In part one of this guide, we provided background information on why a beginner’s guide to 3D printing in hospitals is necessary, and how we are organizing our thought process around three main operational management issues. That is, strategic, tactical, and financial issues related to implementing 3D printing in hospitals.

1. Introduction:  What is operational management?
2. Technical Background
3. Strategic Issues of 3D Printing in Hospitals
4. Tactical Issues
5. Financial Issues      
6. Financial Worksheet
7. Acknowledgments

In this section, we focus on strategic issues related to 3D printing in hospitals.

A Review of Concept:

What are “strategic issues”?

Strategic issues answer the questions “what” and “why”.

Strategic thinking, planning, and actions depend on the following company’s abilities:

• Ability to understand the environment they operate within.
• Ability to recognize developing industrial patterns and trends.
• Ability to anticipate potential issues.
• Ability to predict outcomes and impact of planned initiatives.
• Ability to develop sound fallback plans to mitigate the risk of a miscalculation.

Strategic planning in particular deals with the mission and purpose of the organization, its value proposition, i.e., what value it delivers to the customer, as well as the company’s future direction and growth.

There are three main categories specific for strategic issues of 3D printing in hospitals:

1. Clinical trials
2. Organization and staffing (Which include multidisciplinary team design, and in-house/outsource discussion)
3. Regulatory (FDA), policy, and legal issues

A. Clinical trials:

A clinical trial should be an important part of the strategic consideration because more clinical evidence, especially in terms of clinical efficacy and outcomes, will strengthen arguments for reimbursement. Why is reimbursement so important? That is because unit economics is crucial to the sustainability and scalability of a medical practice.

What is a “clinical trial”?

According to ClinicalTrials.gov, NIH and NML maintain a registry for clinical trials, “a clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes.”

Good clinical trials serve several major purposes, including: 

1. Informing consumers about the values of this technology.
2. Preparing data for new CPT coding and other reimbursement strategies from payers.
3. Inspiring creative innovations. 

Data on clinical outcomes is crucial. In recently published studies, researchers have been focusing on the following outcome metrics: operating room time, hospital stay, surgical outcome and complication, and post-surgical accuracy. Non-quantitative outcome metrics include patient/family satisfaction.

We have recently published several articles on this subject, and since we update theses articles separately, readers can refer to the following articles without us creating redundant sections on this guide:

In Healthcare 3D Printing Clinical Trials,  we discussed the significance of conducting clinical trials and also deconstructed the organizations behind several important registries for ongoing clinical trials.

In Completed 3D Printing Clinical Trials, Part I, we dived a little deeper into the status of currently completed clinical trials on clinicaltrials.gov. 

Please stay tuned for Part II of the above discussion to take a more detailed look at the design and execution of the completed trials.

B. Organization and Staffing:

The reality is that in-house 3D printing service almost always exists in an academic setting when there are enough clinical demand, skills, and research funding in exploring emerging technologies. However, except for rare institutions like the Mayo Clinic, even academic centers have limited manpower and existing resources. Many academic centers’ 3D printing center likely has less than a handful of technicians and clinicians. That’s why optimizing organization and staffing for a 3D printing service, either done in-house or outsourced, is important even before your first 3D printer.

1. Multidisciplinary design: 

3D printing is a very technical activity that most clinicians never received formal education. Vice versa, it takes months for a new biomedical engineer to learn clinical terminologies and relevant anatomy. With a steep learning curve for both, the most efficient way of utilizing talents is to figure out a way to work together and work smartly.

The creation and use of a 3D printed model, surgical guide, or an implant is a process that starts with a patient and ends with an operation.  The following graphic is a simplified version of our old swim lane.

I will walk through this swim lane for 3D printing in hospitals with two hypothetical scenarios based on two recently published papers, one focusing on a customized mandibular implant and the other focusing on personalized orthopedic surgery. [Ref, Ref] The main hypothesis behind these examples is that the location of file manipulation and 3D printing was in the hospital.

Example 1. Fabricating Mandibular Implant using Direct Metal Laser Sintering (DMLS)

Clinical Scenario

The background story of this first example is a patient with mandibular cancer. Conventional treatment after tumor resection is to reconstruct the surgical defect with fibula free flap (or another piece of bone in the body). However, the patient did not do well after repeated reconstruction. This is when the surgical team decided to seek out an alternative solution for this patient.

Imaging Acquisition

Starting from the top of the infographic, the clinical team must request the appropriate imaging studies. In this case, both pre and post-operative CAD/CAM images are available. This will also depend on the radiology technicians to perform the correct study. Radiologists may also play a role in this case by supervising the imaging process and interpret images obtained.

File Manipulation

3D Imaging Lab of this hospital or other 3D imaging engineer can then perform segmentation steps, converting DICOM images to STL. Subsequently, the technician edits the STL file for 3D printing using a mesh generating software. The technician can also calculate the mechanical properties of the final model during this step.

Once the 3D images or models are available, the clinical team can evaluate the images, making diagnosis and generate an initial surgical plan.

Multidisciplinary Meeting

Admin coordinates a multidisciplinary meeting among the engineers, radiologists, surgeons, radiation oncologists, and other care providers for the patient to discuss the best surgical approach and the most optimized implant design complementary to such an approach. A case manager and dietitian may also be involved in this discussion since the disease is disfiguring and intimately involves the digestive system.

Implant, anatomical model, surgical guide CAD design

Depending on the conclusion of the meeting, the CAD designer will use existing patient’s 3D imaging data and model to create a personalized implant and surgical guide. An anatomical model is also often useful for both patient education and surgical planning for the surgeon.

The radiologists and surgeons often intimately supervise the engineers in this step.

Manufacturing Process

Often, with a small budget, the CAD designer also plays the role of an additive manufacturing engineer. However, in this case with metal 3D printing, which has more strict manufacturing requirements, more than one engineer was probably necessary. In this phase, these steps include 3D printing, post-processing, and quality control/validation of the final product. One may also add sterilization and packaging into this step.

Product Delivery and Implant Surgery

Example 2 Personalized Orthopedic Surgery for Internal and External Fixation of Complex Tibial Plateau Fracture

Clinical Scenario

The second example is based on a recently published paper discussing the role of 3D printing in treating high energy complex tibial plateau fracture. [Ref] In these cases, it is often difficult to figure out precise injury of the knee joint, making surgical decision challenging.

Imaging Acquisition

In this case, the orthopedic surgeon would request high-resolution CT, which is ideal to demonstrate bony injury, especially the articulating surface of the knee. The remaining steps are similar to example 1.

File Manipulation

Most of this step is identical to example 1.

Once the 3D images or 3D models are available, the clinical team can evaluate the images, making diagnoses, and generate an initial virtual surgical plan.

Multidisciplinary Meeting

Admin coordinates a multidisciplinary meeting among the engineers, radiologists, trauma surgeons, orthopedic surgeons, and other members in the care team to discuss the best surgical approach of the fixation approach. A speedy team approach is necessary since a trauma patient may have other serious injuries that can affect his/her clinical outcomes.

Implant, anatomical model, surgical guide CAD design

Based on the conclusion of the meeting, the 3D Lab technologist or CAD designer will use existing patient’s 3D imaging data and model to create an anatomical model design highlighting the desired bony injury optimized for surgical planning.

The radiologists and surgeons often intimately supervise the technicians/engineers in this step.

Manufacturing Process

Often, with a small budget, the CAD designer also plays the role of an additive manufacturing engineer. In this case, a polymer-based 3D print with the adequate resolution is sufficient.

In this phase, these steps include 3D printing, post-processing, and quality control/validation of the final product. One may also add sterilization and packaging into this step if the models are to be used within the surgical field.

Product Delivery

The anatomical models can serve multiple purposes ranging from patient education to presurgical planning, to intraoperative guidance.

2. In House versus Outsource:

This is perhaps one of the most common questions:

Should we create a 3D printing lab or should we just outsource the hospital’s 3D printing needs?

