Jesper Lund
email: jesper.lund@hh.se

Activities to Address Challenges in Digital Innovation

Keywords: digital innovation challenges, innovation activities, digital technology, e-newspaper, e-paper

Based on a literature review, this paper identifies four socio-technical challenges relating to innovation actor's interactions in digital innovation. Furthermore, the paper explores how these challenges can be addressed. The challenges are investigated in a case study of digital innovation. The study is based on a two year long research and development project where an e-newspaper concept and a demonstrator based on e-paper technology was developed. Based on empirical findings, the paper presents eight activities which address the identified socio-technical challenges with digital innovation. The activities are: 1) support transparent digital ecosystem relationships, 2) facilitate cross-organizational communication, 3) create digital value blueprints, 4) translate heterogeneous knowledge, 5) involve all relevant user groups, 6) identify, design for, and authenticate digital user values, 7) design for multiple contexts of use, and 8) prototype iteratively.

Introduction

Digitization of analogue products is currently changing our society [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF]. As an example, digital services based on digitization of music, TV, and voice calls have led to digital innovations such as Spotify, Netflix, and Skype. These services are widely adopted and have changed the ways users consume media and communicate via voice over IP. Digitization in this case creates value adding services for consumers who can use these digital services on multiple devices anytime and anywhere. However, digital innovation is not only providing added value to consumers. The mentioned digital innovations are also examples of how digitization creates new markets and rearranges device manufactures and content provider's roles in digital ecosystems. As such, digital innovation has a high impact on firms and entire industries. In the mentioned examples, there have been rapid and profound changes in the music and broadcasting industry, as well as for phone operators. Digital innovation as a notion refers to the embedding of digital computer and communication technology into a traditionally non-digital product [START_REF] Henfridsson | Path Creation in Digital Innovation: A Multi-Layered Dialectics Perspective[END_REF]. The notion also refers to the process of creating new combinations of digital and physical components that produce novel products or services [START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF]. Digital innovation is based on digital tech-nology. Digital technology can be categorized by layers consisting of devices, networks, services and content [START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF]. As different layers of digital technology requires different competencies, knowledge, and resources, innovation actors often need to either setup or join innovation networks to be able to succeed with digital innovation [START_REF] Van De Ven | Running in Packs to Develop Knowledge-Intensive Technologies[END_REF][START_REF] Yoo | The Role of Standards in Innovation and Diffusion of Broadband Mobile Services: The case of South Korea[END_REF][START_REF] Vanhaverbeke | Open Innovation in Value Networks[END_REF]. Given the characteristics of digital technology, digital innovation becomes networked and complex with a need for involving heterogeneous actors and resources [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Boland | Wakes of Innovation in Project Networks: The Case of Digital 3-D Representations in Architecture, Engineering and Construction[END_REF]. The layered modular characteristic, and the generativity of digital technology, pose two specific challenges for digital innovation. Firstly, it requires actors to cooperate over organizational boundaries and demands knowledge exchanges between actors with different backgrounds, competences and knowledge. In other words, digital innovations require multiple actors with knowledge and resources in the different layers of the technology to cooperate [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Powell | Networks of Innovators[END_REF][START_REF] Yoo | Unbounded Innovation With Digitalization: A Case of Digital Camera[END_REF]. Secondly, the generativity of the digital technology creates large and varied audiences with heterogeneous requirements on digital innovations [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Zittrain | The Generative Internet[END_REF][START_REF] Henfridsson | User Involvement in Developing Mobile and Temporarily Interconnected Systems[END_REF]. The combination of this added complexity, heterogeneity, and networked features of digital innovation, are challenging how we innovate successful digital technology [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Yoo | The New Wave of Digital Innovation: Opportunities and Challenges: A Report on the Research Workshop 'Digital Challenges in Innovation Research[END_REF][START_REF] Svahn | The Dual Regimes of Digital Innovation Management[END_REF].

The mentioned challenges primarily relate to the interaction, i.e. the relationships and exchanges between actors in innovation networks working with digital innovation. Several calls for research on socio-technical challenges in digital innovation can be found [see e.g. [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Boland | Wakes of Innovation in Project Networks: The Case of Digital 3-D Representations in Architecture, Engineering and Construction[END_REF][START_REF] Thomsen | Understanding ISD and Innovation through the Lens of Fragmentation[END_REF]. Much of prior research within digital innovation has been dominated by a conceptual nature [see e.g. [START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF][START_REF] Yoo | The New Wave of Digital Innovation: Opportunities and Challenges: A Report on the Research Workshop 'Digital Challenges in Innovation Research[END_REF][START_REF] Svahn | The Dual Regimes of Digital Innovation Management[END_REF]. There are few examples of empirical research on how digital innovation plays out in practice [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF]. This paper aims to address these calls for research, by firstly investigating the specific challenges relating to actor's interactions in digital innovation, and secondly, by empirically investigating activities to address these challenges. The paper is therefore structured around the following research question: What are the challenges with actors' interactions in digital innovation, and how can these be addressed? By identifying challenges with digital innovation in related literature, and presenting suggestions of activities to address these based on empirical findings, this paper primarily contributes with actionable insights to the emerging field of digital innovation.

In this paper, an example of digital innovation from the newspaper industry is used to investigate how these challenges can be addressed. E-paper technology captured the interest of the newspaper industry through revealing the possibility of a newspaper service via an e-paper device with high readability and low power consumption. The digitization of the newspaper presented several opportunities for the industry to reach new markets, and cut production and distribution costs. However, newspapers needed to team up with other actors to be able to explore the digital innovation at hand. The case of the e-newspaper, a newspaper service specifically designed for an e-paper device, illustrates the challenges with heterogeneous actors interacting in an innovation network. Several previously unconnected actors such as newspaper organizations, network providers, software companies, hardware device manufacturers, and advertising companies, had to intertwine their perspectives, business models and technological frames to realize the e-newspaper concept.

Related Literature

Digital innovations as artifacts are based on layered digital technology which can be divided into four different layers: device layer, network layer, service layer, and content layer [START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF]. These layers lay the foundation for two important separations: the separation between service and device due to re-programmability, and the separation between content and network due to homogenization of data [START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF]. Designers can combine components from different layers to create new digital innovations due to standardized interfaces. In every layer there has been an emergence of technical and practical capabilities for using that layer on a nonproprietary model that would make access easier, cheaper, and less controllable by any single actor [START_REF] Benkler | The Wealth of Networks: How Social Production Transforms Markets and Freedom[END_REF]. One effect for digital innovation as a process is that when more actors have access, they also need to collaborate in order to be able to develop digital innovations spanning across all four layers.

Layered digital technology is an example of a modular industry structure that enables independent firms to introduce innovations into established markets. Furthermore, the modularity allows the best players in each of the layers to be involved and innovate, due to users wanting innovations that mix and match components from the different layers [START_REF] Farell | Modularity, Vertical Integration, and Open Access Policies: Toward a Convergence of Antitrust and Regulation in the Internet Age[END_REF]. Hence, digital innovation built on layered digital technology often requires different actors from different fields to cooperate in innovation networks. This knowledge heterogeneity is challenging digital innovation [START_REF] Yoo | Unbounded Innovation With Digitalization: A Case of Digital Camera[END_REF]. Digital technology is also described to have a generative characteristic [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF].

