Co-Authored by: Jeff Vockrodt  and Paul Gadiock 

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The industrialization of 3D printing opens the possibility of making products efficiently with complex structure previously thought impossible or impractical using the tools of the first industrial revolution. Early industrial applications of 3D printed metal parts lowered the weight and reduced the number of components for highly engineered components, such as jet aircraft engine parts. As innovators seek to increase applications, much effort has been underway to expand available materials to include biopolymers and even tissue or cells. 

3D bioprinting employs 3D printing and similar techniques to combine cells, growth factors, and biocompatible materials to fabricate products that mimic natural materials such as printed bone, skin, arteries, and even whole organs. The promise of 3D bioprinting is to leverage the computer-controlled, layer-by-layer additive process of 3D printing to selectively deposit cells to build complex living tissues that can be used in patients. Because the cells can come from the patient, there would be no need for organ donors, and lessened risk of transplant rejection.    

Bringing these 3D bioprinted products to market will require significant investment in order to gain marketing approval from the Food & Drug Administration (FDA). The question immediately arises as to whether innovators in 3D bioprinting will be able to leverage enough patent and FDA marketing exclusivity to make their investment worthwhile. Both (1) the type of patents available and (2) the regulatory pathway chosen will determine the amount of exclusivity available for first movers. 

Patents for 3D Bioprinting

Patents generally provide their owner with a right to exclude others for a limited time period from making, using, offering to sell, or selling the patented invention. 

The scope of what the patent covers is determined by (1) the category of the patent claim being made (e.g., product, the method of using, or method of making), and (2) the breadth of the claim language. To obtain a patent an invention must be new, non-obvious, and directed to the patent-eligible subject matter. 

Printing organs will require new printing techniques and materials. The initial patents found in 3D bioprinting will likely focus on these technologies. One of the main challenges for these kinds of pioneering patents is that they will likely be at or near expiry by the time 3D bioprinted products become available. This happened with other 3D printing technologies and commonly occurs with pioneering patents particularly where a patent term of 20 years is linked to the filing date. A repeat of the early 3D printing patent wars is less likely in the bioprinting space where the safe harbor provisions of 35 U.S.C. 271(e) may shield those practicing the technologies in order to gain FDA approval of 3D bioprinted products.

As the time for regulatory submission and approval approach, 3D bioprinters will likely file more patents directed to the products for which approval is sought. In general, product claims offer the patent owner a broader scope of protection relative to method claims. This is because a product claim can only be avoided by changing the product itself, whereas method claims can often be avoided by using the product differently or making it differently. The complexity of 3D bioprinted products will likely provide many avenues for patenting. 

The patent portfolios of companies who bring these products to market will likely be large, similar to those found for currently approved biologic products. For example, Abbvie has amassed over 100 patents covering its Humira product. The portfolios would likely include claims to the 3D bioprinted products themselves. These product claims would need to include features that distinguish the claimed subject matter from the prior art, which may present a challenge. Another hurdle for product claims is that they are often filed at an earlier stage of technological development, and may expire before products make it to market.  

Aside from patent claims to the products, 3D bioprinting patents will likely also be granted on intermediate products, processes of making (harvesting cells, using cells in bioprinting, constructing organs and tissue from the cells), growth factors and other products used in the manufacturing process. Because 3D printing and bioprinting fundamentally relate to new methods of making, patents directed to various aspects of the process itself may be the most straight forward to obtain. These patents related to the process of 3D bioprinting will likely make up the bulk of patent portfolios covering 3D bioprinted products.  

Regulatory Pathway and Exclusivity for 3D Bioprinting

The FDA has already acknowledged that bioprinting is on the horizon and that a policy framework is needed to help ensure regulatory consistency and predictability. There are generally three categories of medical products that are regulated by FDA―devices, drugs, and biologics―each with their own range of pathways to market. How a medical product is categorized will dictate the group within the FDA that governs the bioprinted product under its authority: 

Further, bioprinted medical products that share a device, drug, and biologic attributes, so-called “combination products,” can blur the lines between FDA regulatory categories. In these scenarios, the FDA’s Office of Combination Products determines the product’s “primary mode of action” and, in turn, the FDA Center that will have primary jurisdiction over the bioprinted medical product. The determination of the primary mode of action typically has a significant impact because each category of medical products is afforded its own regulatory paradigm, some of which are far more demanding than others. 

