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- Herausgeber: John Wiley & Sons
- Kategorie: Wissenschaft und neue Technologien
- Sprache: Englisch
The main goal of this book is to explore the application of 3D printing in medicine and healthcare that could revolutionize drug development and medical equipment production and also improve supply chains, pharmaceuticals, and healthcare.
In the fields of medicine, pharmaceuticals, surgical planning, and personalized medical treatment, the novel emergence of 3D printing technology has opened a wide range of potential applications. With personalized solutions that were previously impossible, 3D printing has opened up novel possibilities in patient care, from developing unique medications to manufacturing prosthetics and implants that are particular to each patient. The 14 chapters in this volume present the reader with an array of subjects including:
- the evolution and background of 3D printing, charting its extraordinary path from its inauspicious origins to its current significance in the field of healthcare. Also discussed are the many kinds of 3D printers that are employed in additive manufacturing, as well as how they are modified for usage in medical settings;
- the current developments in medical science brought about by 3D printing technology, including the clinical uses of 3D printed models in different medical domains, ranging from cardiovascular illness to tumors, and congenital heart disease;
- personalized medicine and the creation of dosage forms utilizing 3D printing methods, the benefits and drawbacks of various 3D printing technologies and the applications of these technologies in healthcare, including the creation of immediate-release tablets, capsules, and implants for a range of illnesses;
- the possibilities of 3D printed anatomical models for surgical planning, the roles of 3D printing technologies that are used to produce surgical guides, knee implants, spinal implants, and other patient-specific applications;
- the current developments in 3D printed medication delivery devices including regulatory concerns;
- the field of personalized medicine using 3D printing, and discusses organ models for preoperative diagnostics, permanent non-bioactive implants, local bioactive and biodegradable scaffolds, and direct printing of tissues and organs;
- the different specialized uses of 3D printing in the medical field, covering topics including hospital management and administration, surgical training for urological operations, ophthalmology, and preserving safety and efficacy in point-of-care.
Audience
The book will be widely read by all healthcare professionals, biomedical engineers, researchers, and graduate students who are seeking to expand their knowledge of efficient techniques of 3D printing technology in the healthcare sector.
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Veröffentlichungsjahr: 2024
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Table of Contents
Cover
Table of Contents
Series Page
Title Page
Copyright Page
Foreword
Preface
1 Introduction to 3D Printing in Healthcare
1.1 Introduction
1.2 The Revolutionary Rise of 3D Printing Technology
1.3 3D Printing Revolution Engineering
1.4 3D Printer Types for Additive Manufacturing
1.5 3D Printing in the Healthcare Industry
1.6 Early-Phase Drug Development
1.7 Customized Drugs
1.8 Advanced Pharmacological Treatments
1.9 Community Medicine
1.10 Clinical Pharmacy Practice
1.11 3D Printing Process and Product Variable Optimization
1.12 Recent Trends in 3D Printing Regulation
1.13 Conclusion
References
2 3D Printing in Medical Science
2.1 Introduction
2.2 Present Clinical Applications
2.3 3D-Printed Models in CHD
2.4 Cardiovascular Disease Models in 3D Printing
2.5 Tumor in 3D-Printed Models
2.6 3D-Printed Models in the Development of CT Scanning Procedures
2.7 Pharmaceutical 3D-Printing Technologies
2.8 Challenges Facing Printed Pharmaceuticals
2.9 Opportunities and Limitations of Using 3D Printing in Healthcare
2.10 Conclusion and Future Direction
References
3 3D Printing in Fabrication of Dosage Form
3.1 Introduction
3.2 History
3.3 Advantages
3.4 Limitations and Challenges
3.5 Personalized Dosage Form
3.6 Bio-Inks
3.7 Applications in Healthcare
3.8 3D Printing Techniques
3.9 Comparison to the Conventional Manufacturing Technique
3.10 Comparisons between Various 3D Printing Techniques
3.11 Bilayer Tablets
3.12 Benefits of Various Disorders
3.13 Cardiovascular Diseases
3.14 Neurodegenerative Diseases
3.15 Other Diseases
3.16 Regulatory Issues
3.17 Conclusions
References
4 The Potential of 3D-Printed Anatomical Model for Surgical Planning
4.1 Introduction
4.2 3D-Printed Approaches: Anatomical Simulations
4.3 Congenital Anomalies: Surgical Planning
4.4 Anatomical Training With 3D-Printed Models
4.5 Advantages, Challenges, and Ethical Concerns
4.6 Fundamentals of 3D Printing
4.7 Additive Manufacturing Techniques
4.8 Surgical Applications
4.9 Cardiovascular System
4.10 Clinical Applications in Preoperative Planning
4.11 Cardiovascular Surgery
4.12 Neurosurgery
4.13 Craniomaxillofacial Surgery
4.14 Orthopedic Surgery
4.15 Interventional Radiology
4.16 Other Interventions
4.17 Conclusion
References
5 Customized Implants and Prosthetics with 3D Printing
