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In Search of a Sustainable Business Model

for a Dutch National Tissue Bank Portal

Finding the ‘profit’ in optimizing the processes

22nd August 2016

Student

Chantal Steegers, student no. 10733574, chantalsteegers@hotmail.com, 06-41633775

Thesis MBA Healthcare Management, University of Amsterdam, Amsterdam

MBA- HC Supervisor

Dr. Jeroen Kraaijenbrink, UvA, jk@kraaijenbrink.com

Internal Supervisor

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EXECUTIVE SUMMARY

This thesis concerns the drawing up of a sustainable business model for a Dutch National Tissue Bank Portal. Much medical scientific research is performed with human tissues and their associated data left over after standard treatment and diagnosis at pathology labs in hospitals. The infrastructure to request, register and obtain the samples and data is organized fragmentally and differently resulting in a lot of unnecessary work for both researchers and pathology labs. There is a great need for a national health research infrastructure facilitating the needs of

researchers and pathology labs. But what could a sustainable business model be for a Dutch National Tissuebank Portal?

This topic is addressed from a design research point of view. The theoretical framework consists of a design research approach combined by literature study on the concept of business models, strategy and business process management and is supported by field work. This thesis addresses four main research questions

concerning ‘who is the customer?’, ‘what does the customer value?’, ‘how can we optimize the processes in this business?’ and ‘what is the underlying economic logic?’ of a Dutch National Tissuebank Portal.

The result is a proposal for a sustainable business model for a Dutch National Tissue Bank Portal. The answer to the customer question is clear: researchers and pathology labs (whom also are the suppliers). What they value is clear too: making it possible to perform more, easier and better research with left over patient samples taking the costs, quality, dependability and speed aspects into account. For

optimizing the processes, it is clear that several stakeholders and partners must take responsibility and accountability for certain parts of the supply and value chain. The PALGA Foundation should perform a coordinating role between the researchers and the pathology labs, by hosting an online request portal. The role of the academic pathology labs could be one of delivering personnel to facilitate the non-academic pathology labs. Due to several uncertainties of whom is willing to take up

responsibility for certain aspects of the intended processes, answering the economic logic question is difficult. The proposed business model deals with a network of organizations functioning in a medical academic setting focusing on doing research made possible by public funding (in other words: how to spend money wisely), as

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opposed to a commercial setting focusing on how to sell as many products possible and make money (in other words: making profit). The intended infrastructure (and economic logic) will depend on how the processes will be continued and organized, after the project period and funding, by the different stakeholders and partners involved.

In conclusion, to further execute and test the sustainability of the proposed business model:

o several stakeholders and partners in the entire supply and value chain must change their current state of practice and see the importance of their role, responsibility and accountability in the entire process;

o they must form joint alliances and pursue a network level strategy to build the necessary health infrastructure and be willing to provide resources to facilitate it;

o and they should invest in a lean six sigma black belt project to make the processes quantifiable in order to estimate how much ‘profit’ (less costs, shorter throughput time) can be made for all partners involved.

This means a transformation of the health research infrastructure landscape is needed. The stakeholders involved such as all 50 pathology labs (suppliers and customers), researchers (customers), PALGA NVVP, UMC’s, the government, industry and grant providers (stakeholders and partners) must see the need to take active part in the process as a network and to structurally organize and finance parts of it.

By optimizing the processes costs for several parties can be cut and the ‘profit’ (in terms of performing more, easier and improved research) can be found. A lean six sigma black belt project could be useful to give insight how much the DNTP reduces costs and creates a better throughput time.

The suppliers, stakeholders and partners mentioned above must form network alliances to be able to agree upon their roles and responsibilities (organizationally and financially), the desired business process and whether a national standard DMTA (data and material transfer agreement) and a joint review procedure are possible in order to add sustainable value now and in the future for the customers and suppliers.

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Only when the partners are willing to form such a unique supply and value chain network in which they collaborate, cooperate and take responsibility for their part in the process, can the proposed business model in this thesis be sustainable and the ‘profit’ be found for all parties involved.

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Preface

I am grateful. I am grateful that so many people supported me the last three years during my work and studies for the Dutch National Tissuebank Portal (DNTP) project and my MBA Healthcare.

I have learned so much from the whole process and from you all individually. From ICT and supply chain logistics to diplomacy and lobbying into change management and marketing strategy. Combining the DNTP project with an MBA in Healthcare was a real challenge, but one that gave me the tools to perform better than I had

imagined was possible. Every person involved in the DNTP had a significant role and made possible what we have accomplished together thus far.

First of all, I would like to thank prof. dr. Gerrit Meijer (NKI) and prof.dr. Folkert van Kemenade (ErasmusMC). Their generosity to let me follow this MBA during the three year DNTP project is truly exceptional. Of course they knew it could be a ‘win-win’ both for the project and myself. I hope that with the realization of the DNTP thus far and this thesis I have been able to come up to their expectations.

Secondly, I would like to thank dr. Lucy Overbeek (PALGA). Her professional and personal support, critical thinking and questioning really helped me to perform as best as I could as project manager of the DNTP initiative.

Also, dr. Katrien Grunberg (NVVP), dr. Hannelore Hofhuis (PALGA), Tony Vendrig (AHOLD), Angelique Verlaan (VUmc) and dr. Annette Gijsbers (PALGA) for their time and effort as advisors for the DNTP project. All your input, thoughts, ideas, questions and jokes made me focus on the end goal we were trying to achieve; building a piece of research infrastructure.

Then, I would also like to thank The Hyve for developing the Portal as it is today. Their employees’ time management, critical thinking and willingness to change route along the way made it a pleasant ICT journey. And we all know most ICT journeys turn out not to be that pleasant!

I am also thanking prof. dr. Gert-Jan van Ommen, dr. Petra Overveld, prof.dr. Cisca Wijmenga, prof.dr. Gerrit Meijer and dr. Erna Erdtsieck for their vision and energy to

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get BBMRI-NL 1.0 and BBMRI 2.0 on the political agenda. Getting policy makers and politicians to understand the importance of health research infrastructure initiatives is crucial for improved patient care. Obtaining public financing for consortia like BBMRI and projects like the DNTP is of great importance. We all know that if we are ever to achieve the 4P goal (personalized, predictive, preventive and participative

healthcare) we have to keep going, explaining and show results of our important research infrastructural work. I am proud to be part of the BBMRI-NL consortium. Arne Hoffman and Nathalie Hijmering, without you two there would be no DNTP. Thank you so much for your patience, effort and devotion during the DNTP project. And for putting up with me.

Of course I won’t forget all the people working at the Amsterdam Business School, UvA, involved in the MBA Healthcare, who helped me during the MBA to get the job done: dr. Jaap van den Heuvel, prof. dr. Ronald Does and Vanessa Rijkeboer; thank you!

