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3D printing has been hailed as a potentially game-changing technology for different industries. Biomedical applications, in particular, have garnered much attention when patients were able to receive 3D-printed, customized, lifesaving medical interventions. But aside from these niche markets for personalized medical devices, can 3D printing ever become mainstream in health care? This article, a guest column from leaders at the Boston Consulting Group, explores what the benefits of 3D-printed devices are and how they are driving the uptake of this technology. It also assesses how fast this adoption is happening and evaluates how – and in which biomedical applications and device markets – 3D printing could best enhance products and allow medtech manufacturers to grow their business.

 

 

THE 3D PRINTING REVOLUTION IS UNFOLDING IN THE BIOMEDICAL ARENA 

 

 

 

The buzz around 3D printing is growing increasingly louder and the market opportunity this technology can bring to medtech manufacturers is certainly real. The global market for joint reconstruction and replacement is expected to increase to $16bn by 2018. The global market for prescription lenses is valued at approximately $13bn today. Spinal implants are a $9bn market. All of these clinical areas have the potential to be enhanced by 3D-printing technologies.

 

 

3D printing has already demonstrated its value across a wide range of industries beyond health care. Companies are using 3D printing to develop products with complex designs that are difficult or impossible to create using traditional manufacturing approaches. These companies better manage the cost of goods sold by eliminating post-processing and assembly steps. And they cost-effectively create "units of one" on demand, since 3D-printing costs remains relatively stable regardless of how many units are printed (unlike casting or injection molding). The ease of one-off printing has historically allowed many companies to use 3D printing for prototyping. In the biomedical field, these benefits (see Figure 1) translate into the following specific value drivers:

 

 

  • Increase productivity. With 3D printers, companies can perform rapid prototyping to create new designs more quickly and enable faster decision-making; the technology makes it much easier to engage "end users" earlier in the product development process. 3D printing also enables novel tools that can make testing more effective and lower costs. Bioprinted cell culture and tissue assays for research and drug testing offer an exciting example of the ways prototyping with 3D printers can help biomedical companies get products to market more quickly.

 

 

 

  • Optimize supply chain. Because products are custom-made with 3D printing, the process reduces waste and scrap material (as opposed to subtractive approaches, like milling). 3D printing can also lower labor costs by reducing the amount of assembly retooling or pre- and post-processing required. The availability of "onsite printing" may also help reduce inventory and simplify logistics. If medical equipment and devices are printed directly in a hospital, for example, it reduces the need for routing from a central facility (which involves field reps, in many instances) and storing inventory onsite. However, foolproof onsite printing solutions will be required to overcome regulatory concerns about patient safety.

 

 

 

  • Revolutionize standard of care. By making products that cannot be manufactured in any other way, 3D printing has the potential to revolutionize the standard of care by addressing previously unmet needs. Take hearing-aid shells, for example. Introduced in 2004, customized hearing aid shells were one of the first commercially relevant 3D-printed end-use parts, and they are now incorporated in most hearing aids sold each year. Because they can be customized, and therefore provide a much better fit, they offer a compelling value proposition for patients.

 

 

  • Change how care is delivered. With 3D printing we will see more products being made directly at the point-of-care, possibly accelerating treatment and reducing the number of visits for patients. 3D printing can also offer less costly alternatives to standard treatments, making advanced medical treatment more widely accessible. 3D-printed prescription glasses for example, could eventually be printed on-demand in a store, at low cost, and in any style imaginable, whether as a fashion statement for customers who want one-of-a-kind designs or as a low-cost option in emerging markets.

 

 

Steady Flow, Not Flood, Of Products

 

While we are seeing a steady flow of new 3D-printed biomedical products entering the market, the absolute number is still relatively low: more likely in the dozens, rather than in the hundreds or thousands. Many have only recently gained regulatory approval and their uptake in the medical community has not yet been established.

 

 

For a 3D-printing application to be successful in the medical domain, it needs to provide value in multiple areas. For example, dental clear aligners are a prime example of what we would call a 3D-enabled "killer app." It’s a patient-customized product ("unit of one"); it needs to be regularly replaced over an extended period of time (multiple units per patient drive up overall volumes); it is a substitute for a costly and painful incumbent solution (metal braces that require an orthodontist's skills to be inserted and maintained) with a more pleasant treatment for the patient, both clinically and aesthetically; and it can be cost-effectively achieved with 3D printing, and only with 3D printing.

 

 

There is a simple reason why we have not seen equally compelling examples to date; it is quite difficult to come up with a 3D-printed product or solution that effectively addresses a significant unmet clinical need, and does so in a cost-effective fashion. However, with 3D technology rapidly advancing, the playing field is getting steadily bigger, and more products approach the sweet spot of 3D printing.

 

 

Each new 3D-printed application enters the market with a very specific value proposition; therefore, we expect 3D printing to transform health care one application at a time (rather than transforming an entire manufacturing ecosystem broadly and fundamentally, like the steam engine or conveyor belt).

