Search

Purpose: The aim of this study was to report data from the first 3 years of operation of the RSNA-ACR 3D Printing Registry., Methods: Data from June 2020 to June 2023 were extracted, including demographics, indications, workflow, and user assessments. Clinical indications were stratified by 12 organ systems. Imaging modalities, printing technologies, and numbers of parts per case were assessed. Effort data were analyzed, dividing staff members into provider and nonprovider categories. The opinions of clinical users were evaluated using a Likert scale questionnaire, and estimates of procedure time saved were collected., Results: A total of 20 sites and 2,637 cases were included, consisting of 1,863 anatomic models and 774 anatomic guides. Mean patient ages for models and guides were 42.4 ± 24.5 years and 56.3 ± 18.5 years, respectively. Cardiac models were the most common type of model (27.2%), and neurologic guides were the most common type of guide (42.4%). Material jetting, vat photopolymerization, and material extrusion were the most common printing technologies used overall (85.6% of all cases). On average, providers spent 92.4 min and nonproviders spent 335.0 min per case. Providers spent most time on consultation (33.6 min), while nonproviders focused most on segmentation (148.0 min). Confidence in treatment plans increased after using 3-D printing (P < .001). Estimated procedure time savings for 155 cases was 40.5 ± 26.1 min., Conclusions: Three-dimensional printing is performed at health care facilities for many clinical indications. The registry provides insight into the technologies and workflows used to create anatomic models and guides, and the data show clinical benefits from 3-D printing., (Published by Elsevier Inc.)

Introduction: External fixation is a critical component of orthopaedic fracture management and is used for various conditions, including trauma and pediatric orthopaedics. However, the availability and high cost of external fixation devices are a concern, especially in rural and developing countries. 3D printing technology has shown promise in reducing manufacturing costs and improving accessibility to external fixation devices. The purpose of this study was to evaluate the mechanical properties of a fully 3D-printed desktop external fixation device and compare the results with the mechanical properties of commonly used, clinically available external fixators., Methods: A fully 3D printable external fixator was designed and printed in polylactic acid at two infill densities, 20% and 100%. The mechanical properties of the 3D-printed external fixators and several commercially available fixators were tested according to applicable sections of the American Society for Testing and Materials F1541 standard protocol in axial, medial-lateral, and anterior-posterior orientations. The primary outcomes measured included failure load, safe load, rigidity, and yield load. The mean differences between experimental and control groups were calculated using one-way analysis of variance and Tukey tests., Results: The 20% infill 3D-printed construct showed poor performance compared with commercially available external fixators in all testing conditions and across most variables. The 100% infill 3D-printed construct was comparable with or superior to all commercially available devices in most testing conditions. The cost for printing a single 3D-printed 100% infill external fixator was $14.49 (United States Dollar)., Discussion: This study demonstrates that a low-cost desktop 3D printer can create an entirely 3D-printed external fixator that resists clinically relevant forces similar to medical-grade industry-standard external fixators. Therefore, there is potential for customizable and low-cost external fixators to be manufactured with desktop 3D printing for use in remote areas and other resource-constrained environments for fracture care., Competing Interests: Dr. Skelley is a consultant to CONMED Corporation on topics not related to the presented material in this manuscript. None of the following authors or any immediate family member has received anything of value from or has stock or stock options held in a commercial company or institution related directly or indirectly to the subject of this article: All other authors have no conflicts of interest. Dr. MacFadden, Mr. Adams, Mr. O’Connor, Mr. Boerhave, and Ms. VanDerWolde., (Copyright © 2024 by the American Academy of Orthopaedic Surgeons.)

Additive manufacturing, commonly referred to as three-dimensional (3D) printing, has the potential to initiate a paradigm shift in the field of medicine and drug delivery. Ever since the advent of the first-ever United States Food and Drug Administration (US FDA)-approved 3D printed tablet, there has been an increased interest in the application of this technology in drug delivery and biomedical applications. 3D printing brings us one step closer to personalized medicine, hence rendering the "one size fits all" concept in drug dosing obsolete. In this review article, we focus on the recent developments in the field of modified drug delivery systems in which various types of additive manufacturing technologies are applied., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Chan, Ranjitham Gopalakrishnan, Traore and Ho.)

