The medical field is undergoing a revolutionary transformation, driven by two cutting-edge technologies: Artificial Intelligence (AI) and 3D printing. When these forces collide, they unleash unparalleled potential for innovation, personalization, and improved patient outcomes. From custom prosthetics to intricate anatomical models for surgical planning, the synergy between AI and 3D printing is reshaping healthcare as we know it. Let’s dive into some of the latest advancements, drawing insights from pioneering researchers and practitioners at the forefront of this exciting intersection.

Personalized Prosthetics for a Better Quality of Life

Creating personalized prosthetics is one of the most compelling applications of AI and 3D printing in healthcare. Merel van der Stelt, a PhD student at 3D Lab Radboudumc, is dedicated to developing prostheses for low- and middle-income countries, utilizing AI for optimized socket shape design (LinkedIn activity). By leveraging AI algorithms, researchers can analyze individual patient data, such as limb shape and movement patterns, to create prosthetics that fit perfectly and function seamlessly. This level of customization enhances comfort, mobility, and overall quality of life for those in need, especially in regions with limited resources.

Moreover, Johann Reinhard, a Research Scientist at Fraunhofer IGD, is pushing the boundaries of 3D printing for eye implants. Using AI to design prints from optical coherence tomography (OCT) images, researchers can create bespoke prosthetic eyes that closely match the patient’s anatomy (New Scientist article). Imagine a future where individuals with eye injuries or congenital disabilities can receive custom-made implants that restore both function and aesthetics. This level of precision and personalization is made possible by AI, which can analyze complex medical images and generate intricate 3D designs.

Enhancing Surgical Planning and Precision

Surgical planning is another area where the combination of AI and 3D printing is making significant strides. Kaiyan Qiu, an assistant professor at Washington State University, uses AI to determine optimal 3D printing parameters for creating surgical planning organ models (WSU press release). Surgeons can generate highly accurate 3D models of patient-specific organs by feeding medical imaging data into AI algorithms. These models allow for detailed pre-operative planning, enabling surgeons to visualize complex anatomical structures and practice procedures before stepping into the operating room. This reduces surgical time and risk and improves patient outcomes by ensuring greater precision and predictability.

Furthermore, Gade Jong, another Assistant Professor, focuses on AI and 3D technologies for anatomical segmentation (Nature article). Precise segmentation of organs and tissues from medical images is crucial for creating accurate 3D models. AI algorithms can automate and refine this process, allowing quicker and more reliable generation of models used in surgical planning. By automating these complex processes, AI enables healthcare professionals to be more efficient and reduce the risk of human error.

Innovations in Bioprinting and Tissue Engineering

Bioprinting, the process of 3D printing living tissues and organs, is a realm where AI is proving invaluable. Ben Kiratitanaporn, a recent PhD graduate, is utilizing AI for 3D cell scaffolds. Cell scaffolds provide the structural support for cells to grow and form functional tissues. AI can optimize the design of these scaffolds, ensuring the proper porosity, mechanical properties, and biocompatibility. Similarly, Guo-Dong Goh, a Research Fellow, focuses on AI for 3D printing tissue-like anatomical models and anomaly detection (ScienceDirect article). AI algorithms can analyze the quality of printed tissues, detecting defects or inconsistencies that might compromise their function.

Associate Professors like Stefanie Mueller at MIT explore human-computer interaction technologies fabricated using 3D printing and AI (MIT news), while Washburn Lab at Carnegie Mellon develops AI for choosing design parameters in the bioprinting of hydrogels (ACS Biomaterials article). Additionally, Demaria at Centro Piaggio, University of Pisa, uses AI to select printing parameters for bioprinting (IJB article). These collective efforts are pushing the boundaries of what’s possible, making the creation of functional tissues and organs closer to reality than ever before.

Drug Delivery and Microneedle Technology

The intersection of AI and 3D printing also opens up exciting possibilities in drug delivery. Moe Elbadawi, a Lecturer, investigates AI, 3D printing, and drug delivery, building upon the work of Alvaro Goyanes at FABRX (ScienceDirect article). By 3D printing personalized drug formulations and delivery devices, we can ensure that patients receive the proper medication in the correct dosage, tailored to their unique needs. This precision approach can improve treatment efficacy and minimize side effects.

Furthermore, Stasoglu at Koç University is leveraging AI to tune 3D printing parameters for microneedle design (MDPI article). Microneedles offer a painless and efficient way to deliver drugs through the skin. AI can optimize the design and fabrication of these tiny needles, enhancing their effectiveness and patient comfort.

Advancements in Wearable Technology and Physiological Monitoring

Wearable technology is another area benefiting from the AI-3D printing synergy. Wei Gao, a professor at Caltech, developed 3D-printed electronic wearable skin that uses AI for physiological monitoring (Science article). These innovative devices can continuously track vital signs and other health indicators, providing valuable data for personalized medicine and early disease detection. Imagine a world where wearable sensors seamlessly integrate with the body, continuously monitoring health and sending alerts when needed.

Defect Detection and Quality Control

Amedeo Bonatti (ORCID) uses AI, particularly expert systems, for defect detection in electron beam melted implants (Liebertpub article). Ensuring the quality and structural integrity of 3D-printed medical devices is critical for patient safety. AI algorithms can analyze 3D-printed objects in detail, identifying any defects or anomalies that might compromise their function. This level of quality control ensures that medical devices meet the highest standards of safety and efficacy.

Devin Roach at Oregon State University also applies AI to 3D printing for biomedical applications. His co-authored article titled “Invertible Neural Networks for Real-Time Control of Extrusion Additive Manufacturing” explores the application of machine learning, specifically invertible neural networks (INNs), to enhance the precision and adaptability of direct ink write (DIW) 3D printing processes. This research is particularly relevant to healthcare due to its potential to improve the fabrication of customized medical devices and implants.(ScienceDirect) Integrating INNs allows for real-time monitoring and optimization of the printing process, ensuring that these medical products meet stringent quality and performance standards. By enabling adaptive control during fabrication, this approach can lead to more reliable and efficient production of complex biomedical structures, ultimately enhancing patient outcomes.

The Future Outlook

The advancements discussed above represent the exciting possibilities when AI and 3D printing intersect in healthcare. As these technologies evolve, we can expect even more groundbreaking innovations. The ability to create personalized medical devices, plan complex surgeries precisely, bioprint functional tissues, and develop advanced drug delivery systems will revolutionize patient care. The integration of AI enhances this process through analysis, automation, and control to ensure that we receive the highest level of patient care. This exciting field has tremendous potential to transform the healthcare landscape and improve lives worldwide.

To learn more about these exciting developments, don’t miss our upcoming virtual event focusing on this very topic.

Keywords: AI in healthcare, 3D printing, personalized medicine, bioprinting, surgical planning, drug delivery, wearable technology.

Related links:

• Artificial Intelligence and Machine Learning in 3D Printing, AR/VR Explores how AI and machine learning are optimizing design, predictive maintenance, quality control, and patient-specific modeling for 3D-printed medical devices and implants. The article also discusses how AI/ML can reduce costs and improve patient outcomes.
• Artificial Intelligence in Healthcare 3D Printing (Webinar) Recap and resources from a theme-based webinar featuring industry and academic leaders discussing the latest AI-driven advancements in healthcare 3D printing.
• When Artificial Intelligence Meets 3D Printing An in-depth article explaining the basics of AI and machine learning, their relevance to 3D printing, and the challenges of integrating AI into real-time 3D printing monitoring and quality control.

Additional 3DHEALS Resources:

1. https://3dheals.com/product/artificial-intelligence-and-machine-learning-in-3d-printing-ar-vr/
2. https://3dheals.com/machine-learning-in-3d-printing-and-bioprinting-a-collection-of-recent-publications/
3. https://3dheals.com/artificial-intelligence-for-segmentation/
4. https://3dheals.com/product/artificial-intelligence-in-healthcare-3d-printing/
5. https://3dheals.com/courses/artificial-intelligence-in-healthcare-3d-printing/
6. https://3dheals.com/artificial-intelligence-updates-for-3d-printing-and-bioprinting/
7. https://3dheals.com/when-artificial-intelligence-meets-3d-printing/
8. https://3dheals.com/tag/machine-learning/
9. https://3dheals.com/artificial-intelligence-and-3d-printing/
10. https://www.youtube.com/c/3DHEALSINNOVATION
11. https://3dheals.com/interview-with-kerim-genc-the-power-of-artificial-intelligence-and-3d-printing/

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Last Thursday, we hosted a conversation with leading innovators and scientists in 3D printing for orthopedics. What makes these discussions so valuable is the inside look into how the field has progressed in the past couple of years and the challenges our influencers face on the technical, regulatory, and user adoption fronts. Here’s a quick read on what went down during our event to bring you up to speed. You can now watch the event on-demand through 3DHEALS Courses.