Depending on existing hospital infrastructure, clinical caseload, and targeting applications, creating an in-house 3D printing center can be expensive and challenging on multiple fronts. Often, it is not a viable initial option for smaller hospitals.

Except for imaging acquisition, outsourcing 3D printing service allows the hospital to bypass the initial financial risk, technical deficiency, and operational challenges. Over the past several years since the book was originally written, there are now many new medical 3D printing service bureaus all over the world, in addition to services available from larger companies like 3D Systems (USA) and Materialise (Belgium). Interested readers can explore our regularly updated directory to find these companies. The end result is more options to the consumers.

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These service bureaus often not only offer 3D printed anatomical models, but also surgical guides and implants. However, the cost of these services is still on the scale of hundreds if not thousands of dollars. That said, while the cost appears high, in high-risk, rare, and complex surgical cases, the return on investment of adding a 3D printing step can make sense to clinicians. Additionally, turnaround times are also less than ideal, ranging from days to weeks.

On the other end of the spectrum, however, a larger academic center may be ready to heavily invest in a centralized 3D printing center. The Mayo Clinic was one of the first medical centers to make this kind of investment. It has been a definite leader of 3D printing in hospitals, setting great examples of making it work. [Ref] Almost all the surgical departments, from pediatrics, neurosurgery, orthopedics, are now routinely using their 3D printing service. The widespread acceptance of the technology within the Mayo Clinic has significantly increased the case volume and helped to justify the cost.

The following questions are common when hospitals are making the decision on creating an in-house 3D printing lab versus using outside vendors:

1. What is the existing infrastructure that could be used for 3D printing in hospitals? 
2. What is the required turnaround time for the applications?
3. What is the necessary equipment for a successful 3D printing center in the hospital? 
4. How much does the clinical team want to get involved in the 3D printing process? 
5. What to look for when selecting for an outsourcing vendor for pre-surgical 3D printing in the hospitals?

What is the existing infrastructure that could be used for 3D printing in hospitals? 

Existing personnel and software may be available to be part of the new service.

For example, larger hospitals like Stanford, UCSF, Children Hospital Boston have existing funding for innovative projects such as simulation programs, 3D imaging,  that can be leveraged to create 3D printing services. Some are already equipped with a 3D printer even before officially establishing a 3D printing lab.

Medical centers with comprehensive imaging services are often equipped with high-quality imaging hardware that can generate high-resolution medical images required for 3D printing. Over the last five years, many major imaging equipment manufacturers (e.g. GE, Siemens) are now equipped with 3D printing protocols from various popular prosthetics or device companies, as well as dedicated 3D printing software upgrades.

Additionally, many hospitals have already purchased licenses for popular 3D visualization software packages such as Vitrea (Vital, USA) or OsiriX (Bernex, Switzerland). These contain many similar DICOM to STL conversion and modification features to other more 3D printing specific software options.

Highly-trained technicians who are already familiar with post-acquisition imaging processing have many of the skills required for file manipulation for 3D printing. The learning curve for these centers will be significantly less steep than a center such as a community hospital.

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What is the turnaround time required for the applications?

Turn around time is a critical factor to consider as many hospital surgical cases are emergent urgent. Any delay in care can cause increased patient mortality and morbidity rate.

Therefore, time factor is important.

The hospital needs to identify the bottleneck among the production steps and investigate if the most time-consuming step can be performed faster outsourced when compared to in-house production options.

Good and effective communication between the requesting clinicians and the 3D printing team is the most important step to quickly conceptualize the best 3D printing strategy. It not only can be time-consuming but also is pivotal in decision making in subsequent steps. Because many surgical cases require a more timely response, major academic hospitals like Stanford have officially incorporated 3D printing as part of their Electronic Healthcare Records (EHR) ordering system.

Ineffective initial communication with either in-house or outsourced 3D printing services will prove costly in time and money.

The next most time-consuming and labor-intensive step is segmentation and image post-processing. If in-house 3D software expertise is already available, then it is much easier to keep this step in-house, since communicating with a multidisciplinary team can be more effective when the engineering step is completed in-house.   

On the other hand, some external vendors have experienced engineering teams who are familiar with clinical needs, often even specific clinician’s needs. They can communicate with the care team in an equally effective fashion. Some vendors offer faster printing and shipping/transportation strategies. They may more quickly scale and modify production to shorten turnaround time and meet the demand.

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What is the equipment needed to achieve successful 3D printing in the hospital?

Software and hardware requirements will highly depend on the goals of the 3D printing center.

For example, the resolution and material requirements for creating a pre-surgical educational model for the patients or medical students will be much less than a model intended for a pediatric cardiothoracic surgeon, who wants to simulate the intra-operative environment for complex congenital heart disease. Flexible materials cost significantly more may be needed for complex vascular surgery. 

The size of the model required will also help determine what hardware is needed. For example, a pediatric heart model is small enough to fit inside the popular desktop 3D printer but an actual sized adult pelvis will not fit.

How much does the clinical team want to be involved in the printing process? 

In general, when extensive multidisciplinary communication among different clinical and engineering teams is needed, an in-house 3D printing service is more efficient and convenient. These include conversations ranging from initial design needs to the correction of errors in the production process. The cost and time of re-designing and reproducing a model can increase significantly with outsourcing. 

Again, the depth of the clinical team’s involvement is variable and individual-based. For example, in complex maxillofacial cases where the surgeons often want to see a variety of surgical strategies, it may make sense to keep the design/segmentation steps in-house and outsource the final printing with an outside vendor. Models intended for educating patients (patients’ families) and students/residents usually do not require extensive in-house multidisciplinary discussion and can be outsourced easily.  

What to look for when selecting an outsourcing vendor for 3D printing in hospitals?

Over the past years, more and more 3D printing companies are now interested in providing services to healthcare providers. A variety of new business models have also surfaced, demonstrating the agility in the industry. These models ranging from placing vendor hired biomedical engineers in contract hospitals, to leveraging machine learning to automate production steps.

Being a separate entity and often at a distance from the hospital, it is important for outsource vendors to understand and respect the sensitive nature of a medical record. It is imperative to prepare a HIPAA compliant data transfer process. Some hospitals use lifeIMAGE (MA, USA) as a way to transfer images to and from a third party. However, given the continuous expansion and emphasis on the interoperability of EHR (electronic healthcare record) and HIS (Healthcare Information System) compatibility, data transfer will be less of an issue in near future.

For complex cases, the ability to effectively communicate with the clinicians requires the vendor to have certain healthcare familiarity or clinical experience. Even with experienced vendors, occasional unsatisfactory products may still be produced and it is important that the vendors can provide adequate customer service to either effectively rectify the mistakes or design backup plans in case of such failure. For example, making multiple versions of the prints with a different design or structural emphasis is one such strategy.

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C. Regulatory (FDA), policy, and legal concerns

This part of the guide will likely change more frequently, check back for updates.

1. FDA Updates

Over the past five years since the book was first written, the FDA has made several major improvements to the regulatory landscape of 3D printed medical devices. The medical devices include 3D printed anatomical models, surgical guides, and implants. The agency also further clarified governing bodies of pharmaceuticals and biologics using 3D printing as the core technology.

These FDA entities focusing on medical applications using 3D Printing inlcude:

• Medical devices regulated by FDA’s Center for Devices and Radiological Health (CDRH),
• Biologics regulated by FDA’s Center for Biologics Evaluation and Research, and
• Drugs regulated by FDA’s Center for Drug Evaluation and Research

For the purpose of discussion of 3D printing in hospitals, the most important regulatory updates include:

1. 3D Printed anatomical model is now regulated under the division of the radiological health of CDRH. For a majority of cases in a hospital, the intended use is regarded as a diagnostic process.
2. FDA finalized its guidance on “Technical Considerations for Additively Manufactured Medical Devices”
3. US FDA recently announced its modernization plans for 510(K) pathway to drive technological innovation in medical device manufacturing. Some of the proposals include using newer or more recently cleared medical devices (less than 10 years) as predicate devices to demonstrate substantial equivalence and the creation of a new alternative 510(k) pathway that will allow approval based on objective safety and performance criteria.

