Emerging technologies: commercial readiness index(CRI) for medical additive manufacturing(AM)

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Supervisor: AF van der Merwe

December 2017 by

Leri Bezuidenhout

Thesis presented in fulfilment of the requirements for the degree of Master in Engineering Management in the Faculty of Engineering at Stellenbosch University

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Declaration

By submitting this thesis electronically, I declare that the entirety of the work contained therein is my own original work, that I am the author and owner thereof (unless to the extent explicitly otherwise stated), and that I have not previously, in its entirety or in part, submitted it for obtaining any qualification.

………..

December 2017 Signature

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Abstract

Technology Readiness Level (TRL) has been widely used as a measure of technology maturity. However, TRL is not necessarily a good indicator of commercial readiness. In the renewable energy sector a Commercial Readiness Index (CRI) is used where only a technology with a high TRL qualifies for commercial readiness. Similarly TRL is used to measure the maturity of Additive Manufacturing (AM) technologies. This research proposes a Commercial Readiness Index (CRI) for Additive Manufacturing. A case-study on maxillofacial Ti6Al4V implants manufactured with AM is referred to in this study.

The Centre for Rapid Prototyping and Manufacturing (CRPM) has been accredited to manufacture implants according to ISO13485. The commercialization of this manufacturing process is currently in the ramp-up phase. The commercial sustainability of the manufacturing process still needs to be valued. This research uses as a base the Commercial Readiness Index (CRI) assessment, created by the Australian Renewable Energy Agency (ARENA) (2014a; De Jager 2017). The ARENA CRI is modified to apply to AM by using the analysis and synthesis approach. The CRI is divided into several independent indicators assessing various commercial aspects, and then they are combined into a single commercial index.

Therefore, the CRI is compiled from commercial indicators: Regulatory Environment, Stakeholder Acceptance, Clinical Performance, Technical Performance, Financial Performance – Cost, Financial Proposition – Revenue, Funding, Industry Supply Chain and Skills, Market Opportunities and Company Maturity. A diverse group of 17 experts assisted in defining maturity in each of the commercial indicators. The compiled results are presented. The value of this research lies in the ability for investors to now assess the commercial viability of using AM in a specific product line. AM is considered a disruptive and emerging technology designated to replace conventional manufacturing processes.

The outcome of this research is a suggested framework showing the Commercial Readiness Index (CRI) of the business process if the Technology Readiness Level (TRL) is matured. The two methods are compared and the result is that there exists a relation between the CRI and the TRL. The TRL can be used to assist in determining the CRI of the project. However, the certain indicators that determine the CRI are not dependent on TRL. The qualitative process used to determine the CRI will help decision makers formulate and implement innovative strategies within the complete product life cycle of this case study. The CRI tool aims at helping Small, Medium and Micro-sized Enterprises (SMME’s) to take their product to the market. This would mean more people embracing AM and enabling the average person to become economically active in the AM industry in South Africa.

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Opsomming

Tegnologie gereedheidsvlak (TRL) word algemeen gebruik om volwassenheid van tegnologie te meet. TRL is egter nie noodwendig 'n goeie aanduiding van kommersiële gereedheid nie. In die hernubare energie sektor word 'n Kommersiële Gereedheidsindeks (CRI) gebruik waar slegs 'n tegnologie met 'n hoë TRL kwalifiseer vir kommersiële gereedheid. Net so word TRL gebruik om die volwassenheid van Toevoeging Vervaardiging (AM) tegnologieë te meet. Hierdie navorsing stel 'n CRI vir AM voor. 'n Gevallestudie oor maxillo-gesig Ti6Al4V-inplantings wat met AM vervaardig word, word in dié studie na verwys.

Die Center of Rapid Prototyping and Manufacturing (CRPM) is geakkrediteer om inplantings volgens ISO13485 te vervaardig. Die kommersialisering van hierdie vervaardigingsproses is tans in die opbou fase. Die kommersiële volhoubaarheid van die vervaardigingsproses moet steeds waardeer word. Hierdie navorsing maak gebruik van die Kommersiële Gereedheidsindeks (CRI), wat deur die Australiese Hernubare Energie-agentskap (ARENA) (2014a; De Jager 2017) geskep is. Die ARENA CRI is aangepas om saam met AM gebruik te word deur die analise en sintese benadering. Die CRI is verdeel in verskeie onafhanklike aanwysers wat verskillende kommersiële aspekte assesseer en wat dan in 'n enkele kommersiële indeks gekombineer word. Daarom word die CRI saamgestel uit kommersiële aanwysers: Regulerende Omgewing, Aanvaarding van Aandeelhouers, Kliniese Prestasie, Tegniese Prestasie, Finansiële Prestasie – Koste, Finansiële Voorstelling – Inkomste, Befondsing, Nywerheid Voorsieningsketting en Vaardighede, Markgeleenthede en Maatskappy Volwassenheid. 'n Diverse groep van 17 kundiges het bygedra tot die bepaling van volwassenheid in elk van die kommersiële aanwysers. Die saamgestelde resultate word aangebied. Die waarde van hierdie navorsing lê in die vermoë vir beleggers om nou die kommersiële lewensvatbaarheid van AM te evalueer. AM word beskou as 'n ontwrigtende en opkomende tegnologie wat aangewys is om konvensionele vervaardigingsprosesse te vervang.

Die gevolg van hierdie navorsing is 'n voorgestelde raamwerk wat die CRI van die besigheidsproses aandui wanneer die TRL volwassenheid bereik het. Die twee metodes word vergelyk en die gevolg is dat daar 'n verband bestaan tussen die CRI en die TRL. Die sekere aanwysers wat die CRI bepaal, is egter nie afhanklik van TRL nie.

