Biomechatronic Design in Biotechnology E-Book

Carl-Fredrik Mandenius

• Herausgeber: John Wiley & Sons
• Kategorie: Fachliteratur
• Sprache: Englisch

Seitenzahl: 374

Veröffentlichungsjahr: 2011

Beschreibung

"... a must-read for all modern bio-scientists and engineers working in the field of biotechnology." - Biotechnology Journal, 2012, 7 A cutting-edge guide on the fundamentals, theory, and applications of biomechatronic design principles Biomechatronic Design in Biotechnology presents a complete methodology of biomechatronics, an emerging variant of the mechatronics field that marries biology, electronics, and mechanics to create products where biological and biochemical, technical, human, management-and-goal, and information systems are combined and integrated in order to solve a mission that fulfills a human need. A biomechatronic product includes a biological, mechanical, and electronic part. Beginning with an overview of the fundamentals and theory behind biomechatronic technology, this book describes how general engineering design science theory can be applied when designing a technical system where biological species or components are integrated. Some research methods explored include schemes and matrices for analyzing the functionality of the designed products, ranking methods for screening and scoring the best design solutions, and structuring graphical tools for a thorough investigation of the subsystems and sub-functions of products. This insightful guide also: * Discusses tools for creating shorter development times, thereby reducing the need for prototype testing and verification * Presents case study-like examples of the technology used such as a surface plasmon resonance sensor and a robotic cell culturing system for human embryonic stem cells * Provides an interdisciplinary and unifying approach of the many fields of engineering and biotechnology used in biomechatronic design By combining designs between traditional electronic and mechanical subsystems and biological systems, this book demonstrates how biotechnology and bioengineering design can utilize and benefit from commonly used design tools-- and benefit humanity itself.

