On the early morning of 5/31/2019, we had our first successful online Pitch3D event. This event is set to be recurrent each month, aiming to create an opportunity for early-stage startups in the realm of healthcare 3D printing, bioprinting, and advanced materials to have first meetings with a curated panel institutional investors. The presentations are meant to be short (10 minutes max.) but aim to get to the bottom line quickly to stage a second 1:1 meeting that would be more in depth and longer with interested investors. The online format also avoids the opportunity cost of the investor-startup meeting due to time and geographic barriers. To pitch in our future sessions, the application is here. To be included in our investor mailing list, you must be qualified institutional investors, please email us directly: info@3dheals.com.

Our live Pitch3D session will occur concurrently with 3DHEALS event globally. Next live Pitch3D will be in Boston on July 18th, 2019. The application is here.

Presenting Startups Summary:

8:00-8:15 AM Deep Health (Isreal)
Deep Health uses advanced AI tools to change the way surgery is planned and done. We are currently concentrating on Spine surgeries due to the complexity of the procedure. 3D Scanning. Software.

8:15-8:30 AM Kumovis (Munich, Germany)

KUMOVIS develops 3D-printing systems for medical applications. Our system is designed to manufacture a high variety of medical products starting from prototyping up to personalized human implants. h

8:30-8:45 AM PrinterPrezz (Fremont, USA)

PrinterPrezz brings together an operating room and advanced
manufacturing expertise under one roof.

8:45- 9:00 AM Fluidform (Boston, USA)

Fluidform 3D printing builds the additive manufacturing platform for 3D printing silicone, 3D bioprinting, and more.

Related Articles:

3DHeals Brazil: Healthcare 3D Printing Next Generation!

Pitch3D! Startup Summaries and Contacts

Pitch3D! Boston, June 18th, 2018- See Who Is Pitching

The post Pitch3D May 2019: Deep Health; Kumovis; PrinterPrezz; Fluidform appeared first on 3DHeals.

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

In my previous posts, I discussed how the transition that we’re observing to digital manufacturing (especially additive manufacturing) means medical device manufacturers are confronted with a new set of risks related to the management and control of the engineering and manufacturing data of their products. I identified five key risk areas that manufacturers must secure in order to safeguard their brand value — I discussed IP risk, liability risk, and confidentiality risk in my last post. In this final post, I’ll focus on two risk areas that are specifically focused on the manufacturing process: production risk and traceability risk.

Loss of control over the production process

Before the digitization of manufacturing, ensuring the quality of a part was less complicated because the barriers to gray-market or counterfeit operators were much higher. For starters, a complex medical part or product would require a precise manufacturing process that involved tooling, costly machinery, and all the human expertise that this involves. So, it was difficult for a rogue operator to (say) manufacture a heart valve or prosthetic.

Today, with additive manufacturing, anybody who has the right 3D printer and materials, along with the digital design files of a part, can manufacture an exact replica of the ‘legitimate’ part. Security technology can prevent this from happening by controlling under which conditions and rules a part can be made from its digital description, and this also addresses the issue of whether the part can be made, by whom, on which machine, and in what quantity.

But what about quality control? Additive manufacturing offers the possibility of fabrication using a wide variety of materials, and let’s not forget that additive manufacturing only recently transitioned from the world of prototyping in R&D labs to becoming a legitimate production process on the factory floor. Machine parameters, part positioning and material quality are critical to ensure manufacturing of medical devices to the correct specifications and standards.

This risk is substantially amplified when we move from centralized manufacturing to distributed manufacturing. It’s relatively easy to manage this quality risk internally, but much more difficult to manage once manufacturing data is shared with legitimate third parties for production (or, worse, stolen for unauthorized production).

Unauthorized manufacturing may lead to sub-standard quality part, a potential costly recall, or a failure that could disrupt entire systems. Any deviance from what has been defined as the original digital “recipe” for the part can create an immense —and possibly lethal— quality risk.

