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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 changing design formats (I don’t think football players will start to wear Ironman helmets) (source and source)

3D printing has advantages in terms of cost, manufacturing, design and process, as well as the ability for mass customization.
The reason why everything is not 3D printed at this time includes but is not limited to laborious post processing, limited build sizes, and unknown regulatory pathways in healthcare and other sectors like aerospace and even consumer goods.
When a 3D printed product fails or something goes wrong with it, there is a potential for litigation. The uncertainty surrounding these potential issues was the focus of a recent webinar hosted by Exponent with presentations from Judd Day and Richard Underwood from Exponent, and Stephen Myersfrom Irwin Fritchie. Presented here are some interesting brain teasers for the future of 3D printing regulation.

Personalized test subjects?

The idea of mass customization is great. Personally, as a runner, I look forward to the soon future when personalized shoes for your feet are no longer just for professional athletes (or behind a very large price tag).

Our current shoes come in discrete sizing. While this may not work for people that are a size 9.25-wide (and you can only get a size 9-wide or 10-narrow) it enables manufacturers to perform quality testing on all the available designs. When there are potentially numerous size specifications and design aspects of shoes, how do you perform quality testing?

Another example given in the webinar was helmets. Do you create tests based on ‘standard’ head forms for product validation? What is a standard head?
In the medical device field, custom devices are for medical cases rare enough that testing cannot feasibly be performed (i.e., there are not enough people with the disease or condition to facilitate testing). With custom devices, there is generally an accepted range of specifications for a certain design that are allowed.
This is a similar idea to what was discussed in the webinar; setting limits to how variable the design of a product can be as a way to enable validation testing. In this way, there are fewer design variables to be test.

Who is liable in case things go wrong?

Photo credit to Annie Spratt

Traditionally, the manufacturer had the most information on a product; the design, materials used, manufacturing process, delivery method to the customer, etc. The parent company may not deal with each of these steps but is normally still responsible for the product’s performance (For example, if I buy a X-brand computer from a secondary reseller and the computer fails I will be redirected to X-brand for service).

With the 3D printing, it is more likely that the designer will not also be the manufacturer.

There are increasingly more commercial 3D printer services and at-home printers; the designer is providing the code to make something and not necessarily connected to the final product. However, the source code/design is not the only factor that affects a products quality; materials, printer, orientation (more for anisotropic materials) and location of the part on the 3D printer bed, as well as post-processing steps must also be considered. One or more people/machines may be responsible for implementing each of these steps.

Because of a decentralized digital manufacturing work flow, liability issues become more complex.

Did you deliver a product or a service?

During the webinar it was highlighted that, in previous court cases, computer code was not considered a product. If the distribution and use of something is the same as a traditional product then it may still be considered a product in the future.

How regulatory bodies will work with this has yet to be fully determined and will likely depend on the product type and industry. An additional layer to the complexity is that product liability law is dependent on where an issue is filed as well as where the product was made.

In design defect litigation, a case is usually won when the risks associated with a design as a whole are found to be greater than the benefits, or an alternative design with minimal change could have made the product less risky. The case is primarily lost when the new design is marginally more effective in one aspect but far less effective in others. With 3D printing, the delineation of benefits gained and risks incurred will be much more complicated since new designs are much easier to implement. For additional info on design defect litigation here is a more detailed piece.

Closing thoughts

There are wonderful possibilities that are enabled with 3D printing and many of us just want to shoot for the moon with our new toolkit!

Potential litigation and necessary testing issues may seem like a school teacher imposing new rules to a wonderful game. However, understanding the issues and coming up with solutions will enable a wider spread adoption of 3D printing and decrease potential dangers (as well as a lot less finger pointing and/or fights if something goes wrong in the design or manufacturing process).

The post 3D Printing: Limitless potential not without risk — Some insights from recent Exponent webinar appeared first on 3DHeals.

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

The post 3DHEALS EVENT RECAP: Legal Landscape of Healthcare 3D Printing – Knowing the Unknown appeared first on 3DHeals.