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Marta Kazmierowska graduated from Hunter College, the City University of New York, with a Bachelor’s degree in chemistry. After returning to Poland she pursued a Master’s degree in green chemistry at Gdansk University of Technology. During her second degree studies, she gained extensive practical knowledge about various 3DP technologies. She practiced at LITHOZ in Vienna where she worked with the lithography-based ceramic manufacturing (LCM), and in Pomeranian Science and Technology Park in Gdynia with selective laser sintering (SLS) and PolyJet technology. Right now she is a CAD/CAM supervisor and EOS M100 operator at a dental prosthesis laboratory. She is interested in all 3D printing technologies and their application in medical and non-medical fields. In her free time, she is building anatomical models from CT data.

Before I discovered 3D printing (3DP), I had several work experiences. In college, I worked as an assistant in a chemistry laboratory and in a pharmacy. I had also previously been a babysitter, a secretary and later on a teacher in an international school. Each of these jobs provided me with different and rich experiences that shaped my personality and way of thinking. However, for me, none of these experiences were truly fulfilling, truly absorbing, or my own… I felt that I was doing things that were already established by somebody else, sort of a template that I’d fill in. And I had an everlasting feeling that I need to do something innovative. I decided to quit the teaching position I had and enrolled on a master course at the Gdansk University of Technology. I quickly found a mentor and during one of our conversations she mentioned 3DP. I started researching the topic – I was mesmerized. That was it! There was one more thing that I knew right away, there is no time to waste! I need practice, practical knowledge, hands-on experience, not only dry facts from books. Through my professor, I contacted amazing people at LITHOZ in Vienna and left for a three-month practice. That experience was one in a lifetime, I gained knowledge, experience and I made true friends. When I came back to Poland, I saw that the 3DP Lab in the Pomeranian Science and Technology Park in Gdynia was opened, so I went there and asked if I could do some volunteering. I was lucky, again. The people were kind and open to share and exchange their knowledge.
The freedom, almost limitless possibilities of different 3DP techniques and the people from the field inspire and motivate me every day. I want to use and spread the power of 3DP to people’s advantage because many things can be done better, faster and generate less waste.
Therefore, I’m happy to be a CAD/CAM supervisor and EOS M100 operator working with CoCr at the dental prosthesis laboratory in Gdansk. I embarked on a mission to convince people from the dental and dental prosthesis field about advantages of the innovative CAD/CAM technologies with the focus on 3D printing.
Creation of precise, fully-functional and biocompatible metal crowns and bridges using conventional lost-wax casting methods is a laborious, multi-step, and time-consuming process, which may not always produce high-quality dental prosthesis parts. The errors can occur at early stages, during impression collection at the dentist, and build up during wax modeling, during metal casting, and during post-processing. The casting process by itself is difficult to control. As a result, the obtained part can have many irregularities, gaps, and air bubbles, which complicate and extend the post-processing step. Also, thick casting sprues, which are directly melted with the crowns, have to be cut away and the surface of a crown have to be polished.

Fig.1. 6-point bridge and one crown obtained with the conventional lost-wax casting technique. Irregular surface, air bubbles, thick and heavy sprues require laborious and time-consuming post-processing, which also generates a lot of waste.