Then, dr. Jeroen Kraaijenbrink, thank you so much for your help with this thesis. Your critical and helpful comments really helped me stay focused and on track. And also thank you for your patience partly due to my first and second pregnancy during one MBA course. I recommend your Strategy Handbook to all people involved in setting up a business or project. It is inspirational and practical; a wonderful and respect worthy combination.

Last, but certainly not least, I want to thank my parents. Their endless support, confidence in me and willingness to look after my son Samuel (when again I had to

work and study) is something I will never forget and cherish my whole life. And finally, Maarten. Thank you for supporting me during these hectic years for both

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7 TABLE OF CONTENTS Executive summary p. 2 Preface p. 5 Table of contents p. 7

I Introduction on the topic

A. The research topic p. 9

B. The research question p. 12

B.1. Working towards a proposal for a sustainable business model p. 13 for a piece of research infrastructure concerning biobanks

II Framing, methodology and results

A. Theoretical framework and methodology p. 15

A. 1. Theoretical framework: Design science research p. 15

A. 2. Rigor Cycle: literature study p. 19

A. 2.1. Business model literature p. 20

A. 2.2. Strategy literature p. 23

A. 2.3. Process management literature p. 25

A. 2.4. The four main business model questions seen from a p. 27 business model, strategy and business process management

point of view

A.2.5. Summary Rigor Cycle p. 30

B. Relevance cycle: field work p. 31

B.1 Stakeholder meetings p. 31

B.1.2. Focus group researchers p. 33

B.1.3. 45 Lab visits p. 35

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C. Design cycle: web-based portal development and p. 38 biobank employees

C.1.Portal development p. 39

C.1.2. Biobank employees p. 40

C.1.3. Summary Design Cycle p. 42

D. Conclusion chapter II: framing and results p. 43

III Proposal for a DNTP Business model

A. The DNTP Business model sketch p. 52

IV Recommendations

A. Recommendations: what is still needed to further test, execute p. 56 and implement the proposed DNTP business model?

Reference list p. 58

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I INTRODUCTION TO THE TOPIC A. The research topic

Much medical scientific research is performed with human tissues and their associated data left over after standard treatment and diagnosis in hospitals. Research that uses these leftover tissues has already led to improvements in treatment (Overbeek et al., 2012). And the manifold use of these tissues and

associated data will be essential for future developments in personalized healthcare (Gander et al., 2013). Advances in medical research, tools and technology have already increased the demand in terms of volume and quality of biological samples used (Vaught et al., 2010). Many diseases are determined by the underlying

biological mechanisms of genes, proteins and molecules. Once the human genome was categorized in 2001, the ‘omics’ (genomics, proteomics and metabolomics) revolution has characterized fundamental findings from DNA from individuals since then.1 Genetic disorders can be characterized from DNA in left over tissues. When additional (anonymized) clinical follow-up data from patients of these left over tissues is obtained, scientists can predict which disorders could occur and from this

information distinguish biomarkers. By doing so, the pathway to translational

research and the 4P medicine (personalized, predictive, preventive and participatory) and healthcare is on its way of becoming reality sooner than later (Meijer et. al., 2015)

But in order to come to this, large volumes of tissue samples and associated clinical data is needed. However, this can only be the case if tissues and data are easily accessible and provided in an optimal way (Gander et al., 2013).

Unfortunately, this is not yet the case.

In the Netherlands it is estimated that there are more than 60 million of these tissue samples stored in all Dutch hospitals with a pathology department (50

pathology labs). (Geesink et al., 2009) Most researchers arrange the process of searching and receiving the tissues themselves. Also, all 50 pathology departments organize the requests (registering, picking and handling, processing, sending and returning) for samples independently and differently. Therefore, there is a lot of

1 http://cisncancer.org/research/what_we_know/omics/omics_revolution.html (visited

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difference in process management, access policies, review procedures, through-put time and reimbursements between laboratories in handling requests. Some have outsourced their biobank, while others leave it to their biobank managers, individual pathologists, secretaries or the researchers themselves to handle the requests. Some request fees while others don’t. Some have a standardized handling and review process put in place, while others don’t. Some are aware of the legal, ethical and social issues, while others aren’t. Due to these decentralized and

non-standardized processes a lot of time and resources are wasted, both for researchers and the pathology labs. This is unfortunate, because the processes of requesting, registering, handling, receiving, reviewing and the associated costs are more or less practically the same for each request in every pathology lab.

A national pathway with a single point of access and contact (web based portal supported by a back office) with logistical and physical support (biobank employees) seems to be what is needed to arrange the searching, accessing and sending of the samples and their associated data efficiently in a centralized and standardized manner (Gander et al., 2013 and Overbeek et al., 2012).

BBMRI-NL (Biobanking and BioMolecular resources Research Infrastructure) received funding from NWO (Netherlands Organization for Scientific Research) to support research infrastructure projects. All heads of the 8 pathology departments of the academic medical centers, the NVVP (Dutch Society for Pathologists) and

PALGA (Pathological Anatomy National Automated Archive; a nationwide network and central database of all pathology diagnoses in the Netherlands since 1971) see the need to implement a standardized and centralized pathway to manage the requests collaboratively. They are very much interested in setting up this piece of health research infrastructure facilitating both researchers and the pathology

departments when it concerns the use of left over tissues and their associated data for research purposes.

The intended piece of research infrastructure should consist of a central web-based portal to request samples from all the labs in the Netherlands supported by a back office. A biobank employee in every academic hospital (8 in total) should be responsible for facilitating several pathology labs in the region with the handling and picking of the requested samples.

The project received 1.2 million euros for three years starting in 2013 and ending in 2016. They asked me, the project manager of this three-year project, to

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draw up a sustainable business model for this piece of health research infrastructure, which we call the Dutch National Tissue Bank Portal. The reason for this request is due to the fact that this one time grant of 1.2 million euro’s is nice, but while most projects have a beginning and an end this project has another aim: spend the money on realizing a sustainable infrastructural solution for the future. The project should therefore consist of several project based activities (with a beginning and an end), but also include a framework from which the several stakeholders of the project (customers, suppliers, partners, grant providers) can build on after the project has ended. Thinking through the business’ processes and accompanying it with a strategy and a business model for the future is a useful tool to achieve this.

