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.

Dr. Alan Dang is a board-certified, licensed orthopedic spine surgeon. He is an HS Clinical Associate Professor at UCSF. Along with his brother, Dr. Alexis Dang, he started the Orthopaedic Rapid Intelligent Fabrication (ORIF) program at UCSF/San Francisco VA and is a founding member of the UCSF Center for Applied 3D+ Technologies.  Dr. Dang is also a capstone mentor and member of the selection committee for the UCSF/UC Berkeley Masters in Translational Medicine program. He is also the co-founder of PrinterPrezz, a 3D printing medical company offering design, prototyping, mass production, and regulation assistance to orthopedic device companies. Alan will join us on the upcoming 3D Printing in Orthopedics event.

3D Printing Ti6Al4V Orthopaedic Implants: As Easy as Counting 1-2-3 (3DHEALS2020 Video)

Jenny: When was your first encounter with 3D printing like? Who first got into 3D printing? Your brother (Dr. Alexis Dang) or you? =)

Alan: I was the first to get into 3D printing, but my brother, Dr. Alexis Dang gets all the credit for developing the processes required to ramp up to in-hospital production.  We started in early 2013 with a MakerBot Replicator 2X.  At the time, I thought the label “Experimental Printer” was just a bit of marketing, and I would only find out many years later that the Replicator 2X was a product where the public announcement was also the first time the engineering team had heard of it.  Since Alexis and I didn’t know that it wasn’t supposed to work, we worked hard to disassemble, tweak, and reassemble the printer.  We actually did get it working reliably, and in doing so, we built a body of knowledge that has helped UCSF and the San Francisco VA Health Center produce reliable precision anatomic models for surgical planning off today’s much more reliable enthusiast-level desktop printers.  At the San Francisco VA, whenever a CT scan is indicated clinically, we consider making a 3D printed model for surgical planning, resident education, or patient education.

In the beginning, we thought 3D Printing in plastic would help novices only, but we quickly saw how precision anatomic models could guide pre-operative plans by even the most skilled and experienced surgeons.  Everyone got a bump from the technology regardless of skill level, and we saw that the everyone was performing at their full potential.  3D Printing continues to be a focus of our research at the University and published on how mechanical performance of plastic surgical retractors are affected by print parameters and post-processing.

Jenny: What inspired you to start your journey from an orthopedic surgeon to eventually co-founding a company focusing on healthcare 3D Printing? 

Alan: At UCSF and the San Francisco VA, we are blessed to have resources needed to generate plastic precision anatomical models in-house on clinical timelines.  A patient can come to the clinic on Monday afternoon and we can have a print-ready for the operating room team on Tuesday morning.

However, moving from 3D printing in plastic to 3D printing in metals such as Ti6Al4V-ELI is a leap that isn’t feasible to do at the university hospital. 

Manufacturing orthopedic implants require advanced manufacturing skills to manufacture in titanium alloy or other advanced materials.  This expertise was not found in the university but was instead found in the semiconductor and advanced software application world.  The four co-founders of PrinterPrezz decided that our collective skills filled the gaps in individual knowledge.

What is most exciting to me about 3D Printing is that it is an enabling technology that not only makes a surgeon’s life better through improved ergonomics, but it also helps patients experience more gratifying lives too.  When surgery is easier or smoother for a surgeon, there are fewer complications and recovery can be quicker for patients.  3D printed structures like lattices can enhance bone on-growth and through-growth, enabling patients to heal better.

Jenny: What were some of your early failures and successes? How did these shape your choices today? 

Alan: In residency, when things got tough, we used to say: “Pressure makes diamonds.”  Our early struggles with getting desktop level plastic 3D printing to reliability standards would shape 

PrinterPrezz’s focus on maximizing reliability of metal 3D printing and optimizing performance of Class II medical devices, such as spinal implants, that are manufactured in Ti6Al4V-ELI.

Jenny: Since you are also part of the VA system as a surgeon, what kind of experience do you have with the VA 3D Printing Innovation network? 

