Trends in Development of Medical Devices

Prakash Srinivasan Timiri Shanmugam, Logesh Chokkalingam, Pramila Bakthavachalam

• Publisher: Academic Press
• Year: 2020
• Print ISBN:
  9780128209608
• eBook ISBN:
  9780128209615
• Topic: Technology & Engineering
• Subtopic: Engineering General
• Index: Technology & Engineering

Trends in Development of Medical Devices covers the basics of medical devices and their development, regulations and toxicological effects, risk assessment and mitigation. It also discusses the maintenance of a medical device portfolio during product lifecycle. This book provides up-to-date information and knowledge on how to understand the position and benefits of new introduced medical devices for improving healthcare. Researchers and industry professionals from the fields of medical devices, surgery, medical toxicology, pharmacy and medical devices manufacture will find this book useful. The book's editors and contributors form a global, interdisciplinary base of knowledge which they bring to this book. - Provides a roadmap to medical devices development and the integration of manufacturing steps to improve workflows - Helps engineers in medical devices industries to anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, government regulations - Presents new strategies that readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce imperfections in production and develop products that enable completely new treatment possibilities

Part I

Proof of concept

Outline

• 1 Advancements in three-dimensional printing for the medical device industry
• 2 ONE-GUI Designing for Medical Devices & IoT introduction
• 3 Biomimetics in the design of medical devices

1

Advancements in three-dimensional printing for the medical device industry

Jaisujitha Jayavelu, Raynham, MA, United States

Abstract

Three-dimensional (3D) printing has created a great evolution in the supply chain and has a wide range of applications in various fields. It has become an essential technology for innovative product launches, with high-quality products and a good business tool to increase its industrial growth in a growing global market. The medical industry is also dependent on 3D printing technology for the customization and personalization of medical devices, equipment, drugs, etc. This chapter mainly discusses 3D printing technologies and the materials used. The chapter also specifies the design guidelines of 3D printing, mainly concentrating on 3D printing in the medical device industry with a brief discussion of the future trends for 3D printing.

Keywords

3D printing technologies; medical devices; design guidelines

1.1 Introduction

Three-dimensional (3D) printing technology was invented in the 1980s to accelerate the growth of rapid prototyping methods, also described as additive manufacturing. The technology is intended to use a vast range of engineering materials to meet design and industrial needs. The process is defined as additive as, instead of removing material, it adds material in successive patterns to create a part of desired shape.¹

The technology gained wide popularity in the mid-1990s in the medical industry and has underwent tremendous growth in the last two decades in efforts to support patient needs and new innovations from industry. According to a study by Deloitte University in 2012, a significant contribution to the worldwide 3D printing sector has been contributed by the medical field, and the projected forecast for turnover related to the healthcare industry is more than $1.3 billion.² Application of 3D printing in the medical field contributes to product and process innovation supporting the following areas:

1. 1. Customization and personalization of medical devices, equipment, drugs, etc.
2. 2. Cost-effective design feasibility
3. 3. Increase in productivity
4. 4. Alignment of design and manufacturing in the upstream innovation phase
5. 5. Enhanced collaboration between cross-functional teams
6. 6. Improved supply chain activities
7. 7. Quick turnaround of product launch

3D printing has created a huge evolution in the areas of supply chain and innovative product launches with high quality, and has modified the business model approach in industries through customization according to end user needs. Moreover, 3D printing is a proven energy-efficient technology, as 90% of the materials used provide lighter and stronger design solutions that last throughout the shelf life.

1.2 Three-dimensional printing technologies

The manufacturing technologies are grouped under three categories:

• • Formative manufacturing: The design shapes are formed over the mold, requiring an expensive mold that can produce huge volumes (e.g., injection molding, casting, forging, etc.). The initial tooling cost can be high but it can be profitable if large volumes are produced downstream (Fig. 1–1).
• • Subtractive manufacturing: This method refers to when the material is taken from a solid raw material (e.g., computer numerical control (CNC) milling, turning, drilling, etc.). These are mostly cost-effective methods used in industries and involve the removal of excess material and are more preferred for low-mid volumes (Fig. 1–2).
• • Additive manufacturing: This method refers to when the material is added in a layered pattern to build a part in an “additive” process. These are widely used for low-volume or prototype builds. In addition to the low startup cost, this method can provide a very high quality based on the choice of processing machine and material used for the application (Fig. 1–3).

Figure 1–1 Formative manufacturing.

Figure 1–2 Subtractive manufacturing.

Figure 1–3 Additive manufacturing.

1.2.1 Overview of the additive (3D printing) manufacturing process

3D printing is a rapid prototyping process that develops a three-dimensional object using an input from a CAD file. This is a prototyping method that uses additive technology, that is, a layered part build to meet the end user needs.

The 3D printing process involves the following steps to design a product:

• • Create model files using CAD: A digital model is generated using CAD software or reverse engineering tools.
• • Create STL (stereolithography): The CAD file format is transferred to 3D printer-friendly language called Standard Triangle Language (.STL). The STL file is fed into a slicer program which aids in slicing down the design file to layers of the object. The conversion of the slicer program to the printers is done through a programming language (called as G-Code) that is fed as input to machines and printers to simulate the programming language to objects.
• • Implement 3D printing techniques: The quality of products produced depends on the choice of 3D printing available in the market for the input fed by the operator. The process has contributed to fast-paced launches in the market by speeding up the design and prototyping phase. The 3D printing methods are broadly classified based on the materials and processes used to create the final products. Performance plastics, metals, ceramics, biomaterials, etc. are used for industrial prototyping. Based on the top classification of materials, that is metals and polymers, the types of 3D printing methods are categorized as follows:
  • • Metal 3D printing
  • • Nonmetal 3D printing

1.2.2 Metal three-dimensional printing technology

Metal 3D printing is more complex and expensive than nonmetal (polymer) 3D printing technology. The metal parts are printed on a wide range of materials from stainless steel to aluminum and titanium. They are more widely applied in the aerospace, automotive, and electronics industries. Metal printing techniques involve six process steps, as depicted in Fig. 1–4.

Figure 1–4

Metal 3D printing is categorized into two methods: direct and hybrid methods.

Direct methods—The objects are directly created in metal. The types of processes include the following:

• • Powder melting technologies
  In laser melting [selective laser melting/ direct metal laser sintering (SLM/DMLS) or digital light processing], ytterbium laser (high temperature) melts the metal powder and builds the object through layered deposition as per the CAD input file. Titanium, stainless steel,...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• List of contributors
• Part I: Proof of concept
• Part II: Design inputs
• Part III: Design outputs
• Part IV: Design transfer
• Index