Especially, because the economics of such national bio-and databanking initiatives is not well understood. Fundamental business principles must be applied to the

development of such a research infrastructure to ensure its’ long-term sustainability and impact. The costs of developing and maintaining operations may have a variety of stakeholders, partners and funding sources. Among the issues that must be considered when proposing a business model are: understanding the need of all stakeholders involved and efficiently managing the whole process to serve their needs, which of course includes costs for sample selection, management, sample distribution, and infrastructure and administration. (Vaught et al, 2011)

A business model is the view of the firm’s logic for creating value by showing how the pieces of a business fit together and how the business works as a system. Strategy is about how to execute a business model successfully. It entails execution and implementation of the business model. (Osterwalder, 2005) So thinking through efficient processes, accompanying them with an implementation strategy and a business model are three necessary ingredients to come to a possible sustainable solution for a Dutch National Tissuebank Portal. This thesis will describe the process of coming to the proposal of a business model and provide recommendations for further testing and implementation.

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B. The research question

The question addressed in this thesis is: what would a sustainable business model look like for a Dutch National Tissue Bank Portal (DNTP)?

To answer this question, I will not only have to provide answers to four key components each business model should address (Magretta, 2002, Osterwalder, 2005, Johnson et al., 2008, Drucker, 1994):

o who is the customer?

o what does the customer value?

o how can we optimize the processes in this business? o what is the underlying economic logic?

but also to the following more detailed (based on expert and field knowledge) questions that refer (and show some overlap) to the above mentioned questions:

1. what does the current process and pathway of searching and obtaining samples and data look like?

2. what would the desired process and pathway look like?

3. which stakeholders or partners could set up and play a role in this pathway? 4. for whom and how could the pathway work?

5. which resources (material and immaterial) are needed for the desired pathway to work?

6. which costs, fees and revenues need to be taken into account for the business model to be sustainable?

7. how can the pathway be made sustainable for the future?

Answering all the above mentioned questions will make it possible to propose a business model, because as we see the four key components / questions of

business models show overlap with the above mentioned questions. After answering these questions, I will also sketch the DNTP Business Model, based on the Strategy Sketch (Kraaijenbrink, 2015). I will do so, not only to make it visually attractive, but especially to be sure I have covered all the essential elements a business model and strategy should entail. The Strategy Sketch contains 10 elements which all have to be thought through to be able to sketch a complete business model.

The research questions will be answered with a combination of literature and field study and structured through a design research framework. Design research starts from the value that needs to be created and then develops a new framework

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for a current problem. It tries to get away from the current ‘what’ and ‘how’ and investigates these two with value creation for others in mind. The ‘what’ and ‘how’ are then redesigned and recreated for the players involved that should lead to the intended value creation.

This thesis also starts with the desired outcome and based on that, works backwards to see what is needed to achieve that. It draws upon literature, expert and field knowledge and the building of artifacts to design a new ‘what’ and ‘how’,

therefore I believe a design research is a suitable framework for this thesis. Based on all the input I will propose a possible sustainable business model for a DNTP. But until it is tested in practice, it is a proposal to achieve a desired outcome. (Dorst, 2011) Because it hasn’t been possible yet to test the proposed DNTP business model entirely, it should still be seen as a proposal to achieve a desired outcome. However, this thesis will end with some recommendations for further testing and implementation.

B.1. Working towards a proposal for a business model for a piece of research infrastructure concerning biobanks

While there is a lot of literature on business models, strategy and process management, in contrast there is almost none on business models or strategy

execution for health research infrastructure or biobank initiatives. The reason for this I believe lies in the history of these disciplines.

Business model literature originated from economics and business studies from where it gained attention since the beginning of the 20th Century. From the nineties onwards it gained momentum and specific attention within business

strategy, IT, innovation and business management studies. Therefore, the concept is used and explained in multiple ways and lacks definitional clarity (Zott et al., 2011). Nevertheless, I believe the different explanations and tools to use and execute a business model or strategy are still very useful in order to offer an integrated and process-oriented perspective to answer my thesis question.

Health research infrastructure and biobanking literature has only gained attention since the beginning of the 21st century. The reason for this, I believe, is because it is all about ‘practical stuff’ medical scientific researchers do not take much interest in, nor should they have to. Health research infrastructure and biobanking indeed is all about the practical, logistical, financial, legal, ethical and social aspects

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of the collection, processing, storage, and dissemination of biological specimens and its associated data (Vaught et al., 2010). Therefore, it is not a typical research topic medical scientific researchers working on unraveling the origin or cure of diseases should have to address in the first place. Nevertheless, since the 21st century health research infrastructure and biobanking as a scientific and management topic has gained more and more attention. Due to large European initiatives such as ESFRI (European Strategy Forum on Research Infrastructures), European funding to set up translational research infrastructures such as within Horizon 2020 and BBMRI-EU, the awareness of the general public that their samples and data are being used, stricter laws, journals demanding accountability and more and more use of large amounts of samples and data in the ‘omics’ era, the business of biobanking as a sort of process management discipline has emerged. But it is still very much in its

infancy.

To answer my research question I will have to make use of the business model, strategy and business process management literature and combine this with practical field study knowledge of the processes involved in the infrastructure of biobanking. I believe such a “pracademic” approach is needed, in order to

understand where and how centralizing and standardizing the processes through a web-based portal and biobank employees can lead to a sustainable business model. This approach is known as design science research.

In Chapter II I will explain this approach and the performed literature study and field work. In this chapter I will discuss the evolvement of the business model literature and tools in relation to strategy and business process management. This chapter will also answer the four main questions as stated above and provide answers to the seven more detailed questions stated above in order to come to a proposal for a business model in chapter III.

Chapter III will state a proposal for a business model for a DNTP based on an existing business model tool.

I will conclude with some conclusions and recommendations in chapter IV for further testing and implementation of the proposed business model in order for it to be sustainable for the future.

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II FRAMING AND RESULTS: METHOD AND THEORETICAL FRAMEWORK USED AND THEIR RESULTS

A. Method and theoretical framework

The method used in this thesis is a design science research approach. Design science is an iterative approach to a real life problem beginning with the desired outcome and based on the processes involved. The DNTP project is exactly that: the overall desired outcome and the processes are known, how and with what to get there was unknown. The theoretical framework consists of literature study on the scientific concepts of business models, strategy and business process management. The literature study is complemented with field work and an iterative design process of developing and introducing a piece of the infrastructure to the stakeholders. The next chapter will elaborate on the origin and content of the design science research methodology.

