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 my last post, 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. In this post, I’ll focus on three of them: IP risk, liability risk, and confidentiality risk.

Loss of control over intellectual property

As the digitization of manufacturing explodes and additive manufacturing becomes more prevalent, most medical device companies will be forced to consider the implications of the loss of control over the digitization of their assets. Just as the music industry suffered major revenue loss when its IP became digital (and was therefore easy to share or distribute illegally), the digital information that describes the design and engineering medical parts data will be a target of counterfeit operations.

The economic damage of IP theft is estimated at over $300 billion per year. [Ref 1] This total includes software piracy, counterfeiting, trademark violations, and other forms of stolen IP. Medical device companies need to take IP protection especially seriously because they are so heavily dependent on innovation and the value-add embedded in their product makes the industry a good target for IP theft. Today’s medical devices embody millions of dollars of research, design, testing, development, manufacturing, and marketing — and can take years to get to market.

In an industry that is at the forefront of rapid innovation, medical device companies must implement stringent and rigorous measures to protect their competitive advantages. Every year brings new rivals, novel solutions, and greater potential for theft. Whether entering a new market, incorporating connected products into their existing solutions, or exploring new manufacturing processes, medical device manufacturers must implement impregnable techniques coupled with legal strategies and a top-down risk awareness culture that protect their IP while enabling the transition to distributed manufacturing.

Liability risk may increase if a product’s design is not secure

Beyond the business and brand reputation risks of a counterfeit product are considerations of the ramifications of the effects of a counterfeit product. From a legal perspective, manufacturers must protect consumers from harm caused by their product and are liable for injury or property damage caused by any defect. In defense to such claims, the manufacturer could plead that it was not the producer of the counterfeit product, or that the product included a component that, unbeknownst to the manufacturer, was in some way defective. Either way, this is likely a lengthy and expensive legal headache.

Due to the personal-injury implications of a defective medical device, there is a heavy burden on every medical device manufacturer to ensure the integrity of all parts along its supply and manufacturing chains. In practice, this means it is essential to be 100% confident that the digital information that describes a product’s design and manufacture cannot be stolen, modified or corrupted. Absent a secure method to protect this information, a manufacturer is exposing itself to enormous potential liability risk and legal costs. The integrity of the medical device digital supply chain is, more than ever, a key priority for the industry.

Loss of control over confidential/personal data

One essential characteristic of the medical industry is its responsibility for PII (Personal Identification Information) and PHI (Personal Health Information), which require HIPAA compliance. Due to the life-critical nature of the services it provides, the healthcare industry is continually under attack by cyber terrorists. Ransomware is the top threat to healthcare organizations. In 2016, this industry suffered at least one breach every day, affecting more than 27 million patient records.

One contributing problem is that most healthcare facilities and organizations are vulnerable to these attacks because they have failed to implement the latest measures to prevent intrusion of hackers and malware. Meanwhile, media reports tend to focus on the personal healthcare records that were held for ransom (or, in some cases, stolen).

However, a recent Washington Post article highlights the fact that medical devices themselves are frequently not secure.

Cybersecurity researchers have also raised alarms about vulnerabilities in implantable medical devices that hackers could exploit to injure or even kill patients. Former vice president Dick Cheney famously had his internal pacemaker taken offline because of hacking fears. [Ref 2]

This highlights the need to ensure that access to, and the data produced, by a medical device cannot be compromised due to a counterfeit product. For example, an individualized medical device may contain personally identifiable information and a data breach may trigger security and privacy laws. Again, this points to the need to ensure that every medical device that is manufactured and released for sale is authentic and includes all the safeguards designed into it by the original engineering team.

Another example would be the prosthesis industry: additive manufacturing is a perfect technology to generate on-demand customized prosthesis. Some of the data contained in the technical data package necessary to manufacture the part may fall under HIPAA scope and as such must meet the most stringent security and privacy requirements.

In my next (and final post), I’ll focus on two cybersecurity risks associated specifically with manufacturing of medical devices: production risk and traceability risk.

References:

1. http://www.ipcommission.org/report/ip_commission_report_052213.pdf
2. https://www.washingtonpost.com/news/powerpost/paloma/the-cybersecurity-202/2019/01/29/the-cybersecurity-202-medical-devices-are-woefully-insecure-these-hospitals-and-manufacturers-want-to-fix-that/5c4f4a661b326b29c3778cef/

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.