Digital technology becomes more and more malleable and dynamic. This generativity enables new functionality and capabilities which can be added after a product is out on the market [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF][START_REF] Zittrain | The Generative Internet[END_REF]. This can once again be exemplified with smart phones acting as platforms for apps or the PC as a powerful adaptable machine. Apps turn smart phones and PCs into adaptable and changeable digital tools, supporting large and varied target groups and many different aspects of use. Digital innovation targeted against everyday use also leads to a change in the view of the user. The notion of a user needs to be expanded beyond users as organizational members [START_REF] Svensson | User Contribution in Innovation Processes -Reflections from a Living Lab Perspective[END_REF]. With today's digitalization, users do not solely use computing capabilities for work or organizational purposes, but they also interact with computing technologies in much broader social contexts [START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF]. As a result, user needs and requirements are often highly heterogeneous in these contexts of use [START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF][START_REF] Henfridsson | User Involvement in Developing Mobile and Temporarily Interconnected Systems[END_REF][START_REF] Svensson | User Contribution in Innovation Processes -Reflections from a Living Lab Perspective[END_REF].

Concurring with the ideas of heterogeneous digital technology and users, there is a growing acknowledgment that digital innovation is a collective achievement by many actors and stakeholders, often with different meanings and conflicting interests [START_REF] Van De Ven | Running in Packs to Develop Knowledge-Intensive Technologies[END_REF][START_REF] Yoo | The Role of Standards in Innovation and Diffusion of Broadband Mobile Services: The case of South Korea[END_REF]. As digital innovation becomes more networked, it drives a need for collaboration which spans over organizational realms [START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF]. During the last two decades there has been a shift in how innovation networks are formed and viewed by organizations. This is especially evident within technology development fields such as digital innovation [START_REF] Powell | Networks of Innovators[END_REF].

Digital innovations that are created and driven by increased heterogeneity of knowledge are redefining services and products. Digital innovation is re-organizing industries, generating new business logics, and changing business models [START_REF] Yoo | Innovation in the Digital Era: Digitization and Four Classes of Innovation Networks[END_REF]. Within fields of rapid technological development, such as digital innovation, there is a great diversity of actors. In the innovation networks formed around digital innovation, firms and universities are critical features to enable innovation capacity. One enabler of this capacity is knowledge dispersion between heterogeneous actors [START_REF] Van De Ven | The Innovation Journey[END_REF][START_REF] Powell | Networks of Innovators[END_REF]. Innovation networks provide access to diverse sources of capabilities and information, and the interaction between the actors increases the innovativeness at the individual firms. Successful interorganizational relationships therefore fuel firm innovation and growth [START_REF] Powell | Networks of Innovators[END_REF].

Innovating in a network can be viewed as a Socio-technical process [START_REF] Yoo | The New Wave of Digital Innovation: Opportunities and Challenges: A Report on the Research Workshop 'Digital Challenges in Innovation Research[END_REF]. Innovation is a social given that, "obtaining, transforming and sharing knowledge is a negotiation and sense-making process, through which an actor's identity and relationships to others are negotiated and re-defined" [19, p. 10]. Innovation processes within heterogeneous networks that involve multiple actors are complex. The complexity becomes even more evident whilst working with digitization of products and services [START_REF] Yoo | Innovation in the Digital Era: Digitization and Four Classes of Innovation Networks[END_REF]. Even so, the strategy to involve several actors in an innovation network is based on the possibilities of resource sharing and therefor, also sharing the risks. This is especially evident in fields of technological uncertainty [START_REF] Powell | Networks of Innovators[END_REF]. Social aspects, such as trust, commitment and power, needs to be facilitated in heterogeneous innovation networks as they influence the relationships between actors in innovation networks [START_REF] Svensson | Exploring Social Aspects Influence on Change in Network Relationships -A Case Study of Digital Innovation[END_REF]. Table 1 presents a summary which highlights how characteristics of digital technology challenge socio-technical aspects of digital innovation according to related literature.

Research Approach

To enable the exploration of the research question a multi-method approach was chosen [START_REF] Mingers | Multimethodology: Theory and Practice of Combining Management Science Methodologies[END_REF][START_REF] Mingers | Combining IS Research Methods: Towards a Pluralist Methodology[END_REF]. Exploratory studies are appropriate in new fields of study where little is known about a phenomenon [START_REF] Patton | Qualitative Research and Evaluation Methods[END_REF]. The use of multiple research methods is especially suitable in exploratory and explanatory studies where there is limited or crude knowledge [START_REF] Pinsonneault | Survey Research Methodology in Management Information Systems: An Assessment[END_REF]. Furthermore, a multi-method approach has the possibility to provide a wide and complete understanding of a phenomenon studied. As different research methods focus on different aspects, combining multiple methods provides a possibility for a richer understanding of a research topic [START_REF] Mingers | Combining IS Research Methods: Towards a Pluralist Methodology[END_REF]. A case study approach was selected in which a digital innovation case was studied from the perspective of challenges and activities that addressed them.

This paper is built on a two-step process. First, it summarizes socio-technical challenges in digital innovation based on a review of related literature. Secondly, it investigates a case of digital innovation to identify activities which addressed the challenges. A two year research and development project called DigiNews [ITEA 03015] was chosen. The project was active between 2004 and 2006 and included partners from Belgium, Spain, Netherlands, France and Sweden. Data concerning the project was also gathered in 2008 and 2010. The research and development consortium formed in the project consisted of several major technology firms, media houses and universities. The DigiNews project aimed at defining, architecting and demonstrating a solution for a digital newspaper (i.e. the e-newspaper). The solution included all parts needed to produce, distribute and consume digital news, i.e. all steps from publisher to reader. The project also explored ways to maximize the chances of a successful introduction to the market; this included the creation of different business plans and strategies. In this paper the project partners in DigiNews are viewed as actors in an innovation network formed around the e-newspaper.

Even though the data was not collected specifically with the intention to identify activities which addressed challenges within digital innovation, the DigiNews project was deemed suitable to do a retrospective analysis of a case of digital innovation. DigiNews was selected for this purpose due to a) the e-newspaper being an example of a digital innovation as it concerns the embedding of digital computer and communication technology into a traditionally non-digital product, and b) DigiNews enables an analysis of the process of creating new combinations of digital and physical components that produce novel products or services.

The actors involved in the innovation network are coming from several different organizations and industries incorporating a highly heterogeneous knowledge base in the network. Also, the technology used to create the e-newspaper is a valid example of layered digital technology which incorporates components on all four layers with different actors engaging in each of the layers. Also, the consumers of an e-newspaper are an example of a large, varied, and uncoordinated audience. Readers, advertisers, and newspaper staff provide a good example of heterogeneous users of digital innovation. Finally, the e-newspaper case is a contemporary and interesting example of a traditional industry in need of finding new digital innovations in order to have the ability to compete with new actors on the market, such as e.g. Google.

The data collection conducted in DigiNews is based on three different sets of data which are primarily generated from design and business model studies (see Table 2). The data from the first set concerning needs and requirements was gathered from eight workshops and ten focus group meetings. To ensure the involvement of the users and to receive the publishers domain knowledge, three different focus groups were initiated; one with users, one with advertisers, and one with newspaper designers. In the focus group sessions, concepts and prototypes of the e-newspaper were developed and evaluated iteratively.

The second data set was initiated with prototype testing during the autumn of 2005. The prototype test was designed to test different design solutions as well as to investigate user attitudes towards the e-newspaper concept. Data set 2 concluded with a real life test of the e-newspaper. Ten families were involved who tested an early version of an e-newspaper, published on an actual e-paper device (in this case the iRex iLiad) during a two week period in autumn of 2006. The real life test was designed to specifically explore pros and cons with an early version of an e-newspaper, as well as the users' preferences and intentions to adopt.