Alan: The opinions expressed in this answer are my own and do not reflect the view of the Veterans Administration, or the United States government.

My brother and I are founding members of the National VA 3D Printing Workgroup.  We received Federal Employee of the Year awards from the San Francisco Bay Area Federal Executive Board for our work to bring the benefits of 3D printing for surgical planning to our Veteran population.  Most people just think of the VA as providing healthcare for our nation’s Veterans.  While that is our primary mission, research and education are equally important.  

Recently, with the Covid-19 pandemic, the VA 3D Printing Innovation has helped our frontline hospital workers by validating print designs and manufacturing face shields.  The San Francisco VA Health Center has additionally used 3D printing to establish a secondary “emergency” supply of critical components that have extended back orders.  Thankfully, the Covid-19 situation in the San Francisco Bay Area has remained manageable for our hospital resources.

Jenny: How is everyone dealing with COVID19 situation at work? 

Alan: The opinions expressed in this answer are my own and do not reflect the view of the Veterans Administration, or the United States government.

For me, work includes both direct clinical care as a physician, as well as my role as the CMO of PrinterPrezz.  The VA has had a pandemic preparedness plan in place since the Bush Administration including telework/telehealth strategies.  This has allowed us to continue to provide on-going care to our Veterans.  UCSF has leveraged the University’s 3D printing resources to repurpose the currently closed library into a plastic 3D printing production facility for locally manufactured face shields.  Over 6,500 shields were manufactured across a fleet of almost twenty printers to bridge the gap between the clinical need and the availability of standard parts.

PrinterPrezz has been doing great. Even before the shelter-in-place orders were officially issued in the Bay Area, we were already taking steps early on to prepare for the possibility of Covid-19 getting worse.  This meant simple things like having structured hand washing time, reminding employees that they are supported with paid time off if they showed any signs or symptoms of any illness, and ensuring our digital infrastructure was resilient and secure enough to allow work-from-home.  When the shelter in place orders came, it was easy to transition to as much work-from-home as possible.  Several local hospitals came to us for support with Covid-19 countermeasures. As a medical-focused contract manufacturer and with our design expertise, PrinterPrezz operations were maintained as essential activities throughout the Shelter in Place period in California.  We’ve already delivered tens of thousands of PPE components all over the Bay Area and are continuing to supporting the Covid-19 response in the next phase of the pandemic.

We have strict adherence to workforce and visitor scheduling to maintain social distance and keep our employees, customers and partners safe as we resume non-Covid-19 operations, coordinate deliveries, and collaborate with customers.

Jenny: What advantages (and disadvantages) does your clinical background bring when it comes to entrepreneurship? 

Alan: Clinicians tend to be cautious and risk-averse, yet must also make quick decisions based upon the best available data or evidence, even if the data is limited.  As an entrepreneur, being able to move quickly and make decisions on the fly while being grounded in facts is essential.  More importantly, clinicians trust in the concept of specialization, the need to call consults, and the concept of an entire healthcare team.  Most startups require a true team effort for success.

Jenny: I know you work closely with your brother Dr. Alexis Dang, who is also very passionate about healthcare 3D printing. What is the dynamic like between you when it comes to working together? 

Alan: We’re only two years apart, so we grew up as brothers and best friends.  We trained at a lot of the same institutions, are both orthopedic surgeons, and share a strong technical background across multiple disciplines from healthcare to computing to even hobbies like photography and hi-fi.  But our personalities are actually very different and that helps us approach problems with different perspectives which is complementary more often than contentious!

Jenny: Software, materials, or 3D printers. It has been a debate in the industry forever as to which is the most important player. What do you think is the most important player in healthcare 3D printing? 

