Challenges Facing 3D Printing in Reconstructive Surgeries

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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