The future of orthopedics: 3D-printed solutions for every part of the body

What if orthopedic surgeons could 3D print every implant they could ever need? No more one-size-fits-all. It’s a bit of an idealistic prospect but innovators such as Nathan Evans are envisioning a future where 3D printing plays a bigger role in orthopedic medicine. Evans is the Senior Vice President of Product Development at restor3d, a company that’s looking to make orthopedic implants more personalized to better meet specific patient needs. Evans brings up a key observation of where the field is headed: the spine (especially spinal fusions) is where 3D printing has found its forte but applications to other areas of the body are still under development. Lower extremity implants are growing, upper extremity implants (such as those for the shoulder) are still in their infancy, and trauma cases are lagging behind.

Falling behind in the trauma area is concerning because there is immense potential for 3D printing to take trauma care by storm, fabricating devices exactly contoured to a patient’s unique injury and anatomy. Evans describes how restor3d encountered a severe trauma case involving a defect in the distal tibia. The surgeons could have used the traditional screws and plates to patch up the defect, but it would have been difficult. In cases like this one, where the options are limited, patient-specific implants can save the day by avoiding amputation or subpar off-the-shelf solutions and giving surgeons and patients the confidence that the best solution for the problem was taken. restor3d has created solutions with this in mind and has made implants for many parts of the body not often sought out by others in the industry, opening up its customer base and expertise beyond spinal problems.

However, Evans notes that 3D printing shouldn’t be considered a solution only for niche orthopedic applications where the problem is so severe or unique that no off-the-shelf device on the market could be used effectively. We’ll severely limit its potential if we keep thinking of 3D printing as a fringe technology. 3D printing shouldn’t be a “desperate times call for desperate measures” but rather an opportunity to provide better outcomes than traditional devices. Evans shows us that while big-name orthopedic companies offer a few different dimensions for knee implants, there is still a vast number of patients with common knee measurements who aren’t getting an implant that exactly matches their needs. If we want better outcomes, we must have the “can I get it just a little bit smaller?” option rather than saying “close enough.”

Accessibility is everything

When Kuntay Aktas started out with electron beam melting (EBM) in the past, the technology was considered efficient and cheaper than other techniques for metal printing. Now, Aktas points out that selective laser melting (SLM) is more reliable, easier to use, and more cost-effective. Making 3D printing of different orthopedic implant materials more accessible is a key focus for Aktas, an experienced entrepreneur with a background in engineering who has co-founded TrabTech, a company using additive manufacturing for orthopedic implants.

Ideally, we’d see a world where custom orthopedic implants made from just the right materials are printed at the point of care (POC) with a simple button. However, Aktas notes there can be challenges with manufacturing titanium devices using 3D printing, with the company looking into titanium alloys and other alternatives. Materials other than titanium hold promise, such as magnesium, but face their barriers. Magnesium, while biodegradable, is hard to work with due to its explosive nature. Exploring new materials in the orthopedics area is a worthwhile endeavor to push the boundaries of what’s possible. Still, it won’t get the traction it needs if the groundbreaking material can’t be easily manufactured using POC printers or the process is so complicated that it can’t be streamlined.

Overcoming the regulatory and cost barriers

At medical 3D printing’s core is the promise of patient-specific implants, but patient-specificity is no easy feat on the technical, financial, and regulatory fronts. Even though customizable implants offer a larger parameter space to fit the patient’s needs, boundaries must still be set to meet regulatory requirements. Evans describes how such 3D-printed devices must have a design envelope to define the limits of what can be reliably fabricated. The added complication is that rather than demonstrating a single worst-case scenario to regulatory agencies, patient-specific devices may have several worst cases, making the regulatory process more expensive and complicated.

Navigating the complexities of patient specificity will continue to be a tough challenge for the industry. Investments in better computational models and using artificial intelligence to provide in silico evidence may shed light on the problem and bring down both the time and monetary costs. However, it will take a leap of faith by scientists, entrepreneurs, funding sources, and surgeons to see that the effort is worth it to continue advancing care for patients with more personalized solutions. Maintaining the status quo for certain conditions in favor of off-the-shelf products will detriment to patient health, leading to subpar outcomes and expensive revision surgeries.

Aside from worst-case scenarios, Kyle Kovach, Quality and Regulatory Manager at JALEX Medical, says that companies should look out for other challenges regarding the premarket submission of their 3D-printed devices. Having the adequate details needed to describe the additive manufacturing process, conducting the necessary performance tests and tests specific to 3D printed parts, addressing residual material on the device, and validating the build process are all key, especially when the FDA’s perspective on 3D printing is continuing to evolve, and reviewer subjectivity comes into play.

A lot of questions are still in the air surrounding the current state of regulations. What will the delays look like regarding FDA approval? Will the quality of FDA review change if there is decreased staffing? How will things change when European companies seek FDA approval to avoid the challenges associated with MDR? One can speculate, but we will all be on the lookout.

And don’t forget the post-processing!

Kovach also raises the point that process validation for 3D-printed devices and proper handling of residual material on manufactured devices are essential factors to address in the regulatory process. Companies must show that they can consistently reproduce their prints across build cycles to ensure that quality doesn’t waver from patient to patient. An essential aspect of maintaining a high-quality product is paying attention to the post-processing steps, which Garren Angacian shares, which are an important strength area for Himed, a company that produces calcium phosphate-based biomaterials. Angacian, the Engineering Manager at Himed, describes how loosely adhered or partially molten beads can be present on titanium 3D printed products, such as acetabular cups, potentially leading to the loosening of the prosthesis and release of titanium into the body. Aluminum oxide blasting to remove the beads can leave behind undesired aluminum oxide residues, whereas the company’s apatitic abrasive leaves behind a nice, clean surface.

What we’re thinking

Mirroring the sentiment from our speakers, patient-specific 3D-printed orthopedic devices promise to improve care for both typical and special cases. However, companies will have to make the case that patient specificity is worth it, even though they will be at odds with the lack of insurance reimbursement for certain custom products, higher costs and turnaround times, a trickier regulation landscape, and reluctance to move away from current methods. Customized printing settings using AI and new biomaterials add even more complexity to the mix. However, the innovators in medical 3D printing, such as our 3DHEALS speakers, have been riding the train of unpredictability for some time. The 3D printing industry has taken off unexpectedly, with promising avenues to address unmet orthopedic care needs. Like much of our audience, we remain cautiously optimistic and hope you join us for the ride.

Subscribe to 3DHEALS and attend our future events live to engage in the conversation.

About the Author: 

Peter Hsu is an editorial intern for 3DHEALS.  He is currently an undergraduate at the University of Illinois Urbana-Champaign and studies bioengineering with a focus on cell and tissue engineering.  He is also minoring in computer science with interests in artificial intelligence and image processing.  Peter conducts research on using computer vision methods to analyze human tissue images and improving the robustness of machine learning workflows.  He is interested in the use of AI to assist tissue engineering and bioprinting research for medical applications.  He is passionate about science communication and leads STEM outreach lessons at schools in the central Illinois area.

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The post Event Recap: 3D Printed Devices In Orthopedics appeared first on 3DHeals.

As the end of 2024 approached, a group of groundbreaking pitch 3D startups took the lead in healthcare 3D printing, bioprinting, and tissue engineering. This article highlights key emerging themes in the space and the startups we have featured on our pitch3D platform. We want to raise awareness of these startups’ cutting-edge technologies and investment potential. Also, please mark your calendar and join us live at the upcoming virtual Pitch3D Demo Day to meet some of our investors, founders, and ecosystem operators.

Key themes that emerge from the pitch decks in the “Pitch3D 2024” folder include:

Innovation in Medical Devices: 

Many of the startups are developing novel medical devices or improving existing ones, often using advanced technologies like 3D printing and bioengineering. Examples include Castomize’s 4D-printed casts, Icarus Medical’s 3D-printed knee brace, and ReConstruct Bio’s personalized breast implants. (See specific company info below.)

Improved Patient Outcomes and Quality of Life: 

The startups emphasize the potential of their technologies to improve patient outcomes, reduce complications, and enhance quality of life. This is evident in CytexOrtho’s focus on restoring joint function, Cellular Vehicle’s aim to make cell and gene therapies more accessible.

Deep Tech:

The 2024 Pitch3D cohort highlights the use of advanced technologies, such as 3D printing, bioengineering, and AI, to create innovative solutions. This is seen in Axolotl Biosciences’ focus on 3D bioprinting, DicomDirector’s use of AR/VR for medical imaging, and Castomize’s use of 4D printing for orthopedic casts.

Personalized Medicine: 

Several startups are developing solutions tailored to individual patients, such as ReConstruct Bio’s and BellaSeno’s personalized breast implants.

Addressing Unmet Needs: 

The startups are targeting areas where there is a significant unmet need, such as knee osteoarthritis (Icarus Medical), breast reconstruction (ReConstruct Bio), and cell and gene therapy delivery (Cellular Vehicle).

Focus on Accessibility and Affordability: 

Some startups emphasize their commitment to making their technologies accessible and affordable, as exemplified by Castomize’s aim to create cost-effective orthopedic casts.

