Many years ago, I first encountered 3D printing (a.k.a. additive manufacturing) at the Radiological Society of North America (RSNA). I remember the 3D-printed anatomical models passed around during the presentation: one for presurgical planning for a complicated meningioma involving adjacent vital blood vessels, and the other for congenital heart disease with various visualization orientations created through creative modular design. That was the eureka moment when I understood that while radiologists sit at the interface of the digital world (CT, MRI, US data) and physical world, 3D printing and perhaps its extension like AR/VR, can provide the ultimate bridge to understand and create new realities for the medical industry. However, the ecosystem of healthcare 3D printing was not yet formalized, and I founded 3DHEALS to help me and others with the struggles of early adaptors. This blog post serves as a resource center to organize all the past knowledge industrial experts and 3DHEALS have collected and shared. They include our way of dissecting the concept of “healthcare 3D printing”, basic concepts that most of you will need to know, and how to dive deeper into this fascinating world that we all grow to love. We will keep updating this Healthcare 3D Printing Resource Center page as they come in. Please feel free to send your request on what needs to be included to: email@example.com.
A few big concepts to know about healthcare 3D printing
What is 3D printing?
3D printing, also known as additive manufacturing or rapid prototyping, has been around for more than half a century. It’s the process of creating three-dimensional objects by adding material layer by layer to form a solid object. The technology was first used in the aerospace industry and then later applied to other industries such as aerospace, automobile, architecture, engineering, dentistry, medicine, and even fashion design. In healthcare, 3D printing can be used to produce medical devices, prosthetics, implants, and surgical guides. Lately, with the scientific advancements, an emerging field using both 3D printing technologies and tissue engineering to create biological scaffolds or cell-embedded 3D models simulating human tissues has also taken off as a related but distinct branch, called bioprinting (or 3D bioprinting), in the past two decades [Thayer, Martinez, Gatenholm]. While its end goal is much more complex than conventional 3D printing, bioprinting shares many technical advantages with 3D printing over conventional tissue engineering methods or conventional manufacturing strategies. These advantages include but are not limited to digital control of the manufacturing process, personalization, mass customization, complexity for free in the design process, among others, which will list below.
What are the pros and cons of using 3D printing to make medical devices?
The top advantages to using 3D printing for medical devices are:
3D printing for rapid prototyping is well established over the years for a variety of industries, and it is the main entry point for the healthcare industry as well. The quick turnaround and money saved from design to prototype are key accelerators in medical device innovation.
With growing interest in personalized medicine at the same or lower cost in healthcare, the need to find solutions to create medical device solutions to human bodies and diseases has significantly grown. 3D printing as a core manufacturing process replacing traditional methods (i.e. injection mold) to meet unit economics in certain industries like the dental aligner and hearing aid industry is now well established. Additive manufacturing continues to penetrate many different sectors in healthcare.
Complexity for free:
3D printing allows for complex (sometimes “impossible”) designs that traditional manufacturing processes simply cannot achieve, or are only possible at an unrealistic price. Many design restrictions for traditional methods no longer apply.
Point of care healthcare:
This is also known as print on demand. Hospitals/healthcare providers potentially no longer need to keep large and expensive inventories for future use. Instead, they could 3D print personalized devices on-demand, saving cashflow and space for other critical missions.
Several good “point of care” Expert Corner blogs can be found below. FDA has also recently started to converse with stakeholders to formalize regulation in the space, suggesting this practice will be more popular in the near future.
Quick production with new design iterations:
With the traditional manufacturing method, design iterations can be costly both financially and time-wise because new tooling and workflow often need to be implemented. With 3D printing, however, many new design iterations are possible without drastically changing the manufacturing cost. Batch one can cost exactly the same as batch two.
Because of the addictive nature of 3D printing, as opposed to subtractive manufacturing, little material is wasted if it is not part of the final product. While there may be a certain percentage of material wasted as a result of supporting structures and impurity incurred as a result of chemical reactions, the waste is theoretically much less than subtractive manufacturing. In addition, because of the design freedom of 3D printing, parts that used to be made as solid components can now have hollow insides with the same or even better mechanical properties.
Digital manufacturing revolution:
3D printing is in fact one of several new tools we have acquired in the past century, collectively called digital manufacturing. In short, 3D printing is a robot too, and it is getting more intelligent every day with the help of creators, rapid design and simulation software advancements, machine vision, machine learning, robotics, and artificial intelligence. One could argue that 3D printing aims not just to replace a large part of conventional manufacturing strategies and labor force associated with it, it also aims to create a new portfolio that traditional methods could never create.