Loss of control over traceability

The integrity and traceability of medical products is critical to prevent counterfeit, maliciously modified, poor quality, or uncertified parts from entering the physical supply chain. Until now, the main cause for concern has centered on the software within medical devices. According to Fierce Medical “medical device recalls reached record highs in 2018 thanks to software complications that are likely to continue with the proliferation of high-tech devices.”[1]

Today, with the increase of additive manufacturing techniques, manufacturers and healthcare facilities must prepare for the infiltration of hardware that may be flawed and whose provenance may be in question. Again, cybersecurity technology offers a way to address these concerns by registering and authenticating each step of the lifecycle of a medical device — from design through to physical fabrication.

Sometimes referred to as the ‘digital thread,’ these secure and immutable transactions enable the device manufacturer to precisely trace how any part or device was manufactured and then determine recalls and address production issues at the root cause. This will provide significant cost reductions and provide additional quality assurance measures. The future of the medical industry will be dependent on the ability to provide the exact knowledge of how and when a medical product was manufactured, from which design revision, and which parameter definition.

Parting thoughts

As medical device manufacturers embrace digital manufacturing techniques, they will turn to technology that protects and validates manufacturing data at rest, manages the data flow through licensing, and maintains decentralized and inalterable records of these movements. When someone’s life is in the balance, it is of paramount importance to ensure the security and integrity of the digital data that enables a part to be manufactured. Particularly in the medical device industry, additive manufacturing demands cybersecurity technology that encrypts, distributes, and traces the digital flow of parts — and that can prevent counterfeits while ensuring that maliciously modified, substandard, or uncertified parts cannot be placed into service.

[1] https://www.fiercehealthcare.com/tech/medical-device-recalls-software-fda-cybersecurity

About the Author:

Stephan is currently the Co-founder and Chief Strategy Officer of Identify3d, a software company that develops software solutions for Digital Manufacturing, in charge of Strategy and Business Development. Identify3d enables the Digital Thread through design protection, manufacturing repeatability, and traceability. Stephan has more than 25 years of experience in Operations, Supply Chain, M&A and Restructuring with companies such as EY, Alvarez & Marsal and REL Consultancy. He holds an M.B.A. from Baruch College’s Zicklin School of Business and a Master in management from Dauphine University (France). Stephan also lectures at the Berkeley-Columbia Executive M.B.A. on performance improvement topics. He is a board member of 3D4pro, an Additive Manufacturing Saas company.

Related Articles:

Five Reasons Cybersecurity Will Play a Critical Role in 3D Printing in Healthcare-Part 1

Five Reasons Cybersecurity Will Play Critical Role in 3D Printing in Healthcare – Part 2

The post Five Reasons Cybersecurity Will Play a Critical Role in 3D Printing in Healthcare – Part 3 appeared first on 3DHeals.

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

In many developing countries, amputees do not have access to a usable prosthetic device. Often times, there is a major lack of resources and conventional prosthetics are too expensive for amputees to afford. The Victoria Hand Project (VHP) makes low-cost, 3D printed prosthetic devices and works with local communities to get proper prosthetic care to the people that need it.

Amputees may want a prosthetic device for many different reasons. For some people, missing limbs can lead to low self-esteem and social exclusion from the community. For others, it can make it difficult to find and maintain meaningful employment. For all, it can make eating, cooking, dressing, and washing challenging to complete. By providing amputees with a usable prosthetic device, confidence is increased, employment can be found and everyday tasks can be carried out without assistance. 

The Victoria Hand is a complete body-powered prosthesis consisting of a hand, a wrist, a limb-socket, and a harness and costs only $240 USD to print, assemble and fit. As a comparison, conventional prosthetic devices can cost thousands of dollars. The Victoria Hand has high functionality, natural appearance, and is custom-made to fit each amputee. 

VHP’s approach has three key features: 

(1) setup of a production/fabrication center and training to make 3D printed prostheses on-site within developing countries; 

(2) training and working with clinical intermediaries and medical practitioners to provide professional care for amputees; 

(3) on-going operations support for both the 3D Print Group and the Clinical Care Group. 