There has been some debate about whether a 3D bioprinted product would be a medical device, a drug, or a biologic product. Because a 3D bioprinted organ would be implanted into a patient during use, it has led some to believe that it could be regulated as a medical device, similar to a pacemaker. In fact, the FDA has been promoting the development of an artificial pancreas device system; however, the agency has been keen to point out it does not consider products that involve biomaterial, synthetic or artificial tissue or organs to meet this definition. Seeing as how the definition of a medical device requires that it “does not achieve its primary intended purpose through chemical action within or on the body of a man . . . .,” some have argued a device classification for bioprinted products as being unlikely. 

More likely, 3D bioprinted products will be deemed either drugs or biologics and regulated as such. FDA regulations define the term “drug,” in part, by reference to its intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Notably, the definition of a drug is very similar to the definition of a device, less the qualifier that it does not achieve its primary intended purpose through chemical action within or on the body. 

By implication, drugs can be expected to achieve their primary intended purpose through chemical action. The FDA interprets that a product exhibits “chemical action” if it interacts at the molecular level with bodily components (e.g., cells or tissues) to mediate (including promoting or inhibiting) a bodily response. Under this interpretation, it is apparent that FDA can expect drugs to operate at a molecular level. Contrast that characteristic with cells and tissues that are regulated by FDA as biologics.

Human cells or tissues intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated by FDA as biologics. Examples of these types of products include bone, skin, corneas, ligaments, tendons, dura mater, heart valves. Based on the definition and examples, it is evident that these products are on a different physical scale than the drugs previously described. However, though finished bioprinted products would seem more akin to tissues, the scale on which the product is actually bioprinted may ultimately decide the category in which the medical product will fall. Suffice it to say that FDA’s current regulatory paradigm does not specifically contemplate bioprinted medical products. Legislation may be required to resolve whether the technology would be a drug or biologic, and the consequent patent implications that flow from that decision.

The Intersection of Regulatory and Patents for 3D Bioprinting

The Hatch-Waxman Act governs the process for FDA approval of generics for products regulated as drugs. One aspect of Hatch-Waxman is that it links FDA approval of a generic to product and method of therapeutic use patents, which are listed in the orange book for each approved product. The existence of orange book patents for a new chemical entity drug can nearly guarantee an additional 2.5 years of market exclusivity on top of the 5 years granted for a new chemical entity, for 7.5 years total. That period may be further extended based on a patent term extension for up to an additional five years for one of the orange book patents. 

Hatch-Waxman’s patent linkage leads to a clear preference for product and method of therapeutic use patent for drugs. This allows the patent owner of a drug product bring an infringement lawsuit while lessening the prospect that the generic competitor would launch its generic product “at risk,” meaning while the patent dispute has not been resolved. Because the bulk of a patent portfolio for 3D bioprinting will likely relate to aspects of the bioprinting process itself as discussed above, many of those patents would not be in the orange book. This could make regulation of 3D bioprinted products as drugs less desirable from a patent owner’s perspective.  

No such patent linkage exists for biologics and biosimilars, which are regulated under the Biologics Price Competition and Innovation Act (BPCIA) enacted in 2010. Instead of tying the exclusivity to particular patents and extending marketing exclusivity based on the listed patent, approved biologics receive 12 years of market exclusivity regardless of the patent situation. There is no equivalent of the orange book for biologics. Instead, patent owners and biosimilar applicants can engage in a “patent dance” to narrow down the number of patents involved in pre-launch litigation. Unlike Hatch-Waxman litigation for drugs which are limited to product and therapeutic use patents, biosimilars litigation under the BPCIA often involves all kinds of patents, including a method of making patents. This could make the biosimilar regulatory pathway more desirable than the drug pathway for 3D bioprinting patent owners. 