Die kwalitatiewe proses wat gebruik word om die CRI te bepaal, sal besluitnemers help om

innoverende strategieë binne die volledige produksiklus van hierdie gevallestudie te formuleer en te implementeer. Die CRI-instrument het ten doel om Klein, Medium en Mikro-grootte Ondernemings (KMMO's) te help om hul produk op die mark te bring. Dit sou beteken dat meer mense AM gebruik en die gemiddelde persoon in staat stel om ekonomies aktief te wees in die AM-bedryf in Suid-Afrika.

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Acknowledgements

This project would not have been possible without the dedicated assistance and input of Johan Els and Gerrie Booysen at The Centre for Rapid Prototyping and Manufacturing.

My sincere thanks to Professor AF Van der Merwe, from Industrial Engineering, Stellenbosch University for his insight and guidance as a mentor.

I would also like to thank the experts in Appendix D for their opinion and time invested in this project.

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List of Figures

FIGURE 1:MAXILLOFACIAL IMPLANT ... 1

FIGURE 2:PROJECT ROADMAP ... 7

FIGURE 3:CRI MATRIX OUTLINE ... 17

FIGURE 4:AS-IS INDICATOR LEVELS ... 18

FIGURE 5:TO-BE INDICATOR LEVELS... 19

FIGURE 6:STATUS SUMMARY LEVEL ... 19

FIGURE 7:PREVIEW OF THE RESULTS IN APPENDIX B ... 20

FIGURE 8:CRISTATUS SUMMARY ... 28

FIGURE 9:TECHNOLOGY READINESS LEVELS (TRLS) ... 33

FIGURE 10:MAXILLOFACIAL TITANIUM AM IMPLANT PROCESS CHAIN (BOOYSEN ET AL.2016) ... 37

FIGURE 11:EMERGING TECHNOLOGIES ... 39

FIGURE 12:REPRESENTATION OF TRL AND CRI(ARENA2014A) ... 42

FIGURE 13:TRL AND CRI FOR MEDIAL AM CASE STUDY ... 44

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List of Tables

TABLE 1:CRI INDICATORS (ARENA2014A) ... 14

TABLE 2:PROCESS CHAIN STAGES ... 15

TABLE 3:CRI INDICATOR MATRIX LAYOUT PREVIEW ... 16

TABLE 4:STATUS SUMMARY LEVEL (ARENA2014A) ... 17

TABLE 5:SUMMARY OF CRI INDICATOR LEVELS ... 27

TABLE 6:TECHNOLOGY MATRIX PREVIEW ... 37

TABLE 7:SUMMARY OF MINIMUM TRL IN EACH PROCESS CHAIN STAGE ... 39

TABLE 8:TRL AND CRI INDICATORS AS A FUNCTION OF CRI ... 45

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Glossary

Additive Manufacturing This term refers to a process by which digital 3D design data is used to build up a component in layers by depositing material. The term “3D printing” is used as a synonym for Additive Manufacturing. (Booysen et al. 2016)

ISO 13485 ISO stands for International Organization of Standardization.

Global market regulators of medical devices require manufacturers to implement a quality management system. The ISO 13485 certification is the preferred method of meeting this requirement. It addresses the quality systems requirements in markets. The benefits of being ISO certified are gaining access to international markets that recognize the certification, and delivering quality consistency for each product manufactured. (Emergo 2016)

Process Chain Kim (2006) defines the process chain as “flexible and

efficient chain, network, or web of related firms that work together to achieve global optimization of a common performance goal for a total supply chain”.

Value Chain The Value Chain concept (Porter 1980) states that an

organization is divided into distinct activities to do business. These activities create value within an organization.

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Abbreviations

AM Additive Manufacturing

ARENA Australian Renewable Energy Agency

BERG Biomedical Engineering Research Group

CRI Commercial Readiness Index

CRPM Centre for Rapid Prototyping and Manufacturing

CSIR The Council for Scientific and Industrial Research

CUT Central University of Technology

DoD Department of Defence

KPI Key Performance Indicator

IP Intellectual Property

IRL Integration Readiness Level

ISO International Organisation for Standardisation

ITI Integrated Technology Index

MRL Manufacturing Readiness Level

NAPPI National Pharmaceutical Product Index

NASA National Aeronautics and Space Administration

R&D Research and Development

ROI Return On Investment

SCOR Supply Chain Operations Reference model

SLS Selective Laser Sintering

SMME Small, Medium and Micro-sized Enterprises

SRL System Readiness Level

SU Stellenbosch University

TC Technology Commercialisation

TIA Technology Innovation Agency

TRA Technology Readiness Assessment

TRI Technology Readiness Index

TRL Technology Readiness Level

UNCED United Nations Conference on Environment and Development

TRRA Technology Readiness and Risk Assessment

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Chapter 1

Introduction

Chapter 1 is the introduction of this research study. This chapter gives the background information regarding the product and the manufacturing company involved. The problem statement and the research question are formed and three objectives are identified. The scope of the problem is discussed and the roadmap for the rest of this document is highlighted.

1.1. Background

Emerging technologies are technologies that are currently being developed and are new to the industry. By analysing the impact of technologies on a current business’ management processes, a framework can be developed to predict what changes the emerging technologies have on that business.

A maxillofacial implant is a customised implant surgically inserted into patients who have lost significant portions of their facial bone structure due to cancer and other diseases.

The maxillofacial implant is manufactured at the Centre for Rapid Prototyping and Manufacturing (CRPM). The centre is located at The Central University of Technology in the Free State, South Africa. The CRPM was established in 1997 as a centre for commercial work and research. They specialise in development of new products through expensive prototyping (Booysen et al. 2016). The implant is manufactured using 3D metal printing and shown as the grey part in Figure 1. The polymer pre-operative model used is the white part.