Lipid nanoparticles (LNPs) are drug carriers for protecting nucleic acids for cellular delivery. The first mRNA vaccines authorized by the United States Food and Drug Administration are the mRNA-1273 (Moderna) and BNT162b (BioNTech/Pfizer) vaccines against coronavirus disease 2019 (COVID-19). We designed a 3D printed Omnidirectional Sheath-flow Enabled Microfluidics (OSEM) device for producing mRNA-loaded LNPs that closely resemble the Moderna vaccine: we used the same lipid formulations to encapsulate mRNA encoding SARS-CoV-2 spike protein. The OSEM device is made of durable methacrylate-based materials that can support flow rates in the mL min -1 range and was fabricated by stereolithography (SLA), incorporating readily adaptable interfaces using commercial fluidic connectors. Two key features of the OSEM device are: 1) a 4-way hydrodynamic flow focusing region and 2) a staggered herringbone mixer (SHM). Superior to conventional planar fluid junctions, the 4-way sheath flow channel generates an evenly focused, circular center flow that facilitates the formation of LNPs with low polydispersity. Downstream, fluid mixing in the SHM is intensified by incorporating a zig-zag fluidic pathway to deliver high mRNA encapsulation efficiency. We characterized the mRNA-loaded LNPs produced in the OSEM device and showed that the enhanced 3D microfluidic structures enable a 5-fold higher throughput production rate (60 mL min -1 ) of LNPs compared to commercial multi-thousand-dollar micromixers. The device produced LNPs of diameter less than 90 nm, with low polydispersity (2-8%) and high mRNA encapsulation efficiency (>90%). The 3D-printed device provides a cost-effective and easily prepared solution for high-throughput LNP production.

The field of craniomaxillofacial (CMF) surgery is rich in pathological diversity and broad in the ages that it treats. Moreover, the CMF skeleton is a complex confluence of sensory organs and hard and soft tissue with load-bearing demands that can change within millimeters. Computer-aided design (CAD) and additive manufacturing (AM) create extraordinary opportunities to repair the infinite array of craniomaxillofacial defects that exist because of the aforementioned circumstances. 3D printed scaffolds have the potential to serve as a comparable if not superior alternative to the " gold standard " autologous graft. In vitro and in vivo studies continue to investigate the optimal 3D printed scaffold design and composition to foster bone regeneration that is suited to the unique biological and mechanical environment of each CMF defect. Furthermore, 3D printed fixation devices serve as a patient-specific alternative to those that are available off-the-shelf with an opportunity to reduce operative time and optimize fit. Similar benefits have been found to apply to 3D printed anatomical models and surgical guides for preoperative or intraoperative use. Creation and implementation of these devices requires extensive preclinical and clinical research, novel manufacturing capabilities, and strict regulatory oversight. Researchers, manufacturers, CMF surgeons, and the United States Food and Drug Administration (FDA) are working in tandem to further the development of such technology within their respective domains, all with a mutual goal to deliver safe, effective, cost-efficient, and patient-specific CMF care. This manuscript reviews FDA regulatory status, 3D printing techniques, biomaterials, and sterilization procedures suitable for 3D printed devices of the craniomaxillofacial skeleton. It also seeks to discuss recent clinical applications, economic feasibility, and future directions of this novel technology. By reviewing the current state of 3D printing in CMF surgery, we hope to gain a better understanding of its impact and in turn identify opportunities to further the development of patient-specific surgical care.

This study presents a biomimetic 3D customizable artificial vascular graft with a highly porous and uniform microscale structure. The structural features were obtained by dip coating of a highly close-packed microsphere suspension on a 3D printed sacrificial template. Considering the structured arrangement of microspherical porogens in the coating layer, the microsphere-leached constructs showed higher uniformity and porosity than the conventionally particulate-leached structures, leading to ultrasoft mechanical compliance. Considering biomechanical compatibility, the resulting elastic moduli were at the sub-MPa level, comparable with those of native vascular tissues. In addition, the developed porous graft was reinforced selectively at the edge regions using a nonporous coating to secure its practical sutureability for clinical use. The sufficiently low cytotoxicity was clinically confirmed to alleviate the stiffness mismatch issues at the anastomotic interface between the native tissue and the artificial graft, thus overcoming the relevant clinical complications. Furthermore, the overall superior properties could be implemented on the 3D printed template for patient-specific medicare, thus implying the manufacturability of patient-specific vascular grafts.