 

 

While hundreds of applications are in the early development and pilot stage, they are not yet commercially available. This is an important distinction that is too often blurred. It’s important to take stock of what’s “real” in the biomedical industry. In this article, a "real" biomedical application is defined as one that has been approved or cleared by US FDA (or equivalent bodies in Europe and around the globe) and is commercially available.

 

 

Figure 2 highlights the commercially viable applications for 3D printing that exist in health care today, and assess their current level of maturity and adoption, the market opportunity, and barriers to entry.

 

 

Top 4 High-Potential Applications

 

Of all biomedical applications in use today, we expect 3D printing to make the biggest impact in following four areas over the next five to ten years: orthopedic products, dental products, cranial and facial implants, and patient-specific surgical guides and medical models (the models, custom-made from medical images, serve as highly accurate reproductions of a patient’s anatomy).

 

 

Orthopedic products. In orthopedics, 3D printing is currently used primarily for hip implants, spinal implants, customized knee replacement, orthotics and prosthetics.

 

 

  • Hip implants: Hip implants are among the more established 3D-printed biomedical products available today. They have been commercially available from several manufacturers, including Lima Corporate, Adler Ortho and Exactech, for almost a decade. 3D-printed hip implants have an important advantage over conventional cups. While conventional cups require the costly step of applying a porous coating to promote bone in-growth, a cup manufactured through 3D printing can include porous surface structures without requiring a special coating, which significantly decreases unit production costs.

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  • Spine implants: Like hip implants, 3D-printed spine implants offer a unique value proposition because they include a porous structure that stimulates bone growth (without requiring a special coating). They also offer improved radiographic visibility, implant stability, and surgical outcomes, though it has not yet been established how they perform over the long term. Several new products have gained regulatory approval, including implants from 4WEB, joimax, K2M, Medicrea, Renovis and Stryker. A 3D-printed titanium device targeted at the cervical spine recently gained publicity after being used for lifesaving surgeries through FDA's emergency use authorization program.

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  • Personalized knee replacement: Close to 700,000 knee replacements are now performed in the US each year – and this number is projected to grow to 3.5 million by 2030. Approximately 90% of the knee-replacement market is controlled by established medtech players. While these companies’ products are not fully customized, the implants are offered in different sizes. A fully patient-customized, 3D-printed knee has been available for several years from ConforMIS, but it has gained limited traction thus far. Many manufacturers and clinicians report that existing knee implants are “good enough” for the majority of patients, and the long-term cost-benefit equation of a fully customized system has yet to be established. We expect the debate about the clinical advantages of custom versus non-custom knee replacements to continue.

 

 

  • Orthotics: Over-the-counter foot insoles are already highly commoditized, but 3D-printed prescription orthotics may have some growth potential. Start-up companies already offer 3D-polymer insoles online. The foot can be assessed via smartphone photo, and 3D-printed custom orthotics are produced and delivered quickly. As of now, 3D-printed orthotics only serve simple indications, such as plantar fasciitis and bunions. However, the strong growth areas in the orthotics market come from other medical indications, such as diabetes, rheumatoid arthritis, and ankle foot orthotics for indications such as drop foot. Because these more complex indications typically require a prescription, they are currently still handled by more established players rather than 3D-printing providers.

 

 

  • Prosthetics: A small number of 3D-printing players are active in the prosthetics market. It is hard to estimate the specific market for prosthetics since the actual prosthetic (the hardware) is typically bundled in combination with patient treatment (such as fitting, rehabilitation and physical therapy), and therefore its market value cannot be easily calculated as a standalone product. The demand for prosthetics will likely drop in the coming years as medical advancements in vascular disease (which cause more than 50% of amputations) continue to emerge. Further, people who need a prosthetic are typically primarily interested in features such as myoelectric control and limb sensation (that is, the hardware and electronics in prosthetics), and less concerned with whether the prosthetic is 3D-printed or not.

 

 

Dental products. The dental segment represents the greatest breakout success for biomedical 3D printing to date. Millions of clear aligners from companies like Invisalign and ClearCorrect are created with the help of 3D printers each year and they are expected to continue to be a major area of growth. In addition to clear aligners, 3D printing is also used for dental implant suprastructures, screws, and abutments. Dental labs are also using 3D printing to make stone models for dental caps, crowns, and bridges; this will remain an important application for 3D printing, but further growth from stone models will be limited in the near term. Some first movers have begun to experiment – not just with models – but with 3D printing dental caps, crowns and bridges directly, and this has potential to go mainstream. For example, it is already possible to 3D-print the metal copings for dental caps and bridges, or entire crowns and bridges for temporary use. However, matching the durability and aesthetics of existing products across the spectrum of dental restoration will remain a challenge for 3D-printed products for some time to come.

 

 

Cranial and facial implants. Two platforms are commercially relevant for cranio-maxillofacial (CMF) implants: polyetherketoneketone (PEKK)-based implants used for skull or facial reconstruction, and bioresorbable implants used as bone fillers for skeletal reconstruction and bone regeneration.

 

 

  • PEKK-based CMF implants: The US-based company, Oxford Performance Materials (OPM), developed a proprietary process to create customized 3D-printed implants for cranial, facial and spinal reconstruction. The 3D-printing process offers biocompatibility, radiolucency and bonelike mechanics and behavior. Studies have also shown superior bone in-growth due to the product’s microtextured surface.