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2. Global Regulatory Updates (CE/CFDA/TGA)

A discussion of the regulatory landscape of 3D printed medical devices will be incomplete without including other major global medical device regulatory agencies.

In early 2019, Khalid Rafi, who is the AM lead for ASTM (American Society for Testing and Materials) International, wrote a nice Expert Corner blog on the global regulatory landscape, titled “A World of Regulation: Updates on 3D printed Medical Devices.” This blog succinctly covered recent updates from CE, CFDA, TGA, Canadian medical device market regulator Health Canada, Brazil’s medical device regulator (ANVISA), in addition to those of FDA’s.

Later in the same year, Rui Coelho wrote a separate Expert Corner blog, focusing on CE regulatory updates regarding 3D printed medical devices. One important change from the European Union came from the new Medical Device Regulation MDR (EU) 2017/745, which states that 3D printed implants are no longer considered custom made medical devices under the CE mark.

In MDR 2017/745, a custom-made product is a medical device that has “specific design characteristics” that make it suitable “for the sole use of a particular patient exclusively to meet their individual conditions and needs”. The new regulation goes on to exclude two categories of medical device product from the custom-made definition:

1. Mass-produced medical device products which are adapted to the specific requirements of a patient
2. Mass-produced products manufactured as per a written prescription

Therefore, “custom-made” can only be applied to products made from scratch. [Ref]

The result of such change is new regulatory uncertainty for the manufacturers of 3D printed medical device, be it a hospital or an outsourcing vendor. However, manufacturers are advised to follow existing medical device manufacturing standards. It is also very likely future CE Mark requirements will be parallel to its U.S. counterpart.

3. Legal Concerns

As the adaption of 3D printing in healthcare grows, hospitals and manufacturers should consider potential legal implications, albeit truly history-defining lawsuits have not happened outside of the intellectual property arena, which is a good thing. However, as with many highly regulated industries such as healthcare and manufacturing, regulation is necessary because the risk of harm is high.

As with many other emerging technologies in highly regulated sectors, 3D printing in healthcare piqued many intellectual discussions from legal experts, predominantly on issues involving product liability, intellectual property, HIPAA, and cybersecurity/data management. For the curious minds, additional in-depth discussion from ReedSmith LLP is worth reading and free to download here. [Ref]

Larger institutions with bigger budgets default to FDA-cleared software for preparing 3D printing files. The most popular FDA cleared software marketed for 3D printing anatomical models are from Materialise and 3D Systems. The concern with non-FDA cleared software is potential inaccuracies and therefore liabilities. However, there has been no ruling against any practitioner or hospital for using non-FDA-cleared software for 3D printing to date. This is not to say clinicians should not exercise caution and care when producing a 3D printed model. To me, this means smaller and newer software companies simply may not have had enough time and budget to get FDA clearance. Additionally, the assumption that FDA cleared 3D printing software providing higher quality end product is also to be proven. At the end of the day, the clinicians and the hospital still bear a majority of responsibility for providing the highest care to the patients.

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In the manufacturing process itself, safety guidelines for managing 3D printing material, operating 3D printers, and post-print processing must be followed to OSHA standards. We will cover material management in a later section of this paper. For patient care, more stringent requirements need to be met as the 3D printed product is used in close proximity and sometimes direct contact with the patient. Currently, a limited number of materials are FDA-cleared and can be sterilized sufficiently to be within the operating field. An even smaller number of materials can be used for implant production. Full understanding of the toxicity and biocompatibility of the 3D printing material used will be critical in compliance with future regulations in pre-surgical applications. 

Overall regulatory concerns have increased the complexity of setting up 3D printing in hospitals. A 3D printed surgical guide is one such example. A 3D printed surgical guide can be produced in-house within 24 hours. However, due to regulatory concerns, some healthcare providers choose to use outside medical device vendors with established regulatory clearance and workflow. This significantly increases the turnaround time from days to weeks, markedly decreasing the appeal of wider adaption such application.

In the next section of this guide, we will discuss the tactical issues of 3D printing in hospitals.

About the Author:

Jenny Chen, M.D.

Jenny Chen, MD, is currently the Founder and CEO of 3DHEALS, a company focusing on education and industrial research in the space of bioprinting, regenerative medicine, healthcare applications using 3D printing. With a focus on emerging healthcare technology, Jenny invests in and mentors relevant startups, especially companies pitching through Pitch3D. She believes a more decentralized and personalized healthcare delivery system will better our future.

Related Articles:

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

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

3DHEALS From Academia (Collective) – This section features recent, relevant, close to commercialization academic publications in the space of healthcare 3D printing, 3D bioprinting, and related emerging technologies.

The post Strategic Issues of 3D Printing in Hospitals – Guide Part 2/5 appeared first on 3DHeals.

Over the last five years, there has been significant growth in the adaption of 3D printing in hospitals. This is a result of a more clarifying regulatory landscape, more governmental supports, and new public and private initiatives.  Notable relevant public initiatives are led by RSNA SIG group, Mayo Clinic, ASME/SME, FDA, America Makes, ARMI. Notable private initiatives are led by JNJ/Depuy Synthes, GE, HP, Stryker, Medtronics, Lima Corporate, Materialise, Formlabs. The concerted efforts from the private and public sectors resulted in a rapid increase in hospital-based 3D printing labs all over the world.  This is further supported by consistently increasing publications on Pubmed. [Figure 1, Source: Pubmed] Within a hospital setting, current major applications remain to be pre-surgical planning, which will comprise the bulk of our discussion.

However, lately, there are two defining directions in the field: point-of-care 3D printing and mass-produced 3D printed implants in the 3D printing healthcare sector, which makes 3D printed personalized implants a possibility for hospital-based 3D printing services. We will incorporate these into our discussion. 

Why this Guide?

Despite the progress, the field remains new, and the most popular questions remain to include the following: 

1. How do we set up a 3D printing center in a hospital? 
2. How can this make economic sense for a hospital? 
3. Should we have a 3D printing center in the hospital (in-house) or should we outsource such service? 

These are exactly the same questions five years ago when I co-authored a book focusing on a systematic thinking process to address these questions by evaluating components of operational management with Michelle Gabriel. However, selling a book is not going to accelerate adaption, instead, I decided to publish this updated online version of 3DHEALS Guide in five digestible parts, focusing and adding new information from field experts from all over the world to provide a foundation to any early adapters.

This is not a show and tells of various fancy technologies and artful displays, but a fundamental thinking exercise to help people through their initial steps of setting up 3D printing service in hospitals.  I hope to use simple languages understood by business, engineering, and healthcare professionals collectively to bridge the gaps in communication. If you find this guide useful, feel free to share it to your fellow makers/innovators. This guide will stay indefinitely free.

This guide is an ongoing project for 3DHEALS and will be updated regularly. We are also working on a page dedicated to all the contributing individuals and organizations for current and future updates, please stay tuned.

The target audience of this guide is wide, including providers, hospital administrators, organizational leaders, entrepreneurs, legal experts, additive manufacturing industrial partners, and investors, among others. Given our broad networks, we hope to maintain the latest wisdom with the help of 3DHEALS partners and community managers.

What’s in this Guide?

This guide will first give a technical overview of 3D printing. Then, we will focus on major operational management issues for hospital implementation of this technology including sample cost analysis and interactive online tools. The book will include clinical examples illustrating the process from idea to implementation, referencing major published data/papers as well as our interviews with early adopters and industrial leaders. 

Specifically, the guide is broken down into the following components:

1. Introduction:  What is operational management?
2. Technical Background
3. Strategic Issues
4. Tactical Issues
5. Financial Issues         
6. Financial Worksheet (To be published)
7. Acknowledgments

Introduction: What is Operational Management?

So what is Operational Management?

Here is a simplified explanation for those who are unfamiliar: 

Operations management is the administration of business practices to create the highest level of efficiency possible within an organization. It is concerned with converting materials and labor into goods and services as efficiently as possible to maximize the profit of an organization [Ref]. In this guide, the goal is to maximize such efficiency in the context of 3D printing in hospitals.

