Interview with Jason Chuen: Shaping Australia’s Medical 3D Printing Environment

In Australia, vascular surgeon, Jason Chuen understands that 3D printing is the exciting next step in personalized medicine, which is why he uses 3D scans and 3D printing to deliver anatomical models. During an interview with 3DPrint.com, Chuen, who is also the Director of Vascular Surgery at Austin Health and Austin Health’s 3D Medical Printing Laboratory (3D Med Lab), suggested that “there is a lot of interest because the field of 3D printing in medicine is growing; we are seeing the doctors and researchers involved more than ever, as well as more application development originating from clinicians.”

At The University of Melbourne, in Australia, the 3D Med Lab supports 3D printing for clinical applications and runs an active research program exploring how it can be used for teaching, procedural simulation, patient education, surgical planning, and prosthetic implants. The first facility of its kind in Australia, 3D Med Lab, frequently prints models of diseased aortas to perform a “practice-run” of surgery. What makes this lab unique is that it is hospital-based, and works with many different specialties. Chuen has been looking into the landscape of medical 3D printing for many years and earlier this month along with his colleague Jasamine Coles-Black, a Doctor and Vascular Researcher at the Department of Vascular Surgery at Austin Health and the 3D Med Lab, organized the fifth annual 3D Med Australia Conference, which he claims is the only meeting of its kind in Australasia, with only one or two more around the world of a similar nature, like Materialise‘s medical 3D printing meetup in Belgium.

Normal anatomical branches on an abdominal aortic model 3D printed on MakerBot Replicator 2X FDM

Chuen and Coles-Black even begun printing out copies of patient kidneys to help surgeons at Austin Health plan the removal of kidney tumors. Moreover, Chuen understands that the immediate challenge in medical 3D printing is ensuring that medical professionals themselves are up to speed with the technology because it is their clinical experience that will drive new applications and projects. 

During our interview, Chuen asserted that the conference has once again proved that Australia is leading the way with cross institution development cooperations, ethical issues surrounding 3D printing and he looks forward to many exciting possibilities of the technology for the future.

Why was the 3D Med Conference so important to the region?

We noticed there were a lot of groups that existed previously that didn’t know about each other and the meeting has become a really good focal point for people to find out about what others are researching and selling. So rather than working on their own and almost in secret, they can join together and create projects that cross different institutions, specialties and disciplines. During the conference, at every corner I encountered groups of people from different universities and cities gathering to hatch a project, proving that there was a very cooperative atmosphere. They all clearly had common interests and discovered that they can work outside of their own space with others. 

What was so unique about the 3D Med Conference?

Because there really aren’t many meetings like this, the areas of interest are still growing, anyone who is working with these technologies have applications in different areas so that is why we have a lot of crossover between the fields. The strength of the confreence comes from encouraging people to have an overview of what was happening in the field, so rather than just understanding technical aspects of technology, everyone started to become knowledgeable about the whole landscape, for example, why we need to care about ethics and regulation, or considering the useful implications of applying techniques from a different area of science and research. 

One of the biggest challenges for 3D printing is?

One of the big problems in customized medical devices and the 3D printing space is that there is uncertainty about what will happen in the future. Apart from the guidance of the US Food and Drug Administration (FDA), there hasn’t been a lot of resources for manufacturers and researchers on how 3D printing and customized medical devices will be regulated. Australia’s own Therapeutic Goods Administration (TGA) representation in the International Medical Device Regulators Forum (IMDRF) has been very strong,particularly around 3D printing and customized medical devices. During the conference John Skerritt, Deputy Secretary of the Australian Department of Health, outlined the broad framework around the field and has engaged in a consultation process with the medical 3D printing community (and we have provided some proposals for the final documentation that will be ready soon.)

Distributed production will present new risks for ensuring the quality control of end products. It will need a fundamental shift in responsibility from the supplier to wherever the medicines or devices are manufactured. That represents a huge change and we have to work out how it could work. But if we get the regulation right then it will transform access to medical products.

Collection of 3D printed objects

What does the future of 3D printing in medicine look like?

The whole point of what we do is improve patient care, so we have to think very carefully about our next steps and analyze whether it is helpful or not. For patients, anatomical models help them see and understand the condition or surgery they plan for. We have done projects and have some conclusive evidence that patient understanding is improved with anatomical 3D printed models. 

