laboratories and outsourced medical manufacturers). In the primary segments consisting of just printer sales, material sales, and related software solutions, the opportunity is estimated to be some $740M.

Medical 3D Printing Question & Answer By SmarTech Publishing

Source: SmarTech Publishing

Healthcare 3D printing represents an attractive segment for both short and long term growth for a number of reasons. First, the breadth of applications across medical and dental segments are well served by today’s existing technologies, in some cases through the development of special medical materials. Printed components are sized relative to the human body, and thus can be manufactured by most systems, with a number of applications seeing print volumes globally of hundreds of thousands, to millions of components per year. Many applications are also highly valuable without the need for significant robust mechanical performance or resistant properties, including medical and dental models, surgical guides, custom instrumentation, and short to medium term prosthetics. Both low cost and professional 3D printers are often utilized today in both medical and dental markets, bringing a wide range of potentially disruptive cost benefits. Finally, healthcare applications are the continued subject of significant well funded medical research.

As a result of the ongoing opportunities in healthcare related 3D printing, SmarTech Publishing has partnered with 3Dprint.com to bring key stakeholders in the industry together at a new business and investment summit titled Additive Manufacturing Strategies – The Future of 3D Printing in Medicine and DentistryThe conference, to be held in January of 2018, brings together all of collective leaders in medical and dental 3D printing to present strategic guidance and developments specific to healthcare 3D printing, powered by SmarTech’s ongoing analysis of the segment.

What’s the Big Deal with Additive Manufacturing Process Simulation Software?

This blog is a continuation of a multi-part blog series, following up the previous installment titled The Role of 3D Printing Software in Realizing the Dream of Advanced Digital Manufacturing. If you haven’t checked out that one yet, do yourself a favor and go read it. It will put into context the basis for this piece, which is a quick discussion of very important (and emerging) area of 3D printing software for the future.

If you’ve been paying attention to the 3D printing software space in the last year or two, you’ve probably noticed a whole lot of talk related to ‘simulation’ software tools. Although a lot of the work that has laid the foundation for several early commercial projects now on the market for additive simulation have been under development for a number of years, chatter about this corner of the software market with regards to 3D printing might seem like it’s come out of nowhere. Manufacturing simulation software tools aren’t anything new –the concept of simulating various elements of the design and manufacturing process of parts has been around for many years. Why all of the recent attention from this community of manufacturing software developers on additive?

The answer, as you can guess, is probably somewhat more complex than what I’m about to offer, but for the sake of simplicity, there are likely two primary reasons.

First, metal additive manufacturing technologies have become significantly more adopted in the arena of high value, complex, production parts within the last three years thanks primarily to the aerospace industry. With a few well known components now in various stages of implementation and production in this area, other industries are quickly beginning to scale up as well. This has naturally moved the process into the sights of worldwide CADCAM and PLM software giants, whom already provide a number of simulation based software tools to manufacturing clients.

The other, more important reason follows the theme of this blog series laid out in the last installment, which is the theory that additive manufacturing or 3D printing is the digital manufacturing process of the future. This means that, though other methods of manufacturing can indeed be included as a digitized process today, additive processes posses the greatest potential to realize the true benefits of digital manufacturing overall.

So, what’s the big deal with additive manufacturing simulation software? Well, let’s dive just a little bit deeper and explore some more themes from SmarTech’s latest market research report on 3D printing software. Simulation software is a big focus for 3D printing software development for two big reasons.

The first one is a bit obvious at this point, and is best demonstrated in the area of metal additive manufacturing –and especially metal powder bed fusion. In fact, there are about a half dozen tools currently in some form of early commercial development which are focusing primarily on simulating this process.

This is because the current standard of use for metal powder bed fusion technology comes with a number of complex technical challenges that usually end up resulting in extra time and costs, reducing the benefits of AM –sometimes considerably. Failed builds using metal powder bed fusion result from a lack of visibility between design changes or build set-up through to the actual building of the part. Without a way to simulate the additive process, engineers make design changes essentially blind to the potential for the design or set-up decisions they make to make the build fail –resulting in huge delays and cost increases. Of course, there is a correction for this which certain companies in the industry are now becoming quite good at –experience through trial and error (and again, lots of wasted money and slow implementation).