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Page | 2 Each maxillofacial implant is customized to fit a specific patient. The computed tomography(CT)/ Magnetic resonance imaging(MRI) scans of the patient’s face are used to print an additive manufactured preoperative model, which is then reversed engineered, using Geomagic software and manufactured to fit the patient (Booysen et al. 2016). Therefore, each implant is different in mass, size and shape.

The entire manufacturing of the maxillofacial implant process consists of several steps that cannot all be done at CRPM. Many steps in the process chain is outsourced to other companies and then sent back to CRPM. These outsourced processes make it difficult to determine the exact value of the maxillofacial implant. The process chain of the manufacturing of the maxillofacial implant is created within previous research (Bezuidenhout 2016) and shown in Appendix A. With determining the value of the product, several risks arise that may influence the overall cost of manufacturing a maxillofacial implant at the CRPM.

Previous research (Bezuidenhout 2016) identified that the manufacturing of a maxillofacial implant proved to be theoretically unfeasible due to the risks being too high, however the physical process resulted in a successful implant and a clinically acceptable risk to the patient. This raised the question on how a process with a perceived low Technology Readiness Level (TRL), can indeed produce a product that is clinically ready or in engineering terms medical-commercially ready.

Therefore, in order to move from theoretical feasibility to real feasibility, a mechanism to analyse the technology and commercial risks needs to be developed. The current process can give insight into the processes followed to manufacture this product and what needs to be done for a transition from the current research phase to a sustainable production phase. The maxillofacial implant manufacturing process is used as a case study.

Business activities that contribute to sustainability were difficult to determine due to complexity of environmental and economic systems and the emerging of new technologies. Mechanisms exist to handle such complexities and to classify gaps between what makes a business sustainable and otherwise conventional.

1.2. Description of the problem

1.2.1. Problem Statement and research question

The commercialization of medical additive manufacturing processes is currently in the ramp-up phase. Also the commercial sustainability of the manufacturing process still needs to be valued. The research question investigates how to use emerging technologies to move to a commercially sustainable business.

The current state will be used as the starting point of this research. Within the emerging technology phase there are an uncertain number of resources and the number to manage these risks is still

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Page | 3 uncertain. In steady state there are a sufficient number of resources to manage risks. You want in each case to manage the risks to have it in an ideal sustainable position. The risks identified are specifically concerning the emerging technologies based on a sustainable business.

Determining the technology maturity of the technologies used in the current process, can yield results to answer the research questions. Although the technology risks are retired through the Technology Readiness Levels (TRL) 1-9 framework, at a certain level commercial uncertainty and risks enter the deployment phase. New technology entering the market place faces several barriers during the commercialisation process. In South-Africa, the support for development of new metal additive manufacturing products has been through upfront grants and government funding (De Beer et al. 2016). Rapid change in projects can lead to increased risks and commercialisation challenges (ARENA 2014a).

To answer the research question addressed in this project, it must be determined at what level of the TRL the technology is classified as being mature, and how to integrate the individual TRLs of the activities in the process chain to get to the Commercial Readiness Index (CRI) of the project.

The outcome of this research is a suggested framework showing the Commercial Readiness Index (CRI) of the project for the activities when the Technology Readiness Level (TRL) is matured. This tool brings two systems together; the system of manufacturing titanium AM implants and the comprehensive approach that identifies opportunities to bring the product to the market. The result is a complex framework which offers commercial opportunities for the stakeholders involved. The CRI tool aims at helping SMME’s to take their product to the market.

1.2.2. Scope

The aim of this research is to build a framework that shows the CRI of the project as a function of TRL. Other researchers can use this framework to determine the risks of emerging technologies in terms of the individual TRLs in the process. This framework only focuses on the maxillofacial implant (“the product”) at first, in order to set up the framework.

The product is categorised as being customised for each individual person. The process of manufacturing the maxillofacial can be classified as delivering a service to the patient. This product should also be additive manufactured in titanium using Selective Laser Sintering (SLS). The product should conform to the ISO13485 (Booysen et al. 2016) standard and be feasible in real life. It is important to note that the product in question is not bio-degradable.

The research focusses on the process of manufacturing a product within a project. Therefore, special attention is given when we are referring to the product within the process and vice versa. In this thesis we talk about the complete sustainable product. The manufacturing process delivers the product. The TRL is the combined TRL of the product and the process. The TRL of the product therefore includes the supply chain, quality and production process. Challenges of building this framework include the

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Page | 4 key performance indicators (KPIs) that need to be identified in order to measure the current and future states in terms of commercialization, the process of transitioning from the TRL to the CRI. Within this research, there is flexibility within the design. This thesis does not look at the flexibility of cost and time in the manufacturing process. Only a single enterprise is referred to. Clustering of enterprises is not included now, but is the strategic intent.

1.2.3. Objectives

The objectives are based on the three-legged trade off. Each objective contributes to the final output of this project. The output can only be achieved and be feasible if all three objectives are met. Each objective mentioned is measurable. The objectives are only mentioned in this chapter. Chapter 2, 3 and 4 describes the methodology used to investigate each objective. Objectives 1 and 2 are independent and stand on their own. Any one of them can be attempted first. Objective 3 takes the findings and results from Objectives 1 and 2 to integrate with the literature related to Objective 3.

Objective 1: Identify the as-is state and the to-be state of the manufacturing process chain of the maxillofacial implant at the CRPM

The as-is state is the state used to describe the current state of the project. Determine the as-is state by analysing the current position of the CRPM in terms of commercialization. Base the to-be state on what the maxillofacial process could be if the process is analysed according to real feasibility.

Indicators indicating the commercialization position need to be identified and addressed. Identify the to-be state by determining the indicators of what makes a project sustainable and therefore commercially ready. The to-be state is the state we want to achieve in the future and we will therefore be working towards it.