5.1 Introduction
5.2 Image Acquisition and Prosthesis Design
5.3 Manufacturing the TAV Prosthesis
5.4 Patient Information
5.5 Commonly Used 3D Printing Technologies in the Medical Field
5.6 Material Sintering
5.7 Process Chain for Customized Prosthetics and Implants
5.8 Applications
5.9 3D Printing Technology for a Customized Implant and Prosthesis Production
5.10 Benefits of 3D-Printing-Customized Implants and Prostheses
5.11 Limitations and Future Directions
5.12 Conclusion
References
6 Advanced Drug Delivery Systems with 3D Printing
6.1 Introduction
6.2 Modern 3D-Printing Technologies
6.3 SLA-Printed Drug Delivery Devices
6.4 DLP-Printed Drug Delivery Devices
6.5 CLIP-Printed Drug Delivery Devices
6.6 TPP-Printed Drug Delivery Devices
6.7 FDM for Advanced Drug Delivery Applications
6.8 Local Drug Delivery Devices
6.9 Surgical Intervention and Postoperative Implants
6.10 Challenges and Future Perspectives
6.11 The Multi-Material Additive Manufacturing Technique
6.12 Regulatory Issues of Drug Delivery Medical Device
6.13 Scalability and Cost Factors
6.14 Conclusion
References
7 Exploring the Fabrication of 3D-Printed Scaffolds for Tissue Engineering
7.1 Introduction
7.2 Scaffold Architecture Design
7.3 Scaffold-Based Technique
7.4 Scaffold-Free Approach
7.5 Bioreactor
7.6 Design Considerations
7.7 Conclusion
References
8 Personalized Medicine with 3D Printing
8.1 Introduction
8.2 History of 3D Printing
8.3 Technologies for 3D Printing in Pharmaceutical Research and Development
8.4 Medicinal Applications for Inkjet Printers
8.5 Binder Jet Printing
8.6 Medicinal Applications for Binder Jet Printing
8.7 Fused Deposition Modeling
8.8 Selective Laser Sintering
8.9 Pressure-Assisted Micro-Syringe
8.10 The Possibility of 3D Printing in Individualized Medicine
8.11 Dose Personalization
8.12 Modifying Release Profiles
8.13 Combination Tablets—Polypills
8.14 3D Printing for Everybody
8.15 3D Printing in a Clinical Setting
8.16 Regulatory Aspects
8.17 Conclusion
References
9 3D Printing Techniques in a Medical Setting
9.1 Introduction
9.2 Medical 3D Printing on Four Different Levels
9.3 Fabricating Local Bioactive and Biodegradable Scaffolds
9.4 Characteristics of Scaffolds
9.5 Enhancing the Mechanical Properties of Scaffolds
9.6 Directly Printing Tissue and Organs
9.7 Biomedical Material in 3D Printing
9.8 Medical Metal Materials
9.9 Medical Polymer Materials
9.10 Medical Ceramic Materials
9.11 Limitations
9.12 Conclusions and Future Directions
References
10 3D Printing in Hospital Administration and Management
10.1 Introduction
10.2 Role of 3D Printing in Medicine
10.3 What Can Go Wrong
10.4 Techniques for 3D Printing in Clinical Settings
10.5 Design Input and Output
10.6 Production Process and QA
10.7 Image Acquisition
10.8 Segmentation
10.9 Printing the Model
10.10 Validation and Verification of Processes
10.11 Collaboration Between Medical Professionals
10.12 Unique Obstacles and Regulatory Issues
10.13 Conclusion
References
11 Emerging Applications of 3D Printing in Plastic Surgery
11.1 Introduction
11.2 3D Printing
11.3 3D Printing in Medicine
11.4 Preoperative Planning
11.5 Intraoperative Guidance
11.6 Bioprinting for Plastic Surgery Applications
11.7 3D Printing in Plastic and Reconstructive Surgery
11.8 Preoperative Planning: Soft Tissue Mapping
11.9 Preoperative Planning: Vascular Mapping
11.10 Preoperative Planning: Bony Mapping
11.11 Intraoperative Guidance
11.12 Surgical Training
11.13 Patient Education
11.14 Patient-Specific Prosthesis
11.15 Conclusion
References
12 Safety, Efficacy, and Point-of-Care for 3D Printing in Healthcare
12.1 Introduction
12.2 The Call for Standardization and Guidelines
12.3 Applications and Benefits of Medical 3D Printing
12.4 Deciding to Become a POC Manufacturer
12.5 Obtaining 3D-Printing Management Support
12.6 Setting Up a Platform to Assist POC 3D Printing
12.7 Powder-Based Binding Method
12.8 Conclusion
References
13 3D Printing in Robotic Urosurgery
13.1 Introduction
13.2 Potential Urological Applications
13.3 Patient-Specific 3D Models Help Experienced Surgeons Plan, Practice, and Guide Complicated Procedures
13.4 Surgical Training Using 3D Generic Technique Models
13.5 Patient Education and Counseling
13.6 Conclusion
References
14 3D Printing in Ophthalmology
14.1 Introduction
14.2 External Eye Illness and Corneal Disease
14.3 Corneal Tissue Bioprinting
14.4 Drug Delivery
14.5 Glaucoma
14.6 Drug-Eluting Implants
14.7 Minimally Invasive Glaucoma Surgery Devices
14.8 Regulatory Considerations
14.9 Expert Opinion and Future Directions
14.10 Conclusions
References
Index
End User License Agreement
List of Illustrations
Chapter 1
Figure 1.1 Common stages in 3D-printed format.
Chapter 2
Figure 2.1 Manufacturing processes required to create products via 3D printing...
Figure 2.2 Dissimilarities between organ models and tissue models (such as tis...
Chapter 3
Figure 3.1 Main advantages of 3D printing technology in the fabrication of ora...
Chapter 4
Figure 4.1 Design proposal for a retrospective study.
Chapter 5
Figure 5.1 Different types of customized implants.
Figure 5.2 Additive manufacturing for medical applications and the difficultie...
Chapter 6
Figure 6.1 A 3D-printing system for hydrogel-based topical drug delivery. Admi...
