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3D Printing in Hospitals (Guide): Acknowledgement, References

November 27, 2020 | 1 Comment

In 2016, when I co-authored the first edition of ” A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery“, 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 book as a regularly updated online version of 3DHEALS Guide in five digestible parts, focusing on and adding new information from field experts from all over the world to provide a foundation to any early adapters.

The first time I learned about 3D printing (a.k.a. additive manufacturing ) for pre-surgical planning was in 2012 during RSNA (Radiological Society of North America) in Chicago. As a small box containing pieces of a 3D-printed heart from a pediatric patient was passed around the conference room, I could tell that the room stopped breathing. For me, it was a sensational moment as a radiologist and as a healthcare provider. Having a patient’s disease in three-dimension in my hands was unimaginable. I immediately wanted to learn more about the technology and how I, as a radiologist, could use it to help my clinical colleagues. However, to me, the road to implementation was not simple and almost obscure.  The barrier to entry for such technology seems to require one to be a combination of a designer, a mechanical engineer, and a software developer, and lastly a healthcare provider. 

Not giving up, I started organizing meetings focusing on learning and discussing healthcare 3D printing solutions in San Francisco called 3DHEALS, hoping to create a community composed of various disciplines to start to have more practical conversations to accelerate the adaptation of the technology.

Michelle and I met at an after-work healthcare technology conference, and we instantly hit it off because of our complementary knowledge and interest in healthcare, operational management, 3D printing, and engineering. We are both fascinated with the complex process of integrating promising technologies into healthcare. On top of that, Michelle’s background in both operations management and material science and engineering, and mine in medicine and education add unique perspectives to this book. 

That said, we both are fully aware of our limitations in various aspects of the subject of 3D printed surgical planning and do not proclaim to be field experts. This post serves as part 7 of this Guide series to thank individuals and companies for their insights and relationship with us and publication reference. Since our Guides are regularly updated and our conversations with our ecosystem never stop, this page will be updated whenever our guides are updated when appropriate.

Now On Demand:

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

Acknowledgements: 

We would like to give special thanks and acknowledgment to the following individuals: 

  • Dr. Parit Patel (Assistant professor of plastic and reconstructive surgery at Loyola Medicine)
  • Dr. Elliot Brown (Assistant professor of radiology and biomedical imaging at Yale University)
  • Dr. Jose Morey (Medical scientist with IBM Watson project, adjunct professor of radiology and biomedical imaging at the University of Virginia)
  • Mr. Glen Jett from Sutter Health for providing valuable financial insights.
  • Dr. Justin Ryan (Arizona State University Post-Doctoral Researcher, Phoenix Children’s Hospital Research Scientist) for providing valuable feedbacks and research on 3D printing for pediatric congenital heart cases.
  • Dr. Justin Ryan
  • Mr. Shannon Walter (Stanford School of Medicine, Manager of 3D and Quantitative Imaging Laboratory)
  • Mr. Chris Letrong (Stanford School of Medicine, 3D Technologist)
  • Dr. Ben Taragin (Children Hospital at Montefiore, Director of Pediatric Radiology)
  • Dr. Joaquim M. Farinhas (Neuroradiology, Montefiore Medical Center)
  • Materialse Inc. 
  • Whitecloud Inc. 
  • Stanford School of Medicine

References:

