A business case for a shared resource laboratory facility at the VUmc

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(1)Master of Business Administration in Healthcare Management. The Amsterdam MBA – Company Project. A business case for a shared resource laboratory facility at the VUmc. by, Juan. J. García Vallejo, 10973222. Supervisor UvA:. Prof. J. Strikwerda. Supervisor VUmc:. Prof. Y. van Kooyk. Submission date: January 31st, 2017.

(2) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Statement of originality This document is written by Juan J. Garcia Vallejo, who declares to take full responsibility for its contents. The text, illustrations, tables, and analysis presented in this document are original and no sources other than those mentioned in the text and its references have been used in creating it. The Amsterdam Business School MBA program is responsible solely for the supervision of the completion of the work and not for the contents.. In Amsterdam, January 30th, 2017. Statement of originality. 2.

(3) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Executive summary. Contrary to many opinions, the observations made by Gordon Moore already 50 years ago on the rate of technological developments in the semiconductor and digital electronics industry have proven correct so far. The benefits for the biomedical scientific community have been tremendous, for that companies are developing more and more instrumentation at affordable prices that provide limited, but still enabling applications. Yet, the kind of instrumentation that provides real competitive advantage to research institutions has only but increased its net price per unit. In consequence, for biomedical research institutions to stay ahead of the competition, they need to invest a large proportion of their internal funding for the periodic renewal of their research instrumentation assets. A way in which many institutions have responded to this challenge is by creating transversal intra-organizational service units –often called shared resource laboratories or core facilities– that provide access to expensive high-end technologies at an affordable cost for individual researchers. This strategy resembles the development of shared service centers in the structure of the multidivisional organization. The goal of this Thesis was to investigate the possibility of transforming the cytometry technology platform of the Department of Molecular Cell Biology & Immunology of the VU University Medical Center into a cytometry shared resource laboratory for the entire organization, with a particular focus on the necessary change in operational management, the effects of introducing a cost recovery strategy, and the organizational challenges for both MCBI and VUmc; all in the light of the shared service center theories of business organizations.. Executive summary. 3.

(4) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. The result of this work was the establishment of O2Flow, a shared resource laboratory created with the mission of enabling scientific discovery in fundamental and translational biomedical research by providing affordable access to state-of-the-art technologies, services, and scientific and technical expertise in flow, imaging, and mass cytometry. The chosen organizational model, a hybrid intra/inter-organizational shared service center, implies that instrumentation and personnel are detached from their original units and belong to an independent entity within the organization that provides services to any research laboratory according to an agreement that details prices and service level. The financial model of choice involves internal and external billing for cytometry with the goal of achieving a partial cost recovery (including personnel). In order to facilitate this, the deployment of a software system to control scheduling and instrument usage is crucial to allow the automated generation of payment requests with minimal involvement of administrative and financial personnel. In parallel, the O2Flow will be operated using a business score card system aimed at increasing customer acquisition, stimulating instrument usage, and facilitating external customer usage. By enhancing and clustering both the technological possibilities and the expertise, the VUmc will be able to achieve higher levels of performance that will result in more and better publications, attract prestigious scientists, and facilitate the acquisition of more research funding. The organization of research infrastructures in the Institution will slowly change towards the adoption of the model described in this Thesis. Not only it will provide the VUmc with a higher competitive advantage towards other academic hospitals in Europe, it may be the only affordable way for the VUmc of maintaining up to date its currently existing research infrastructures.. Executive summary. 4.

(5) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Table of contents. Statement of originality Executive summary Table of contents I. Introduction A. Shared resource laboratories in the life sciences B. Economic and business theory of shared service centers C. Particularities of shared resource laboratories for cytometry. II. Objective of this Thesis A. Approach for the generation of a Business Plan for O2Flow. III. Business plan for O2Flow A. Business description B. Business model generation C. Market and industry analysis D. Marketing plan E. Operations plan F. Financial plan G. Milestones and implementation plan. IV. Non-technical section A. Summary B. Conclusions C. Recommendations. V. References VI. Acknowledgements VII. Appendices List of Tables List of Figures. Table of contents. 2 3 5 6 8 11 16 24 26 29 29 30 64 66 67 74 79 81 81 81 85 87 92 94 105 106. 5.

(6) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. I. Introduction Biomedical research is witnessing an era of dramatic technological advances that are transforming the landscape of modern Science. New technologies, whether representing disruptive or incremental innovations1, have shorten their life cycles so that newly introduced methodologies very quickly become the current standard. At the moment of market introduction, new technologies tend to be characterized by high prices that are the result of new product development and manufacturing costs, as well as new product exclusivity (Figure 1). Exclusivity is achieved by marketing campaigns that make use of limited release programs and coincide with the publication of high impact manuscripts that contribute to quickly turning cutting edge technology into the new standard. This generates a vicious circle in which research institutions need to invest frequently in new technology to be able to publish in high impact journals, a widely-used quality indicator for research institutions. This process typically occurs at a fast pace, putting a high pressure on research institutions to be equipped with the newest technology.. Figure 1. The cycle of innovation in Life Sciences can be described as a spiral, in which the diameter represents how widespread is the technology.. 1. A technological advance is referred to as disruptive when the biological measurement generated did not exist before. Incremental innovation technologies are characterized by being able to produce measurements faster, more accurately, or in higher dimensions as compared to already existing technologies. I. Introduction. 6.

(7) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. The price of new technologies has increased in such way (Figure 2) that instrument acquisition can no longer be done by a single research group or department. As expected, technologies in the field of biomedicine tend to behave in a similar manner as in computational science (Moore, 1965). Moore’s law predicts that the number of transistors per circuit doubles every two years and, in consequence, facilitating a proportional decrease in price. The same trend can be observed in the field of cytometry instrumentation (Figure 22). While the amount of quality-adding features increase exponentially, the cost of each of this features dramatically decreases over time. Paradoxically, this also results in an increase of the price of high-end instruments. As a result, two product types have emerged that aim at two different customer segments: Fully-loaded highend instruments with a prohibitive price tag, and the affordable low configuration options. While the first ones are aimed at large facilities and frontierbreaking research groups, the latter are meant for smaller institutions and widespread usage. In addition, often the handling of new technology requires also a specialized training, making it even more difficult for smaller groups to cope with the exploitation of the newer technology. The way Figure 2. Evolution of cytometer price at the time of market introduction. a, Average market price (corrected by inflation 1) at the time of introduction. Bubble diameter indicates the number of features (number of lasers, channels, high-throughput analysis, and sorting). b, Evolution of the cost per feature, calculated as the ratio of average market price (corrected by inflation) to a feature score (number of lasers x number of channels x possibility for high throughput x possibility for sorting).. scientific institutions have coped with this cycle of innovation (Figure 1) and exploitation of new technologies is by creating shared resource laboratories (SRL) to host similar technologies with the interest of lowering the cost to the. 2. Cytometer prices refer only to Becton Dickinson instruments. Information on price was kindly provided by Dr. R. van den Beemd (Sales and Marketing Manager for the BeNeLux at BD Biosciences). The field of cytometry has been largely dominated by two companies over the last 40 years (Becton Dickinson and Beckman Coulter). Release of instrumentation by both companies has gone in parallel and price differences were minimal. I. Introduction. 7.