Figure 6.2 Three-dimensionally printed mesoporous scaffolds for drug delivery.
Chapter 7
Figure 7.1 The process of making a 3D-printed scaffold. (a) Computer-aided des...
Figure 7.2 Schematic showing the construction of a 3D-printed scaffold and the...
Chapter 8
Figure 8.1 3D-printed personalized cancer medicine for better diagnosis, progn...
Figure 8.2 3D-printed medicine for individual patients.
Chapter 9
Figure 9.1 Different medical applications of 3D-printing technology.
Chapter 10
Figure 10.1 Characterizing the properties of 3D oral pharmaceutical dosage for...
Figure 10.2 3D-printed medicine for the management of chronic diseases.
Chapter 11
Figure 11.1 Pharmaceutical 3D printing.
Figure 11.2 Pathways from imaging to 3D-printed prototypes.
Chapter 12
Figure 12.1 Applications of hot-melt extrusion coupled with fused deposition m...
Figure 12.2 Schematic illustration of powder bed binding technique.
Chapter 13
Figure 13.1 The procedures involved in the patient-specific three-dimensional ...
Figure 13.2 3D-printed models are used to teach surgeons about robotic urology...
Chapter 14
Figure 14.1 Procedure for 3D printing and bioprinting.
Figure 14.2 Anatomy of the eye and the associated 3D-printed therapies.
Guide
Cover Page
Table of Contents
Series Page
Title Page
Copyright Page
Foreword
Preface
Begin Reading
Index
WILEY END USER LICENSE AGREEMENT
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Scrivener Publishing100 Cummings Center, Suite 541JBeverly, MA 01915-6106
Publishers at ScrivenerMartin Scrivener ([email protected])Phillip Carmical ([email protected])
3D Printing in Healthcare
Novel Applications
Rishabha Malviya
Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University
and
Rishav Sharma
Department of Pharmacy, School of Medical and Allied Sciences, Galgotias University
This edition first published 2024 by John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USA and Scrivener Publishing LLC, 100 Cummings Center, Suite 541J, Beverly, MA 01915, USA© 2024 Scrivener Publishing LLCFor more information about Scrivener publications please visit www.scrivenerpublishing.com.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions.
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Limit of Liability/Disclaimer of WarrantyWhile the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials, or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read.
Library of Congress Cataloging-in-Publication Data
ISBN 978-1-394-23420-2
Cover image: Pixabay.ComCover design by Russell Richardson
Foreword
It is a matter of great joy and satisfaction for me to introduce this unique book entitled 3D Printing in Healthcare: Novel Applications, edited by Dr. Rishabha Malviya and his team. I am excited to explore this exhaustive resource that explains vividly the multidimensional potential of 3D printing technology and its integration into healthcare.
3D printing has transformed into an immense tool that is revolutionizing healthcare. In this book, Dr. Malviya and the co-authors have successfully explained the deep impact of 3D printing on ever-evolving medical research, pharmaceutical development, surgical planning, and personalized medicine.
The book begins with an insightful introduction that provides a historical background for the use of 3D printing in healthcare and illustrates the impressive development of the technology. The subsequent chapters explore various features of 3D printing, highlighting its numerous uses and the potential for transforming patient care and therapeutic approaches.
The chapters on the current advances in the incorporation of 3D printing in medical science provide readers with an exclusive overview of fascinating therapeutic applications, ranging from cardiovascular disease models to tumor simulations. The researchers also submit insightful knowledge about the potential and difficulties of the pharmaceutical industry to prepare them for further investigation.
The extensive discussion of the function of 3D printing in surgical planning is one of the strongest points of this compilation. The development of anatomical models, patient-specific prosthetics, implants, and surgical guidance are discussed in chapters 4 and 5. The authors have skillfully described the benefits, difficulties, and moral issues associated with the application of 3D printing in surgical practice.
The readers will receive a thorough understanding of the effects of 3D printing on medicine delivery systems in the later chapters. Furthermore, chapters 6 and 7 explain various 3D printing methods, along with their applications in medical devices and their regulatory concerns.
The adaptability of 3D printing methods across medical specialties is demonstrated well in chapter 8. The chapter provides an exhaustive account of the future of regenerative medicine by examining the development of organ models, long-lasting implants, and local scaffolds.
Chapters 9 through 14 add to our knowledge about how 3D printing has the potential to revolutionize fields such as hospital management, urology, ophthalmology, and plastic and reconstructive surgery. The book emphasizes aptly the diversity and limitless prospects provided by 3D printing for improving patient care and medical education.
The authors have adroitly organized this harmonious collection of information, masterfully compiling insights into a paragon that will certainly become an integral tool for professionals as well as academicians.
I wish that prospective readers will take advantage of the countless possibilities of 3D printing in healthcare as presented in this book and keep pushing forward into frontiers of knowledge and creativity to blaze a new, transformative path.
Prof. Ranjit Singh
Vice Chancellor
Shobhit University, Gangoh
Saharanpur, UP India
Preface
This book, 3D Printing in Healthcare: Novel Applications, aims to enlighten readers about the rapidly developing field of 3D printing and its significant effects on the healthcare sector. 3D printing has emerged as an innovation with enormous potential to change how we approach healthcare as technology pushes the frontiers of invention.
In the fields of medicine, pharmaceuticals, surgical planning, and personalized medical treatment, the novel emergence of 3D printing technology has opened a wide range of potential. With personalized solutions that were previously impossible, 3D printing has opened up novel possibilities in patient care, from developing unique medications to manufacturing prosthetics and implants that are particular to each patient.