You may also like:

1. Five Reasons Cybersecurity Will Play a Critical Role in 3D Printing in Healthcare – Part I, by Stephan Thomas
2. 3D Printing Poses Unique Security Risks for Medical Devices by Farah Tabibkhoei
3. Cybersecurity for 3D Printed Medical Devices, Less Crazy and More Useful Than Bitcoins by Jenny Chen
4. Decentralized Healthcare — Part II: Breaking It All Down by Jenny Chen

The post Five Reasons Cybersecurity Will Play Critical Role in 3D Printing in Healthcare – Part 2 appeared first on 3DHeals.

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

In this series of three articles, we explore five critical risk areas related to data integrity, their consequences, and ways to mitigate them.

Additive manufacturing (AM) is fundamentally changing how the medical industry designs, manufactures, distributes, and maintains products. Soon, all medical products will be part of a digital process — from design through simulation to manufacturing. Additive manufacturing has the potential to offer a faster, more flexible supply chain that accelerates the prototyping process, decreases time to market, reduces waste, and better serves the needs of clients and patients. This benefits the industry in the development of prosthetics, implants, bioprinted organs, spare parts for medical equipment and drugs by lowering the cost production and enabling fully customized products to be made available at the time and place of need.

But, like any other industry going through the digitalization of its products, new challenges are emerging that have created vulnerabilities along the supply chain. The digitization of the medical industry is unique in many ways because of manufacturing regulations, healthcare compliance, and the sensitivity of data such as electronic health care records and personal data.  

According to the RegData’s Industry Regulation Index, the medical industry ranks in the top 10 most-regulated industries because of the high volume of data and rapidly shifting requirements. Additionally, medical manufacturing is a $156B market and is one of the top five most-targeted industries for cyber attacks.

As the medical industry digitizes its supply chain and manufacturing processes, there are five key challenges related to management and control of data (such as the design, engineering and manufacturing data required to additively manufacture anything).

1.      IP risk: if competition (through either legitimate or nefarious actions) gets access to these data, this ultimately leads to potential loss of revenue for the owner of the IP (by way of comparison, consider how the entertainment industry was transformed by the arrival of file sharing and unauthorized reproduction).

2.             Production risk: parts can be produced by any owner of a 3D printer, without following any standard or material requirements — and lacking quality control. This can easily lead to products of inferior quality and performance.

3.             Traceability risk: the lack of connection between a physical part that is additively produced and its digital twin can lead to concerns about the authenticity of part (Did it originate from the latest design? Was it manufactured the right way with the appropriate material? And so on).

4.             Liability risk: since manufacturers are liable for defects in their products — defects in design, manufacture, or foreseeable misuse — the loss of control over data or production process can lead to greater exposure or even legal liability regarding product defects and misuse.

5.             Confidentiality risk: protecting the confidentiality and privacy of personal health data is critical in the medical sector. Therefore, some of these data will be associated with design and manufacturing data for the production of individualized medical devices such as as customized prostheses, implants, and bioprinting. There are implications here regarding data risk exposure that the healthcare sector will have to address.

In my next article, I will discuss these risks in more detail and review options and approaches to help mitigate them.

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:

Cybersecurity for 3D Printed Medical Devices: Less Crazy and More Useful Than Bitcoins – by Jenny Chen, M.D.

3D Printing Poses Unique Security Risks for Medical Devices – by Farah Tabibkhoei, J.D.

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

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

The post Five Reasons Cybersecurity Will Play a Critical Role in 3D Printing in Healthcare – Part 1 appeared first on 3DHeals.

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

The congressional testimony by Mark Zuckerberg, CEO/founder of Facebook this week has left many in deep reflection. The data leak and the implicated political influence by a foreign country on the US politics woke many Americans (and perhaps the world) up. Fifteen years ago, when everyone in college just signed up for Facebook and excited about the phrase “social media”, few could imagine these dark days like this week. Few they were, but not none. The growth of the internet and mega-startups like Google, Twitter, and Facebook outpaced our ability to forecast, reflect, and protect against potential downside of technical revolutions. Therefore, as the city of San Francisco is getting ready for one of the largest cybersecurity conference RSA 2018 next week, it is a good opportunity to remind everyone again that in the realm of healthcare 3D printing, cybersecurity vulnerabilities are innumerable and need to be addressed now, or it will be an expensive lesson for all.