Objective 2: Determine the emerging technology activities within the process chain

The process chain from previous research (Bezuidenhout 2016) is used to identify the technology elements within process chain activities. This is done by dividing the process chain into events and activities. The events and activities are then grouped into stages of the process chain. The technologies within the events are identified with the help of CRPM experts. The TRL is the tool used within a generic usable process to identify which technology is emerging and which is not.

Objective 3: Measure the CRI as a function of TRL

Objective 1 and 2 are now used to determine a strategic path to move from the as-is state to the to-be state, for the emerging technologies. The tools used from the previous objectives are analysed and the integration of the tools are discussed.

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1.3. Methodology

1.3.1. Thesis methodology

The methodology of this study is described by a systematic way of approaching the problem statement. Each step in the methodology is done only after the previous step has been completed. The methodology indicates the specific skills and techniques applied in order to answer the research question. The strategic path between the as-is and to-be state is a suggested framework. It suggests a stepwise process to follow and it gives an indication of how to work from start to finish. This framework set up as the roadmap of this study and is tested against arguments of experts within the industry. The methodology within each objective is described in the chapters that discuss the specific objective. The methodology is based on the information from other literature references.

Against the above background, it is proposed that the study should be done in a qualitative paradigm. The researcher attempts to understand the TRL descriptions as described in literature. By utilising the qualitative approach, an attempt will be made to understand the CRI indicators in terms of medical AM.

1.3.2. Literature analysis methodology

The effort in this study consisted of a systematic online search of literature databases (Google Scholar, Science Direct and ResearchGate). Since the review of TRL in general is readily available in literature, the main concern in the study was about the review of the commercial readiness index approach, and how to implement it for medical AM products. The literature review considers the availability of peer reviewed journals and conference proceedings papers on literature databases. The search was done by combining the keywords of commercial readiness and technology readiness. In cases where these keywords did not provide sufficient results, a combination of maturity and sustainability were used.

The timeframe for the journals ranges from 1980 to the present. This is because the preliminary article that was first published and the starting date of earlier studies were also considered.

The aim of this thesis was to obtain knowledge of commercial readiness for the specific case study of medical AM. The characteristics of AM technologies and their manufactured products are discussed. This is to give the reader insight into the importance of this product. This article will attempt to discuss the TRL and its shortcomings as a tool for measuring the process maturity of the specified product. The CRI will then be discussed as a supporting tool for TRL. Conclusions are drawn based on these findings.

From the start it was clear that commercial readiness is not yet used within AM in South Africa. This is a potential weakness of this thesis which relied mainly on published work as well as internet sources.

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1.4. Research Design

In this research design, numerical and textual data is used in the analysis of the research and also to draw conclusions from the outcome of the research questions.

Existing data is used to set-up the current process and activities of the project within the process chain using Microsoft Visio. The researcher has high control over this model and can adapt or change it as the state of the project changes. By making use of primary textual data such as participatory research from the CRPM, the emerging technologies of the project can be determined.

Elements of research design are worked out during course of study due to the qualitative approach. Conceptual questions are asked to experts in certain industries. The data is collected within expert transcripts. This data is used to validate the information. The results show a qualitative framework based on quantitative literature studies.

1.5. Case

Study:

Custom

Ti6Al4V

Medical

AM

maxillofacial implant

The researcher needed to obtain further knowledge on AM and the characteristics of these products in South Africa. The discussion on the case study is given within the Introduction chapter because of the case study being generic for emerging technologies. Throughout the thesis, the researcher will attempt to explain certain aspects by referring to examples from the case study.

1.5.1. Custom medical devices within AM

Additive Manufacturing products within the medicine industry are of high value and small physical volume, and custom-designed within the AM technology they continue to deliver innovative solutions for customer needs. In 2012, 16.4 % of the total system-related revenue for AM was for medical application (Snyder 2014).

Choices on how to deploy AM across business, are presented by either changing the capital versus scale relationship, or changing capital versus scope relationship. The impact is on supply chains and product design respectively.

AM has a key ability to impact on inventory and distribution which influence the supply chains of medical devices. When product lead times are long, a key function of inventory is to buffer against demand uncertainty. Companies look to decrease unit cost and delivery time as well as to improve product delivery precision(Snyder 2014). This can lead to supply chain evolution and represent opportunities for AM companies. AM can improve the build and fit of the product with regards to the patient, especially within the medical device industry which focuses on enhanced customization. The alignment between medical devices and AM is strong, due to the demand for low-volume, high-customized products with life dependent outcomes.

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1.5.2. Technology Readiness within AM

One of the seven changing technologies of 2016 is the digitization of matter. In future, 3D printers will not only create cars, houses and other objects, but also human tissue, bones and custom prosthetics. Three-dimensional printing, which brings together computational design, manufacturing, materials engineering and synthetic biology, reduces the gap between makers and users, and it removes the limitations of mass production (Montresor & Forum 2016).

The development of AM technologies in South Africa has been through provisional and upfront grants (De Beer et al. 2016). Grants from the government can be useful in assisting companies with funding for their projects. New projects are facing increased risks due to rapid changing and evolving of technologies, especially projects that go from desktop to demonstration at commercial scale (ARENA 2014a).

1.6. Project Roadmap

The visual layout of the project is shown in Figure 2. Chapter 1 describes the background, problem statement and objectives as well as the methodology followed. Chapters 2, 3 and 4 each represents the three objectives mentioned earlier. Each of these chapters describes the Literature, Methodology, Research and Findings, as well as the Results of each individual objective.

Chapter 2 and 3 represent Objective 1 and 2, respectively. Both these objectives are independent of one another. The literature for each objective is only relative to that objective. Chapter 4 represents Objective 3. This chapter uses the information and results gathered from the previous two objectives to answer the research question. By using qualitative analysis and a scientific method it is possible to discuss Chapter 4 based on Chapter 2 and 3. Chapter 5 concludes the entire project and gives a critical overview of what could have been done differently and where research gaps lie for future researchers. Throughout the document, the medical AM case study will be used as supportive example to strengthen the arguments made.