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Pitch3D 2024 Cohort:

Cytoink:

Medical research has many challenges, such as the high cost and lengthy timelines for drug development, with a significant failure rate in clinical trials due to reliance on inaccurate animal testing and significant drug assays. Cytoink offers a solution to these challenges through its human-relevant 3D tissue models, which can accelerate and improve biomedical R&D. These models can lead to significant cost savings and faster time-to-market for new drugs.

Allumin8

There is a high rate of complications in spine fusion surgeries, particularly screw loosening. Allumin8’s technology addresses this issue by improving bone fixation and promoting bone growth. Allumin8’s proprietary technology is a Porous Pedicle Screw System, a 3D-printed orthopedic and spine hardware that mimics bone and can deliver therapeutics directly to the patient.

Castomize: 

Current orthopedic casts can be heavy, uncomfortable, and not very strong. Castomize is a med-tech startup based in Singapore that uses advanced manufacturing techniques to create orthopedic casts that are lighter, stronger, and more comfortable for patients.

Axolotl Biosciences: 

Axolotl Biosciences, located in British Columbia, Canada, recognizes the potential of 3D bioprinting to transform healthcare. However, the field is still developing and requires specialized expertise. Currently the startup offers a suite of products and services, including bioinks, 3D tissue models, and consulting, to support research and development in 3D bioprinting, to advance human health.

Akita Bio: 

Drug development and research are often slow, expensive, and can yield unreliable results. This is partly due to limitations in traditional cell culture and animal models. Akita Bio, based in Helsinki, Finland, has developed scalable organ-on-chip platforms that offer a more physiologically relevant model for drug development and research. These platforms aim to accelerate research, improve cost-efficiency, and generate more reliable results.

Icarus Medical Innovations: 

Knee osteoarthritis is a widespread and debilitating condition, and current treatment options often fall short of providing adequate pain relief and restoring mobility for a large patient population. Icarus Medical Innovations has developed the Ascender Knee Brace, a custom, 3D-printed brace designed to alleviate pain and improve function in patients with knee osteoarthritis. The brace is adjustable and can unload significant weight from the knee joint.

CytexOrtho: 

Osteoarthritis is a common joint disease that causes pain, stiffness, and disability. Current treatments are often limited in their ability to restore joint function and prevent disease progression. CytexOrtho is developing a 3D woven bio-textile implant for joint repair in osteoarthritis patients. Their product aims to restore joint form and function and has shown promising results in preclinical studies.

Cellular Vehicle: 

Cell and gene therapies (CGTs) are promising to treat many diseases, but their manufacturing and delivery are complex and challenging. Based in San Mateo, California, the company is developing the Odyssey System, a technology that standardizes and automates the preparation and administration of CGT doses. This aims to make these therapies more accessible to healthcare providers and, ultimately, to more patients.

ReConstruct Bio: 

Breast reconstruction and augmentation often involve invasive procedures and carry risks associated with artificial implants or tissue flaps. ReConstruct Bio, a venture from Harvard’s Wyss Institute, is developing personalized, regenerative breast implants using a patient’s own fat tissue. This approach aims to offer a safer, more natural, and longer-lasting solution for breast reconstruction.

PathKeeper Surgical: 

Spine surgery can be complex and carries risks of complications, including inaccurate screw placement and suboptimal spinal alignment. PathKeeper Surgical offers radiation-free, accurate, and cost-effective optical navigation and robotic technology for spine surgery. Their technology aims to improve surgical precision and patient outcomes.

ALM Ortho: 

Complex orthopedic implant cases can lead to limb loss or impaired limb function. Current solutions for limb lengthening and reconstruction are often limited by old technology platforms. ALM Ortho uses advanced technology to develop enhanced product solutions, including a bone-anchored prosthetic for amputees and custom products for complex orthopedic implant cases. These solutions aim to salvage limbs and restore limb functionality.

Z-Polymers: 

Traditional super-polymers often rely on toxic chemicals and have high greenhouse gas emissions during manufacturing. Z-Polymers has developed Tullomer, a new super-polymer that is strong, lightweight, inert, recyclable, and made with significantly less energy than traditional super-polymers. Tullomer aims to offer a more

Bellaseno: 

The breast implant industry has a large market size with significant medical needs due to breast surgeries for post-cancer reconstruction, congenital defects, and silicone implant complications. There are high complication rates with silicone implants, including encapsulation, rupture, pain, and breast implant illness, leading to high removal and revision rates. BellaSeno has created a resorbable scaffold using the patient’s fat tissue to regenerate natural breasts. This addresses the safety issues of silicone implants and creates natural-feeling breasts. Over 40 patients with follow-ups of up to 4 years are very satisfied with the results. There have been no removals, infections, capsular contractures, or other major complications related to the scaffold.

DicomDirector: 

A significant and expanding market for advanced medical imaging and AR/VR technologies suggests substantial commercial potential for Intravision XR. DicomDirector is transforming 2D medical images into 3D holograms viewable in AR and VR, with applications in surgical planning, patient education, and medical education. The company operates on a subscription-based business model and has already secured contracts with major companies and healthcare providers.

NOVUS Life Sciences Ltd.: 

NOVUS Life Sciences Ltd. is a Hong Kong-based startup focusing on biomaterial research, development, and manufacturing established in 2014. The company focuses on pioneering 3D printing solutions for biomaterials and medical technologies, aiming to improve human health globally. Its flagship bioactive bone cement is Bonlecule. They also provide medical 3D printer filaments and related design, printing, testing, and sterilization services. By 2024, NOVUS had served over 50 corporate clients in 25 countries.

Related links:

Healthcare 3D Printing Innovations: Pitch3D 2023 Highlights

Pitch3D 2022: Newborns, Warriors, and The Changing World Order

Exploring Six Policy Areas Impacting Healthcare 3D Printing, Bioprinting- Guide
The Ultimate Resource Center for Healthcare 3D Printing

Angel Investor in Life Sciences: Putting Our Money Where Our Passions Lie

Newborns, Warriors, Unicorns, Winners: Commercialization of Healthcare 3D Printing In 2020

The post Pitch3D: Most Innovative Medical 3D Printing Startups 2024 appeared first on 3DHeals.

Point of care 3D printing (POC 3DP) offers an exciting opportunity to fabricate patient-specific medical devices and models within the clinical setting.  Such models can help explain procedures to patients and for surgical planning, while custom-made implants can improve patient care.  At our recent 3DHEALS event, we learned about the latest from five experts bringing the future of POC 3DP to life.

Benefits of point-of-care 3D printing

Dr. Mark Tan, Radiologist and Clinical Lead of the Singapore General Hospital 3D Printing Centre, recognizes POC 3DP’s potential to improve treatment efficacy, increase efficiency, expand options for physicians, and increase a hospital’s resiliency during shortages.

Dr. Tan described that POC 3DP can be a crucial component in treating trauma cases where time is limited.  The convenience of having a readily accessible 3DP lab within the hospital enables fast turnaround times for printing patient-specific devices and delivering them to surgeons.

Dr. Tan also pointed out that POC can be particularly useful in cases where there is not a high market demand for the hospital’s desired 3D-printed object. Having the capability for a hospital to print itself can help meet that need when outsourcing cannot. Additionally, the proximity of a lab makes it easier for surgeons to provide input while making highly complex surgical guides and other intricate prints.

Starting POC 3DP at a hospital

Shannon Walters, Executive Technical Director of Stanford University’s 3D and Quantitative Imaging Laboratory, shared some important prerequisites for starting POC 3DP.

One starting point for individuals looking to build POC 3DP is acquiring the necessary space for 3D printers, as not all rooms within a clinical facility may be suitable for 3DP.  Factors such as adequate ventilation for user safety, proper printer power sources, and the potential for allergic reactions to certain printing materials should be considered.  Walters said they could not do powder bed printing after considering allergic reactions.

Another critical component is establishing rapport with the hospital’s specialties by identifying pain points and showing that 3DP can provide value to them.  As Dr. Tan mentioned, physicians requiring fast delivery times or frequent input during the process may find value in POC 3DP.  Determining how to track the POC 3DP program’s efforts early on becomes valuable for providing evidence to funding sources and securing space.

Walters noted the importance of iterating on and optimizing workflows. Individuals setting up POC 3DP can coach physicians on reducing the number of materials asked for in a print and help them determine whether printing at full scale can be avoided. Other methods include finding better ways to remove support material and identifying better segmentation software.

Another piece of the puzzle is managing 3D printing orders.  Chris LeCastillo, Innovations Manager of the Stanford 3D and Quantitative Imaging Laboratory, talked about how they started by taking requests using email and tracking orders using Smartsheet, a third-party management platform.  While their foray into POC 3DP had a humble beginning with one FDM printer, LeCastillo showed how their lab successfully scaled up.

Now, the 4-printer, 11-member team receives requests through the medical records system Epic and tracks prints using in-house software.  The lab continues to grow by expanding its ordering process to its children’s hospital and building upon its quality management system.