While there is some uncertainty as to how the FDA will regulate 3D bioprinting, the character of these products suggests that assuming no new category of regulation is created, they are likely to be regulated as biologics. The lessons learned from BPCIA litigation is likely relevant for 3D bioprinting. While BPCIA litigation is relatively new, we know that obtaining a large patent portfolio surrounding important products has been important for branded biologics manufacturers. This suggests 3D bioprinters should actively seek to patent all aspects of their 3D bioprinting processes. 

About the Authors:

Jeff Vockrodt advises companies on patent matters involving chemical and life science technologies, including pharmaceutical, medical device, and biotechnology inventions. Jeff has overseen the preparation and prosecution of hundreds of patent applications involving a wide range of technologies, including additive manufacturing and biopharmaceutical patents. Jeff has served as lead counsel in inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB). Jeff is a registered patent attorney with a chemical engineering background. He served for four years as patent examiner before the United States Patent and Trademark Office and a law clerk in the US International Trade Commission before entering private practice. He is currently a partner at Arent Fox LLP and adjunct professor teaching IP, Regulation & Compliance for Biotechnology at Katz Business School, Yeshiva University.  

Paul Gadiock is a is a Senior Attorney in Arent Fox’s Life Sciences group where he provides premarket and postmarket regulatory solutions on a variety of subject matters for medical product clients. Paul regularly counsels on conventional medical products as well as transformative technologies including digital health, 3D printed products, and regenerative therapies. As a former policy director at FDA and business development leader at a national biotechnology company, he brings unique first-hand experience with the development and application of regulatory programs to benefit clients at all stages of the medical product life cycle. Paul speaks frequently at industry conferences and writes articles and legal alerts on cutting-edge topics concerning the life sciences sector. 

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The post 3D Bioprinting and Biologics: A Look at Patent and FDA Market Exclusivity Strategies appeared first on 3DHeals.

Erik Birkeneder is an intellectual property attorney and a partner 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. Mr. Erik Birkeneder will be a speaker at the #3DHEALS2018 conference on April 20-21st, 2018.
Jenny: When was the first encounter you had with 3D printing? What was that experience like? What were you thinking at that moment?
Erik: In 2012, when I first read “Makers, the New Industrial Revolution” by Chris Anderson I realized how transformation this technology would be and how it would impact intellectual property. I read as much as I could after that and began to seek out work in this field. After that, when I met Jenny some years ago, I was excited to walk with her on this journey of making 3D printing more accessible in health care. That motivated me to learn as much as I could about the industry, and study the IP and patent implications very carefully.
Jenny: What inspired you to start your journey/company/career/research in 3D printing (bio-fabrication/bio-printing)?
Erik: See above.
Jenny: What motivates you the most for your work?
Erik: As a lawyer with a biomedical engineering background, I love the opportunity to work on technologies and for companies that are changing the world. Much of this innovations are coming through the digital health and 3D printing space, and to be a small part of that is humbling.
Jenny: What is/are the biggest obstacle(s) in your line of work? If you have conquered them, what were your solutions?
Erik: One is that startups have such little knowledge of how IP laws impact their businesses and many of them make irreversible mistakes early on before they can afford good legal counsel. I have done a series of presentations at incubators that have helped solve that problem, and have a relatively open door to answer entry level questions for companies working on technologies I believe in.
Jenny: What do you think is (are) the biggest challenge(s) in 3D Printing/bio-printing? What do you think the potential solution(s) is (are)?
Erik: From my perspective, I think understanding how intellectual property can be protected will be one of the biggest challenges, as 3D printing creates a host of opportunities and pitfalls for IP. If they are not properly protected, much loss of IP will occur with new companies in this space. I think identifying legal counsel with deep expertise in the space will be critical to avoid these pitfalls.
Jenny: What advice would you give to a smart driven college student in the “real world”? What bad advice you heard should they ignore?
Erik: Take ownership of your life and your career path. Ignore the “shoulds” and expected and well-worn paths.
Jenny: What were/was the best investment you made in 3D printing/bio-printing/bio-fabrication?
Erik: Reading many books on the topic and researching many of the patent and legal issues.
Jenny: What was/is the biggest risk you took in your career?
Erik: Betting my future on expertise in digital health and 3D printing.
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Erik: Hiking, meditation, reading, and food!
 