A metal crown that is too tight, too loose or doesn’t fit on a model, is a nightmare that can happen to the most skilled and experienced dental prosthesis technician. Additionally, when producing big and multi-pontics bridges, there is a high chance that they will bend. Another disadvantage of the conventional metal casting is waste production.
Innovative CAD/CAM technologies allow to: collect precise digital impressions, and then design and produce very detailed metal crowns and bridges. The intraoral scanners are more comfortable for the patient since no goopy, short-lived impressions are needed. The entire scanning procedure happens in real-time at the dentist’s office. A doctor, in a split of a second, electronically sends obtained scans to a dental prosthesis CAD/CAM department, where specialized technicians make projects of metal crowns and bridges on the computers. The scans and projects can be stored and accessed at any time, eg. for retrospective studies, whereas most of the impressions can be only used once. The digital impressions can also be 3D printed in eg. digital light processing (DLP) technology. The 3DP models are more detailed than the gypsum models and almost no waste is generated during their production. If the dentist’s office doesn’t have an intraoral scanner, conventional impressions can be sent to our laboratory. In this case, we make our .stl projects by scanning gypsum models.
Obtained .stl project is then analyzed in additional programs, which check for errors in a digital net, orient the part and generate the support structures. Once the part and its support structures are ready, they are transferred to the EOS M100 printer which uses the direct metal laser sintering (DMLS) 3DP technology.

Fig.2. EOS M100 printer which uses the direct metal laser sintering (DMLS) 3DP technology.
M100 produces precise, high-quality, high-density metal crowns and bridges in a matter of few hours with no human interference. The parts are built in a layer-by-layer fashion, by application of a thin metal powder layer by the ceramic coater and exposition of layers by a high-intensity ytterbium laser.

Fig.3. Ytterbium laser tracing and melting the contours of support structures on a thin surface of the evenly distributed powder.
Fig.4. Metal crowns and bridges produced on an EOS M100 printer in the DMLS technology. The detail of the parts is precise due to scanners which replicate exact morphologies of patient’s teeth and due to 30µm printing layer thickness. The surface of parts is smooth and easy to finish. More than 80 metal points can be produced in a single cycle!
After the finished run, the printer is carefully cleaned. The biocompatible, medical-grade CoCr powder is screened on a sieve of a specific size and reused in next cycles. Therefore, almost no waste is produced because only the material that is needed for the part and its supports are used. The parts on a building platform are then sanded and placed in the oven. The thermal treatment in the inert Ar atmosphere gives parts final structural properties and reduces the tensions so the probability of twisting and bending is minimal. After the thermal cycle, the parts are detached from the building platform and undergo post-processing. The support structures have a form of small pins they do not go deep inside the part. Therefore, they can be easily removed with pliers by a squeezing and twisting motion. Once the supports are removed, the parts need surface polishing and quick sanding, since the surface of printed crowns and bridges is already smooth and regular.

Fig.5. A Precise, detailed and smooth surface of DMLS metal dental prosthesis parts together with tiny, easy to remove support structures.
Due to the exact and detailed image obtained with a scanner and thin printing layer (30 µm) the fitting of even the biggest 14-point bridge is almost perfect, so no laborious fitting on the model is needed. Such parts are ready to be used for eg. porcelain application. Due to the precise DMLS technology, the density of produced metal crowns and bridges reaches almost 100% so there is no gassing during the porcelain application process.

Fig.6. Building platform with CoCr crowns and bridges.
Thanks to the innovative CAD/CAM technologies we are able to produce in one cycle more than 80 metal points in a matter of few hours! And we are able to do more than four cycles a day! Therefore, this technique minimizes the errors, amount of work and waste, producing a large number of high-quality parts in less than a workday!
I speak with dentists and dental prosthesis technicians on a daily basis and try to convince them to these innovative approaches. I believe that big and small obstacles can be overcome because of a wide variety of options and solutions that are recently available on the market. Every day these solutions expand and right now are at a hand’s reach and they don’t have to be costly. Therefore, I’m motivated to speak to doctors and technicians and make small steps towards creating better future for them and their patients.

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Authors : Jenny Chen, M.D. and Adele Wang

3D printing[1] (3DP) has become a key driver in the progress of healthcare technologies in recent years. Along with other high-valued, high-complexity, one-off manufacturing such as in defense, aerospace, jewelry and automobile parts, the production of medical models, implants, prosthetics, surgical guides and even live tissue are becoming increasingly viable with the advent of 3D printing technology.
Despite the struggles experienced by public 3D printing hardware companies like 3D Systems and Stratasys, the adoption of 3DP is continuing its strong trend. Terry Wohlers, the leading 3DP industry analyst, estimated in the 2015 Wohlers Report that the additive manufacturing (AM) industry, consisting of all AM products and services worldwide, grew 25.9% YOY to $5.165 billion in 2015. The report also estimated 13% of the market[2] to be in medical, which puts the size of the healthcare 3D market at about $671M….