Objective: To assess the effectiveness of a 3D-printed custom mask fitter in lieu of N95 respirators among ophthalmologists and other eye care professionals who may not be prioritized to receive N95 respirators amidst the coronavirus disease 2019 pandemic., Methods: This was a proof-of-concept study from a tertiary eye care center in Oakville, Canada. All participants underwent the N95 Qualitative Fit Test with a custom mask fitter secured over an American Society for Testing and Materials Level 3 face mask. Participants answered a 10-point Likert scale questionnaire on comfort, ease of use, and feasibility of the custom mask fitter, as well as comfort of a regular face mask., Results: Twenty participants were recruited. Of the 20 recruited, 18 (90%) successfully passed the fit test. The median scores for comfort, ease of use, and everyday feasibility for the custom mask fitter were 3.5, 4.5, and 3, respectively, whereas the median score for comfort of a regular face mask was 8.5., Conclusion: A reusable, low-cost, 3D-printed custom mask fitter is a potential effective alternative to an N95 respirator among eye care professionals but may require improvement in its design and comfort. This is especially relevant in the context of a limited supply of N95 respirators amidst a global pandemic., (Copyright © 2021 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.)

Additive manufacturing (AM) has continuously grown in recent decades. Enhanced quality, further development of technology, and fall in prices make AM applicable and capable for various industrial applications, also for the manufacture of medical devices. 3D printing offers the possibility for an unprecedented adaptation to the anatomy of each patient, generating medical devices on a case-by-case basis. In many jurisdictions, custom-made devices qualify for an exemption to pre-market approval standards. This regulation is called into question by new technologies, like AM. Therefore, this article compares the current regulatory requirements for custom-made devices in Europe, the United States, and Australia and discusses the impact on 3D printed devices. It concludes that not all jurisdictions have yet adjusted their regulatory framework for custom-made devices to technological advances. Remaining uncertainties must be eliminated in order to help manufacturers comply with the regulatory requirements, emphasizing key aspects of AM., (© 2022 Walter de Gruyter GmbH, Berlin/Boston.)

Introduction: Three-dimensional (3D) printed spinal cages are a new design of intervertebral body fusion devices. Clinical data on these devices are limited. The objective of this study was to describe six-month events for a new and older cage design., Methods: A retrospective, descriptive cohort study of patients that received a 3D-printed-titanium or PEEK (polyetheretherketone) cage with single-level lumbar fusion was performed using a United States hospital-based database. Outcomes evaluated were device-related revision and non-device related reoperation events 6 months after lumbar fusion. The 3D-printed-titanium and PEEK groups were propensity-score matched. Both unmatched and matched groups were descriptively analyzed. There were 93 and 2,082 patients with a 3D-printed-titanium and PEEK cage that met study criteria. The sample size was 93 patients per group after matching., Results: There were no occurrences of revisions in the 3D-printed-titanium and eleven occurrences in the PEEK group before matching; PEEK had no occurrences of revision after matching. Ten total reoperation events were identified., Discussion: Our findings suggest occurrence of 6-month revision or reoperation is similar or lower for both cages than reported in published literature. The low occurrence of early events for 3D-printed-titianium cages is promising. Further, real-world studies on 3D-printed cages are warranted.

Recent advancements in the bioinks and three-dimensional (3D) bioprinting methods used to fabricate vascular constructs are summarized herein. Critical biomechanical properties required to fabricate an ideal vascular graft are highlighted, as well as various testing methods have been outlined to evaluate the bio-fabricated grafts as per the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) guidelines. Occlusive artery disease and cardiovascular disease are the major causes of death globally. These diseases are caused by the blockage in the arteries, which results in a decreased blood flow to the tissues of major organs in the body, such as the heart. Bypass surgery is often performed using a vascular graft to re-route the blood flow. Autologous grafts represent a gold standard for such bypass surgeries; however, these grafts may be unavailable due to the previous harvesting or possess a poor quality. Synthetic grafts serve well for medium to large-sized vessels, but they fail when used to replace small-diameter vessels, generally smaller than 6 mm. Various tissue engineering approaches have been used to address the urgent need for vascular graft that can withstand hemodynamic blood pressure and has the ability to grow and remodel. Among these approaches, 3D bioprinting offers an attractive solution to construct patient-specific vessel grafts with layered biomimetic structures., (Creative Commons Attribution license.)