Chapter 1 introduces the subject and builds the groundwork for study. It delves into the evolution and background of 3D printing, charting its extraordinary path from its inauspicious origins to its current significance in the field of healthcare. Also discussed are the many kinds of 3D printers that are employed in additive manufacturing, as well as how they are modified for usage in medical settings.
Chapter 2 reviews current developments in medical science brought about by 3D printing technology, including the clinical uses of 3D printed models in different medical domains, ranging from cardiovascular illness to tumors, and congenital heart disease.
Chapter 3 explores personalized medicine and the creation of dosage forms utilizing 3D printing methods. It also discusses the benefits and drawbacks of various 3D printing technologies and the applications of these technologies in healthcare, including the creation of immediate-release tablets, capsules, and implants for a range of illnesses.
Chapter 4 explores the possibilities of 3D printed anatomical models for surgical planning, while chapter 5 explores the roles of 3D printing technologies that are used to produce surgical guides, knee implants, spinal implants, and other patient-specific applications.
In chapter 6, our researchers have examined the current developments in 3D printed medication delivery devices. This section also covers regulatory concerns and potential developments in this area.
Chapter 7 explores the field of personalized medicine using 3D printing, and chapter 8 discusses organ models for preoperative diagnostics, permanent non-bioactive implants, local bioactive and biodegradable scaffolds, and direct printing of tissues and organs.
Chapters 9 to 14 explore extensively the different specialized uses of 3D printing in the medical field, covering topics including hospital management and administration, surgical training for urological operations, ophthalmology, and preserving safety and efficacy in point-of-care. Throughout these chapters, readers will find insightful information about the potential of 3D printing to revolutionize each of these sectors.
3D Printing in Healthcare: Novel Applications will be a useful tool for researchers, healthcare professionals, and tech enthusiasts. We encourage researchers to experience the boundless possibilities of 3D printing in revolutionizing healthcare and defining a better future for patient care globally. We are deeply grateful to everyone who helped with this book and greatly appreciate the dedicated support and valuable assistance rendered by Martin Scrivener and the Scrivener Publishing team during its publication.
The Editors
1Introduction to 3D Printing in Healthcare
Abstract
In this technologically advanced decade, many cutting-edge hybrid applications, innovations, and smart utilities are being developed and implemented all over the world to improve and streamline everyday life. India’s young population is a huge draw for these ventures. The healthcare system is increasingly incorporating these technologies into its central operating model. The primary application of 3D printing in the healthcare industry is the creation of prototypes or cells for immediate clinical use. However, their use has enormous potential in Indian healthcare and research. Both current and potential applications of 3D printing in medicine fall into several broad categories. This chapter provides an overview of 3D printing with a wide range of growth potential and brings together researchers from the engineering and healthcare fields.
Keywords: 3D printing, healthcare, 3D-printing revolution engineering, additive manufacturing, healthcare industry
1.1 Introduction
In healthcare, 3D printing has yielded several advancements that, while remarkable now, might seem boring in a few years when even more spectacular breakthroughs are made. Titanium cranial implants have been 3D-printed at Walter Reed Army Medical Center [1], and a woman’s jaw was replaced with a 3D-printed prosthesis there as well [1]. In 2013, surgeons used an implant fabricated by the 3D printing company Oxford Performance Materials to replace 75% of a man’s skull [2]. After discovering a rare kind of cancer in a man’s pelvis, surgeons in the United Kingdom had to replace half of his pelvis [3]. Replacement hip cups have been made and put into tens of thousands of patients [4]. Other pharmacological treatments of 3D printing include the fabrication of bionic ears [5], attractive ears [6], and prosthetic ears. Almost all hearing aid housings are now 3D-printed [7]. In the United States alone, over 17 million teeth aligner molds are 3D-produced annually [8]. Newborns with life-threatening respiratory issues are being saved nearly routinely by tracheas and tracheal splints created using 3D printing technology [9]. It is not usually high-end, pricey 3D printers that are employed for these kinds of jobs. Surgical tracheal implants have been made using 3D printers and materials available to the general public. Custom scaffolding for a tracheal implant wa being 3D-printed by doctors at the Feinstein Institute for Medical Research using a Maker-Bot machine (about US$2,000) and PLA filament [10]. Using MakerBot machines, biodegradable medical implants made for each patient have been 3D-printed to treat bone infections and cancers [11]. There have been significant 3D printing initiatives focused on the human heart. Sabanci University in Turkey has 3D-printed aortic cells [12]. By 2023 [13], researchers at the University of Louisville hope to have successfully 3D-printed a human heart. Advanced Solutions, located out of Kentucky, plans to employ its bio assembly-Bot printer to pull it off [14]. In 2013, a high school student in California used a 3D printer to create a functional prototype of a patient-specific artificial heart [15]. Washington University in St. Louis is working on a 3D-printed membrane that can be stretched to fit over a patient’s current heart like a glove to keep it beating. Built-in