Not only are amputees able to get replacement parts easily and on-demand, but the local economy is supported by creating jobs for people living in the country. 

All of this is made possible with 3D-printing technology! The Victoria Hand Project first began as a Master’s project in 2001 by the Executive Director of the project, Dr. Nikolai Dechev, while at the University of Toronto. Dr. Dechev wanted to create a hand capable of adaptive grasp so amputees could have a device that had a more mechanical function, could grip onto objects better and looked more natural. The hand was ground-breaking but, as it was originally machined from metal, cost thousands of dollars to manufacture. It wasn’t until 3D printing became readily available that the hand was looked at again. 3D printing paved the way for the success of the project, with parts manufactured at a fraction of the original price. 

Grand Challenges Canada provided a grant in September 2014 to further the research and, in February 2015, the first trials in Guatemala began, with patients testing the 3D-printed Victoria Hand for up to eight weeks. The users not only gave insightful feedback but also loved the hand, asking to keep it after testing was done. This sparked the idea for the Victoria Hand Project—a non-profit organization that could develop a high-quality, low-price prosthesis for the developing world. Established officially in July 2015, VHP has since partnered in seven different countries around the world and fit over 100 amputees with trans-radial (below elbow) and trans-humeral (above the elbow) upper-limb prosthetic devices.

The Victoria Hand is currently available in seven countries worldwide

A woman in Cambodia uses the Victoria Hand to wash dishes

Kevin from Guatemala holding a 3D printed ball with his 3D printed prosthetic hand

With feedback from the in-country partner groups, prosthetists and amputees, VHP works to make the device even better and more user-friendly. VHP’s mission is to provide upper-limb prosthetics to amputees in need, and hope the future brings chances to help many more amputees across the world!

See some of the newest innovations, including a Child’s Hand and a Force Doubler, at VictoriaHandProject.com

About the Author

Kelly Knights is a fourth-year biomedical engineering student at the University of Victoria who has been volunteering with the Victoria Hand Project since September 2016. Kelly completed a co-op work term with the Victoria Hand project in Fall 2018, where she assisted with the design, development, and testing of the new Force Doubler device and the Child’s Hand. Kelly has also been involved with media outreach, the creation of training documentation and assembly of the Victoria Hand. 

The post A Helping Hand to Those in Need—Improving the World with 3D Printing appeared first on 3DHeals.

(This was originally published on Linkedin)

Do you think that Community Based Personalised Healthcare will be enabled by a new process based regulatory system?

The U.S. Senate approved Scott Gottlieb, M.D. as the next FDA Commissioner on May 9 by a vote of 52 to 47.

Deregulation Advocate

Gottlieb has a track record as an advocate for deregulation and was on President Trump’s transition team. Earlier, he was a senior adviser to the presidential campaign of Wisconsin Governor Scott Walker. In addition to being an industry consultant, he previously served as a deputy FDA commissioner and a high-ranking official at the Centers for Medicare and Medicaid Services (CMS) during the George W. Bush administration.

He’s also been an advocate of speeding the approval process through shorter trials. He has also criticized the agency as being too restrictive in its views on “off-label” promotions. With federal courts applying First Amendment free speech rights to device manufacturers providing truthful “off-label” information, we are likely to see dramatic changes in that area.

“Longer, larger trials that require drug makers to evaluate ‘hard’ endpoints (like how long a cancer patient lives) rather than ‘surrogate’ endpoints (like a drug’s ability to shrink tumors) give FDA reviewers more statistical confidence. Reviewers prefer these drawn-out trials because they insulate the FDA from critics who say that it isn’t focused enough on safety. But bigger trials increase the time needed to develop a drug, keeping it out of the hands of patients,” he wrote in the Wall Street Journal in 2010.

Gottlieb is expected to implement FDA mandates in the recently passed 21st Century Cures Act, which is, among other things, designed to speed the approval process by relaxing certain clinical trial requirements. The Act requires the FDA to consider the use of “real world evidence,” including patient reports, anecdotal data and observational studies.