This white paper will provide insights on current health care 3D printing market estimation and prediction, as well as current investment strategies and patterns. 

Ms. Wang has over 10 years and $200+ million in M&A experience. Previously, Ms. Wang served as Senior Manager of Corporate Development at EFI, Inc., where she helped develop and execute the Company’s acquisition growth strategy. During her tenure, Ms. Wang successfully managed and closed numerous M&A transactions, representing over $100 million in aggregate value. Her efforts enabled EFI’s target of $1 billion revenue in 2016. As part of the Wells Fargo Corporate Development team, Ms. Wang executed strategic acquisitions of asset-backed loan portfolios and aircraft leasing JV’s, representing over $110 million in aggregate value. Prior to, Ms. Wang was part of the Wells Fargo Corporate FP&A group, focusing on forecasting, budgeting and analysis for the Wholesale Commercial Banking division. She was instrumental in the post merger integration of the Wachovia Bank acquisition, as well as in the implementation of key company-wide finance initiatives.

Jenny is trained as a neuroradiologist, founder/CEO of 3DHEALS, a company focusing on curating healthcare 3D printing ecosystem. Her main interests include medical education, 3D printing in the healthcare sector, and artificial intelligence. She is also a current adjunct clinical faculty in the radiology department at Stanford Healthcare.

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2016 was an exciting year for healthcare 3D printing. Heavy investments, mergers and acquisitions, and strategic partnerships from front-runners of the industry seem to mark the beginning of an exciting era for the industry.

Top Ten Events in 2016 in Healthcare 3D Printing

1. January 2016, Stryker Bought A 3D Printing “Farm”:

2016 started with a BAM! after Stryker announced its new 3D printing facility costing upwards 400 million dollars. Fully aware of the competitive landscape of medical implants, Stryke’s investment in 3D printing is in alignment with its innovative culture. Immediately following that, in March, Stryker received FDA clearance for its 3D printed spinal fusion device, not the first in the company’s history. Also, because of intrinsic technical advantages of 3D printing, using the technology as a production tool may also save the company money in the long run, especially in light of increasing number of FDA approved 3D printed implants.

2. January 2016, Johnson & Johnson Partners with Carbon 3D for Surgical Devices: 

What Johnson & Johnson is up to next has been the focus of 3D printing and healthcare lately, as its increasing interest in digital manufacture is becoming very clear. This can be traced back to its partnership with Organovo a few years ago, to its emphasis on personalized medicine and precision medicine. Given Carbon’s CLIP technology, a formidable collection of materials, and a strong life science division including ex-FDA experts, the partnership will prove exciting to the entire industry in the next few years.

3. March 2016, 3D System Announces State-of-Art Healthcare Technology Center:

3D System has a long history of involvement in healthcare. To date, it is still the main partner with Align Technology, serving as the best example of mass customization. After several acquisitions ranging from Medical Modeling to Simbionix, it is finally consolidating its multiple lines of products ranging from simulation tools to implants into a comprehensive design and production center for healthcare solutions.

4. April 2016, Formlabs announces its first biocompatible resin, Dental SG:

A leader in desktop SLA printing technology, Formlabs announces class 1 biocompatible resin this year. The most immediate beneficiary is the dental community, where is an increasing interesting in bringing multiple manufacture processes in-house, ranging from surgical guides, braces, to dental crowns, among others. More and more printer choices and material selection from desktop 3D printing community can not only make many existing procedures cheaper and faster but can also encourage more profession innovations in a clinician’s office.

