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The Australian Bioprinting Workshop for Tissue Engineering and Regenerative Medicine was founded to create a community of scientists, clinicians, and engineers to work in synergy with industry,...
This is a weekly updated collection of press articles on innovations using 3D printing against COVID-19, complementing our existing COVID19 3D Printing information page, which includes our webinar...
In this issue, we included three latest publications focusing on 3D printing for congenital heart disease and a novel organ on a chip model focusing on cardiac toxicity. The first two articles focus...
In the previous section of this guide, we went in-depth about the tactical issues surrounding 3D printing in hospitals, which include an array of contributory elements ranging from talent allocation, hardware/software selection, to material management. In this section of the guide, I will focus on the financial issues of 3D printing in hospitals. To review, financial issues answer the question of “how much”. In the healthcare arena, it includes a discussion of “reimbursements“. Doing business in healthcare is not a straightforward “profit-and-loss” spreadsheet. The reimbursement pathway of emerging technology is tortuous, and the pricing strategy of devices and services is even more opaque to most.
Morphology and composition have a direct effect on the final implant microstructure. The microstructure has great importance in the implant strength. The smaller the material crystals are, the more grains there are, and consequently more internal boundaries. Internal boundaries lead to bigger resistance to the atom’s mobility, which is related to strength When material failures, normally happen by cracking, cracks are generally initiated by irregular pores, rounded pores usually do not initiate cracks, so control feedstock is mandatory to control the process-induced porosity and cracking.
In the previous section of this guide, we went in-depth about the strategic issues surrounding 3D printing in hospitals, which included the critical role played by clinical trials, organization and staffing, and regulatory/legal concerns. In this section of the guide, I will focus on the tactical issues in 3D printing in hospitals. To review, tactical issues answer the questions focusing on "how". In other words, tactical consideration refers to how a company plans to get the job done or achieve a strategic objective. Tactical planning considers the resources available (time, money, people) along with the risks or challenges that may be encountered. Based on tactical consideration, the company determines the most efficient way to use resources to achieve strategic goals with quality results.
Before discussing issues specific to each entity in the 3D printing chain, one general issue is exposure created by a lack of established FDA regulations and industry standards. Generally, compliance with FDA, ASTM, and/or ISO regulations and standards are important shields for companies to employ in defense of a lawsuit. Even if your company or entity is not required to comply with FDA regulations, well-established guidance helps companies understand issues and expectations. With 3D printing, however, it does not have the same extensive history or regulatory framework safety net. On December 5, 2017, the FDA adopted the final form of its guidance document on 3D printing entitled “Technical Considerations for Additive Manufacturing.” The guidance does not cover the point of care printing nor bioprinting issues. The guidance does not establish specific requirements but rather describes issues to be considered and addressed by manufacturers during product testing and manufacturing development stages. While the guidance does suggest having procedures and validation processes to address certain issues unique to 3D printing—such as the use of reused materials, software integration, and build path variables—it does not identify any specific “how to’s” for those procedures or tests. Without such guidance or applicable standards, manufacturers are in the unenviable position of having the FDA identify a concern, but not offering any consensus standard for addressing it. ASTM International has developed some consensus standards for additive manufacturing. Committee F42 has developed standards for testing and evaluating methods for the materials used as well for the manufacturing processes. However, there are no specific standards addressing many of the issues and validation processes identified in the FDA’s guidance.
In part one of this guide, we provided background information on why a beginner's guide to 3D Printing in Hospitals is needed, and how we are organizing our thought process around three main operational management issues. That is, strategic, tactical, and financial issues related to implementing 3D printing in hospitals.
Over the last five years, there has been significant growth in the adaption of 3D printing in hospitals. This is a result of a more clarifying regulatory landscape, more governmental supports, and new public and private initiatives. Notable relevant public initiatives are led by RSNA SIG group, Mayo Clinic, ASME/SME, FDA, America Makes, ARMI. Notable private initiatives are led by JNJ/Depuy Synthes, GE, HP, Stryker, Medtronics, Lima Corporate, Materialise, Formlabs. The concerted efforts from the private and public sectors resulted in a rapid increase in hospital-based 3D printing labs all over the world. This is further supported by consistently increasing publications on Pubmed. [Figure 1, Source: Pubmed] Within a hospital setting, current major applications remain to be pre-surgical planning, which will comprise the bulk of our discussion. However, lately, there are two defining momentums: point-of-care 3D printing and mass-produced 3D printed implants in the 3D printing healthcare sector, which makes 3D printed personalized implants a possibility for hospital-based 3D printing services. We will incorporate these into our discussion.