Ideas to Implementation: — What are the major operational management challenges in using 3D printing for pre-surgical application today?

Hui Jenny Chen, MD and Michelle Gabriel, MS, MBA
(This blog is adapted from our recent publication A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery)

The healthcare 3D printing sector represents 15% of the global 3D printing industry revenue generated and is growing rapidly at 20–25% Compounded Annual Growth Rate (CAGR). (REF: 1, 33). While the application of such novel technology in healthcare has generated significant excitement, healthcare 3D printing remains nascent with multiple one-off or low-volume prints except in the areas of hearing aids and dental applications. Growth has been predicted by a number of major analysts, mostly at a rate of double digit percentage.

The expiration of several major 3D printing patents (REF 40), rapid innovations and emerging applications have fueled this anticipation of growth. However, this rapid growth has also posed significant challenges to policy makers, the FDA, and the existing legal process. The combination of a lack of sufficient clinical data, funding, sound business strategies, and the opaque regulatory/legal landscape presents a significant barrier to entry for many.

Although there are no established regulations for healthcare 3D printing, either in the U.S or globally, governments are starting to seriously address this need The US Food and Drug Administration is actively involved with evaluating the safety and effectiveness of 3D printing for medical applications and promoting its use. The FDA website has a significant amount of information and links on Additive Manufacturing. In May 2016 the FDA published a guideline document Technical Considerations for Additive Manufactured Devices which is broadly organized into two section design and manufacturing considerations and testings considerations. The document is open for public comment.

In 2012 President Obama’s showed visible support of the additive manufacture industry through the creation of the National Additive Manufacturing Innovation Institute (NAMII). (NAMMI is a public- private institute for manufacturing innovation headquartered in Youngstown, Ohio with $70 million in funding. )

Adoption of this technology for pre-surgical applications has demonstrated early, quantifiable clinical benefits on an anecdotal basis, especially in terms of decreasing operating time (REF:13,17). Increasing interest in the adaptation of this technology from the hospital and surgical centers across the globe is evidenced by a simple Pubmed publication search. (REF: 2–8, 10–14 , 18,19) . Formal clinical trials, however, have been few and far between and these are required before the healthcare applications can really become mainstream.

However, the roadmap to a successful implementation of 3D printing for pre-surgical planning remains obscure and disjointed.

To find solutions, we must identify the issues first. In Table I below, we grouped various operational management issues into three categories. In our follow up blogs, we will discuss each issue more in-depth, referencing our book and adding updates.

Our intention is that by clarifying the challenges and issues in operational management, we can provide a framework that will make implementation easier (and perhaps cheaper) for everyone who is interested in investing in the space.

Table I. Major operational management considerations

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