Metallic Biomaterials Processing and Medical Device Manufacturing

Cuie Wen, Cuie Wen

• Editorial: Woodhead Publishing
• Año: 2020
• ISBN:
  9780081029664
• Categoría: Technology & Engineering
• Categoría: Materials Science

Metallic Biomaterials Processing and Medical Device Manufacturing details the principles and practices of the technologies used in biomaterials processing and medical device manufacturing. The book reviews the main categories of metallic biomaterials and the essential considerations in design and manufacturing of medical devices. It bridges the gap between the designing of biomaterials and manufacturing of medical devices including requirements and standards. Main themes of the book include, manufacturing, coatings and surface modifications of medical devices, metallic biomaterials and their mechanical behaviour, degradation, testing and characterization, and quality controls, standards and FDA regulations of medical devices.

The leading experts in the filed discuss the requirements, challenges, recent progresses and future research directions in the processing of materials and manufacturing of medical devices. Metallic Biomaterials Processing and Medical Device Manufacturing is ideal for those working in the disciplines of materials science, manufacturing, biomedical engineering, and mechanical engineering.

• Reviews key topics of biomaterials processing for medical device applications including metallic biomaterials and their mechanical behavior, degradation, testing and characterization
• Bridges the gap between biomaterials design and medical device manufacturing
• Discusses the quality controls, standards, and FDA requirements for biomaterials and medical devices

Part 1

Introduction

Outline

• 1 Introduction to biomedical manufacturing
• 2 Material selection for medical devices

1

Introduction to biomedical manufacturing

Khurram Munir, Arne Biesiekierski, Cuie Wen and Yuncang Li, School of Engineering, RMIT University, Melbourne, VIC, Australia

Abstract

Recent advances in computer-aided design and manufacturing, along with other engineering and manufacturing technologies, in conjunction with discovery of novel materials have revolutionized the biomedical industry. These systematic, methodological, and technological improvements in the manufacturing processes have also enabled the development of novel products and devices in the biomedical field, offering greater functionality and just-in-time patient-specific medical solutions. In this context, biocompatible metallic materials have attracted interest from a wider scientific community, including materials scientists, engineers, biologists, and medical doctors, who seek to exploit the biomechanical properties of these materials for variety applications in the biomedical sector. In the past two decades, a tremendous success has been achieved in development of biomedical grade alloy compositions, which are readily available in the market; however, these materials still suffer from several shortcomings. This indicates the need for more rigorous research to devise novel, optimized, biocompatible compositions with enhanced functionalities to be suitable as candidate materials for biomedical devices. The main objective of this book is to cover the aspects related to biomedical device manufacturing from both materials and manufacturing perspectives. The first chapter reviews and desired characteristics, classification, and procedures to attain approval of these biomedical devices from relevant regulatory authorities. Finally, the recent progress on the availability of these biomedical devices in the industry is reviewed.

Keywords

Biomedical device manufacturing; regulations; classification of medical devices

1.1 Introduction

A medical device is any device intended to be used for medical purposes to restore function. Medical devices are generally developed to benefit patients and facilitate health-care practitioners to accurately diagnose and treat patients, and so help to overcome injuries and disease, thus improving their quality of life. These medical devices must be proved safe and effective before regulating government authorities of respective country allow their marketing, commercialization, and eventual application in a clinical role [1]. The safety of the medical devices can be validated by addressing the potential risks associated with their intended use. These associated risks also govern the amount of testing required to establish regulatory pathways of these medical devices. As a general rule, an increase in associated risks can only be allowed if there is also a concomitant increase in the potential benefit to the patient [2,3].

It is difficult to establish a precise, global definition of medical device because of the presence of numerous government regulatory authorities worldwide that manage and controlling the market of medical devices in their respective countries. However, in general, other than drugs, all medical-related instruments, apparatuses, materials, machines, appliances, implants, in vitro reagents or calibrators, software, or other similar articles can be considered medical devices. For example, according to the United States Food and Drug Administration (FDA), a regulatory authority to control and manage the premarket approval (PMA) of medical devices, a medical device is any article, including software, intended to be used by humans for the diagnosis, prevention, monitoring or treatment of a disease, injury or physiological process. This includes products such as complex capital equipment [including operating theater equipment and diagnostic imaging equipment such as X-ray machines and magnetic resonance imaging (MRI) scanners], advanced electronic devices (such as ear implants, artificial hearts, and other implantable devices); simple, low-risk devices (such as bandages and walking sticks); and diagnostic devices such as in vitro diagnostic (IVD) test kits [3–6].

The use of medical devices for treating injuries is not new, as it is traceable far back to ancient times. For example, Neolithic dentists used flint-tipped drills and bowstrings during BCE 9000. It is also evident from a recent finding of a 6500-year-old tooth packed with beeswax, which demonstrates the earliest evidence of a dental filling, that was found in part of a human jaw excavated in Lonche, Slovenia [7]. Similarly, in Baluchistan, Pakistan, archeologists have discovered the indications of usage of several types of medical devices during the time of ancient Rome [8]. The modern medical device market was estimated to be worth US$209 billion in 2006, which increased to US$250 billion in 2013 [9]. Due to this rapid growth, the medical device sector is considered a heterogeneous and dynamic sector. According to MarketWatch [10], as of today, the global medical device market size is valued at US$425.5 billion and is expected to increase to US$612.7 billion by 2025, with a compound annual growth rate of 5.4% during the forecasted period. This boom in the medical device global market is largely due to an increase in the aged population, as well as accidents, and sports-related injuries, which fuels the ever-increasing demand for orthopedic, dental, cardiovascular, ophthalmic, and IVD devices, as well as improved diagnostic imaging, wound management, and care needs for specialties such as diabetes or nephrology. These medical devices vary significantly in complexity and applications. Modern, commercially available medical devices can potentially replace almost every part of the human body with partial to full functional support, as shown in Fig. 1.1 The development of medical devices has witnessed steady growth over the years due to progress made in the areas of materials science and manufacturing technologies.

Figure 1.1 Various existing implantable medical devices available in the market for the human body [11]. Reproduced with permission from S. Ramakrishna, L. Tian, C. Wang, S. Liao, W.E. Teo, Medical de...