Useful blogs can be found here:
The top disadvantages to using 3D printing for medical devices are:
While the advantages listed above paint a rosy picture for the future of 3D printing in healthcare, its current market is limited because of the following challenges. 3DHEALS live webinars aim to address many of the following challenges, hoping to connect with innovators and entrepreneurs to solve these challenging areas:
Unclear regulatory landscape
One of the most frequent pain points for everyone has been the lack of consistent and clear regulatory guidance. However the years, FDA has been proactive in creating bilateral conversation opportunities and has created several guidance documents on 3D printed medical devices, most notably, its “Technical Considerations for Additive Manufactured Medical Devices”. Currently, it is addressing potential issues with 3D printing for “point of care”. Most other regulatory bodies, including CFDA, EU, TGA, and Canada Health typically mirror regulatory guidance.
For those who want to learn more about FDA and EU regulation of medical devices, our Expert Corner blogs have a few useful posts:
Limited material selection
3D printing products are ultimately the combined result of software, hardware, and material. Either thermoplastics or photopolymerization, the material selection is limited for all processes simply because the field is still in its infancy. It is perhaps not inaccurate to claim that “Chemistists Rule the World”. One of the most valuable 3D printing companies in the world, Carbon 3D, relies on its formidable material portfolio. Maybe one can view 3D printing as the digital control of chemical reactions that result in physical objects.
That said, even more challenges exist for healthcare and life science applications, as both the materials and end products need to pass stringent toxicity and biocompatibility testing. In addition, lack of toxic by-products, bio-absorbability, biomimetic mechanical properties, and steriliabilty are often required, further limiting available material options.
For those who want to learn more about biomaterials, stay tuned for the upcoming 3DHEALS Biomaterials Guide and virtual events focusing on this evolving topic. Additional Expert Corner blogs can also be found here:
Limited build size
While the build plate size for prototyping can be satisfied for most medical devices, given finite dimensions of the human organs. Size can be a limiting factor if one prints an entire human body all at once. One scenario is the spine or 1:1 ratio pelvic bones, which are outside of typical medium-size build plate for common desktop 3D printers. One workaround is to create modular designs that can print smaller parts and be assembled together. However, the assembling and design process both take extra time, which translates into cost.
Post-processing can be complicated
Most 3D printed parts will need some form of cleaning up to remove support material from the build and to smooth the surface to achieve the required finish. Different 3D printing processes also have unique postprocessing timing and procedures. Oftentimes, this step is labor-intensive, making 3D printing not as autonomous and less palatable to mass production. Typical post-processing methods include curing, welding, water jetting, sanding/smoothing, chemical soak and rinse, air or heat drying, polishing, coating, painting (if you desire different colors), and many others. For those who are interested in learning more, stay tuned for our upcoming virtual events focusing on post-processing. The amount of post-processing required depends on factors including the size of the part being produced, the intended application, and the type of 3D printing technology used for production. So, while 3D printing allows for the fast production of parts, the speed of manufacture can be slowed by post processing. In the case of medical devices, this step is even more important and should be part of the quality control process for the manufacturing process, as the raw material is often toxic or pyogenic. Design accuracy could also be affected by inadequate design without anticipating potential changes due to the post-processing step.
Scalability is limited
While the starting cost for 3D printing can be much lower than traditional manufacturing strategies, there is a magic number for every kind of 3D printing process to achieve the optimal unit economics. However, this number is typically in the 10-100K range. Once the number is larger than this “magic number”, the economic benefit of using 3D printing disappears compared to the traditional manufacturing method. Fortunately, for medical devices, this number may actually favor adaption as one pointed out in our Microfabrication for Medical Devices conference.
Mechanical properties may be insufficient or inaccurate from design
3D printed products are ultimately composed of layers glued or cured together. This results in intrinsic vulnerability to delaminate under certain stresses or orientations. This problem is more significant when producing items using fused deposition modeling (FDM), while polyjet and multijet parts also tend to be more brittle. In other words, the parts are not homogeneous as the parts produced by injection molding. The other issue with 3D printed parts is lower “tolerance”, which means the final print may differ from the original design. Both can create major issues in healthcare products, especially those that go into and stay in human bodies. Here is a blog that could help with your understanding:
As 3D printing as an industry grows, there is an increasing possibility for IP and copyright infringement as well as counterfeit production. Given the high values of hard-earned intellectual properties, we have invited several legal experts to address potential issues and IP strategies on future 3D printed medical devices or bioprinted medical products (see blog links below). This will be an evolving field that will unfortunately only grow with new lawsuits. For those who are on the creator side, in terms of medical devices, we have a Guide on Cybersecurity for Medical Devices that is worth a read.