The final set of data involves seven interviews with eight respondents. The interviewees represented five newspaper actors, and two technology actors in the project. The interviews, ranging between approximately 30 and 160 minutes, were recorded and later transcribed. The interviews were built around themes such as background, learning outcomes, value networks, business models, technical and design aspects of the e-newspaper, internet and other media channels, and the influence of different technologies on the organization and management. This data set also contained documentation which mirrored the whole DigiNews project. The documentation includes project meeting minutes, agendas, preliminary and final reports, and deliverables from the project. The data also consisted of the project application, as well as some external technical reports. In this paper, data from all datasets are used to enable a retrospective analysis based on the summary of socio-technical challenges with digital innovation. However, it is primarily the interview data from dataset two and three and the documentation from dataset three, that are used to provide the foundation for the empirical case.

The transcribed interview data, as well as the documentation was analyzed as follows. A coding technique [START_REF] Miles | Qualitative Data Analysis[END_REF] was used to thematically categorize the data based on the four identified socio-technical challenges with digital innovation. In order to categorize the data, patterns were sought after and identified in the data [START_REF] Miles | Qualitative Data Analysis[END_REF]. Excerpts in the transcribed material, as well as in the documentation, were marked with assigned colors. This facilitated data categorization according to the corresponding themes. These themes were then summarized and used in the paper to illuminate empirical aspects of the four socio-technical challenges.

4

The Case of the E-Newspaper

In late 2003, an innovation network was formed in relation to a research and development project called DigiNews. At the core of the project was the e-paper technology, a new display technology with promising features.

The main advantage with e-paper technology was that it could provide users with the same reading experience as traditional paper. Compared to traditional displays such as LCD and LED displays, e-paper has a reflective display technology without back light. Most e-paper technologies have a high resolution that is comparable with the resolution used in traditional newspapers. Compared to traditional displays it was also very power efficient, as power is only required when updating the display. All in all, epaper technology was (and still is) a promising technology for industries such as newspapers or book publishers.

Based on e-paper technology, the e-newspaper concept was a possible digital innovation that could address some of the problems the newspaper industry was facing. At the time, newspapers were forced to think in new ways as most of them faced declining subscription and advertising revenues. The e-newspaper concept included two parts: the e-paper device and the e-newspaper as a service, e.g. the content published on the device. The e-newspaper supported mobility in the sense of allowing updated news anytime and anywhere, and could be seen as a digital news service published on an epaper device. A wide diffusion of this digital innovation would dramatically reduce production and distribution costs. Therefore, the e-newspaper was an interesting prospect for the newspaper industry. Moreover, there was a belief that the e-newspaper could reach new audiences, e.g. young people. The challenge for a successful launch lied within finding enough additional value for the users to choose an e-newspaper before a printed one. Another challenge with the e-newspaper innovation was that a successful launch concerned both the adoption of a device, the e-paper device, and new services [START_REF] Ihlström Eriksson | A User Centered Innovation Approach Identifying Key User Values for the E-Newspaper[END_REF].

The innovation network initially formed around DigiNews consisted of 24 actors from nine European countries representing industry, SME, research labs, and academia. The five industry actors initially involved included Philips Applied Technologies, who was responsible for developing the e-paper technology. A technology based on E-ink, one of the dominant designs of e-paper technology available. Within this group of actors several newspapers were either indirectly (via The Swedish Newspaper Publishers' Association) or directly involved. Furthermore, a large R&D unit from the British Broadcasting Corporation (BBC) was involved. The 12 SMEs that were initially involved included actors developing supporting technologies for the e-newspaper such as text-to-speak, cryptographic communication, secure and mobile payment solutions, wireless communication, display and device developers, audio and video streaming and decoding, and mobile applications. Seven academic or research lab actors were initially involved with expertise ranging from publishing systems, network communication, software and hardware development, collaborative design, interaction design, usability studies, and field studies.

Worth noting is that two perspectives were used when designing the e-newspaper concept. One perspective was more futuristic and disregarded some technical restrictions. The other perspective was used for the design of the demonstrator used in the final evaluations of the e-newspaper. Both perspectives focused on the potential of e-paper technology. However, as this technology was not fully developed when the project was initiated, there was a technological uncertainty regarding the potential of epaper. To make a distinction between the two perspectives in the case description, the "e-newspaper concept" and the "e-newspaper demonstrator" is used when applicable. If only the "e-newspaper" is referred to, the text is including both perspectives.

Modular Cooperation

The e-newspaper, based on layered digital technology, exemplifies the need to involve multiple actors to enable this particular digital innovation. Newspapers had to be involved in the content layer to produce news and stories. Also, advertisers had to be involved in this layer. Research labs, newspapers, and SMEs had to be involved in the service layer of the e-newspaper. A multitude of services were involved in the e-newspaper, ranging from secure and mobile payment solutions to location based systems and text to speak. In the e-newspaper, the device layer consisted of the e-paper device. This device included a display of e-paper and communication interfaces to distribute content to the device. Furthermore, it had memory capabilities to store content. Finally, several actors had to be involved in the network layer, both from academia and research labs as well as SMEs to investigate suitable future communication networks to be used. The e-newspaper concept was initially planned to be distributed via different media with different characteristics.

The actors came from four different levels; industry, SME, research labs, and academia. Within every level there were quite different interests, goals, perspectives, and knowledge bases that meshed up in the innovation network. For example, the interests of the research labs differed somewhat from the academic partners who had a more open agenda to what was possible to focus on in the project. There were similar differences in interests and goals when comparing industry actors with SME actors. The SMEs had quite narrow interests mapping towards their profiles and competences while the industry actors had a wider room for movement within the innovation and design process of the e-newspaper.

The different goals, and in some cases opposing interests, of the heterogeneous actors led to conflicts that had to be handled. The most apparent conflicts were between Philips, who developed the main prototype of the e-paper device, and the newspaper actors. Early on in the project, Philips presented ideas on how the e-newspaper could be produced and distributed. In these ideas they viewed themselves as a central hub where content (both ads and news) were stored in a database owned by them. Philips then planned to package the content and deliver the e-newspaper themselves out to the readers. In this scenario, newspapers were transformed to content deliverers, losing both their distribution channels and their relations to the readers as well as to the advertisers as customers. The first schematics of this e-newspaper concept made it clear that there were very different goals and interests, but also perspectives, that had to be handled in the innovation process.

The management of the project was responsible for handling the conflicting interests of the heterogeneous actors involved in the innovation network. Reviewing minutes of meeting, revealed conflicts of interest during the whole project. These conflicts challenged the collaboration and the commitment of different actors in the project. This became apparent when actors started developing solutions that were not compatible.

Reviewing the documentation, one problem with conflicting interests and collaboration issues was determined to be rooted in the power balances within the network. As the project was managed by Philips, their views and interests were dominant when deciding the focus of the innovation process of the e-newspaper demonstrator. This created problems in some of the meetings and led to commitment issues from some of the other actors. For example, newspapers did not agree on the business model proposed by Philips as it embodied a conflict of business interests. Philips did also disregard findings in the user studies which led to several identified issues during the evaluations of the e-newspaper demonstrator.

Knowledge Exchanges. Another challenge concerning heterogeneous actors is knowledge distribution. Trying to share and distribute knowledge over organizational boundaries about technical aspects, as well as business and design aspects relating to newspaper domain knowledge, were sometimes challenging. These difficulties could be seen in the discussions concerning the needs and requirements of the e-newspaper, as well as business models and value chains (for more details, see [START_REF] Ihlström Eriksson | Forming a Value Network -Analyzing the Negotiations between Actors in the E-Newspaper Case[END_REF]). Due to a difference in work culture and tradition, the newspaper industry and the consumer electronic industry had a hard time communicating, sharing knowledge, and overall fully understanding each other's perspectives.