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  2. Chen HJ, Gabriel M. Healthcare 3D printing in academia. 3D https://3dheals.com/healthcare-3d-printing-in-academia/. Published October 1, 2015.
  3. Friedman T, Michalski M, Goodman TR, Elliot Brown. 3D printing from diagnostic images: a radiologist’s primer with an emphasis on musculoskeletal imaging—putting the 3D printing of pathology into the hands of every physician. Skeletal Radiology, 1–15. http://doi.org/10.1007/s00256-015-2282-6. Published November 23, 2015.
  4. Koleilat I, Jaeggli M, Ewing JA, et al. Interobserver variability in physician-modified endograft planning by comparison with a three-dimensional printed aortic model. Journal of Vascular Surgery, 1–8. http://doi.org/10.1016/j.jvs.2015.09.044. Published June 17, 2015.
  5. Vaquerizo B, Theriault-Lauzier P, Piazza N. Percutaneous Transcatheter Mitral Valve Replacement: Patient-specific Three-dimensional Computer-based Heart Model and Prototyping. Revista Española De Cardiología (English Edition), 1–9. http://doi.org/10.1016/j.rec.2015.08.005.
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  7. Cai T, Rybicki FJ, Giannopoulos AA, et al. The residual STL volume as a metric to evaluate accuracy and reproducibility of anatomic models for 3D printing: application in the validation of 3D-printable models of maxillofacial bone from reduced radiation dose CT images. 3D Printing in Medicine, 1–9. http://doi.org/10.1186/s41205-015-0003-3.
  8. Rybicki FJ. 3D Printing in Medicine: an introductory message from the Editor-in-Chief. 3D Printing in Medicine, 1–1. http://doi.org/10.1186/s41205-015-0001-5.
  9. VanKoevering KK, Morrison RJ, Prabhu SP, et al. Antenatal Three-Dimensional Printing of Aberrant Facial Anatomy. Pediatrics, 136(5), e1382–e1385. http://doi.org/10.1542/peds.2015-1062.
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  19. Mazzoni S, Bianchi A, Schiariti G, et al. Computer-Aided Design and Computer-Aided Manufacturing Cutting Guides and Customized Titanium Plates Are Useful in Upper Maxilla Waferless Repositioning. Journal of Oral Maxillofacial Surgery. 2015:73(4), 701–707. http://doi.org/10.1016/j.joms.2014.10.028.
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  24. Watson RA. A low-cost surgical application of additive fabrication. Journal of Surgical Education. 2014:71(1), 14–17. http://doi.org/10.1016/j.jsurg.2013.10.012.
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  26. Wong KC, Kumta SM, Geel NV, et al. One-step reconstruction with a 3D-printed, biomechanically evaluated custom implant after complex pelvic tumor resection. Computer Aided Surgery: Official Journal of the International Society for Computer Aided Surgery. 2015:20(1), 14–23. http://doi.org/10.3109/10929088.2015.1076039.
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  28. Peasah SK, McKay NL, Harman JS, et al. Medicare non-payment of hospital-acquired infections: infection rates three years post implementation. Medicaid & Medicare Research Review. 2013:3(3). https://www.cms.gov/mmrr/Downloads/MMRR2013_003_03_a08.pdf.
  29. Willis DR. How to decide whether to buy new medical equipment. American Academy of Family Physicians. 2004. http://www.aafp.org/fpm/2004/0300/p53.html.
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  31. Small T, Krebs V, Molloy R, et al. Comparison of acetabular shell position using patient specific instruments vs. standard surgical instruments: a randomized clinical trial. The Journal of Arthroplasty. 2014:29(5): 1030–1037. http://dx.doi.org/10.1016/j.arth.2013.10.006.
  32. Frakes DH, Ryan JR, Almefty KK, et al. Cerebral aneurysm clipping surgery simulation using patient-specific 3d printing and silicone casting. World Neurosurgery. 2016:88,175-181. http://www.worldneurosurgery.org/article/S1878-8750(16)00112-1/abstract.
  33. Sher D. New study confirms 3d printing market to grow to $17 billion by 2020. 3D Printing Industry. 2015. http://3dprintingindustry.com/2015/08/24/new-study-confirms-3d-printing-market-grow-17-billion-2020/.
  34. Zaleski A. Here’s why 2016 could be 3D printing’s breakout year. Fortune. 2015. http://fortune.com/2015/12/30/2016-consumer-3d-printing/.
  35. Sher D. Many 3d printing patents are expiring soon: heres a round up & overview of them. 3D Printing Industry. 2015. http://3dprintingindustry.com/2013/12/29/many-3d-printing-patents-expiring-soon-heres-round-overview/.
  36. Earls A, and Baya V. The road ahead for 3-D printers. PwC. 2014. http://www.pwc.com/us/en/technology-forecast/2014/3d-printing/features/future-3d-printing.html.
  37. After explosion, US Department of Labor’s OSHA cites 3-D printing firm for exposing workers to combustible metal powder, electrical hazards: Powderpart Inc. faces $64,400 in penalties. S. Department of Labor: Occupational Safety & Health Administration. 2014. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=NEWS_RELEASES&p_id=26019.
  38. Azimi P, Zhao D, Pouzet C, et al. Emissions of ultrafine particles and volatile organic compounds from commercially available desktop three-dimensional printers with multiple filaments. ACS Publication. 2016. http://pubs.acs.org/doi/full/10.1021/acs.est.5b04983.
  39. 3d printing safety. Carnegie Mellon University. http://www.cmu.edu/ehs/fact-sheets/3D-Printing-Safety.pdf.
  40. Columbus L. 2015 roundup of 3d printing market forecasts and estimates. Forbes. 2015. http://www.forbes.com/sites/louiscolumbus/2015/03/31/2015-roundup-of-3d-printing-market-forecasts-and-estimates/.
  41. We cant wait: Obama administration announces new public-private partnership to support consortium of businesses, universities, and community colleges from Ohio, West Virginia and Pennsylvania co-invest with federal government in a manufacturing innovation institute. The White House. 2012. https://www.whitehouse.gov/the-press-office/2012/08/16/we-can-t-wait-obama-administration-announces-new-public-private-partners.
  42. Standard Terminology for Additive Manufacturing – General Principles-Terminology (ASTM) ISO/ASTM 52900:2015(E)
  43. Gross BC, Erkal JL, Lockwood SY, et al. Evaluation of 3d printing and its potential impact on Biotechnology and the chemical sciences. Analytical Chemistry. 2014:86, 3240-3253. http://pubs.acs.org/doi/ipdf/10.1021/ac403397r.
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  50. Ejaz F, Ryan J, Henriksen M1, David Frakes, et al. Color-coded patient-specific physical models of congenital heart disease. Rapid Prototyping Journal. 2013. http://ipalab.fulton.asu.edu/wp-content/JournalPubs/RPJ_2013.pdf.
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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.

