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.