Industry Ties

Gottlieb is a physician and venture capitalist. As is usual with FDA commissioner nominees, ties to industry is a contentious focus of his Senate hearings. According to federal ethics filings, Gottlieb plans to recuse himself for a year from agency decisions involving more than 20 companies that he has worked for, invested in or had some other kind of financial relationship with.

According to filings, he is also selling off financial interests and resigning from positions in several companies. For example, as a partner in the venture capital firm New Enterprise Associates, Gottlieb invested in a laboratory-testing company called American Pathology Partners and five other firms.

As a managing director at the investment banking firm T.R. Winston & Co., he has investments in 13 client companies, including one that is working on treatments for sickle cell disease and another that is focusing on Duchenne muscular dystrophy.

According to the Wall Street Journal, Gottlieb made $3 million in gross income during 2016 and through March 1, 2017. That amount included $1.85 million from T.R. Winston.

New Look FDA

If Gottlieb is able to put his stamp on the agency, we are likely to see faster pathways to approvals, a stronger emphasis on post approval data collection and more information flowing between device makers and physicians.

What we don’t know is whether or not Gottlieb will have to follow President Trump’s orders to repeal two regulations for every new one. Whether he will have to accept deep budget cuts that could affect his ability to implement the 21st Century Cures Act and how far Trump will push him in his stated goal to “slash restraints” at the FDA to speed up what the President has called a “slow and burdensome” process of drug approvals.

About the Author: 

Dr. Paul D’Urso

Dr. Paul S D’Urso is a Neurosurgeon and the Founder & Executive Chairman of the Anatomics group of companies in Melbourne, Australia. Dr. D’Urso’s unique experience in research, clinical practice, teaching, commercialization, and medico-legal opinion has made him an internationally recognized Australian neurosurgeon, scientist, and innovator.  Dr D’Urso invented the technology of BioModelling with groundbreaking PhD research and founded Anatomics, one of the worlds most innovative medical software & device companies in 1995. Anatomics is a nonprofit company that has helped many thousands of severely affected patients and is committed to implementing the vision of ‘Community Based Personalised Healthcare’ via its AnatomicsRx software architecture.
Dr D’Urso was a fellow at the Cambridge University Neurosurgery unit and a clerk at Harvard Medical School. He has published and presented over 130 scientific papers, holds multiple international patents and has won over 30 prestigious research prizes.

As a medical practitioner for over 28 years, Dr D’Urso has accumulated a wealth of experience at Court in all jurisdictions. Dr D’Urso provides expert opinion for plaintiffs, defendants and for the Crown and is accredited by prestigious medico-legal opinion services.

The post Gottlieb Shake-Up Coming To FDA appeared first on 3DHeals.

Last November,  Frankfurt, Germany received the biggest crowd in Additive Manufacturing. Formnext2018 is the major showcase for the AM technology and its accessories. Formnext 2018 filled two halls of Frankfurt Messe, which means a double than last year.

Additive manufacturing is becoming more mature, we can now produce final components in polymers or metals in quantities that make sense in the manufacturing world. In addition, we have full control of this new process, full production was the tone of the show. Machine builders showcased features about fast builds, parts quantities measured in pieces per year, and process automation like heat treatment and build plate management inside the machines.  Most of the demo parts were fully filled build plates.

Picture Courtesy of Materialise

On the healthcare side, companies presented equipment capable of making biomodels with multiple textures and materials, models that can simulate surgical procedures perfectly; polymer cutting guides to make precise bone resections;  equipment capable of making polymer and metal implants with the right geometry, properties, and osseointegration;and computer systems capable of create shapes based on human body physiology.

Most current build preparation systems, with optional functions or not, can simulate the build process with good precision and geometrical correction about the thermal, stress, and supports displacement, in laser powder bed fusion process. Similar systems will be available to other AM process soon. New supports calculation algorithms are making the built more stable and repeatable. DED and EBM processes are being supported by some systems and should have the same coverage as FDM and LPBF processes in a short time.