Interview with Oventus CEO Dr. Christopher Hart

January 5, 2017 | 0 Comments

Oventus logo - high res close (2)O2Vent t DL Lower
J: Hi! Chris, thanks for taking some time with the 3DHEALS audience for this interview. Can you tell us a little about yourself?
C: I am a dentist by trade with a few qualifications including a bachelor of Dental Science with honours and a bachelor of science in biochemistry and physiology from the University of Queensland as well as an M.Phil. by research in Biomedical Science from Cambridge University. I have been in clinical practice since 1998 and since then built a national network of dental clinics within Australia which I sold to private equity investors in 2013. In clinical practice I developed a special interest in craniofacial pain, reconstructive dentistry and sleep dentistry. In terms of the latter I am a severe apneic myself also suffering from Nasal Obstruction. Within my patient population I recognized that approximately half of my patients also suffered from increased nasal congestion as evidenced by them being obligate mouth breathers or oro-nasal breathers. I recognized that airway issues were a major issue for patients developmentally in terms of development of malocclusion and also in adults in terms of obstructive sleep apnea. I also recognized that a failure to address these issues in the patient population meant that the long term oral health of my patients and the success rates of the dentistry I was performing was at risk.
 
J: Have you always been a very creative/innovative person?
C: I think whenever I didn’t have an answer I would go looking for one and if one was not available I would always try to solve the problem with lateral thinking. A lot of innovation is common sense that is not contained by conventional thinking or dogma.
 
J: Tell us about the story behind the inception of Oventus?
C: Out of my own personal desperation, having failed CPAP treatment and having difficulty using oral appliances due to my nasal obstruction, I fashioned an airway out of some flexible saliva ejector tubes in an attempt to get air to the back of my throat unimpeded. This worked for me and was in fact the first O2Vent device. I then started making a similar device out of plastic for my patients which was working for them but was very labour intensive and resulted in a very bulky device with limited space available for the airway so while it was working reasonably well for patients it was not commercially viable as a treatment. The incorporation of CAD design and 3D printing in titanium was a game changer and addressed these issues with an airway that was five times bigger (the same as a healthy human nose in fact) much lighter weight (30 grams) and much smaller in size (60% smaller).
oven210316-27
J: What are some of the tipping points of the Oventus story?
C: The first major tipping point was when I met the current CEO Neil Anderson and he then introduced the concept to the CSIRO (Australia’s peak research body) and kicked off a project to start designing the devices with CAD software and then 3D printing them in titanium. From then we developed a device that was on the market in about a year. This was the product development tipping point.
Shortly after that we reached another tipping point where as a result of one press release we had several thousand patients register on line for the device in a matter of weeks. We could only make about 1000 devices so this was the business tipping point and the catalyst to take in some investor funds to scale up manufacturing further develop the product pipeline.
 
J: Are the regulatory entities in Australia/US challenging to understand and comply with? What are you experiences with these areas?
C: They are both different but there are clear guidelines as to what is required to comply. In many ways the US system is easier to comply with as there is more structure. In both cases it has been very important to engage advisors that understand the landscape and how to navigate through it. For our first device the O2Vent Mono there were predicate devices for a 510K FDA application and for our second Device, the O2Vent T, we are able to use our own device as the predicate. This process was relatively straight forward and there are also existing reimbursement codes for oral appliance therapy for the treatment of OSA. As our clinical evidence builds, our unique technologies and resulting products could in the future lead to their own reimbursement codes. These could be as a result of the airway being used in the treatment of nasal obstructers or connecting the airway to CPAP machines for lower and more comfortable positive air pressure.
 