(8) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. beneficiary research departments, agglutinating expertise, and optimizing usage capacity. The genesis of these technology-oriented SRL parallels in many ways with the development of shared service centers (SSC) (Strikwerda, 2010) and product platforms (Simpson, 2004). In the following sections, the characteristics of both SRL and SSC will be elaborated in detail. Finally, the particularities of the application of SRL best practices to the field of flow cytometry will be discussed in detail as a prelude to the development of a business plan for a flow cytometry SRL at the VU University Medical Center.. A. Shared resource laboratories in the life sciences Already more than 10 years ago, the National Institutes of Health, the prime and most prestigious research facility of United States Department of Health & Human Services, conducted a large survey on over 300 leading biomedical scientists from academia, government, and the private sector in order to identify the necessary priorities that are essential to accelerate progress in biomedical research (Zerhouni, 2003). The result of this survey clearly identified that a fundamental need of the scientific community was the preparation of an adequate toolbox to support the scientific challenges ahead. Such toolbox should provide the research community with wide access to technologies that should be more sensitive, robust and flexible. Research in engineering and biotechnology for the development of such technologies was thus recognized as a major driver of scientific research in the 21st century and identified the need to bridge expertise and technological development with the needs and requirements of fundamental, applied, and translational biomedical scientists. To make possible an effective interaction between these two worlds –technology-driven engineering and biomedical research– core facilities began to evolve into what today is known as Shared Resource Laboratories or SRLs. Whereas the term core facility defines a laboratory that brings together resources (infrastructures or technology platforms) to make them available and facilitate operation to users within a large institution, the term SRL incorporates an additional, but crucial, connotation to the goal of any core facility. As an evolution of the core facility, the I. Introduction. 8.

(9) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. SRL provides not only access to cutting edge technology, but also tailored advice and support by highly skilled technology-minded scientists. The stress on the additional scientific and collaborative goals of SRLs clearly sets them apart from the classical concept of core facilities and places the SRL goals into the continuous scouting and implementation of advanced technologies (Moore & Roederer, 2009). Amongst the multiple technologies that often give rise to the organization of SRLs, are genomics, proteomics, imaging, and cytometry. Irrespective of the obvious technological differences amongst these disciplines, the services that any SRL provides are often similar and include access to specialized instrumentation, consulting on experimental design, data analysis, and data interpretation, as well as training in any of the mentioned services. In addition to this user-oriented services, SRLs have set a number of internal goals aimed at maintaining a quality standard and economic sustainability. To this purpose, SRL have extended responsibilities on the testing and selection of appropriate research instrumentation, the generation and maintenance of quality management programs, and the research, development and implementation of new applications and tools. Moore and Roederer developed in 2009 a manual of best practices for SRLs in which seven key aspects were highlighted for a successful SRL (Figure 3), independently of the technology associated to the SRL (Moore & Roederer, 2009). The seven best practices for an SRL according to Moore and Roederer are the following: 1) SRLs should have a consistent and continuous financial support from the institution. The institution should see the SRL as a necessary investment to provide the means for an effective implementation of the scientific program of all researchers. 2) The SRL should have a scientific director that holds high qualifications and reputed prestige in the technological area of interest. The role of the scientific director should be serving as institutional contact for principal investigators and researchers interested in using the services of the SRL, as well as providing advice and consultancy with regards to experimental design and data interpretation. In addition to its service role, the scientific director should devote 50-70 % of his/her time to developing a technology-centered independent research line.. I. Introduction. 9.

(10) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. 3) Create a human resource management strategy that prioritizes the recruitment and retention of highly skilled operators. The operators of the SRL are equivalent to the frontline employees of any business and should have a client centered mentality. The focus of the SRL operators should be on providing training to users, consultation on data analysis and interpretation and, whenever needed, assisting instrument operation. Excellent operators are critical to the success of the SRL staff and efforts should be made towards creating policies for their retention. These policies should focus on salary advantages, continuous education and exposure to scientific and technical meetings. 4) Education should be a foundation principle of the SRL, not only of users, but also of principal investigators, and the SRL staff. Through strategic educational programs, the SRL should contribute to develop highly trained users that can act as “super-users” and, therefore, ambassadors of the facility. In addition, the organization of technology Figure3. The seven best practices of a successful SRL, according to Moore and Roederer (2009).. oriented seminars should be a useful way to continuously educate the SRL users.. 5) Establishing an exhaustive quality management program. This is necessary to ensure that the data generated by the SRL is of the highest quality in terms of accuracy and reproducibility. In addition to this, a strict quality management program can help identify problems (instrument malfunctioning) before they become critical and, therefore, provide the means and opportunity to cut cost on repairs by an efficient preventive maintenance. 6) Scouting for new technologies. It is the responsibility of the SRL to stay up to date with the latest technological developments and make efforts towards the acquisition and development of technology ahead of the competition. This is the best strategy to attract new users to the facility. I. Introduction. 10.

(11) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. 7) The SRL should have a sound financial plan in place. This is necessary to ensure the viability of operations and should be aimed at providing services in a cost-effective manner. The financial plan should include a 5-year plan that forecasts future usage, the expansion of the existing technology, and the replacement of outdated instrumentation.. B. Economic and business theory of shared service centers. The multi-divisional firm and the need for shared service centers Until the early 20th century the most extended firm structure was the unitary form (also known as the U-form), later developed into the functional organization (F-form, see Figure 4, left panel) to introduce the principle of function-related specialization. The U-form business structure allowed for unification and consistency because all strategic and decision making process was centered at the corporate office. Despite of the advantages regarding direct control, growing and expansion under this model were limited. A few pioneer companies, like DuPont and General Motors were the first to transition into the multi-divisional form (also known as the M-form, see Figure 4, right panel) as a means to achieve a certain level of diversification and growth within the company. For these companies, adopting the M-form proved to facilitate the management of diverse production lines and, at the same time, maintain a high efficiency and maximization of profit. However, it wasn’t until the 1960s that the M-form became a widespread form of business organization. The M form was characterized by the existence of a central office that would be responsible for overall strategic decisions and a number of self-contained resource-owning divisions with a certain level of independence that that could make their own operational decisions. An important aspect of the M-form is that divisions are guided and controlled by financial targets from the corporate center (Palmer, Jennings, & Zhou, 1993). The corporate center, thus, sets the business scope, appoint divisional managers, and assess their performance periodically.. I. Introduction. 11.

(12) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Although the M-form is considered one of the greatest innovations in the 20th century, multiple variations and adaptations have evolved over the last years to cope with more flexibility in the production process and lower costs of information. The main reasons for departing from the Mform dogma of business organization has been the emergence of the role of knowledge in the economic process, the emergence of generic technologies, the need to lower the costs of coordination, the search for synergies between business units, but also other problems associated with the M-form (the agency costs) have triggered organizational re-design attempts, such as high costs due to duplications of functions, internal battles over resources due to the business unit resource allocation policies of the classical M-form, the lack of standardization across different business units, the lack of cooperation between business units (often seen as competitors), and a potential loss of market opportunities as a result of placing too much attention in internal competition, but also losing opportunities that could arise from cooperation. Other reasons may be the need to exploit knowledge as a semi-public good, to provide better process descriptions to allow for the sharing of processes in combination with lower coordination costs, and the emergence of high cost generic technologies with L-shaped (as opposed to the Ushaped) curve type cost dynamics.. Figure 4. The firm structure in the M (right) and the F-form (left) businesses.. I. Introduction. 12.