POC 3DP in action: use cases

Dr. Neha Sharma, Deputy Head of the Medical Additive Manufacturing (Swiss MAM) Research Group and the 3D Print Lab at University Hospital Basel, is using POC 3DP to enhance craniomaxillofacial surgeries.  Dr. Sharma and colleagues designed an MDR-complaint workflow for 3D printing patient-specific polyetheretherketone (PEEK) cranial implants.

Dr. Sharma described how they used POC 3DP to fabricate a cranial implant for a patient, starting with in-house imaging and design of the implant.  They were able to print the device within 4-5 hours, sterilize within the same day, and have it implanted the next day.

Bringing 3D printing into clinical institutions also has the benefit of training residents and healthcare providers who need to become knowledgeable in the increasing use of 3D printing in the medical field.  Dr. Sharma presented their outreach activities and courses, including their involvement in the upcoming September Symposium on 3D Printing for Life Sciences in Basel.

Making POC 3DP attainable

An essential step towards advancing POC 3DP is to lower the barrier for hospitals to start innovating in this area.  Brian Overshiner, Manager of the Ricoh 3D for Healthcare Innovation Studio, explained to us how the company has created an end-to-end workflow to make POC 3DP more attainable for hospitals.

With a press of a button, physicians can directly send patient scans from their hospital’s radiology viewer to Ricoh and work with their biomedical engineers to segment the images.  This focus on creating end-to-end platforms streamlines the handling of the various logistics involved in POC 3DP, such as Ricoh’s feature of incorporating a quality control management system into this process.

Recently, the company announced their POC 3DP manufacturing facility with Atrium Health Wake Forest Baptist to produce patient-specific anatomical models.

Outlook for POC 3DP

While POC 3DP presents substantial benefits, several challenges remain.  For example, Walters noted that it is optional for healthcare insurance to cover 3D printing as part of a patient’s care.  Such coverage, however, does not pay for other essential components such as technologists, materials, and printers.  Dr. Sharma also talked about how reimbursements are still not covered in Europe even if hospital management sees the value in 3D printing.  Managing these costs will be necessary for POC 3DP programs in the future.

Building the necessary quality management system and taking steps to ensure regulatory compliance for POC 3DP will also be critical for hospitals moving forward.

While POC 3DP has its fair share of logistical challenges, the opportunity to bring the customizability of 3DP to the clinic will propel patient care further with improved implants and increased use of patient-specific anatomical models.  Sharing and commercializing solutions to these logistical hurdles, such as print management software and quality control systems, can be an effective path forward.  To join our future events live and stay updated with the latest in this area, subscribe to 3DHEALS.

About the Author:

Peter Hsu

Peter Hsu is an editorial intern for 3DHEALS.  He is currently an undergraduate at the University of Illinois Urbana-Champaign and studies bioengineering with a focus on cell and tissue engineering.  He is also minoring in computer science with interests in artificial intelligence and image processing.  Peter conducts research on using computer vision methods to analyze human tissue images and improving the robustness of machine learning workflows.  He is interested in the use of AI to assist tissue engineering and bioprinting research for medical applications.  He is passionate about science communication and leads STEM outreach lessons at schools in the central Illinois area.

Relevant Links:

Event Recap: 3D Printing and AI in Orthopedics
Event Recap: Innovation in Melt-Electrowriting (MEW) & 3D Printing

Event Recap: In Silico Simulation for Medtech and Biopharma

3D Printing At the Point of Care (On Demand, 2024)

Dental 3D Printing 2024: What’s New (On-Demand, 2024)

The post Event Recap: Point of Care 3D Printing appeared first on 3DHeals.

While the power of 3D printing lies far beyond the visual awe from the geometric lattices, unique mixtures of organic and synthetic curvatures, many of us were drawn to the technology often because of our visual experiences in our early encounters. Along with the amazing 3D objects that were made and designed entirely differently are stories that are inspirational and encouraging. For example, this box of 3D printed congenital pediatric heart pieces shown during RSNA, a radiology conference I went to almost a decade ago, was my earliest interaction with 3D printing.

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That’s why we decided that we should create and promote an Instagram account to increase the visibility of the creators in the healthcare community and showcase their work to as wide an audience as we could through our #3DHEALSPOST campaign as well as our Instagram Live events last year. We want to continue to be inspired and to inspire others. The result was phenomenal and we have met many inspiring individuals. Here we want to give a Kudo to the top Instagram posts we have reposted through 3DHEALS account. Make sure you give them a Kudo and follow their accounts.

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12. Point of Care with 3D Printed Cast (@3dxcast)

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11. The Power of Our Love and Heart (@esun3dprinting
@tehnalab)

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10. From Cosplay to Prosthetics #PrintedbyPrusa (@printedbyprusa
 @marsgizmo)

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9. Dave Makes Stuff! (@davemakesstuffbc)

What is even cooler is that Dave has made his designs available for download on Thingiverse!

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8. I want to grow up to be Dr. Johnny Uday (@udayjohnny)

Along with this post (cranial prosthetic design by Dr. Uday), there is a recent interview with him that is very worthwhile reading. Stay tuned for the upcoming podcast with Dr. Uday so we can all learn how to create magic like this in the near future.

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7. FRESH Bioprinting Technique (and Cellink) is Everywhere, and We Love them! (@sygnis_nt3d @cellink3d)

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6. Good 3D Printed Orthotic and Prosthetic Designs – Smart Latticing is the Key (@s_d_pro95)

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5. We love dogs…and their 3D Printed Prothesis (@divedesignco)

Check out our IG Live interview with Alex and Adam from Dive Design recently.

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4. Dental 3D Printing: Smooth 3D Workflow can be a piece of Art (@surfctcom @dr.anthonypallotto)

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3. Dave Makes Stuff Rock! (@davemakesstuffbc)

Another blockbuster anatomical design by Dave, also downloadable!

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2. We are making 3D printed implants for animals too! (@udayjohnny)

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1. Can generative design create better medical devices? (@genic_systems)

This is our number one post of the year. This post not only generated a massive number of likes and impressions but also many meaningful conversations among designers and 3D printing engineers, and clinicians. The creator of this post is Peter Domeracki, CEO of Genic Systems, and we hope to hear more from him in 2022.

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Related Articles:

Interview with Dr. Johnny Uday: 3D Printing for Animals

Product Design for Veterinary 3D Printed Prosthesis

IG Live: Tomi Kalpio: CEO of Brinter

Prof. Ali Khademhosseini: Academic Entrepreneur

Robert Pugliese: Design for Healthcare with 3DPrinting

No More Manual Work: Interview with Xkelet CEO and Co-founder Jordi Tura (Video)

3DHEALS Guides (Collective) – This is where we dive deep into subjects that you will find helpful for your projects and career.

3DEALS Expert Corner (Collective) – This is where we invite field experts to write their perspectives in a first-person narrative. To write for this column, please email: info@3dheals.com

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.

The post Twelve Viral Healthcare 3D Printing Instagram Posts in 2021 We Shared appeared first on 3DHeals.

If you had a thousand dollars ten years ago, would you invest in a 3D printing company like 3D Systems (DDD) or Align Technology (ALGN)? (Figure 1) Obviously, one can draw conclusions based on retrospective data shown below, but one could also argue that 3D printing is still an emerging technology and that as an industry its growth potential could outpace that of a specific medtech company. Both arguments are sound. History does not necessarily predict the future, and this blog does not aim to give investment advice. However, the story of a brilliant technology company looking for the killer app to thrive is an all-too-frequent rerun in the entrepreneur world, 3D printing or otherwise. There are a lot of cool things we can make, but only a handful of ideas can break through to change the industrial landscape, fate, and humanity. I am an outsider to the additive manufacturing industry, an end user and provider in healthcare, and it is my opinion that 3D printing needs the healthcare industry, and not the other way around. At least not yet. During our recent virtual mini-conference focusing on “Design for 3D Printed Medical Devices”, Jade Myers (Rochester Institute of Technology, Visiting Scientist/Adjunct Faculty, Rochester, NY) and Nicholas Jacobson (Translational Research Faculty- CU Anschutz, CEO-MIX Surgical Technologies) provided design insights of 3D printed medical devices they were working on used in dramatically different environments.  This article aims to summarize some takeaways from this conference. 

3D printing brings innovation power to designers and clinicians

Customization, freedom of complexity, materials innovation are feeding the increasing potential of 3D printing in making the next generation of medical devices. Jade illustrated the possibility of not only making new lattices but also the ability to translate clinicians’ needs more directly into her design of prosthetic sockets. Nicholas, being a part of a medical innovation lab (inWorks), regularly works with many different medical specialists. With the ability to rapidly transform ideas to prototypes or even end products, he was able to not only meet the needs but also often fulfilling dreams of the clinicians. While not everyone can be a good designer, 3D printing has brought innovators closer to the realization of their ideas. 3D printing enables “embedding” engineering, value, and even identities of the designer, sometimes the clinician him or herself into the medical devices they create.