The example of researchers disseminating users' needs and requirements as design and usability guidelines could also be used to explain challenges in relation to knowledge distribution. When researchers provided input to the design of both the epaper device, as well as the e-newspaper service, much of it was disregarded or not deemed as important by the developers. Based on these examples, it appeared that it was indeed challenging to share knowledge and learn from each other in a network with heterogeneous actors. Finally, the last challenges identified concerned alignment of interests between the actors involved. It seemed as if it was hard for the involved industries to sometimes move away from existing paths and to think in new ways. To enable the realization of the digital innovation at hand, an alignment of interests between actors involved in the different layers of the technology seemed to be necessary. This could be seen in the occasionally rigid ways that both the consumer electronic and the newspaper actors looked at their products and services. This can be traced in both interviews and minutes where existing business models were most often discussed as role models for the e-newspaper. This lack of alignment in interest between technology developers and the newspapers were in retrospect hindering the development of the e-newspaper concept.

Diverse Consumer Groups

Viewing the e-newspaper from the challenges related to diverse consumer groups, the following empirical observations can be made. The e-newspaper is an example of a digital innovation that is targeted towards everyday use. As such, it is a mundane artifact targeted towards a wide group of users. The newspaper industry did not want to limit their target group to the people that already read traditional newspapers on a daily basis. They wanted to also reach new target groups and offer a digital innovation that could be widely adapted and possibly replace the traditional newspaper. As such, the digitization of the newspaper led to that a more heterogeneous user group of readers was targeted.

It was not only the market aspect of the e-newspaper that led to heterogeneous user groups. The context of use for the e-newspaper was also wide. Something that led to this was that new needs and requirements were identified compared to the traditional newspaper. Mobility was identified as an important value of the e-newspaper concept during workshops that were conducted with readers and newspaper staff, as well as in the testing and evaluation of the e-newspaper. This value included portability, e.g. the possibility to bring the e-newspaper with you while commuting or traveling. Accessibility and updates were other identified aspects important for the e-newspaper concept, e.g. to be able to always access and get updated content. Localization was also identified as an aspect of mobility which included contextualized content (e.g. ads and news). Even if portability is something that relates to a traditional newspaper as well, localization together with accessibility and updates are not (for more details, see [START_REF] Ihlström Eriksson | A User Centered Innovation Approach Identifying Key User Values for the E-Newspaper[END_REF][START_REF] Åkesson | Designing and Evaluating the Calm Electronic Newspaper[END_REF]).

Finally, a challenge for the e-newspaper realization was the willingness to change within the different user groups. In the design, test and evaluation of the e-newspaper it became evident that all three user groups had to have their needs and requirements met in order to be willing to adopt an e-newspaper. For some readers, an e-newspaper would in most cases lead to new reading habits. This was appreciated in some cases, in others not (for more details, see [START_REF] Ihlström Eriksson | A User Centered Innovation Approach Identifying Key User Values for the E-Newspaper[END_REF]). Again, the heterogeneity of the readers meant that the design had to be very flexible and adaptable. At the same time, the newspaper staff and advertisers heterogeneity challenged the design process to incorporate a very wide set of needs and requirements.

Heterogeneous User Requirements. These aspects of the e-newspaper, together with a heterogeneous user group, did challenge the design process of this particular digital innovation. From a user perspective, the heterogeneous needs and requirements led to several design challenges. These concerned, for example, creating a design that retained the traditional newspaper feel (to satisfy existing readers habits) while simultaneously having features that would attract a young target group (for more details, see [START_REF] Åkesson | Designing and Evaluating the Calm Electronic Newspaper[END_REF]). In addition to this, the different contexts of use meant that a flexible and adaptable service had to be designed. A service that not only included delivering updated and context aware news, but also ads that were targeted to the right group of users, as well as to the right time and location.

As the e-newspaper had to meet heterogeneous requirements and needs, both the device and the service had to be flexible and adaptable. Even so, the e-newspaper was not designed to be generative and malleable, it was deemed to have to provide tangible user values for the readers. Not only the readers of the e-newspaper were heterogeneous, but also the advertisers as well as newspaper staff could be classified as heterogeneous users. These users all had very different purposes of using an e-newspaper (and the backbone publishing system). The design of the e-newspaper had to be able to handle a wide set of different types of ads supporting needs and requirements of advertisers ranging from small businesses to large national businesses. From a newspaper staff perspective, the e-newspaper had to provide an interface to existing publishing systems which were quite diverse. Furthermore, the editing of an article was restricted based on the technical properties of the e-newspaper demonstrator. The design therefore had to handle the different type of journalists' and newspaper designers' requirements.

To be able to handle the heterogeneous user needs and requirements, a user centered design process was planned and carried out in DigiNews. By including all identified user groups in the design of the e-newspaper concept, a complex set of needs and requirements were identified. To be able to handle these, focus groups were created to both design and evaluate the evolving e-newspaper concept. However, as one of the industry actors of the network did not prioritize the findings, the e-newspaper demonstrator used to test the e-newspaper was not fully aligned with the identified user needs and requirements. Several issues influencing adoption became evident and were identified in the final evaluation of the e-newspaper demonstrator (for more details, see [START_REF] Ihlström Eriksson | A User Centered Innovation Approach Identifying Key User Values for the E-Newspaper[END_REF]).

Discussion and Conclusion

The DigiNews case illustrates all four identified challenges and also illuminates some activities which can address these challenges. These suggested activities are discussed below and summarized in Table 3.

Modular Cooperation

As shown in this case, different layers of the modular technology required actors with diverse knowledge bases and interests to cooperate in DigiNews. As a result, the digital innovation process became complex and networked. This is similarly described in the related literature [START_REF] Benkler | The Wealth of Networks: How Social Production Transforms Markets and Freedom[END_REF][START_REF] Farell | Modularity, Vertical Integration, and Open Access Policies: Toward a Convergence of Antitrust and Regulation in the Internet Age[END_REF][START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF][START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF][START_REF] Van De Ven | Running in Packs to Develop Knowledge-Intensive Technologies[END_REF][START_REF] Yoo | The Role of Standards in Innovation and Diffusion of Broadband Mobile Services: The case of South Korea[END_REF].

In the e-newspaper case, there were several instances of conflicting interests between different levels of actors. It was rather hard for the involved actors to move away from existing paths of innovation, and align their interests with each other in order to find new value chains and business models. In hindsight, it seems like problems relating to alignment of interest, e.g. to find new ways of collaborating and being flexible by meeting half way in order to be able to act on identified user values, might be one of the reasons behind the initial problems with the e-newspaper innovation.

Another challenge in the modular cooperation was related to the conflicts that arose during the case. Some of the conflicts could be traced to the different cultures and backgrounds of the actors. The different backgrounds and cultures, as well as different knowledge basis, challenged the collaboration on several occasions in DigiNews. Some of the reasons for these challenges probably relate back to conflicting interests.

A way to address these challenges could be to create more transparent processes. If the innovation actors are explicit regarding their goals, interests, and agendas during the initiation of a network, some of the problems identified in the case would have been solved. Based on the DigiNews case, it becomes apparent that there needs to be activities which can facilitate the communication and collaboration between the heterogeneous actors involved in digital ecosystems. The activities need to create relationships and involve relevant actors to enable both the development and implementation of digital innovations. One way to handle conflicting interests, conflicts and power balances could be to conduct activities which create and communicate a blueprint for the value network in a digital ecosystem. Such a blueprint would illuminate different actors' roles in both the development as well as the implementation of a digital innovation and could therefore be used to explicitly address actors' interests and roles in an ecosystem.