(13) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Multiple solutions have been proposed and are being practiced to overcome these problems, amongst them the creation of shared service centers (SSC). An SSC is an accountable unit within the organization that has as mission to provide specialized services to other units within the organization. The service provided is regulated by a service level agreement (SLA). The SLA dictates not only the time, quality, and quantity of the services delivered, but also the (internal) prices that need to be satisfied for the provision of the services (Strikwerda, 2010; 2006). This definition separates clearly SSCs from central staff departments and external service companies (outsourcing), which is summarized in Table I. A consequence directly emanating from this definition is that SSCs are cost centers, not profit centre, even though they contribute to maximizing the overall profit of the firm in many (measurable) ways. The services provided by the SSC are decided by the unit managers that benefit from the service provided, of course, within corporate guideline; but they never involve performing statutory tasks nor developing policies. Thus, in summary, SSCs are independent units that provide service to other business units within the organization with the ultimate goal of allowing these business units the possibility to focus their time and energy on to external customers and strategic goals. Table I. Comparison of SSC, outsourcing, and centralization of services (*KPI, key performance indicator; #SLA, service level agreement) (Soalheira & Timbrell, 2014; Strikwerda, 2014). Attributes Accountability Performance targets *. Use of KPI & SLA Location Orientation Core business Culture Costs Classification Run by. I. Introduction. #. SSC. Outsourcing. Centralized. Business units. Business units. Corporate. Service excellence. Service excellence. Cost reduction. Widespread. Widespread. Rare. Most convenient. External. Corporate headquarters. Operations. Head office. Head office. Provide service according to operational needs. Provide service according to contract. Provide service according to corporate policies. Operational. External. Staff. Per service, detailed SLA. Per service, detailed SLA. Blind cost center. Independent unit. Outsourced unit. Corporate. Entrepreneur. External service. Accountant. 13.

(14) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Benefits and disadvantages of shared service centers The drivers that typically trigger companies to consider the possibility of setting SSCs are broad. In general, companies set SSCs when they identify hidden costs in the provision of internal support services, when quality is not appropriately measured, and when internal customer expectations are not known or achieved. The following summary provides a detailed analysis of the organizational motivations for SSCs: -. To support functions in the organization that have become too expensive and/or are growing too fast. This applies also to organizations that have multiple and geographically dispersed locations.. -. To provide access to enabling technologies to more than one business units.. -. To improve functions in the organization that are being performed with poor service levels, often associated to a back office silo mentality (Lacity & Willcocks, 2008).. -. To develop standardized systems for functions that are needed in more than one business units in the organization.. -. To prevent duplication of work across units and/or unnecessary local administration.. -. To overcome the lack of appropriate business intelligence tools and information to provide access to relevant management information.. -. To enable the wish (or need) of managing the growth of the organization without incurring into disproportionate financial investments and/or administrative personnel.. -. To eliminate the lack of collaboration between different business units that have shared goals, but different financial incentives.. -. To comply with changes in legislation at an affordable cost.. -. To cope with large corporative changes, such as mergers and acquisitions.. -. To cope with globalization and an increased international competition.. Besides behaving as countermeasures for the issues described above, implantation of SSCs also contributes to higher organizational efficiency and effectiveness. Increased efficiency results from the implantation of best practice processes, achieving economies of scale, obtaining a greater span of control, lowering labor costs, optimizing technology investments, improving reproducibility through standardization, and, last but not least, achieving inter-departmental I. Introduction. 14.

(15) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. synergies. Increased effectiveness, on the other hand, arises from the implementation of SLAs. SLAs provide the peace of mind to the business units that demand the service as well as the management, so that they can focus on what really matters in their positions, whether it is about customer focus, decision-making, or operations. The processes that are best suited to become part of an SSC are those that are not strategically critical to the organization and, yet, are common across different business units. Examples of these are many of the human resource administrative processes, management accounting, IT services, or tax and legal activities. Importantly, the focus on SSCs has changed over the last years. In the past, the primary goal of the implementation of SSCs was cost reduction, standardization, and consolidation of processes. Nowadays, the aim has shifted towards enhancing services and providing higher value activities; thus, becoming strategic partners of the organization in order to drive growth and enable business innovation. However, SSCs also have some potential drawbacks that need to be considered carefully before implementation. An inherent consequence of creating higher order structures that encompass personnel and resources from different business units is that both the management and the different units involved need to be perfectly aligned to the goals of changing the organization and achieving higher results from the implementation of SSCs. What often happens is that there are no visible changes in the organization and former roles and relationships are kept, creating conflicts and undermining the morale of the personnel assigned to the SSCs. Fortunately, although not trivial, this issue can be overcome with an adequate change management strategy for the implementation of SSCs. A more serious issue refers to the shift in the corporate strategy of the firm that implies the design and development of SSCs. Once all SSCs are all rolled out and performing their work, the organization may have achieved a higher level of productivity and lowered operational costs, but it is more vulnerable to changes in the market that require redesign of operations or business units. They might have become too dependent on the SSCs, therefore the reason of not choosing strategically critical processes for the constitution of SSCs. Other issues that may arise could be the transfer of inefficient process from malfunctioning I. Introduction. 15.

(16) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. business units to the new SSC, and the dependency on local management and motivation for the success of the SSC. SSCs have increasingly evolved beyond the walls of the multi-divisional organization and, today, more and more SSCs extend their services their own organization. This concept, coined as interorganizational service centers (or ISS) allow cooperation between companies that move beyond traditional outsourcing (van Fenema, Keers, & Zijm, 2014).. C. Particularities of shared resource laboratories for cytometry Fundamentals and historic development of cytometry As the greek origin3 of the word already indicates, cytometry is the science of measuring properties of cells (Robinson & Roederer, 2015). Although often cytometry is used as a synonym of flow cytometry, the term collectively refers to a number of different variants that nowadays include flow cytometry, imaging flow cytometry, and mass cytometry. Flow cytometry is a technology with a relatively short history (Picot, Guerin, Le Van Kim, & Boulanger, 2012; Shapiro, 2004) that finds its routes in a cell counter first reported in 1934 (Moldavan, 1934). This first application aimed at the counting of red blood cells by means of a photoelectric measurement device attached to the ocular lens of a microscope stage focused on a capillary tube through which the suspension of cells was forced to flow. Although rudimentary and hardly practical, it contained the basic elements of what later turned into a widespread technology. But it was not until 1949 that the first patent on the underlying principle of the flow cytometry technology was filed by Wallace H. Coulter (US Patent 21953, in press), leading to the development of the first commercial flow cytometer, the Coulter Counter (Robinson, 2013). The technology developed by Coulter, still used today by hematological diagnostics cytometers, allowed the accurate counting of cells in suspension but provided limited information about the. 3. cyt-: cell (κύτος) and -metry: process of measuring (µετρία).. I. Introduction. 16.