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Good design requires patient observations and end user conversations

However, just because we have another powerful tool, it does not immediately translate into a product that is needed. There is a unanimous agreement among many that careful observation and awareness of the care delivery environment are critical before the conception of worthy ideas. These require the designers to not only listen carefully of what patients and doctors are talking about, but also a close observation of their workflow, care delivery environment, as well as larger socio-economic, regulatory, and reimbursement atmosphere. In other words, it is unlikely for one to create a good solution without living in Haiti and getting to know some amputees or observing surgeons in the operating room on a regular basis. 

For example, Jade mentioned that 80% of the world’s amputees are in developing countries and have no previous access to proper prosthetics. Part of the reason behind such a high amputee rate is because of poor overall healthcare infrastructure, where amputation is often the first solution to many diseases and traumas and not the final resort as in more developed countries. This ultimately translates into the need for a solution that would work with a low-resource environment. That “low resource” includes lower financial power, lower access to healthcare, and even lower availability of a power supply. Understanding these overarching factors will enable designers to not only create useful prosthetics but also an easy and affordable workflow that can be quickly adopted by local clinicians. 

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During an interview with Stanford Biodesign, even the legendary surgeon and inventor Dr. Thomas Fogerty emphasized the importance of observation throughout his innovative career. That is, observation of everything and everyone is the key to finding a problem that is worth solving. 

Good design requires consideration of many technical factors and iterations

In addition to many considerations of the environmental factors described above, technical details are obvious dictating elements in a good final design product. More specific to 3D printing, engineering concepts like anisotropy for FFF, moisture control, stress concentration, parts geometry, etc., are critical to the design of medical devices like prosthetics. 

Additionally, one or more factors are likely missing in the initial prototype, and design iteration is almost required before reaching a wider patient population. In healthcare, safety and efficacy mandate repeat testing, and a well-defined quality assurance process. This was well demonstrated in a recently published article focusing on a novel COVID-19 mask due to the supply chain crisis during the pandemic. 

Cultural shifts happen when the Design is done right

During his presentation, Nicholas joked that his 3D printed anatomical models were called a good “paperweight” a few years ago when the clinicians were skeptical of the utilization. Similarly, Dr. Fogerty mentioned that it is not good when the clinician said “nice”, and terrible when the clinician said “interesting”. While blaming the conservative nature of the healthcare system (and it is) for not adopting new ideas quicker, a well-designed product that would prompt a doctor to immediately open his/her checkbook is a good sign of the viability of a new device. 

Chicken or eggs? 

I personally argue that great (and not just good) designs are more important than changing people’s current attitude. Cultural changes will take place when the product is so good that either the consumers are willing to pay a high price to get it (in the case of 3D printed anatomical models in high-risk procedures), or the consumers feel disappointed when they can’t afford the procedure right away (in the case of Invisalign).  

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There would be many good designs and ideas, which include most of the 200+ FDA approved/cleared or thousands more in the pipeline of 3D printed medical devices today. Great designs are difficult because as I have mentioned above, it requires not just hardcore technical skills but also being able to observe and embed oneself into the environment where there is a need for innovation. The goal of innovation also should not be monetization or using 3D printing as a core technology, as industrialists in the 3D printing world or capitalists may disagree with good reason, but solving the most urgent humanitarian issues with the best technologies. Most difficult of all is perhaps the practice of art in medicine, where intuition and empathy that only come after we set our goals right. 

About the Author:

Hui Jenny Chen, M.D.

Jenny Chen, MD, is the Founder and CEO of 3DHEALS, a company focusing on educating, connecting, and discovering innovators and entrepreneurs in the space of bioprinting, regenerative medicine, healthcare applications using 3D printing. She is also a practicing neuroradiologist and holds degrees in both medicine and radiology from the David Geffen School of Medicine at UCLA. She has completed fellowship training in neuroradiology at Harvard Medical School/MGH. She has served as Adjunct Clinical Faculty in neuroradiology at Stanford University Medical Center between 2013 through 2021. With a focus on healthcare technology, Dr. Chen serves as a startup mentor and advisor to 3D technology startups as well as Kyto Life Sciences and Technologies. She created the Pitch3D program that connects early-stage startups to various fundraising strategies and directly to 35+ institutional investors in the space of healthcare 3D printing and bioprinting. Her interests lie in automated biology, patient-specific medicine, biofabrication, and has a vision of a decentralized and personalized healthcare delivery system for our near future.

Now On-Demand:

Related Links:

3D Printing In Hospitals: A Beginner’s Guide 1/5

Insight into Digital Design and Orthopaedic 3D Printing

Product Design for Veterinary 3D Printed Prosthesis (podcast/youtube)

Interview with Professor David Zopf

3D Bioprinting: Chiasm of Art, Design, Science, Technology, Evolution

3DHEALS Guides (Collective) – This is where we dive deep into subjects that you will find helpful for your projects and career.

3DEALS Expert Corner (Collective) – This is where we invite field experts to write their perspectives in a first-person narrative. To write for this column, please email: info@3dheals.com

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.

The post Designing 3D Printed Medical Devices appeared first on 3DHeals.

3D Printing (3DP), also referred to as Additive Manufacturing (AM), offers cost-effective and customizable solutions for the creation of anthropomorphic radiotherapy phantoms. These phantoms are employed in vitro to aid in the treatment planning of cancer patients and ensure the quality assurance (QA) of novel radiotherapy techniques. By utilizing 3D printing technology, these phantoms enable the experimental validation of personalized radiation doses and help minimize the impact of ionizing radiation to surrounding healthy tissues.

Modern radiotherapy involves the use of Computed Tomography (CT) imaging, 3D-treatment planning, and the implementation of comprehensive QA processes to produce highly conformal dose distributions and ensure the safe and accurate delivery of the planned treatment. It is common to manufacture phantoms using the molding and casting process, that emulates the radiation properties of the average human tissue as radiation dose cannot be directly measured from patients.

QA processes are often conducted using phantoms ranging from simple geometries (i.e., blocks) to anthropomorphics, in conjunction with various dose measurement tools like thermoluminescent dosimeters (TLDs), radiochromic films, or ion chambers. Well constructed anthropomorphic phantoms available in the market consists of tissue-equivalent materials that provides a good representation of the average person’s cartilage, spinal cord, spinal disks, lung, brain, sinus, bone, and soft tissue, with varying degrees of complexity for clinically relevant sex and ages. Despite this, a common theme behind these phantoms are their costs (i.e., specialized tissue-equivalent materials, high manufacturing expenses and lengthy lead-times) and their limited adaptability aka “one-size-fits-all”. These phantoms only replicate average human proportions, lack personalized tissue heterogeneity, and fail to accommodate pathological features, thus limiting the potential of personalized treatments enabled by the advancing radiotherapy technology. For instance, the current radiotherapy phantom market lacks options for emulating obese patients and offers limited ranges for simulating pediatric patients [1]. With the growing amount of 3DP literature in the healthcare sector, is it possible to customize functional phantoms to address such limitations?

This article discusses some of the basic concepts surrounding the manufacture of 3DP phantoms, their clinical significance and requirements, their associated manufacturing techniques and materials, and the future of 3DP phantoms for radiotherapy use.

Anthropomorphic radiotherapy phantoms for treatment planning.

The treatment planning procedure is a significant part of radiotherapy, which determines the optimal treatment parameters to be used for the management of a patient’s disease via radiotherapy means. These treatment parameters include target volume, dose-limiting structures, treatment volume, dose prescription, dose fractionation, dose distribution, the positioning of the patient, treatment machine settings, and adjuvant therapies (e.g. chemotherapy, hormone therapy, targeted therapy, or biological therapy) [1]

Other than QA, phantoms also act as a human proxy to experimentally visualize and evaluate treatment options tailored for the patient. This importance signifies the current limitations of anthropomorphic phantoms as they only follow the average body proportion and radiation attenuations of a ‘healthy’ person, and lack patient-specific pathological features, particularly for the emulation of lesion shape, density, and positioning [2]. Therefore, these limitations provide a significant opportunity for the 3D printing technology in highlighting low manufacturing costs and phantom customization.

Customization of phantoms enabled by 3DP.

3D printing provides opportunities for the inexpensive manufacture of customizable devices as observed from the current literature not only for radiotherapy phantoms but also for other radiotherapy devices including bolus and compensators to achieve personalized dose distributions for irregular surfaces; electron beam shielding devices to block ionizing beams and scattered rays; immobilizers to secure patients during treatment to avoid unnecessary movements during treatment and; brachytherapy moulds to allow targeted radiation treatment using catheters to allow the insertion of radioactive seeds close to the lesion [3,4].

Novel 3D printing workflows have been developed to accommodate imaging tissue-like heterogeneity utilising 3D printing materials, via modification of infill parameters, and the in-house development of materials to modify their radiation attenuation properties.

Types of 3DP phantoms.

Early versions of additively manufactured radiotherapy phantoms were manufactured as-shell phantoms, which are hollowed phantoms filled with various tissue-equivalent materials (sawdust, silicone gels, cork).

The emergence of better AM technologies has attracted interest in exploring the simulation of human tissue heterogeneity, classified as as-printed phantoms. Heterogeneity in printed phantoms can be achieved using material extrusion (MEX) (well known as fused deposition modeling (FDM)) printing parameters such as infilling patterns and percentage, printing nozzle size, temperature, and more recently, the modification of material extrusion rate.