Patients are interested to know what will happen in the future, especially with 3D printed kidneys and stents. But the truth is that that technology is very far away. We may never be able to 3D print an organ, not at least the way we imagine it to be. Realistically, if we are talking about an organ for transplantation, we have to think that no matter what the organ looks like, the question is: does it do the job? For example, if we were thinking about bioprinting in order to replace a kidney, as long as it performs the function of the kidney, it doesn’t matter what shape it comes in. And for that, we have to be able to reproduce a structure. This could be in shapes, rather than in one block, or it could be a composition of an external and an internal device, meaning we would be looking into something that is assembled. Today the technology to have the replacement kidney is available, it is a dialysis machine, yet you wouldn’t expect a dialysis machine to look like a kidney. The same is going to happen with 3D printed organs, where we need to separate the appearance and structure of the organ from the function. In the end, the function is what matters.

As such, if we were to imagine what a 3D printed heart would look like, we would need to go into the field of soft robotics or mimicking natural structures, all of that changes fundamentally how we think about organs for the human body.

How can your particular medical field benefit from 3D printing?

As a vascular surgeon, I’m also looking at 3D printed stents, and there is quite some work around that. Mainly it is based on printing something that looks like a stent, but it is very difficult to reproduce the mechanical properties of a stent using 3D printing. The benefits revolve around the different materials that could be used with 3D printing, for example, if you could reproduce a stent in a bioabsorbable plastic it would allow surgeons to deploy it with embedded drugs (like antibiotics and pain medication) that get released at a set time. There are a lot of options in terms of using multi material technology in customized implant production, as well as great precision, and that is an area where 3D printing helps. 

Ideally, we need to understand the technology to know where the errors can happen. But in general, it is improving, both in hardware and software, the challenge will be about making it accessible. We have done randomized trials around anatomical models for teaching, education and simulation. There are already some 3D printed medical devices, such as for joints and implants. It would be ideal to have assessments of the economics to determine whether the anatomical models will be worthwhile. 

How is Australia changing the paradigm of medical 3D printing?

Australia has world leading technology, but in terms of the way we have collaborated and worked together, we are quite unique. Even globally one of the big problems is finding the groups that are doing this kind of work. We have been in touch with research groups in Poland, Boston, and Toronto, even engaging with large centers like the Mayo Clinic, in Minnesota. Key collaboration between international centers are great and we are keeping an eye out for other major hubs of activity, like in China, South Korea, and Europe. We need to link up all the international groups, that’s where we see things are going!

[Image credit: 3dMedLab, Austin Health]

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Main Challenges and Investments for 3D Printing of Medical Devices

Ahead of the Additive Manufacturing for Medical Devices Forum, we asked leading industry professionals about the biggest advantages and challenges in using additive manufacturing compared to traditional manufacturing processes. The results have been compiled into an infographic report to highlight opportunities and solutions to close the gap between research and commercialisation.

The survey results will provide insights on the following questions and more:

  1. Is your organisation looking to introduce additive manufacturing, or expand its use in the next 12 months?
  2. What do you feel are the biggest advantages and opportunities in using additive manufacturing for the medical device industry compared to traditional manufacturing processes?
  3. How much is your organisation planning to spend on additive manufacturing services and solutions in the next 12 months?
  4. What is the biggest challenge your organisation is facing in adopting, implementing and/or using additive manufacturing? 

View the infographic to receive:

  • A full analysis on the key benefits and challenges associated with adapting additive manufacturing in highly regulated industries
  • Solutions to close the gap between research and commercialisation
  • Top predictions to ensure additive manufacturing maintains a leading position globally

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Industrial Design and Development Company Chooses EnvisionTEC for the Production of Accurate Prototypes

P5 Designers (P5) is a traditional, project-based design and development business based in Milford, NJ. The company boasts dozens of patents in product, packaging and manufacturing design. P5 has built up an enviable reputation in the industry and supports businesses in the production of a wide range of products, from toys to medical equipment.

The elite team at P5 is composed of cross-trained researchers, industrial designers, and engineers providing an end-to-end service including: project management, product preparation, product design, prototyping and packaging design.

Within the research and development process, there is a need for multiple prototypes and iterations of those prototypes. With traditional manufacturing methods, those prototypes are often hand crafted, made from molds or milled.