Alan: With my conflict-of-interest declared, I would say that role PrinterPrezz has in collaborating with clinicians is the most important element of healthcare 3D printing.  No one asks if the anesthesiologist, the nurse, or the surgeon is the most important person in the operating room.  Without the team working together, the patient isn’t going to have a successful outcome.  It goes beyond that.  There are teams of people dedicated to cleaning the operating room between cases, teams of people who sterilize and maintain instruments along with room equipment, teams of people who ensure that electricity, air conditioning for the operating room is reliable, teams of people to ensure that gloves, gowns, masks, needles, IV tubing, medications are stocked, teams of people to call the patients before the day of surgery to make sure they remember their preoperative instructions and teams of people to follow-up to make sure the recovery is smooth. 

While you can do things solo under austere conditions (like a battlefield), the best scenario is having an entire team focused on success and recognizing that the team goes far beyond your immediate contacts.

PrinterPrezz is the only ISO-13485 contract manufacturers to have an open platform with software from multiple vendors, materials from multiple vendors, and 3D printers from multiple vendors with an infrastructure to cross-pollinate between technologies.  We rely on teams of people, each focused on critical components of medical manufacturing including the FDA regulatory process involved at every step of the development and production.  Our customers want a successful outcome, and when we consistently select the best combination of technologies for a given project, and teams of people are focused on what they do best, everyone wins.  Our expertise with all aspects of the supply chain is one way we’ve been able to reverse engineer and delivered thousands of critical components to local hospitals.

Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice do you think they should ignore? 

Alan: Everyone understands the idea of learning from one’s own mistakes.  However, that lesson often gets lost when thinking about how we interact with others.  Research shows that college freshmen are more politically polarized today than they have been in the previous 50 years.  College is actually the best time to meet people with different views and come to respect and understand them even if you completely disagree with their opinions.  Being able to calmly understand conflicting opinions based upon the same set of data is essential.  It doesn’t mean that you have to agree with someone else in politics — you just need to be able to understand how some facet of an opposing opinion may make sense to that person, and if you need to, you  can quantify their opinion internally as the equivalent of a “mistake.”  The us-vs.-them mentality is a damaging part of our world today and it shows up even in subtle ways.  How many times have you seen a reality singing or dancing show where a single judge offers a lackluster review with constructive criticism and gets booed by the audience instead of being considered as another data point?

The ability to weigh opposing opinions based upon identical facts translates into the real world of entrepreneurship directly.  Imagine that you’re the CEO of a startup that needs to determine if path A or path B is the best path for the company’s resources.  As a real-world problem, more research won’t necessarily elucidate the answer.  As a real-world problem, there may not be a way to split the middle or to do both simultaneously.  

The first mistake would have been building a team where there was group think, and only Path A was presented or considered.  The second mistake would be trying to solve every problem with harmony or splitting the differences equitably may not be possible.  Chances are that you will have a better time assessing tough decisions if you’re used to having a wide diversity of opinions.

With all that said, “bad advice” is probably defined as advice based upon faulty knowledge.  But instead of ignoring it, it may be better to consider, even for a moment, how the person giving that advice came to the wrong conclusion. At PrinterPrezz, we promote learning as a team and as a core value of our company.

Jenny: What was the best investment you made in 3D printing? 

Alan: Personally, it was in putting in the time to learn and troubleshoot that early Makerbot Replicator 2X.

Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?

Alan: I have a three-year-old and a one-year-old now, so there isn’t a lot of spare time anymore!  When I do get some free time, I enjoy photography and listening to music on a hi-fi system.  During the pandemic, my wife and I began to spend more time cooking at home and that’s been really fun to try out new recipes. 

Jenny: What is your favorite quote? Why?

Alan: I don’t have a single favorite quote – but at least in the context of entrepreneurship, one of my favorites is from Jen-Hsun Huang: “There is no technology that will not be commoditized faster than you can take your company public.”

Jenny: What does the word “3DHEALS” mean to you?  =)

Alan: Hope for a better tomorrow.

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Orthopedic Surgery in the Era of Industry 4.0 – An Interview with Carlsmed CEO Mike Cordonnier

The post Interview with Dr. Alan Dang, co-Founder of PrinterPrezz appeared first on 3DHeals.