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1.7. Project Timeline

This project started on 1 January 2017 and was completed on 1 September 2017.

1.8. Conclusion

The research question that this research looks at is how to use emerging technologies to advance to a sustainable business by using TRL as a measuring tool within the CRI. The objectives identified to answer the research question are: 1. Identify the as-is and to-be business state of the manufacturing process chain of the maxillofacial implant at the CRPM. 2. Determine the emerging technology activities within the process chain. 3. Measure the CRI as a function of TRL. The proposed methodology is done in a qualitative paradigm using expert opinion and journal articles to get a general understanding of TRL and CRI.

Each chapter will attempt to discuss the entirety of each objective. This first chapter discusses the overall project roadmap. It gives an overview of what the researcher attempts to achieve with this thesis. The industrial partner is mentioned and the case study of AM is described. Further detail on the case study and literature based on the introduction, will follow.

The case study will focus on the innovative solution of medical AM products. Most of the Research and Development (R&D) comes from upfront grants. In this evolving industry, emerging technologies increase the risks of this supply chain. We will focus on commercializing this supply chain by looking at the movement from desktop to demonstration in terms of commercialization.

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Chapter 2

Objective 1: Identify the as-is and to-be state of the

manufacturing process chain of the maxillofacial

implant at the CRPM

Chapter 2 describes the entire Objective 1 from literature references to the results based on findings, as well as the methodology that follows. The chapter will start by looking at several articles and author views for this objective: Identify the as-is and to-be state of the manufacturing process chain of the maxillofacial implant at the CRPM. A methodology is formed for this objective based on the literature review. Following the prescribed method, the findings and results are described and several recommendations are made based on the discovery. The objective is based on the research question. The literature attempts to answer the research question.

2.1. Literature

In order to identify the to-be state you had to use the definition of commercial sustainable business. Sustainable business can be called the to-be state. Let us now look at commercially sustainable business characteristics.

2.1.1. Commercially sustainable business characteristics

Sustainable development is the “development that meets the needs of the present without compromising the ability of future generations to meet their own needs” (Brundland 1987). Closely linked to this definition is the concept of sustainable production which emerged in 1992 at the United Nations Conference on Environment and Development (UNCED) (Veleva et al. 2001). Sustainability compromises of environmental, social and economic criteria (Spangenberg & Bonniot 1998).

Designing a sustainable business one must take into account profit, user value, business activity, life cycle cost and life cycle environment (Kondoh & Mishima 2011). Investors want evidence of good corporate governance, particularly business strategy and risk management (Keeble 2003). This can lead to the way in which businesses decide to align their activities with sustainable business principles.

It is difficult and complex to clarify the activities within a business that contribute to the sustainability of the operations. In order to handle such complexities in a systematic and comprehensive manner, businesses need to think upstream in cause-effect chains, and consider indirect influences as well as direct influences in their decision-making and communication processes (Kondoh & Mishima 2011). In order to identify such complex activities, we can look at indicators influencing sustainability of a business.

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2.1.2. Indicators influencing the commercial sustainability of a business

Developing and using indicators to set up a sustainability framework should be a dynamic process that incorporates decision-making (Keeble 2003). Internal and external stakeholders can have differing views on sustainability indicators. It is important to incorporate both opinions when setting up the sustainability indicators. When implementing the indicators, it is critical to keep in mind to assign accountability to managers or executives. This will help to understand how decision-making can influence the sustainability performance (Keeble 2003).

Indicators provide key information in the form of numerical measurements about physical, social or economic systems (Veleva et al. 2001). There are three objectives of indicators: raise awareness and understanding, inform decision-making, and measure the progress towards the established goals of the firm. Veleva et. al (2001) developed a framework of five levels that they use to identify key performance indicators of sustainability within a project. Arthur D. Little Limited (Keeble 2003) created an assessment framework to assess the indicators of sustainability within a project. Their framework can be used throughout the lifecycle of the project performance to assess impacts, and decision-making, and to track the project performance.

Technical and economic viability, market potential and value capture are things companies can use to determine new technologies’ attractiveness (Maine et al. 2005). The financial overheads for running machines and buying feedstock are potential barriers to the commercialisation of AM (Royal Academy of Engineering 2013). Accelerators in commercialization include organizational support, market proficiency and organizational-integration (Nijland et al. 2014). The word “maturity” is encapsulated within the notion of “readiness” and are therefore used interchangeably (Tetlay & John 2009).

Australian Renewable Energy Agency (ARENA) (2014a) has identified indicators to reflect on the commercialisation process of their industry. They use a Status Summary, described by indicators, to evaluate at which level of business the project is. Individual projects will not raise the overall business status but rather cause an increase or decrease in indicators.

As described by ARENA (2014a), the future state is the state the company wants to achieve with respect to business objectives and sustainable goals. This state can be achieved by identifying indicators relevant to the above and that could accompany the company’s principles. These indicators can help to set targets to-be achieved by the company through a project. Indicators reaching the highest level have reached the level of maturity and therefore are commercially ready. We can therefore argue that sustainability and commercially ready can be interchangeable.

The current state is the current state of the project or business. Determining the targets and indicators of the to-be state can be helpful in setting up the current state with regards to the foreseeable future indicators. Therefore in order to improve on the indicators we can make use of innovation to determine the to-be indicator targets.

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2.1.3. Creating value through innovation

To understand how an enterprise creates value to customers, a business model needs to be built to represent the processes and the way a business converts payments received into profits. Understanding business design, customer needs, and possible technological trajectories, business pioneers can profit from product innovation (Teece 2010). Several technological entrepreneurs have secured returns by the way of integrating innovation within a value chain (Gans & Stern 2003).