Leseprobe

Contents

Cover

Title Page

Copyright

Preface

Chapter 1: Introduction

1.1 Scope of Design

1.2 Definition of Biomechatronic Products

1.3 Principles of Biomechatronics

1.4 Brief History of the Development of Biomechatronic Products and Engineering

1.5 Aim of This Book

References

Part I: Fundamentals

Chapter 2: Conceptual Design Theory

2.1 Systematic Design

2.2 Basics of Technical Systems

2.3 Psychology in the Systematic Approach

2.4 A GENERAL Working Methodology

2.5 Conceptual Design

2.6 Abstraction in Order to Identify Essential Problems

2.7 Developing THE Concepts

2.8 Concluding Remarks

References

Chapter 3: Biotechnology and Mechatronic Design

3.1 Transduction of the Biological Science into Biotechnology

3.2 Biological Sciences and Their Applications

3.3 Biotechnology and Bioengineering

3.4 Applying Mechatronic Theory to Biotechnology: Biomechatronics

3.5 Conclusions

References

Chapter 4: Methodology for Utilization of Mechatronic Design Tools

4.1 Idea of Applying the Mechatronic Design Tools

4.2 Table of User Needs

4.3 List of Target Specifications

4.4 Concept Generation Chart

4.5 Concept Screening Matrix

4.6 Concept Scoring Matrix

4.7 Hubka–Eder Mapping

4.8 Functions Interaction Matrix

4.9 Anatomical Blueprint

4.10 Conclusions

References

Part II: Applications

Chapter 5: Blood Glucose Sensors

5.1 Background of Blood Glucose Analysis

5.2 Specification of Needs for Blood Glucose Analysis

5.3 Design of Blood Glucose Sensors

5.4 Description of the Systems Involved in the Design Concepts for Glucose Blood Sensors

5.5 Conclusions

References

Chapter 6: Surface Plasmon Resonance Biosensor Devices

6.1 Introduction

6.2 Design Requirements on SPR Systems

6.3 Mechatronic Design Approach of SPR Systems

6.4 Detailed Design of Critical SPR Subsystems

6.5 Conclusions

References

Chapter 7: A Diagnostic Device for Helicobacter pylori Infection

7.1 Diagnostic Principle of Helicobacter Infection

7.2 Mechatronic Analysis of Urea Breath Test Systems

7.3 Description of the Systems Involved in the Design Concepts for the Urea Breath Tests

7.4 Aspects of the Design for Efficient Manufacture

7.5 Conclusions

References

Chapter 8: Microarray Devices

8.1 Principles, Methods, and Applications of Microarrays

8.2 Specification of Needs

8.3 Design of Microarrays

8.4 Description of the Systems Involved in the Design Concepts

8.5 Conclusions

References

Chapter 9: Microbial and Cellular Bioreactors

9.1 Bioreactor Development During the 1970s–1990s

9.2 Missions, User Needs, and Specifications for Bioreactors

9.3 Analysis of Systems for Conventional Bioreactors

9.4 Novel Bioreactor Designs

9.5 Conclusions

References

Chapter 10: Chromatographic Protein Purification

10.1 Background of Chromatographic Protein Purification

10.2 Specification of Needs for Protein Purification Systems

10.3 Design of Purification Systems

10.4 Unit Operation Purification in a FVIII Production Process (Case 1)

10.5 Micropurification System Based on a Multichip Device (Case 2)

10.6 Conclusions

References

Chapter 11: Stem Cell Manufacturing

11.1 State of the Art of Stem Cell Manufacturing

11.2 Needs and Target Specifications for Scaled-Up Stem Cell Manufacturing

11.3 Setting Up an Efficient Manufacturing System by Using Biomechatronic Conceptual Design

11.4 Conclusions

References

Chapter 12: Bioartificial Organ-Simulating Devices

12.1 Introduction

12.2 Design of Bioartificial Organ-Simulation Devices

12.3 Analysis of Bioartificial Liver Systems

12.4 Conclusions

References

Chapter 13: Applications to Process Analytical Technology and Quality by Design

13.1 Pat and QbD Concepts

13.2 Needs of The PAT/QbD Players and Resulting Specifications

13.3 Application of Design Methodology to PAT/QbD

13.4 Applying Mechatronic Design on a PAT System for Online Software Sensing in a Bioprocess (Case)

13.5 Conclusions

References

Glossary

Index

Copyright © 2011 by John Wiley & Sons, Inc. All rights reserved.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey.

Published simultaneously in Canada.

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Library of Congress Cataloging-in-Publication Data:

Mandenius, Carl-Fredrik, 1954–

Biomechatronic design in biotechnology: a methodology for development of biotechnological products / Carl-Fredrik Mandenius, Mats Björkman.

p.; cm.

Includes bibliographical references and index.

ISBN 978-0-470-57334-1 (cloth)

1. Biotechnology. 2. Biomechanics. 3. Biomedical engineering. I. Björkman, Mats, 1955- II. Title.

[DNLM: 1. Biotechnology–methods. 2. Biomedical Engineering–methods. 3. Chemistry Techniques, Analytical. W 82]

TP248.2.M366 2011

610.28–dc22

2010054066

Printed in Singapore

oBook ISBN: 9781118067147

ePDF ISBN: 9781118067123

ePub ISBN: 9781118067130

Preface

The purpose of this book is to provide the reader with an introduction to systematic design principles and methodology when applied to biotechnology products. Certainly, none of these fields is new on the block – it is the combination of them that brings about a novel approach in this book. The theory of systematic design has almost entirely been devoted to mechanics and electronics, and the biotechnology field has had much of its roots in white biology and in (bio)chemical engineering.

Thus, we are dealing with a subject that lies on the border between biological technology and mechanical and electric engineering. The aim is to integrate important aspects of biological technology with mechanical and electric engineering. In writing a book of this type, there are two major ways of organizing the material, either from the perspective of mechanical design engineering or from the perspective of biotechnology. We have chosen the first for the simple reason that we have used mechatronics methodology from mechanical design engineering as a basis and applied it to biotechnology. When doing so, we have adapted the methodology to what we call a biomechatronics approach.

We presume the book will have mainly two categories of readers, those with a background in biotechnology and related areas and those with a background in mechanics and electronics. We have tried to keep most of the text on a level where both categories of readers would be able to understand the subject. When this has not been possible, due to space constraints, we have instead provided rather detailed lists of reference literature.

We realize that a great deal of the biotechnical details in the application cases in Chapters 5–13 are probably rather difficult to understand for a person with a background in mechanics and/or electronics. You would need a thorough knowledge of biotechnology in order to comprehend everything in these chapters. However, the main ideas of how to utilize and work with the presented biomechatronic design methodology are possible to understand when reading these chapters. It is not necessary to understand all the biotechnological details in order to have great benefit from these chapters.

We have provided in the book nine application cases from a rather diverse collection of biotechnology products, such as biosensors, analytical instrumentations, production equipment for cell culturing, and protein purification. Some of the products could be characterized more as systems products rather than discrete physical products, for example, PAT-based quality systems.

Readers with their own practical experiences could select from these application cases those relevant to their area of practice. Still, it is necessary to first grasp the general methodology approach and tools, especially explained in Chapter 4 and related to fundamental design theory in Chapter 2, before starting reading specific application cases.

The readers who wish to have a complete overview should of course go through most of the chapters.

We take a great pleasure in expressing thanks to our colleagues Dr. Micael Derelöv and Dr. Jonas Detterfelt for contributing many valuable ideas and suggestions, in particular, to the initial studies of the subject of the book. Valuable contributions on inquiries and interviews with developers and companies were made by Maria Uhr and Annika Perhammar.

We also thank our academic colleagues in engineering, medicine, and biophysics: Drs. Katrin Zeilinger, Jörg Gerlach, Bo Liedberg, Danny van Noort, and Ingemar Lundström.

We are also grateful to many biotechnology companies and their personnel who have shared their experiences and endeavors in the development of biomechatronic products. In particular, we would like to mention Drs. Stefan Löfås, Ulf Jönsson, at Biacore; Lasse Mörtsell at Belach AB; Stellan Lindberg at Hemocue AB; Stefan Nilsson and Johan Rydén at Noster AB; Dario Kriz at European Institute of Science AB; and colleagues at Cellartis AB.