In this guide, the issues related to operational management are categorized into three (Table I) [Ref]: 

Strategic Issues:

Strategic issues answer the questions “what” and “why”.

Strategic thinking, planning, and actions are rooted in the following company’s abilities:

• Ability to understand the environment they operate within.
• Ability to recognize developing industrial patterns and trends.
• Ability to anticipate potential issues.
• Ability to predict outcomes and impact of planned initiatives.
• Ability to develop sound fallback plans to mitigate the risk of a miscalculation.

Strategic planning in particular deals with the mission and purpose of the organization, its value proposition, i.e., what value it delivers to the customer, as well as the company’s future direction and growth.

That is, are we focusing on the right thing? 

Tactical Issues:

Tactical issues answer the question “how”.

Tactical consideration refers to how the company plans to get the job done or achieve a particular strategic objective.  Tactical planning considers the resources available (time, money, people) along with the risks or challenges that may be encountered. Based on tactical consideration, the company determines the most efficient way to use resources to achieve strategic goals with quality results.

That is, are we doing things right? 

Financial Issues:

Financial issues answer the question of  “how much”. In healthcare areana, it includes a discussion of “reimbursements“.

Doing business in healthcare is not a straightforward “profit-and-loss” spreadsheet. The reimbursement pathway of emerging technology is tortuous, and the pricing strategy of devices and services is even more opaque to most.

2. Technical Background:     

• 3D Printing Techniques and Materials   
• Typical 3D printing workflow   
• Values and limitations of 3D printing     
• 3D Printing for pre-surgical planning
• 3D Printing for Implants

A. 3D Printing Techniques and Materials

3D printing techniques have grown since the first stereolithography (SLA) systems were created in 1986.  The nomenclature surrounding the printing techniques has suffered from a lack of standardization. Recently, the American Society for Testing Materials (ASTM) designated seven 3D printing processes, each of which is represented by one or more commercial technologies. [Ref] The following table lists the processes, the technologies, the printing resolution of these technologies, and the medical applications that can be produced by each process (Table II).  

Each process uses specific materials with specific properties that relate to medical applications, which are summarized in Table III.

With this general information as a starting point, users should be able to determine what methods and materials could be used for their specific needs. 

Currently, 3D printers are either high-end or high-performance machines for industrial applications or very low-end and low-capability machines for hobbyists. New mid-priced, good-quality printers have started to emerge. Predictions are that these will be used by small- to mid-sized businesses that will grow the market in 2016. [Ref]

The emergence of these new printers has been driven by the expiration of key early patents for the different technologies, including SLA in 2009 and Fused Deposition Modeling (FDM) in 2011. [Ref] The most recent is Selective Laser Sintering (SLS), whose patents expired in 2014. [Ref]

B. Typical 3D Printing Workflow

  A typical 3D printing workflow includes the following steps:

There are quite a few publications with more comprehensive and detailed discussions on the technical aspects of how to optimize each step. [Ref, Ref, Ref] This section serves as a summary of the process and to familiarize the audience with typical healthcare 3D printing terminologies:

a. Image acquisition

Many surgical patients today will have a cross-sectional imaging exam prior to surgery. Cross-sectional imaging exams in general include Computed Tomography (CT), Magnetic Resonance Imaging (MRI), ultrasound (US), and Digital Rotational Angiography (DRA). However, if the surgical team anticipates using 3D printing for surgical planning, suitable imaging protocol becomes the first critical step. [Ref, Ref]  For adult patients, the optimal axial slice thickness depends largely on the anatomic structure of interest, and should be around 1 mm to 2 mm. For pediatric patients, the slice thickness could be thinner, in the sub-millimetre range. 

Similar to 3D surface rendering, while it is still possible to construct a 3D object using slice thickness greater than 2 mm, a lot of anatomical information will be missing, and the clinicians need to be aware of the degree of inaccuracy in the final print. If vascular structures are of concern, intravenous contrast is needed with adequate bolus timing like any other vascular imaging study.

In general, the goal of imaging acquisition is to obtain images with enough structural contrast for later segmentation. Other important factors to consider include kernel selection, CT dosage, and MRI sequence. If 3D printing is considered as part of surgical planning, consulting a radiologist before image acquisition is important to achieve the optimal results. In addition to protocol, other adverse factors impeding a successful acquisition will need to be considered including motion artifacts, metallic or bony streak artifacts, sub optimal contrast opacification, and unusual body shape and size. [Ref]   

b. File Manipulation

DICOM and WG-17

DICOM^®, also known as Digital Imaging and Communications in Medicine, is the international standard for medical images and related information. It defines the formats for medical images that can be exchanged with the data and quality necessary for clinical use. DICOM^® is recognized by the International Organization for Standardization as the ISO 12052 standard.[Ref]

Almost all the acquired radiological images, such as MRI, CT, Xrays and etc, follow DICOM^® standard. Lately, the standard extends into ophthalmology and dentistry. It is important because DICOM^® images are the source data for any 3D technologies, ranging from 3D printing to augmented and virtual reality. [Ref]

DICOM^® is first published in 1993. In 1998, WG-7 3D (“Working Group 17”) was established to focus on a variety of 3D technologies using DICOM images as source data. [Ref]

Segmentation

During segmentation, a particular region of clinical interest is outlined/selected on each image based on pixel information to construct a three-dimensional object. This region of interest (ROI) can be a complex anatomical structure or particular pathology that needs to be surgically treated. This process can be both semi-automated and manually performed. Often, practitioners use a combination of both to achieve a final satisfactory 3D object.  This is the most time consuming and laborious step, and lately, many startups and researchers are using artificial intelligence to optimize this step.

DICOM to STL file conversion

While medical images are stored as DICOM, most 3D printers only recognize certain file formats, most commonly, stereolithography (SLS) or Standard Tessellation Language (STL) files. It is the most accepted standard file format that interfaces between 3D software and 3D printers.

Lately, newer file formats such as 3MF and AMF are receiving more attention in the 3D printing community, and possibly will become newer standard file formats for newer generation of 3D printers.

Traditionally, medical image Picture Archiving and Communications Systems (PACS) do not have the capability to perform the conversion to 3D printer file formats. However, there are many third-party software solutions to convert 2D images to 3D structures.

For example, the Mac-based DICOM viewer Osirix ( Geneva, Switzerland) is a widely used solution. Blender and 3D Slicer are well accepted free open-source tools. In terms of paid solution, Materialise Mimics and 3D Systems have FDA cleared solutions that received 510K clearance for 3D printing anatomical models.

In addition, more and more major PACS vendors such as GE and Siemens are updating their systems to include this functionality in their future versions. Soon, it will be a standard package when purchasing a scanner.

File optimization for final print (Mesh correction)

Along with the common 3D printable files such as STL, there is associated surface geometry in the form of connected triangles. This geometric information is also known as a “mesh”. The mesh must be mathematically continuous (“manifold”) to be ready for physical 3D printing. (3) This involves meticulous mesh correction steps to fix these geometric “errors” without losing significant anatomic accuracy. With a few exceptions  (e.g. inkjet technology), a mesh with discontinuity (“holes”) cannot be printed. 

c. 3D Printing

This step will construct the physical object based on the corrected mesh. This could be a single-step or multi-step process depending on the size and complexity of the digital design.  Lately, researchers are working on further automation of the 3D printing process using machine learning and artificial intelligence.

d. Post-processing

After the object is printed, it is often necessary to remove the residual material or supporting structures. Post-print polishing, coloring, reconstruction, or material hardening (infiltration) may also be necessary depending on the use of the print. [Ref] Two notable startups that provide post-processing technologies are DLyte and Post-Processing Technologies.

e. Validation and quality control [Ref, Ref, Ref]

Errors can occur during each of the previously described steps. Accumulative errors can be significant. There are a few suggested existing validation/quality control processes, but in general, this is an area of active investigation and improvement. First, the practitioner, preferably a radiologist or specialty imaging expert can compare the final mesh with the initial imaging study before the file is printed. Second, the surgeons can obtain intra-operative measurements and compare those to the 3D printed object. Third, practitioners can re-image the 3D printed object and compare the images with the patient’s images for differences. Others have also developed phantoms to validate the accuracy from digital design to physical print [Ref].