Based on these insights, the following three activities are suggested to meet the challenge of modular cooperation in digital innovation: a) support transparent digital ecosystem relationships, b) facilitate cross-organizational communication, and c) create digital value blueprints. Knowledge Exchanges. Knowledge needs to be shared and dispersed between heterogeneous actors in order to support a digital innovation process [START_REF] Van De Ven | The Innovation Journey[END_REF][START_REF] Yoo | Innovation in the Digital Era: Digitization and Four Classes of Innovation Networks[END_REF][START_REF] Powell | Networks of Innovators[END_REF][START_REF] Yoo | Unbounded Innovation With Digitalization: A Case of Digital Camera[END_REF]. The literature highlights some challenges, e.g. how to manage the heterogeneity of ITknowledge resources when working with digital innovation [START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF]. Scholars also write about how innovation capacity is enabled by knowledge dispersion [START_REF] Powell | Networks of Innovators[END_REF]. In DigiNews, different knowledge bases challenged communication and knowledge sharing within the network. There seemed to be a need for facilitating knowledge sharing between actors, and finding objects that could be used to communicate over knowledge boundaries.

In digital innovation, there needs to be knowledge transfer activities which are organized in way that support exchanges between actors with different knowledge, agendas and innovation trajectories [START_REF] Boland | Wakes of Innovation in Project Networks: The Case of Digital 3-D Representations in Architecture, Engineering and Construction[END_REF]. In DigiNews, this was done by setting up workshops with different actors to ideate and transfer knowledge and perspectives between the involved actors. These knowledge transfers were primarily done from users to researchers, and from researchers to the developers. The researchers translated findings from the user studies into personas, user scenarios, mock-ups, prototypes, and requirement documents to enable a knowledge transfer between user groups and technology developing actors. As such, these translations of knowledge activities helped disperse and exchange knowledge between the heterogeneous actors involved in the innovation network.

Based on these findings, the following activity is suggested to meet the challenge of knowledge exchanges in digital innovation: translate heterogeneous knowledge.

Diverse Consumer Groups

Generativity of digital technology makes digital innovations malleable and adaptable. This generativity leads to large, diverse, and uncoordinated user groups and markets [START_REF] Yoo | Organizing for Innovation in the Digitized World[END_REF][START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF][START_REF] Yoo | Research Commentary -The New Organizing Logic Of Digital Innovation: An Agenda For Information Systems Research[END_REF][START_REF] Zittrain | The Generative Internet[END_REF]. Diverse consumer groups have several implications for digital innovation processes, one of these is the variety of contexts of use. Having a variety of contexts of use requires flexible and adaptable digital devices and services that are malleable. This is both a design and a technical challenge that needs to be addressed when working with digital innovations targeted towards everyday use. The generativity of digital technology needs to be incorporated in the design of both devices and services to support large and varied user groups. In DigiNews, the e-paper device and its technical backbone did not open up for third party apps like e.g. today's smartphones. As the e-newspaper bundled hardware and service, technical and usability limitations in the e-paper device might have inhibited the adoption of the first versions of the e-newspaper. Today, numerous newspaper services exist for different tablets and these services are in most cases not coupled with hardware devices.

Besides different contexts of use, the e-newspaper presented the diverse user groups with different values. In DigiNews, readers, newspaper staff and advertisers all had different purposes and the e-newspaper provided different kinds of user value depending on use group. The added value for the different groups of users had to be acknowledged and designed for. Again, this was handled in DigiNews by actively involving all of the users in the design and innovation process. However, the diverse user groups also required activities that investigated user value, designed for this value, and authenticated the value in real life evaluations.

Based on these insights, the following three activities are suggested to meet the challenge of diverse consumer groups in digital innovation: a) involve all relevant user groups, b) identify, design for, and authenticate digital user values, and c) design for multiple contexts of use. These activities also relate to the last identified socio-technical challenge with digital innovation, heterogeneous user requirements.

Heterogeneous User Requirements. Large, diverse, and uncoordinated audiences of digital innovations lead to heterogeneous user requirements [START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF][START_REF] Henfridsson | User Involvement in Developing Mobile and Temporarily Interconnected Systems[END_REF][START_REF] Svensson | User Contribution in Innovation Processes -Reflections from a Living Lab Perspective[END_REF]. In the case of DigiNews, the e-newspaper product with accompanying services aimed to replace the traditional newspaper. However, when digitizing a mundane product as the newspaper, there was a need to involve a very wide and heterogeneous base of users. Examples of users involved were readers, advertisers, and newspaper staff.

Heterogeneous user requirements and needs resulted in difficulties in the design and innovation process of the e-newspaper. The digital innovation process of the e-newspaper included a user centered approach to handle the challenge of heterogeneous needs and requirements. The process aimed at involving all the different user perspectives and therefore readers, newspaper staff and advertisers were all included. However, this approach was time consuming and expensive. Therefore, there still seems to be a need to find methods and techniques that can identify heterogeneous users' needs and requirements, and package these in communicable ways. In DigiNews this was done by prototyping and iterative testing, which led to guidelines for the design of the e-newspaper complemented with the rationale for every guideline.

Based on these findings, the following activity is suggested to meet the challenge of heterogeneous user requirements in digital innovation: prototype iteratively.

In conclusion, Table 3 summarizes a set of activities, originating from the empirical findings, which aim to address the identified challenges in digital innovation. Based on these findings, future studies are suggested to further investigate how digital innovation can be orchestrated to address socio-technical challenges in digital ecosystems. This paper could then be regarded as a first stepping stone for these investigations. Design flexible and adaptable digital devices and services that are malleable.

Heterogeneous user requirements

Prototype iteratively

Iterative prototyping can be efficient to identify and evaluate heterogeneous user requirements.

Table 1 .

 1 Socio-technical challenges with digital innovation

	Challenge	Description	Reference
	1. Modular co-	Modular layers of digital technology	2, 4, 5, 6, 16, 17
	operation	enable digital innovation. Different
		layers require actors with diverse
		knowledge bases to co-operate in
		innovation networks. As a result,
		digital innovation processes become
		complex and networked.
	1.1 Knowledge	Knowledge between heterogeneous	9, 10, 19, 20
	exchanges	actors needs to be dispersed to enable
		innovation capacity. The translation
		and exchange of knowledge between
		heterogeneous actors is challenging.
	2. Diverse	Generativity of digital technology	1, 2, 4, 11
	consumer groups	enables adaptability of a digital
		innovation after it is implemented.
		This generativity leads to large,
		diverse, and uncoordinated user
		groups and markets.
	2.1 Heterogeneous	Large, diverse, and uncoordinated	2, 12, 18
	user requirements	audiences of digital innovations lead
		to multiple use contexts and
		heterogeneous user requirements.

Table 2 .

 2 Overview of data collection

Data collection No. of respondents Type of data Data set 1

		Needs and requirements	54	8 future workshops and 10
				focus group meetings
	Data set 2	Prototype testing Real life evaluation	36 12	Observation, interview, questionnaire Online diary, questionnaires, interviews
	Data set 3	Interviews Documentation	8 -	Interviews with newspaper and technology actors Reports, agendas, minutes from
				meetings

Table 3 .

 3 Activities to address socio-technical challenges in digital innovation

	Challenge	Suggested activity		Description
	1. Modular co-	Support transparent digital	Create transparent relationships
	operation	ecosystem relationships	to illuminate actors' initial
			goals, interests, and agendas in
			digital ecosystems.
		Facilitate cross-	Facilitate the communication
		organizational	and collaboration between the
		communication	heterogeneous actors involved
			in innovation networks.
		Create digital value	Create and communicate a
		blueprints	blueprint for the value network
			in	a	digital	ecosystem
			illuminating different actors'
			role in a digital innovation.


