Emerging Trends in Medical Plastic Engineering and Manufacturing

Markus Schönberger, Marc Hoffstetter

• Publisher: William Andrew
• Year: 2016
• Print ISBN: 9780323370233
• eBook ISBN: 9780323374651
• Topic: Technology & Engineering
• Subtopic: Biotechnology in Medicine
• Index: Technology & Engineering

Emerging Trends in Medical Plastic Engineering and Manufacturing gives engineers and materials scientists working in the field detailed insights into upcoming technologies in medical polymers. While plastic manufacturing combines the possibility of mass production and wide design variability, there are still opportunities within the plastic engineering field which have not been fully adopted in the medical industry. In addition, there are numerous additional challenges related to the development of products for this industry, such as ensuring tolerance to disinfection, biocompatibility, selecting compliant additives for processing, and more.This book enables product designers, polymer processing engineers, and manufacturing engineers to take advantage of the numerous upcoming developments in medical plastics, such as autoregulated volume-correction to achieve zero defect production or the development of 'intelligent' single use plastic products, and methods for sterile manufacturing which reduce the need for subsequent sterilization processes.Finally, as medical devices get smaller, the book discusses the challenges posed by miniaturization for injection molders, how to respond to these challenges, and the rapidly advancing prototyping technologies.- Provides a roadmap to the emerging technologies for polymers in the medical device industry, including coverage of 'intelligent' single use products, personalized medical devices, and the integration of manufacturing steps to improve workflows- Helps engineers in the biomedical and medical devices industries to navigate and anticipate the special requirements of this field with relation to biocompatibility, sterilization methods, and government regulations- Presents tactics readers can use to take advantage of rapid prototyping technologies, such as 3D printing, to reduce defects in production and develop products that enable entirely new treatment possibilities

1

Introduction

Abstract

The introductory chapter aims to give a quick but hopefully deep enough first insight into the excitement about plastic and medical devices including engineering and manufacturing. Medical devices without plastics are definitely unthinkable currently and will be definitely due to the fast-emerging, new manufacturing technologies and the vast variety of materials, which are suitable for medical device applications. Unlike others, the world of medical devices is driven mainly by regulatory attempts and actual needs, if health is considered as the number one aspect of everybody’s life. But, as you may have recognized already, even the medical device world is driven by additional forces behind. After reading the introductory chapter, the reader should have gained a first understanding about the complexity with medical devices by reducing maybe existing barriers, especially for currently nonmedical-related engineers. Major topics within this book are introduced shortly, and a recommendation on how to address the whole book is given.

Keywords

Advantages of polymers; Definition of medical device; Driving development forces; Medical device engineering; Plastic engineering; Regulatory affairs; Targeted readership; User’s manual

Outline

1.1 Introduction 1

1.1.1 Plastics and Medical Device Manufacturing or Engineering 2

1.1.2 Regulatory Affairs—Just like Sports 3

1.2 The Books Target Group 4

1.2.1 What Is a Medical Device? 5

1.3 User’s Manual 6

1.3.1 Useful Landmarks in This Book 6

1.4 Medical Device Engineering—Advantages of Polymers 8

1.4.1 Metals and Ceramics as Primal Materials to Plastic Application 8

1.4.2 Technical Advantages of Polymers 9

1.4.3 Technical Advantages for Medical Devices 10

1.5 Medical Devices—a Conservative World? 11

1.5.1 Complexity 11

1.5.2 Legal and Ethical Liability 12

1.5.3 Medical Work Environment 12

1.5.4 Profit Margin versus Medical Device Innovations 13

1.6 Forces behind Future Design and Manufacturing Trends 14

1.6.1 Demographic Trend and Cost Reduction 14

1.6.2 Health Insurance Systems 15

1.6.3 Regulatory Efforts and Legislative Measures 15

1.6.4 Engineering Developments and Consumer Markets 16

1.1. Introduction

Compared to other elaborate disciplines like medical or pharmaceutical sciences, medical engineering is a rather young discipline, however, well established for some decades already. Although professional medicals in fact use tools and devices to back up their efforts in healing injuries and diseases from their very first beginnings; technical professionals were involved as executing contractors only for very long time. It appears to be obvious that who else than a practicing surgeon knows the best what his instruments should be designed and manufactured like. Therefore, for centuries, medical doctors asked blacksmiths and precision mechanics to manufacture devices following their specifications. Still, developing and manufacturing medical devices is a complex and interdisciplinary field to what the input of the final operator is crucial. However, as a relatively young discipline that came into existence roughly at the beginning of the twentieth century, medial engineering mainly adapted existing knowledge and technologies for its specific needs, making it a unique blend of sciences like medicine, biology, (bio) chemistry, pharmacy, classical mechanical engineering, and many more. Moreover, no one is capable of covering all this in the profoundness required. Even today, many people imagine that developing medical devices is still a job for medical professionals, just alike the art of healing. This effect does include frequently professional medics, patients, and even engineers. But if you compare it to the world of aviation: do you want to board a jet plane designed and manufactured by the specifications of the pilot only, or would you prefer one that had professional engineers involved? You see, developing and manufacturing medical devices is a discipline that requires professionals from many disciplines, however, at least medical professionals and engineers.