A 1. Design science research

Design science research stemmed from a desire to ‘scientise’ design in the ‘60s of the 20th Century. (Cross, 2006) Its purpose was “to promote the study of and research into the process of designing in all its many fields” (Cross, 2006 p. 3). Especially the emergence of computer science and information systems sparked the beginning of this new research theory and methodology. It was Herbert Simon

(1969) who established the foundations for design science research. He stated it would be “a body of intellectually tough, analytic, partly formalizable, partly empirical, teachable doctrine about the design process” (Cross, 2006 p.3-4) The 1980s saw the establishment of design as a coherent discipline of study in its own right. The

dominant view was that design has its own things to know and its own ways of knowing them. Design research as a scientific discipline means the processes of design are studied on in its own terms, within its own specific culture, based on a reflective practice of evaluation and cooperation within a multi-disciplinary team. It is a participatory process in which designers are partners with the problem owners who together are in search of solutions. Design research now functions on an

international scale and is a scientific acknowledged form of a research methodology. (Cross, 2006)

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According to Dorst (2011) organizations having trouble dealing with open and complex problem situations have become more and more interested in ‘design research’, ‘design thinking’ and ‘design as a discipline’. The reason for this is because it is based on an open, participatory, backward and productive thinking process. Design thinkers try to get away from the current ‘what’ (a product, system or service) and ‘how’ (working principle; how the stakeholders involved work together) and investigate these two with value creation for others (the customers, suppliers, stakeholders) in mind. The ‘what’ and ‘how’ are then redesigned and recreated for the players involved in a creative way that should lead to the intended value creation. In a sense one could say they work backwards; they start from the value that needs to be created and then develop a new frame for the ‘what’ and ‘how’. In most

sciences the formal logic is based on the ‘what’ and the ‘how’ leading to a ‘result’. If one of the three is unknown, a hypothesis is stated and the unknown is subjected to experiments in an effort to falsify them. Design researchers or thinkers start with two unknowns: the ‘what’ and the ‘how’. The outcome is the known factor; the intended value creation. When a promising or interesting frame is proposed, the designer moves to actually developing or forming the new ’what’ and ‘how’. Then their next step is reasoning forward; a test to see if the ‘what’ and ‘how’ combined actually create the intended value. Until this test, the frame-as-proposed, is merely a possible way forward. (Dorst, 2011) It can best be seen as a proposal to achieve a desired outcome.

My methodology, started with the question why should there be a DNTP. I started researching this question by constructing a vision of an ideal situation of the processes of searching and acquiring pathology samples. This was based on a combination of field work and literature study investigating the current and ideal situation. I visited 45 pathology labs in the Netherlands to hear their thoughts, ideas and concerns and try to inspire them to take active part in the DNTP. I spoke to several stakeholders to find out what their concerns and wishes were. Then I partially implemented a new ‘what’ and ‘how’ together with the most important stakeholders. Unfortunately, for this thesis, I was not yet able to test if this frame actually will lead to the proposed value creation. But in chapter III, I will give some recommendations to complete this last and important step.

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For my research I will use the three cycle design research methodology of Hevner (2007). His pragmatic method of design research for information

systems/information technology projects, combines field knowledge with scientific knowledge and a hands-on iterative process knowledge to build a desired outcome for a practical problem.

(Hevner (2007))

Hevner (2007) states that design science research is an embodiment of three closely related cycles of activities. The figure above shows that the relevance cycle bridges the contextual environment of the research project with the design science activities (the ‘how’). The rigor cycle connects the design science activities scientific

knowledge and expertise that informs the research project (also the ‘how’). The central design cycle iterates between the core activities of building and evaluating the design artifacts and processes of the research (the ‘what’). These three cycles combined should lead to value creation.

All these aspects are needed to set up a DNTP and propose a sustainable business model for it. The DNTP has a big IT component to it (the development of a web-based portal), but also involves several logistical (national process optimization through the introduction of biobank employees) and managerial processes (getting stakeholders engaged, involved and committed).

As the project manager I had to find ways to implement a new ‘what’ and ‘how’ that serves the unmet needs of both researchers and all pathology labs, so that the DNTP creates value for these stakeholders involved. I also explicitly had to try to

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find an appealing answer to the ‘why’ question. Why is it important in the first place to have a DNTP? What is the purpose and reason of setting up this piece of

research infrastructure? This question is important, because research shows that change is more successful when organization’s leaders are able to convince their stakeholders with a compelling story of why it is important to change the current situation or practice. Transformational leaders who are able to emphasize the

purpose of what they are doing, thus reasoning from the ‘why’ to the ‘how’ and ‘what’ inspire and will be more successful in achieving their goals. (Ten Have et al., 2013, Kraaijenbrink, 2015, p. 80 and Sinek, 2009)

I have used Hevner’s three cycle design as follows: rigor cycle = literature study, relevance cycle = field work and design cycle = portal development and introduction of national biobank employees.

The method for the rigor cycle in this thesis consists of literature study on the scientific concepts of business models, strategy and business process management. These concepts are chosen because they all form an important part of designing a sustainable business model. The current and desired processes of searching and acquiring pathology samples for a large part determine the strategy how to design a new ‘what’ and ‘how’. The strategy and processes determine the business model. Therefore, these concepts are of importance to be able to propose sustainable business models for a DNTP.

The method for the relevance cycle consists of field work based on 45 lab visits, stakeholder meetings and a focus group with researchers. This field work unravels the requirements that are needed and wanted from the environment (client, supplier and other important stakeholders or partners point of view). It identifies the problems and opportunities and gives important insight in the current and desired processes. It also serves as the first important step of strategy generation: activating key stakeholders and the third important step: assessing strategy through customer and supplier testing. (Kraaijenbrink, 2015).

The method for the design cycle consists of the lean and agile iterative

learning process of building the web-based portal with the SCRUM methodology and introducing the eight national biobank employees. The SCRUM methodology works with a backlog in which the client and the contractor determine the end product that has to be developed. The actual development is performed in sprints (several two-week lasting cycles in which certain episodes of the backlog are developed in which

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the client’s feedback plays an important role). Introducing national biobank

employees to facilitate the 50 labs also provided useful information on how the new process of searching, registering and sending of samples and data could work with the portal in operation. This cycle gave insight in how the ‘what’ (the portal and biobank employees) could work for all the users and what their roles and responsibilities could be.

The next chapter will cover the methodology of the rigor cycle.

A2. RIGOR CYCLE: literature study

The concepts business model, strategy and business process management are often misunderstood and used interchangeably. A business model is the view of the firms’ logic for creating value. It shows how the pieces of a business fit together and how the business works as a system. Strategy is about how to execute a business model successfully. It entails execution and implementation of the business model. Due to this distinction, we can say that a business model in itself cannot be

successful. It is how it is implemented (the form it takes in reality) that determines its success. (Osterwalder, 2005)

Business model implementation is therefore according to Osterwalder a strategic issue. Strategy for a large part concerns how the processes within a business (workflows, responsibilities, infrastructure and systems) are shaped. Osterwalder (2005, p. 8) calls this the business triangle. He understands this

business triangle “as a building plan that allows designing and realizing the business structure and systems that constitute the operational and physical form the company will take” which is constantly subject to external pressures. Not all business model and strategy experts agree with Osterwalder’s definition and distinction between strategy and business modeling. Within the business model literature, I will elaborate on some other viewpoints.