Today’s tools seek to give users of metal additive manufacturing a way to gain insight on their design and build set up strategies and decisions in order to reduce or eliminate potential failures, before the manufacturing or printing even begins. This is important because it removes the barrier of process specific experience that is currently required and limiting adoption of additive manufacturing technologies to a select few organizations.

This primary reason is the path to fast adoption of such software tools, and one of the reasons we see AM process simulation software growing from less than $5M part of the chain today, to nearly a $170M portion of the 3D printing software market by 2027.  But that figure actually doesn’t speak to the second second area of integration for simulation-based software technologies in AM’s future –one that has perhaps even larger implications.

One of the reasons we believe additive manufacturing/3D printing is the digital manufacturing technology is because today’s additive processes have the greatest potential for digital control compared to incumbent subtractive technologies. Not only is the actual geometric shape of the part being formed under digital control, but the actual material properties of the part are also being formed digitally in the same process. Material properties in AM can be influenced both by geometry through complex designs only possible through AM, and also through microstructural control as the material itself is fused, melted, or otherwise distributed in a volume of space.

Because of the potential to control the entirety of the manufacturing process in a digital manner (rather than just the shaping of the part), simulation tools can potentially realize even greater benefits than ever before. It can be leveraged during the design process to automate and inform engineers intelligently, while providing a means of “digital certification” for parts. On the back end, it can be paired with emerging in-situ process monitoring capabilities of additive machines to confirm the expected simulated outcomes with real time build data. The latter two components can be finally combined with digital inspection software to form a concept that we call the ‘AM Quality Assurance Continuum’ powered by software, visualized below.

AM Process Simulation Software

Clearly, additive process simulation is a big deal for the future of AM. In the next and final installment of this series,  we explore the final piece of the concept for The Role of 3D Printing Software in Realizing the Dream of Advanced Digital Manufacturing –how 3D printing and process simulation software combine to enable the future of generative design and digital manufacturing.

3D Printing Software & Realizing the Dream of Advanced Digital Manufacturing

Note from Scott Dunham, Vice President of Additive Manufacturing Research at SmarTech

3D printing technology is often heralded as a digital manufacturing technology. And for some reason, this really gets a lot of people excited. What’s the big deal? 3D printing takes a digitally designed ‘part’ in the form of a converted CAD file, and then makes the part in an automated and computer controlled process. So what? The world has been using computer controlled manufacturing technologies for a long time.

What if I now told you that 3D printing technology is not only digital manufacturing technology, but it is the digital manufacturing technology. Well, obviously this wouldn’t really be true, for a couple reasons. First off, we just established that digital manufacturing has been in existence and widely utilized for some time. Secondly, a lot of what is 3D printed today doesn’t really qualify under “manufacturing” in the context of fabrication of production parts going into products and systems as a final component.

And yet, I would still stand by that statement -3D printing is indeed the digital manufacturing technology. At least for the future. How? This is where 3D printing software comes in to really expand the idea.

Making a model or a prototype or a final use part using a computer controlled technology isn’t the revolution. The revolution is in applying vastly available digital resources to empower manufacturing. Things like near-infinite cloud computing power. 3D printing is the digital manufacturing technology because physics-based limitations are alleviated, and the ability to actually digitally control the manufacturing process is increased by orders of magnitude, all through the concept of layer-by-layer manufacturing. In fact, don’t think about 3D printing processes like metal powder bed fusion or photopolymerization as ‘building parts,’ think about them as ‘distributing mass in a volume of physical space.’

Software is often referred to as the glue which holds together the hardware and materials in 3D printing. But for the future, not only is it the glue connecting these two other elements, but it will also become the catalyst by which the potential of advanced digital manufacturing can be realized. In our latest report for software for 3D printing, SmarTech explores the current efforts to actualize through 3D printing digital manufacturing software concepts which have existed for nearly a decade or more, but which haven’t yet been able to be fully exploited. Thanks to additive manufacturing, all of that will change.

This is the first in a multi-part series of blogs which lay out how the world of manufacturing will change through a digital manufacturing revolution powered by additive, and catalyzed by software. We aren’t simply talking about designing digitally and then using computers to control a machine to fabricate the design. We’re talking about totally rethinking how parts and products are designed, function, optimized, made, qualified, and certified.