Since the beginning, members of the team at P5 have been involved with 3D printing. Although additive manufacturing had improved productivity and reduced costs, P5 needed more accurate results. They recognized that to stay ahead of the competition and ensure the best results for their customers they would need to invest in the best machines in the market. For manufacturing, P5 needed a machine that could closely mimic the final injection molded part and give the customer a true reflection of the look and feel of their final product.

After testing a number of brands and technologies, P5 was sold on the EnvisionTEC Perfactory. The printer allows the production of everything from a tiny medical part to large packaging models – quickly, painlessly and accurately. Additionally, the range of resins available for the EnvisionTEC Perfactory provides a huge number of options. This includes hard and soft materials, flexible, tough and even temperature resistant materials.

These processes are both time consuming and expensive, requiring specific skills and tooling to achieve. They also result in a vast amount of wasted material. Additive manufacturing is becoming a vital part of prototyping for many companies. Multiple iterations and design tweaks can be achieved quickly and without the need to reproduce or modify molds. Additionally, unlike milling techniques, there is no specialist tooling required. P5 has been using 3D printing for a number of years, recognizing that its implementation has not only removed many of the costs associated with the R&D process but also improved the speed at which concepts can be turned into real-world objects. Multiple iterations of a prototype can be printed simultaneously. Speeding up the decision-making process.

“3D printing is vitally important to the product design process. It helps us bring into the 3D dimensional realm some of the concepts that we have. The ease of use, the amount of detail we get and the vast materials selections available was something that was missing in most other manufacturers. The quicker we can start putting things into our hands, the quicker we can start developing the fit and feel that is so vital to any good product design part.” – Mr. Paul Carse – Owner, P5 Designers

“When we are in the heat of a project, especially in the very early stages where we are doing a lot of design development, we will use this machine for maybe 2-3 weeks straight with non-stop building. Reliability has never been an issue.” – Ms. Kelly Duncan – Industrial Designer, P5 Designers

Since the purchase of the EnvisionTEC Perfactory, the team at P5 have embraced its flexibility and speed. The accuracy of the machine has allowed them to produce prototypes to very high tolerances and accurately to their digital designs. Accurate prototypes that reflect the production items can be produced and handled by the customer very quickly. This allows clients to see and feel their vision and adjust designs to achieve the look and feel they desire. The dimensions of the build plate and Z height on the Perfactory allow for multiple iterations of a design to be printed at the same time, so options can be presented to the client. This capacity also allows for larger objects to be produced with equally fine detail. When adjustments are required, these can be quickly achieved with re-prints in a matter of minutes or hours.

The patented technology employed by the printer results in exceptional surface quality with very little visible stepping. This increases the speed of prototype production further by reducing the finishing time required. The range of EnvisionTEC materials and the ability to painlessly switch these for different jobs makes the machine very flexible, allowing them to fulfill the needs of more customers. For example, the ability to print medical devices on one print, then switch to clear bottles on the next.

After using the Perfactory for hundreds, if not thousands of jobs it has proved reliable and provides consistent results time after time. The team at P5 can rely on the machine, knowing that even when leaving it overnight to complete prints, they will return to a completed job, and a printer ready to accept the next.

“We want to make our concept models as close to injection moulding as possible. So we’ll make sure that everything has a uniform 1-1.5mm wall thickness which a Perfactory has no problem doing. It makes really clean crisp parts, which is great.” – Ms. Kelly Duncan – Industrial Designer, P5 Designers

The large Z height on the Perfactory allows for the production of even large models. Additionally models can be printed horizontally or vertically to maximize yield per print. Even small medical devices can be produced to extremely high tolerances.

Since EnvisionTEC machines are STL agnostic the team at P5 are not locked to a single CAD provider. Moving is simple. Additionally, as all EnvisionTEC Perfactory machines are based on the same principles and are compatible with the same resins, expanding the printing capacity is easy. Machines can be added without the vast cost of retraining their team or implementing new software.

EnvisionTEC offers a full range of desktop, full-production and high-speed continuous 3D printers for the production of highly detailed prototypes for design verification and testing or for real mass production of custom products. Learn more here. Want to download the case study, you can go here.