C. Values and Limitations of 3D Printing in Hospitals

Traditional manufacturing methods, like the drill press, lathe, or milling machine, need to be operated by the maker. The work piece needs to be aligned, measured, and machined by the user, which introduces human error into the making of the part. In contrast, 3D printing is a hands-off manufacturing process; just by pressing a button, whatever you design will be made.

Benefits of 3D Printing

The benefits of using 3D printing over traditional manufacturing make it suitable for situations requiring:

1. Rapid prototyping
2. Mass customization (e.g. Invisalign)
3. Decentralized manufacturing enabling a more flexible supply chain and potentially further a decentralized healthcare delivery system.
4. Lowering distribution and inventory costs (Post of care 3D printing)
5. Complex geometries that 
   1. Cannot be manufactured by any other method.
   2. Have improved material property (e.g. strength, elasticity, transparency).
   3. Can be manufactured more cost-effectively with 3D printing.

Limitations of 3D Printing

3D printing also has some current limitations that may not lend it to some applications:

1.Time-Consuming

3D printers can take hours rather than minutes to complete a piece and thus do not lend themselves to mass production for certain applications, especially in emergent surgical cases.  Lately, faster and newer printers are now on the market, but pricing and material limitations create barriers. A majority of hospitals and clinics still rely on extrusion-based 3D printers using thermoplastics as bread and butter starting hardware. 

2.Material Limitations

The limited selection of 3D printing material, especially those deemed suitable for medical use (i.e. biocompatible, sterilizable, of good strength, multi-color, and affordable), hinders broader application. 

3. Size Limitation

The size of the objects intended for printing also limits applications, as printers capable of making larger prints are more expensive and there are fewer options available. In addition, larger prints may take a significant amount of time to print, which would not be acceptable for clinical cases with time constraints. 

4. Mechanical Properties

Final printed object mechanical properties can be inconsistent due to different printing orientation.

D. 3D Printing for Pre-Surgical Planning

 Currently, the three main pre-surgical applications using 3D Printing include:

1. Pre-surgical planning, including strategy development through improved ability to simulate and manipulate models. 
2. Creating anatomical models with haptic feedback.  [Ref]
3. Improving communications among multidisciplinary clinical care providers and between clinicians and patients.

     These cases can be categorized into the following areas:

1. Surgical strategy development: e.g. surgical approach, device selection, surgical tool selection [Ref, Ref, Ref, Ref, Ref, Ref, Ref, Ref]
2. Surgical guides [Ref, Ref]
3. Patient/patient family education [Ref]
4. Education or training tool [Ref, Ref]

For each case, provider must ask ,”Does 3D printing add value in addition to conventional imaging and existing virtual planning tools?”

For the medical community to fully embrace a new technology, supporting evidence based on rigorous scientific methodologies is required. Recent examples of adoption of emerging technologies in healthcare include functional MRI, computational simulation, robotic-assisted surgeries. For each of these technologies, collection of clinical evidence was necessary not just for patients and clinicians, but also for the payers to fund their use.

In the past several years several major academic institutions such as the Mayo Clinic, Cleveland Clinic, Boston Children’s Hospital, and Stanford Healthcare have taken the lead. Collectively, these academic centers made significant advancements in exploring 3D Printing through clinical trials with larger patient populations.

Popular software and hardware companies like Materialise, Formlabs, Ultimaker, Stratasys, and HP have worked together in creating a workflow for point-of-care 3D printed anatomical models (Mimics InPrint Certification Program).

Most trials, publications, and advancements have occurred in the fields of orthopedics, pediatric surgery, and maxillofacial reconstruction surgery. We will explore the topic of “clinical trials” more extensively in part two of this Guide.

These studies serve not only as meaningful metrics of clinical outcomes, but also inspire future study design and technique with establishing tangible workflows.

Throughout this guide, we will provide real-life examples based on the academic publications and direct expert interviews. We are also embedding clinical examples with our Instagram posts. since this is a dynamic ever-changing field where creativities thrive.

E. 3D Printed Implants

As I have mentioned earlier, to have sustainable solution for both healthcare and the 3D printing industries, there are two emerging initiatives:

1. Production friendly solution

2. Point of Care delivery.

Finding the perfect applications that are in alignment with these directions will make financial sense for both sector.

A 3D printed implant, especially those manufactured at or close to a hospital, seems to fulfill both criteria. In the last few years, entrepreneurial and research activities are mainly in metal and PEEK based 3D printed implants. This trend is also in alignment with recently published data by FDA researchers in terms of FDA-cleared 3D printed medical devices.

For example, in 2019,  Lima Corporate, a metal 3D printing orthopedics implant manufacturer, and Hospital for Special Surgery, an orthopedics specialty hospital created a facility close by the hospital, so that on-demand complex implants can be produced at the point of care.

Similarly, in 2019, Stryker teamed up with multiple organizations in Australia for a project called “Just in time implants”, where on-demand patient-specific implants can be produced for the patient after bone tumor resection.

In a different model, hospitals or healthcare providers act as device manufacturers and create facilities within the premise of the hospitals or clinics. For example, startups such as Kumovis and Apium both provide point of care 3D printers that can manufacture PEEK implants. The role of hospitals as a manufacturer is somewhat intimidating without a clear regulatory landscape.

In the next section of this guide, we will dive deeper into the strategic issues of 3D printing in hospitals.

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About the Author:

Jenny Chen, M.D.

Jenny Chen, MD, is currently the Founder and CEO of 3DHEALS, a company focusing on education and industrial research in the space of bioprinting, regenerative medicine, healthcare applications using 3D printing. Dr. Chen holds degrees in both medicine and radiology from the David Geffen School of Medicine at UCLA and completed fellowship training in neuroradiology at Harvard Medical School. She currently serves as Adjunct Clinical Faculty in neuroradiology at Stanford University Medical Center. With a focus on emerging healthcare technology, Jenny invests in relevant startups and also serves as a startup mentor. Her investment focus is companies pitching through Pitch3D. She believes a more decentralized and personalized healthcare delivery system will be in our future.

Related Articles:

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

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

3DHEALS From Academia (Collective) – This section features recent, relevant, close to commercialization academic publications in the space of healthcare 3D printing, 3D bioprinting, and related emerging technologies.

The post 3D Printing In Hospitals: A Beginner’s Guide 1/5 appeared first on 3DHeals.

Hui Jenny Chen, MD and Michelle Gabriel, MS, MBA
(This blog is adapted from our A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery)

Clinical trial design should be an important part of the strategic consideration because more clinical evidence, especially in terms of clinical efficacy and outcomes, will strengthen arguments for reimbursement. According to ClinicalTrials.gov [52], a registry for clinical trials maintained by NIH and NML, “a clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes.”

Good clinical trials serve several major purposes such as:

a) Informing consumers about the values of this technology.

b) Preparing data for new CPT coding and other reimbursement strategies from payers.

c) Inspiring creative innovations.

Data on clinical outcomes is crucial. In recently published studies, researchers have been focusing on the following outcome metrics: operating room time, hospital stay, surgical complication, and post-surgical accuracy. Non-quantitative outcome metrics include patient/family satisfaction.

There are two public clinical trials registered on clinicaltrials.gov for pre-surgical applications (Link). The first one is a recently completed randomized controlled clinical trial (Link) from Cleveland Clinic, “Acetabular Shell Positioning Using Patient Specific Instruments” which has shown a statistically significant increase in anteversion accuracy when using a 3D printed surgical guide over traditional planning methods in total hip arthroplasty (THA) [31]. A limitation to the study is a modest sample size of 36 patients although it is larger than most recently published studies. A second drawback of the study is the lack of information on other clinical outcomes, including hardware loosening and failure as a result of inaccurate placement. This latter issue will require long-term, continuous follow up with the patients.