Three-dimensional (3D) printing is an additive manufacturing technique where objects are created under computer control. Apart from opening many avenues of manufacturing, 3D printing of medicine has become a lucrative area in research. The technology can deliver customised and effectively on-demand treatments for individuals with unique needs; drug delivery system capable of dispensing spatially accurate and low volumes of medicine; preparation of medicine comprised of complex composition and geometric shape. Advent of 3D printed drugs like Spritam ® has been FDA approved which have heightened the hopes. Pharmaceutical industry at present is shifting from mass production to personalised medicine as it promises future production of on-demand printed drugs with customised doses, increased productivity and cost-effectiveness. The goal of this article is to outline and explore the various approaches, along with the key aspects of drug printing, and also allow space for exploration of the main areas of 3D printing to be tackled in the future in order to make it an effective manufacturing route for the pharmaceutical industry.

Objective: In response to ongoing concerns regarding transmission of the novel coronavirus (COVID-19), surgical practice has changed for the foreseeable future. Practice guidelines recommend only urgent or emergent surgical procedures be performed to minimize viral transmission. This effectively limits standard training and practice for surgical residents. The purpose of this article is to describe opportunities in surgical simulation, and highlights the challenges associated with training in the COVID-19 era., Design: This is a perspective summarizing the potential role of surgical simulation to target training gaps caused by decreased surgical caseloads., Conclusions: This manuscript concisely discusses simulation options available to training programs, including the novel concept of "surgical kits." These kits include all instruments necessary to simulate a procedure at home, effectively pairing safety and utility., (Copyright © 2020. Published by Elsevier Inc.)

Background: The use of frameless stereotactic robotic technology has rapidly expanded since the Food and Drug Administration's approval of the Robotic Surgical Assistant (ROSA) in 2012. Although the use of the ROSA robot has greatly augmented stereotactic placement of intracerebral stereoelectroencephalography (sEEG) for the purposes of epileptogenic focus identification, the preoperative planning stages remain limited to computer software., Objective: To describe the use of a 3-dimensionally (3D)-printed patient model in the preoperative planning of ROSA-assisted depth electrode placement for epilepsy monitoring in a pediatric patient., Methods: An anatomically accurate 3D model was created and registered in a preoperative rehearsal session using the ROSA platform. After standard software-based electrode trajectory planning, sEEG electrodes were sequentially placed in the 3D model., Results: Utilization of the 3D-printed model enabled workflow optimization and increased staff familiarity with the logistics of the robotic technology as it relates to depth electrode placement. The rehearsal maneuvers enabled optimization of patient head positioning as well as identification of physical conflicts between 2 electrodes. This permitted revision of trajectory planning in anticipation of the actual case, thereby improving patient safety and decreasing operative time., Conclusion: Use of a 3D-printed patient model enhanced presurgical positioning and trajectory planning in the placement of stereotactic sEEG electrodes for epilepsy monitoring in a pediatric patient. The ROSA rehearsal decreased operative time and increased efficiency of electrode placement., (Copyright © 2019 by the Congress of Neurological Surgeons.)

Care for patients during COVID-19 poses challenges that require the protection of staff with recommendations that health care workers wear at minimum, an N95 mask or equivalent while performing an aerosol-generating procedure with a face shield. The United States faces shortages of personal protective equipment (PPE), and surgeons who use loupes and headlights have difficulty using these in conjunction with face shields. Most arthroplasty surgeons use surgical helmet systems, but in the current pandemic, many hospitals have delayed elective arthroplasty surgeries and the helmet systems are going unused. As a result, the authors have begun retrofitting these arthroplasty helmets to serve as PPE. The purpose of this article is to outline the conception, design, donning technique, and safety testing of these arthroplasty helmets being repurposed as PPE., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The use of frameless stereotactic robotic technology has rapidly expanded since the Food and Drug Administration's approval of the Robotic Surgical Assistant (ROSA™) in 2012. Although the safety and accuracy of the ROSA platform has been well-established, the introduction of complex robotic technology into an existing surgical practice poses technical and logistical challenges particular to a given institution., Objectives: To better facilitate the integration of new surgical equipment into the armamentarium of a thriving pediatric neurosurgery practice by describing the use of a three-dimensional (3D)-printed patient model with in situ 3D-printed tumor for presurgical positioning and trajectory optimization in the stereotactic biopsy of a pontine lesion in a pediatric patient., Methods: A 3D model was created with an added silicone mock tumor at the anatomical position of the lesion. In a preoperative rehearsal session, the patient model was pinned and registered using the ROSA platform, and a mock biopsy was performed targeting the in Situ silicone tumor., Results: Utilization of the 3D-printed model enabled workflow optimization and increased staff familiarity with the logistics of the robotic technology. Biopsy trajectory successfully reached intralesional tissue on the 3D-printed model. The rehearsal maneuvers decreased operative and intubation time for the patient and improved operative staff familiarity with the robotic setup., Conclusion: Use of a 3D-printed patient model enhanced presurgical positioning and trajectory planning in the biopsy of a difficult to reach pontine lesion in a pediatric patient. The ROSA rehearsal decreased operative time and increased staff familiarity with a new complex surgical equipment., (Copyright © 2019 by the Congress of Neurological Surgeons.)