A lot more expensive than bitcoins.

There are several reasons 3D printing is favored as the enabling technologies in Industry 4.0:

· Complexity for free

· Mass customization

· Decentralization of the manufacturing and distribution process

These characteristics are also perfect for manufacturing the next-generation medical devices and hopefully providing a more personalized, on-demand healthcare services at lower costs.

Nonetheless, these very benefits also pose additional cybersecurity vulnerabilities throughout the product lifecycle. From design, manufacturing, to distribution. A lot more than traditional manufactured medical devices.

· Design stage: First of all, it is not hard to imagine that stealing design is made a lot simpler when the entire product is digitally manufactured. There is no need for reverse engineering no matter how complex the product is. In fact, there is evidence that some design can be copied simply based on the vibration of a 3D printer at work. [1] Second, tampering critical component of a design via cyber attack is now possible. [1,2] A tampered hip implant design surely will result in a patients’ suffering and lawsuits but tampered implantable electronic devices like cardiac pacemaker will have more grave consequences.

· Manufacturing stage: Recently NYU researchers have shown that not all defects can be detected using current quality control techniques. [1] Intentional or unintentional design data corruption may result in such defects bypassing conventional quality control that can pose serious health risks. The same group of researchers also shown that simply changing the orientation of extrusion head will result in a structure with entirely different mechanical properties. [1]

· Decentralized manufacturing and distribution: One of the major benefits of digital manufacturing is that the same digital blueprints can be transmitted via the internet/cloud into any 3D printer located anywhere in the world. Such decentralized manufacturing ability allows for an entirely different supply chain, including solving the transportation problem, cost saving due to efficient inventory and storage. In healthcare, one eventual goal for many is to be able to produce personalized medical devices on-demand with this decentralized system. However, every step along the chain will put the device manufacturer at risk of losing proprietary design to defective end products. Things can be even more complicated if patients’ data is breached and used in a malicious way. For example, it is not too hard to imagine losing sensitive biometrics data or tampered electronic implantable device to a military personnel can pose national security risk no less than our current concern around the presidential election.

Similar to 3D Printing, the FDA also issued its recommendations in cybersecurity surrounding ANY medical devices [3,4]:

“1) Medical device manufacturers and health care facilities should take steps to ensure appropriate safeguards. Manufacturers are responsible for remaining vigilant about identifying risks and hazards associated with their medical devices, including risks related to cybersecurity. They are responsible for putting appropriate mitigations in place to address patient safety risks and ensure proper device performance.

2) Hospitals and healthcare facilities should evaluate their network security and protect their hospital systems.”

Currently, there are a few 3D printing cybersecurity startups, namely 3DP Security, Identify 3D, however, no company so far focuses on developing dedicated cybersecurity solution for 3D printed medical devices or 3D printing software. (Oh yeah, please PM me if you are starting one.)

So, this loops back to bitcoins. Bitcoins are considered speculative, i.e. it can be worth nothing or a lot tomorrow. However, what is valuable to all is the knowledge that blockchain, the underpinning technology behind bitcoin has successfully withstood cyber-attacks for more than 9 years. [5]

Between a bitcoin and another “coin” with the encrypted design of a 3D printed medical-device, which one will you pick?

References:

1. https://www.designnews.com/3d-printing/3d-printing-has-urgent-need-cybersecurity/42281071756489

2. https://bdtechtalks.com/2017/07/05/the-cybersecurity-risks-of-3d-printing/

3. https://www.mddionline.com/why-cybersecurity-must-be-part-medical-device-architecture

4. https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm

5. https://www.forbes.com/sites/omribarzilay/2017/08/21/3-ways-blockchain-is-revolutionizing-cybersecurity/#14619d452334

You may also like:

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

3D Printing in Hospitals: Challenges and Solutions, a Children Hospital Perspective

The post Cybersecurity for 3D Printed Medical Devices, Less Crazy and More Useful Than Bitcoins appeared first on 3DHeals.

Niall Haslam is the CTO for Axial 3D. He will be a speaker at our upcoming London event. 