5. April & May 2016, Stratasys, Materialise, and More Collaborate with Clinical Partners.    

In recent years, more and more medical doctors are open to 3D printing as an excellent surgical simulation tool. Many consider it more useful than existing 2D medical imaging or computational simulation in improving operational safety and outcome by providing additional visual and haptic experiences for the surgeon before the actual surgeries. However, lack of reimbursement due to insufficient clinical evidence makes a wider adoption of the technology challenging. In April, Stratasys announced its strategic partnerships with the Jacobs Institute for clinical studies and innovations. Immediately following that, another industrial giant Materialise announced its support to clinical trials and collaboration with healthcare providers during the RAPID conference. These partnerships among industrial leaders and major clinical and research institutes will undoubtedly accelerate data accumulation and innovation in the next few years.

6. May 2016, FDA Issues Long-Awaited 3D-Printing Guidance for Medical Devices:

This news is probably the most important announcement to the field of healthcare 3D printing, no matter what part of the ecosystem you belong to. Readers can also find the latest updates on the FDA website. The guideline in many ways will dictate the direction of future innovations and business strategies.

7. May 2016, HP Delivers First Ready-To-Print 3D Printing System, Collaborates with Materialise, Siemens, Autodesk for software:

HP Jet Fusion 3D printing technology claims to be up to 10x faster, and more than half cost reduction. Speed and cost are two very critical (and sometimes life-saving) factors in healthcare products, especially if production rather than prototyping is the end goal. Additionally, open software and material platform will significantly accelerate the potential of innovative use in the healthcare since high costs in these areas have been prohibitive in the past.

8. September 2016, GE’s Billion Dollar Purchases:

This year, General Electric bought itself two expensive early Christmas gifts, two large metal 3D printing companies, Arcam AB and SLM Solution Group. Both companies have a long history of products in both aerospace and healthcare verticals. GE itself has an extensive healthcare portfolio. Having these two companies will not only lower costs from in-house innovation cycle and production, but it will also add implant and medical device market share for GE.

9.    November 2016: Terarecon and Whiteclouds Partnership for Healthcare Solutions:

During a global radiology meeting in November (RSNA), the two companies announced their partnership to provide enterprise level one-button solution to create 3D printing simulation models for doctors. This is the first-of-its-kind collaboration between a 3D printing service bureau and a medical software company, signifying the value medical providers place on a more streamlined digital workflow.

10.  December 2016, Organovo launches a second commercial product:

Last but not the least, Organovo Inc. ended the year with an uplifting announcement that it will start the second commercial product focusing on kidney tissue. This is a natural extension of the company’s existing liver tissue product. Although total organ production remains in the realm of “Westworld,” advancements in commercial bioprinting and tissue engineering now, allow for a much shorter pharmaceutical R&D cycle, reducing costs and avoiding tough ethical questions raised in animal testing. The additional unspoken benefit of IP protection by keeping drug development in-house will also manifest itself as globalization increases in drug development.

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Based on our recent publication (A Roadmap from Idea to Implementation – 3D Printing for Pre-Surgical Applications) we will publish a series of shorter blogs based on the topics presented in the book to share the essential elements of the book to the public. Our goal of writing this book and these blogs is to attract like-minded folks to 3DHEALS, a community that is dedicated to fostering health care 3D printing ecosystem and encouraging more conversations among innovators from different disciplines.