We owe gratitude to Abbott, Agilent, Affymetrix, Biodot, Charité Universitätsmedizin Berlin, GE Healthcare, Hemocue, Johnson & Johnson, Kibion, KronLab Chromatography, LifeSpan, Roche Diagnostics, Q-Sense and Mr. Anders Sandelin for providing us figures and pictures.

We would like to thank the Swedish Agency for Innovation Systems (VINNOVA) and Linköping University for financially supporting our research on this topic.

We appreciate the support from John Wiley & Sons, Inc., Hoboken, in the production of this book.

Finally, we would like to express our sincere gratitude to all the skillful scientists and engineers who have contributed immensely to the development of design science in a variety of areas of technology. Without them, this book would not have been realized.

Carl-Fredrik Mandenius Mats BjÖrkman

LinköpingNovember 2010

Chapter 1

Introduction

1.1 Scope of Design

Design is a concept with many aspects. So far, there exists no generally accepted definition of the concept. The word design has different meanings in different disciplines and fields. However, in general terms the verb design normally does refer to the process of planning, constructing, and creating a physical structure and functions of a physical artifact. Design can also refer to the process of creating the structure and functions of systems or services. In most cases, the concept of design is related to the development of new products.

Design is also characterized by having significant impact on most areas of human life. Almost all objects we interact with have gone through a design stage: the house we live in, the household machines for food preparation, and the vehicles that transport us to our office. Our mobile telephone is integrated into a complex communication network designed for optimal interconnection. The pills to cure the headache after work are a result of drug design. The examples from daily life are endless.

Of the designed products we encounter daily, many have a biotechnology origin although most people do not recognize them as being designed using materials or methods derived from biotechnology. This could concern products such as fermented food and beverage, biological drugs, or diagnostic tests used by the medical care unit in the aftermath of flue.

These biotechnology products are examples of design that includes a wide range of considerations, of course, not only from biology but also from physics and chemistry.

All modern design is, with few exceptions, based on scientific laws and principles. Previous experiences are almost always considered when a new product is designed. Sometimes, a product design can be based on a new invention or a discovery. This is an aspect that is often present for biotechnical products. Biotechnical innovations are, in comparison with many other fields, often based on new inventions or scientific discoveries. This puts extra demands and strains on the design process, as the design task is more complex and complicated compared to the design of a new product that is based on an existing product or range of products. In the latter case, there exist more experience and knowledge of the utilized technology. Furthermore, the scientific basis of the product is better known.

The design concept is not limited to physical artifacts or devices – design is also required for manufacturing processes to produce the designed products and services to support them. Biotechnology products are examples of that.

Design in industry has in recent years gone through a significant development and vitalization in order to strengthen product development in a world of increasing global competition, higher demands from customers, and with tighter regulations. One example of this development is the trend among the producing companies of selling products not only as a single physical unit but also in combination with a service related to the physical product [1]. Furthermore, this trend goes in the direction that the relative value of the service part increases while the physical product part decreases. However, the proportion between the value of the physical product and the service differs very much between different product categories. Traditionally, the service part has often been added to the physical product offer to the customers.

The trend has led to an outspoken industrial interest augmented by significant research efforts on how to integrate the design with a combination of the physical product and its required service. This is often referred to as Product Service Systems design [2]. This new approach means new challenges for the producing companies [3] such as designing their physical products to fit Product Service Systems. In addition, the Product Service Systems approach gives opportunity to close the material flows with product remanufacturing in an economic and environmentally beneficial manner [4]. One of the large business incentives for the producing companies is that the customer relationship is improved that also increases the possibilities for product remanufacturing within the product life cycle [5].

Another aspect of design that grows in importance is the sustainability of the designed product. Sustainable design aims to design products that support a sustainable development in society. In 1987, the World Commission on Environment and Development (WCED) defined sustainable development as “a development that meets the needs of the present without compromising the ability of future generations to meet their own need” [6]. As a consequence, sustainable design has three dimensions that must be addressed. The product must be environmentally, economically, and socially sustainable.

The examples in this book address all these dimensions as biotechnology products are intended to improve the health and well-being of people. The sustainability aspect is explicitly not discussed, yet it has a strong impact through economical use of biomechatronic products.

1.2 Definition of Biomechatronic Products

We refer frequently in this book to mechatronics. A mechatronic product is a product where the fields of mechanical, electronic, computer, control, and systems design engineering are combined in order to design a useful product [7, 8]. Most of our more advanced consumer and business-to-business products are mechatronic products comprised of combinations of mechanical and electronic components [9]. We may think of a car as a mechanical product. That was true for a Ford Model-T, but today a modern car is a highly advanced mechatronic product where the value and cost of the mechanical components are continuously decreasing in relation to the electronic components and subsystems. Many of our “mechanical” consumer products are in fact controlled by microcomputers/microprocessors. A relatively inexpensive product such as the modern digital consumer camera is based on highly advanced microchip technology for creation of a digital image and the camera is controlled by advanced electronics and microprocessors. Digital cameras are intended for a mass consumer market and the advanced key components are mass-produced. The result is that the development and manufacturing costs can be distributed over a vast number of individual cameras decreasing the unit price of the cameras that, in fact, are highly advanced mechatronic products. Cheap does not have to imply simple anymore.