(17) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. different cell types present in the suspension. This Coulter counter technology was later improved with the implementation of the principles of laminar flow by Crosland-Taylor in 1953. The improvement introduced by Crosland-Taylor –hydrodynamic focusing– is still used to date and allowed the alignment of cells within the fluid by the injection of a slow flow cell suspension into a fast-flowing sheath fluid stream. An important landmark in the history of the flow cytometry technology (Figure 5) came from the solution to a completely unrelated engineering problem; the development of inkjet printers. It was previously known that when a stream of fluid emerges out of an orifice is hydrodynamically unstable, unless an external force is applied to the stream, it breaks into droplets with an unpredictable pattern. The discovery that the application of electrostatic charges provides a means to control the size and direction of the droplets. This principle was later implemented by Mack Fulwyler (Fulwyler, 1965) into a modified Coulter counter and, hence, he was able for the first time to sort droplet-encapsulated cells in 1965. The technology advanced quickly and the first commercial fluorescence-based cytometers were available in the US and Europe between 1968 and 1972.. Figure 5. Key chronological events in the historical evolution of modern cytometry.. Undoubtedly, the contribution of Len Herzenberg (Dangl & Lanier, 2013; Herzenberg et al., 2002) was crucial in many ways. Not only he understood the potential of fluorescence-labeled monoclonal antibodies in enabling applications based on flow cytometry but he catalyzed the early development of the first commercial instruments. Ironically, Herzenberg had to work hard to convince the medical device division director of Becton Dickinson (BD) to pursue the development and commercialization of fluorescence-based flow cytometers, since the company’s I. Introduction. 17.

(18) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. evaluation of the potential market of such instrumentation was minimal and restricted only to a few research centers worldwide (Lanier, 2014). They could not be more wrong, as flow cytometry turned out to become a billion-dollar industry and a major branch of the company. The flow cytometry technology evolved slowly over the decade of the seventies and eighties to occupy a central place in hematological and immunological research and diagnostics. In the last decade, the technology has dramatically expanded thanks to advances in computing, the chemistry of fluorochromes, and the development of new detectors. The incorporation of an ultrafast CCD camera and a set of objectives allowed the acquisition of images in flow and the development of a whole new type of application, imaging flow cytometry (George et al., 2004). More recently, the advent of mass cytometry (Bandura et al., 2009), based on the use of stable metal isotopes in combination with inductively-coupled plasma time-of-flight mass spectrometry, has allowed the measurement of up to 45 simultaneous parameters without the need for correcting spectral overlap, one of the major drawbacks of fluorescence-based flow cytometry. With over 100 companies in the flow cytometry industry to date, the cytometry business is worth more than $3 billion yearly (Robinson & Roederer, 2015). Cytometry has historically evolved in parallel to Immunology (Figure 64), but its applications currently extend to all fields of research and clinical medicine and have been suggested to have a greater impact in biomedicine than any other existing technology. This has prompted multiple companies to produce small sized cytometers with limited possibilities that have contributed to the democratization of the technology, while high-end Figure 6. Evolution of scientific publications in the fields of cytometry and immunology.. instruments are being developed at an amazing pace and easily pass the half a million-dollar price tag.. 4. Based on a PubMed (https://www.ncbi.nlm.nih.gov/pubmed/) search using the terms: “CYTOMETRY” OR “FACS”, and “IMMUNOLOGY”. Data includes all publications until 2015 and was retrieved on Jan 17th, 2017. I. Introduction. 18.

(19) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Cytometry SRL management principles Interestingly, the great majority of the available literature on SRL for the life sciences refers mainly to flow cytometry SRLs. Due to the particular aspects of this technology, there are specific issues on SRL organization that apply to cytometry SRLs and have recently been reviewed by members of the International Society for the Advancement of Cytometry (ISAC)5 in a document published by ISAC’s flagship journal, Cytometry (Barsky et al., 2016). This document aimed at defining the minimal standards for a flow cytometry SRL and providing a sort of a manual of best practices that ultimately will provide the guidelines for the creation of a world-wide network of ISAC-recognized Centers of Excellence (Figure 7). It took the ISAC committee in charge of this document nearly two years to collect all the information by means of interviews, surveys, workshops, and open discussions during the annual ISAC congress (CYTO) and, thus, the resulting manuscript should be taken as a consensual agreement by the majority of existing SRLs across the world. The ISAC guidelines for best practice in flow cytometry SRLs include the following aspects: 1) Standard operating procedures (SOPs). SOPs are reference protocols that provide a framework to sustain best practices both in the management of the facility and the laboratory work. The aim of SOPs is to guarantee the reproducibility of frequent procedures and are especially important in SRLs manned with multiple operators. An example of such SOPs was provided as supplementary material and has been included in Appendix Figure 7. Best practices in a Cytometry SRL, according to Barsky et al, 2016.. 1. It is recommended that SOPs. 5. The mission of ISAC is “to serve a multidisciplinary community by leading technological innovation, scholarship, and the exchange of knowledge in the quantitative cell sciences” (http://isac-net.org/). ISAC publishes a scientific journal (Cytometry) on new advances and applications in the field of cytometry, as well as repository of protocols for cytometry (Current Protocols in Cytometry). In addition, ISAC organizes CYTO, a yearly congress that highlights the current trends in the field, and hosts CYTO University (CYTOU), an online portal to peer-reviewed educational material on cytometry technology and applications. I. Introduction. 19.

(20) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. should be prepared in different categories, namely, training and education (all users should receive the same information during training, including a detailed benchmark to determine when users are authorize for self-operation of instrumentation), instrument maintenance (who is responsible, of which instrument, how often, and how much), instrument quality control (who is responsible, how often, which procedure, and what are the acceptable passing criteria), biosafety (these SOPs should be approved by the institutional biosafety committee), lab policies and procedures (what are the rules of the laboratory in terms of behavior, billing, and scheduling), emergency situations, sample preparation, instrument setup and monitoring, and data management. 2) Training and education. As with the development of SOPs, an adequate training and education program is essential for the maintenance of high quality standards. Although cytometry-related educational content may already be present in existing academic programs, it is important that cytometry SRLs build a training and education program consisting of both theoretical and practical content for both, the SRL staff (for the purpose of continuous education) and the users. As much as possible, the training programs should be personalized, specially the practical aspects. An essential aspect for the success of a cytometry SRL should be keeping SRL staff up to date with the highly dynamic and quickly evolving field of cytometry. This can be achieved by encouraging enrollment of staff in cytometry certification courses6 and specialized conferences, webinars, and seminars. The topics that should be covered by the cytometry SRL education and training program should include at least the following: a. Instrumentation. The obvious technology-centered nature of the cytometry SRL calls in for a specific focus on promoting an understanding of the theoretical background of cytometry instrumentation, as well as the particularities of instrument usage (conventional operation and sample acquisition). In addition, laboratory biosafety, as well as chemical and environmental safety policies and. 6. This is a certification issued by ISAC in cooperation with the International Clinical Cytometry Society (ICCS). From spring 2017, the American Society for Clinical Pathology (ASCP) will also join this certification program (www.cytometrycertification.org). I. Introduction. 20.