Introduction: Future challenges for the U.S. Department of Defense (DoD) include operating in a contested environment against near-peer adversaries. Providing casualty care in an anti-access/area denial (A2/AD) region would be potentially challenged by impaired logistical ability to reconstitute supplies or adapt to evolving needs. Additive manufacturing (AM), also known as 3D printing, offers an ability to regenerate stocked items as well as modify them or even create novel products de novo., Materials and Methods: This article discusses relevant technology and applications for deployed medical forces. Additionally, as proof of concept, we outline our design process for a novel 3D-printed surgical retractor., Results: Our "Air Force Retractor" prototype highlights the potential of using AM to create or augment surgical instruments downrange., Conclusions: This paper encourages further investigation of the use of AM/3D printing downrange to create surgical instruments and medical supplies in austere, A2/AD, and other logistically challenging environments. Not only would this support regeneration of supplies, but also modification and even creation of novel products to adapt to changing needs. If 3D files could be created of common surgical instruments for print on designated resins downrange, and FDA approval obtained, an online library of files could be created for easy access to DoD members across the globe to support our nation's commitment to provide the best possible care for service members any time, any place., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2020. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Laser printers emit high levels of nanoparticles (PM 0.1 ) during operation. Although it is well established that toners contain multiple engineered nanomaterials (ENMs), little is known about inhalation exposures to these nanoparticles and work practices in printing centers. In this report, we present a comprehensive inhalation exposure assessment of indoor microenvironments at six commercial printing centers in Singapore, the first such assessment outside of the United States, using real-time personal and stationary monitors, time-integrated instrumentation, and multiple analytical methods. Extensive presence of ENMs, including titanium dioxide, iron oxide, and silica, was detected in toners and in airborne particles collected from all six centers studied. We document high transient exposures to emitted nanoparticles (peaks of ∼500 000 particles/cm 3 , lung-deposited surface area of up to 220 μm 2 /cm 3 , and PM 0.1 up to 16 μg/m 3 ) with complex PM 0.1 chemistry that included 40-60 wt % organic carbon, 10-15 wt % elemental carbon, and 14 wt % trace elements. We also record 271.6-474.9 pmol/mg of Environmental Protection Agency-priority polycyclic aromatic hydrocarbons. These findings highlight the potentially high occupational inhalation exposures to nanoparticles with complex compositions resulting from widespread usage of nano-enabled toners in the printing industry, as well as inadequate ENM-specific exposure control measures in these settings.

Benefits from the use of cadavers in anatomical education are well described. Historically, human embryos and fetal cadavers were used in anatomy education to understand development and congenital malformations. Recently, three-dimensional printed models produced from archival fetal specimens, and online repositories of images from archival collections of embryos and fetuses, have been used as an educational tool in human development courses. Given that the archival specimens were likely obtained prior to the era of informed consent, this raises questions about their appropriate and ethical use. Because some institutions in the United States retain archival collections of embryonic and fetal specimens that were once used as educational tools, their existence and utility require frequent reexamination against contemporary ethical frameworks to guide appropriate use or utilization. Four ethical rationales for uses of these collections are examined, including destruction, indefinite storage, use in research, and use in health professions education. Guidelines for the use of archival collections of human embryos and fetuses are presented. Indefinite storage and use in health professions education are supported, while use in research is also permitted, however, such use is limited and dependent on circumstance and purpose. The development of current digital repositories and three-dimensionally printed models based on archival collections that were collected without informed consent, or those promoting commercial opportunity, are not supported. New embryonic and fetal donations obtained with informed consent should include reference to potential uses with new technology and virtual, genetic, or imaging applications., (© 2019 American Association of Anatomists.)