Furthermore, contrast variations can also be achieved by constructing phantoms with two or more different AM materials (multiple material printing); doping filaments with high-density materials such as bismuth and barium sulfate to increase the observed HU range; and the use of controlled voided structures within the manufactured phantoms to precisely controlled HU values.

Recent studies have illustrated the combination of these manufactured phantoms with commercially available motion platforms and in-house motion devices to further stimulate body movements, especially the thorax’s respiratory movements (classified as 4D-AM phantoms) (see Figure 3). See more recent reviews of 3D printing phantoms in the literature from [3, 4, 5, 7]. 

Figure 3 below illustrates more in detail that 3DP phantoms are divided into two manufacturing processes, (1) direct manufacturing process utilizing only commercial or in-house 3DP materials for manufacture phantoms, and (2) indirect manufacturing process utilizing 3DP materials (commercial or in-house) and are assembled with tissue-substitutes (non-3DP materials) to manufacture phantoms). These 3DP phantoms are categorized into a solid phantom, a deformable phantom utilizing deformable 3DP materials, or a 4D phantom, which are either solid or deformable phantom attached to a motion platform to simulate patient movements.

Video 1. Comparison of 3DP bone phantom with the associated patient CT dataset [8].

Clinical requirements and implications.

More recently, printing guidelines and recommendations for 3DP in medicine have been developed by the SIG (Special Interest Group on 3D printing), a group representing the Radiological Society of North America [9]. The guidelines and recommendations are divided into four main processes including:

1. Medical image acquisition – commonly used imaging modality involves CT or MRI. Associated patient data should have sufficient spatial resolution to accurately represent anatomy to be modelled.
2. Image data preparation and manipulation – includes image segmentation, 3D CAD design, and file documentation.
3. Generation of the 3D-printed model –involves the printing process, post-processing, and model inspection.
4. Quality Control program – involves the delivery and discussion with referring physicians, pre-operative planning, material biocompatibility, cleaning, and sterilisation, and clinical appropriateness. 

Regarding printing materials, it is essential to consider the photoelectric and Compton effects when comparing result outputs with human tissues. Photoelectric effect serves as the dominant phenomena at low x-ray energies ranging below 200 KeV, hence for imaging modalities (CT, MRI, PET). At higher x-ray energies up to 10 MeV, Compton effects can be considered as the dominant phenomena, where material attenuation differs depending on their elemental composition, signifying how radiation doses are distributed [1]. Ideally, 3DP phantoms aim to simulate not only the patient’s proportion and pathological features but also both the imaging attenuation of human tissues, the photoelectric effect, and the dose attenuation of tissues, the Compton effect.

Also, for any given 3D printing material to be tissue or water equivalent, it must have the same effective atomic number, number of electrons per gram, and mass density. However, since the Compton effect is the predominant mode of interaction for MV photon beams in the clinical range, the necessary condition for water equivalence for such beams is the same electron density (number of electrons per cubic centimetre) as that of water.

The future of 3DP phantoms.

Despite lower manufacturing costs and complex geometrical capabilities of 3D printing in developing anthropomorphic radiotherapy phantoms, there exists numerous uncertainties with regards to their reproducibility and sustainability.

At present, the commonly utilized 3DP technology for developing phantoms, MEX, is still yet to be fully exploited to its full potential for manufacturing clinically viable phantoms for routine use. MEX comes with inherent limitations in comparison with other printing techniques such as Material jetting technologies (MJT) and Stereolithography (SLA) where significant void defects are observed, which in turn produces structurally weak and non-uniform dense objects affecting the phantoms reproducibility and sustainability.

In comparison to the huge growth of 3D printed surgical guides and implants in the healthcare industry, 3DP phantoms will soon be able to compete clinically and be more accepted globally as clinicians and engineers work towards quantifying the associated manufacturing uncertainties, explore innovative 3DP methods, and tissue-equivalent materials for the customization of 3DP phantoms, and its implementation for complex case studies comparing 3DP phantoms and commercial phantoms. Furthermore, it is also recommended that proper documentation of these 3DP phantoms (i.e. printing parameters, printing machine description, the body-site of application, imaging modality used, material and printing costs, printing and time, printing workflow, post-processing procedures) be implemented as it will play a significant role in providing guidance for developing clinical regulations and cost reimbursements for such devices in the future.

Acknowledgements:

Some references in this work are a collection of collaborative efforts conducted during my PhD at RMIT’s Centre for Additive Manufacturing (RCAM) under the supervision of Professor Martin Leary and Distinguished Professor. Milan Brandt and Sir Peter MacCallum Cancer Centre physical sciences department involving Professor Tomas Kron and Senior medical physicist, Dr. Adam Yeo.

References:

[1] Khan, F.M., Gibbons, J.P. and Sperduto, P.W., 2016. Khan’s treatment planning in radiation oncology. Lippincott Williams & Wilkins.

[2] Kron, T., Ungureanu, E., Antony, R., Hardcastle, N., Clements, N., Ukath, J., Fox, C., Lonski, P., Wanigaratne, D. and Haworth, A., 2017. Patient specific quality control for Stereotactic Ablative Body Radiotherapy (SABR): it takes more than one phantom. In Journal of Physics: Conference Series (Vol. 777, No. 1, p. 012017). IOP Publishing.

[3] Tino, R., Yeo, A., Leary, M., Brandt, M. and Kron, T., 2019. A systematic review on 3D-printed imaging and dosimetry phantoms in radiation therapy. Technology in cancer research & treatment, 18, p.1533033819870208.

[4] Tino, R., Leary, M., Yeo, A., Kyriakou, E., Kron, T. and Brandt, M., 2020. Additive manufacturing in radiation oncology: a review of clinical practice, emerging trends and research opportunities. International Journal of Extreme Manufacturing, 2(1), p.012003.

[5] Leary, M., Kron, T., Keller, C., Franich, R., Lonski, P., Subic, A. and Brandt, M., 2015. Additive manufacture of custom radiation dosimetry phantoms: An automated method compatible with commercial polymer 3D printers. Materials & Design, 86, pp.487-499.

[6] Leary, M., Tino, R., Keller, C., Franich, R., Yeo, A., Lonski, P., Kyriakou, E., Kron, T. and Brandt, M., 2020. Additive manufacture of lung equivalent anthropomorphic phantoms: a method to control hounsfield number utilizing partial volume effect. Journal of Engineering and Science in Medical Diagnostics and Therapy, 3(1).

[7] Filippou, V. and Tsoumpas, C., 2018. Recent advances on the development of phantoms using 3D printing for imaging with CT, MRI, PET, SPECT, and ultrasound. Medical physics, 45(9), pp.e740-e760.

[8] Tino, R., Yeo, A., Brandt, M., Leary, M. and Kron, T., 2021. The interlace deposition method of bone equivalent material extrusion 3D printing for imaging in radiotherapy. Materials & Design, 199, p.109439.

[9] Chepelev, L., Wake, N., Ryan, J., Althobaity, W., Gupta, A., Arribas, E., Santiago, L., Ballard, D.H., Wang, K.C., Weadock, W. and Ionita, C.N., 2018. Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios. 3D printing in medicine, 4(1), pp.1-38.

About the Author:

Rance Tino

Rance Tino attained a Bachelor of Engineering (Biomedical Engineering)(Honours) at the Royal Melbourne Institute of Technology (RMIT) in 2017. Since graduation, Rance has continued the academic pathway at RMIT and have recently completed his PhD with the Victoria Comprehensive Cancer Centre (VCCC), Peter MacCallum Physical Sciences department in developing a customizable Radiotherapy Phantoms using 3D printing for end-to-end testing of personalised treatment plans.

Related Articles:

3D Printing and Bioprinting For Cancer Care – Guide

From Academia: Bioprinted Cancer Models, Microprinted Imaging Probe, 3DTech for Congenital Heart Disease

From Academia: Four-axis 3D printing, Efficacy of 3D printed model for breast cancer reconstruction, and Cultured Meat

3D Printing for Cancer Treatment – Radiation Therapy Liver Phantom

The post 3D Printing of Customizable Phantoms in Radiation Oncology appeared first on 3DHeals.

Want to write a piece for 3DHEALS Expert Corner? Email us: info@3dheals.com

(This is an expert post in both Chinese and English.)

3D打印骨科植入物在中国的应用概况以及商业转化中的挑战

3D打印技术在制造多孔结构、拓扑优化结构以及梯度材料领域具有技术上的优势，同时与传统制造技术相比，3D打印技术更易于实现植入物的批量定制化生产。这些优势为3D打印技术在骨科植入物制造中的应用发展带来了潜力，骨科植入物制造业是3D打印技术最早实现产业化应用的领域之一。

3D printing technology has technical advantages in the manufacture of porous structures, topologically optimized structures, and gradient materials. At the same time, compared with traditional manufacturing techniques, 3D printing technology is easier to achieve mass customization of implants. These advantages have brought potential to 3D printing technology in the manufacture of orthopedic implants. The orthopedic implant manufacturing industry is one of the earliest fields of industrial application of 3D printing technology.

