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13 Wear andFriction Mechanism Study inKnee andHip Rehabilitation
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Chapter 14
Challenges andPerspective ofManufacturing Techniques inBiomedical Applications
YusufOlatunjiWaidi , NipunJain , SaswatChowdhury , RanjitBarua , SamirDas , ArbindPrasad , andSudiptoDatta
Abstract The technology of additive manufacturing is used in various sectors like
construction, biomedical engineering, healthcare, aerospace, and many more. Because of the many advantages of this technology, this is being widely used in the healthcare industry. For example this is used in organ printing, disease modeling, surgery, tissue engineering, veterinary medicine, pharmaceuticals and customized implants. In this chapter, we shall briey discuss the problems of this technology in the healthcare sector and its future prospects.
Keywords Additive manufacturing · 3D printing · Biomedical devices · Tissue engineering · Disease modelling
Authors “Yusuf Olatunji Waidi”, “Nipun Jain”, and “Saswat Chowdhury” have equally contributed to this chapter.
Y. O. Waidi · N. Jain · S. Datta (*) Department of Materials Engineering, Indian Institute of Science, Bangalore, Karnataka, India e-mail: yusufwaidi@iisc.ac.in; nipunjain@iisc.ac.in
S. Chowdhury Department of Bioengineering, Indian Institute of Science, Bangalore, Karnataka, India e-mail: saswatc@iisc.ac.in
R. Barua Centre for Healthcare Science and Technology, Indian Institute of Engineering Science and Technology, Howrah, West Bengal, India
S. Das Biomaterials and Tissue Engineering Lab, School of Medical Science and Technology Indian Institute of Technology, Kharagpur, India
A. Prasad Mechanical Engineering Department, Katihar Engineering College (Under Department of Science, Technology and Technical Education, Government of Bihar), Katihar, Bihar, India
A. Kumar et al. (eds.), Applications of Biotribology in Biomedical Systems,
https://doi.org/10.1007/978-3-031-58327-8_14
433© The Author(s), under exclusive license to Springer Nature Switzerland AG 2024
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14.1 Introduction

With the advent of more advanced manufacturing technologies concurrent with the ever-increasing and complex clinical needs, the biomedical devices sector is wit­nessing a paradigm shift. Currently, different classes of materials, namely metallic, ceramics, polymeric and composites, are typically used for fabricating medical devices. In fact, recent times have enabled bio fabrication, i.e., the manufacturing of biological systems integrated with soft polymeric materials, to be an integral part of manufacturing. Another development in the biomedical manufacturing space is the emergence of additive manufacturing technologies that aid in rapidly prototyping customized medical devices. This is truly the need of the hour, as it overcomes the limitations of conventional manufacturing processes by providing enormous exi­bility in design and material candidates, expanding the scope of medical devices. Different categories of additive manufacturing technologies are available depending on the class of material used, its physical form, nal desired product requirement, and properties. Each technique will have its advantages and disadvantages, and hence, an optimal trade-off is often needed to achieve the desired biomedical device with the desired properties. Among the multitude of biomedical applications of additive manufacturing, the most prominent include the creation of anatomical models and phantoms for surgical training, patient-specic prosthetics and implants, 3D tissue mimetic models for drug testing, biopharmaceuticals for drug delivery, etc. [1]. The increased adoption of additive manufacturing in the medical eld is due to its key benets such as customization of medical implants suiting exact patients’ needs, relatively low cost with minimal wastage of material, reduced production time, and design freedom [2]. Despite these advantages, additive manufacturing has still not matured enough for large-scale production owing to its relatively low speed compared to conventional manufacturing processes [3]. However, this can be a blessing in disguise, especially in the biomedical sector, where high accuracy com­bined with customization is required in small numbers. This is because of the unique demands of medicine and personalized therapy that change a lot with patients. The working principle of most additive manufacturing processes, except the form and processing of feedstock, remains the same, and it begins with capturing the clinical data through either Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) modalities. Afterward, these scanned images are modied into a computer­aided design (CAD) model using Digital Imaging and Communications in Medicine (DICOM) software [4]. The prepared 3D CAD models are then processed through MIMICS or similar 3D software to assess the optimal tment and generate the required Standard Triangulation Language (STL) format of the desired implants to be fed to the printer [5]. Post generation of STL le, the input parameters such as unit layer thickness, print tool and bed/platform temperature, pressure/ow rate, print orientation/hatch spacing, raster angle, type of input current, types of lasers (if any) and its parameters (such as power density), etc., need to be optimized accord­ing to the desired nal part accuracy, type of material and printer being used. Figure14.1 shows the schematic of the entire workow of generating printed parts
14 Challenges andPerspective ofManufacturing Techniques inBiomedical Applications
Fig. 14.1 Workow of a typical additive manufacturing process, leading to the generation of bio­medical devices [4]. (Reproduced with permission from Elsevier [4])
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for various biomedical applications via additive manufacturing (AM). The work­ow begins with obtaining patient data in the form of CT scans and eventually completes with printing the customized medical device.
