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.
- Introduction: What is operational management?
- Technical Background
- Strategic Issues of 3D Printing in Hospitals
- Tactical Issues (Pending)
- Financial Issues (Pending)
- Financial Worksheet (Pending)
- Acknowledgments (Pending)
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 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.
- Clinical trials
- Organization and staffing (Which include multidisciplinary team design, and in-house/outsource discussion)
- 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:
- Informing consumers about the values of this technology.
- Preparing data for new CPT coding and other reimbursement strategies from payers.
- 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.
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)
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
|3D Printing in Hospitals||PROS||CONS|
|IN-HOUSE||1. Possibly faster|
2. Possibly cheaper
3. More accessible for experiments and innovations at the facility
4. More efficient for multi-disciplinary team communication
5. Staff may already have software experience from 3D visualization software
6. Potential to sell services to other medical centers
|1. Need space to run equipment |
2. Need staff to learn to use the software, use, clean and maintain the equipment.
3. Need special facilities for production, finishing, and cleaning.
4. Not be able to make all applications – some will still need to be outsourced.
5. Need a wide variety of machines and materials that would add complexity to the effort
|OUTSOURCE||1. No dedicated staffing, training or space requirements|
2. Less financial risk
3. Less time spent on image post processing by technologists or radiologists
4. More variety of printers and materials to choose from.
5. Vendors provide expertise.
|1.Possibly slower than in -house|
2.Possibly more expensive than in-house
3. May be more prone to error due to added steps and entities involved
4. HIPPA compliant data transfer agreement and protocol need to be followed
The following questions are common when hospitals are making the decision on creating an in-house 3D printing lab versus using outside vendors:
- What is the existing infrastructure that could be used for 3D printing in hospitals?
- What is the required turnaround time for the applications?
- What is the necessary equipment for a successful 3D printing center in the hospital?
- How much does the clinical team want to get involved in the 3D printing process?
- 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.
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.
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.
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:
- 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.
- FDA finalized its guidance on “Technical Considerations for Additively Manufactured Medical Devices”
- 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.
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:
- Mass-produced medical device products which are adapted to the specific requirements of a patient
- 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.
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, 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.
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