截至2017年底获得FDA 医疗器械注册证的3D打印医疗器械已超过了100个，其中包括了多款由不同品牌制造的3D打印脊椎植入物和关节植入物。

More than 100 3D printing related medical devices have received FDA medical device registration certificates by the end of 2017, including a variety of 3D printed spinal implants and joint implants made by different brands.

相比之下，中国骨科医疗器械制造商在3D打印骨科植入物商业转化方面的进展较慢。截至2018年，中国有3个3D打印骨科植入物产品获得了医疗器械注册证，包括：

In contrast, Chinese orthopedic medical device manufacturers have made slow progress in the commercial conversion of 3D printed orthopedic implants. As of 2018, China has three 3D printed orthopedic implant products that have obtained medical device registration certificates, including:

• 2003年，上海交通大学医学院附属第九人民医院与上海晟实医疗器械科技有限公司合作获得个体化人工假体注册许可证（包括髋、膝、肩、踝、腕关节）。
• In 2003, Shanghai Ninth People’s Hospital cooperated with Sheng Shi Med to obtain individualized artificial prosthesis registration licenses (including hip, knee, shoulder, ankle, wrist).

• 2015-2016年，北京爱康宜诚医疗器材股份有限公司获得了三个金属3D打印植入物注册证：髋臼部件和椎体假体、椎间融合器。
• 2015-2016，AK Medical has three 3D printing products approved by CFDA.

• 2018年，西安科谷智能获得了个体化下颌骨重建假体注册证。其材料为Ti6Al4V铸造钛合金材料，通过与个体病患骨缺损形态匹配的铸造型壳（3D打印光敏树脂型消失型）铸造而成。
• In 2018, the personalized mandibular reconstruction prosthesis of Xi’an Kegu Intelligent Machine Co., Ltd was approved. The material used is a Ti6Al4V cast titanium alloy material, which is cast by a casting shell (3D printing photosensitive resin type disappearing type) matched with the shape of the individual patient’s bone defect.

与商业转化情况不同的是，3D打印骨科植入物在中国骨科临床治疗中的应用是处于国际先进水平的。中国部分三级甲等医院在临床中应用3D打印植入物已有多年历史，例如：上海交通大学附属第九人民医院在2014年就已将金属3D打印个性化假体用于骨盆肿瘤切除与重建手术。此后，上海第九人民医院在腕关节、踝关节、胸骨、髋关节等复杂骨科手术中又多次应用了3D打印的个性化金属植入物。除此之外，北京大学第三医院、空军军医大学唐都医院、广东省骨科医院等三级甲等医院（见图1）也陆续在复杂骨科疾病的治疗中应用了3D打印骨科植入物。

In contrast to the commercialization of 3D printed implants, the application of 3D printed orthopedic implants in the clinical treatment of orthopedics in China is considered at the advanced level internationally. Several lower-level hospitals in China have applied 3D printed implants in clinical practice for many years. For example, the Ninth People’s Hospital affiliated to Shanghai Jiaotong University has used metal 3D printed personalized prosthesis for pelvic tumor resection and bone reconstruction in 2014. Since then, the hospital has applied 3D printed personalized metal implants in complex orthopedic operations such as wrist joints, ankle joints, sternum, and hip joints. In addition, Peking University Third Hospital, Air Force Military Medical University Tangdu Hospital, Guangdong Provincial Orthopaedic Hospital, and other lower level hospitals (see Figure 1) have also applied 3D printed orthopedic implants in the treatment of complex orthopedic diseases.

Figure 1

可见，临床对于3D打印植入物存在多样化的需求，特别是在进行骨肿瘤治疗等复杂疾病修复治疗领域对于3D打印技术存在刚性需求。那么，在这种情况下，是什么原因导致3D打印植入物在中国的商业化进展缓慢呢？

影响3D打印骨科植入物商业转化的因素可以归纳为以下几点（见图2）：

Therefore, it is evident that there is a diversified demand for 3D printed implants in clinical practice, especially in the field of complex disease repair and treatment such as bone tumor treatment, which has a solid demand for 3D printing technology. So, in this case, what is the reason for the slow progress of commercialization of 3D printed implants in China?

Factors affecting commercialization of 3D printed orthopedic implants can be summarized as follows (see Figure 2):

• 技术因素 Technical factors
• 管理因素 Management factors
• 意识层面接受度 acceptance factors
• 法律法规的支持 Policy support
• 人才与教育 Talen & Education

Figure 2

结合中国的具体情况，在临床需求端，虽然3D打印骨科植入物在部分治疗中得到了应用，但3D打印技术并没有成为国内医生所普遍接受的技术，这是该技术商业化的其中一个挑战。

Combined with China’s specific situation, although 3D printed orthopedic implants have been applied in some treatments at the clinical demand side, 3D printing technology has not become a technology widely accepted by domestic doctors. This is one of the challenges for  commercialization.

从企业方来看，无论是增材制造技术的人才、医工结合的人才、打印材料、打印设备，还是后处理工艺，都没有做好植入物大规模制造的准备；另一方面是针对个性化植入物而言，在制造一些复杂个性化植入物时，对3D打印技术是刚性需求，但是由于这些个性化需求为企业带来的利润有限，这使得有实力的传统骨科医疗器械企业进入该领域的动力不足，而凭借3D打印技术生存的初创型医疗器械企业，也存在着实现盈利的挑战。

From the enterprise perspective, whether it is lack of talents in additive manufacturing, lack of talents with combined medical science and rehabilitation engineering backgrounds, lack of appropriate printing materials or equipment, or lack of post-processing technology, there is subsequently a lack of readiness for large-scale implant manufacturing. In terms of personalized implants, there is a definite need for 3D printing technology. However, because of the limited profit, the powerful traditional orthopedic medical devices manufacturers do not have enough motivation to enter this space, and medical device startups that survive with 3D printing technology also have the challenge of realizing profitability.

在医疗器械审批法律法规方面，国内法律法规的设置相对滞后，也是3D打印骨科植入物商业转化所面对的挑战之一。不过利好的一面是，相关法规、标准正在完善中，比如说CFDA已发布了“定制式增材制造医疗器械注册技术审查指导原则（征求意见稿）”。

In terms of medical device laws and regulations, the setting of the Chinese domestic laws and regulations is relatively lagging behind, and it is also one of the challenges faced by the commercialization of 3D printed orthopedic implants. However, the positive side is that relevant regulations and standards are being improved. For example, CFDA has issued the “Guidelines for the Review of Technical Registration for Customized Additive Manufacturing Medical Devices (Draft for Comment)”.

尽管存在着种种挑战，中国3D打印领域的先行者们仍在政策法规、行业标准的完善、临床应用、产品研发等领域推动着3D打印骨科植入物技术的发展。根据3D科学谷的市场观察，目前有一批新的3D打印定制化植入物正在进行商业转化，这些企业主要集中在中国华东、华中区域，预计2020年左右这些植入物将陆续获得医疗器械注册证。

Despite the challenges, the pioneers in China’s 3D printing industry are still driving the development of 3D printed orthopedic implant technology in areas such as policy and regulation, industry standards, clinical applications, and product development. According to the market observation of 3D Science Valley, a number of new 3D printed customized implants are currently undergoing commercialization. These enterprises are mainly concentrated in East China and Central China. It is expected that these implants will get registered around 2020.

About the Author:

Daisy Zhu is co-founder of 3D Science Valley , a commentary media platform focusing on additive manufacturing. She is responsibe for the publication of white paper of 3D printing in dental industry, orthopedic industry as well as rehabilitation appliances industry. She is one of the authors of the book ‘ 3D Printing in Automotive Inudstry Technology and Development Report’ and ‘3D Printing and Industrial Manufacturing’. She has been the keynote speaker at several medical forums , entrepreneurship salons and popular science activities. 

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Medical 3D printing is becoming more mainstream with the announcements of FDA 510K cleared software vendors, certified 3D printing systems, and preliminary data tracking and reimbursement such as the Category III CPT codes 0559T, 0560T, 0561T, and 0562T to be later implemented July 1, 2019, for 3D printed anatomic models and guides. All of this news has been long awaited within this growing field, but many challenges still await us. As the engineer responsible for the operations of the 3D Printing Center at Washington University Campus, which supports all of the BJC HealthCare enterprises including St. Louis Children’s Hospital, I’m constantly working towards solutions to cases requiring 24 hour turnarounds, creating seamless integration of our center’s services with standing hospital IT infrastructure, and of course, keeping the center’s books in the black. 

One of the challenges I’m working to address is, how will we stand out when more and more hospitals adopt 3D printing? Most children’s hospitals with 3D printing capabilities have a few highlighted high-risk patient cases, which is great for the hospital and those stories have the potential to attract philanthropic donors. However, should the 3D printing center specialize in one area over others in order to stand out? Some centers focus more on surgical simulation, one surgical specialty, or sometimes even one certain surgical procedure. Or at the end of the day, is it more about volume?