This thesis aims at proposing a sustainable business model for a DNTP and consists of partly executing it by changing the processes involved. It is for this reason that I chose these three concepts for my literature study, because like Osterwalder, I believe they form the business triangle of a DNTP.

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A 2.1. Business model literature

Although Peter Drucker didn’t explicitly use the term business model in his notable Harvard Business Review (HBR) article in 1994, his theory of the business was about assumptions what a company is paid for. From this article and the emergence of the personal computer and spreadsheets, the term business model came into use. Literature in the 50’s and 60’s (also Druckers’) focused primarily on business

competition based on price. But later on Drucker was less interested in how to make money and more in the assumptions surrounding that question like; who is the customer, what does the customer value, how does the business make money and what is the underlying economic logic that explains how the company can deliver value to the customers at an appropriate cost. (Magretta, 2002 and Ovens, 2015)

In 2002 Joan Magretta wrote another important article in HBR focusing on business modeling. It elaborated on Drucker’s article because it not only agreed that business models are a set of assumptions, it also made clear that business models are part of a value chain and that the concept of a business model is not the same as the concept of strategy. A business model includes all the activities associated with making something and all the activities of selling something. It should be a description of how the business runs (the processes involved) in contrast to a

competitive strategy which explains how the business will perform better than others. It was Alex Osterwalder in 2004 who developed a comprehensive model on how to construct the assumptions underlying a business model. His business model canvas is an organized way to think about and lay out the assumptions on the nine key activities and resources of a business in a value chain. (Ovens, 2015)

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Osterwalder’s Business Model Canvas consisting of 9 building blocks

In 2008 Mark Johnson, Clayton Christensen and Henning Kagermann presented another important article in HBR about reinventing business models. It focused on the customer value proposition and stated that companies should first and foremost start with figuring out how to satisfy the customer who needs to get a real job done. (Jonhson, 2008)

Ramon Casadesus-Masanell and Joan Enric Ricart elaborated further on the concept of a business model in their articles in HBR and Long Range Planning in 2010 and 2011 by explicitly distinguishing and combining the concepts of business model and strategy. They stated that “a business model is a reflection of a firm’s realized strategy. Little is gained from separating the concepts when strategy maps one-on-one onto business model … The substantive difference arises when the firm’s contingent strategy calls for business model modifications.”

From 2011 onwards we see that the concepts of business model and strategy gain more and more attention and popularity both separately and adjoined. A new and refreshing look on business models in relation to strategy, is written by Jeroen Kraaijenbrink (2015). He introduces an alternative to Osterwalder’s business model canvas called The Strategy Sketch. He does so because he believes the term business model has became rather superflous. He also believes that the business model canvas does not cover all the essential elements a company should think of when drawing up their business model and executing it. He combines the concepts of generating and executing business models with strategy. The missing essential elements are an organisation’s strategic purpose and the notion of competition. His strategy sketch adds these elements and also sets a better level of abstraction of the elements alike in order to make it a more practical tool to use to propose a business model.2

2

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Kraaijenbrink’s Strategy Sketch consisting of 10 key elements to make strategy work for your business model.

The elements mentioned in Kraaijenbrink’s Strategy Sketch and Osterwalder’s Business Model Canvas show some overlap. For instance, being able to explain your key resources and competences, risks and costs, partners and a good value proposition seem to be essential for both business model tools.

I believe that when the questions stated in Chapter 1 about the current and desired DNTP processes are answered I shall be able to propose a business model and use that information to fill in the Strategy Sketch of Kraaijenbrink.

This short overview of what I think is most relevant business model literature for this thesis makes clear that the evolving literature on business models goes from seeing a business model on how to earn money (Drucker), to the direct and intimate relation between strategy generation and business model execution. I also believe and agree with Kraaijenbrink and Osterwalder that they should go hand in hand. Hereafter I will provide a short overview of what I think is the most relevant strategy literature for this thesis.

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A 2.2. Strategy literature

There exists an abundance of literature on strategy. Strategy as a discipline has evolved to different sub disciplines; such as corporate strategy, business strategy, marketing strategy and competitive strategy. Therefore, it is impossible to cover it all. But in essence, for me, it is about how a ‘business’ (whether it is small or big, part (unit level) or whole (corporate), or a project) executes their mission, vision, goals and plans. Strategy is something different than a mission (who are we and why are we in this business?), a vision (where do we want to go with our business?), goals (how are we going to realize our vision?) and plans (who, when, where and with what are we going to realize our goals?). Strategy is the result of the combination of choices executives and (project) managers make on realizing their mission, vision, goals and plans in order to create value and a competitive advantage. (Favaro, 2012) Value for the customer and in the end, of course also, a competitive advantage for their business or project.

It was Michael Porter’s 1979 article “How Competitive Forces Shape Strategy” in HBR that questioned the till then dominant money and price driven strategy

perspective. He added four additional elements on what strategy is which marked his famous five forces framework on strategy:

Porter (1979)

With this model he shifted the view of business strategy on the pricing pressures from rivals to all the forces in a company’s competitive environment. From then on much more was written on tools how to form and execute a strategy, like the SWOT

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analysis, the BCG matrix, the balanced scorecard, the business model canvas and the strategy sketch. (Ovens, 2015)

In 1996 Porter wrote an article on the definition of strategy. Apparently, this was still not defined accurately. Still today there isn’t a universally agreed upon definition of strategy. (Kraaijenbrink, 2015, p.17) Stripped down to its essence most strategy experts will agree that the fundamentals of strategy still lie in an

organizations ability to generate and execute the basic questions Drucker

addresses, because that can determine a business’ unique way of sustainable value creation. When stripping that down to its essence again; “an organizations true strategy appears implicitly in what it does; in its processes, actions, and routines.” (Kraaijenbrink, 2015, p. 20) which should be described in their business model.

I believe strategy is the way a business generates and executes their business model. Generating it involves activating stakeholders, mapping it in a model, assessing and testing it and describing it in words and visualizing it in pictures for the stakeholders to be understood. (Kraaijenbrink, 2015, pp. 30-31) Execution of a business model for a large part concerns how you organize the people, processes and technology of the business.

For the DNTP it is all about how we are going to be able to organize the people, processes and technology of searching, requesting, handling, picking, receiving and sending back pathology samples. For a major part this involves the organization of ICT and logistical and physical processes spread between different stakeholders. These stakeholders will have to be able to work together as a network and pursue a network level strategy demanding inter-organizational relationships and cooperation. They will have to understand that they all play an important part in the entire process to make research easier. Their goals can and should be mutually beneficial because reaching them is easier by doing it together. (Meyer, 2007, chapter 8). Pursuing a network-level strategy between several organizations is not an easy task to achieve. In order to do so, they will have to combine their processes, work together and change their current state of practice to achieve a desired new process. This also involves change management knowledge and tactics.