When a start-up company decides to launch its product independently, the value of technology and profitability will depend on several factors. Key capabilities and their complementary assets need to be developed to ensure that innovation offer value to the customer. The multiple dimensions of uncertainty need to be managed and the scarce resources must be focused on to establish market presence (Gans & Stern 2003).

Innovators represent the trade-off between establishing a novel value chain and competing against established firms versus leveraging an existing value chain and earning returns through market ideas. The commercialization stage is the first opportunity for firms to define their strategy and position within the market.

Porter’s (1980) competitive advantage strategy focuses on the dimensions of quality, speed, innovation and cost, thus being the profit ratio. According to Nieman and Bennett (2006) “organizations can create and maintain a competitive advantage by focusing on dimensions such as quality, speed, innovation and cost”. Competitive advantage implies that the organization offers superior customer value, and indicates the distinctive differences between an organization and its competitors. AM has the capacity to simplify and shorten the manufacturing supply chain. Graham Tromans explained: “If you are manufacturing these parts on site then you don’t need transportation, and you remove unnecessary international shipping, so manufacture is nearer to the consumer.” This could create opportunities for local, regional or national manufacturing centres, and already supports on-site rapid prototyping (Royal Academy of Engineering 2013).

Low-volume production offers opportunities for customisation and it can reduce the use of materials due to its efficient geometries, but its benefits are not universal. “You do not get energy-reducing economies of scale in AM like you do in traditional methods of manufacturing such as injection moulding,” said Dr Chris Tuck (Royal Academy of Engineering 2013).

Innovative companies create competitive advantage by focussing on high quality, niche products to sell to their customers. They are not interested in cost effectiveness. Nieman and Bennet (2006) suggest that companies should focus on creating a competitive advantage rather than having best practices.

Different forms of competition co-exist in all industries and are a concern for most of them. Schumpeter (1950) describes “competition through innovation” as a destroying element. Two contrasting ways of competing is through optimizing productive resources. This is to gain market allowed margins of profit, called “competition through efficiency”. The other contrasting way is to disrupt the market through introducing innovations, which will give a temporary advantage to the firm over other firms (Conceição et al.

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Page | 12 2002). AM cannot be categorized as one type of innovation. An example of one type of innovation is classifying it as a disruptive innovation, but some companies do not view it as a threat due to the technology that is not yet competitive. Another example is radical innovation in AM within the medical industry. AM has dramatically reduced the cost of prostheses and has allowed the production of prostheses to people without medical training or education. (Steenhuis & Pretorius 2017)

The market pull view, analysed by Rosenburg (1972), moved from an empirical observation to the normative world of management policy. Responding to market needs may not provide the leading edge in technological superiority needed for companies to get a breakthrough in innovation. Rosenburg (1982; 1994) showed the complexity of the process through which new technologies are created and commercialized. “Customisation is a real business opportunity, especially in the healthcare sector,” said Professor Richard Hague, Director of the EPSRC Centre for Innovative Manufacturing in Additive Manufacturing at the University of Nottingham (Royal Academy of Engineering 2013).

Chandler (1990) describes success as bringing growth to businesses and increasing economies of scale. Schumpeter (1950) elaborated by saying that more resources to invest in and technology opportunities can lead to higher leverage in the market place and better relationships with suppliers and customers (Porter 1988). Mathews (1996) defined that organizational learning is equated with a firm’s ability to accommodate for changes such as products, technologies and markets. He further identified three elements: information, people and organizational units to further systemize the concepts of organizational learning (Conceição et al. 2002).

Business analysts focus on the amount a company spends on R&D as an indicator of its competitive strength. It is more important to focus on translating these R&D efforts into products that satisfy the market needs. Technology integration is the approach that companies use to choose and refine the technologies employed in a new product, process or service (Iansiti & West 1997).

The number of technologies that companies can choose from has grown dramatically. Product life cycles have shortened dramatically, forcing companies to develop and commercialize new technologies faster than ever. By designing processes that integrate their research base with existing emerging markets, companies can position themselves and the nation to excel in an increasingly complex technological future (Iansiti & West 1997).

2.2. Methodology

So, based on literature, the CRI of the project explains the project’s commercial position. As described by Porter (1980) and by previous research based on the value chain created for this project (Bezuidenhout 2016), the maxillofacial product is an innovative product. The value chain created forms the basis of understanding the manufacturing process of the maxillofacial implant.

Using TRL, CRI and the experts at the CRPM, a strategic path can be identified to move between the as-is state and the to-be state of the manufacturing process in terms of their product. The descriptions are

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Page | 13 customized from the renewable energy description to fit the specific case study. No quantification or qualification is rendered.

This research uses as a base the CRI assessment, created by the ARENA (2014a; De Jager 2017). The ARENA CRI is modified to apply to AM by using the analysis and synthesis approach. The CRI is divided into several independent indicators, assessing various commercial aspects. A raw version CRI matrix based on ARENA indicator description is given to the CRPM to see were problems with the matrix may lie. Experts are identified and interviewed to get a better understanding of each indicator level. The experts ‘opinions are used within an iteration process and combining the iterations into a single commercial index. The CRI matrix is then updated and again given to the CRPM. This time to see where the challenges may lie within the CRPM. The steps involved within this objective include:

1. Conduct research on the explanation of commercialization and what it means for a business. 2. Identify indicators of commercialization from research articles.

3. Develop raw matrix with indicators to challenge the matrix with the CRPM.

4. Conduct interviews with experts from relative industries to validate the indicators and their descriptions.

5. Update the first version indicators to form a second version of indicator description.

6. Conduct a second round of interviews with experts based on their opinion of the second version of indicator description.