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While 3D printing is a 30-year-old technology, its applications are believed to be still at infancy stage. Expiring patents, lower cost printers, more materials, improved healthcare specific software allow for more players to get involved and identify new opportunities in healthcare vertical. Although still a small percentage of total manufacture market share, the tremendous potential of healthcare 3D printing is undeniable in the overnight transformations of the orthodontics (i.e. Invisalign) and hearing aid industry. It is expected that this field will grow exponentially in the near future.
However, being inspired by the vibrant startup culture of the Silicon Valley and San Francisco, we had this not-so-crazy idea that we should bring the technologists and healthcare providers under one roof to create meaningful healthcare products for the humanity with this powerful new tool, which some consider comparable to the internet and the computer industry. Therefore, we created 3DHEALS about two years ago to achieve that goal. Since our inception, we have successfully created five eventsin SF, drawing attention from various sectors ranging from the healthcare providers, innovators, to regulatory/legal experts, healthcare systems, and more. It made us realize that it takes a village to make revolution happen, and that many challenges can only be overcome by a well-organized ecosystem.
We are hoping that by organizing the 2017 global event, 3DHEALS will contribute to fostering this burgeoning yet still fragile ecosystem.
We welcome everyone who is actively engaged or simply interested in the application of 3D printing (a.k.a. additive manufacturing) technology in healthcare sector to join this new global community. This includes, but not limited to, healthcare professionals, professional societies, entrepreneurs, developers, investors, designers, legal experts and regulators.
We are welcoming an audience interested in the medical and dental application of 3D printing technologies, bioprinting, those interested in the regulatory and legal issues related to digital manufacturing, among others.
3DHEALS2017

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Raise your hand if you have seen Elon Musk’s recent presentation on Mars expedition and eventual colonization. If not, I highly recommend watching it.
I was very skeptical when I first heard about his plan.
Actually, I was a little enraged. With all the problems and sufferings we have on Earth, why bother tackling a problem so remote and so fantastic? What is so meaningful about that?
After watching Elon’s presentation, however, I had a change of heart. It was quite inspiring.
While I don’t think Elon’s plan for Mars is comprehensive enough to be successful (and safe) yet, I echo his starting point for taking on this ambitious task. ( Part 2 of this blog will explore how 3D printing and bio-printing could make the trip safer.)
“Why go anywhere?” Elon asked. This is not necessarily a rhetoric question, because to some (myself included), the answer may not be all that clear.
The true motivation behind expedition is often beyond personal gain and curiosity. There is a deeper kind of driving force. It is the driving force that inspired our ancestors to invent tools and to discover fire millions of years ago. It is the driving force that enabled us to land the moon and to discovered nuclear power. We have this driving force because that is who we are, and that is what gives humanity meaning. It is a force that comes from our deepest desire to survive for as long and as much as possible as a species.
I see similar driving force propelling the healthcare 3D printing industry forward despite uncertainties, challenges, and criticisms. I feel privileged and encouraged to be able to observe and facilitate the birth of an impactful ecosystem that is slowly forming around us.
 
 

The post From Mars Expedition to Healthcare 3D Printing – Pondering after Elon Musk’s Presentation on Sept 27th, 2016 Part 1: “Why go anywhere?” appeared first on 3DHeals.

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Although cyber threats are nothing new to the healthcare industry, the rise of 3D printing in the medical industry presents unique cybersecurity challenges for medical device manufacturers and hospitals.  In July 2016, researchers at the New York University (NYU) Tandon School of Engineering found that 3D printing poses cybersecurity risks in the manufacturing process that could affect the reliability of the end product.  The study found that a hacker could potentially alter the printer head orientation without detection, affecting the strength of the device by as much as 25 percent.  Alternatively, a hacker could manipulate a 3D printer while it is connected to the internet to introduce internal defects as the device is being printed.

Although 3D printing offers many manufacturing benefits by making it possible to print customized devices on demand offering better fit and greater comfort for patients, the digital transmission of design files makes it more challenging to ensure sensitive confidential patient information is protected.  Confidential patient information contained within patient imaging  (e.g., computed tomography (CT) or magnetic resonance (MR) imaging) is vulnerable to being compromised or stolen in the digital transmission process.  Mishandling HIPAA-protected information carries heavy penalties and has resulted in more than $9 million in fines in 2016, according to the U.S. Department of Health & Human Services.