sensors identify approaching issues, and electrodes shock out potentially fatal arrhythmias [16]. San Diego, California-based company Organovo is 3D-printing drug-testing tissue and is developing a 3D-printed human liver, both of which have the potential to eliminate the need for the current standard of care and the use of animals to ensure a drug’s safety and efficacy before it hits the market [17]. Some scientists are trying to develop drugs that can be printed out in 3D and used locally or at home [18]. Due to the high number of amputees in war-torn countries, such as the Sudan (where there are 50,000) and Uganda, low-cost 3D printers are being employed to create prostheses for these individuals [19]. The United States Army is also interested in applying 3D-printing technology to mitigate some of the negative effects of combat. The army and the University of Nevada are working together on a project to 3D-scan soldiers from head to toe and save the information in case a soldier loses an arm or a leg in a battle. The lightweight, inexpensive 3D-printed hand developed at Oak Ridge National Laboratory has potential applications in robotics, prosthetics, surgery, and the handling of hazardous chemicals [20]. To produce a gripping action, the finger joints receive pressurized fluid from a hydraulic pump driven by an electric motor that is housed in the palm. The fingers open and shut because of a cam driven by an electric motor, which is coupled to two master pistons through five slave pistons. The fingers’ hydraulic coupling means they will easily shape themselves to anything they grab. Facial reconstructive surgery has also benefited greatly from the use of 3D printers, including a full-face replacement performed in Belgium [21]. Reconstructing injured nerve tissue with graphene and 3D-printed scaffolds is the focus of research at Michigan Technological University [22]. Surgical guides and models are excellent examples of medical use for 3D printing. Surgeons are now 3D-printing models of a patient’s organs to study in advance of the operation. Instead of operating on a live patient, it is preferable to study models to spot anatomical irregularities and plan a course of action [23]. Doctors at Miami Children’s Hospital 3D-printed an identical copy of a 4-year-old girl’s heart so that they could practice for such a tough operation on the organ. Before functioning on an actual teen’s brain, doctors at Boston Children’s Hospital practiced on a 3D-printed variant of one. The organs of conjoined twins were successfully 3D-printed and used by surgeons at Texas Children’s Hospital to plan and rehearse the separation of the babies [24]. Chinese scientists have used a 3D-printed replica of a human body to practice separating conjoined twins sharing a digestive track. Surgeons used the model to practice cutting through bone joints and skin connections to identify the most effective method for separating newborns. Moreover, 3D-printed models are being employed to train the next generation of neurosurgeons. For medical techniques, such as knee replacement, 3D-printed surgical guidance is invaluable [25]. Software that can transform 2D x-rays into 3D models can be employed to print such instructions. Surgical guidelines and models are increasingly being printed by certain hospitals using 3D printers—for instance, Materialise, a Belgian 3D-printing startup, has set up shop in Fuwai Hospital, China’s largest cardiovascular institution. For medical uses, 3D printing appears to be a technology that evolves in waves. Researchers quickly saw the potential for CAD/CAM in the medical area, not long after its initial use in fields like mechanical engineering and design. The first patient-specific implants, such as those used to repair holes in the skull, became accessible just a few short years later. Compositional methods, such as CNC milling, were still in use at the outset, but as time went on, new additive manufacturing (AM) possibilities became popular. Selective laser sintering (SLS) and three-dimensional powder printing (also known as “additive manufacturing”) were the most common laser-based techniques utilized for biomedical applications, although they were initially restricted to metals and ceramics, respectively [26]. The emergence of fused-deposition modeling (FDM) as the first advanced manufacturing methodology based on extrusion and using polymeric materials was a crucial first step. FDM of poly(lactic acid) or polycaprolactone has been studied a lot as a way to make porous 3D scaffolds with a certain shape on the outside and inside for use in biological applications like tissue engineering. These polymers were also the earliest examples of AM using biodegradable ingredients [27]. It was possibly due to the inadequate materials that could be utilized (the majority of the initial AM machines could only perform with a minimal number of different materials) and the high expense of the machines. However, things have changed radically since a wide range of inexpensive 3D printers became accessible. Many of these printers can print in several materials, providing the versatility needed for innovations [28]. The ability to directly manufacture artificial tissues was made possible by the development of ink-jet and extrusion-based technologies that allow for the incorporation of living cells in the printing process (“bioprinting”). As a result, the last few years have witnessed a surge in the number of papers on the issue of 3D printing in medicine from academics all over the world as well as the launch of several conferences dedicated specifically to the subject.
These are the current trends that investigators see as having the most momentum:
New biomaterials that can be used with various AM techniques are being developed.
Increased cell integration for therapeutically relevant cell-laden structures.
Production of highly regulated spatial patterns for the assembly of more complex structures, including those made of several materials and/or distinct types of cells.