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3DPOD: 3D Printing Podcast Episode 5: 3D Printing In Medicine

Hello everyone we really hope that you enjoy a new episode of the 3DPod. Maxwell Bogue and I had a lot of fun making this episode. In this 3DPod we talk about 3D printing in medicine. What impact is it making? What is happening in hospitals? What is happening in the developing world? We talk about implants, braces, personalized medicine, polymers and metals. We talk about DIY medicine and groups of people making their own medical devices and lots more. We really hope you enjoy this episode. As always do give us feedback and suggestions. You can find all of the podcasts including direct download, Spotify and Apple here.

Interview with Dr. Albert Woo: How can Hospitals and Surgeons Harness 3D Printing Today?

Dr. Albert Woo is the Chief of Pediatric Plastic Surgery and Director of the Cleft and Craniofacial Center at Hasbro Children’s Hospital and also an Associate Professor of Surgery, Pediatrics & Neurosurgery at The Warren Alpert Medical School of Brown University. Albert has done extensive work in CMF (cranio maxillofacial) and pediatric surgery including a lot of research and significant experience in things such as Endoscopic Craniosynostosis Surgery and ocular facial surgery. Additionally, he is the Director of the Lifespan 3D Printing Lab. Albert has for a number of years now played a pioneering role in bringing 3D printing into hospitals and in using 3D printing for surgery. The current trend in 3D printing labs in hospitals has partially pioneered by Albert at St. Louis and now at Lifespan. I found it hugely inspirational to meet Albert at Additive Manufacturing Strategies in Boston. I’d met good Doctors working with 3D printing and good engineers who were trying to get 3D printing into medicine but here was someone who bridges the gap in understanding our technology and how it can be applied. We interviewed him to see how hospitals and surgeons can harness 3D printing today?
Why as a surgeon are you excited about 3D printing?
3D printing is extremely exciting to me because it represents the future of medicine. Particularly in my profession as a plastic surgeon specializing in craniofacial abnormalities, it is well understood that every individual is different and that every face is unique. In that regard, it seems unreasonable to think that while everyone is different, we can still perform the exact same operation on each individual. The promise of 3D printing is that it can help us to understand the nuances that are particular to each person and to design or alter surgical procedures to best fit each person’s needs.
Beyond this, the use of surgical guides and computer designed implants help us as surgeons to provide consistency and accuracy in our operations. Generally, all patients want their doctors to “be experienced”. Why? Because they are hoping for the best possible result, and the idea of experience is a surrogate for accuracy and predictability. One of the advantages of 3D printing is that it can provide an inexperienced surgeon with the tools to plan a procedure down to the millimeter in accuracy —  in essence, helping that physician get comparable results to that of a master with decades of experience. Wouldn’t you want your doctor to have this technology available if it could potentially improve your surgical results?
What is holding back 3D printing in surgery?
Every technology has hurdles to adoption. In general, medical 3D printing is largely in its infancy. Most physicians have no idea about this technology to begin with, have no access to 3D printing, and are inherently wary to adopting new, “unproven” or “unconventional” ideas. Many have been doing things the same way for decades and see no need to change. Indeed, when frustrated with hiccups in a procedure, angry surgeons will often yell out, “We do it the same way every time!” 3D Printing threatens change and not everyone likes change.
Beyond this, based on my experience with the additive manufacturing industry, it seems clear that communication barriers exist. 3D printing companies are very used to speaking the language of manufacturers but do not know how to speak to clinicians. Similarly, engineers designing materials do not have a great idea of the challenges facing those performing procedures on patients.
Finally, smooth workflows have yet to be ironed out. You can’t just buy a printer today and start printing medical models or implants in 30 minutes. The printers require specialty software provided by separate companies which frequently do not work with the original vendors. Moreover,  there is a dearth of trained professionals to create medical models (and even training opportunities if you want to learn). How many of us feel comfortable building a computer from scratch and purchasing all the parts and software separately? This is where we are in the field now, prior to the advent of companies like Dell which put everything together for us. These issues will need to be ironed out before Medical 3D Printing becomes mainstream.
Do you see patient specific procedures as having a bright future or will their applications be more limited?
Eventually, I predict that virtually all procedures will become patient specific. It is only a matter of time as technologies become faster and more ubiquitous. Certainly, today, there are some fields that will require more patient specificity early while others may be delayed in adoption. My field of craniomaxillofacial reconstruction, for instance, is highly specific to each person. This can also be said for pediatric heart abnormalities, each of which are highly variable with very little room for error. On the other hand, hip surgery may be less focused on patient specificity since there is arguably a larger room for error in most of those cases.
What 3D printing materials are would you like to see developed?
Currently, too many 3D printing companies have their own proprietary materials which are the only ones available on some of their high end printers. Unfortunately, proprietary information, while lucrative to individual companies, can limit the growth of the field in general.
We need more work on materials that are FDA approved for use in the body. Silicone is an obvious choice as we have decades of experience implanting this in human beings. A huge number of implants currently incorporate silicone as a component (including artificial joints, facial implants/prostheses and even breast implants used not only for augmentation but to help reconstruct women after breast cancer surgery), allowing for easier adoption versus other proprietary materials.
 