What is called by the industry post processing, I call finishing,  are advancing fast. Things like automated support removal, build plate separation, heat treatment and surface finish are being really integrated into the chain and had a big exposure in the show.

ASTM and ISO held a joint workshop discussing the standards development for additive, all the most important officers of both organizations were present and a good panel with the biggest standards specialists in industry discussed the main challenges we face while developing it.

Additive manufacturing is a new technology, now available for the manufacturing of real-life products. AM has the innovation capacity for any sector, from fixture devices to medical devices,  aerospace parts, to tooling and production equipment to complete final automotive components. AM should no longer be seen as a substitute to well-established process that make products properly with well-adjusted supply chains. It is important to keep in mind that AM is initial, final and complimentary to processes like machining and injection molding in making large quantities of parts. These traditional processes have precision requirements not met by metal AM yet. By being a polymeric or metallurgical process, AM   has its limitations and needs proper use.

Additive Manufacturing is a process to add to the traditional manufacturing process. It must be integrated into the factories, must be understood and developed. Yes, additive machines and systems have its “marvelous” features as well as challenges, but our industry will progress to implement and improve itself. We can soon experience an exponential jump to better-designed products and massively improved manufacturing. Formnext2018 confirmed we are on the right path!

About the Author:

Fabio Sant’Ana has Precision Mechanics degree and Business Administration Bachelor’s , born and raised in São Paulo he has 25 years experience in helping companies to aquire and take full advantage of 3d Machining and Additive Manufacturing Equipment . Entrepreneur and knowledge avid is member of stardarts organizations ASTM F42 Additive Manufacturing , ABNT CEE-261 Manufatura Aditiva e ABNT CB-26 Odonto-Médico-Hospitalar . CAD/CAM , Surface Modelling and EBM specialist he is passionate in connect people and companies to the right tools to accomplish the mission.

The post Formnext 2018 Healthcare: Production is the Key appeared first on 3DHeals.

“São Paulo has the best public health system in the country , but even with that São Paulo’ population is still suffering on the hospital queues and dying because our system is too slow to meet the need of a 22 million population. Innovation can lead to a much better use of resources and ease this suffering.”

 
 
Community: São Paulo /  Brazil

3DHEALS members can get in touch with Fabio Sanches Sant´Ana here.

Jenny: Fabio, please tell us one quote that represents you.
Fabio: (“If you can look, see. If you can see, notice.”) – José Saramago, Nobel Laureate, Literature. ( This means more in Portuguese [laughing] )
Jenny: Tell us a little about yourself. (Where are you from originally? Where are you located? What are you working on?)
Fabio: Born and Raise in São Paulo , Campo Belo Neighborhood , I started my career right after my precision mechanics degree in the CAD/CAM field  working for Mastercam dealer for Brazil, after some time was hired by the company who democratized the CNC machining in Brazil by bringing high tech machines under good cost/benefit relation from Taiwan to the local market. My company started dealing for Swiss and  CNC machine companies specialized in medical devices manufacturing, and since 2013, we are specialized in Additive Manufacturing Technology for Aerospace and Medical Industries.
Jenny: What made you decide to become a 3DHEALS community manager?
Fabio: Brazil needs to advance the use of additive manufacturing in healthcare. The country sustained a large economical loss in recent years, and this caused a big gap in the actual technological status of AM in Brazil.
Jenny: If you have already organized a 3DHEALS event, what were your experiences like? (Photos?) Anything unexpected happened?
Fabio: I just started , we just put Jenny in contact with the Inside3dprinting São Paulo event .
Jenny: What do you think of innovations in healthcare 3D printing or bioprinting? What do you hope to see in the next five years? 10 years?
Fabio: This is advancing fast, the use of biomodels is growing and saving lives and resources, the implant making is amazing and soon we are going to have additively made tissue to be used in human body.  
Jenny: If you have done 3D printing before, what have you made/designed? 
Fabio: I help customers to develop implants like hip joints and spinal cages. I normally do some models in my desktop machine or my suppliers make samples for them