J: What/who inspired you to use 3D printing technology to prototype, and then to manufacture Oventus device?
C: The bulk of the handmade device and the cost and time to make these devices by hand meant that it was not commercially viable. The devices are also custom made bespoke for each patient and contains within it a complex hollow three-dimensional structure that could not be milled, cast or moulded so 3D printing was the only viable manufacturing process. The ability to custom design a large number of devices with complex hollow three dimensional airways and print them simultaneously made the device manufacture scalable and commercially viable.
Adjustment key in device 1
J: What are the most significant differences between making your device with 3D printing and traditional manufacture?
C: Time, cost, weight, size, effectiveness, scalability and commercial viability. The handmade device took about 18 hours to make one, it was more than twice the size, three times the weight and the airway was only one fifth the size.
 
J: Why is 3D printing necessary, in creating the bilateral airway to the back of throat ?
C: Any time a complex hollow custom three-dimensional structure is required it can only be made by additive manufacturing. Doing this by hand is not viable so 3D printing is the only viable option.
 
J: What do you think can be improved in terms of 3D printing technology that would enable Oventus to continue to improve?
C: At the moment 3D printed titanium products need to be polished. We are finalising a mechanical polishing solution at the moment which will be a huge benefit but a finer quality finish on the printed surface would be a break through particularly when considering finishing internal surfaces. In terms of 3D printing of plastics there is a need for commercial size open-source machines to allow the opening up of development of new materials. Large companies that limit the use of materials to the ones they supply are inhibiting the growth of the 3D printing field. Across all types of 3D printing we need more speed at lower cost. I think it is similar to the early days of computing.
 
J: What are your biggest challenges in using 3D printing technology? How did you overcome these?
C: We were really pioneers in this field so there were many challenges, for example there was no scalable software to design our devices, we needed to validate the accuracy of the build as well, we needed to develop finishing techniques, we needed to test for adherence to different polymers for the tooth engagement, we needed to find out what the tolerances were in terms of wall thickness and build quality and many more. Some of these issues we solved internally with good old fashioned lateral thinking and problem solving but many of these challenges were solved through collaboration with other groups that had specialised skills in each of these areas and then managing those collaborations to a commercial end point.
 
J: What are your biggest challenges in making Oventus successful? How did you overcome these?
C: Oventus is a paradigm shift in the treatment of OSA. Like many new technologies the initial response to a new concept from the incumbents can be scepticism and doubt. Often the response can also be particularly aggressive. I think the Oventus technology is quite elegant in its simplicity and so we have certainly been the recipient of some aggressive actions taken by incumbents that failed to develop something similar. We take this as a compliment. Flowing from this the two most common questions we encounter are “How can it work if it is so simple?” and “Why didn’t someone else think of it?” We could take that as an insult but what it really means is that we have to communicate more clearly as to how it works and why it was developed. So the answer is continuing to build clinical evidence and the communication of this. As Oventus builds its product pipeline on the patented 3D printed airway platform it will become more apparent that this is a unique solution for which there is a clear indication, a massive unmet clinical need, a growing body of evidence and over time this will convert to an acceptance that it is a new paradigm and a standard of care for the treatment of OSA either on its own or incorporated into complimentary technology.
 
J: What makes 3D printing technology particularly interesting to you?
C: 3D printing is the only way to manufacture the Oventus devices so that is of particular interest. Over and above that it opens up a whole host of different opportunities the scale of which we are not yet grasping. The applications in the dental field alone are extraordinary. If I could work on a dozen businesses at once I might develop some more applications myself but I think I will need to leave that to others. It has massive benefits in terms of the provision of health care but the wider applications are just as exciting.
 
J: What do you think are the biggest barrier(s) in scaling 3D printing in dentistry? And in healthcare at large?
C: I think the biggest barriers are the regulatory and reimbursement hurdles, the cost of the equipment, print speed and quality of the surface finish. The technology related issues are either in the process of being solved for, or are on the cusp of a solution. We are certainly focussing on some of these ourselves. In terms of regulatory and reimbursement we are lucky at Oventus in that we are a class II device so the regulatory hurdles are not so profound (compared to say a class III implantable) and there are existing reimbursement codes for some of our technology. The early adopters will no doubt pave the way for others in terms of these issues. The cost of the equipment will undoubtedly come down over time. The printers are in effect big computers. The rate limiting step will likely be validation of the cheaper emerging technologies but this will only hold the tide back for a short while.
 
J: What is your forecast of the 3D printing industry in dentistry? And in general in healthcare?
C: The big opportunity will be in the manufacture of complex hollow three dimensional structures and serial customization combined with the fact that additive manufacturing is low cost in terms of input costs and can be considered green manufacturing in many ways. I think the applications are huge and we really don’t know right now how far that will go. In combination with 3D imagining technology, CAD design and the development of different media (e.g. cell scaffolds and tissue cloning etc.) I think anything is possible.
 