(21) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. procedures associated to the use of cytometry instrumentation should be part of compulsory training programs. b. Experimental design. In order to ensure a high quality of the data acquired within the SRL, specific education should be provided on the experimental design. This should include information regarding the inclusion of controls, the capabilities of the instrumentation, as well as necessary protocols and reagents on sample preparation prior to acquisition. The education provided in this section should be consistent with the MIFlow-Cyt7 guidelines (Lee et al., 2008; Spidlen, Shooshtari, Kollmann, & Brinkman, 2011). c. Reagents. There is a wide variability in the size and composition of cytometry SRLs and some provide users access to a wet lab. For these SRLs, it should be desirable to provide users educational support in an adequate use of reagents and protocols related to sample preparation prior to acquisition. d. Laboratory safety. SRL staff and users should be protected from any kind of hazards related to the facility. The best way to prevent accidents is to include laboratory safety procedures in the education and training program. e. Data analysis. This aspect should focus on providing an adequate background information on disciplines related with the analysis of cytometry data (instrumentation, statistics, biology, and photonics) as well as practical training with the appropriate software. Obviously, adherence to MIFlowCyt guidelines should be highlighted. f. Facility policies. The goal of including facility policies in the training of new users is to help them get use with the culture of the organization, as well as preventing conflicts within the SRL. 3) Quality assurance. Proper quality assurance in cytometry SRLs should include instrument preventive and corrective maintenance. In addition, the instruments should be properly calibrated and a registration of instrument performance kept available.. 7. MIFlow-Cyt stands for minimum information about a flow cytometry experiment. These guidelines. establish the criteria to describe cytometry experiments in such detail (both the number of items and the depth of detail) that they provide sufficient information for their correct interpretation. I. Introduction. 21.

(22) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. 4) Laboratory safety. One of the issues that is often reported on shared facilities is that the mix of internal and external users that are present at the facility for only a short time makes it difficult to enforce adequate safety practices. For this purpose, best practices in the form of specific SOPs and appropriate training programs should be present to ensure a safe working environment. Regardless of specific cytometry-related rules, the SOPs should be compliant with local and national biosafety regulations. 5) Data management. The main output of cytometry SRLs is the generation of data. Therefore, long-term data preservation and access is of critical importance. Differences across institutions exist, varying from situations in which the information technology (IT) function is fully transferred to a separate-central department to SRLs that are fully responsible for data storage. Accordingly, the data management plan of the cytometry SRL should be adapted to the IT strategy of the institution. In any case, any cytometry SRL should have SOPs in place related to data collection, quality assurance, description and preservation of data files and computer maintenance for cytometry systems (Parks, 2001). In addition, data privacy strategies should be implemented when cytometry SRLs provide services for industry and patient care. 6) Staffing. This involves determining the number and qualifications of staff related to the size of the SRL, the diversity of instrumentation available at the facility and, last but not least, the strategic goals of the facility (and institutional context). Ultimately, a proper mix of individuals with sufficient diversity in terms of personality and expertise maybe crucial in achieving optimal performance in the facility. 7) Operations. Management of a cytometry SRL can be compared to running a small company. Functions such as operations oversight, strategy management, financial and fiscal management and planning, self-evaluations, and external reviews need to be considered and implemented in due time. In terms of management, it is advisable to have a qualified manager and/or director with clear roles and reporting duties, as previously described by others (Moore & Roederer, 2009). The manager/director should be invested with reasonable authority to make short- and long-term decisions regarding operations in I. Introduction. 22.

(23) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. the cytometry SRL. In addition, the work of the manager/director should be subjected to oversight and evaluation by an advisory board composed of researchers (ideally) with a bestowed interest in the proper operation of the cytometry SRL, such as frequent users (super-users), principal investigators with budget authority on the SRL, and other researchers with an institutional influence. Performance should be assessed via periodic reports containing internal and external user surveys, external core reviews, and benchmarking comparisons. The performance evaluation can be part of an extended annual review that could also include a business plan for the facility and an annual budget plan. These guidelines are a comprehensive approach to overseeing all current possibilities within the field of cytometry SRL management and constitute an excellent starting point for setting up a new cytometry SRL. However, the particularities of every institution may dramatically condition the development of the SRL management plan and should be carefully taken into consideration during the business plan development phase.. I. Introduction. 23.

(24) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. II. Objective of this Thesis As discussed in section I.B, SSCs are ideal tools for the exploitation of specialized expertise and resources across different units of an organization and contributing to reducing costs, benefit from existing excess capacity, and providing higher value to the organization. Cytometry has become a fundamental method in the life sciences that provides support and enables applications in multiple disciplines ranging from fundamental (Cell Biology), translational (Immunology) and clinical research (Hematology and Oncology). The last 10 years have witnessed an explosion in the development of both fluorescence- and mass-based detection methods that are revolutionizing the field. However, these methods are only available at very high costs that makes it impossible for individual departments to afford. Worldwide, there is a trend to move towards SRL-based scientific institutions, were cytometry SRLs take the responsibility of maintaining complex equipment and bundling the expertise to ensure that users get the best service at an affordable cost and in a financially sustainable manner for the entire organization. During the last 5 years, the department of Molecular Cell Biology & Immunology (MCBI) of the VUmc has been extremely successful in attracting several infrastructure grants that have transformed the former MCBI Technology Platform into the most advanced and complete cytometry hub of the Netherlands. With an asset value that is well beyond 3 million EUR and 2.5 FTE assigned to the operation of the facility, operational costs have raised to a level that may compromise the future of the facility. Dying from its own success is a risk that MCBI’s Technology Platform cannot afford. Furthermore, the potential for applications in multiple translational and clinical research fields, including Oncology and Neurosciences, is a value that should be exploited by as many VUmc researchers as possible. By transforming MCBI’s cytometry hub into a cytometry SRL, we will be achieving higher economies of scale that will enable us in lowering operational costs, but also achieving higher specialization that will help us deliver a higher quality service to all our users. Not only MCBI’s cytometry facility should contribute to the success of other VUmc departments by enabling high impact publications, it should also help in attracting grants, collaborations with the biopharmaceutical industry, and recruiting valuable personnel. II. Objective of this Thesis. 24.

(25) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. With these goals in mind (Figure 8), I set out to explore by means of a business plan the feasibility and potential for the establishment of a cytometry SRL that takes advantage of the existing resources and expertise currently present at MCBI. Further, the business model, as well as an operation and financial plan will be delineated to pave the way for the successful implementation of a Figure 8. Arguments for the implantation of a Cytometry SRL at the VUmc.. cytometry SRL at the VUmc.. The VUmc is living exciting times. The alliance, and future merge, with the AMC is contributing to a radical transformation of the institution that will bring the resulting organization into the spotlight as one of the biggest and most prestigious research centers in Europe. In this context of transformation, and especially in the light of the incipient genesis of a Comprehensive Immunotherapy Center, as well as the current efforts in the expansion and transformation of both Cancer Center Amsterdam (CCA) and the Neuroscience Campus Amsterdam (NCA), the creation of a network of shared research facilities should stand as an absolute priority. Besides the goal in exploring the possibilities for the much-needed founding of a cytometry SRL, this business plan will surely contribute to facilitating a similar process for other crucial facilities.. II. Objective of this Thesis. 25.