Jenny: Most of our community managers are entrepreneurial and adventurous, what risks/adventures have you taken that you’d like to share with us? Any hopes or regrets?
Fabio: I’ve owned my business since 1998, and there were hard times. At that time I used to carry a 29-inch tube monitor in my small car to be able to do CAD/CAM and CNC presentations. The projectors were very expensive and not popular at that time, and that cost me a lot of back pain!! To be able to manage your company size and resources in a country not economically stable like Brazil is the main challenge I had to face.  
Jenny: Who would you like to find and to include in the 3DHEALS community you are building?
Fabio: To be able to connect medical to engineering community is what I want the most.  
Jenny: What would you like to accomplish with this new 3DHEALS community in the future?
Fabio: Enable additive manufacturing to make people’s lives better
Jenny: What do you think about the innovation environment (for health tech or for general technology) in your city? What can be done to improve it?
Fabio: It’s improving. Many new techniques are appearing through doctors and engineers separately, and I would like to see them connect!
Jenny: What are you most proud of about your city?
Fabio: São Paulo is the locomotive of the country!
Jenny: What are you most proud of about the innovation community in your city?
Fabio: São Paulo is the natural base for startups in all industries.
Jenny: What do you think are the top priorities in healthcare innovations for your city/community?  
Fabio: São Paulo has the best public health system in the country, but even with that, São Paulo’s population is still suffering on the hospital queues and dying because our system is too slow to meet the need of a 22 million population. Innovation can lead to a much better use of resources and remove the suffering a bit .
Jenny: What do you hope to accomplish through your role as the 3DHEALS community manager?
Fabio: I hope to help, and this is my effort
Jenny: What do you do for fun?
Fabio: Fishing and hang out with friends for some beers and some Churrasco! Also after a successful bariatric surgery, I became a walker, I walk 5 km a day.
Jenny: Anything else?  
Fabio: I am glad I joined the tribe!
 

The post Interview: Fabio Sanches Sant´Ana, San Paulo, Brazil appeared first on 3DHeals.

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3DHEALS GALICIA 2017

 

Dear colleagues and friends,

 

Additive manufacturing (AM) has become a common technology in many departments, although regulations for its use in healthcare facilities may sometimes not be as clear as we would like. Last year, upon my arrival at the European Face Centre (EFC), Professor Maurice Mommaerts and I considered AM an interesting field for research because of many doubts surrounding its products. Mrs. An Vijverman, a lawyer who specializes in Belgian and European life sciences legislation, shared with us her valuable professional opinion regarding the European Union (EU) and Belgian laws related to medical devices. We hope that an interesting peer-reviewed manuscript with a detailed discussion will soon be accepted for publication, though I would like to share a summary of our conclusions here.

 

Additive manufacturing or three-dimensional (3D) printing, includes techniques used to (re)produce an object from a data set typically in Standard Tessellation Language, allowing us to shift from conventional subtractive- (milling, turning, cutting) or net shaping- (casting, molding, forging, stamping) based manufacturing. Mr. Charles Hull obtained the first approved AM patent in 1986, and in 1989, Stratasys developed the fused deposit filament molding (FDM) printer, now likely the most commonly used type of desktop 3D printer. Other types of AM printers (per the American Society for Testing and Materials) are Stereolithography, Material Jetting, Binder Jetting, Directed Energy Deposition, Powder Bed Fusion and Sheet Lamination that can use various materials, such as paper, wood, polymers, or metals.