To combine and synthesize expertise from the fields of mechanical, electronic, computer, control, and systems design engineering in a design process in order to design a product is not an easy achievement. The major task is to come up with an optimal combination of the different fields of engineering and technologies. This is accompanied with a huge risk for suboptimizations.

A biomechatronic product, as this book focuses on, is a mechatronic product with a substantial element of biotechnology added that shares all these characteristics of the mechatronic product.

In order to emphasize this, we define the biomechatronic products in the following way:

A product where biological and biochemical, technical, human, management and goal, and information systems are combined and integrated in order to solve a mission that fulfils a human need. A biomechatronic product includes a biological, a mechanical, and an electronic part.

The generic biomechatronic definition used here pinpoints a unique feature in design that a biological system in the product is an active part of the design concept. By that, our definition of a biomechatronic product focuses on what systems are included and constitute important parts of the product [10].

Common biomechatronic products include, for example, many products used for production of food and medicine, medical analysis equipment, and so on. This book focuses on these types of biomechatronic products.

1.3 Principles of Biomechatronics

Figures 1.1 and 1.2 represent the biomechatronic system. A biomechatronic product can be seen as a physical realization of a biomechatronic system. The biological part exerts activity on the mechanical and electronic parts. The mechanical part exerts activity on the biological part and/or the electronic part. The electronic part exerts activity on the mechanical part and/or the biological part. Importantly, external stimuli elicit effects. This may be, as in the figures, directly on the biological part that creates activity or changes activity owing to the stimulus, or it is mediated through the mechanical and/or electronic parts. The tripartite system is required to create the reading (or response).

Figure 1.1 In a biomechatronic system, biological, electronic, and mechanical activities interact in the overall function of the designed object.

Figure 1.2 A biomechatronic system in operation.

The abstraction of the object can be applied to a number of today's technical systems in biotechnology.

A biosensor is an example of a biomechatronic system – an analytical device that measures a substance interacting with a biological part, for example, an antibody. Such an interaction may cause a change in activity, for example, a mass change, which causes a change in mechanical oscillation of a quartz crystal, which in turn is electronically recorded by a pair of electrodes. This recording is then transduced to a display reader. The biosensor is a so-called quartz crystal microbalance (QCM) as shown in Figure 1.3 where a piezoelectric crystal is oscillating with a frequency determined by the mass load on the crystal [11, 12]. The surface of the crystal is covered with a bipolar layer of amphiphilic molecules that mimics biological membrane. For example, nucleotide sequences are immobilized to the membrane and can bind, or hybridize, with complementary DNA sequences. Thus, the QCM is a biomechatronic product since it exemplifies exactly what Figure 1.2 illustrates.

Figure 1.3 A biomechatronic system example: a quartz crystal microbalance biosensor. Reproduced with permission from Q-Sense.

A bioartificial liver [13] is another example of a biomechatronic system – a contained liver cell culture converts xenobiotics/drugs by its metabolic activity (Figure 1.4). A mechanical system, consisting of pumps and valves, directs nutrients and patient blood to the liver cells entrapped in a plastic cage that allows liquid perfusion. Electronic circuits measure activity and control pumps and valves and by that the liver. Human liver cells are cultured on a tubing network of gas- and liquid-permeable channels with a structure mimicking the liver tissue. The system has, as shown in Figure 1.4, a mechanical part consisting of pumps, valves, and plastic containers and an electronic part consisting of sensors and actuators that interact with the biological liver cells growing and metabolizing nutrients perfused through the system. The tripartite system is fully interdependent and, by that, also adheres to Figure 1.2.

Figure 1.4 A biomechatronic system of a bioartificial liver device [8].

Reproduced with permission from Charité Universitätsmedizin, Berlin

.

1.4 Brief History of the Development of Biomechatronic Products and Engineering

From a historical perspective, biomechanical products and systems have been created in societies very early. The electronic part of biomechatronic products, however, was developed first during the twentieth century after the technical development of electricity at the end of the nineteenth century.

Biology and mechanics were merged already at least 4000 years BC [14]. Artifacts and excavations from ancient Mesopotamia and Egypt show examples of breweries and wineries on an industrial scale. Recipes for production have been interpreted from hieroglyph tables and cave paintings show snapshots of equipment. This was actually a sort of early Standard Operation Procedures (SOPs) [15]. During the ancient Roman period, factories were set up for industrial olive oil and vinegar manufacture with hundreds of workers.

These historical examples are, in a wide sense, biomechanical inventions. They brought in the grape culture at an industrial level and combined it with technical mechanical devices. Of course, electronics was not applied at this developmental stage.

