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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Q: What is the biggest business risk you have taken?

A: Ha. We risked everything to take on the task of starting Tangible Solutions. I had 4 jobs at one point just to make ends meet while we were getting started. We took out a credit account to put the down payment on our first two machines. 80+ hour workweeks 7 days a week for next to nothing. It’s a huge risk.

Mr. Chris Collins, Chief Operating Officer and Co-Founder of Tangible Solutions, is an industry leading Mechanical Engineer. Listed on 2 Patents, He has intimate knowledge of Engineering Design for overall manufacturability of products, especially for 3D Printing; and applies kinematic design and analysis techniques through engineering design software. He has significant experience applying and manufacturing trabecular structures for medical implant applications. Mr. Chris Collins will be a speaker at #3DHEALS2017.

Q: What is your vision on the intersection of 3D Printing and healthcare?

A: Right now, I see AM & Healthcare intersecting most heavily in the emergency custom implant arena. There are many articles surrounding the topic. As we move forward with the technology, we will see titanium orthopedic implants taking over.

Q: What do you specialize in? What is your passion?

A: I specialize in mechanical design for Additive Manufacturing. Particularly implementing trabecular (randomized porous) structures in medical devices. This has become a passion of mine through experience. There is nothing like knowing that I contributed toward a design that will soon help improve the quality of life for an individual.

Q: What is the biggest potential impact you see 3D printing having on the healthcare industry?

A: In regard to the manufacturing world: I see the biggest impact being on the orthopedic implant industry. There are a multitude of devices, custom plates, etc, that could benefit greatly from design freedoms offered by AM. Something I’m not as familiar with is bio-printing. I think this is truly a game-changer when it comes to growing an organ or other functional body parts is something that isn’t far off — if it doesn’t already exist in some capacity.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: Some of the biggest challenges are quality & regulatory. These are seen as hurdles by some, but the safeguards are in place for a reason, and we’ve all just got to work together to reach reasonable solutions through gaining a better understanding of the processes on both sides of the proverbial fence.

Q: What is the best business lesson you have learned?

A: There have been so many lessons learned throughout the entrepreneurial process… Some of the most important in relation to Additive is that you’ve absolutely got to design for the process. Printing the same part that can be easily injection molded, milled, turned, cut, etc is often the opposite of the correct use of the technology. Engineers must have an understanding of the factors that drive cost in an additively manufactured part, and the benefits associated (often improved performance).

Q: What is the biggest business risk you have taken?

A: Ha. We risked everything to take on the task of starting Tangible Solutions. I had 4 jobs at one point just to make ends meet while we were getting started. We took out a credit account to put the down payment on our first two machines. 80+ hour workweeks 7 days a week for next to nothing. It’s a huge risk.

Q: What crucial skill should people aiming to work in this industry acquire?

A: There is a huge gap in technical operators of equipment. Training programs are few & far between, and experienced techs are already gainfully employed inside a business that has a demand for that position. This is a big reason that TS is largely involved with local Community Colleges as well as Universities in the development of technical skill-sets.

Q: What is your vision on the next step for metal 3DP in healthcare?

A: I think the next step is production-level capacities for Titanium orthopedic devices. Although I am admittedly ignorant to the state of bioprinting.

The post Interview: Mr. Chris Collins appeared first on 3DHeals.

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3D Mesh of a Femur

Imagine if you would: a soldier, injured in battle with a near fatal leg injury in the field due to an IED explosive.

Imagine the horror in the face of the platoon leader upon seeing such a devastating blast injury – a gaping wound with skin, muscle ripped to shreds and a gaping hole between the ends of the bones shattered beyond repair; no time to look for body parts, move the soldier to the M.A.S.H. unit and hope he survives. Temporizing debridement and dressings and splints and then shipped off to safe harbor for definitive care.

An external fixator with multiple serial debridements and surgical flaps help close the wound and control infections. Repeat surgeries for granulating pus treated intermittently by state of the art hospitals and top-notch specialists in Hamburg and DC. Eventually escaping infection, further lengthening and grafting procedures to fill the bone void with new bone, and a satisfactory outcome with a grotesque painful deformed leg hatched up by scars. A limp for life, but always a hero.

Alternatively, the hero loses viability of the leg and is left with a stump of an amputation.

How would that feel if it happened to you?

3D Mesh of a Femur

Imagine instead if you were, that same soldier, same blast, same horror. Only this time, the M.A.S.H. unit has a futuristic art biological tissue printer. In that case, stabilize the patient hemodynamically, cleanse the wound and remove dead tissue. Apply an in-vivo nano-bot scanner to the sterile field that maps out the defects and tissue vacancies to create a 3D model of the bone and soft tissue defect in the field. An output of human bone, muscle and skin to replace the defect and closure and fixation with biologically enhanced repair vectors, all 3D printed together. The 3D printer incorporates antibiotics and growth factors within the tissue model with pre-made fixation points and anchors to allow rapid reconstitution back to pre-injured state with human-guide surgi-bots.

Now, it’s just healing and rehab. But wait, the device also incorporates bone promoter therapeutics and anti-microbial agents within the structure such that, as the tissue integrates, it heals fast and allows earlier strength, motion and return to function. That same patient still returns a hero, but now with a decent pain-free leg and back to his family in one piece. No metal, no hardware to remove, full integration and reconstitution of human tissue.

How would that make you feel?

Remarkable, right?

This epithet is only intended to share an extreme of our needs today. We can achieve this impossible dream and make it into a reality through real science and an evolving field of experts that is growing. The future is only limited by our vision and our desire to pursue the limits of our frontiers at a pace that cannot be hindered by anything but our imagination.

This is simply one future of 3D printing in Orthopaedics.

About the Author

Dr. Faisal Mirza is an orthopaedic surgeon in private practice, OrthoSynthesis, in Silicon Valley where he focuses on surgical and non-surgical restoration of function, preservation of mobility and promotion of musculoskeletal health and regeneration.

His experience spans across biotech industry, drug & device regulation, and academic practice as Medical Director, Global Bone Health Development, Amgen; Medical Officer, Device Regulation and Research, FDA; and Clinical Assistant Professor, Stanford University VA Palo Alto.

Faisal fosters innovation and development of biologics, devices and combination products through his consulting startup, Clarity Synergy. Having trained at the University of Western Ontario and McMaster University in Canada, Dr. Mirza now considers San Francisco home where he lives with his wife and two children.

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