Mike Cordonnier is CEO and co-founder of Carlsmed, a San Diego based Med Tech company. Carlsmed’s Corra system utilizes predictive analytics to create patient-specific surgical plans and 3d printed implants to improve patient outcomes for spine surgery.  Mike has held various leadership roles for large MedTech companies NuVasive, Zimmer Biomet, and Orchid Orthopedics as well as early-stage startups Ellipse Technologies and X-Spine Systems.  Mike is passionate about leveraging technology to improve patient outcomes and decrease the cost of healthcare.  Mike has a B.S. in Mechanical Engineering from the University of Dayton. Mike will be a speaker for 3DHEALS2020 Orthopedic Panel.

Jenny: What was your first encounter with 3D printing like?  

Mike: My first 3D printer that I purchased was in 1998.  It was an early generation of a plastic Fused Deposition Modeling (FDM) 3d printer that I used for making prototypes of electronics cases for handheld diagnostics.  Making 3d printed rapid prototypes saved months in time to market.

Jenny: What were some of the earliest projects you did with 3D printing? 

Mike: I started using 3d printing for medical device purposes in 2008.  One of the first applications of medical 3d printing was for complex clavicle fracture repair.  Working in collaboration with a trauma surgeon and medical device manufacturer, we created an internal fracture reduction system with 3d printed personalized surgical instruments.

Jenny: How did you decide that healthcare and specifically orthopedics will be your focus? (Was this driven by external factors like patients, or was this driven by more internal reasons, such a fascination with life science? )

Mike: I had a sports accident when I was in college and shattered my patella.  While the prognosis was that I may not be able to properly walk again, thanks to the expert surgical work and various medical devices implanted, I have since become a successful marathon runner.  My personal experience drives my mission to provide patients and surgeons better tools and medical devices to allow people to return to an active lifestyle.

Jenny: If you can go back 5 or 10 years, what would you have done differently? 

Mike: I firmly believe that the experiences over my last 5 to 10 years have provided me the wisdom and built the relationships needed to go where I need to be in the next 5 to 10 years.

Jenny: Software, materials, or 3D printers. It has been an ongoing debate in the industry forever as to which is the most important player. What do you think is the most important player in healthcare 3D printing? 

Mike: What drives success in healthcare 3d printing is when the software, materials, and machines work in harmony to achieve the patient and surgeon’s needs.

Jenny: Can you share how Carlsmed differentiates itself from other companies that also produces 3D printed spinal solutions? 

Mike: Carlsmed has developed a platform to generate data driven surgical plans for patients with spine disorders.  Based on the surgeon review and approval of the surgical plan, we 3D print the personalized spine implants needed to achieve the pre-operatively plan.  This is an advancement in the current standard of care for spinal fusion surgery, which requires surgeons to modify the patient anatomy to select the best fit stock sizes of spine implants during surgery. 

Jenny: What was your biggest victory in 2019? Please share that story with us.  

Mike: In 2019, Carlsmed successfully completed the first four level lumbar adult degenerative scoliosis correction procedure with personalized interbody fusion devices on a human cadaver.  This was a landmark moment for the industry, validating the promise of personalized spine fusion surgery. 

Jenny: What is the biggest challenge you are facing in 2020, and how do you plan to overcome this?   

Mike: This year, we are commencing our clinical launch of the data driven surgery platform and interbody fusion devices.  We have had overwhelming response from the surgical community to participate in our clinical launch and our biggest challenges is to scale the infrastructure needed to support the demand.  We are implementing proprietary software tools to intelligently automate processes where possible and a mix of machine learning and human clinical intelligence to continually improve the personalized surgical plans.

Jenny: What does the word “3DHEALS” mean to you?  =)

Mike: 3DHEALS is much more than a tagline, it is a way of life.  It is a reminder that the ultimate purpose of advancements in medical technology is to make treatment simpler, less costly, and more effective for every individual patient.  

