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.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals) on Oct 5, 2020 at 10:11pm PDT

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.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals) on Oct 9, 2020 at 10:00am PDT

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.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals) on Oct 5, 2020 at 10:12am PDT

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.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals) on Sep 27, 2020 at 6:38pm PDT

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.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals) on Sep 13, 2020 at 11:38pm PDT

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.

View this post on Instagram

A post shared by 💡Healthcare 3D Printing💡 (@3dheals) on Sep 21, 2020 at 11:32am PDT

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.

View this post on Instagram

#repost @ntopology Stochastic lattice capabilities in nTop Platform 2.0 ⚡️ like this ALIF spinal implant. . . Parametric, field-driven design allows for complete control over randomization, gradient and beam thickness ? . . . Register for our webinar tomorrow, March 31, 3020 at 2pm EST to learn how to create custom workflows for orthopaedic devices. ? Click the link in our bio to signup . . . . #paramedic #engineering #engineer #simulation #lattice #3d #3dprinting #3dmodeling #3ddesign #designtechnology #tech #biomedicalengineering #biomed #advancedmanufacturing #additivemanufacturing #3dsoftware #ntopology #ntop #geometry #implants #medical #titanium #aluminum

A post shared by ?Healthcare 3D Printing? (@3dheals) on Sep 29, 2020 at 11:58am PDT

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.

Want to write a piece for 3DHEALS Expert Corner? Email us: info@3dheals.com

Where do you see yourself in 5 to 10 years? It’s a common question asked during the interview process. The purpose of the question isn’t to obtain some clear objective answer. Rather, the purpose of the question is to assess one’s ambitions and to determine if the candidate is a career goal-oriented. Let me augment the question slightly. Where do you see your 3D printing program in 5 to 10 years?

The question may have posed a real challenge to early adopters of “point-of-care” manufacturing several years ago. However, we are now in the early stages of seeing real reimbursement for hospital-based 3D printing programs. The Category III CPT code 0559T and its modifier 0560T can be used when producing a 3D printed patient-specific model to aid in pre-operational planning. While the Category III CPT code 0561T and its modifier 0562T pertain to 3D printed patient-specific surgical guides. The implementation of these codes (as of July 2019) is a real milestone within the point-of-care manufacturing community, but there’s still much work to be done. 

For starters, Category III CPT codes are used to track the utilization of emerging technologies, services and procedures. The Category III CPT codes description does not establish a service or procedure as safe, effective or applicable to the clinical practice of medicine. While some private health insurance companies may reimburse for some portion of a 3D printing service, don’t count on Medicaid or Medicare to until the Category I CPT codes exist. A private health insurer can deny the claim of a 3D printed model for patient care on the basis that 3D printed models have not been proven effective in significantly improving the course of patient care and will be deemed not medically necessary.

So, how does the community tackle this challenge?

The Radiological Society of North America (RSNA) and the American College of Radiology (ACR) plan to initiate a new medical 3D printing clinical data registry to collect 3D printing data at the point of clinical care. A joint ACR-RSNA committee will oversee the registry intended to pilot in the fall of 2019. The ACR’s National Radiology Data Registry (NRDR) system will host the 3D printing registry. The registry will provide the quantifiable data supporting the claim that 3D printing to create anatomic models and guides has a significant positive impact on patient care such as reducing blood loss, time in the operating theatre, length of postoperative stay, readmissions; minimizing complications, increasing patient consent, and other important metrics that have long been difficult to capture and report in peer-reviewed literature.

On an individual level, say the tech, engineer, or physician running the day-to-day operations of the 3D printing program, more challenges appear. When in the process of patient imaging to 3D printing are these codes implemented? It’s becoming the popular opinion that one (or more) of these codes is charged under radiology, which makes sense, but only if, at the time of ordering the imaging (CT, MRI, or 3D ultrasound) or interpreting the images, the physician knows an anatomic model will be 3D printed. At the same time, imaging standards for 3D printing typically fit for virtual 3D reconstructions, for which there are already Centers for Medicare & Medicaid Services (CMS) reimbursement through codes 76376 and 76377. It’s important to note that 3D recon (or post-processing) codes cannot be used in conjunction with the new 3D printing codes. This clash may stem from that a virtual 3D reconstruction is one of the steps in producing an anatomic 3D printed model.