 
 
 

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By Norbert Sparrow, Editor in Chief at PlasticsToday, UBM Canon

This article was originally published in Plasticstoday.com on April 12, 2017.

3DHEALS2017 UCSF, April 20th, 2017

If you’re interested in the intersection of 3D printing and medical technology and happen to be near San Francisco, CA, next week, you might want to carve out some time to attend the 3DHEALS 2017 Global Conference: 3D Print Life. 3D HEALS is dedicated to the proposition that great things can happen if you bring together technologists from the start-up culture of Silicon Valley and the Bay Area and healthcare stakeholders under one roof. The organization has been around for a couple of years and has produced five successful events during that time. By reaching out to various stakeholders in the healthcare system, technology, regulatory affairs and more, “it made us realize that it takes a village to make revolution happen, and many challenges can only be overcome by a well-organized ecosystem,” write event organizers on the website. “We are hoping that by organizing this global event, 3DHEALS will contribute to fostering this burgeoning yet still fragile ecosystem.” Event organizers expect more than 400 attendees and approximately 40 speakers addressing all aspects of 3D printing in the medical space. It is scheduled for April 19 and 20 at the Mission Bay Conference Center at the University of California San Francisco. For more information, go to 3dheals.com.

Bedside printing: Who’s liable when things go horribly wrong? One aspect of the medical 3D-printing ecosystem that will become a hot topic when healthcare establishments start printing medical devices in house is the question of liability. The Legal Intelligencer published an enlightening article about this recently, “ The liability of hospitals and doctors printing 3D medical devices .” Traditionally, a manufacturer producing a 3D-printed device is subject to product liability claims. “But, when a hospital or doctor prints the device at their own facility, who is responsible if that device causes a patient harm?” writes Marion Munley, who offers well-informed insights into this looming legal conundrum. I use the word “looming” advisedly. While “bedside printers” are not yet a reality, the notion of printing personalized medical devices that conform to individual patient anatomies or other patient-specific medical needs is beyond tantalizing. The technology, for the most part, is available; what is standing in the way are the regulatory hurdles and, as Munley cogently notes, the legal thickets. For now, hospitals and doctors probably can’t be held strictly liable as suppliers of medical products, writes Munley. “They are considered to be akin to a consumer or user of a product when the product’s use is incidental to the provision of medical services, and are shielded from being held strictly liable.” The line between manufacturer and service provider will blur, however, “as hospitals and doctors begin to print 3D devices in bulk quantities and sell them to their patients,” Munley adds. Under current law, practitioners and medical establishments could be liable for negligence if a patient is injured by a defective in-house 3D-printed device, notes Munley, but that is difficult to prove. Depending on the circumstances, patients could also file a malpractice claim. There is a bit of a vacuum in this area of the law, which is concerning to Munley, “since it is widely anticipated that hospitals and doctors will significantly increase their production of 3D medical devices on-site, [and] patients injured by these 3D devices will face legal hurdles.” In the meantime, Munley concludes, the “FDA will have to continue to ensure that these products are safe, as well as properly regulated, until the law catches up with this rapidly evolving technology.”

Mark your calendar for 3DHEALS2018, April 20–21st, 2018

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By Eric Barnes, AuntMinnie.com staff writer

This article was originally published on AuntMinnie.com on April 25, 2017.

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3DHEALS2017: Regulatory Panel, April 20th, 2017

April 25, 2017 — Many of the qualities that make 3D printing such an exciting field are the same ones that create a perilous legal environment for the industry, according to experts at last week’s 3DHeals conference. From patent protections to product liability, 3D printing’s sparse legal track record and unique manufacturing processes raise issues that lack clear answers.