7. Update the indicators to form a third indicator description version.

8. Conduct a brainstorming session with the experts at the CRPM to determine the as-is and to-be state of the project from the case study – AM medical – by using the third version commercial indicators. This is to see where the CRPM challenges may lie.

9. Document the analysis and decisions in Microsoft Excel on a CRI matrix, showing the indicators and their commercial readiness levels.

10. Use the indicator levels’ results to determine the CRI of the project, by relying on research documents.

2.3. Research and Findings

2.3.1. Determine the CRI indicators

From the literature we can summarise that the commercial indicators should include stakeholders (Keeble 2003), technical viability (Maine et al. 2005), market opportunities and proficiency (Maine et al. 2005; Rosenburg 1972; Gans & Stern 2003; Nijland et al. 2014), economic viability and value capture (Maine et al. 2005; Nieman & Bennet 2006), organizational support (Nijland et al. 2014) and strong R&D efforts (Iansiti & West 1997).

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Page | 14 The ARENA(2014a) indicators include all the above indicators with descriptions of each. Therefore, we are using the ARENA indicators as they are an expanded summary of the indicators already mentioned by previous authors.

ARENA(2014a) explained their indicators based on a renewable energy case study. In this case, the case study is medical AM. Each of the eight indicators is written and customised to fit this specific case study. It is still unconfirmed that the characteristics of AM and that of renewable energy are similar. The level of the CRI AM indicators and their descriptions is formulated by the CRPM and several experts for specifically the AM industry.

The researcher identified a ninth indicator and tenth indicator, Clinical Performance and Funding, as described in Table 1. This is due to the fact that medical AM needs to conform to medical and clinical specifications, which will also influence the CRI. The process within AM medical is a technical process, but the product must be evaluated according to clinical performance. In the case, for example, of an aerospace case study, the Clinical Performance indicator will not be used, another indicator based on that case study might be necessary to include. The summary of the ten CRI indicators used in maxillofacial implant case study is in Table 1.

Table 1: CRI indicators (ARENA 2014a)

Number Indicator Description

1 Regulatory Environment The maturity of the planning, permitting and standards relating to the technology.

2 Stakeholder Acceptance The maturity of the process for evidence-based stakeholder consultation.

3 Clinical Performance The method to estimate or monitor the extent to which the actions of a healthcare practitioner conform to practice guidelines, medical review criteria or standards of quality. 4 Technical Performance The availability of discoverable technical performance

information.

5 Financial Performance –

Cost

The availability of robust, competitive financial information linked to capital and operating costs and forecast revenues, allowing investors to take increasing levels of future market and project risk.

6 Financial Proposition –

Revenue

7 Funding Money provided, especially by an organization or

government, for a particular purpose.

8 Industry Supply Chain

and Skills

The development of a competitive and efficient industry product and skills supply chain required to support a commercially viable sector.

9 Market Opportunities The development from a hypothetical commercial plan to the demonstration of a viable market (local and/or overseas) via competitive channels to market and sustainable business models.

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Page | 15 10 Company Maturity The development of the sector to include established

companies with strong credit ratings and established performance records.

Each indicator is further described, making use of a level 1-6 indicator description (ARENA 2014a). Each indicator level is described in detail in Appendix B. Level 1 is at the lowest level of the commercial indicator in question and Level 6 is at the highest. The levels influence the overall CRI status. In order to calculate the CRI status, the average of all the indicator levels is used. Each of these indicators is validated with several experts in relevant industries. Once the indicators are valid, the CRI classification for each can begin.

Based on literature (Veleva et al. 2001), we know that performance should be measured by goals, therefore, to improve from what is described in ARENA (2014a), a time goal is set with each to-be level to help the industrial partners to keep track of their as-is state relevant to their to-be state.

2.3.2. Determine as-is state with the CRI indicators

2.3.2.1. Process chain breakdown

In this case study, the process chain from Appendix A is broken up into events and then grouped into three stages; Design, AM process and Post-processing. This is due to the entire process chain being at different maturity levels, and it is easier to evaluate the entire process by looking at three stages within the process chain. Furthermore, the different stages are to help the industrial partners realise at which stage their attention is needed. The description of each stage is in Table 2: Process chain stages.

Table 2: Process chain stages

Stage Process Description

1 Design Section in the process where the customisation happens. This stage is also dependent on the person doing the design.

2 AM Process This stage involves pre-processing, process and part removal. The manufacturing part is based on SOPs and standards.

3 Post-processing All the events and steps after the part is removed from the manufacturing machine. Also involves steps that are outsourced to other companies.

2.3.2.2. Setting up the CRI indicator matrix

The matrix is set up to accommodate for the changes in indicator description levels from the original case study of renewable energy (ARENA 2014a) to the medical AM case study. A layout preview for this matrix an Appendix B is shown in Table 3.

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Table 3: CRI indicator matrix layout preview

Indicator: Regulatory Environment

Process Chain Stages

Time Goal Medical AM CRI indicator description Renewable energy CRI indicator description (For reference only)

Level Design AM Process

Post-processing 6 3 1. 5 2 2 4 4 2 3 2 1

Table 3 indicates the process in determining and classifying the two states of the project. Each indicator is analysed according to this matrix. In this preview, the indicator in question is Regulatory Environment. The indicator levels as well as the descriptions of each level are indicated. In the preview it is indicated by number 1. The process chain stages are mapped out in the matrix to clearly see the different stages.

2.3.2.3. Classify the levels of the as-is state with the CRI indicators

First the as-is state is identified by reading through each indicator level and making use of expert knowledge. The to-be state is determined by deciding where the CRPM wants to be within a certain time frame. This is then the to-be state indicator level. This level is the highest indicator level the CRPM wants to achieve within their time goal. In order to move from the as-is to the to-be state, the steps must be indicated. Therefore, the steps in between each state are also described.