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The post Orthopedic Surgery in the Era of Industry 4.0 – An Interview with Carlsmed CEO Mike Cordonnier appeared first on 3DHeals.

Adam Clark is CEO and President of a Nationally Recognized Contract Manufacture of 3D Printed Titanium Implants, Tangible Solutions. Tangible Solutions provides large-scale precision Additive Manufacturing solutions to the Orthopedic Implant Industry.

After an accomplished career with the US Army as a Green Beret, Mr. Clark worked in Human Performance & Productivity programs as a Contractor for the Department of Defense. Eventually, his path led to the medical industry becoming a founding member of Tangible Solutions, a Contract Manufacturer of 3D Printed Titanium Orthopedic Implants.  Clark became CEO of Tangible Solutions in 2016. He will also be our speaker to the upcoming Cleveland 3DHEALS speaker this Thursday.

Jenny: When was the first encounter you had with 3D printing? What was that experience like?

Adam: Chris invited me to the first Tangible Solutions Office, which was in Charlie’s garage.  We were there to discuss standing up the business and working out the visions, sales and what that strategy would look like.  I knew the applications of Additive Manufacturing, but up to that point, I had no hands-on experience.  Before we sat down to discuss the vision for Tangible, Chris showed me the 2 Stratasys uPrints, and then asked me “What do you want me to print you?”. I told him to print me a knife. He went about the business of getting the machine ready and I went upstairs to get ready for our meeting, shortly followed by Chris.  About 2 hours later, Chris went down the garage and brought back an assembled plastic pocket knife.  I still have it today.  It was an eye-opening moment of the potential Additive Manufacturing can bring to the world.  It still gives me goosebumps.

Jenny: What inspired you to start your career in 3D printing?

Adam: At the time Chris approached me, I was working for a Defense company and my job was to scour the land for factories to refurbish Humvees from the United States Marine Corps.  I found a shuttered factory after a shuttered factory.  It was really sad and disheartening. Communities devastated. It was then I started to explore ideas of how I could have a positive influence on the Amerian Economy through manufacturing, but looking for something I was passionate about.  When Chris and I finally got together, I found a technology that had so much potential and was being underutilized.  I knew what I wanted to do, and then I found how I wanted to do it.  Today, Tangible Solutions is a Nationally Recognized Contract Manufacture of 3D Printed Titanium Orthopedic Implants proudly manufactured in Dayton, Ohio.  We reside in what used to be a shuttered factory, of which the lights are back on, and supplying the orthopedic market with high-quality solutions.

Jenny: Who inspired you the most along this journey in healthcare 3D printing?

Adam: First, my relationship with God has been strengthened through this experience.  It is through him that all these opportunities are possible.  My faith is as strong as it has ever been and I am so thankful.  My father was a huge influence.  Especially when times were hard.  He never let me wallow in my failures, and called me out when I was down.  He listened to all of our practice presentations and even paid me to do some work for him in his business when I was completely broke.  My business partner, Chris Collins has been a very inspiring person for me as well.  His tenacity to be the best and willingness to ‘slug it out in the trenches’ is unmatched.  He doesn’t back down from tough conversations and stands his ground.  He’s also had my back as we’ve grown as entrepreneurs and individuals.

Jenny: What motivates you the most for your work? 

Adam: My purpose to contribute to the American Economy by way of manufacturing the highest quality products for customers around the world.  It means so much to slap ‘Made in the USA’ on the products we ship out the door.  As our focus as a Contract Manufacturer of 3D Printed Titanium Implants has been honed over the years, I have been able to see first hand how the products we make give people their lives back.  Enabling them to live without pain and get back to experiencing the best life has to offer.  It’s an amazing feeling.  My family is a huge motivating factor.  Being able to show my children that anything is possible.  That you really can build anything you want from nothing so long as you are willing to put in the work and maintain focus on your vision.

Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?