At a panel session discussing these issues at the San Francisco conference, intellectual property specialist Eric Birkeneder, from the Nixon Peabody law firm, and Colleen Davies, a partner at Reed Smith and a member of the firm’s Life Sciences Health Industry Group, talked about law in the emerging field.
Birkeneder said his firm started working in intellectual property in issues related to 3D printing about a year and a half ago, about when Nixon Peabody pulled together a task force to gather knowledge and create strategies for the field.
Protecting intellectual property
“Traditionally, we want to protect the product with patenting and maybe sometimes the process for making it. But for 3D printing, there are so many different products and processes that can be patented, including scans if you’re doing medical implants,” Birkeneder said.

Read more…

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“The ‘law of 3D printing,’ if such can be said to exist, challenges those existing specialties and divisions, if only by linking the intangible and ever-changing world of “cyberlaw” to our relationship with manufacturing and manufactured objects.”

Martin Galese is General Counsel for Formlabs, a desktop 3D printing company. Formlabs produces high-resolution desktop 3D printers for engineers and designers. Before joining Formlabs, Mr. Galese worked as an IP litigator at the law firm of Kirkland & Ellis LLP in New York City and pursued his passion for 3D printing after hours. Mr. Galese’s earlier Patent-Able project, turning expired patents into 3D printable models, has been covered by both the NY Times and Popular Science. Mr. Galese has previously spoken about legal and policy issues involving 3D printing at the Annual Corporate IP Counsel Forum, 3D Printshow New York, 3D/DC and before the Intellectual Property Owners Association, the Boston Bar Association, the Harvard Journal of Law and Technology, and the Cardozo Arts & Entertainment Law Journal.

Q: What is your vision on the intersection of 3D Printing and healthcare?

A: Of all the industries benefiting from the 3D printing revolution, healthcare has the potential to be among the most radically transformed. As the pharmaceutical industry moves steadily towards personalized drug interventions, so too will medical devices become increasingly customized for patients and treatment needs. 3D printing is the enabling technology for that transformation.

Formlabs Class I Biocompatible : Dental SG Resin

Q: What do you specialize in? What is your passion?

A: I see my role as General Counsel for Formlabs as providing the integrated approach and broad view of generalist to a field of increasingly focused and silo-ed field-specific legal experts. The “law of 3D printing,” if such can be said to exist, challenges those existing specialties and divisions, if only by linking the intangible and ever-changing world of “cyberlaw” to our relationship with manufacturing and manufactured objects.

Q: What inspired you to do what you do?

A: As a sci-fi fan, I have dreamed about what a post-scarcity world might look like. And as an IP litigator, I have had the opportunity to see the ways in which legal rules shape R&D today and might shape our technological future. I see 3D printing bringing these threads together, providing innovators, scientists, and doctors with tools today to help bring future technologies to everyone more quickly. The chance to work in this industry, help it grow, and provide such powerful tools to our customers is very fulfilling and inspiring for me.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: One of the more significant challenges lies in training healthcare workers, who may be largely unfamiliar with any manufacturing technology, in the appropriate use of 3D printing technology. Without excellent resources and support, medical users of 3D printers may lack the tools and skills to provide the full benefits to their patients.

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“People aiming to work in the 3D printing industry should strive to think outside the box given all of the legal and regulatory unknowns with 3D printing. This mindset is critical to exploring ways to shape the law and regulations to promote innovation in healthcare in an ethical manner.”

As a senior associate in Reed Smith’s Complex Litigation Group, Farah Tabibkhoei’spractice focuses on product liability, managed care, creditors’ rights, and 3D printing. As a 3D printing enthusiast and member of Reed Smith’s cross-disciplinary 3D Printing Team, she closely monitors the complex legal and regulatory issues arising from additive manufacturing, affecting clients across a wide range of industries from healthcare to manufacturing to automotive, to identify risk, develop risk management strategies, and effectively problem solve. Ms. Tabibkhoei has been an invaluable contributor to the 3DHEALS legal blog. You can see some of her writings here. She will also be a speaker at 3DHEALS2017

.Q: What is your vision on the intersection of 3D Printing and healthcare?