Others are under the opinion that the charge or reimbursement should reroute to the parent department of the 3D printing program. After all, not all 3D printing programs are birthed from radiology, rather some programs origins are in plastic, orthopedic, or cardiothoracic surgery. Or does the charge occur at the end-user, the operating room? One goal of these codes is to obtain some sort of standardization across hospital-based 3D printing programs. If that is the case, then having a unified answer to this question plays an important role.

Placing the code under a radiology charge may be more feasible when referencing the Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios. Published in 2018, this article from the journal 3D Printing in Medicine provides a list of many diagnoses categorized in a scoring system (1 through 9) based on the frequency of anatomic 3D printing associated with the said diagnosis. The higher the rating, the more likely an anatomic 3D printed model is considered. The rating and diagnosis can only be taken into consideration as the surgeon will have the final say. Not every Truncus Arteriosus (rating 9) will be 3D printed, but not every Ventricular Septal Defect (rating 3 to 5 depending on size and complexity) is automatically ruled out. 

In the case of an audit, or perhaps for the sake of traceability, integrating a 3D printing program’s workflow with the institution’s electronic health record. Take Epic for example. Epic Systems is one of the largest providers of health information technology, used primarily by large U.S. hospitals and health systems to access, organize, store and share electronic medical records Hospitals that use this software held medical records of 64% of patients in the U.S. and 2.5% of patients worldwide. Creating custom orders in Epic, like the workflow for 3D printing, could take weeks to months at a time with no CPT code to tie the order to. However, now a hospital can create its own customizable 3D printing workflow based on its needs. As annoying as it can be at times, I prefer to gather as much information as I can upfront with multiple physician approvals from imaging to 3D print. Data input such as expected surgical date, priority, turnaround time, anatomy, diagnosis, imaging, and accession number, and sterility capability are worthwhile collecting. Further add-ons in the workflow can include scheduling time for physician review of segmentation and the 3D computer-aided design (CAD) prior to printing, with options to record the time and date of the approvals, when the model has started and finished printing, who the model was delivered to and when. 

Where do you see your 3D printing program in 5 to 10 years? I have had to answer this question several times when developing proposals, not just for my program but for other hospitals as well. I would say the future is hopeful. More medical centers are dipping their toes in and adopting this technology every year, all of which will have data to contribute to the registry. In 2 years, we may very well have the quantifiable data needed to apply for Category I CPT codes for 3D printing anatomic models and surgical guides. Three years from now, the challenge of seeking reimbursement for the use of this technology and service may seem like a distant memory.

Ten years from now we may shift our focus to 3D printing metal, tissues/organs, and or pharmaceuticals in-house for patient care and how to get those services reimbursed.

About the Author:

Robert Wesley. 3D Printing Engineer, St. Louis Children’s Hospital, USA.

Bio: Robert is an experienced biomedical engineer, who has managed hospital-based 3D printing programs. He has acted as a consultant non-profit medical centers looking to invest in the 3D printing space in the Southwestern, Midwestern, and Southeastern regions of the United States. He works closely with research teams in designing and producing prototypes, and with clinical teams to identify anatomy, design and manufacture models, and apply quality standards to the entire process. Focused on capturing tangible cost-savings, he works with business development, finance and accounting, and with supply chain to track the utilization of these in-house centers versus outsourcing to external vendors.

Related Courses:

Introduction to 3D Printing in Hospitals by Robert Wesley

Related Articles:

3D Printing in Hospitals: Challenges and Solutions, a Children Hospital Perspective

Reimbursements for 3D Printed Anatomical Models and Surgical Guides – Decoding the CPT Codes

Pricing Strategies for 3D Printing Related Medical Devices

Healthcare 3D Printing Clinical Trials

Cardiac 3D Printing: The Heart of the Matter

3D Printing Has Come of Age But How Safe Are the Devices Going Into Our Mouth?

Idea to Implementation: Reimbursement, the Elephant in the Room

The post 3D Printing in Hospitals: The Road to Reimbursement appeared first on 3DHeals.