Also in the field of practical medicine, the biology and mechanics were integrated. In ancient Egypt, medicine reached sometimes a surprising high technical level – in some respects, the medical treatments were technical although the biological understanding was shallow.

Another early example of a sort of bioreactor is the beehive. The biological component – the bee – carried out the transformation from nectar to honey. The technical invention, the hive, nourished the bee swarm and recovered the product.

Brewing and fermentation technology developed slowly until the nineteenth century when Louis Pasteur finally was able to bring a scientific understanding to biological transformation on a molecular and cellular level [14]. Early twentieth-century microbiology refined this knowledge for new microbial strains and products. Electricity became a way to transform energy in the biological system that previously was limited to mechanical functions. Thus, temperature control of a culture could be done and mixing devices could be integrated into the first generation of bioreactors 100 years ago.

The timeline of Figure 1.5 illustrates the connectivity of the biotechnology and history. What could be added is that the progress in biotechnology development seen in this timeline was the result of scientific discoveries done in parallel [16, 17]. These achievements were not possible without the development of natural sciences and can be associated with names such as Linnaeus, Jenner, Mendel, Leeuwenhoek, Darwin, Watson, and many others [17–19].

Figure 1.5 The historical development of biomechatronic products and production systems.

Its seems very likely that the continuation of the time arrow of Figure 1.5 will in the near future be decorated with numerous new inventions and follow-up products extruding into the micro- and nanoscale world of biotechnology. If this development is augmented by systematic design approaches, the new biotechnology products have a better potential to gain high quality at an earlier stage of development.

1.5 Aim of This Book

The overall aim of this book is to support the task of designing biomechatronic products. It is very complex to design mechatronic products and the task is further increased in complexity when the biotechnological element is added in the form of biological activities and systems. This is illustrated by the bioartificial liver above. The focus in the book is on how to integrate and handle this biotechnological element in the integrated design process for the design of biomechatronic products and systems.

We try to fulfill the aim by several means. As the major enabling means, we propose and present a generic methodology for systematic design of biomechatronic products. This biomechatronic design methodology includes a number of design tools for supporting the work in the different stages or parts of the methodology. This is mainly done in Chapter 4, which can be seen as the central chapter of this book.

The presented methodology and design tools are all based on existing and well-established methodologies and design tools from the field of mechanical engineering. These are presented mainly in Chapters 2 and 4. The methodologies and tools are further developed and adapted to include the biotechnological elements of biomechatronic design. Biotechnology in mechatronic design is treated mainly in Chapters 3 and 4.

One important aspect of the presented biomechatronic design methodology is that it gives the means for supporting the communication between experts in the different fields of engineering that are involved in the design. Many suboptimizations in designs are the result of misunderstandings in the communications.

The presented methodology and design tools are applied to a number of biomechatronic products and/or systems. This is covered in Chapters 5, 6, 7, 8, 9, 10, 11, 12, 13. These applications give an insight and understanding of how the methodology could be applied and used.

The applications in Chapters 5, 6, 7, 8, 9, 10, 11, 12, 13 also give comprehensive descriptions of many different types of modern biomechatronic products and systems. These descriptions can be of great interest, especially for readers unfamiliar with biotechnology products, regardless of the applications of the biomechatronic methodology.

It is possible for the reader to focus on the chapters that describe biomechatronic products and systems of special interest for the reader. However, we strongly advise the reader to also read the other chapters, as all applications are not implemented in the same manner. The different applications act as examples of how it is possible to apply and utilize the presented methodology and design tools in different ways. There is not just one way of using them. This is clearly illustrated in the different application chapters.

References

1. Lifset, R. (2000) Moving from products to services. J. Ind. Ecol. 4, 1–2.

2. Sundin, E., Lindahl, M., Ijomah, W. (2009) Product design for product/service systems: design experiences from Swedish industry. J. Manuf. Technol. Manage. 20, 723–753.

3. Sundin, E., Ölundh Sandström, G., Lindahl, M., Öhrwall Rönnbäck, A., Sakao, T., Larsson, T. (2009) Challenges for industrial product/service systems: experiences from a learning network of large companies. In: Proceedings of CIRP Industrial Product/Service Systems (IPS2), Cranfield, UK, April 1–2 pp. 298– 304.

4. Sundin, E., Bras, B. (2005) Making functional sales environmentally and economically beneficial through product remanufacturing. J. Cleaner Prod. 13, 913–925.

5. Östlin, J., Sundin, E., Björkman, M. (2009) Product life-cycle implications for remanufacturing strategies. J. Cleaner Prod. 17, 999–1009.

6. United Nations (1987) Report of the World Commission on Environment and Development. General Assembly Resolution 42/187, December 11.

7. Bradley, D.A., Loader, A.J., Burd, N.C., Dawson, D. (1991) Mechatronics: Electronics in Products and Processes. Chapman & Hall, London.

8. Karnopp, D.C., Margolis, D.L., Rosenberg, R.C. (2006) System Dynamics: Modeling and Simulation of Mechatronic Systems, 4th edition. Wiley.