The Legal Landscape in Healthcare 3D Printing (on-demand course)
How should I define healthcare 3D printing?
In the earlier years of 3DHEALS, when people hear the term “healthcare 3D printing”, they immediately related this to two highly publicized imageries: One was the 3D printed e-Nable prosthetics, the other was the vision of 3D bioprinted implantable human organs advertised by Organovo. While both are compelling stories, understanding of the complexity of novel therapeutics and the medical device was lost.
We define “healthcare 3D printing” as a collective term that includes all the healthcare and life science applications leveraging the power of 3D printing and 3D bioprinting. While there are numerous healthcare applications that can use 3D printing, they can be roughly grouped into three main subcategories: medical 3D printing, dental 3D printing, and bioprinting.
What are the major 3D printing processes?
3D printing techniques have grown since the first stereolithography (SLA) systems were created in 1986. The nomenclature surrounding the 3D printing process has suffered from both a lack of standardization and rapid availability of new techniques. Recently, the American Society for Testing Materials (ASTM) designated seven 3D printing processes, each of which is represented by one or more commercial technologies.[Ref:SME.org]
These seven processes include vat photopolymerization, binder jetting, material jetting, powder bed fusion, material extrusion, direct energy deposition, and sheet lamination. For those interested, we have compiled a more comprehensive table for these seven major 3D printing processes.
What is bioprinting?
Bioprinting employs the same fundamental concepts as conventional 3D printing, including digital design and additive manufacturing of a physical structure in a layer-by-layer fashion. However, bioprinting uses exclusively organic materials with or without cells as the building block for the “3D model”, with a final goal of generating a three-dimensional tissue. Comparable to any 3D printed structure, printing tissues have the following prerequisites: (1) determine the printing paths; (2) load the desired bioink (a cell-laden gel-like substance); (3) control the printer; (4) perform post-printing evaluation.
Here are additional introductory bioprinting educational materials:
What are the major bioprinting processes?
The current three main modalities of 3D bioprinting are inkjet, extrusion, and laser-assisted methodologies. These modalities fall under two distinct categories 1) drop-on-demand (DOD) and 2) continuous. Inkjet and laser-assisted systems are DOD methods because they generate droplets that serve as the delivery vehicle of printing materials. In extrusion systems, the material emanates continuously in the same manner toothpaste gets extruded from its tube. Additionally, the microvalve-based method is another DOD-type modality. These modalities are discussed in our guide to bioprinting skin to give the readers more concrete examples of how these could be used for commercial purposes.
The advantages of DOD are the precise placement of printing material and fine control over droplet volume for creating heterogeneous constructs consisting of multiple cell types and materials. In contrast, continuous extrusion systems cannot achieve such nuanced deposition, making them less well suited for printing heterogeneous structures.
How can I wrap my head around all these different healthcare applications?
One method is to use three subcategories: medical 3D printing, dental 3D printing, and bioprinting. These are the most popular subjects in the community both in terms of research and entrepreneurial activities.
However, another way we could classify thousands of healthcare applications that could leverage 3D printing is the “inside out” approach. This method is particularly useful for 3D printing companies to find the “killer applications for 3D printing” systematically.
There are four major categories with this approach:
Group 1 includes exoskeleton, wearable, prosthetics, and orthotics. They also include applications in the dental sector and hearing aid industry since most of them are applied relatively superficially and can benefit from the mass customization of personalized medical devices. These were visible and also some of the earlies adaptions of additive manufacturing technology.
Several Expert Corner blogs have dived deeper into the subjects of 3D printed prosthetics:
While 3D printing is important in the actual delivery of the prosthetics and wearables, incorporating 3D scanning into a clinician’s workflow has been the focus of several Expert Corner blogs and webinars:
Group 2 includes advanced medical models, surgical guides, simulation models. They are most useful in pre-surgical planning and have been validated by numerous publications in the past.
For those who are interested in learning more, our Guide on 3D Printing in Hospitals will provide most of what a beginner would need, including a comprehensive business model.
Group 3 includes higher FDA classification medical devices, which include mostly implants. Over the past decades, most 3D-printed implants are made of metal powder due to favorable material properties and relatively consistent regulatory pathways. The second choice of 3D printing material for implants is PEEK or ceramics. According to one recent 3DHEALS webinar, 3D Systems has manufactured over 2 million implants to date. In addition to implants, another similarly regulated but less common application is 3D printed stents. With the advancement of 3D microfabrication, it is conceivable that this will be the next frontier of commercialization.