J: What would you tell the next generation of entrepreneurs in dental and healthcare 3D printing about being innovative and building companies?
C: Three things:

  1. Think outside the box and back yourself.
  2. If someone tells you something cannot be done it is not that “it” cannot be done but just that the person telling you that can’t do it.
  3. Make sure you believe in what you are doing because when the going gets tough it is a lot easier to keep going if you believe in it.

 
J: What is your ultimate vision about Oventus? 3D printing in dentistry?
C: For Oventus I think we are just starting to scratch the surface of what 3D printing has allowed us to do. It has given us access to the oropharynx to allow unrestricted breathing, deliver oxygen and air pressure, to monitor efficacy and compliance and to gather information on what is happening in this part of the anatomy. The applications for this airway technology are not just in OSA but also in the fields of sports, orthodontics, anaesthetics, therapeutics and diagnostics. In terms of 3D printing in dentistry the applications certainly in terms of implant surgery and bone regeneration will be profound. There will also be a plethora of applications in prosthodontics, orthodontics and oral maxillofacial surgery to name a few.
 
Chris crop (Small) - Copy

As Clinical Director of Oventus, Dr Chris Hart is overseeing the launch of the O2Vent to patients and through clinicians. Prior to establishing Oventus, Chris owned and managed a multi-site national dental practice, training institute and management consultancy which he recently sold to private equity investors. He now works full time as the Oventus Clinical Director and sits on the Oventus Board as founder and major shareholder.
Chris also acts as an adviser to various bodies within the dental industry as well as the health care sector more broadly on the commercial aspects of health care delivery.

 

Book: A Roadmap from Idea to Implementation – 3D Printing for Pre-Surgical Applications

November 28, 2016 | 0 Comments

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3D Printing for Surgical Applications
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.

Product Liability : Biocompatible Materials in 3D Printed Products

November 27, 2016 | 1 Comment

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As companies continue to innovate, they are turning to 3D printing technology to build customized, patient-matched 3D printed dental and medical devices that incorporate biocompatible materials. Advances in 3D printing technology have made it possible to print human tissue using a combination of stem cells and biocompatible materials. Researchers are working on using 3D printing technology to print organs suitable for transplantation, with the goal of alleviating the shortage of donor organs and saving lives. Earlier this year, Vertex Dental, based in the Netherlands, developed the first CE Class IIa-certified materials, which are biocompatible, and approved for 3D printing dental applications such as dental splints, crowns, and bridges.
Biocompatible materials are not without risks. On June 16, 2016, the FDA issued a FDA Guidance entitled “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’” to assist manufacturers of devices that come into contact with the human body in evaluating the potential for an adverse biological response resulting from contact of component materials of the device with the body.
For suppliers of these component materials that are shipped to manufacturers to be integrated into end products used by patients, this raises the question of whether a component part supplier may be liable for injuries caused by defects in the end products. In other words, if a 3D printed device that comes into contact with a patient’s body causes an adverse reaction, can the supplier of the biocompatible material be held liable for defects in the finished product that incorporates the material?
In a decision published in May 2016, Webb v. Electric Co., 63 Cal. 4th 167 (2016), the California Supreme Court explained that suppliers of component parts are not liable for injuries caused by a finished product unless (1) the component itself was defective and caused injury or (2) the supplier participated in integrating the component into a product and the integration caused the product to become defect and cause injury. The reasoning is that while component suppliers must adequately warn buyers (e.g., manufacturers integrating the components into end products) of risks associated with the component, it is not reasonable to expect them to monitor all of the potential products that may incorporate their component part and all the potential risks associated with these finished products.
Legal Issues of Healthcare 3D printing
Furthermore, under the bulk supplier doctrine, where a raw material that is a component of a finished product, is supplied in bulk and intended for further processing (e.g., heating, cooling, etc.), the raw materials supplier is not liable for harm caused by the defective design of a finished product. The rationale is that it would be overly burdensome to require raw materials suppliers to become experts on all of the end products in which the raw materials may be used and investigate the use of these materials by manufacturers over whom these suppliers do not exert control.
To mitigates risks of liability, materials suppliers should provide adequate warnings of the inherent risks associated with these component materials to the immediate purchaser of these products and take reasonable measures to ensure that appropriate warnings will be conveyed to those encountering these materials. Suppliers should also disclaim warranties about the suitability of the materials for use in end products. Additionally, suppliers should notify manufacturers that they are responsible for determining the suitability of the component materials for the devices they are manufacturing.

About the Author :

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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.