1.1.1. Plastics and Medical Device Manufacturing or Engineering

Plastic materials and modern medical devices make a perfect fit. Many designs would not be feasible without this extensive collaboration of both engineering entities. In a view of a medical device engineer, it is easy to enthuse about the advantages of plastic utilization. Simply spoken, plastic materials meet the established requirements like process ability, resistance, mechanical properties, biocompatibility, and sterilization capability for the majority of engineered medical devices. As you would expect, plastic materials play a major role for most medical device fields and are processed regularly. At the beginning of the introduction of plastics in the medical device world, standard materials, often addressed as technical type, had been used due to the lack of specific medical grade¹ plastic materials. In accordance with the general awakening need for specific regulatory boundaries, intended to increase consumer protection and device quality, specialized plastic materials and hygienic manufacturing plus packaging techniques have been introduced for plastic medical devices for decades and since improved constantly. It is an interesting circulation system: new technical opportunities lead to new regulatory measures and vice versa. The technical development regarding plastics, medical device design and its manufacturing, is changing constantly and offers uncountable possibilities for current and future medical device engineers to participate with this world. However, the aspect of emerging technologies for plastic medical devices must always be seen in combination with changing or evolving regulatory boundaries. A highly interesting arising manufacturing technology like industrial 3D printing can be considered worthless as manufacturing approach for the medical device industry, if regulatory aspects are not identified adequately and correspondingly addressed.

1.1.2. Regulatory Affairs—Just like Sports

When getting engaged in medical devices as professional engineer, it is crucial for you to have some understanding for facts and correlations that clearly are not covered by technology in its classical understanding. Some of them may appear interesting but still eerie to you, like surgical techniques or the medical basics of some diseases. Others, like aspects of rules and regulations (often referred as regulatory affairs), seem to be useless or you are aware of their crucial importance, but still could not develop a passion, yet. Put simply, you tend to think about some aspects, especially regulatory affairs, as boring. Like most young and probably many old engineers, we sensed about regulatory frameworks the same way at the beginning of our career as medical engineering professionals. After getting in touch more deeply, we have developed a different impression and recognize these to be not a necessary evil. Now, we rather see these as useful and valuable tools backing up our engineering work (and hopefully yours as well) and help us to work within the rocky world of liability issues or simply spoken the biological system, often referred as the human body. We understand the difficulty to see the actual importance of regulatory for young and elaborating engineers. You may compare it with baseball, a sport that is not really appreciated in most of the world, but has an enormous background in some countries, where the rules and general understanding of the sport is widely known. As young and skilled batter you clearly focus on hitting the ball as hard as you can. Aspects like techniques for training, advices from the trainer or tactics basing on the games of the rule are anything but interesting for you. You (should) know about their importance, but you probably deal with them only half-assed. However, when becoming a more experienced and elaborate player, you will see, hitting the ball is only the last act in a sequence of actions that is embedded in a complex field of knowledge and experience, many of them from beyond the world of sports. Moreover, knowing the rules of a sport sometimes is more important for winning the match than personal skills or fitness. Therefore, our intention is to give you a comprehensive set of facts and correlations that are essential and useful for you as an (young) engineer, who is or will be involved in the world of engineering or manufacturing plastic medical devices. We strongly encourage you to mess around with the sometimes ill-reputed aspect of rules and regulations. It is impossible to cover all imaginable aspects and situations you might encounter, but considering our set of tools, you will develop a way of thinking that is useful to deal with them. One of the most important one is clearly you are and should remain engineer. Your comprehensive knowledge upon technology, design and manufacturing is your asset, and the object of desire within the process of medical device development and manufacturing. Today’s medical professionals usually are aware that beyond your classical skills you could acquire a broad understanding of their work and needs, making you an intermediator between both worlds. As this is the very understanding of our own engagement in medical devices, we both take always clearly the view of an engineer in this book. May it become a companion for your first step into, or a personal trainer for your daily work within the wonderful and amazing world of medical device engineering.

1.2. The Books Target Group

By reading this introduction, you obviously show increased interest in the world of medical devices or maybe you are already more or less deeply involved in it. This is the first match between you, as valued reader, and us, as the authors, who are seeking to provide you a comprehensive set of knowledge and tools for this world. While developing this book, we both did reflect designated target groups whom to dedicate it to, and thus did define three major groups:

1. Engineering students ogling with medical device world

2. Non-Engineer professionals engaged in medical devices

3. Experienced engineers interested in emerging technologies

This does require to briefly introduce the basics, that you either never heard before, or you simply want to repeat or engross. For professionals involved in medical devices as non-Engineers, we provide basic understanding for technologies and processes utilized, giving them a clue about what technicians are currently and might be in the future thinking and working. Finally, professional medical engineers will find interesting aspects and emerging trends, ranging from the latest state of the art to future developments in medical devices. However, what in precise is the object of interest?

1.2.1. What Is a Medical Device?

As object of a rather young scientific discipline, the term medical device is used in many aspects and in consequence is subject to many definitions. For layperson, it does include any apparatus or device intended for application by a medical professional within his work, ranging from a surgical blade, rather simple in design, to elaborate machines for modern medical imaging like X-ray or computer tomography. A recurring characteristic of medical devices is that they are intended in some way to detect, prevent, monitor, treat or alleviate diseases, injuries, or disabilities. They are intended mainly for application by trained and experienced medical professionals and their primary mode of action is physical in nature, contrary to drugs, that exhibit a chemical mode of action. This understanding of medical devices is used by close to all competent authorities that regulated their markets, and thus will be subject to this book. Fur...

Table of contents

• Cover image
• Title page
• Table of Contents
• Series Pages
• Copyright
• About the Authors
• Preface
• Acknowledgments
• 1. Introduction
• 2. Regulations for Medical Devices
• 3. Design of Plastic Medical Devices
• 4. Generative Manufacturing Technologies—The Future?
• 5. Emerging Manufacturing Technologies
• 6. Emerging Trends
• 7. Looking through the Crystal Ball
• Glossary
• Index