9. Cetinkunt, S. (2007) Mechatronics. Wiley.

10. Derelöv, M., Detterfelt, J., Björkman, M., Mandenius, C.F. (2008) Engineering design methodology for bio-mechatronic products. Biotechnol. Prog. 24, 232–244.

11. Ngeh-Ngwainbi, J., Suleiman, A.A., Guilbault, G.G. (1990) Piezoelectric crystal biosensors. Biosens. Bioelectron. 5, 13–26.

12. Fung. Y.S., Wong, Y.Y. (2001) Self-assembled monolayers as the coating in a quartz piezoelectric crystal immunosensor to detect Salmonella in aqueous solution. Anal. Chem. 73, 5302–5309.

13. Gerlach, J.C., Lübberstedt, M., Edsbagge, J., Ring, A., Hout, M., Baun, M., Rossberg, I., Knöspel, F., Peters, G., Eckert, K., Wulf-Goldenberg, A., Björquist, P., Stachelscheid, H., Urbaniak, T., Schatten, G., Miki, T., Schmelzer, E., Zeilinger, K. (2010) Interwoven four-compartment capillary membrane technology for three-dimensional perfusion with decentralized mass exchange to scale up embryonic stem cell culture. Cells Tissues Organs 192, 39–49.

14. Bud, R. (1993) The Uses of Life: A History of Biotechnology. Cambridge University Press.

15. Gaudillière, J.P. (2009) New wine in old bottles? The biotechnology problem in the history of molecular biology. Stud. Hist. Philos. Biol. Biomed. Sci. 40, 20–28.

16. Mason, S.F. (1962) A History of the Sciences. MacMillan, New York.

17. Prigogine, I., Stengers, I. (1984) Order Out of Chaos. Bantam Books, New York.

18. Schneer, C.J. (1960) The Search of Order. Harper and Brothers, New York.

19. Watson, J.D. (1968) The Double Helix: A Personal Account of the Discovery of the Structure of DNA. Atheneum, New York.

Part I

Fundamentals

Chapter 2

Conceptual Design Theory

This chapter summarizes fundamental principles of mechatronic design with the mechanical engineering perspective. We present here the concepts in mechatronics upon which are based the biotechnology applications discussed in this book. The chapter does not bring up biotechnology aspects per se – this will be saved for the following chapters.

2.1 Systematic Design

2.1.1 Design for Products

“The main task of engineers is to apply their scientific and engineering knowledge to the solution of technical problems, and then to optimize those solutions within the requirements and constraints set by materials, technological, economic, legal, environmental and human-related considerations,” say Gerald Pahl and Wolfgang Beitz [1], two German researchers who have made significant impact on research, teaching, and training in mechanical design engineering for several decades.

However, the scope of design is not restricted to mechanical engineering, it applies to all engineering sciences and its basic principles are as much applicable to engineering design problems and solutions in electronics, physics, information technology, chemical technology, and biotechnology, for example.

Technical problems become concrete engineering tasks after their clarification and definition that engineers have to solve to create new technical products. These products may vary widely: mechanical products, electric devices, power plants, chemical processes, software programs, and so on.

The steps in the creation of the products are several, for example, identification of needs and constraints, the original idea, the conceptual elaboration of the idea, considerations of alternative ways to realize the idea, the building or construction work of a first prototype, and the (mass) manufacturing of it (Figure 2.1).

Figure 2.1 Principle for stepwise product design under needs and constraints.

The invention of a new product is the typical main achievement of design and development engineers, whereas its physical realization is the main accomplishment of manufacturing engineers. However, it is very important that there is a close cooperation between the development engineers and the manufacturing engineers during the product realization process. The design of the product and the design of its manufacturing system must be performed concurrently in an integrated process. This is vital in order to increase the possibility of achieving not only a product that is adapted and suitable for manufacturing but also an efficient manufacturing process and system (Figure 2.2).

Figure 2.2 The concurrent development of design solutions and manufacturing process.

It is clear that design of products is an engineering activity that

has the potential to affect almost all areas of human life;should take advantage of using the laws and insights of science;can be built upon specific experience;provides the prerequisites for the physical realization of novel ideas.

The approach in this book is that design should be done systematically. This is the dominating approach in both industry and academia. Another way to say this is that in systematic respect, designing is the optimization of given objectives within partly conflicting constraints [2]. User requirements changes gradually, so a particular solution can be optimized only for the actual circumstances.

Nowadays, it is considered important to design new products with an eye on the whole product life cycle (Figure 2.3). The sustainability aspect, mentioned in Chapter 1, is an example of this. This introduces an extended view to designing – in such organizational respects the design can be an essential part of the product life cycle. This cycle is triggered normally by either a market need or a new idea, or both. It starts with product planning and ends when the product's useful life is over, with recycling/remanufacturing or environmentally safe disposal.

Figure 2.3 The product life cycle.