3D Printing at the US Dept of Veterans Affairs: Boundless Opportunity to Innovate Veterans Healthcare

October 28, 2016 | 0 Comments

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At the US Dept of Veterans Affairs (VA), there is a small but growing group of clinicians seeking to incorporate 3D printing and the larger arena of digital design and fabrication into clinical care. As the largest integrated healthcare provider in the US, the VA operates over 150 hospitals and almost 1,000 outpatient clinics in every corner of the US, serving about 9 million Veterans a year. Over the past couple years, the most comprehensive list of digital fabrication resources currently owned by the VA has been compiled and it includes about 20 3D printers and associated design software and 3D scanners. This capacity is augmented by 3D printing service bureaus if the needed technology is not already in-house. Recently a multidisciplinary Digital Fabrication Application Leadership Team was created which includes members from radiology, rehabilitation medicine, prosthetics, biomedical engineering and research. Our main goal is to educate VA staff about the current and potential uses for 3D printing in healthcare to encourage its wider adoption across the VA. More liberal funding of medical devices and allowances for creating custom solutions for Veterans give the VA a unique opportunity to become a national leader in the integration of 3D printing throughout a wide variety of healthcare services.

Here are 2 quick clinical use case examples. This first example comes from my time in the Assistive Technology Program at the McGuire VA hospital in Richmond, VA. I was working with a Veteran with quadriplegia on mounting his Galaxy Note smartphone to his wheelchair in a position that allowed him to fully control the phone. He wanted to be able to change the phone orientation from vertical to horizontal depending on which app he was using. The original design of the mount product we were using involved turning a knob to change the orientation which he could not manage. I designed the red 3D printed add-on to remove the knob and allow the phone to “click” into a vertical position with the integrated spring and be held horizontal by a physical stop.
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The second example comes from Dr. Beth Ripley a radiologist at the Seattle, WA Veterans hospital. She is using 3D printing to enhance the care of Veterans by improving understanding of complex patient anatomy. As medicine continues to advance, there are more and more minimally invasive treatment strategies for diseases such as cancer (renal tumor 3D printed model) and heart failure. This means surgical incisions are smaller, portions of vital organs are increasingly spared and patients recover faster. Medical imaging coupled with 3D printing can play a role in planning for these procedures by allowing physicians the opportunity to see and interact with patient anatomy before a patient goes to the operating room. Our hope is that 3D printing will speed treatment and recovery of Veterans.

About the Author : 

Benjamin Salatin
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“As a Clinical Rehabilitation Engineer, I serve as the technology expert on multidisciplinary rehabilitation therapy teams throughout the complete service delivery process for a wide variety of Assistive Technology (AT). I possess a broad range of experience that includes program development, performing clinical studies, creating prototype AT devices, scientific publishing and presenting about AT.
During my 5 yrs at the McGuire Veterans Hospital’s Assistive Technology Center in Richmond, VA I pioneered the use of digital fabrication within the rehab clinic setting to collaboratively design and build custom assistive technology with Veterans and their therapists. I have now become the leading advocate for digital fabrication within the US Dept of Veterans Affairs, seeking to see it incorporated across the entire healthcare spectrum and am currently building a national network of users and equipment across the agency. This network also includes other agency partners such as FDA and Defense Dept healthcare.
I am also very interested in helping to spread expertise about Assistive Technology around the world to regions that are still developing their rehabilitation services. Of particular interest to me are Asia and Africa.”

From Mars Expedition to Healthcare 3D Printing – Pondering after Elon Musk’s Presentation on Sept 27th, 2016 Part 2: “Zero-G Game and Pizza”

October 16, 2016 | 0 Comments

Photo credit: NASA
This series of blogs was originally inspired by Elon Musk’s recent Mars speech. Although Elon and his team at SpaceX may very well succeed in sending pieces of electronics and team of robots to Mars successfully within the claimed timeframe, I think it is crucial to re-think space medicine to make manned “Mars expedition” an actually meaningful goal.
Part 1 of this series discusses why it is important to think about space expedition seriously for humanity’s future, and explains how 3D printing in healthcare carries equally paramount weight for our future and for this ambitious goal.
While few of us had the opportunity to space travel in their lifetime (me included), it is clear to most that the major healthcare challenges in space traveling are the following based on our past experiences: [Ref 1-4]
a.    Negative effects on human body in Microgravity
b.    Spacecraft as a highly confined and controlled chamber
c.    Limited resources for medical care and recovery onboard
d.    Lack of scientific evidence on the effect of long duration inflight human survival and morbidity
Figure 1 is a compiled graph on the medical conditions encountered during in flight medical events from 1981 to 1998 for the American astronauts (STS1-STS89).  Mind you that these incidences happened on super healthy individuals who had the most positive attitude towards space exploration when signed up for the adventure.
 