Jenny: When was the first encounter you had with 3D printing? What was the experience like? What were you thinking at that moment?
Niall: I first came across 3D printing in Dublin at UCD in 2010. The School of Architecture had an early mCor paper based printer in the building next to Complex and Adaptive Systems Laboratory where I was working at the time. One of the engineers from the Genetic Algorithms team had been using it to print the outputs of one of their designs for electricity pylons. The machine had its own room and took up most of the space. It was very noisy and slow, but it made really cool objects. I was intrigued and started experimenting with creating protein structures to help explain how protein-protein interactions worked. Quite quickly moved on to using FDM printers as they were able to handle some of the more complex shapes. It was clear to me that these machines were going to be very important in education and visualization. It was great to meet the guys from mCor again recently and see the enormous progress they have made since those early prototypes. Their machines are now able to produce the most wonderful colors and detail in their prints. You’d never know that it was made from paper!
Jenny: What inspired you to start your company in 3D printing?
Niall:  I joined axial3D to be a part of making medical 3D printing routine. 3D printing is having an enormous impact on healthcare already, and we are only at the beginning. The range of healthcare applications for medical 3D printing is growing rapidly, and there is still some work to do in making it accessible to the surgeons and healthcare provider. A key area to be addressed is the software. Combining clinical and technical understanding with machine learning to develop automation of the process will drive the adoption of 3D printing in healthcare. Tools are needed for augmenting segmentations as well as ensuring good manufacturing processes in fabrication is adhered to. I’ve always enjoyed working in new technologies and exploring their limits. This has given me an insight into how to get products off the ground but also to make sure that they are going to be used and be useful to the user. My colleagues have that same drive, to make 3D printing routine, and with the medical, software and machine learning skills we have, we are uniquely placed to make 3D printing easier and more affordable for healthcare practitioners.
Jenny: Who else inspired you the most along this journey in 3D printing?
Niall:  I am inspired mostly by the surgeons who use the technology. They are the true innovators. They are not content that a 2D or 3D visualization is giving them all the information they need, and they want to improve their insight to increase the chance of a better outcome for their patient. These people are not happy with the status quo, they want tools to make them better. Even if they are leaders in their field already, they still see the potential of 3D printing to deliver improvements. Early adopters are needed in every industry, and in healthcare where there is a conservative approach to adopting new innovations, they are more important than ever.
Recently, Transplant Surgeon, Tim Brown visited the axial3D offices to meet the team. He gave a talk at our offices on the surgery and how he has been using 3D printing in transplant surgery. He talked about the life-changing impact of transplant surgery and I found his dedication to improving outcomes inspiring. He was part of the Belfast team who carried out five kidney transplants in a single day to equal a UK record, falling just short of the world record of 6, held by a US hospital.
Jenny: What motivates you the most for your work?
Niall: I’m motivated by a desire to improve processes and make things easier for people. I’m a big believer in making the best option the easiest to follow. The tools we create make it easier to do the right thing by default. With service delivery, we have spent the last year refining our web platform to make it even easier to order an anatomical print for surgical planning. We’ve been lucky to get funding from the UK government to collaborate with Ulster University in applying design thinking methodologies to our service. This has resulted in a more streamlined service and better user experience. This is also obvious in our 3D printing workflow platform which is used by 3D printing laboratories to manage the production of medical 3D prints within the hospital setting. Here we have applied the same techniques to improve the flow of data and ensure that the engineering staff captures the right information, at the right time-points, to provide the underlying foundation for task management, tracking, reporting and quality assurance.

(photo source: axial 3D pelvic trauma model)