2.1.2 Origin of the Design Tasks

It is common that systematic design projects, related to (mass) production or batch production, are initiated by a product planning team after carrying out a thorough analysis of the market needs. A number of issues are essential to consider:

The Novelty of the Product. Does a similar product already exist? Biotechnology has in this respect been favored for entering a virgin market area with many opportunities. The product may be based on a new scientific discovery. This is not uncommon for the biomechatronic products. The novelty aspect has therefore often been easy to accomplish. With a maturing biotechnology market segment, this has become more difficult.The Production Cost. It must be realistic and within the tolerance limit of the market.The Complexity of the Product. The design applications in coming chapters address the complexity of biomechatronic design. However, biomechatronic products are not the sole complex product type – large-scale mechanical systems or mechatronic products can often be very complex products themselves before merging with the biotechnical dimension.Realistic Goals. Goals must be realistic and must not cross the limits of aspirations. This is both a restriction and a challenge for the creativity and imagination of the design team. Some of the products we will discuss approach this limit, such as artificial organs, stem cells, and biological microchips.

The essential considerations above create a number of working tasks and activities for the design team that should be approached systematically. But first, let us bring up a few historically established design issues that have driven design achievements over the past years and shaped the way we apply design today.

2.1.3 Development of Design Thinking

From a recent historical perspective, it is possible to mention a few steps of particular importance for the ascent of design thinking.

An important theoretical contribution was the identification of governing scientific principles and economical constraints that conduct systematic design behavior [3]. Concerning the form of the design, these principles are related to (1) minimizing production cost in order to improve the competitive edge of the design solution, (2) minimum space, which is close to the former, where it is assumed that the smallest product that can fill the same need is the most attractive solution, (3) minimum weight, another criterion that strengthens the product is that it is reasonably inexpensive, (4) minimum losses in the production of the product, and (5) optimal handling when using the product.

In the design and optimization of individual parts and simple technical artifacts of the product, these principles could and should be followed.

Another valuable contribution was the introduction of the four design perspectives that are applicable to most new products and consequently are the fundamental design factors (Figure 2.4). These are (1) working principle, (2) material, (3) form, and (4) size of the design object [4]. All designed products can be described from these aspects. They are interconnected and dependent on needs, production volume, production costs, and a couple of other constraints. The four aspects are by necessity investigated and developed in this sequence. First, identify and decide on the working principle, then select suitable materials, and finally consider the form and the size.

Figure 2.4 The four design perspectives suggested by Tschochner.

Another approach to systematizing the design was to start with an overall layout and then set main dimensions and general arrangements [5]. Then, this overall design was divided into parts that could be handled in parallel in the design work process. When doing this, the identified design tasks were systematically varied and with this a number of alternatives could be generated from which the optimal solution could be identified.

Later on, the design working process was divided into distinguishable phases [6]. The first is the establishment of the working principle based on an idea or invention. The second is the embodiment of the idea where the form is laid out and supported by calculations based on scientific rules and knowledge. The third phase is the implementation of the first and second phases. Although seemingly straightforward, these phases were and are occasionally overruled resulting in unfavorable consequences.

An important step in the development of the existing systematic design theory, now often referred to as the basic systems approach, was taken in the 1960s [7]. This is based on a thorough and critical analysis of the task (goals, specification, and overall function), followed by a systematic search for solution elements and their combination into a working principle. Subsequently, these combinations are analyzed critically in order to identify shortcomings and find a remedy for alleviating these shortcomings, and by that, present a new solution. This solution is further analyzed, recombined, and optimized. The way to develop a new product has many traits that are further developed in the biomechatronic approach we apply in this book.

2.1.4 Recent Methods

No doubt, several of these early theoretical ascents have been integrated into today's design methodology.

A relatively novel approach that is particularly relevant to biological problem formulation is the introduction of a reasoning based on flows, energy, and signals [8]. Although originally it was concerned with characterizing mechanical systems, it is particularly appropriate to apply on biological systems.

An important contribution was made by Vladimir Hubka in the 1970s [9–11] to the establishment of the fundamental principles of a comprehensive design science. This included the introduction of a common design terminology and the use of common symbols in design diagrams (Figure 2.5). It also introduced a clearer notion of the design process both on an abstract level and in actual tasks. By that, guidelines for the activities of designers were set up and could be applied in industrial design practice. We have chosen to follow up on many of the Hubka principles by involving modules and tools, such as the biological systems entity (as will be further discussed in Chapters 3 and 4 where scientific design terminology and symbolism introduced by Hubka are explained in more detail).

Figure 2.5 The scientific design terminology and symbolism introduced by Hubka.

Economical assessment in systematic design is a key to success of the product especially in later stages of the product life. Attempts to improve the possibilities of assessing the cost for design alternative early in the design process have been facilitated by using computer-based calculations and support by databases [12]. By systematically breaking down the parts of the solutions, the necessary details can be reached.

Several other valuable contributions to systematic design have been made during the recent period. Most of them are based on the fundamentals mentioned above [13–16]. Also, these works have inspired the methodology applied in this book.