Tony Cornford
email: t.cornford@lse.ac.uk

Valentina Lichtner
email: v.lichtner@leeds.ac.uk

Digital Drugs: An Anatomy of New Medicines

Keywords: pharmaceutical preparations, individualized medicine, digital drugs, healthcare, assemblage

de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.

Introduction

Anatomy: 1. The art of studying the different parts of any organized body, to discover their situation, structure, and economy; dissection.

[…] 4. The act of dividing anything, corporeal or intellectual, for the purpose of examining its parts; analysis; as, the anatomy of a discourse. (http://en.wiktionary.org/wiki/anatomy)

Medicines 1 and the ways we use and regulate them are changing, transformed by digitalization [START_REF] Yoo | Computing in Everyday Life: A Call for Research on Experiential Computing[END_REF]. This reconfiguration is associated with visions of scientific, therapeutic, managerial and financial breakthroughs from 'better' medicines and in particular 'better' digitally mediated medicine use practices. Expectations include: help in meeting the needs of aging populations with multiple chronic diseases, the targeting of medicines to individuals (personalization) to significantly increase efficacy and reduce overall cost, and computerized clinical decision support that can reduce the burden of harm caused by adverse drug events (ADEs). The pharma industry too is reconfiguring as it faces increasing competition from 'generics', reductions in the pipeline of new medicines entering the market and the 'patent cliff' off which large pharma companies fear to fall [START_REF]Pharma 2020: The Vision -Which Path Will You Take[END_REF][START_REF] Goozner | The $800 Million Pill -The Truth behind the Cost of New Drugs[END_REF]. Such pressures spur changes in how current drugs are marketed, distributed and paid for [START_REF]OFT: Medicines Distribution: An OFT Market Study[END_REF]. Pharmaceutical business models are realigned to build new relations between patients, health care institutions and the pharma industry, with drug products enmeshed in or recast as a set of services, and with payment (pricing/reimbursement) shifting from the 'product' to outcomes. The digitalization of medicines is reflected in a number of overlapping areas of contemporary research and development including electronic prescribing, stratified medicine, personalized medicine, smart drug platforms, medical profiling, pharmacovigilance, value based pricing and pharmacogenomics (Table 1). The specifics of the "The utilisation of electronic systems to facilitate and enhance the communication of a prescription or medicine order, aiding the choice, administration and supply of a medicine through knowledge and decision support and providing a robust audit trail for the entire medicines use process." (Connecting for Health, quoted in [START_REF] Cornford | Learning Lessons from Electronic Prescribing Implementations in Secondary Care[END_REF]) On DSS, see also: [START_REF] Shoenbill | Genetic Data and Electronic Health Records: A Discussion of Ethical, Logistical and Technological Considerations[END_REF]. For an example of the application of DSS and EP in personalized medicine see: [START_REF] Bell | Development and Use of Active Clinical Decision Support for Preemptive Pharmacogenomics[END_REF] Decision support; error reduction; contributing to electronic patient record and Big Data repositories.

Stratified medicine (SM)

"Refers to the targeting of treatments (including pharmacological and non-pharmacological interventions) according to the biological or risk characteristics shared by subgroups of patients." [START_REF] Hingorani | Prognosis Research Strategy (PROGRESS) 4: Stratified Medicine Research[END_REF] See also: [START_REF] Hamburg | The Path to Personalized Medicine[END_REF] Often combined with, or used as synonym for Personalized medicine (PM) "Targeting therapy and making the best decisions for groups of similar patients"; finding those who benefit most (or face greater risk), finding those who respond to this treatment.

Personalized medicine (PM)

"An emerging practice of medicine that uses an individual's genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease. Knowledge of a patient's genetic profile can help doctors select the proper medication or therapy and administer it using the proper dose or regime" (National Human Genome Research Institute, cited in [START_REF] Shoenbill | Genetic Data and Electronic Health Records: A Discussion of Ethical, Logistical and Technological Considerations[END_REF]). See also: [START_REF] Schleidgen | What Is Personalized Medicine: Sharpening a Vague Term Based on a Systematic Literature Review[END_REF] Targeting therapy and making the best decisions for a specific patient, on the basis of how the body will respond to treatment; selecting the right/best therapy on the basis of the patient's 'omics' and expected response to active ingredient(s).

Smart Drug Platforms (SDP)

"The same pharmaceuticals you take today, with one small change: each pill [contains] a tiny sensor that can communicate, via a digital health feedback system, vital information about medication-taking behaviors and body's response" (paraphrased from [START_REF]Proteus Digital Health: Digital Medicines -Shifting the Care Paradigm[END_REF]). Also seen in wearable devices often linked to mobile phone e.g. Apple HealthKit.

Smart pills, smart patches (e.g. [START_REF]Proteus Digital Health: Digital Health Feedback System[END_REF]). Devices and platforms for data acquisition and analysis. Tight feedback on medicines as released in the body.

Medical profiling (MP)

The process of determining a patient's 'omics' (a person's characteristics in terms of molecular components and biological pathways, such as genes, transcriptomic, proteomic, metabolomic, and autoantibody) for purposes of PM or SM [START_REF] Chen | Personal Omics Profiling Reveals Dynamic Molecular and Medical Phenotypes[END_REF]. See also: [START_REF]Bioethics: Medical Profiling and Online Medicine: The Ethics of 'Personalised Healthcare' in a Consumer Age[END_REF] Informing SM categorizations and PM therapeutic decisions.

Value based pricing (VBP)

Payment to drug suppliers on the basis of the therapeutic benefit achieved. [START_REF] Buntin | Health Information Technology: Laying The Infrastructure For National Health Reform[END_REF][START_REF] Vargo | Evolving to a New Dominant Logic for Marketing[END_REF] Linking outcome data at patient level to payment; rebalance risk/reward

Pharmacovigilance (PV)

The assessment of the public health importance of potential new signals found in medicines-use data (e.g. adverse drug reactions) and the confirmation and quantification of risks identified and risk minimization measures (paraphrased from [START_REF]Medicines and Healthcare Products Regulatory Agency: Pharmacovigilance -How We Monitor the Safety of Medicines[END_REF]). For an example of use of digital sources (e.g. social media) for this purpose, see [START_REF] Freifeld | Digital Drug Safety Surveillance: Monitoring Pharmaceutical Products in Twitter[END_REF] Adverse event reporting systems, population scale outcomes data via EHR; prospective analysis.

Pharmacogenetics (PG)

"Examines inherited or acquired variations in genes that dictate drug response, disposition, or toxicity and explores how these variations can be used to optimize medication therapy." [START_REF] Goldspiel | Integrating Pharmacogenetic Information and Clinical Decision Support into the Electronic Health Record[END_REF] Similar to PM and MP, but specific to genetic profile and pharmaceutical therapy. Genomics and genomic profiling; epidemiological resources.

Anti-counterfeiting (AC)

Falsified medicines are fake medicines that pass themselves off as real, authorized medicines. Falsified medicines may: contain ingredients of low quality or in the wrong doses; be deliberately and fraudulently mislabeled with respect to their identity or source; have fake packaging, the wrong ingredients, or low levels of the active ingredients (paraphrased from European Medicines Agency web site). See also: [START_REF] Almuzaini | Substandard and Counterfeit Medicines: A Systematic Review of the Literature[END_REF] Supply chain integration (bar codes, security codes; tamper proof packaging); consumer services (website seals/logos) and digital services.