However, some regulatory and scientic challenges associated with AM are per­sistent to date. This holds true, especially for the medical sector, which has wit­nessed a surge in the adoption of different AM processes. However, the growth is rather slow due to the lack of suitable standard procedures. Some of the standards widely adopted are ASTM F279212a, ISO/ASTM DIS 52910.2, ISO/TC 261 and ISO 17296-4:2014 for processing; ISO 10993-1 and ASTM F 2129 standards for chemical characterization; ASTM 756 and ISO 10993-6 standards for testing bio­compatibility of the implants [5]. However, there are a lot of avenues within AM, where such standards don’t exist, such as rendering techniques for the generation of CAD models, slicing software for making STL les, processing parameters, and choice of printing technique. In this chapter, a detailed overview of the various AM techniques, the types of materials that can be processed, and their unique challenges and future scope are enlisted.
14.2 Manufacturing ofMetallic Materials
Metals are a widely used material for many biomedical applications, including orthopedic implants, spinal cord fusion devices, joint replacement implants, cardio­vascular stents and other load-bearing applications [6]. The ideal requirements for metallic biomaterials include non-toxicity, non-immunogenicity, optimum
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mechanical properties, and high corrosion resistance. A sequence of oxidation­reduction reactions occurs between the metal surface and body uids, leading to possible ion release, allergies, etc. The most widely used metallic biomaterials are stainless steels, cobalt-chrome alloys, and titanium-based alloys. Stainless steels are widely used in craniofacial reconstruction as bone plates, intermedullary nails, rods or screws, owing to their high corrosion resistance, favorable strength and relatively low price [7]. The most commonly employed stainless steel is 316L.Co-Cr alloys exhibit high hardness values and wear resistance and hence nd use in load-bearing bone applications and articial joints, such as complete knee and hip replacement prostheses and acetabular cups [8]. The next common type of metallic biomaterials are titanium and titanium-based alloys again in orthopedic implants and accessories due to their favorable corrosion resistance, high strength-to-density ratio, and Young’s modulus mimicking native bone tissue compared with other alloys [9]. From a commercial standpoint, pure titanium (CP-Ti) and Ti-6Al-4V alloy are the most widely used metallic materials for implant development. While pure titanium is mostly limited to dental applications due to its limited mechanical properties, Ti-6Al-4V alloy is more favored for hip and knee implants, bone plates, etc., where good mechanical properties are desired [10].
Magnesium-based biomaterials are also increasingly being used as biodegrad­able implants, owing to their sufcient tensile strength, fracture resistance, and low magnesium density [11]. Moreover, the release of magnesium ions favors new bone formation and is benecial for general metabolism [12]. The biodegradation kinet­ics of magnesium implants can be tuned by alloying with other elements, like zinc and calcium.
Historically, a range of conventional techniques have been in place for fabricat­ing metal-based medical devices, such as forging, investment casting, hot rolling, and machining. However, in the past few decades, additive manufacturing has replaced the conventional ones. As the name implies, it relies on the addition of material in a layer-wise manner to yield the nal product from a computer 3D model. Undoubtedly, the ability to produce implants of near-net sizes that are a bet­ter match to the patient’s anatomy is an undisputed advantage in the biomedical realm, especially in reconstructive surgeries to treat craniofacial fractures for improved aesthetics and functional performance [13]. 3D printing also promises to fabricate stable and reproducible architectures with nano-, micro-, and macro-level hierarchical features better than conventional techniques like gas foaming, freeze­drying and electrospinning. Additionally, complex architectures, curved channels, and functional gradients of properties are some attributes wherein 3D printing can be used with ease [14]. However, in practice, this is not yet accomplished due to the inherent processing challenges, like pores collapsing during assembly, which in turn affects the overall structural stability. To maintain printing accuracy, it is imperative to reduce printing speeds to ensure near-perfect solidication of the previously deposited layer before the next layer [15].
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