The second study is currently enrolling (Link). It is focusing on 3D printed patient-specific simulations for endovascular aneurysm repair as a pre-surgical training tool.

https://3dheals.com/ideas-to-implementation%e2%80%8a-%e2%80%8awhat-are-the-major-operational-management-challenges-in-using-3d-printing-for-pre-surgical-application-today/

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Anatomy: Disarticulating Congenital Heart Disease ; Purpose: Provide example of Transposition of Great Arteries Mustard Switch procedure; Print Technique: Fused Deposition Modeling (FDM); Image Source: Computed Tomography of the Chest, 1 mm voxel resolution; Segmentation Difficulty: Very Difficult; ensuring no overlap of structures was difficult, many different models; Credit: Chris Letrong, Shannon Walters — Stanford University Department of Radiology, 3D and Quantitative Imaging Laboratory.

In a future healthcare world, physicians may be able to 3D Print any particular part of a patient’s anatomy with the press of a button. At present, however, precision DICOM image segmentation is more complex than many articles and presentations seem to suggest. I use medical 3D software daily to accomplish 3D replication, visualization, and quantification. Even before 3D Printing, I observed that most automatic and manual segmentation tools could use significant improvement. Since attempting more than 50 patient-specific 3D anatomic models, this observation is reinforced. Perhaps the repeatability and usability of many segmentation tools suffer due to lack of user input during the development of algorithms. Medical 3D software developers may have an opportunity to improve segmentation algorithms by leveraging user knowledge and preferences.
I perceive a lack of connection between those who spend thousands of hours using segmentation and those who design software that segments DICOM data. Many anatomic structures that may need 3D printing (and thus, segmentation) are not clearly delineated, homogenous, isolated, and uniform due to pathology or anomaly. Additionally, image quality adds the variables of graininess, artifact, slice thickness, and anatomic coverage. These variations in quality image data from CT or MR scanners increase the difficulty to successfully implement automatic segmentation. Perhaps we can move toward semi-automatic segmentation, with software vendors accepting various logic to improve segmentation time and accuracy. Other limitations for segmentation exist such as user familiarity with software tools, understanding of anatomy, and understanding the need for a 3D printed model. This post will focus on segmentation tools, provide a perspective on current limitations based on image quality, and propose some actions to help us arrive at the distant future of truly automatic segmentation.

What is segmentation?

Each vendor has a unique set of terminology for this, but the essence of segmentation is to identify and isolate voxels that represent any anatomy of interest. Two implementations of segmentation are; a) assigning a mask to a dataset indicating active voxels or b) deletion/removal of voxels not included in segmentation. Managing the models and masks is also unique in methodology and terminology per software vendor.
Methods of segmentation are both automatic and manual. Automatic segmentation can be threshold- or atlas-based. Threshold-based segmentation uses pixel brightness and patterns throughout the DICOM data to isolate or remove structures.  Atlas-based segmentation uses a database of anatomic structure shapes and attempts to find similar patterns in the current DICOM dataset. Many vendors have a threshold-based automatic segmentation method and “freehand” manual segmentation method.

What should be segmented?

The segmentation in this post refers to identifying and isolating anatomic structures within DICOM datasets. Structures are typically differentiated in the datasets by either discreet pixel intensity values ore relational differences in signal intensity. The context of any given DICOM acquisition must be taken into account to understand which intensity values represent which anatomic structures; contrast, dose, timing, and patient status can impact the pixel intensity of any given organ.
For CT Scans, brightness measures are standard for various structures across most scanners; but many factors can affect whether the image accurately reflects such brightness with the correct patterns. The CT brightness measure is referred to as Hounsfield Units (HU). MRI signal intensity is dependent upon habitus, coil selection, magnetic fields, distance to coil, and much more. With more variables, MRI has a higher possibility of signal variations when multiple factors contribute. The signal intensity using phased-array MRI coils can cause gradients of signal intensity for a structure, such as the posterior surface of a kidney measuring double the signal intensity of the anterior surface.
Ultimately, segmentation of any anatomic structure is largely based on identifying the voxel intensity values which represent it. This is likely why most automatic segmentation tools are based on threshold. Unfortunately, many factors hinder optimal imaging that make such segmentation a simple task.  

Issues with segmentation

Several issues with threshold-based segmentation are;
Heterogeneous Structures: osteoporosis is an example; a patchy-looking bony structure rather than a nicely delineated bone shape of a normal young person.
Image Noise: mottles the appearance of the entire dataset, making homogenous structures appear heterogeneous. This will impact the ability to identify in entire organs and/or shapes.  
Artifacts: metal implants, various types of motion, and other artifacts contribute to inaccurate representations of anatomic structures. At present, I have not witnessed any threshold-based segmentations able to correct for artifacts.
Several issues with atlas-based segmentation are:
Non-standard anatomic representations: Many 3D Prints are likely to be of non-standard anatomy; atlas databases are typically built upon normal anatomy.
Image Noise: mottles the appearance of the entire dataset, making border detection much harder for the algorithms to identify.
Artifacts: metal implants, various types of motion, and other artifacts contribute to inaccurate representations of anatomic structures. Borders of affected structures will not conform to atlas models because the signal characteristics will not match any in the database.  

What can be done?

First and foremost, all software must keep a robust manual segmentation tool as a backup to any automatic/semi-automatic method. Despite any adherence to my suggestions or others’, it is unlikely in the near-term that every patient condition and image type can be accommodated using automatic segmentation. With that said, I believe that three steps can help vendors achieve greater results in providing automatic segmentation that works despite the many image quality issues that arise.

1. User-driven development of segmentation algorithms
2. Semi-automatic approach, allowing logic to drive the segmentation approach
3. Validation of segmentation algorithms on standardized datasets

1. User-Driven Development

Developers should request feedback/involvement from users to improve segmentation algorithms. Much of current medical 3D software is likely designed around radiologist workflows, largely due to radiologists being the most obvious users of 3D software and having a role in purchasing decisions. There is a growing cohort of 3D Imaging Laboratories that utilize non-radiologists (technologists and others) to perform advanced functions on patient DICOM datasets. This non-radiologist population will likely grow as 3D Printing and other kinds of visualization and quantification proliferate. Vendors that singularly accommodate radiologists concerns may not achieve the needs of other users.

2. Semi-Automatic Segmentation

Given the myriad of image quality issues that will not dissipate soon, developers should acknowledge the need to overcome issues of heterogeneity, artifact, and image noise. Perhaps this could manifest as a questionnaire that optionally appears when segmentation begins. This questionnaire may ask the user about image quality factors; whether and where artifacts exist, ask users to set bounding boxes, and perhaps ask the users to quickly identify each structure in the dataset with a click. Using such logic, perhaps future segmentation can use atlas or threshold tools better to identify the desired anatomy with much more information from which to base segmentation algorithms on.

3. Validation of Segmentation

This may be far-fetched, but it would be nice to have an independent set of DICOM data from which 3D software can be applied to and potentially scored. Segmentation could be a single category of analyses, with subcategories of the vendor, MR, CT, and even further subcategories of an artifact, image noise, and so on. If all developers were forced to test on the same data, users could more effectively evaluate which tools might be best for their specific location and requirements. To fairly apply this tool, anonymized data from each CT/MR vendor with all the different kinds of equipment and image quality variable representations must be collected and prepared for analysis.

Where to begin?

Similar to gaining traction from 3D Printer vendors toward medical community needs, our community will need to show the returns on vendors investing resources to solve our problems. As this community grows, the issues will become more important. Radiologists involved with 3D printing at this point are in a position of leverage and should begin demanding that segmentation tools accommodate the myriad of needs that 3D printing will ultimately present. Perhaps the suggestion of a semi-automated approach is something that will benefit radiologists in other workflows than 3D Printing. All of us can track issues, articulate them carefully and think about ways to rate software based on objective measures such as the validation method suggested above. Lastly, without direct involvement with the developers, it is difficult to perceive how segmentation tools will ever truly meet the needs of the users, their needs, and the data they are forced to work with.

