Comprehensive KCE Report Offers Framework and Overview of 3D Printed High-Risk Medical Devices

According to a new report, published under a Creative Commons license by the Belgian Health Care Knowledge Center (KCE), the combined medical and dental sectors make up the third largest 3D printing market, right after the industrial and aerospace sectors, accounting for roughly 13.1% of all 3D printing usage. 3D printing has definitely made a major impact in the medical field – the use of more realistic 3D printed medical models in hospitals was one of the top 3D printing themes of 2017, and the market for 3D printed medical devices, which the FDA released new guidance about last month, has been growing steadily.

Manufacturers can use digital 3D files, like MRIs, CTs, and CAD drawings, to create customized, 3D printed medical devices that match a specific patient’s anatomy, regardless of how complex the internal structure is. The report says, and we know it to be true, that this capability has “sparked huge interest in 3D printing of medical devices and other 3D printed applications in medicine.”

The report, titled “Responsible use of high-risk medical devices: the example of 3D printed medical devices,” breaks down the three main types of medical devices that 3D printing technology can be used to fabricate:

• Customizable (several individualized items produced in sequence or simultaneously)
• Standard (identical parts too expensive or complex to be produced using other methods)
• Custom-made (unique, custom models or devices fitted to individual patients).

“As the 3D technology for devices matures, regulators, physicians, payers, manufacturers and other actors involved in the 3D printing process will need to address the risks and challenges that this technology inevitably brings,” the report states. “This report aims to provide the actors involved with a framework for a managed practice and use of 3D printing/3D printed medical devices in Belgium. We focus on high-risk medical devices since they have the highest potential risks for the patient and they are often the most expensive for the payer. The presented framework can be generically used for other high-risk innovative medical devices.”

3D Systems/K2M 3D printed bone implant.

The goal of the report was to draft an operational framework for general 3D printed medical devices, and high-risk ones by extension, and the objective was to offer an overview, rather than assess evidence on the safety and effectiveness of using 3D printing technology for these devices.

Medical devices are separated out into class according to the associated risk, and high-risk ones include, among others, implantable or long-term surgically invasive devices that come in contact with the heart, central circulatory system, or central nervous system, and implantable/surgically invasive devices that are meant to correct, control, diagnose, or monitor heart defects or circulatory defects by coming into direct contact with these body parts.

In addition to giving a brief overview of the 3D printing process, the report covers a few specific research questions:

1. What is the effectiveness and safety for the patient of 3D printing technology for medical indications?
2. What is the available evidence on cost-effectiveness of 3D printing technology for medical indications?
3. What are the legal issues related to 3D printing/3D printed medical devices?

The first question was originally focused mainly on custom 3D printed implants, but after consultations with stakeholders, the scope was widened to include 3D printed surgical guides and planning models because, as the report states, “these were reported to be the most clinically relevant and most frequently used applications.”

The fourth chapter of the massive report includes several tables and citations comparing various studies and economic evaluations of 3D printed medical devices, in terms of both cost and time.

“In two studies there appeared to be a benefit using the 3D-printed technology with respect to the length of hospital stay,” the report states.

“On the cost side, 3 studies indicated that 3D-printing techniques resulted in net cost-savings compared to traditional techniques.”

Materialise Surgical guide.

The report also addresses several legal issues related to 3D printed medical devices, such as data protection, intellectual property rights, liability, patients’ rights, and reimbursements.

If you’re interested in learning more, you can find the full scientific report, and supplements, on the KCE website. Authors of the comprehensive report include Irm Vinck, An Vijverman, Erik Vollebregt, Nils Broeckx, Karlien Wouters, Mariel Piët, Natalija Bacic, Joan Vlayen, Nancy Thiry, and Mattias Neyt; Vinck, Vlayen, Thiry, and Neyt are all with KCE. The Project Coordinator was KCE’s Nathalie Swartenbroeckx (KCE), while Reviewers included Irina Cleemput and Chris De Laet. External experts were also consulted, including representatives from Materialise, UZ Leuven, FAGG – AFMPS, Michigan State University, UCL, and others.

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