A: 3D printing will vastly improve patient care by allowing surgeons to use 3D-printed surgical models for pre-surgical planning, thus reducing time in the operating room. 3D printing will also enhance patient education because it will help physicians explain medical conditions and treatment options to their patients by using 3D models, which will facilitate informed treatment decisions.

Q: What do you specialize in? What is your passion?

A: I am a senior associate in Reed Smith’s Complex Litigation Group and a member of the firm’s 3D Printing Task Force with a focus on medical device product liability, 3D printing, and managed care. My passion is high-stakes litigation and exploring the ways new technologies such as 3D printing shapes the law.

Q: What inspired you to do what you do?

A: I became inspired to expand my practice to 3D printing after watching Dr. Anthony Atala’s TED talk on printing a human kidney. It became clear to me that 3D printing would not only transform medicine by creating customized, on-demand medical supplies and medications, but would also force traditional legal principles to change to keep up with the technology.

Q: What is the biggest potential impact you see 3D printing having on the healthcare industry?

A: The biggest potential impact 3D printing will have on the healthcare industry is improved access to healthcare in rural and poverty-stricken areas of the world where medical resources are scarce. 3D printing will allow greater and quicker access to more affordable and customized medical supplies and procedures for those in need.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: Challenges in the 3D printing healthcare sector will include widespread adoption of 3D printing among physicians, costs associated with training personnel on how to use 3D printing, and getting health plans to provide reimbursement for 3D printing procedures and/or devices because the risks are relatively new and unknown.

Q: What is the best business lesson you have learned?

A: Do what you love and the money will follow.

Q: What is the biggest business risk you have taken?

A: The biggest business risk I have taken is going to law school.

Q: What crucial skill should people aiming to work in this industry acquire?

A: People aiming to work in the 3D printing industry should strive to think outside the box given all of the legal and regulatory unknowns with 3D printing. This mindset is critical to exploring ways to shape the law and regulations to promote innovation in healthcare in an ethical manner.

Q: How will accessibility of the technology affect the cost of procedures?

A: The costs of procedures will depend, in large part, on whether health plans will reimburse doctors and hospitals for these procedures. There needs to be more funding for 3D printing research and development in the medical field to prove its safety and efficacy compared with traditional medical procedures. Additionally, widespread adoption of the technology among clinicians will help lead to greater reimbursement of these procedures and lower costs.

Q: Where do you get the training required to make informed decisions?

A: I read and learn about the latest developments in 3D printing through industry and legal experts including a talented and cross-disciplinary team of attorneys (insurance, environmental, IP, to name a few) within my firm who are similarly vested in the future of 3D printing.

Q: How will 3D printing impact product liability?

A: 3D printing raises new and unanswered legal questions with respect to product liability including what is a product, who is a manufacturer, and where does liability fall when a 3D printed product is found to be defective? Does the strict liability doctrine apply to 3D printing or are we left with negligence?

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“This democratization of manufacturing means no entry barriers and blurred lines between who is the manufacturer and who is the patient or user of the medical device. Traditional strict product manufacturing principles will not fit this new landscape and legal guidelines will need to be developed regarding regulatory and tort legal issues.”

Colleen Davies is a member of the Life Sciences Health Industry Group, practicing in the area of product liability, life sciences and commercial litigation. She has served on Reed Smith’s Senior Management Team as Global Chair of Litigation and as Global Head of Legal Personnel. She has also served on the firm’s Executive Committee. Colleen’s client base primarily consists of major pharmaceutical, medical device, software, hardware, electronic and consumer product manufacturers. While Colleen’s experience extends into various product manufacturing arenas, her specialty areas remain in pharmaceutical, medical device and consumer product liability defense. She also counsels product manufacturers on all phases of product development. Here, her work addresses manufacturing and marketing issues such as product warnings, design development, document retention policies, claims management, media relations and crisis management. Colleen is active in a number of legal defense organizations and is also a frequent lecturer and author on substantive issues relating to product liability defense. She will be a speaker at #3DHEALS2017.