Arguably, one of the biggest challenges in ramping up a medical 3D printing center is predicting the volume of surgical procedures the center will support in its first 5 years (aside from personnel, capital, and space).

For anyone not familiar with this practice, this is one of the factors your business development team takes into consideration when generating the hypothetical ROI. Within any hospital, the volume may be difficult to estimate, especially in pediatrics, where we try to avoid exposing such young patients to the harmful side effects of MRI and CT, if we can get the patient to lie still long enough that is.

Going one step further is the integration of 3D printing and high-quality 3D dataset protocols so that we don’t have to re-image the patient if the referring physician or surgeon would like model days or weeks after the patient has been imaged or has returned home. 

Returning home in good health, that’s something we all want for our patients. I often forget how many of our patients are unaware of how this technology is used in healthcare. Recently, a group of students was touring the hospital as part of a STEM program. A great joy of mine is to explain to a child how a 3D model is made and why we decided to 3D print it that way. Mainstream or not, this technology is still disrupting healthcare, not just limited to what happens on campus, but also by exposing the next generation to it.

About the Author:

Robert Wesley is a Tennessee native who started his career at Nicklaus Children’s Hospital in Miami. It was there he was introduced to in-hospital 3D printing. As a biomedical engineer in pediatric cardiac surgery, he worked to expand the hospital’s 3D printing capabilities and vision beyond its congenital heart program. A couple of years later he did consult work for a few southeastern children’s hospitals with emerging 3D printing programs, before finding his way to St. Louis Children’s Hospital of BJC HealthCare. In St. Louis, Robert runs the operations of the 3D Printing Center at Washington University Medical campus which services all 15 BJC hospitals, Washington University School of Medicine, and local/regional hospitals, under the direction of Christine Pavlak, Dr. Shafkat Anwar, Dr. Kamlesh Patel, and Dr. Eric Eutsler.

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The concept of 3D printing (or additive manufacturing) in medicine is nothing new to physicians. Indeed, ever since computed tomography (CT) scans could be converted into 3-dimensional images in the early ‘80s, companies have sought to create 3D printed models of skulls and other anatomic structures. Surgeons, in particular, have been ordering custom anatomic models for decades now and services have expanded from creating simple skull models to customized patient-specific implants and virtual surgical planning.

A movement is now afoot to bring the factory into the hospital. With the explosion of 3D printing technologies, commercial-grade 3D printers have become more affordable than ever. As a result, doctors and other medical providers now have the potential to control the process of medical modeling themselves, without the need to outsource this work to commercial entities.

There are some clear benefits to bringing these capabilities in-house. The obvious one is the cost. Commercial entities currently charge hospitals thousands of dollars for these services – frequently more than surgeons get paid for the surgery itself. The ability to create these models in the hospital could decrease these costs dramatically, by 50% or more. Speed and convenience are also significantly enhanced. Models can be created at our institution as quickly as within 12 hours versus a minimum of 3-4 days and more typically 2 weeks from commercial sources. Finally, the risk of hospitals also is decreased. By necessity, medical providers must provide PHI (protected health information) to vendors. In the current era where major companies are hacked regularly, decreasing the number of external vendors also optimizes the protection of patient health information.

One would think that with such clear advantages present, hospitals all across the nation would be furiously working to start their own 3D printing labs. In reality, however, few such labs exist across the country and those who have attempted to start such services have frequently encountered surprising resistance to doing so. So why is this? 

The answers are not always clear and may differ at each particular institution, but there are definitely a number of key factors which pop up as recurring themes.

Business Plan

“Show me the money.” – Jerry Maguire

The reality is that all corporations, including hospitals, are in the business of making money. As a result, no enterprise in additive manufacturing will ever become successful without a reasonable business plan. Unfortunately, clinicians (who are frequently the advocates of this technology) are not well-versed in these types of discussions and arguments such as “it improves patient care” and “it’s the right thing to do” literally have CFOs seeing red.

Start-Up Costs

As with the start of any business, getting started isn’t necessarily cheap, or easy. While one might be able to purchase a low-grade FDM (fused deposition modeling) printer on Amazon for less than $500, professional quality machines start at the $30-50,000 level and top-of-the-line PolyJet/MultiJet machines with multi-color capabilities extend to the hundreds of thousands of dollars. Commercial software can also cost somewhere around $20-30,000 per workstation per year and experienced technicians or engineers to manage the printers continue to add to the costs of upkeep.

Lack of Expertise (and Training)

Even with enthusiasm on the part of institutions to proceed, medical 3D printing is such a highly-specialized, nascent field that few individuals have the qualifications to start a hospital- or clinic-based 3D printing lab from the ground up. Who is qualified to get this started? A clinician? A radiologist? An engineer? A 3D printing technician? The reality is that each of these individuals may have a subset of the skills necessary to develop a functional lab but few have possessions of all the skills necessary to do so. Moreover, even when there is a strong interest in training in this field, few companies provide the resources necessary to get started. 

Bureaucracy

“No good deed ever goes unpunished.” – #285 in the Ferengi Rules of Acquisition, Star Trek Universe 

Finally, bureaucracy may not sound overly menacing, but I have experienced a few factors which can serve to be insurmountable on a daily basis. Hospitals, like many large institutions, have a well-developed middle management process. One cannot help to feel that at many organizations, there is a culture of “no”. Middle management does not get rewarded for moving projects along or bringing good ideas to fruition. Rather, they get paid whether your project lives or dies. Your outstanding idea, therefore, may simply translate to more work on their part. In a sense, they are literally incentivized to kill your project and make you go away. Turning such people around to get on your side may be the greatest challenge of all. 

The Answers

So what are the answers to these challenges? Needless to say, one should take heart for all is not lost. Having developed two 3D printing labs at separate institutions (St. Louis Children’s Hospital/Washington University School of Medicine; Rhode Island Hospital/The Warren Alpert Medical School of Brown University), the answers differ to some extent based upon the specifics of each institution.

To cut to the chase, however, one must speak to hospital administrators in the language of dollars and cents. This may require some research into the business models of hospital finance. In general, hospitals get paid based on DRG (diagnosis-related group) codes, meaning that they often receive a flat fee for specific procedures, regardless of the costs incurred. As a result, custom models are often not directly reimbursed and can significantly cut into the profits of these institutions. Demonstrating a clear cost saving for models ordered for some of these procedures can translate goodwill into concrete financial benefits.

A close evaluation of financial records will demonstrate to most institutions that they are currently spending on the order of hundreds of thousands of dollars for custom models for surgical planning. Moreover, common sense dictates that patient-specific, 3D printed models will only continue to grow in popularity among physicians as more and more become convinced of their benefits. Logic, similarly, would dictate that supporting an in-house manufacturing lab would not only allow the printing of models for a fraction of the cost of commercial entities but that this would serve as an important cost-containment device for the future, as this technology is forecasted to grow exponentially.

Support from the top is frequently critical to get such processes underway. Middle management is often eager to please when they realize that key figures in the organization are invested in your success. Once the financial backing is obtained, full-time technicians may need to be hired to run and maintain these machines. As noted, few individuals exist with the full set of skills necessary so most training is on-the-job. Thankfully, support and advice are frequently from a small but enthusiastic cadre of labs like ours who have started from the ground up.

Most importantly, few undertakings ever get accomplished without passion. The greatest challenge, then, is simply finding that individual with the right spark to get the fire going. Could this be you?

About the Author:

Albert S. Woo, MD, FACS is a board-certified plastic and reconstructive surgeon who specializes in the treatment of cleft and craniofacial anomalies. This work has led to a particular interest in three-dimensional imaging and printing of complex surgical models. He is an Associate Professor of Surgery, Pediatrics, and Neurosurgery at The Warren Alpert Medical School of Brown University and serves as the Chief of the Division of Pediatric Plastic Surgery, Director of the Cleft and Craniofacial Center at Hasbro Children’s Hospital, and Director of the new Lifespan 3D Printing Laboratory.

Besides medical 3D printing, Dr. Woo’s clinical interests include the surgical treatment of patients with craniosynostosis, complex and syndromic craniofacial abnormalities, and cleft deformities. In particular, he is internationally recognized as an expert in cleft palate repair, after having developed a new surgical technique for this procedure. He is also nationally recognized for his expertise in Endoscopic Craniosynostosis Surgery, with numerous papers and national presentations on the subject. With more than 60 peer-reviewed publications, numerous chapters and a book, Dr. Woo remains committed not only to clinical excellence but also to advancing research in the treatment of craniofacial anomalies.

Dr. Woo currently is a member of numerous societies including the American College of Surgeons, the American Society of Maxillofacial Surgeons, the American Cleft Palate-Craniofacial Association, the American Association of Plastic Surgeons, and the American Society of Plastic Surgeons. He is the recipient of numerous awards, including recognition by Best Doctors in America since 2011 and Castle Connolly’s Top Doctors.

Dr. Woo was a speaker at our 3DHEALS Boston event last year (2018).

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