(26) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. A. Approach for the generation of a Business Plan for O2Flow There exist multiple tools that help in the generation of business plans (Creating a Business Plan, 2007; Finch, 2013; Kraaijenbrink, 2015; Osterwalder & Pigneur, 2013; Sahlman, 1997). Although they differ somewhat in the composition and order of the different elements that should be present in the business plan, this should not be a critical issue since the most important information (business description, customer value proposition, environment analysis, competitive analysis, market analysis and plan, operational plan, and financial plan) is contained in all of them. An entrepreneur writes a business plan with an audience in mind. In this particular case, the audience is mainly (but not exclusively) scientists in the life sciences. Since scientist are particularly used to abstract representation of ideas, I have chosen to follow the guidelines of the Business Model Generation Canvas (Osterwalder & Pigneur, 2013), a richly illustrated manual that place special emphasis in abstract representation of business concepts and relationships. During the last year and a half, I have served as Scientific Advisor to the Technology platform of MCBI. My goal during these months has been to use the concepts learned at the MBA-HC to transform a clearly obsolete structure into a facility that is prepared for the future challenges in an ever more collaborative environment in biomedical research. The result of these efforts (see Appendix 2 for a detailed chronology) is the birth of O2Flow, crystalized in the form of a Grand Opening Symposium on November 10th, 2016 (see Appendices 3 and 4). The present business model is, therefore, the result of the shaping of the facility during the last 18 months. Because understanding the current situation of the business is crucial to make a solid business plan, I have collected all the information on usage of the facility during 2016. Instrument usage can be measured at two time-points, when scheduling appointments or at the moment of measurement usage. Until now, scheduling has been performed with the help of Microsoft. II. Objective of this Thesis. 26.

(27) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Outlook Calendar8. Unfortunately, this application does not provide a time signature of the scheduling and allows users to delete appointments in retrospect, which could introduce a bias. Therefore, I have chosen to collect all information about usage by looking at the date and time information of all files generated during instrument acquisition. This is a tedious task which was facilitated by the writing of an R script (Ihaka & Gentleman, 1996)9 that reads the headers of all cytometry files and allows the extraction of multiple parameters. Unfortunately, every instrument generates a different file format and not all files were stored in a consistent manner, which demanded carefully double-checking and correcting of all information. A session was defined as the lapse of time between the acquisition of the first and the last sample. Obviously, this provides only actual usage and does not inform about the time that the instrument was booked, but not used. However, as discussed before, usage is the most reliable source of information not subjected to bias that we have at this moment. To investigate whether scheduling and actual usage differed significantly, I picked up an instrument and a month at random and collected both the sessions booked via Microsoft Outlook Calendars and the actual usage via the collected data files. The results of this comparison are shown below (Figure 9) and clearly indicate that users tend to schedule longer sessions than they actually need. Therefore, the information on usage shown throughout this business plan, although accurate, reveals an underestimation of the potential earnings and indicates that a rationalization process of operations is urgent. Another conclusion that can be drawn from this information is that the implementation of tools that allow both scheduling and instrument usage monitoring while collecting all information for administration purposes should be a priority. Not only it will contribute to making users aware of better adjusting the scheduling to the required usage time, it will also help making informed decisions that will affect the management of operations and the future of the facility.. 8. https://support.office.com/en-us/article/Introduction-to-the-Outlook-Calendar-bc7ce542-72a7-4bc5-8c595bb5700620e4?ui=en-US&rs=en-US&ad=US&fromAR=1 9 This was done by Jan Verhoeff. II. Objective of this Thesis. 27.

(28) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Figure 9. Comparison of reporting based on scheduling via Microsoft Outlook Calendar (Booking) vs instrument usage (Usage) for the Fortessa during June 2016. a, By applying a fee that is proportional to time, it is possible to estimate the potential earnings depending on the method used for monitoring. The potential earnings based on Booking almost doubled those of Usage. b, This was not due exclusively to cancelled sessions, since only 13 (out of 85) sessions were cancelled. c, What really made a difference was that only 4 (out of 20) customers used the instrument within a 20 % difference of the time scheduled. That is, they consistently overestimated their needs. d, A consequence of this behaviour was that the instrument was booked more often that it needed to, possibly preventing some users from accessing the instrument and creating unnecessary queues. Thus, whereas the reality was that only 2 days the instrument was being fully utilized (indicated with red bars), what users experimented was that in almost 60% of the time, they had to queue in order to have access to the instrumentation. For more information on how utilization and potential earnings were calculated, see III.B.5 and III.F.. II. Objective of this Thesis. 28.

(29) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. III. Business plan for O2Flow. A. Business description O2Flow evolves from the cytometry technology platform of the MCBI Department at the VUmc with the mission of enabling scientific discovery in fundamental and translational biomedical research by providing affordable access to state-of-the-art technologies, services, and scientific and technical expertise in flow, imaging, and mass cytometry. O2Flow will serve primarily the biomedical research community at the VUmc, but will be open to all other researchers with cytometry-related research questions in the Amsterdam area and beyond. Through the implementation of a simple, intuitive and client-oriented web-based application (Stratocore PPMS) we will facilitate scheduling of our instrumentation and services to all our customers regardless of their host organization. The same tool will automate a billing system so that charge backs can be directly applied either internally or externally without additional administrative work. An additional advantage of this tool is that it will provide realtime information on scheduling and utilization of O2Flow’s assets and help the management make decisions regarding the strategic focus of the organization. Based on estimates on the usage of O2Flow’s instrumentation during 2016, setting a strategy aiming at increasing usage per instrument by 10 % and attracting 15 % more external users will result in partial cost recovery (including salaries) already in 2018. O2Flow will provide a high value proposition to its customers not only for providing state-ofthe-art cytometry services at an affordable price and much cheaper than the competition, but also by delivering world-class scientific and technical expertise and advice to support customer’s applications, as well as facilitating training in education in cytometry, a key technology in biomedical sciences. O2Flow will lead the way for other technology platforms of the VUmc in order to constitute a world-class network of infrastructures that will set the VUmc ahead of the competition in biomedical scientific research. III. Business plan for O2Flow. 29.

(30) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. B. Business model generation 1. Customer segments SSCs typically serve internal customers within the organization. Although, this is mostly the case for O2Flow, this business plan has the ambition of also attracting external customers in order to maximize benefits and under the conditions that allowing external10 customers to have access to our facilities will not have a significant effect (in delays) to internal users. The market of cytometry facilities conforms a very specific niche defined by the applications that modern cytometers provide. A clear distinction needs to be made of whether the facility serves diagnostics purposes or exclusively research applications. In the case of facilities that provide diagnostics tests, the requirements for quality assurance are completely different and very strictly regulated (Todd, Sanchez, Garcia, Denny, & Sarzotti-Kelsoe, 2014), whereas the regulations affecting research cytometry facilities relate mainly to biosafety issues (Holmes et al., 2014). Obviously, legal regulation regarding the provision of services condition many aspects of the operations and set up of the facility. O2Flow will be serving only the research community and, thus, diagnostics-related legal regulations can be avoided. The analysis of customer segments (Figure 10) can be approached from two different perspectives. On one hand, the type of services provided, and on the other their personal and professional characteristics. Whereas the first classification can be useful in deciding what services to provide, the second may help in optimizing the services for an improved personal customer experience. According to the services provided, three customer segments can be recognized, academic research groups, the biopharmaceutical industry, and a geographically extended mixed group of customers interested in education about cytometry. Since cytometers require that cells are prepared in a liquid suspension prior to analysis, cytometry applications have classically been 10. As long as the financial implementation of this plan is not effective, the distinction between internal and external customers is as follows: Internal refers to users within MCBI and External refers to users from other departments or other organizations. This definition may change once O2Flow becomes a trans-divisional unit, closer to the definition of an SSC. III. Business plan for O2Flow. 30.