Q: What is your vision on the intersection of 3D Printing and healthcare?

A: 3D printing will transform personalized medicine — and in the process, disrupt traditional legal principles. My vision is to be part of a legal team that is ahead of the curves this legal landscape develops.

Q: What do you specialize in? What is your passion?

A: I am a Partner in Reed Smith’s Life Sciences Practice Group with a specialty focus on product liability issues for medical device and pharmaceutical companies. My passion is team building — and for this reason, I joined a group of lawyers to form our firm’s 3D Printing Task Force. This team is a cross disciplinary group of lawyers who specialize in 3D printing legal issues — including product liability, intellectual property, environmental, insurance recovery and regulatory matters (including reimbursement issues).Our published white papers include: 3D Printing of Manufactured Goods: An Updated Analysis and 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles.

Q: What inspired you to do what you do?

A: My inspiration came from my cousin Dr. Redmond Burke, a pediatric cardiovascular surgeon at Nicklaus Children’s Hospital and a pioneer in the use of 3D printed models to assist in surgical planning and patient management. http://www.stratasys.com/resources/case-studies/medical/nicklaus-childrens-hospital His work prompted me to learn more about 3D technology and eventually question how the technology will challenge traditional legal principles of product liability for medical devices and other products.

Q: What is the biggest potential impact you see 3D printing having on the healthcare industry?

A: 3D printing will turn manufacturing as we know it upside down as every physician, hospital and even consumer will eventually have the ability to be a product manufacturer. For example, individuals have already used 3D printers to print their own dental products. This democratization of manufacturing means no entry barriers and blurred lines between who is the manufacturer and who is the patient or user of the medical device. Traditional strict product manufacturing principles will not fit this new landscape and legal guidelines will need to be developed regarding regulatory and tort legal issues.

Q: What challenges do you see arising in implementing 3D printing in healthcare sector in the next 5 years?

A: One challenge in the legal arena relates to the apportionment of potential liabilities should an injury occur. There are multiple challenges in accountability and traceability to determine whether the injury occurred due to a defect in the digital file; a corrupted copy of a model digital file; the 3D printer itself; human error in implementing the digital design; negligence in using the 3D printer and/or materials; or defective replacement parts.

Q: What is the best business lesson you have learned?

A: Nothing trumps listening.

Q: What is the biggest business risk you have taken?

A: Assuming a business position in Senior Management.

Q: What crucial skill should people aiming to work in this industry acquire?

A: Collaboration and teamwork are key skills given the cross disciplinary nature of the legal issues.

Q: How will accessibility of the technology affect the cost of procedures?

A: For medical device product manufacturers, eligibility for reimbursement by government or private insurance companies is a key legal issue. Manufacturers should assess early on how they can align their strategies with that of the medical payors.

Q: Where do you get the training required to make informed decisions?

A: I have been lucky enough to work at a global law firm that offers industry expertise across the life sciences field.

Q: How will 3D printing impact product liability?

A: As is typical with technology and innovation, 3D printing is moving faster than the la w and regulations that guide its use.In many instances, the consumer or even the hospital is the manufacturer — and this fact makes the application of traditional legal principles difficult. In the short term, the law is likely to develop on a case by case basis with regulatory developments occurring along the way.

The post Interview: Ms. Colleen Davies appeared first on 3DHeals.