For the DNTP knowledge of the current and desired processes and the

willingness of the involved organizations to form a networked value and supply chain can and should be derived from the stakeholders (customers, suppliers, partners) themselves. This knowledge should then be combined with theories and tools from

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scientific literature on business process management to see how to achieve more effective and efficient processes within their networked supply and value chain. The methods used in the relevance cycle, such as stakeholder meetings, a focus group and lab visits were conducted to hear thoughts and ideas from the stakeholders themselves. With this information a new pathway of processes will have to be implemented for the DNTP infrastructure to work. This involves knowledge of business process management. In the next paragraph I will cover what I believe is the most relevant literature for this thesis on business process management.

A 2.3. Business process management literature

The industrial revolution in the 18th Century saw a transition from small scale craftsman production, based on personal skill and tradition, to mass fabrication in factories based on standardization and efficiency. (Mast et al., 2012) In the 20th Century organizations underwent another professionalization. Technological

innovations and improvements on management structures and methods resulted in highly productive and competitive companies that focus on quality and efficiency in their product process development. Besides management and technology

innovations, also industrial statistics and quality engineering gained scientific and business attention. (Mast et al., 2012) New methodologies like Total Quality

Management, Business Process Management, the Toyota Production System, Lean and Lean Six Sigma emerged from these disciplines. What they have in common is that they all focus on process optimization through five performance indicators; quality, reliability and dependability, speed, flexibility and cost. Organizations have to be good on all performance indicators, but can distinguish themselves from their competitors by having a different strategic trade-off. Company A can be dependable, have quality products and be cheap but slow in delivering, whereas company B can also be dependable and offer the same quality products, but be expensive and fast in delivering. Company C, who offers the same quality products, is dependable, expensive and slow will be outcompeted by A and B. It is the added value for the customer (cheap/ slow versus expensive/fast) that determines their competitive strategy and value proposition. In order to know your value proposition, it is necessary to have a thorough understanding of the business processes.

Knowing the business processes is key to understand what is really going on in a business in order to achieve operational excellence. (Slack, 2012) For the DNTP

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it is important to know the current processes of searching and acquiring samples but also if and how efficiencies (cost reduction, throughput time optimization) can be found to optimize the processes for the customers (researchers), the suppliers (pathology labs) and the partners (PALGA, NVVP, the eight academic medical centers) involved. In order to propose a sustainable business model, it is necessary to first understand the processes, technology and people involved when searching and acquiring pathology samples from pathology labs. Later on it will be necessary to test if the desired pathway actually is more effective and efficient than the current state of practice. This can best be done with a Lean Six Sigma black belt project. During a three-month period, the processes (with and without DNTP) are observed and measured in order to make them quantifiable and see if and how efficiencies (cost reduction, throughput time optimization) are are accomplished.

According to Strikwerda (2012) within business’ and business models,

processes have to follow proposition (the customer value proposition) instead of the long held view that structure should follow strategy. A more precise design of

especially the processes involved within business is needed

.

Therefore, to

understand the processes involved it is important to make use of research methods involving field expertise, such as stakeholder meetings and focus groups and to incorporate these in the design cycle. The design cycle should be performed with some of these key-users making use of an iterative design process (in software development this process is known as SCRUM).

Before I continue with the relevance and design cycle, I will put the four key business model questions into perspective of business model, strategy and process management for the DNTP. After the relevance and design cycle, I should also be able to answer the seven more detailed sub questions in order to propose a more complete sustainable business model for the DNTP.

A.2.4 The four main business model questions seen from a business model, strategy and business process management point of view

In my introduction I stated that the basis of most business models include four key components / questions:

o who is the customer?

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o how can we optimize the processes in this business? o what is the underlying economic logic?

In order to answer these four questions, I should not start with which business model tool to use or how to fill in the different business model aspects of that tool. I should start with the question what is the opportunity to satisfy a customer who needs a real job done. Johnson (2008, p. 54) calls this the Customer Value Proposition (CVP) which consists out of three elements: 1. the target customer (who is the customer?), 2. the job to be done and 3. the offering (what does the customer value?).

The target customer for the DNTP is the researcher and the 50 pathology labs. The job to be done is fulfilling the researchers’ need of samples/ data from one or several of the 50 pathology labs in order to start their research. The job to be done for the labs is to facilitate them in handling these requests, by offering them help through biobank employees. The DNTP can offer both target customers a single point of access to the desired products and information (one request portal to access all 50 labs and for the labs an overview and track and trace of their requests) and the service that the samples and data will be sent to them through biobank employees.

Secondly, also according to Johnson (2008, p. 54), the processes of how this job can be done effectively and efficiently with the key resources and the key

processes should be described set within a profit formula (how can we optimize the processes involved and what is the underlying economic logic?). While Johnson is focused on a profit formula based on a revenue model, cost structure, margin model and resource velocity, my proposed business model in chapter III will not be able to answer these questions straightforward. The reason for this is because the business area I am investigating here is set in a public (medical academic) sphere as opposed to a commercial sphere. Making money with left over patient samples and data is not the purpose (and even is unlawful), doing research with them is the purpose, which means spending public money as efficiently and effectively as possible. The

‘products’ we are talking about are left over human tissues and their associated data, which by law, shouldn’t and cannot be commercialized. In other words, there is no and cannot be a price for these samples/ data. There only is the cost of the

processes involved to get the samples/data from the labs to the customer which of course can be compensated in some way or another. It will always cost money to deliver samples/data to the researcher, but by optimizing the resources and

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processes involved it could cost partners (and the customer) less (in terms of time, resources and thus money) and the job can be done more effectively and efficiently. This should be further investigated in the relevance and design cycle. For BBMRI-NL, that pursues the strategy of creating a better research infrastructure in the Netherlands, which should be sustainable and affordable, finding ways to optimize the processes is important. Research performed by PALGA in 2008 indicated that if labs and all stakeholders involved were to charge the full costs of requesting and obtaining samples (excluding laboratory services) the costs would be around € 200,- per sample. (Synops, 2008) Although this research was based on several uncertain assumptions (amount of requests, amount of samples per request etc.) it does make one important point clear; grant providers (like BBMRI-NL, but also NWO and

KNAW) need to be aware of the costs involved in the entire process of obtaining samples and data from different biobanks and create appropriate funding streams. Full cost recovery paid by researchers simply is not possible, because they don’t get funding for these costs. (Albert et al, 2014) Also, long-term, sustainable financing to set up such a biobank research infrastructure is difficult to obtain. (Warth, 2014) If funding is present, as it was for the DNTP project, many grant providers assume that after initial investments it should be able to operate sustainably and independently. But sustainability and independence is challenging for the discipline of biobanking within a health research infrastructure for several reasons: the diversity of

stakeholders involved, the network oriented approach and the one-sided dimension of economic driven value metrics for grant providers and other stakeholders. The term sustainability is often used meaning economically self-sustaining, but this restricted definition is not sufficient for research infrastructure initiatives like the DNTP. (Watson et al. 2014) I would like to broaden the term sustainability also including non-financial aspects, such as taking responsibility and accountability for parts of the value and supply chain by the stakeholders and partners involved.