Adam: Once Tangible was mature enough to make the leap to standing up our Factory, we found many challenges.  Cash flow management, validation of 3D Printing Technology for use in medical implants, and ISO Certification are the top three that come to mind.  You can say that we have conquered all three, but they all have their continuous challenges.  Really, that is what makes all this fun.

Jenny: What do you think is (are) the biggest challenge(s) in 3D Printing/bio-printing? What do you think the potential solution(s) is (are)?

Adam: Acceptance.  Just a few months ago I called a prospect, and he called Additive Manufacturing ‘Black Magic’.  I asked him to put down his book “The Scarlet Letter”, and hear me out.  He was having none of it, ha.  There is a lot of misinformation that stems from Additive Manufacturing really being in its infancy.  For instance, we have customers that believe it requires a new 510(k) Submission in order to onboard a new vendor. In reality, that is not the case. The FDA is very well versed in Additive Manufacturing and industry is not giving our regulatory bodies enough credit on their increased awareness, understanding, and management of the technology.  This is something we can take confidence in especially since the use of Additive Manufacturing is proliferating.

Jenny: If you are granted three wishes by a higher being, what would they be? 

Adam: First, I would thank that higher being – God, for the challenges and obstacles that have made our team who we are today.  But for the question: 1. Introduction of future team members who know how to do ‘Whatever it takes’ (Tangible Solutions Core Value).  2. Continue to foster the trust and love our team has for each other. 3. More prospects to pick up their phone when we call with our message!

Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?

Adam: Don’t freak out when you hit the ground and your plan falls apart.  That’s all it was, a plan.  It’s up to you to dig in when times get tough.  Hold the line at all cost, that’s what makes you a legend.  People will tell you to quit, but they don’t have the same vision or context around your situation. When they tell you to quit, do not seek their advice anymore.  You are the only person that has to live with the consequences of your decisions, nobody else.  Find people you can trust and will make you better.  Speak your mind and don’t be afraid to ask questions. Asking questions makes you smarter.

Jenny: If you could have a giant billboard to promote a message to millions and even billions of people in our community, what message would that be?

Adam: Stop talking about what can be done to industrialize Additive Manufacturing, it’s already being done in Dayton, Ohio.

Jenny: What were/was the best investment you made in 3D printing/bio-printing/bio-fabrication?

Adam: Titanium metal printers.  Making it our sole focus to be the Contract Manufacturer of 3D Printed Titanium Orthopedic Implants.

Jenny: What were/was the worst investment you made in 3D printing/bio-printing/bio-fabrication?

Adam: 3D Printing Plastics as a service.  Low margins, low barriers to entry, and you have to compete with the companies that sell the machines.

Jenny: What was/is the biggest risk you took in your career? 

Adam: Selling off all capital equipment that did not contribute to the production of 3D Printed Titanium Orthopedic Implants, making it our sole focus in order to become the best.  It’s paying off.

Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?

Adam: I enjoy camping, spending time with my children, cast-iron cooking, lifting and reading.

Jenny: What is your favorite quote? Why?

Adam: “Be a simple kind of man, be something you love and understand.”  This lyric is from ‘Simple Man’ by Lynyrd Skynyrd.  Being a Momma’s Boy, I love this song being from a mother to her son.  This song is a good reminder that our lives can be complicated by our decisions, and you can always take solace that there is somebody above.  It’s important to keep our lives simple to avoid clouding the vision for our life with things that do not matter.

Jenny: What does the word “3DHEALS” mean to you?  =)

Adam: We’ve had the pleasure of watching Jenny pour her heart and soul into 3DHEALS from the beginning, and it is extremely inspiring.  3DHEALS is accelerating legitimate conversation and opportunity for the medical community in regard to 3D Printing and BioPrinting.  As time goes on our society will benefit from these early conversations.

Related Articles:

Interview: Jan Jensen, Trailhead Biosystems

Interview: Greg Cebular, The Technology House (TTH), Ohio

Interview with Sam Onukuri, Johnson & Johnson

Metal 3D Printing to Biofabrication: Interview w/ Dr. Herderick

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