Background: Despite novel assessment tools and 3D simulation, patient's desire for implant size change is one of the most common reasons for revision surgery after primary breast augmentation. In this study, we analysed outcomes and predictive indicators for revision surgeries in a cohort of patients operated on by a single surgeon., Patients and Methods: All consecutive patients who underwent revision augmentation surgery between 2013 and 2017 by the first author were included in this study. Besides review of medical records, subgroups based on the indication for revision surgery were compared and statistically analysed., Results: A total of 110 patients were included in this study. Revision surgery was performed 97.2 months on average after primary augmentation. Eighty-six per cent of patients received larger implants. Indications for revision surgery and associated subgroups were: (1) wish for bigger implants (38%), (2) complication + wish for bigger implants (26%), (3) complication (29%), (4) complication + wish for smaller implants (3%) and (5) wish for smaller implants (3%). Subgroup analysis showed that patients who underwent revision surgery for bigger implants were significantly younger compared to patients who suffered a complication or desired smaller implants. Time to secondary augmentation was significantly shorter in case of wish for size change compared to complications as reason for revision surgery. Implant sizes differed significantly in patients where volume change was the sole indication for surgery compared to revisions performed due to complications., Conclusion: In our cohort of patients, almost all patients who underwent revision surgery after primary breast augmentation received bigger implants. Patients who specifically wished for size change were younger, asked for surgery earlier and received larger volumes compared to patients who underwent revision surgery for other reasons., Level of Evidence Iv: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

One of the novel and progressive technology employed in pharmaceutical manufacturing, design of medical device and tissue engineering is three-dimensional (3D) printing. 3D printing technologies provide great advantages in 3D scaffolds fabrication over traditional methods in the control of pore size, porosity, and interconnectivity. Various techniques of 3D-printing include powder bed fusion, fused deposition modeling, binder deposition, inkjet printing, photopolymerization and many others which are still evolving. 3D-printing technique been employed in developing immediate release products, various systems to deliver multiple release modalities etc. 3D printing has opened the door for new generation of customized drug delivery with built-in flexibility for safer and effective therapy. Our mini-review provides a quick snapshot on an overview of 3D printing, various techniques employed, applications and its advancements in pharmaceutical sciences.

Advanced manufacturing techniques such as 3-dimensional (3D) printing, while mature in other industries, are starting to become more commonplace in clinical care. Clinicians are producing physical objects based on patient clinical data for use in planning care and educating patients, all of which should be managed like any other healthcare system data, except it exists in the "real" world. There are currently no provisions in the Health Insurance Portability and Accountability Act (HIPAA) either in its original 1996 form or in more recent updates that address the nature of physical representations of clinical data. We submit that if we define the source data as protected health information (PHI), then the objects 3D printed from that data need to be treated as both (PHI), and if used clinically, part of the clinical record, and propose some basic guidelines for quality and privacy like all documentation until regulatory frameworks can catch up to this technology. Many of the mechanisms designed in the paper and film chart era will work well with 3D printed patient data., (Copyright © 2018 Elsevier B.V. All rights reserved.)