(31) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. used in research fields in which the cell of interest existed in suspension in its natural habitat. This involves mainly the fields of Immunology, Cell Biology, and Hematology. However, multiple methods have been developed over the years that allow the manipulation of normal or pathological tissues and organs to generate single cell suspensions (Dressler & Visscher, 2001). Thanks to these protocols, research in Physiology and Oncology can now benefit from cytometry applications. The added value of cytometry for these disciplines is the capacity to discriminate the expression levels of different marker on a per cell basis; which is a great advantage over other widespread technologies such as genomics and proteomics. Very recent applications now allow the analysis of tissues by mass cytometry even if the tissues have not been processed to a single cell suspension (Leelatian et al., 2016). Figure 10. Analysis of the customer segments of O2Flow according to the business model canvas generation model. For an integrated business model canvas of O2Flow, see Appendix 4.. The palette of medical disciplines that can benefit from cytometry is not restricted to the abovementioned. Cytometry helps researchers understand how blood cell subpopulations change as a consequence of physiological adaptations, disease, or any kind of treatment. Alternatively, measuring the properties of blood cell subpopulations can help identify specific cellular III. Business plan for O2Flow. 31.

(32) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. biomarkers that can help diagnose disease, provide prognostic information to medical professionals, or even predict responses to therapy. These applications may derive specifically from the analysis of blood subpopulations (Chattopadhyay, Gierahn, Roederer, & Love, 2014; Irish, 2014), but can also be enabled by the characterization of small extracellular vesicles (Kormelink et al., 2015; Maas et al., 2015), a field that has generated an enormous interest in recent years (Nolan, 2015). This possibility opens the doors of O2Flow to a bigger customer segment, namely, research groups investigating peripheral blood biomarkers and biopharmaceutical companies interested in profiling the effects of their products using minimally invasive methodologies. Cytometry applications do not restrict to the analysis of cellular subtypes frequencies and phenotypes; they also allow the sorting of these subpopulations to purity to further investigate the functional properties of the cell types of interest or dissect their molecular composition using other technologies such as genomics and proteomics. These applications may be of interest specially to those researchers focused on understanding the pathobiology of specific cell types. However, the possibility to sort cells to purity has an added value to researchers that investigate the molecular mechanisms of disease (Functional Genomics and Oncogenomics) using gene-targeting methodologies, such as the recently developed CRISPR/Cas9 system (Komor, Badran, & Liu, 2017). In addition, thanks to the concentration of knowledge on cytometry, O2Flow will be able to provide education to (potential) cytometry users at both graduate and post-graduate levels. Potential customers in this segment are local universities with biomedical Master programs (VU, VUmc, AMC, UvA, Amsterdam University College), other neighboring Dutch universities and research centers (Dutch Cancer Institute, Sanquin, LUMC, Utrecht University, Hubrecht Institute, ErasmusMC, etc), as well as research organizations (Dutch Flow Group, Dutch Immunology Association or NVVI, and the International Society for the Advancement of Cytometry or ISAC), and companies. Special mention in the latter group deserves ThermoFisher, a company that organizes a prestigious yearly meeting (CYToMORE11) and is very interested in organizing it in Amsterdam within the coming two years.. 11. https://www.thermofisher.com/nl/en/home/products-and-services/promotions/cytomo-2016.html. III. Business plan for O2Flow. 32.

(33) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. O2Flow customers can be classified according to three categories or personas (Tynan & Drayton, 1987), as illustrated in Figure 11. The most frequent user, represented by Sophie’s avatar, is generally a young PhD student or post-doc that perform scientific research in the field of immunology or cancer and within the framework of her research project. Sophie has a temporary appointment on a research project and has no budget responsibility. She is not married, lives in a small apartment in the city and has no family obligations, so often takes advantage of this to work off peak hours. She is a technology gig and can’t live without her smartphone. She values receiving quick support when she needs it, being able to run her samples when they are prepared without waiting queues, being independent, and having access to cutting edge technology that makes her feel that she is doing something unique. She uses the facility to obtain data for her presentations and articles.. Figure 11. Avatars representing the customer segments of O2Flow.. III. Business plan for O2Flow. 33.

(34) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Sophie’s supervisor, Ronald, enjoys a permanent position at the university and is worried about obtaining sufficient grants for his research. He is married, has young kids, and lives in a residential area outside the city, so his time availability at the university is reduced and needs to be very practical in terms of meetings. His goal is to do the most with the meager budget assigned to his project and he values high quality data that will make him score his next big paper on the way to better funding for his research. He appreciates having access to the latest technology in cytometry, because that sets his research ahead of competitors and helps him in obtaining grants. The final persona in the pool is August, a former professor who is now CSO of a spin-off of the university. He has a scientific background and would like to close the bridge of innovation to exploit scientific discoveries into commercial solutions. He has an entrepreneur spirit and focuses on quality and uniqueness to stay ahead of the competition. An important differentiating factor that sets apart these personas is that only Sophie has direct contact on a daily basis with O2Flow’s operators and facilities, whereas the contact of Ronald and August with O2Flow is indirect and often via the scientific advisor of the facility. The majority of O2Flow customers are geographically located in the Amsterdam Zuidas area, corresponding to scientific researchers of the VU, UvA, and VUmc that perform their work at the O2 Building, VU Campus, and CCA building. However, the location of O2Flow in a rather central area of the Netherlands, well communicated by public transportation, and the proximity to an international airport (Schiphol), expands the action radius of O2Flow to the Randstad (for analysis, sorting, and education) and Northern/Central Europe (for education). In 2016, there were 74 users registered in O2Flow, of which 33.8 % were external. There were 8 principal investigator groups registered as internal and, at least, 14 groups registered as external. A summary of the distribution of users per group, as well as their registration to each of the different instruments is provided in Table II.. III. Business plan for O2Flow. 34.