In spite of the fact that the processes (requesting, registering, searching and sending of samples/data) are more or less the same for each request, the end product (which samples/ data are sent to the researcher) is tailor made. This can be compared to a make-to-order versus a make-to-stock business process. Although all the samples are already made and stocked in the 50 pathology labs, deciding which ones are appropriate for the researcher is a very precise and tailor made process, which involves knowledge of pathology and epidemiology. The basic costs of the

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overall process per request (key assets, direct costs, indirect costs) can be calculated, but the resource velocity is hard to determine (we cannot predict how many, how often or how big a request will be). Therefore, the profit formula in my business model will contain possible solutions for optimizing the key resources and processes involved by the different stakeholders, so less money is spent on serving the researcher. To determine the costs involved now and with a DNTP, a lean six Sigma black belt project is wise to do. Mast et al (2012) describe this approach thoroughly, making clear that it is very important to understand the processes

involved before and after an intervention to be able to determine its’ success in terms of less costs and optimized throughput time. The DNTP project wasn’t able to

perform a lean six sigma process and cost analysis during the project period, therefore this is a recommendation for further testing and implementation.

The key resources needed to deliver the CVP are the eight national biobank employees, the portal, information (how the customer can make use of the portal and the employees) and creating alliances to improve the research infrastructure for the future. The current resources (lab personnel) are fragmented and scattered over all 50 labs. There is no national overview of who and how many requests are made and what the throughput time is for the researcher. The idea is that with the portal a single point of access can be accomplished, that gives the researcher a tool to access all 50 labs at once, and the labs a tool to monitor the requests and have a track and trace of where the samples are. This will definitely also benefit their research quality system for their accreditation. Secondly, the portal can provide a national overview of who requests (research groups/ field of expertise), how many requests are made and how many and which type of samples and data are

requested. That information can be very useful for research and funding purposes. Third, the national biobank employees will make it easier for labs to satisfy

researchers and also to ensure standardization and more quality control in assessing which samples are relevant. But these are all still assumptions that the relevance and design cycle activities should further investigate.

Now that I have briefly answered the four main questions with help of Johnson et al, I will proceed with the relevance and design cycle to answer my seven more detailed questions. After I have also answered those, I will incorporate the

information into a business model making use of the Strategy Sketch. I will do so, not only to make the proposed business model visually attractive, but also to make sure I

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have incorporated all the necessary elements to make up a business model. I will use Kraaijenbrink’s Strategy Sketch because as I stated earlier, I think this is a refreshing and very practical tool that has all the essential elements in it. The proposed DNTP Business model Sketch can be found in Chapter 3.

A.2.5 Summary Rigor Cycle

The rigor cycle shows that to be able to propose a sustainable business model for a DNTP, it is important to have an interdisciplinary approach making use of tools and theories from strategy, business models and process management. Strategy cannot be seen separate from the business model and the business model cannot be seen apart from the processes involved nor the strategy. They form the business triangle of a DNTP. But, this theoretical knowledge is only part of the DNTP business triangle to propose a sustainable business model. To truly understand the processes,

chances and obstacles, stakeholders (customer, supplier, partners; the environment) need to be asked to share their expertise and knowledge. That is the main idea of the rigor cycle; connecting the design science activities (setting up the artifacts and processes (portal and biobank employees)) with scientific knowledge and practical expertise from the environment that informs the research project.

Learning from the practical expertise is part of the relevance cycle, in which field work has been performed to gather this knowledge. The relevance cycle knowledge should be accompanied with theoretical rigor knowledge and these should be incorporated into the design cycle activities. The next chapter will cover the relevance cycle.

B. Relevance cycle: field work

The relevance cycle consists of field work in order to know and understand the requirements, processes, wishes and concerns of the stakeholders (customers, suppliers, partners, competitors) involved. For this project I visited 45 pathology labs, organized a focus group with researchers and performed stakeholder meetings.

B.1. Stakeholder meetings

In January and February 2013 stakeholder meetings were performed with three main partners in the process: PALGA, the NVVP and the heads of the pathology

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departments of the 8 academic medical centers. The meetings were fairly informal but led by an agenda and the principal investigators, Gerrit Meijer and Folkert van Kemenade both pathology professors, of the DNTP project.

The reason to talk to these stakeholders was first of all to gain knowledge of their current role and perceived accountability in the process. Secondly to ask them how they think the desired process and their role (and perhaps also other partners’ roles in the process) should look like. Because PALGA, the NVVP and the heads of the pathology departments of the academic medical hospitals had initiated the DNTP project and received funding for it from BBMRI-NL, it was not necessary to address the importance of establishing a central web-based portal with biobank employees to facilitate the labs. What was important to know was what they perceived to be their accountability in setting up and developing the DNTP now and in the future.

The NVVP, PALGA, and the academic medical centers all saw PALGA as the coordinating back office for the central web-based portal during and after the project period. The costs of developing the portal would be financed with project money and thereafter, PALGA would become responsible for further development and

maintenance. Luckily PALGA also saw this as a good investment and as their responsibility towards their subsidiary, the Ministry of Health, Welfare and Sports, and their suppliers, the 50 pathology labs, to take this task upon them. But there were worries about increasing workload and legal barriers that should be addressed beforehand.

Although the NVVP supported the DNTP initiative, they stressed that they were not in the position to force the pathology labs (the suppliers of the samples and data) to collaborate. What the NVVP could do, was provide lobby and

communication tactics to try to convince labs to collaborate and to guide researchers towards the central web-based portal. They didn’t directly see it as their responsibility to provide the labs and researchers with standard Material and Data Transfer

Agreements (DMTA’s) or fee-for-services. They are also not in the position to try to accomplish one national review procedure. The current situation entails that each lab reviews the request independently. The NVVP is willing to communicate the

existence of these processes and documents if they were present. Unfortunately, this still is not the case. Therefore, researchers have to sign several (or sometimes none) DMTA’s from labs and are dealing with different fees, invoices and review procedures to obtain the data and samples.