The private sector has already supplied us with advanced AM machines, many of which are adaptable to a wide range of biomaterials and working circumstances. Most modern extrusion-based devices have various dosing systems, allowing for the application of several materials inside a single scaffold. Combining materials from various classes, such as ceramics and polymers, can provide interesting new features in a structure or be utilized to create a structure that is a good match for a defect at an anatomical interface (where two or more types of tissue meet) [29]. In the past 20 years, the multidisciplinary field of 3D printing in medicine and surgery has grown steadily and quickly, providing a step toward an emerging revolution in precision medicine that is now simpler to realize and put into practice. Three-dimensional printing bridges traditional medical specializations to facilitate individualized care. Recent years have seen a rise in studies aimed at adapting 3D-printing technology for use in medicine. The application of cutting-edge technology like 3D printing has made it possible to provide patients with individualized treatment. The hopes of doctors, the hypotheses of creative scientists, and the skill of avant-garde doctors all played a part. Researchers should think about using innovative approaches that will aid many patients today and in the future. Conventional preoperative and interoperative models have given way to the 3D printing of personalized implants and regenerative tissue systems. Researchers begin with patient-centered models and utilize them to construct intricate geometries that reflect the form and function of the human body. Researchers from many different scientific and medical fields as well as engineers and physicists work together to further 3D printing’s applications in medicine and surgery [30]. When put together, it provides a quick way to profit from the growth of 3D printing beyond the realm of traditional engineering. In a fascinating twist, 3D printing has the potential to be more than a quick fix in the medical field. Creativity, originality, and a willingness to take risks are needed to create a paradigm shift in healthcare delivery. Experts in the field of 3D printing are constantly refining their techniques, and readers will go through them. In addition to cutting-edge, cutting-edge materials are employed as printed substrates. Developing the tools to make science fiction a reality is essential to bringing about a long-term change in the healthcare industry [31]—a time when medical care is tailored to each individual rather than being generic and applied to everyone. There are substantial benefits to be gained in terms of delivering long-term treatment. To become a reality, researchers need to develop 3D-printable applications that make use of high-performance materials. The most promising technique for improving and prolonging human life is 3D bioprinting. Even though the technology is just getting started, its potential is quite promising. Even though 3D printing as a whole is classified as an additive process, as it develops complex things and geometries layer by layer, it is not an additive process in and of itself. The most promising future lies in entrusting the idea to bold and innovative thinkers who will take it to new heights. The addition of increasingly complicated materials to 3D printing yields fascinating and adaptable results, even if polymers remain the primary material [32]. With 3D printing, it is possible to readily personalize medical components without breaking the bank. In a short amount of time, custom-made implants and parts may be produced. Modern polymers allow for the production of lighter and more robust parts. In addition, 3D-printed components with embedded mechanisms may be produced locally. The recent years have seen a paradigm shift toward the creation of individualized medication delivery methods due to additive manufacturing [33] and other technological advancements in the field of dosage form design for improved therapeutic efficacy. When compared to traditional drug delivery methods, the capacity to create individualized medication products with extensive control over the quantity, shape, and size of the dosage form to suit individual patients is a major benefit. Furthermore, manufacturing does not require any such adjustment of the formula or number of parts in advance, whereas traditional manufacturing sometimes necessitates such optimization for batch manufacture. When compared to additive manufacturing, conventional production takes more time, requires more resources, and costs more money. On top of that, instead of using a population-centric strategy, the quick design and development of individualized medication therapy for specific patients are now possible with the use of additive manufacturing technology [34]. In the 1980s, the aerospace, automotive, electronics, and medical device sectors were the first to use additive manufacturing. The pharmaceutical and healthcare sectors, for example, have shown increased interest in the science of additive manufacturing over the past few decades for the creation of a wide range of medicinal items and medical equipment [35]. Nearly three decades ago, in [36], 3D printing was invented as a means of producing complex medical devices and drug delivery systems by the deposition, binding, or polymerization of materials in consecutive layers. Infinite possibilities exist for creating medicine delivery systems tailored to each patient. Medication formulation design may be directly translated from the drug dose provided to a patient based on their age, gender, weight, body surface area, and other physiological characteristics [37]. The versatility of 3D printing allows for the creation of objects of a wide range of geometric shapes and sizes, and the technology also has the added advantages of low manufacturing costs and almost nonexistent variation from one unit to the next. Therefore, 3D printing is helpful in the production of artificial tissues and organs for biomedical purposes as well as the design and manufacture of different drug delivery systems for therapeutic uses. Because of its many uses, 3D printing is increasingly being considered for use in mass production, and there has been an uptick in efforts to develop more adaptable and reliable approaches to printing using the technology [38]. The first 3D-printed medicine, Spritam® (levetiracetam), was granted FDA approval on August 3, 2015 to treat provisional, myoclonic, or generalizable tonic–clonic seizures. The dosage form was an orodispersible tablet, created and patented by Aprecia Pharmaceuticals of the United States and distributed under the ZipDose® technology platform. 3D printing makes it possible to make a highly flexible composition with a drug loading capacity of up to 1,000 mg per dose, with the option of personalized distribution based on the patient’s requirement and at a significantly reduced cost compared to traditional production methods [39]. Figure 1.1 summarizes a schematic depiction of the aforementioned standard 3D-printing procedure.
Figure 1.1 Common stages in 3D-printed format.
1.2 The Revolutionary Rise of 3D Printing Technology
In the 1980s, a group of scientists at the Massachusetts Institute of Technology in Boston, United States, led by Emanuel Sachs, developed the first functional 3D printer. 3D printing has followed the guidelines of binder jet technology [40], which entails first depositing a layer of powder and then spraying the solidified areas with a liquid binder. Several adjustments to the underlying science of 3D printing were later made to facilitate the creation of items with great process efficiency for a wide range of uses. Additional developments were made to enhance the effective use of materials, allowing for more adaptability and precision in the creation of items. In 1986, computer-aided drawing techniques and programs were merged with the method of “3D printing,” in which materials are stacked onto a substrate to produce an item with three dimensions. In an x–y plane, the technique is similar to that employed to adhere to printed material [41]. To print the complete item to the desired thickness, the printer must travel along with the z-axis. By carefully adjusting the nozzle geometry and motion, an approach may be used to print objects of varied sizes and shapes. Additive manufacturing relies heavily on 3D printing, rapid prototyping, and scaling up applications [42].