2.2 Basics of Technical Systems

The term technical systems comprises a wide range of artifacts or collection of artifacts. It encompasses many sciences and technologies, for example, physics and derived branches, including mechanics, thermodynamics, materials science, and so on. It can also include chemistry with chemical technology and reaction engineering, biotechnology and computer science and engineering, just to mention some of them.

All technical tasks are performed by technical artifacts or objects, following certain instructions, executed by a human operator, electronic actuators, or software programs.

A classification of technical artifacts has been suggested by Hubka [10]. This is based on function, working means, complexity, production, product, and other critical conditions. This type of classification is not always useful due to its disparity and varying origin. More useful is often to apply system boundaries in which the technical objects will exert their actions, based on inputs and outputs. The form of these inputs and outputs is energy, material, or signals.

2.2.1 Energy, Material, and Signals and Their Conversion

In technical objects, energy is often manifested as mechanical, electrical, optical, or chemical energy. Material is characterized by weight, color, substance, and other conditions. Signals can in some sense be regarded as information; it is an electrical analog signal, a digital signal, or a chemical signal substance. Signals can also be complex sequences and arrays of signals, such as messages, speech, and books.

Energy can be converted from one form to another in the technical system. In a combustion engine, thermodynamic energy is converted to mechanical energy; in a muscle fiber, biochemical energy is converted to mechanical energy; and in a water power plant, hydrodynamic energy is converted to electrical energy.

Materials can be converted as well. Metals can be melted and mixed to produce alloys. Food nutrients can be converted to vital energy in a growing body. Polymers can be shaped to desired forms with specific functions.

Signals can also be converted, or as more commonly said, be transmitted, displayed, recorded, and received. This conversion occurs, for example, in a biological cell in the brain and in the eye when reading a message, in an electrical circuit in a computer, and so on.

Important for design work is that energy takes the form of mechanical, thermal, electrical, chemical, optical, nuclear, force, heat, current, and biological energy.

Materials appear in the form of gas, liquid, and solid dust, and also as raw materials, as test sample, and as workpieces. Furthermore, materials also appear as end products and components.

Signals are in design work accompanied with characteristic features, such as signal magnitude, display, control impulse, data, or information. Conversion of energy, material, and signals can normally be related to quantity and quality (Figure 2.6).

Figure 2.6 Conversion of energy, material, and signals in a design object.

2.2.2 Interrelationships of Functions

When describing and solving a design problem, it is appropriate to apply the term function to the general input–output relationship of a system that executes a task.

This has the advantage of providing a system description with a clear and easily reproduced relationship between these inputs and outputs. Applying this will be very helpful for solving a technical problem.

Once the overall task is well defined, which should be made clear from the inputs and outputs, the overall function of the system can be described.

The overall function can be divided into subfunctions that also have defined subtasks.

In the design work, it is very useful to carefully consider the meaningful and compatible combination of subfunctions into an overall function. This provides the designer with a function structure. This structure may be varied to satisfy the overall function (Figure 2.7). The figure illustrates this where it is shown how the structure includes energy, material, and signals.

Figure 2.7 The function structure where the overall function is broken down into a variety of subfunctions that all convert energy, material, and signals.

2.2.3 Interrelationship of Constructions

A concretization of the function structure leads to a construction structure. By this, the subfunctions are embodied by physical, chemical, or biological processes. A majority of subfunctions are of mechanical or electrical/electronic engineering nature for most products. Thus, objects where mechanical and electrical parts are the main design issues dominate over the others. So far, biological processes are almost absent in the theoretical design literature.

What is well studied and described is the physical process. This is realized by physical effects occurring under certain geometrical and material conditions. This results in a working interrelationship that fulfils the function necessary for performing the task.

A further concretization of the working interrelationship paves the way for a construction structure of the design. For this interrelationship, the modules, assemblies, and machines with their connections deliver a more concrete technical system.

2.2.4 Interrelationship of Systems

Since the technical system normally is a part of a large technical product context, a design cannot be successful without considering this higher level. This will include human beings, laws of the society, and the surrounding physical environment. In systematic design, this level is referred to as the system interrelationship. It is especially useful for studying effects from the interacting environment, humans, unpredictable effects, external information, and so on. Table 2.1 shows the levels of interactions we have discussed illustrated with an example from mechatronic engineering – an espresso machine. In fact, this also has a biological component in its input material.

Table 2.1 Different Levels of Interaction and Interrelationships in an Espresso Machine.

2.3 Psychology in the Systematic Approach

The systematic design approach has its roots in the human psychology and our inherited way of thinking.

Often, we form our thinking along the relationship of concrete with abstract descriptions. The way to move our ideas from one concrete solution to another concrete solution goes over a state of abstraction.

Another relationship of importance is the whole and the parts. We have the ability to dissect the wholeness of an idea into its parts, but we also have the ability to bring together parts to the wholeness, or even to another wholeness than we originally dissected (Figure 2.8).

Figure 2.8 The process in the brain during systematic design.

A third relationship that influences design thinking is space and time. In what order should the parts operate and where in space?