Shannon Walters, MS RT(MR), Stanford University Department of Radiology, 3D and Quantitative Imaging Laboratory  
Shannon been a radiologic technologist since 1998 and completed a Masters of Information Systems in 2014.  He has worked in Stanford 3D and Quantitative Imaging Laboratory since 2008, assuming the role of Manager in 2013. The field of advanced visualization is a perfect fit for Shannon’s intense interests in computers and healthcare.  Shannon has been involved with 3D Printing since 2013 and has generated more than 50 patient-specific models as of mid-2016.

Related Articles:

Part 1: Considerations for Implementing a 3D Printing Core Service in Your Hospital: A Technical Analysis

Part 2: Considerations for Implementing a 3D Printing Core Service in Your Hospital: A Technical Analysis

Interview: Jeffrey Sorenson, President and Chief Executive Officer of TeraRecon

The post Segmentation: The Real Struggles Behind Converting DICOM to Patient-specific 3D Printable Models appeared first on 3DHeals.

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3D printed heart -copyright Materialise

Written by Erik Birkeneder and Valerie Breslin Montague
Doctors are increasingly printing 3D models of a patient’s anatomy to plan for surgery or to aid in diagnosis.  For instance, a cardiac surgeon may take an MRI or CT scan of a patient’s heart to create a plastic model of the heart to plan a valve repair. However, many hospitals do not have 3D printing equipment in-house, so the hospital may send the MRI or CT scans to a company that specializes in 3D printing. Sending these scans outside the walls of the hospital could trigger the privacy and security requirements of HIPAA.

When health care providers send data with certain patient “identifiers” to third parties, the arrangement generally triggers HIPAA. In the case of 3D printing, the substance of what is transmitted, oftentimes a scan of an organ or body part, may not be deemed to be “identifiable” under HIPAA. For example, patient identifiers include the obvious information like names and social security numbers, but also include “biometric identifiers, including finger and voice prints,” “full face photographic images and any comparable images,” and “any other unique identifying number, characteristic or code.” Although many organ, tissue, bone and other body part scans likely will not be deemed to identify a particular patient, others might, such as images that contain fingerprints or dental models.

Prior to transmitting any images or data, health care providers must analyze whether the information to be sent to the 3D printing company is subject to HIPAA (or any other state or federal laws protecting patient confidentiality). If the information does contain patient identifiable information, referred to as “protected health information” under HIPAA, either due to the content of the image, the patient’s name or record number on the image or other data identifying the patient in what is transmitted, the provider must enter into a HIPAA business associate agreement with the 3D printing company.

3D printing companies also should take care when preparing models for hospitals, physicians and other health care providers. Generally, if a 3D printing company is the recipient of protected health information, the company becomes a “business associates”, subject to a number of the HIPAA regulations, such as requirements to adopt designated policies and procedures, conduct a security risk assessment and train the company’s workforce on HIPAA compliance. The company can avoid these compliance efforts by working with its health care clients to ensure that no protected health information is transmitted during the arrangement.

Disclaimer: The foregoing is not intended to convey or constitute legal advice, and is not a substitute for obtaining legal advice from a qualified attorney. You should not act upon any such information without first seeking qualified professional counsel on your specific matter.
JOIN US FOR A MORE IN-DEPTH DISCUSSION ON THE LEGAL ISSUES RELEVANT TO HEALTHCARE 3D-PRINTING ON AUGUST 10TH, 2016

Authors:

Erik Birkeneder is an intellectual property attorney at Nixon Peabody that focuses on health care related patents. Erik also serves as outside general counsel for a number of digital health companies and helps them navigate the unique privacy, and other regulatory hurdles that are facing this industry, including in 3D printing. He has a Master’s in Biomedical Engineering from University of Wisconsin Madison where he performed research on the impact of neuropeptides on wound healing in diabetics, and has a law degree from University of Minnesota.

https://angel.co/erik-birkeneder


Valerie Montague represents a variety of health care providers, digital health vendors, senior living facilities, nonprofit trade associations, life sciences companies and vendors of health care providers. Valerie is a Certified Information Privacy Professional/United States (CIPP/US), the preeminent credential in the field of privacy.

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(Cont’d) Considerations for Implementing a 3D Printing Core Service in Your Hospital: A Technical Analysis – Part 1

Verification and Labeling

After completing your segmentation and modeling work, you may be in a hurry to get your part on the 3D printer. However, there is an opportunity to unintentionally introduce errors in the above steps. Prior to printing, the accuracy of your final file should be verified against the original DICOM imaging. Did you take liberties and over-smooth or remove a key feature from the model? Did you cut away a structure that would be an important landmark for the surgeon? I would highly recommend a software solution that allows the user to overlay the STL surfaces back on the Dicom data. This will allow you to verify accuracy (and establish credibility with your surgical colleagues) as well as make subtle adjustments or refinements to the model.

Figure 4- Contour verification of prepared heart model demonstrated in Mimics Innovation Suite

Ensuring traceability of your 3D prints will also reduce the opportunity for making errors with your 3D printing program. As you scale your operation and build greater volumes of models, it is critical to understand what models are coming off the printer and what case they each belong to. To reduce the chance of mixing models or providing the wrong model to a surgeon, each anatomical model should be pre-labeled with software prior to printing. Use a requisition number that will trace back to the medical records to ensure traceability of your 3D models. You will also want to use labels if you create mirror images or want to clearly indicate what side of the patient the model was derived from. This will reduce the chance for operator confusion and eliminate the chance they may operate on the wrong side of the body.

Figure 5- Applying a text label to a heart model using Mimics Innovation Suite

Communication

Close collaboration between personnel is key in this process. It is necessary to define the scope and use of the model with the surgeon or interventionist prior to starting the process in addition to verification near the end. This can be facilitated through web meetings or face-to-face discussion. It can also help to have a software solution capable of exporting a file format which can be interrogated by the surgeon. It is highly unlikely that your surgeon will be able to open an STL file! Exports such as 3D PDFs can be an excellent tool for this purpose allowing efficient transfer and sharing of data within an environment of a simple PDF reader.

Figure 6- 3D PDF communication tool exported from Mimics Innovation Suite

3D File-Fixing

The STL file format is the universal digital 3D modeling format for 3D printing. This is the file that will be fed to the 3D printer to slice and build the part. Not all STL files are created equal. The number and quality of the triangle facets will determine the eventual quality of your printed part. You may also find very thin walls in the model that fall under the minimum resolution of your printer or that will be very brittle and tear-sensitive. It is imperative to have a robust STL diagnostic and fixing tool to ensure a successful and quality build. Nothing is more frustrating that build failures attributed to errors in the digital file. This is an area where significant time and money can be lost.

Figure 7- File fixing in preparation for 3D printing in Mimics Innovation Suite

3D Printing: How to Choose?

Insource or outsource? This is the first question you should ask. Outsourcing will allow you to minimize your upfront capital investment but is typically associated with longer lead times. Outsourcing can also be advantageous in the rapidly evolving market of 3D printers. What equipment you buy today could soon be obsolete with better and lower-cost technology being brought to market. From a purely economic standpoint, outsourcing is often the best strategy to get started.

If you decide to invest in a printer, where should you start? 3D printers come in many different technologies which all have their advantages. FDM, PolyJet, laser sintering, stereolithography, and binder jetting all have unique advantages for certain applications. Resolution, speed, materials, color and of course cost, are key factors you should consider. Leverage experts in the industry to understand what technology makes the most sense given your use case and budget.

In addition to understanding the best 3D printer for your program, you’ll also need to understand the space required to house it. Certain printing technologies take up a very small footprint while others may require dedicated facilities. Some machines require additional equipment to clean the models after printing or will have greater maintenance associated. Fully understand all of these considerations before making your choice.