The as-is state is indicated by number 2 in red in Table 3. The reason for classifying the project at this level is indicated in the column head.

In some cases all the stages are at the same level and in other cases one stage will have a higher indicator than the other. In Table 3 the three process chain stages each have their own reasons for being classified at the represented levels, therefore, each description is independent of their corresponding stages.

2.3.2.4. Classify the levels of the to-be state with the CRI indicators

The to-be state is determined by using the same steps as in determining the as-is state. The to-be state identified is indicated by the number 3 in yellow in Table 3. The steps or goals set out to achieve this level are typed in the column head.

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Page | 17 In some cases the as-is indicator is more than one level below the to-be indicator level, therefore the steps involved in each level to accomplish the to-be level indicator must be acknowledged. This is indicated by number 4 in Table 3.

2.3.3. Determine the CRI Status Summary Level

2.3.3.1. CRI matrix outline

The indicator levels used in Appendix B are now used to set up the CRI matrix. The outline of the CRI matrix is shown in Figure 3.

Figure 3: CRI matrix outline

The CRI contains six indexes that correspond to the six levels of the indicators mentioned. These six indexes are referred to as the Status Summary Level. Table 4 describes each summary.

Table 4: Status Summary Level (ARENA 2014a)

Level Status Description

6 “Bankable”

grade asset class

Driven by same criteria as other mature energy technologies. Considered as a "Bankable” grade asset class with known standards and performance expectations. Market and technology risks not driving investment decisions. Proponent capability, pricing and other typical market forces driving uptake.

5 Market

competition driving widespread deployment

In context of long-term policy settings. Competition emerging across all areas of supply chain with commoditisation of key components and financial products occurring.

4 Multiple

commercial application

Becoming evident locally although still subsidised. Verifiable data on technical and financial performance in the public domain driving interest from variety of debt and equity sources however still requiring government support. Regulatory challenges are addressed in multiple jurisdictions.

Regulatory Environment Stakeholder Acceptance Clinical Performance Technical Performance Financial Performance Costs Financial Proposition Revenue Funding Industry Supply Chain and Skills Market Opportunities Company Maturity Bankable Grade Asset Class Market Competition Driving Widespread Deployment Multiple Commercial Applications Commercial Scale-up Commercial Trial Hypothetical Commercial Proposition Indicators S tat u s S u m m ar y L eve l

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Page | 18

3 Commercial

Scale up

Driven by specific policy and emerging debt finance. Commercial proposition being driven by technology proponents and market segment participants – publicly discoverable data driving emerging interest from finance and regulatory sectors

2 Commercial

Trial

Small scale, first of a kind project funded by equity and government project support. Commercial proposition backed by evidence of verifiable data typically not in the public domain.

1 Hypothetical

commercial proposition

Technically ready – commercially untested and unproven. Commercial proposition driven by technology advocates with little evidence of verifiable technical or financial data to substantiate claims.

A Status Summary or CRI of 6 is the highest CRI for a company which indicates that company is matured in terms of Commercial Readiness.

2.3.3.2. Add the as-is indicator levels on the matrix

The as-is indicator levels that were determined previously are then mapped on the CRI matrix in Figure 4. For each stage of the indicator level there is a representative red block. The numbers 1, 2, and 3 each represent the Design, AM process and Post-processing stages of the process chain. All the other indicators are mapped out on this matrix according to this process.

Figure 4 : As-is indicator levels

2.3.3.3. Add the to-be indicator levels on the matrix

The to-be state is mapped out in the same way as the as-is indicators. The only difference is that it is represented by the colour yellow as mentioned previously. Figure 5, shows the to-be indicator level’s contribution to the Status Summary Level. The position of the indicator level on this matrix must correspond to the level as determined by the experts, while classifying each individual level.

Regulatory Environment Stakeholder Acceptance Clinical Performance Technical Performance Financial Performance Costs Financial Proposition Revenue Funding Industry Supply Chain and Skills Market Opportunities Company Maturity Bankable Grade Asset Class Market Competition Driving Widespread Deployment Multiple Commercial Applications Commercial Scale-up Commercial Trial Hypothetical Commercial Proposition Indicators S tat u s S u m m ar y L eve l 1 2 3

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Figure 5: To-be indicator levels

In Figure 5, the three stages all have the same reason or steps to achieve this level therefore they are placed in one square.

2.3.3.4. Determine the Status Summary Level

The average of the indicators in each case is calculated to get the as-is and to-be CRI described by the Status Summary Level (ARENA 2014a; De Jager 2017). Making use of the average calculation can in some cases be problematic, as some indicators may have more of an influence than others if level of importance were to be assigned to each indicator. In this research, it is attempted to use the average, but also to reflect on the possibilities of alternative methods on this approach.

Figure 6 shows the status for the as-is state, represented by a red circle, and the to-be state represented by a yellow circle.

Figure 6: Status Summary Level

Regulatory Environment Stakeholder Acceptance Clinical Performance Technical Performance Financial Performance Costs Financial Proposition Revenue Funding Industry Supply Chain and Skills Market Opportunities Company Maturity Bankable Grade Asset Class Market Competition Driving Widespread Deployment Multiple Commercial Applications Commercial Scale-up Commercial Trial Hypothetical Commercial Proposition Indicators S tat u s S u m m ar y L eve l 1 2 3 1 2 3 Regulatory Environment Stakeholder Acceptance Clinical Performance Technical Performance Financial Performance Costs Financial Proposition Revenue Funding Industry Supply Chain and Skills Market Opportunities Company Maturity Bankable Grade Asset Class Market Competition Driving Widespread Deployment Multiple Commercial Applications Commercial Scale-up Commercial Trial Hypothetical Commercial Proposition Indicators S tat u s S u m m ar y L eve l 1 2 3 1 2 3