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

There are many active discussions in professional societies and across legal forums, but current regulatory, policy, and legal guidelines are very incomplete or non-existent for medical applications of 3D printing, ranging from medical device manufacture to pre-surgical applications. As more healthcare providers and legal experts are getting involved in the field, the final details on regulatory and legal issues for the production process will slowly but surely unfold. In fact, several major law firms are now leading the way in establishing a subspecialty related to medical 3D printing as can be seen in several recent publications. [45,46]

Because 3D printing pre-surgical applications are very new, healthcare and service providers can only speculate on potential regulatory and legal issues based on similar scenarios with applications of other new technologies. Therefore, it is foreseeable that regulatory issues may need to be carefully considered every step along the way, from design to production. For example, in the medical imaging post-processing (for example, segmentation and DICOM to STL conversion), there is currently no established software standard. Although a few popular software systems such as Mimics (Materialise, Belgium) and Osirix (Pixmeo, Switzerland) are FDA-approved, it is still debatable if FDA-approved software must be used. Many current users default to FDA-approved software, fearing pending regulatory ruling that could make their new workflow obsolete, but in reality, there is no evidence that using non-FDA-approved software would necessarily produce lower quality products. It is also unclear how extensively the FDA should be involved in software development intended for pre-surgical 3D printing applications. For example, although it is commonly accepted that FDA approval is needed when software is used for diagnostic and treatment purposes, multiple software selections are often involved in the process. Some argue that the CAD component of the workflow need not be FDA-approved, but others will argue that every single design step will ultimately affect the quality of the final printout. Very recently, during the draft of this book, Food and Drug Administration published a new draft laying out a framework to discuss developing more specific guidelines for the industry, signifying the importance of staying up to date on the regulatory rules related to this new technology. [59]

Additionally, the associated ownership, patent, and liability issues associated with digital design are also increasingly gaining attention. [46, 54] The intensity of the debate on whether a 3D digital file can be patented was demonstrated in a recent case involving Align Technology Inc. (California, U.S.A.) and ClearCorrect (Texas, U.S.A.). [54] As another hypothetical example, if a color-coded congenital heart model is proven effective in pre-surgical planning for pediatric congenital heart disease, should and can the color-coding process be patented? Also, if there is an unexpected corruption of 3D Printing digital file for an implant which subsequently causes harm in patients, who should be liable for the mistake and to what degree? Similar questions need to soon be addressed by lawmakers and the legal community.

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 different post. 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, only a handful of materials are FDA-approved and can be sterilized sufficiently to be within the operating field. An even smaller number of materials can be used for implant production. [47]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.

Regulatory concerns have significantly increased the complexity of many 3D printing applications. A 3D printed surgical guide is one such example. A Patient Specific Instrument (PSI), or 3D printed surgical guide can be produced on an in-house 3D printing center within 24 hours. However, due to regulatory concerns, many healthcare providers choose to use outside medical device vendors with regulatory approval. This significantly increases the turn around time to up to weeks, markedly decreasing the appeal of using a patient-specific instrument (PSI).

Idea to Implementation: Organization and Staffing of A Multidisciplinary 3D Printing Team

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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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As the organizers of 3DHEALS events, it may surprise people that we could never accurately predict the outcome of 3DHEALS conferences. That includes what the speakers will discuss, what kind of audience we will attract, and what kind of new connections will be made.
Since its inception, 3DHEALS events have pleasantly surprised us in many ways every time.  The community we have attracted is small, intimate, but also powerful and capable. That is probably the most constant thing we can predict.
For our August 3DHEALS legal conference, we had the pleasure of listening to the most original presentations on legal issues related to healthcare 3D printing, from IP/Patent concerns (Erik Birkeneder from NixonPeabody), to medical device liability (Colleen Davies from ReedSmith), to new digital security software development for healthcare 3D printing (Stephan Thomas from Identify3D).   The Q&A session moderated by past FDA fellow Dr. Mirza was as stimulating as the presentations, as the audience was composed of the usual mixed of intellects with backgrounds ranging from healthcare consultants, legal, journalist, engineering, environment risk scientist, healthcare providers, and beyond.
Our readers can watch the recordings of the conference on YouTube soon.
 
 

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August – Edgeinterns , Francis Kong and Megan McLeod

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

3DHEALS Legal Conference- August

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