Jenny: What is/are the biggest obstacle(s) to your work? If you have conquered them, what were your solutions?
Niall: The biggest obstacle for not just our company, but all medical 3D printing solution vendors, is who ‘owns’ medical 3D printing, and therefore who pays. Inside the National Health Service (NHS) in the UK we’ve been fortunate to navigate this and be listed in the procurement framework to provide 3D printed models, much like a vendor would provide plates or screws for surgery. In the United States, there is a need for insurance to start recognizing medial 3D printing, in all forms, to ensure reimbursement for their use. I don’t think this is too far away, as the impact data is growing each day. Budget is always a problem when a new technology is introduced, but it is becoming easier as more departments want to be involved. In our experience, once a surgeon, no matter how skilled, holds a 3D printed model of their case in their hands, they really understand the impact of added insight.
Jenny: What advice would you give to a driven college student in the “real world”? What bad advice you
heard should they ignore?
Niall: I would tell them to work on something that they are happy working on. There is no substitute for passion when it comes to research. Working hard on something you don’t particularly care about is always going to be a struggle. If you find something that you like working on then you don’t mind putting in the hours required to succeed. Part of this is also about learning to be comfortable with failure. If you aren’t enjoying something it’s ok to walk away, you’ve learned something about yourself and have freed up a time to work on something more productive.
Jenny: If you could have a giant billboard to promote a message to millions and even billions of people in our community (i.e. healthcare 3D printing and bio-fabrication), what message would that be?
Niall: I’m a big believer in design thinking and so I’d have to say ‘Start small – experiment’. This allows you to create a more sustainable solution and one that will get used more. Don’t just rush out buying a printer – think about the whole service offering and the long-term view of your printing needs. This prototyping approach allows you to build your understanding of what you need before you invest. We hear a lot of stories about machines being bought without anyone to operate them, or without a defined application. We work with hospitals to gather the data before they build the business cases or make investments which work well.

(Team Axial 3D, front row, right: Niall Haslam, left: Daniel Crawford)

Jenny: What were/was the best investment you made in 3D printing/bio-printing/bio-fabrication?
Niall: Our investment in machine learning has already reaped enormous rewards. We’ve created a number of important collaborations with public and private health trusts as well as research-intensive universities both in Europe and the US. We’ve also recruited a number of key staff and are rapidly building our capabilities, including through the NVIDIA Inception program. This investment will continue as we gain further operational efficiency from augmentation of our processes. Already we are able to significantly reduce the amount of time spent segmenting and spend more time on quality assurance. The machine learning platform is giving us more time to ensure that we are doing production correctly. We’ve also been looking at blockchain and related technologies. There is a lot of hype around this right now. I think it has the potential to have a major impact on supply chain management and manufacturing. The baked in the provision of provenance and security is going to be vital as we move to bioprinting. I think we’re going to have to learn a lot of lessons about manufacturing bespoke products at scale in the 3D printing world before we can start to offer that as a service commercially. People need to have absolute confidence in the supply chain and manufacturing process in order for bioprinting to be adopted by the world. I think blockchain may just be one of the underpinning technologies that give people the confidence in the manufacturing process.
Jenny: What was/is the biggest risk you took in your career?
Niall: Joining axial3d from a large corporation was a big risk for me. I had a great role in my previous company and was very happy. The lure of a startup in medical technology was too great though, and the opportunity to work at the ground level was very exciting. It’s been a real roller coaster as we’ve now launched our new software products and started deploying to customer infrastructure. In the last ten years, we’ve seen a massive jump in the number of startups globally. I believe this is in part due to a realization by corporations that it is tough to innovate. Bigger companies tend to be invested in their existing cash cows and slower to embrace new technology and potential efficiencies. Here at Axial3D, we believe in continuous improvement and we are able to push improvements into production monthly.
Jenny: What do you enjoy in your spare time? What are you passionate about outside of your work/3d printing?
Niall: I’m a big believer in open data – information about our society that is freely available and made available by large and small organizations. Some examples are the likes of OpenStreetMap – an initiative similar to Wikipedia but for maps. This kind of resource has been invaluable when providing aid to disaster zones as NGOs can plan more effectively. To me, this is an extension of open-source software. Open source software has been transformative in unlocking innovation in the last twenty years. Linux, Firefox and Apache software have all changed the way we deploy and think about technology nowadays. Similarly, I believe that many innovations in the next twenty years will be driven by open data sets. We can see this already in the smart cities where information about bike rental schemes, for example, is freely available so people can practice their machine learning skills by predicting if bikes will be at a particular stand at a particular time. Open data challenges have already delivered real impacts in healthcare. In the UK several challenges have opened public health data to examination by scientists, statisticians, and programmers resulting in real improvements in the provision of healthcare by identifying previously overlooked problems and identifying new solutions. It would be great to see some progress in this direction in radiology – the availability of common shared open datasets would allow benchmarking of machine learning algorithms and promote progress in this application domain. Initiatives like the 3D print Exchange at the NIH show the potential of open data in 3D printing.
 Meet Niall in person during our London Event. 

The post Interview: Niall Haslam CTO of Axial 3D appeared first on 3DHeals.

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

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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