 

 

  • Bioresorbable CMF implants: Two products are currently available on the market: 3D-printed bioresorbable implants used to cover burr holes and repair fractures and 3D-printed bone filler used to repair neurosurgical burr holes. These 3D-printed implants are designed to be porous in order to facilitate bone healing, and they don’t require metal plating as reinforcement, which means they can be used as an alternative to bone harvested from the patient for complex skeletal reconstruction. The implants can also be customized to fit a patient’s anatomy. We do see long-term potential for 3D-printed bioscaffolds beyond CMF applications and we address advances in this area in the “implantable organs” section (below).

 

 

Surgical guides and medical models. 3D printing enables physicians to visualize a patient’s unique anatomical details and create personalized, patient-specific guides for complex surgical procedures. These surgical guides can help surgeons better identify entry points, screw trajectories and implant specifications in order to improve accuracy, efficiency and outcomes. The primary application for surgical guides is in orthopedics. In addition, 3D-printed medical models can be used in place of animal models, cadavers and mannequins to test new biomedical products and train physicians. It can also be used in surgical preplanning, which represents an exciting opportunity that could enhance many surgical interventions. The primary use cases for medical models today are:

 

 

  • Product validation and verification: 3D-printed products can be used to simulate a clinical environment, allowing medical companies to test products on realistic patient anatomy before clinical trials and better understand how the product performs. This helps companies validate concepts quickly and get products to market faster.

 

 

  • Physician training and education: Physician training is severely limited by the drawbacks of working with animal models, cadavers and mannequins. These models can be expensive, difficult to obtain, and not sufficiently representative of human anatomy. The 3D-printed models, on the other hand, are based on real human anatomy, readily available, modifiable to simulate a range of anatomies and pathologies, and usable in any environment.

 

 

  • Surgical preplanning: Medical models created through 3D printing allow physicians to optimize the therapeutic approach before ever stepping foot in the operating room. 3D-printed surgical models simulate live tissues, provide an unobstructed view of a patient’s unique anatomy, and offer physical, spatial and tactile orientations that can’t be matched by computer models. (See box.)

 

 

 

Looking Ahead

 

As 3D-printing technologies become more sophisticated, new materials become available, and prices fall, we will see even more novel applications emerge – and some of them could be groundbreaking. Bioprinted assays for research and drug testing, complex implantable organs, and 3D-printed drugs and drug delivery devices offer just three examples of the ways 3D printing have the potential to dramatically change the future of medicine in the long-term:

 

 

  • Bioprinted assays for research and drug testing: In 2014, the US-based company Organovo commercialized the ExVive 3D Bioprinted Human Liver Tissues – the first such assay on the market. Companies worldwide are building proprietary bioprinting platforms to create 3D cell cultures and tissues that mimic elements of human organs. In the long term these will serve as valuable tools to complement in vitro testing, animal testing and clinical studies. However, there likely won't be a broad impact right away, since it is very difficult to meet the high standards for validation and reproducibility when dealing with living materials. Also, biologic structures can take days or weeks to generate, and require specific skill and infrastructure to keep them alive and functional. In the absence of suitable standardization and automation technology, bioprinted products will not be easily mass-produced in the near-term.

 

 

  • Complex implantable organs: Several research centers have successfully created bioprinted organ tissues, including skin, bladders, tendons, and heart valves. Since 2012, 3D-printed tracheal splints have been successfully implanted and research is being conducted to use these tracheal splints as scaffolds combined with human stem cells. In addition, the solid-organ transplant market is tremendous. In the US alone, approximately 100,000 patients await kidney transplants, while only approximately 17,000 transplants are performed each year. Organovo claims they are three to five years away from clinical trials for 3D-bioprinted human liver tissue for direct transplantation to patients. That said, there are major technological barriers in the development of entire transplantable organs and it may take decades before these become available.

 

 

  • 3D-printed drugs and drug delivery devices:FDA has already approved a 3D-printed prescription pill for consumer use: Spritam, a medication used to treat certain types of seizures caused by epilepsy. The pill disintegrates easily when added to liquid and is therefore easier to swallow – an important benefit for patients who have difficulty swallowing hard pills (such as infants or stroke victims). The long-term potential for 3D-printed drugs is extremely promising as it opens the door for personalized medicine. Instead of a one-size-fits-all pill, companies can readily manufacture patient-specific doses or a single bespoke pill to replace difficult combination therapies. It’s even conceivable that consumers could one day print their own medicines at home. Regulatory approval will undoubtedly present a hurdle that will slow the commercialization process for 3D-printed drugs.

 

 

There are a number of other applications of 3D printing that may be relevant in niche markets, as well as many additional examples that we have not yet even imagined.

 

 

The 3D printing revolution in health care is happening – one application at a time. While dental clear aligners may have been the first killer app in health care, they won’t be the last. Health care companies need to keep their eyes open and be prepared to act swiftly when opportunity knocks.

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