 
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Therefore, Elon’s conclusions that a) Mars trip will be deadly (based on current space healthcare technologies), and b) he himself would not partake the trip are 100% correct.
Me, neither.
Thus, before we can seriously think about “Zero-g pizza and games”, let’s seriously think about how 3D printing (and bioprinting) can potentially save lives and help out with challenges facing human expedition to the deep space: [Ref 5]
a.    3D printing allows for significantly increased supply in missing, damaged, and out-of-date parts inflight. Currently, even for ISS, it takes months to supply these parts. Besides the cost to produce and ship, in medical situations, missing parts can be deadly in a confined chamber like a spaceship. Having digital manufacture onboard, the crew will not only have on-demand medical equipment (from forceps to robotic parts) in a timely fashion; they will also have the most up-to-date equipment from the Earth control station as their long journey continues. The combination of telemedicine/remote diagnosis and digital manufacture will prove crucial to keep a sizable crew alive to destination.
b.    3D printing will improve onboard nutrition. Can you imaging eating pizza or potatoes for 30 days? Or anything for 30 days or longer? With an onboard food 3D-printer, the crew can enjoy a much larger selection of on-demand foods that will meet the nutrition requirements, not only depending on where they are during the journey but also depending on the crew’s variable health conditions at a specific point in time during the journey.
c.    3D printing and bioprinting will allow for more space medical research. The lack of biomedical research in space is evident and is a major barrier to a true human expedition into the deep space. (Who in their right minds want to go on a 100% deadly adventure?) However, with the increasingly available 3D printing/bioprinting technologies, having human like tissues and simulation biological devices such as “Organ-on-a Chip” [Ref 6]will allow for more space biomedical research at significant lower human risk and cost.
d.    Bioprinting may allow for direct inflight wound care and beyond. Lead by companies such as Organovo, direct tissue repair and organ replacement using bioprinting are not just excerpts from science fictions but tangible solutions to humanity in the next few decades. In combination with other areas of “precision medicine”, 3D printing/bioprinting will make Mars colonization a reality for us humans, and not just robots.
Join 3DHEALS 2017 Global Conference for more discussions on Healthcare 3D Printing at UCSF Mission Bay Campus.
References :

  1. “Space Medicine” http://www.spacesafetymagazine.com/spaceflight/space-medicine/
  2.  “Space Medicine” https://en.wikipedia.org/wiki/Space_medicine
  3. 6 Ways Medicine in Space is Completely Different from on Earty.http://time.com/3937912/space-medicine-lindgren/
  4. Aerospace Medicine. http://www.nasa.gov/
  5. http://www.space.com/25176-astronaut-3d-printer-space-station-video.html
  6. Organ-on-a-Chip http://wyss.harvard.edu/viewpage/461/

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

October 3, 2016 | 0 Comments

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.
 
 

Aging in the Era of 3D Printing (and Bioprinting)

September 20, 2016 | 0 Comments

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Aging in the Era of 3D Printing (And Bioprinting)
This post is inspired by my recent presentation at a Silicon Vikings event “Aging in the Era of Digital Health”.
Aging. Yes. Ugh.
This topic can be more profound, controversial, and philosophical to most than technical, but since we are a technical forum with a highly practical audience, I would share some thoughts focusing on the simpler technical aspects by asking and answering the following questions: 

  1. What goals are we trying to achieve in managing an aging population with the help of 3D printing/bioprinting?

These goals can be summarized (Figure 1) as elongating of life span, improving quality of life, and last but not the least reduce or at least contain the cost to society while achieving the first two goals. These three goals are interdependent.
In the history of U.S. healthcare at least, although technologies have effectively achieved miracles in attaining the first two goals, the cost of healthcare has skyrocketed very much because our population now has many more options to defy many life tragedies. This will not be a sustainable model going forward in human history, containing cost while bringing in new technology should be equally important in future healthcare innovations.
In addition to creating new products that can elongate life and improve life quality, 3D printing has large potential to reduce cost to society by its innate technical advantages over conventional manufacture:

  • Mass customization
  • Complete digital process, therefore easily transferrable and modifiable
  • Reduction in production cost
  • Efficient material/waste management
Goals for healthtech for aging

Figure 1. Goals for Aging 2.0

  1. What are we doing in 3D printing/ bioprinting to achieve these goals?

While 3D printing (or additive manufacture) is a 30-year-old concept, it is only in recent decade, it is considered a major potential player that can revolutionize the future of healthcare, and of course, managing a large growing aging population. There are four main areas of application with this technology for the aging population (Figure 2):