A 3D printed artificial bone substitute would also be a great material to have. Ideally, we would want materials that would get incorporated into the human body, with tissue in-growth, rather than metals or plastics that are separate.  Such “non-autogenous” materials have higher chances of infection and failure than living human tissue. Further, the body has an incredible ability to heal itself. On the other hand, a metal implant has a limited shelf life before it is expected to fail. This is why many people are so excited about the field of bioprinting and regenerative medicine.
How do 3D printed surgical models help you?
I use 3D models for multiple purposes. Anatomical models help us to understand complex 3D geometry far better than anything we can see on the screen. The surgeon is then able to use many more senses to get an intuitive understanding of complex spatial relationships. We can also cut the models and practice our surgeries or use the models to custom design or fit patient-specific implants or prostheses.
These models are also sometimes critical to help patients and their families understand what is going on so that they can make informed medical decisions. Moreover, 3D models have incredible potential for medical education. Sometimes, unique deformities present only once in many years. Obviously, medical students and trainees will not be the ones doing those operations. But imagine if they could – on a model. Wouldn’t that be worth it to train the next generation of doctors?
We often say that a 2D picture is worth a thousand words. If so, how much is a 3D model worth? There is little wonder why virtually every conjoint twin separation and face transplant surgery performed in the last decade has utilized 3D printing in some manner to help with the procedure. 
This is going to sound crazy but seriously, let’s arm surgeons with 3D printing pens? They’re really good at cutting things away how about letting them add material to patients?
This is certainly worth a discussion. To be honest, I would say that we are still a ways out from this just yet. But I’d be happy to chat further about it with people who see the value of it.
We’ve seen comparatively little work on custom post-operative braces and things like that?
Yes, this is largely due to cost and materials. While there has been huge interest and advancements in 3D printed “robotic” hands, notably less work has been done with lower extremity prostheses. This is because of the extreme load that artificial legs put onto the 3D printed structures. While standard consumer FDM materials can handle the load on a hand, they cannot provide reasonable support for legs. As a result, the pool of those with the resources to help in this arena is dramatically smaller. This will likely not improve until accessibility to metal printers or higher grade materials has been democratized.
We also see few developments in 3D printed surgical tools. For many kinds it wouldn’t make sense but would you see a need for more custom surgical tools?  
It is funny that you mention this as I have worked with industry to help develop some of these tools. One of my projects is a custom bone bending instrument and multiple iterations were printed on an FDM machine before a functional instrument was created out of stainless steel. Unfortunately, there is little market for creation of speciality tools as these instruments do not make companies money. You buy one tool and have it for a decade. Implants, however, are put in every single day. As a result, many companies do not see a great ROI on development of specialty tools and only do so if they feel that it is critical to keeping their current business of selling the implants themselves.
How do we best educate hospitals on what 3D printing can and can not do?
This is an interesting question. I would suggest that it is critical for 3D printing companies to get physicians who actually perform the procedures involved. I have seen numerous efforts fail when companies have not done this as there is frequently no one to translate the world of 3D printing into the medical environment. On the flip side, physicians are notoriously wary of speaking to company reps or salespeople. Personally, I equate them somewhere on the level of used car salesmen. No one can understand the unique hospital environment and the challenges facing surgeons than another surgeon. As a result, I would posit that physician champions will be critical to the further adoption of 3D printing in medicine.
If I’m a doctor and want to learn how to use 3D printing in my practice where and how can I learn about this?
Ahh, there’s the rub. This can be an exceedingly difficult and frustrating endeavor. While extensive resources exist for companies and individuals who have the wherewithal to invest tens of thousands of dollars a year in custom software licenses, few options are available for an enthusiast or those who simply want to learn more with limited resources. Thankfully, one standout software package is 3D Slicer, a free and open-source platform for analyzing medical image data developed in part through funding from the National Institutes of Health (NIH). Training is also extremely difficult to come by. Regarding development of 3D printing programs, the best I can suggest would be to contact those who have successfully done so to ask for advice. Unfortunately, the activation energy to do this remains fairly high. 