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The eight heads of the academic pathology departments were willing to provide a biobank employee to facilitate the labs in their region during the project period and with financial support from the project. After the project period and funding was over, the DNTP had to be financially capable of paying these employees. How this could or should be accomplished, was not clear. They did understand that, although the biobank employees are paid by them to facilitate other labs and requests in their region, their own academic researchers would profit the most of this infrastructure. If labs make use of these biobank employees, they will not send an invoice to the requester. In that way, the academic researchers profit the most of the intended research infrastructure.

These stakeholder meetings showed that the three main strategic

stakeholders all see the need for this piece of national research infrastructure. But the uncertainty of the costs after the project funding and their un-ability to ‘force’ cooperation of the labs to make use of the intended infrastructure (portal and biobank employees) makes it difficult to fully commit themselves to a DNTP. Although they see the need of setting up a national DMTA and review procedure, they do not see it as their responsibility to do so.

B.1.2. Focus group with researchers

On the 14th of February 2013 a focus group with researchers from different

disciplines took place in VU academic medical center (VUmc) Amsterdam. The focus group lasted 2,5 hours, was led by me and the agenda was divided in the 4 main process steps of acquiring pathology samples:

1. searching samples, 2. requesting samples, 3. receiving samples and 4. returning samples. The head of the pathology department of VUmc, the secretary of the NVVP and PALGA provided me with several names of researchers with different medical backgrounds (oncology, pathology, hematology, KNO, MDL and epidemiology) but with experience using pathology samples for their research. 17 Researchers were invited by email with an explanation of what a focus group is and the topic of the focus group. 7 Researchers attended the focus group.

The reason to perform a focus group with researchers was first of all to gain knowledge of the current processes, obstacles and chances searching and receiving samples and data from the labs. Second of all, to inform them (the customers of the

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DNTP) of the intended national DNTP pathway and to ask how they think the desired process should work.

The most important and agreed upon outcomes per discussion topic were discussed and put in a brief results document (see appendix 1). Names or input per participant was not noted for privacy reasons. The results of the searching topic were:

o researchers usually already know which patients (sample numbers) are relevant;

o personal contacts with pathologists are essential for searching and finding the right samples. In order to know which sample is relevant, you have to read the whole pathology report. Therefore, a pathologist or someone with pathology knowledge is a prerequisite;

o sometimes it is better to gather your own samples and data from patients than requesting them nationally from labs in order to have full and private access to the data and samples. In other words, setting up an own biobank is

sometimes preferred due to publication and grant funding opportunities; o besides samples you need clinical follow-up data from other sources to

answer your research question.

The requesting topic led to the following results:

o requests are mostly made at the own academic center (not nationally), due to the many different procedures and requirements of the labs. But national requests would be best to find the most appropriate and complete sample and dataset.

The receiving topic learnt that:

o it takes long, sometimes up to 1 to 2 years, to receive samples from multiple labs;

o communication with labs is difficult, they all have different procedures and requirements;

o it usually helps to go to the labs yourself to search and collect the samples. This also requires a lot of organization and time, but usually this process is faster than waiting for the labs to send the samples.

The return topic showed that:

o returning samples is not done often by researchers;

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The outcomes of the desired process showed that researchers were enthusiastic about the DNTP initiative, but were worried about the costs that would come with it. Researchers receive funding to perform their research, not to be busy with

administrative and logistical ‘stuff’. But the reality now is that researchers have to do all these administrative and logistical ‘stuff’ themselves to get hold of samples and data from the labs. Although they do not have the idea that there are costs

associated with obtaining their samples and data, of course there is. Their time is actually budgeted to do research, not to spend a year or more getting hold of samples and data. Grant providers are not aware how much time and effort (and thus money) it costs to get hold of samples and data before researchers can start with the actual research. These administrative and logistical tasks are not taken into account by the grant providers.

This focus group with potential customers showed that the current process of searching, requesting, receiving and returning samples is mainly based on personal contacts, limited to one or two hospitals and performed by the researcher

themselves if the lab approves. Researchers are annoyed that obtaining samples and data costs them a lot of effort and time. The DNTP initiative with a central request web-based portal and biobank employees facilitating the labs could be of great use for researchers, but only if the costs to request and receive the samples are not too high and the delivery time is not too long. Also grant providers should be aware of the need of this infrastructure and be willing to pay part of the costs

involved.

B.1.3. 45 lab visits

From March 2013 till December 2015 I visited 45 pathology labs from the 50 in total. The reason for this was first of all to inform them (as the suppliers of the samples and end users of the portal) of the DNTP initiative. They are important stakeholders in developing and implementing a DNTP. If the labs do not know of this initiative, of which they form one of the key resources, the DNTP will not be a success. Second of all, to gain knowledge what their stance is towards setting up a centralized and standardized pathway to request and deliver samples to researchers. If a majority of the labs are not supportive of the initiative and therefore are not willing to collaborate and cooperate, the DNTP will fail. Thirdly, to see if it is possible to get them aligned

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to form an important part of the intended unique collaborative supply and value chain. If the majority of the labs prove to be positive and willing to form a

collaboration of networked partners, further plans could be made to implement the DNTP (portal and biobank employees) in the design cycle.

An email was sent to the head of the pathology lab to ask if a visit and presentation was appreciated. If so, I recommended them to have several

pathologists and other employees present whom are involved in handling research requests.

The visits consisted of a standardized Prezi presentation in which the intended future situation with a DNTP (web-based portal supported by the PALGA back office and eight national biobank employees) was visualized. Especially the ‘why’ question of the DNTP was addressed: why is it important in the first place to set up a DNTP? My answer was: first of all, to achieve more, easier and improved use of tissue samples and data to accelerate health research for better patient care. Secondly, it can be useful for the labs to get their research quality system for

accreditation purposes in order. Due to the portal labs will have a real time (and online) oversight of who has ‘their’ samples and data and for which purposes. And due to the biobank employees, standardized and controlled procedures of assessing which samples and data are relevant to answer the research question can be

achieved.

After the presentation an open discussion took place with the pathologists, secretaries and/or biobank managers present. At the end of the visit the head of the pathology lab was asked if they were willing to sign a letter of intent declaring their support and collaboration in setting up a DNTP. This was intentionally not a strict legal contract or agreement for several reasons. First of all, because we didn’t yet know how the processes and responsibilities would be organized. Second of all, to not scare-off the suppliers with formal contracts. And third, to maybe be able to use the signed letters of intent as a promoter towards the other partners and BBMRI-NL. When they see the overall willingness of the labs to participate they might also be more prone on re-assessing their own role and responsibility in the supply chain collaboration. For BBMRI-NL it could give support towards policy makers of the importance of setting up national research infrastructures.

Some labs already had set up a professional procedure of obtaining samples and/or data, including a DMTA, review procedure and a fee-for-service. Some labs

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