1.3 3D Printing Revolution Engineering
Although printers first started making flat items in the 1970s and 1980s, they used simple processes including casting, molding, shaping, joining, and processing [43]. Researchers have developed a wide variety of novel ways to process 3D printing. Many different methods have been developed for the layout and customization options of 3D geometries, for the transition of an image into mathematical methods, and for the subsequent translation into the objects of the desired shape and size with the aid of equipment control systems [44], all with the help of specialized computer software that allows for visual personalization. Due to its foundation in the additive manufacturing method—wherein an item is constructed by adding layers of material—3D printing relies on sophisticated computer simulations based on the 3D’s methodology outlined previously [45]. The threepronged strategy of design, development, and distribution is important to the practice of effective tailored medicine therapy. Computer-simulated or CAD-designed models of the objects of interest are used to prepare the artwork in the preceding three stages of production. The printer examines the file the program generates, deciphers the command, and constructs the 3D-printed item or therapeutic items, which are then sent directly to the client or patients. There are several kinds of 3D printing used in fields like drug distribution and biomedicine. Some of the most well-known techniques are stereolithography (SLA), selective laser sintering (SLS), semi-solid extrusion (SSE), and binder jet printing (BJP) [46]. Emanuel Sachs is credited with developing the BJP method, which has been characterized as the “first generation” of 3D printing. This technique requires first laying down a powder layer but instead dumping the adhesive on top of it to harden it into the desired form. The printer creates items by depositing material layer by layer, just like in traditional inkjet printing (IJP). S. Scott Crump invented SEM as a second-generation 3D-printing method in 1989 (patent 5121329 was granted in 1992). Extrusion is the technique through which a substance is produced. The materials for 3D printing are typically melted or mixed into a slurry before being extruded through a nozzle to form the desired 3D shapes. Molding items from liquid plastic or metal by forcing them through a nozzle is another possible use of the method. Aside from the additive manufacturing process, FDM is another common method of 3D printing. The term “fused filament manufacturing” describes another name for this process. The thermoplastic filament is heated and passed between rollers to create the 3D objects, which are then extruded through a nozzle. The objects’ three-dimensional geometry is modeled in CAD software before being printed in a filament, one layer at a time. Michael Feygin invented sheet lamination (SLM), commonly known as laminated item production (patent 4752352 submitted in 1987, granted in 1988). This process utilizes a high-powered laser beam to vaporize many layers of material before revealing the desired three-dimensional form, making it possible to fabricate objects from a variety of materials. Direct energy deposition (DED) and powder bed fusion (PBF) are the final two techniques for creating three-dimensional structures, and they are identical in that they both utilize a high energy flow on a powder bed of building material to create the required items. There are several different 3D-printing techniques now in use, each with its own set of pros and cons. Strong mechanical durability, biocompatibility, and human safety are necessities in the pharmaceutical industry. Furthermore, the additive manufacturing building materials employed are crucial to a successful printing process [47].
1.4 3D Printer Types for Additive Manufacturing
To create an item with the specified geometrical and functional properties, 3D printers are utilized to supply external energy in the form of casting, thermal ablation, or laser energy. The techniques of additive manufacturing, which will be discussed further on, serve as the basis for the creation of commercially available printers. As stated in [19, 20], speed, efficiency, and cost-effectiveness in printing are the most important factors to consider when choosing a 3D printer for routine use and commercial usage. As an additional need, the commercial manufacturing of printed products needs access to scaled models of 3D printers. Only FDM, SLA, SLS, and PBDbased 3D printers are now commercially accessible for use in the pharmaceutical industry, and these printers come in a range of maximum capacity configurations.
1.5 3D Printing in the Healthcare Industry
Since 3D printing eliminates the need for human intervention, it can boost production efficiency while decreasing the cost and number of flaws in manufactured goods [17]. 3D printing shifted not only the focus of industrial automation but also the nature of industrial production due to its versatility and ability to change and manufacture a wide range of geometries. Rapid advances in 3D-printing technology are reshaping the pharmaceutical industry by allowing manufacturers to produce more consistent medicinal items of higher quality [7, 11]. This is especially true in biopharmaceutical product development, which relies on creating pharmaceuticals using traditional manufacturing procedures. The field of biomedical engineering, which focuses on the development of surgical and diagnostic medical tools, has also profited from 3D printing. This chapter is an updated version of earlier reviews [21] on the use of 3D printing in the development of pharmaceutical products and other biological applications.
1.6 Early-Phase Drug Development
It is important to create a workable formulation of the active component in the first stages of drug development so that clinical safety and effectiveness studies may be conducted. To formulate a dosage form for assessing the therapeutic effects of the new medicine, one must first conduct a comprehensive examination of the physiochemical characteristics of the active ingredient. Early in the medication development process, 3D printing may be employed to construct dosage forms with less overhead [12, 22]. However, it enables the fast printing of pharmaceutical formulations with high dose flexibility and bioavailability characteristics, which have been necessary for formulations designed for various patient groups in various geographic regions and for achieving the different requirements of clinical sites to expedite the progression of clinical studies within constrained time frames. Traditional manufacturing methods do not offer these advantages since they require more time and money to complete extensive preformulation studies to improve and scale up the process before making the dosage forms [13, 14].
1.7 Customized Drugs
Although 3D printing can create unique medications for specific patient populations, it allows for more individualized and effective treatment plans. As a result, 3D printing has great potential as a therapeutic solution for the treatment of complicated disorders, including epilepsy, Alzheimer’s disease, and cancer, in both young and old patients [48]. The goal of customized treatment is to optimize pharmacokinetic and pharmacodynamic responses by administering the optimal dose at the optimal time for each patient. In addition to a patient’s genetic composition, gender, age, and weight are taken into account during dose titration and formulation of the dosage forms in this type of therapy. In contrast, the bulk of the patient population can only be served by conventional dose forms since they are based only on set strengths. Also, 3D printing allows for on-site fabrication, whereas traditional treatment typically requires setting up a whole manufacturing set-up with high-end machinery. Therefore, 3D printing has the potential to shift therapy away from a population-based focus and toward a more individualized one [49].