The FDA has acknowledged the need for effective cybersecurity measures to ensure the safety and efficacy of medical devices and protect patient health.   In October 2014, the FDA issued a guidance entitled Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The guidance, although not specific to 3D printed devices, sets forth recommendations for manufacturers to develop cybersecurity controls during the design and development stages of a medical device as well as in preparing FDA premarket submissions for software and devices using software.  The FDA urges manufacturers to establish a cybersecurity vulnerability and management approach as part of the software validation and risk analysis required by 21 C.F.R. part 820.30(g) governing design validation.  The FDA also recommends that device manufacturers adopt security measures to protect medical devices including, but not limited to, limiting access to devices to trusted users only and ensuring trusted content.

While the FDA recommends the use of design controls to assure medical devices will maintain their integrity from the point of origin to the point at which the device leaves the control of the manufacturer, 3D printing raises the question, “When is a device considered to have a left a manufacturer’s control?”  Unlike traditionally-manufactured medical devices that get physically shipped, 3D printed medical devices are sent electronically in the form of a CAD file from the manufacturer often to a service bureau to print off-site.  Has the device left the manufacturer’s control after the CAD file was sent?  After the medical device is 3D printed?   The law is unsettled on these issues.

The FDA has also addressed the postmarket management of cybersecurity issues in medical devices.  In January 2016, the FDA released a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices, which sets forth the FDA’s post-market recommendations.  The FDA encourages manufacturers to monitor, identify, and address cybersecurity vulnerabilities as part of their postmarket management of medical devices and sets forth elements of an effective postmarket cybersecurity program.  The program includes defining the risk acceptance criteria of a device; identifying cybersecurity signals and creating a process for intake and handling of vulnerability information; conducting cybersecurity risk analyses; and implementing device-based features to mitigate the risks on a device’s functionality.

In May 2016, the FDA issued a draft guidance regarding 3D printed devices for the first time.  The guidance entitled Technical Considerations for Additive Manufactured Devices addressed technical considerations associated with the design, manufacturing, and device testing of 3D printed devices.  Although not addressing cybersecurity, the FDA acknowledged patient safety risks associated with the file format conversion process.  Because additive manufacturing requires files to be compatible across the various software applications that are used, the file formats must be converted to ensure compatibility and this process creates a risk of errors that can negatively affect the shape and dimensions of the finished device.  The FDA explained that “patient-matched devices that follow the patient anatomy precisely are especially vulnerable” to errors in the file conversion process because “anatomic curves are typically geometrically or mathematically complex and can create difficulties when calculating conversions.”  The FDA recommends that manufacturers “test all file conversion steps with simulated worse-case scenarios to ensure expected performance, especially for patient-matched devices” and maintain and archive final device files in standardized formats that are able to house additive manufacturing information.

It remains to be seen whether the FDA will issue a guidance regarding cybersecurity considerations specific to 3D printed devices.  However, device manufacturers and hospitals should regularly conduct cybersecurity risk assessments in conjunction with their Information Technology, risk management, and legal departments under the protection of applicable legal privileges to minimize exposure to regulatory or legal action.

Farah Tabibkhoei is a member of the Complex Litigation Group at Reed Smith LLP.  Her practice focuses on medical device product liability, managed care disputes, and 3D printing.  Farah can be reached at FTabibkhoei@ReedSmith.com.

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3D Printed Orthopedic Implants in China and the Challenges in Commercialization

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Infographics: Legal Landscape of Healthcare 3D Printing Innovations

Healthcare industry is notoriously highly regulated. The legal issues surrounding healthcare 3D printing technologies are not only complex but often completely unknown to both the scientific and the entrepreneur communities. As the healthcare 3D printing community grows exponentially, even the legal experts themselves are sometimes struggling to keep up with new problems facing with the rapidly growing field and innovations. Come and join us at 3DHEALS August event focusing on some of the most interesting legal topics surrounding healthcare 3D Printing.

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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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