Interview with Carolyn DeVasto Global VP of Commercialization at BIOMODEX

Organ twins, 3D prints made from CT scans, 3D printed parts helping doctors train or do complex surgeries is something we hear about all of the time. BIOMODEX is hoping that we’ll see many more of these cases in the years to come. The France and US based firm is trying to make true organ twins for a large selection of medical cases. This could change medical training and have impacts on preoperative planning. They also hope to 3D print these organ replicas in such a way that they feel and interact with the doctor in a realistic way. We interviewed BIOMODEX‘s VP Of Commercialization Carolyn deVasto to find out what their plans are.

What is BIOMODEX?

We are a medical technology company based in Paris and Boston, using 3D printing technology to produce synthetic organ twins from patient-specific images for physician advanced training and patient-specific rehearsal. Our 3D-printed organ twins with haptic feedback similar to that of a patient, paired with our stations offer a unique end to end, clinical training experience.
When and why did you get started with 3D printing?

3D printing allows for manufacturing complex shapes, with accuracy, repeatability and short turnaround time. When working in the medical field you need all. There was an unmet need in providing a realistic way for physicians (people of hands) to train on organs that provide haptic feedback similar to that perceived during a real operation, which is extremely important. With FEA modeling and using multi-material printing, which gives us the ability to control down to the micron level in the production process, we have been able to leverage our technology to disrupt clinical practice and experience.

What is INVIVOTECH?

INVIVOTECH is our patented technology to “functionalize” additive manufacturing. Our proprietary algorithms embed the biomechanics of the organ and surrounding tissue, providing realistic haptic feedback.”

How are these parts made?

“Our process is very detailed. First, we receive patient specific data from medical imaging, then we utilize a number of software programs for CAD, segmentation, FEA modeling and INVIVOTECH implementation… next we 3D print. After printing we have a very detailed post processing methodology to ensure the quality and integrity of each print.”

Who uses them?

Today we work with Medical Device companies globally. They can train physicians on how to use their products and do patient specific procedure rehearsal’s. We recently opened our US Headquarters in Quincy, MA to better serve the US and increase our printing capacity as we are projecting over 2000 organs to be printed globally in 2019. In the future, our vision is to work directly with hospitals and physician to improve the pre-operative planning practice.

What is the advantage of using them?

A huge differentiator for us is the haptic feedback because of INVIVOTECH, physicians love it. We also provide the most clinically relevant experience, allowing physicians to use our solution in the lab under fluoroscopy and in some cases using TEE (trans esophageal echocardiography) or ICE (Intra Cardiac echography). The industry loves it because it is compact, portable and easy to use.

What types of parts do you have?

Today we focus on Hemorrhagic Stroke in the Neurovascular space and Left Atrial Appendage Closure in the Structural Heart space with more to come…
BIOMODEX’s technology is a platform that can address any clinical indication where hands on training and preoperative rehearsal is critical.

What is a station?

The station is where the 3D printed organ twin is plugged. Each station is developed to provide blood simulation (same density, viscosity and temperature as blood), and access to the 3d printed region of interest. We have paid special attention to creating a compact, portable and quick to set up and take down solution… so easy my 8 year old can do it!

How do you see the future of your market evolving?

Our future vision is all about improving procedure safety and clinical outcomes by revolutionizing preoperative planning. The patient is our focus, so in the future any time a physician feels it will be beneficial they will be able to use BIOMODEX to test drive a procedure and develop the best strategy for the patient and their specific anatomy.

Why should I choose you to work with?

Today we have revolutionized training, tomorrow we will do the same for preoperative planning. You could choose to work with us because of our innovation, clinical expertise, quick turnaround time, service and clinical specialists in the field but at the end of the day you should choose to work with us because we both agree that it’s all about the patient!