 

The EFC runs two FDM printers (MakerBot Replicator 2 and MakerBot Replicator 2X), which provide up to 0.100-mm layer resolution and 7,522 cm3 (25.2 cm L × 19.9 cm W × 15.0 cm H) of building volume using 1.75-mm diameter polylactic acid (PLA) filaments for consistent and environmentally friendly (biodegradable) printing. Such printers should be in a ventilated area to avoid accumulation of toxic fumes released from melted PLA. If the printed product will be in direct contact with a patient, it should comply with the Medical Device Regulations document first published by the EU Council in 1993 (Directive 93/42/EEC) and its latest amendment released in 2016. Broadly defined, a medical device (MD) is an instrument (hardware and software) used for diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease. A custom-made device (CMD) is “any device specifically made in accordance with a written prescription of a doctor of medicine, of a dental practitioner or of any other person authorized by national law by virtue of this person’s professional qualifications which gives, under his responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.” (Directive 93/42/EEC, 2016) Once a product is determined to be an MD or CMD, the device is classified into one of three categories outlined by Directive 93/42/EEC (2016) based on the product’s type and length of body contact. These categories are summarized in Table 1. If the product will not touch a patient (e.g., models used for mock surgery), it is not considered an MD.

Table 1. Medical device (MD) classification criteria according to Annex VII of Directive 93/42/EEC, 2016.

 

Directive 93/42/EEC (2016) includes over 16 annexes that address MD-related issues, such as essential requirements for patient health and safety depending on the MD’s category, materials involved, packaging (sterile or non-sterile), labeling, and waste disposal procedures. Custom-made devices should have a unique identification number with manufacturer details, the doctor’s name with professional qualifications, the patient’s name, and the purpose of the device. This information should be available for 10-15 years if the product is implantable. Biocompatibility is of key importance. The International Standard Organization (ISO) establishes guidelines with which any MD that is meant to be in contact with a patient must comply (ISO 10993-1; 2009). The standards describe the structured biological evaluation of such an MD that must be planned, carried out, and documented by an experienced professional.

 

Summary:

• Models for teaching purposes, studying complex bony structures, performing a mock surgery, for molding a plate or an orbital floor mesh require no special oversight because they will have no direct contact with a patient.
• Custom-made devices that will be in direct contact with a patient, including surgical guides, orthognathic wafers, and facial implants, are classified according to EU Council Directive 93/42/EEC (Table 1) and must adhere to standards described in ISO 10993-1.

Although PLA is widely used in surgeries, FDM printer filaments are not ISO- certified, likely because the material is too porous and its low melting point for conventional sterilization will not guarantee its dimensional stability. Other thermoplastics used for CMD construction, such as acrylonitrile butadiene styrene from Stratasys and polyethylene terephthalate (PET or PETE) and nylon 680 from Taulman 3D, have been granted Class IIa status under ISO 10993. Thus, under specific circumstances, CMDs composed of these materials can be in contact with the patient for up to 30 days. The sterilization process is generally achieved through flash steam or ethylene oxide, depending on the specific product.

If one is manufacturing a CMD within the European Community (CE), one must be aware that:

– CE marking cannot be placed on the CMD unless it is intended for clinical investigation (Articles 17 and 18 of Directive 93/42/EEC, 2016).

– A CMD can be marketed if it complies with Article 42 and Annex XI of Directive 93/42/EEC (2016), which describe a conformity assessment procedure addressing general safety and performance requirements outlined in Annex I and related text. Article 4 of the directive specifies that if the product was manufactured within a health institution, the product shall be considered “in service” and must, therefore, comply with CE regulations. However, an exception to the former rule is outlined in Article 4.4a. If the device is kept at the institution, its manufacture passes appropriate quality management procedures, and the health institution provides information upon request regarding its use to their competent authority, including detailed information about the device and its production, then the device does not need to comply with CE regulations. A device produced in-house is not considered “on the market” if the product is not sold to a third party or to a patient; one such case includes surgical guides and models. Nevertheless, the local regulations in each country should be verified. For example, Belgium institutes a more flexible policy (Koninklijk Besluit van 18 Maart 1999 betreffende de medische hulpmiddelen) under which no clearance from the EU Council is needed for CMDs.Proper standardized regulations for AM are needed. Future changes to Directive 93/42/EEC regarding MDs are likely imminent.

Please comment how you print, sterilize, and market AM devices in your countries!

About the Author:

 

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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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Infographics: Legal Landscape of Healthcare 3D Printing Innovations

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

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