aging and 3d printing

Figure 2

  1. External assistive device – Devices like exoskeleton, hearing aids, prosthetic have taking over the media lately mainly because the regulatory landscape is simpler and the potential reduction in cost is large.
  2. Implantable device/ Implants – By 2012, at least twenty-five 3D printed implants have been FDA approved. Premature failure of orthopedic implants has been a major hurdle in taking care of the aging arthritic population. Longer lasting, personalized implants in theory will reduce the overall cost to society in orthopedic management of the elderlies. One step further, the potential of embedding electronic devices/sensor into customized 3d printed implants will open up a new territory for health data collection and management.
  3. Personalized pharmacy – A 3D printed pill can take full advantage by incorporating information on geometry, compound release profile, and patient-specific data into a single pill. In the age of poly-pharmacy, manufacturing such new generation of pills will reduce complication and improve compliance.
  4. Bio-printing and regenerative medicine for either direct tissue repair or organ replacement. There are developing technologies in creating bioprinters that can repair high grade burn injury (Link). More notable, larger bioprinting companies like Organovo has contracted with L’Oreal recently to revolutionize the R&D process of large pharmaceutical companies by increasing efficiency and decreasing animal testing. The concept of bioprinting can be partially understood by understanding 3D printing. However, there are large differences between the two technologies. While bioprinting occasionally use similar digital manufacture process to produce scaffold for tissue engineering, it also relies on many other areas of biotechnology such as stem cell technology. It is possible that regenerating a new functional organ may eventually be completely independent of additive manufacture process in the future.

In a word, it seems 3D printing will likely stay as part of our future healthcare, and a large part of our future heathcare will be caring for an aging population.

Join 3DHEALS 2017 Global Conference for more discussions on Healthcare 3D Printing at UCSF Mission Bay Campus

Game Changer : 3D Printing in Dentistry and Facial Reconstruction

3D Printing in Dentistry: From a Broken Tooth to Digital Revolution

September 14, 2016 | 0 Comments

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3D Printing in Dentistry: From a Broken Tooth to Digital Revolution
Nancy calls me at 1:30, “I just ate an olive pit and cracked my tooth. A big chunk of it is gone, it hurts and is really sharp against my tongue”. Nancy arrives at my office at 2 with half of her back molar has chipped off. Her teeth get scanned with an intraoral scanner and we design a digital crown. Next the design gets sent to a milling machine that precisely carves it out of a block of porcelain. At around 3:30 Nancy has a functional, permanent, esthetic new tooth in place of her chip and is back at work.
Nancy’s injury happens all the time in my office. Our digital workflow, computer assisted design and computer assisted milling (CAD/CAM) allows us to create strong and precise teeth restorations in under 2 hours. A few years ago this took two weeks.
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Milling is a great way to make teeth but there are some limitations. The shapes we can mill are limited by the shape and size of the cutting instruments. In other words smooth round objects are easier to mill where as sharp or thin objects are difficulty. Teeth tend not to be smooth and round.
Color is another limitation of milling. It is very difficult to add different colors or translucencies to a milled crown. Currently the approximate color of a tooth is taken and a solid block of that color is milled into a crown. Teeth are not a single color but are actually made of multiple shades and opacities of enamel.
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3D printing offers a solution to these limitations. By adding material we can make it almost any shape we want from a paper-thin veneer to a deep molar grove. It also has the potential to add different shades and translucencies to our restorations making them look more natural.
Currently we are using 3D printers in dentistry for surgical guides, temporary prosthetics and treatment panning. The big jump will be when we can throw away our milling machines and start printing veneers and crowns that can be placed permanently the same day of treatment.

3D printing Healthcare

Form 2, 3D printed night guard

Sirona the leading manufacture of digital crowns and milling machines suggests digital printers to still be several years away before they are ready for the dentists office.
One of the major limiting factors is that milling is really fast. It takes about 5 min to mill a block of porcelain into a crown then 15 min to bake it. 3D printing has a ways to go before it can catch up to those times.
As printing times get closer to milling I predict a fast adaptation of this technology. Printing opens up the possibility to produce a crown that can be color matched to adjacent teeth pixel by pixel. That will be a game changer is cosmetic dentistry.
About the Author: 
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Dr. Russell Taylor received his Doctorate of Dental Medicine from McGill University in Montreal Canada. Subsequently, he went on to complete a residency in Advanced General Dentistry at the University of the Pacific in San Francisco. Currently, Dr. Taylor practice’s clinical dentistry in San Francisco and is an adjunct faculty member at the University of the Pacific Dugoni school of Dentistry. He also serves as a director for the San Francisco Dental Society. Dr. Taylor lectures throughout the United States on cosmetic dentistry as well as dental implants. He also volunteers within California in large-scale clinics that provide no cost dental service to the under served. Internationally, Dr. Taylor provides charity dental services in countries like Ecuador, Vietnam and the Fijian islands. He is focused on starting a residency program in Vietnam for new graduated dentists to help them better serve their community. Dr. Taylor’s is passionate about incorporating technology into in his dental practice to promote, maintain and restore oral health.

 

Interview: Dr. Nima Massoomi, Board Certified Oral and Maxillofacial Surgeon