Origins and Character of Digital Drugs

Medicines have always been hybrids (actor networks) -in part biochemical actor (active molecule(s)), in part material delivery system (pill, infusion, suppository, box, leaflet, cold chain), in part informational resources (representations and scripts to validate therapeutics and designate safe and appropriate use). And all bound up with complex and diverse social, scientific and economic interests and practices. However, the examples in Table 1 suggest that contemporary medicines in use become more materially, informationally and algorithmically complex, e.g. more digitally potent. We identify these as digital drugs 2 -that is:

2 There is a possibility that something like a clinical medicine might emerge and be administered in a form that is essentially a pure digital phenomenon, e.g. an abstract 'program' of biochemical action to be compiled, 'downloaded' and 'run' in the body. More simply, a therapy such as a gym routine might be seen this way. For example the UK NHS 'Couch to 5K' is a therapy embodied in podcast downloads for achieving basic fitness through running [START_REF]NHS Choices: Couch to 5K[END_REF].

A Google search of 'digital drugs' will also give information on possible audio-based psychotropic recreational drugs -so called 'digital highs'. In the sense that music can change your mood, perhaps even suppress pain, this is plausible. However, the general professional opinion is that the technology of 'binaural beats' is an interesting sensory phenomenon but psychotropically ineffective and that those who do get high are experiencing at best a placebo effect [START_REF] Connolly | Can 'Digital Drugs' Get You High? BBC News[END_REF].

drugs that are both dependent on and substantially constituted by multiple digital representations and connections, and whose use and effectiveness is strongly mediated through digital means.

The lens we use to study digital drugs is assemblage [START_REF] Marcus | Assemblage. Theory[END_REF] -drugs as performed bundles of artefacts, interests and practices that connect and interact with wider wholes, including clinical work (use), research practices that validate utility/value and mitigate/metricate risk (clinical trials, systematic reviews, pharmacovigilance) and regulatory frameworks to guide practice (regulations, protocols and guidelines).

In using the concept of assemblage we follow the broadly Deleuzian approach [START_REF] Marcus | Assemblage. Theory[END_REF][START_REF] De Landa | Intensive Science and Virtual Philosophy[END_REF]. Assemblage signifies digital drugs as events and conjunctions in time and sources of qualitative difference (something happening, some things entangled, something noticed, something different, a process or processes at work, an enactment). In the Deleuzian vocabulary an assemblage is rhizomic, a question of emergence (emergent properties, generativity) in open systems -"the always-emergent conditions of the present" [START_REF] Marcus | Assemblage. Theory[END_REF]. An assemblage is not then a 'thing' (as in a network), with specific life-span or essence. Rather, assemblage is understood in a metaphysics in which "the concept of multiplicity replaces that of substance, event replaces essence and virtuality replaces possibility" [START_REF] Smith | Gilles Deleuze[END_REF]. This implies actions and performance of complex and multiple causality/functional interdependencies (e.g. as a medicine is found in a body or bodies, modeled in a genomic profile, supplied, or prescribed), and is not tied to a fixed format or a single unambiguous event or outcome. This is in contrast to the term hybrid used here to refer to the (digital) drug as artefact and actor, including its mix of material/digital resources and its evolved sociomaterial agency. We might say that assemblage is a concept applied to the 'instantiation' of the drug hybrid in use -the 'here and now' in a context (including in virtual contexts and in simulations).

We approach digital drugs by opposing the concept to its non-digital or pre-digital i.e. analogue version. The generations of medicines within our established regulatory structures, including the post-Thalidomide medicines, are essentially analogue drugsseen as organic artefacts operating in an organic world of the body. Norbert Wiener, commenting on the probabilistic world of quantum mechanics, notes "the recognition of a fundamental element of chance in the texture of the universe" [26, p. 11]. In this sense anything analogue/organic is incomplete and uncertain ("...this random element, this organic incompleteness" [26, p. 11]). This 'incompleteness' certainly applies to medicines and their use. We are used to (or resigned to) the 'quantum' effect in medicines even as we strive for a stronger and stronger evidence base and thus certainty. Indeed the quantum is rather large given that most drugs prescribed to people do not work as desired most of the time 3 . Contemporary moves to digitize medicines may be seen as an attempt at closing down 'this organic incompleteness' within a digital certainty -e.g. through stratified medicine, genomics etc. as well as anti-counterfeiting systems or pharmacovigilance. It is tempting to imagine, as some proponents of these approaches do, that the shift to digital will drive down the quantum effect as it opens access to mechanisms that can validate actions and reduce error terms by orders of magnitude. This is not our position. Through the concept of assemblage, we argue, the quantum of the digital is made apparent, seen for example, in the simulated or more generally in the multiplicities that digital ontology accommodates.

Yoo's definition of digitalization recognizes this transition from analog to digital as fundamental: "the encoding of analog information into a digital format and the possible subsequent reconfigurations of the socio-technical context of production and consumption of [the associated] products and services" [29, p. 137]. He proposes that such digitalization occurs in various ways: at the level of a physical object (e.g. a digital infusion pump in place of an analog gravity infusion roller clamp; a 3D tamper proof bar code on a package), at the level of digital/digitally mediated routines (a digital algorithm for prescribing; a smart phone app to raise adherence to therapy), or as new representations (a genomic account of personalized efficacy; a digital information resource on drugdrug interactions driven by massive electronic health records databases).

Any division between a digital drug (and digital quantum) and an analogue drug (and organic quantum) is not of course clear cut. Transitions occur over years as existing resources are reconfigured in digital forms and new resources added or retro-fitted. Our argument is, however, that as more of the active work we expect medicines to do (their agency) is (co)located in the digital, as digital resources and mechanisms are added and combined, and as this agency (re-)aligns to specific interests and goals, be they therapeutic, social or economic, then the nature of what a drug is, and how a medicine of medicines is practiced, 'tips' and something distinct and new emerges -a different kind of drug, a different set of practices, different assemblages. This in turn implies, we argue, new social, organizational and market structures.

Thus, as Yoo's definition of digitalization suggests and as assemblage requires, our interest is not focused ultimately on the digitizing of the information/object or the new digital routines or new representations, significant though these are -and of course we do need to consider the specific characteristics of digital products and services (as products/artefacts and as representations/services) and the 'bit string' economics that they obey [START_REF] Quah | Digital Goods and the New Economy[END_REF]. But it is the 'subsequent reconfigurations' that are foreshadowed as seen in events and actions that we explore.

Three Domains: (In-)Use, Research, Governance

We approach digital drugs as assemblage from the perspective of three traditional domains in which they are by convention 'assembled' and within which issues of their value are addressed. These are the domain of clinical and therapeutic use, the domain of reflexive enquiry and research (gathering of 'evidence', knowing), and the domain of regulation and governance. These three domains are well established, each with its own practices and an established role/narrative as how we benefit (or not) from medicines. We do not consider here the biochemical domain, important though it is. These domains are of course interlinked, and one of the characteristics of medicines digitization is that these domains connect more and more e.g. events/assemblages are larger, stronger, richer, and more dynamic.