Here are some of the latest Expert Corner blogs focusing on metal 3D printing:
Group 4 includes bioprinting applications that are so new that they do not yet have clear regulatory guidance. Most of the commercially available products cater to the research community and are not yet for human use. However, this is one of the fastest-growing fields in the past five years, with the inception of more than 100 “bioprinting” related companies in 2021 alone. These applications have two major aims: 1) Organ and tissue replacements 2) 3D cell cultures of 3D tissue model for more rapid and cheaper drug development and eliminating the need for animal testing. In the past several years, we have curated a variety of free live virtual events, focusing on various aspects of bioprinting ranging from specific medical applications, common materials, to critical supporting elements (e.g. stem cell technologies, extracellular matrix, alternative biofabrication methods like melt eletrowriting and electrospinning) in the bioprinting ecosystem.
Andrew Hudson, co-founder of startup Fluidform, wrote an excellent series highlighting the current status and future of bioprinting, including major technical challenges facing the industry.
Additional general bioprinting related Expert Corner blogs including topics on biomaterials and stem cells can be found here:
More specific organ system and end application-focused blogs focusing on bioprinting:
3D Printing and Bioelectronics (On-Demand)
3D printed pharmaceuticals can also be grouped into Group 4 since the regulation around pharmaceuticals is still in its early stage and likely a hurdle to many new drugs before they could be widely adopted. To learn more about 3D printed drugs, check out our Guide to 3D printed drugs and related on-demand recording.
A close adjacent field is 3D printing nutriceuticals and 3D printing food. Several startups working on 3D printing drugs are also exploring 3D printing vitamins and food.
3D Bioprinting for Food(on-demand course)
Parallel to this method of categorization is the regulatory concerns around the technologies. The lower number groups suggest a more well-defined regulatory landscape and less risk to the patients (i.e. lower classification in terms of medical devices).
Why should I care about Healthcare 3D printing?
Whether you care or not, like any technological revolution, 3D printing will take over a significant portion of the MedTech market over time, from ideas to implementation. The more pressing questions should be: 1) Where is 3D printing in healthcare now? 2) Where it will be widely adapted next 3) When it will impact my personal healthcare? That is exactly why we have created extensive educational and networking opportunities with our virtual events and blogs. These well-curated contents will update you with the latest from experts in real-time from the industry, academia, and startup world.
3DHEALS Guides (Collective) – This is where we dive deep into subjects that you will find helpful for your projects and career.
3DHEALS From Academia (Collective) – This section features recent, relevant, close to commercialization academic publications in the space of healthcare 3D printing, 3D bioprinting, and related emerging technologies.
3DHEALS Company Directory – This is where we regularly add new companies working on healthcare 3D printing. We only add the company if it has invested a significant percentage of resources and efforts into the space, and not just any 3D printer company that also can print a prosthetic arm. Please reach out to us if you would like a Premium version of this Directory. We reserve the right to add or remove companies from this Directory based on ongoing changes in the industry.
3DHEALS Podcast – If you are short on time, download 3DHEALS podcast “the lattice” for some information interviews. 3DHEALS invites technological game-changers, entrepreneurs, venture capitalists, world-class clinicians, scientists, and other expert stakeholders to have deep-dive conversations on how to re-invent healthcare using 3D printing, bioprinting, and related emerging technologies. (Click here to read about the inception of this healthcare 3D printing podcast.)
3DHEALS Online and Offline events – This is how we started. Our virtual events happen on Thursdays and in-person events depend on local community managers and local pandemic safety guidelines.
What if I want to start a company in healthcare 3D printing?
The better future of both healthcare and 3D printing depends on innovations. However, science projects that cannot be commercialized to benefit humanity will remain just that “science projects”. There is nothing wrong with being just a scientist. However, if you want to make an impact on the world in a meaningful way, entrepreneurship may be the right path for you.
Some of the most exciting aspects of working at 3DHEALS are discovering early-stage startups, their founders, seeing new trends and visions, and learning about adjacent technologies, and the forces behind them. However, changing the world is not easy, and fundraising remains one of many challenges founders in healthcare 3D printing will meet. Since April 20th, 2018, 3DHEALS has hosted numerous online and offline Pitch3D sessions, introducing 40+ startups from all over the world to more than 30 institutional investors who are interested in healthcare 3D printing, bioprinting, and adjacent fields including AI and cybersecurity (within 3D printing), 3D scanning, VR/AR, 3D Visualization, synthetic materials, and regenerative medicine. However, beyond the technological appeal, the goal of Pitch3D is to encourage healthcare innovations focusing on a decentralized healthcare delivery system of personalized solutions. We believe that is the natural progression of our society because of the past industrial revolutions.
For fundraising and investment-related blogs, please check out our Pitch3D page.