The US Food and Drug Administration approval of the first 3D printed tablet in 2015 has ignited growing interest in 3D printing, or additive manufacturing (AM), for drug delivery and testing systems. Beyond just a novel method for rapid prototyping, AM provides key advantages over traditional manufacturing of drug delivery and testing systems. These includes the ability to fabricate complex geometries to achieve variable drug release kinetics; ease of personalising pharmacotherapy for patient and lowering the cost for fabricating personalised dosages. Furthermore, AM allows fabrication of complex and micron-sized tissue scaffolds and models for drug testing systems that closely resemble in vivo conditions. However, there are several limitations such as regulatory concerns that may impede the progression to market. Here, we provide an overview of the advantages of AM drug delivery and testing, as compared to traditional manufacturing techniques. Also, we discuss the key challenges and future directions for AM enabled pharmaceutical applications., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of"personalized medicine"., Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required., Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain., Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Purpose: Thoracoscopic esophageal atresia (EA)/tracheoesophageal fistula (TEF) repair is technically challenging. We have previously reported our experiences with a high-fidelity hybrid model for simulation-based educational instruction in thoracoscopic EA/TEF, including the high cost of the tissue for these models. The purposes of this study were (1) to create a low-cost synthetic tissue EA/TEF repair simulation model and (2) to evaluate the content validity of the synthetic tissue simulator., Materials and Methods: Review of the literature and computed tomography images were used to create computer-aided drawings (CAD) for a synthetic, size-appropriate EA/TEF tissue insert. The inverse of the CAD image was then printed in six different sections to create a mold that could be filled with platinum-cured silicone. The silicone EA/TEF insert was then placed in a previously described neonatal thorax and covered with synthetic skin. Following institutional review board-exempt determination, 47 participants performed some or all of a simulated thoracoscopic EA/TEF during two separate international meetings (International Pediatric Endosurgery Group [IPEG] and World Federation of Associations of Pediatric Surgeons [WOFAPS]). Participants were identified as "experts," having 6-50 self-reported thoracoscopic EA/TEF repairs, and "novice," having 0-5 self-reported thoracoscopic EA/TEF repairs. Participants completed a self-report, six-domain, 24-item instrument consisting of 23 5-point rating scales and one 4-point Global Rating Scale. Validity evidence relevant to test content and response processes was evaluated using the many-facet Rasch model, and evidence of internal structure (interitem consistency) was estimated using Cronbach's alpha., Results: A review of the participants' ratings indicates there were no overall differences across sites (IPEG versus WOFAPS, P=.84) or experience (expert versus novice, P=.17). The highest observed averages were 4.4 (Value of Simulator as a Training Tool), 4.3 (Physical Attributes-chest circumference, chest depth, and intercostal space), and 4.3 (Realism of Experience-fistula location). The lowest observed averages were 3.5 (Ability to Perform-closure of fistula), 3.7 (Ability to Perform-acquisition target trocar sites), 3.8 (Physical Attributes-landmark visualization), 3.8 (Ability to Perform-anastomosis and dissection of upper pouch), and 3.9 (Realism of Materials-skin). The Global Rating Scale was 2.9, coinciding with a response of "this simulator can be considered for use in neonatal TEF repair training, but could be improved slightly." Material costs for the synthetic EA/TEF inserts were less than $2 U.S. per insert., Conclusions: We have successfully created a low-cost synthetic EA/TEF tissue insert for use in a neonatal thoracoscopic EA/TEF repair simulator. Analysis of the participants' ratings of the synthetic EA/TEF simulation model indicates that it has value and can be used to train pediatric surgeons, especially those early in their learning curve, to begin to perform a thoracoscopic EA/TEF repair. Areas for model improvement were identified, and these areas will be the focus for future modifications to the synthetic EA/TEF repair simulator.

Background: EUS-guided biliary drainage (EUS-BD) has emerged as an alternative rescue method in patients with failed ERCP. Opportunities for teaching and training are limited because of a low case volume at most centers., Objective: To evaluate a stereolithography/3-dimensional (3D) printing bile duct prototype for teaching and training in EUS-BD., Design: Prospective observational feasibility study., Setting: Tertiary referral center., Subjects: Twenty endosonographers attending an interventional EUS workshop., Intervention: A prototype of a dilated biliary system was prepared by computer-aided design and 3D printing. The study participants performed guidewire manipulation and EUS-BD procedures (antegrade procedure and/or choledochoduodenostomy) on the prototype. Participants were scored with the device on a scale of 1 to 5 via a questionnaire. Participants' success rate for various steps of the EUS-BD procedure was noted., Main Outcome Measurements: Subjective and objective evaluation of the prototype regarding its overall applicability, quality of radiographic and EUS images, and 4 steps of EUS-BD procedure (needle puncture, guidewire manipulation, tract dilation, stent placement)., Results: Fifteen participants returned the questionnaire, and 10 completed all 4 steps of EUS-BD. The median score for overall utility was 4, whereas that for EUS and US views was 5. Participants with experience in performing more than 20 EUS-BD procedures scored the prototype significantly lower for stent placement (P = .013) and equivalent for needle puncture, tract dilation, and wire manipulation. The success rate of various steps was 100% for needle puncture and tract dilation, 82.35% for wire manipulation, and 80% for stent placement. The mean overall procedure time was 18 minutes., Limitations: Small number of participants., Conclusion: The 3D printing bile duct prototype appears suitable for teaching of and training in the various steps of EUS-BD. Further studies are required to elucidate its role., (Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)