1.8 Advanced Pharmacological Treatments
Advanced dosage forms including numerous doses of narrow therapeutic index medications to assist long-acting pharmacological therapy may benefit from 3D printing. Patients using standard dose forms typically need to take numerous tablets for one illness indication to keep the medication levels in the blood for longer periods for the intended therapeutic activity [50]. Reduced patient compliance, missed doses leading to blood level changes, and high expenditures are only some of the disadvantages of this method. 3D printing instead allows for the creation of polypills that can contain several dosages of a medicine or other substances [51]. Therefore, the 3D-printing method of medicine distribution is highly advantageous for various conditions where polypills are indicated for patients, including asthma, cancer, cardiovascular disorders, tuberculosis, and epilepsy.
1.9 Community Medicine
Community medicine or the cultivation of self-reliant medicinal practices within a community is gaining traction. It would be especially helpful in places where there is a shortage of medical personnel. The 3D-printing method can help establish important milestones in the development of community healthcare delivery. Patients can tailor their dose needs to meet their illness requirements [52] rather than depending solely on the advice of healthcare providers. Drugs can be printed using personal 3D-printing equipment at the community pharmacy level or even at home with the help of specialized software that generates the data given by the patient. This method might be used in regions in need, such as outlying communities, military bases, and locations dealing with natural disasters. A few of the benefits of this strategy include less need for doctors and nurses, less medication waste, and simpler medication availability.
1.10 Clinical Pharmacy Practice
The 3D-printing method has applications in clinical pharmacy practice, just like it does in community medicine. Patients often visit a dispenser (chemist or pharmacist) with prescriptions given by their doctor to receive the final dosage forms [26]. Using the doctor’s instructions and 3D-printing technology, a contemporary pharmacist might have the drug ready in an individual dose within minutes. Medication scarcity might be avoided, and individualized pharmacological therapy could be implemented more easily into standard clinical practice [16, 27].
1.11 3D Printing Process and Product Variable Optimization
There are still certain obstacles to overcome in 3D printing despite the many advancements and automation that have been made in the field. Due to the large array of printers based on various printing processes, it is crucial to have a comprehensive awareness of the factors that need altering for optimal 3D printing to manufacture high-quality dosage forms with adequate durability, safety, and effectiveness [28]. As an added note, the ability to create and maintain 3D printers is crucial for the creation of tailored pharmaceuticals [53, 54]. Producing 3D-printed items also requires a solid grounding in polymer chemistry and excipient characterization.
1.12 Recent Trends in 3D Printing Regulation
In 2015, the Food and Drug Administration (FDA) authorized the first 3D-printing product, providing a major boost to the industry and encouraging biopharmaceutical manufacturers to utilize 3D printing as a cutting-edge technique in the creation of new pharmaceuticals and biomedical equipment [30–35]. The FDA published Technological Considerations for Additive Manufacturing of Medical Devices in December 2017 in answer to the need to “provide significant policy insights, the operating mindset of the agency, as well as key chemistry, manufacturing, and control necessities for the approval of 3D-printed drug products and medicines” [36]. In contrast, there are still a lot of unknowns when it comes to printer specs and formulation quality control requirements for dosage form development. There is a wide variety of printers available today, each with its own set of technological criteria (OS compatibility, hardware specifications, print speed, and print quality), manufacturer’s ethos, and price point. As a result, there is a wide range in the quality of dosage forms made with these machines. As a result, designers employ a QbD methodology to guarantee that the final product is consistently of high quality. Critical material attributes (CMAs), critical process parameters (CPPs), or diagnostic parameters utilized throughout the manufacturing process and in the inspection of the final product are all given special attention in this approach to quality control. In addition, it is suggested to look into the connections between the shapes of 3D-printed devices and the in vitro–in vivo product performance of characteristics like drug release and PK drug absorption. More than a hundred different biomedical devices are already available, all made possible by 3D printing. In a recent statement, the United States Food and Drug Administration’s Center for Drug Evaluation and Research (CDERUSFDA) addressed several concerns regarding the use of 3D printing in the pharmaceutical and medical industries. The Food and Drug Administration’s Centers for Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health are cooperating to create a strategy for bringing about this paradigm shift in medicine as a result of the promise that 3D printing holds for a new era of highly individualized healthcare. Health Canada has assessed that the printed materials are sophisticated enough to warrant review under the Innovative Pharmaceutical Products Pathway [55]. The pathway is designed for assessing products that integrate biologics and medical device components into a single manufacturing process to create individualized therapeutic solutions. In a similar vein, the European Medicines Agency (EMA) has taken moves toward authorizing newly manufactured medicinal goods made by utilizing 3D-printing techniques, which make use of software programming and electrical hardware equipment. As part of its role, the government agency also required comprehensive CE marking certification of electronic components. To ensure effective oversight, the MHRA has also agreed to draft such comprehensive guidelines that suppliers must adhere to while developing an electronic master file for submission to regulators. For regulatory purposes in Japan, new goods developed by the 3D-printing method have been labeled regenerative medicines by the PMDA. HSA’s regulations on the use of 3D-printed medications and medical equipment are quite similar to those established by PMDS in that they treat such items as novel products that must be produced per cGMP guidelines [56].
1.13 Conclusion
The use of 3D printing in the medical industry holds a great deal of potential, particularly due to the technology’s capacity to generate highly individualized products at the point of treatment. Having said that, this scenario also poses difficulties in terms of exercising sufficient monitoring. As the use of 3D printing becomes more widespread, regulatory monitoring will need to evolve to keep up with the technology and guarantee that the advantages of using this technology outweigh any potential drawbacks.
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