Figure 8- Example of flexible 3D printed heart model (Image courtesy Materialise)

Personnel and Training

You will need specific skill sets to run an effective 3D printing service. Knowledge in imaging and anatomy/pathology is required for accurate segmentation. A level of engineering skill is needed to prepare your 3D models in the best way for printing. Additional resources may be needed to clean models and maintain machines. The scale of your operation will determine the resources needed. Start small and lay out a plan for organic growth. By starting at a small scale, it will help to build momentum with clinicians and administrators to support the activity. If you build it, they will come! Make sure to learn from and be trained by experts in the field. Master the process from image acquisition through 3D printing. This will ensure that you avoid common pitfalls and are operating in the most efficient way possible.

Figure 9- Example of multi-material 3D printed model of heart and airway anomaly (Image courtesy Materialise)

Final thought

Although 3D printing as a core service in a hospital is still in its infancy, many innovative institutions have been blazing a path. Leverage the experts both in industry and among your peers who have developed similar programs. This might mean working collaboratively on a few cases as a service or visiting other established medical 3D printing facilities. Establishing a new technology such as 3D printing can seem like an overwhelming endeavor. However, by taking into account the many considerations and requirements from the beginning, it will help you to develop a plan to start and grow a successful service for your institution.

Todd Pietila

Sr. Business Development Manager – Materialise

Todd.Pietila@materialise.com

References

Di Prima, M., Coburn, J., Hwang, D. et al. 3D Print Med (2015) 2: 1. doi:10.1186/s41205-016-0005-9

About the Author

Todd is a Senior Business Development Manager at Materialise where he specializes in delivering 3D software and 3D printing consultancy to the healthcare field. With a background in Biomedical Engineering, he has spent more than 6 years at Materialise in various engineering roles focused on applications of 3D printing in medicine.

His current position involves working directly with healthcare providers to develop and implement 3D printing solutions in clinical practice.

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3D Printing has emerged as a disruptive technology in the healthcare field. Over the past 20 years, it has been leveraged with great success to plan complex medical procedures, produce custom devices and instruments, and to better train future clinicians. As the accessibility to the technology increases, many hospitals are beginning to adopt 3D printing labs or service lines to support the growing level of interest from physicians.  By bringing the technology in house, it supports a reduction in 3D printing lead times compared to outsourcing methods, and helps to build knowledge and drive innovation within the hospital.

Equal to the tremendous potential of 3D Printing, there are also significant challenges to its widespread adoption. Reimbursement challenges, lack of robust evidence proving efficacy, and technical difficulties all contribute to this. One of the largest barriers to overcome is the technical know-how to implement a new disruptive technology in the existing clinical workflow.

So where to start when considering the implementation of a 3D printing program, large or small? What does the entirety of the 3D printing process look like in a medical center? Some questions to ask and considerations to take into account when setting out to start your own 3D printing core lab.

Departmental or Institutional?

Is your goal to support a single medical discipline with 3D Printing? Or to provide a large-scale service institution-wide? The answer to this question will determine not only the resources needed to run the lab, but also the appropriate software and hardware necessary to optimally support specific medical disciplines with 3D printed models. Understand the modeling requirements for each discipline you are seeking to serve prior to making significant investments. Your workflow will look very different if you are building models to support congenital heart surgery as opposed to bone models for complex cranio-maxillofacial reconstructions.  By increasing the scope of the lab and servicing a larger pool of clinicians, it will also help to justify the significant capital and operational costs to acquire equipment and run a quality service.  Higher volumes of model requests will result in greater economies of scale for your organization.

Figure 1- 3D printed skull defect and custom cranio-plate (Image courtesy Materialise)

Imaging Is Everything

When building patient-specific models or medical devices, great imaging is the precursor for accurate 3D models and an efficient process. CT or MRI? Contrast-enhanced or non-contrast? Each modeling application will have unique imaging requirements, so a close collaboration with your imaging departments is key. It is also important to define the appropriate protocols for imaging and to educate surgeons on the importance of this for model making. This preparation will avoid the need to re-scan a patient or to work with less than optimal imaging to create a 3D model. In general terms, it is best to acquire high resolution, both spatial and temporal, images to achieve the best 3D printing results (thin-slice, gated imaging). Lean on the expertise of your radiology colleagues to assist in optimal protocol definition or reach out to the industry experts for recommendations.

Ordering and Communication

How does a surgeon indicate when he/she would like a model to support a procedure? Do they send an email or walk to the lab to discuss in person? When does it make sense to implement a more sophisticated ordering system? There is no clear answer for this. I wouldn’t let this hinder your ability to get started. Start simple and develop close working relationships with your surgeons before building a more robust ordering system into the clinical workflow. Be prepared to handle this challenge as the operation is scaled to handle greater volumes of cases.

Software for the 3D Printing Workflow

Appropriate processing of your medical imaging data for 3D Printing is often an overlooked part of the workflow. To optimize your workflow from Dicom imaging to the 3D printer, it is best to find a single software solution that addresses each step of the workflow. This will save you time and reduce headaches and errors that can arise when linking steps between software programs licensed by different vendors. Considering that the results of your modeling will be used to supplement clinical decision-making, it is also imperative to use software tools that are cleared for medical use and have been cleared through the FDA 510k pathway. This was also referenced in a recent paper published by researchers at the FDA in May 2016. Although they determine that cleared software should be used to process the patient imaging, they state that the 3D printer is outside the scope of regulation similar to a traditional desktop laser printer (Di Prima et al, 2016).

As a general rule, start first by fully understanding the needs of the clinician for a specific use case. Will the model be used as a pre-surgical planning tool? Or for education or training? Understand the necessary anatomy and additional landmarks needed in the model in order to work most efficiently. By fully understanding the scope of the project from the beginning, it will ensure a useful model for the surgeon, save time in the segmentation/modeling process, and often lead to a faster build using less material.

Image Processing

The considerations for preparing CT, MRI, or 3D ultrasound data for 3D printing are very different from traditional image post-processing and 3D volume rendering techniques. Choose an appropriate software tool that has a strong combination of automated and manual segmentation functionality. Often the cases that will most benefit most from 3D printing are also the most complex in terms of anatomical anomalies. This can challenge even the most sophisticated segmentation algorithms, so also find a tool that enables efficient manual intervention during segmentation when necessary. In addition, it is useful to have a tool that can reconstruct and render your STL files within the software instead of a simple STL export option. This gives you the advantage of seeing and verifying what you have created prior to 3D printing.

Figure 2- Congenital heart anatomy segmented with Mimics Innovation Suite software

3D Modeling

Segmenting the medical imaging is only half of the 3D modeling battle. Often, the more determinative and labor-intensive part of the 3D printing process is the further preparation and augmentation of your segmented anatomy prior to 3D printing. This can include features such as cleaning and smoothing to remove artifacts, adding connecting geometries to hold anatomy in the proper anatomical positions, adding thickness to represent vessel walls, cutting of the model to achieve optimal visualization, and indicating color or multiple materials. The considerations are many. How you prepare the 3D model will determine how useful the print will be clinically, how much time and material will be required to build the part, and the feasibility of printing and cleaning the eventual model.  A robust toolset and a ‘design for 3D printing’ mindset must be adopted to achieve success.

For example, if your surgeon requests a model to plan a repair of facial trauma, he/she may also want to understand the optimal outcome to restore cosmetics and function. For this, it would be helpful to provide a second model of the patient’s anatomy mirrored across the midface to understand what the optimal reconstruction outcome would look like. For a complex heart procedure, the surgeon will want to understand the intricacies of the intra-cardiac anatomy or landmarks for a specific valve or vessel. This will require you to prepare the heart model with windows or cut along a split line to achieve this visualization and separate components to identify another color in the model. Each application of 3D printing will have very different 3D modeling requirements.

Figure 3- Cut-away view of heart generated with Mimics Innovation Suite 3D modeling software

About the Author
Todd is a Senior Business Development Manager at Materialise where he specializes in delivering 3D software and 3D printing consultancy to the healthcare field. With a background in Biomedical Engineering, he has spent more than 6 years at Materialise in various engineering roles focused on applications of 3D printing in medicine.
His current position involves working directly with healthcare providers to develop and implement 3D printing solutions in clinical practice.

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