(35) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Table II. Distribution of O2Flow users per principal investigator group and per instrument. Group. User/group. ISX. Calibur. CyAn. Fortessa. MoFlo. denHaan. 4. 2. 1. 4. 4. 0. deVries. 5. 5. 0. 0. 1. 0. GarciaVallejo. 3. 2. 1. 0. 2. 0. Mebius. 8. 2. 0. 6. 6. 4. vanDie. 1. 0. 1. 0. 0. 0. vanEgmond. 9. 2. 4. 4. 7. 0. vanKooyk. 13. 5. 9. 8. 9. 4. vanVliet. 6. 0. 5. 4. 3. 3. Subtotal MCBI. 49. 18. 21. 26. 32. 11. AMC. 3. 2. 1. 0. 0. 0. Neurosciences. 1. 0. 0. 1. 1. 0. Dermatology. 1. 0. 0. 0. 1. 0. Hematology. 1. 0. 0. 0. 0. 1. Linxis. 1. 1. 1. 1. 0. 1. Liver Diseases. 1. 0. 0. 0. 0. 0. Microbiology. 1. 0. 0. 0. 0. 1. Nephrology. 1. 0. 0. 0. 0. 1. NeuroSurgery. 1. 0. 0. 0. 0. 1. Oncogenetics. 1. 1. 0. 0. 0. 1. Other. 5. 1. 1. 2. 1. 0. Pathology. 1. 1. 0. 0. 0. 0. Physiology. 4. 0. 0. 2. 2. 0. RNC. 3. 1. 2. 1. 1. 1. Subtotal External. 25. 7. 5. 8. 6. 8. Total. 74. 25. 26. 34. 38. 19. Although it seems that the number of external users is in good balance with the number of internal users (approximately 1 external user for every 2 internal users), the proportion of usage time is completely different, being internal usage time as much as 90 % of the total usage time (Figure 12), indicating that there is plenty of room to stimulate external users make more use of the facility. III. Business plan for O2Flow. 35.

(36) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Figure 12. Distribution of user groups according to instrument usage time. The pie chart shows in between brackets the percentage of usage with respect to total instrument time. The bar chart indicates the percentage of usage of each of the external groups with respect to the total external usage time.. 2. Value Propositions The mission of O2Flow is to enable scientific discovery in fundamental and translational biomedical research by providing affordable access to state-of-the-art technologies, services, and scientific and technical expertise in flow, imaging, and mass cytometry. Accordingly, the value proposition of O2Flow gravitates over three principles: - Providing access to cytometry services: O2Flow is the most complete and advanced cytometry facility in the Netherlands. As such, it provides researchers with the widest array of possibilities in terms of mass cytometry, imaging flow cytometry, and flow cytometry analysis and sorting. Thanks to our quality control program, O2Flow is able to ensure that data acquisition follows the highest standards and is compliant with current European biosafety regulations. O2Flow has a cost-recovery oriented financial management plan that guarantees the sustainability of the facility, as well as the access to emerging new technologies, ensuring that feasibility of long-term collaborations and guaranteeing that O2Flow remains equipped with state-of-the-art instrumentation. - Providing expertise and advice: The personnel of O2Flow has more than 10 years of experience working together as a team in the field of cytometry. Our collective expertise enables us to provide the highest quality of operational service in terms of data acquisition and analysis. We cooperate actively with the Analytical Chemistry facilities of MCBI, which allows us to conjugate antibodies and prepare special reagents tailored to the needs of. III. Business plan for O2Flow. 36.

(37) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. our customer’s projects. Often, preparing large antibody panels is an arduous task, requiring multiple iterations. Our long-standing expertise and knowledge on the possibilities and properties of our instruments allows us to provide our customers with the necessary advice and support during the process of panel design and optimization that results in shortening lead time till panel readiness and reducing total reagent costs. Last, but not least, we provide our customers with support in the incorporation of our state-ofthe-art facilities into grant applications, including proof of concept experiments to highlight both the possibilities and the feasibility of your project. - Providing education: O2Flow has a solid educational program on cytometry covering three types of knowledge dissemination: (i) All our customers receive an individualized training for the Figure 13. Analysis of the value proposition of O2Flow according to the business model canvas generation model. For an integrated business model canvas of O2Flow, see Appendix 4.. instruments needed in their research. This training is adapted to their experimental needs and is often. performed with their own samples. We continue to provide continuous education and support to our customers on daily acquisition and usage through continued interactions at the work floor. (ii) We provide master classes and lectures on the immunology courses provided by MCBI, including Experimental Immunology, Tumor Immunology, Immunity & III. Business plan for O2Flow. 37.

(38) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. Disease, and Advanced Immunology. In addition, we periodically invite prestigious speakers in the field of cytometry to deliver lectures on their topic of expertise (see Appendices 3 and 4). (iii) We will start providing a 3-day post-graduate course on cytometry intended for all PhD students of the VUmc, AMC, NKI, and Sanquin in the fields of Immunology and Oncology. The goal of the course will be to provide PhD students with an in-depth knowledge on the cytometry possibilities within O2Flow and how to better apply them to their own projects. Importantly, the organization of O2Flow as an SRL of the VUmc with a full integration of a cost recovery strategy allows us to provide our services at a fraction of the cost of other facilities and the guarantee of long-term sustainable operation. Also because of our financial management plan, we are able to scout for new technologies and, in this way, stay at the forefront of technological developments in the field of cytometry, so that our users will be able to take us as strategic partners for their projects. We strive for the highest quality of operation, education, and management, and this has a reflection on the prestige of our facility.. 3. Channels O2Flow approaches its customers using three channels, namely, direct marketing through a dedicated website, a platform pilot management system (PPMS), and the activities of O2Flow’s scientific advisor (acting as salesforce) and O2Flow’s associated partners (intermediary marketing channel). Table III provides a summarized analysis of the channel types and phases that each one covers. The website of O2Flow12 is hosted under the institutional website of MCBI13. The O2Flow website provides brief and basic information about the mission and goals of the facility, as well as the instruments available and their applications. There is also a link to a web page where the O2Flow team is described and a small bio is provided next to the picture of each O2Flow 12 13. https://www.vumc.nl/afdelingen/moleculairecelbiologie/technologycentermcbi/20710791/ https://www.vumc.nl/afdelingen/moleculairecelbiologie/. III. Business plan for O2Flow. 38.

(39) O2Flow, a business case for an SRL at the VUmc Juan J. Garcia Vallejo. member. Since the O2Flow website is hosted under an institutional site, a number of conditions regarding formatting apply that restrict both the lay-out and the amount of information that can be provided, as well as the lay-out. As a result, the current website, although consistent with the institutional website, is rather meager and brief, as compared to similar organizations14. Considering the importance of Figure 14 Analysis of the channels of O2Flow, according to the business model canvas generation model. For an integrated business model canvas of O2Flow, see Appendix 4.. websites in creating an image of quality of an organization and facilitating potential new customers. (Grönroos, 1984; Lin, 2007), it should be convenient to plan the commissioning of the design and implementation of an improved website. There needs to be a balance between the investment necessary for the design and maintenance of an adequate website and the expected economic return (increased number of customers). A possibility to keep costs as low as possible would be to invite companies in the field of cytometry (instruments and reagents manufacturers) to place advertisements on the website. The website’s design should match the following characteristics: -. Permanent information: o Provide the mission and vision of O2Flow, its history and future challenges. o Information on the instrumentation available, with links to applications. The link should take the viewer/potential customer to a webpage where a scientific application is discussed in the context of a research paper, ideally from a member of MCBI or a collaborator (but contributed by O2Flow).. 14. https://sydneycytometry.org.au/#. III. Business plan for O2Flow. 39.

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