In-Use

As suggested above, digital drugs emerge in part out of efforts to computerize existing medicines use practices (prescribing, supply, administration, adherence, etc.) and in this way 'digitalize the object' with consequential ontological changes. Since the turn of the millennium it has been a key ambition of developed country health care policies to computerize prescribing in both primary care and secondary care and specifically to exploit the benefits of clinical decision support systems (CDSS) in helping prescribers select the right medicine for the patient, and to do so on the basis of a (digital) medical record (e.g. providing clinical data including in areas such as allergies), and data on recommended therapeutic strategies, available medicines, cost/cost effectiveness, and the effects of interaction among them (e.g. [START_REF] Blumenthal | The "Meaningful Use" Regulation for Electronic Health Records[END_REF]). Similarly in the administration of medicines to or by patients, technological systems and devices such as smart pill boxes or text alerts are deployed to encourage or enforce adherence and record actual use [START_REF] Dixon | An Informatics Approach to Medication Adherence Assessment and Improvement Using Clinical, Billing, and Patient-Entered Data[END_REF]. Much of this work has necessarily been piecemeal (perhaps better described as 'targeted') as specific clinical practices and operational needs have been given computer 'support' (prescribing, dispensing, supply, administration, audit, 'academic detailing', phamacovigilance, etc.). CDSS are also understood as a necessary technological infrastructure, a necessary representation, without which a widespread application of personalized medicine cannot be contemplated [START_REF] Kawamoto | A National Clinical Decision Support Infrastructure to Enable the Widespread and Consistent Practice of Genomic and Personalized Medicine[END_REF], e.g. to enable the use in clinical practice of the 2500 genetic tests now already available [START_REF] Shoenbill | Genetic Data and Electronic Health Records: A Discussion of Ethical, Logistical and Technological Considerations[END_REF][START_REF] Welch | Clinical Decision Support for Genetically Guided Personalized Medicine: A Systematic Review[END_REF]. The potential therapeutic value and/or service value that motivate such projects include improved safety and reduction in errors and harm, more consistency of (good) practice, more efficient operations with less waste, and better documented therapy. In this way initiatives to computerize medicines-use are by convention set against the familiar litany of contemporary existential health care problems: rising health care costs, unacceptable error rates and the harm they cause, demographic change, managing a growing burden of treatable chronic disease. Ambitions of progress in these areas are predicated on the existence of good informational infrastructures that represent valid forms of data (e.g. [START_REF] Buntin | Health Information Technology: Laying The Infrastructure For National Health Reform[END_REF]). Many of these ambitions have not yet been fully met but the quality, coverage and scale of data infrastructures improves over time.

More system-focused policy motives reflect a desire for more net value (i.e. more health benefit and less harm) and value for money out of budgets for medicines. In the English NHS about 50 million population generate a yearly drugs bill of about £12bn. This leads to a perceived need to exploit digital technologies both to help control this significant line of expenditure and to increase the effectiveness of what is spent in improving health outcomes. Models of the use of digital drugs and their regulation are founded on ideas of digital systems for establishing efficacy, expressing protocols and in the realization of individual patient's care pathways. This approach to medicines and their use is portrayed as offering a 'personalized' (or stratified) service (or services) wrapped around the medicine. Perhaps most significantly, the personalization process -the process to match your genetics and medical history, test results and other 'omics' 4 to what is known about medicines and therapy -becomes a separate institutional endeavor. Thus a new industry of 'diagnostics' has emerged (with economic value) which serves through devices, tests, data analysis and protocols to control and target therapy choice and therapy delivery -generating a trajectory of events. This is an arena of practice in which the balance of business interests and clinical or public health interests is today unclear. More generally the development of an industry and services for diagnostics can be seen as an example of a 'service-dominant logic' (servitisation) [START_REF] Vargo | Evolving to a New Dominant Logic for Marketing[END_REF] as a drug becomes less a standard product, and is more performed by a complex set of value generating services (value here being taken in multiple senses of the word; see above). The clinical utility of the therapeutic intervention (its relevance and usefulness in patient care [START_REF] Lesko | What Is Clinical Utility and Why Should We Care?[END_REF]) "becomes a moving target" as information on its benefits and risks increases for groups or for individual patients [START_REF] Lesko | What Is Clinical Utility and Why Should We Care?[END_REF]. As part of this, 'patients', their bodies and their carers may (but it is in no way inevitable) become more active participants in therapy, with their involvement too digitally mediated -a possible reconfiguration of the patient and their role as actor and information source (e.g. in consultations) to a data source (e.g. through wireless monitors or smart pills).

The health value a medicine generates, and the ability to identify this, becomes an open and multiple question -how to find a value-in-use (e.g. the model of a market in services, and in particular digital services). This moves away from traditional ideas of a value-in-exchange (the model of a market for products). This change in perspective is directly seen in contemporary policy debates as national systems and payers consider 'value based pricing'-e.g. paying (or not paying) for the therapeutic service (or outcome), not for the molecule, and using a multi criteria algorithm and feedback to identify those that pass the value test and those that fail it [START_REF] Claxton | Value Based Pricing for NHS Drugs: An Opportunity Not to Be Missed?[END_REF][START_REF] Claxton | Value-Based Pricing For Pharmaceuticals: Its Role, Specification and Prospects in a Newly Devolved NHS[END_REF].

Research -Evidence in the Doing

A large armory of methods and techniques are today available to support scientific enquiry into medicines biochemical efficacy and other consequences and side effects (e.g. their validation as safe and effective) including statistical measures of outcomes as in a controlled trial, and synthetic metrics such as Number Needed to Treat (NNT) and Number Needed to Harm (NNH). These methods, refined in the past 70 or so years, underpin the established processes through which a new medicine is developed, tested and then licensed for specific uses. It is also the basis for the primary means by which a healthcare professional is given guidance on what medicines to use, when and how.

Research findings are synthesized into protocols or guidelines for practitioners based on clinical data with or without some element of health economics (value for money). In the UK for example, a national body -the National Institute for Health and Care Excellence (NICE) -prepares guidance on drug treatments which balances clinical and therapeutic benefits against cost 5 . Fundamental to this is the use of randomized control trials (RCT) and the types of knowledge that can be derived from trials, both individually and through meta-analysis (e.g. Cochrane reviews). It is in this way that we confidently (i.e. within confidence intervals, given the 'random element and organic incompleteness' of life) assert the therapeutic value and risks of a new medicine for specific conditions and/or subpopulations, or recompute them for older drugs. However clinical trials in their traditional form are increasingly considered unsuitable to obtain the evidence on benefits and risks of medicines tailored to specific individuals -for example a trial now has to assess both the efficacy of the treatment and the efficacy of the diagnostic that underpins the stratification, the co-dependent development of drugs and molecular diagnostics [START_REF] Lewis | Ethics, Evidence and Economics in the Pursuit of "Personalized Medicine[END_REF]. As Lewis et al. suggest of personalized medicine "[It] forces us to question contemporary biomedical views of evidence, including its generation and use in decision making" [START_REF] Lewis | Ethics, Evidence and Economics in the Pursuit of "Personalized Medicine[END_REF]. There is thus a new focus on a set of complementary approaches to metricate value generated by medicines as they are to be used and as they are revealed through intensive digitization in the domain of use. Individual patient data collected/entered by clinicians at the point of care, or provided by the patient (now a data source), are aggregated into 'Big Data' as a potential basis for a new knowledge. A range of new analytic tools analyze or 'mine' these often non-standardized data and sift through the 'data turmoil' [START_REF] Schneeweiss | Learning from Big Health Care Data[END_REF]. Among these analytic resources, for example, are new data-driven approaches to test the relationship between biomarkers and clinical outcomes [START_REF] Ren | Research Methods for Clinical Trials in Personalized Medicine: A Systematic Review[END_REF] or for standardizing function instead of components in RCTs of complex interventions [START_REF] Hawe | Complex Interventions: How "Out of Control" Can a Randomised Controlled Trial Be?[END_REF]. Alternatively, "real-time surveillance of individual patient outcomes" [START_REF] Lesko | What Is Clinical Utility and Why Should We Care?[END_REF] may complement trials and improve evidence and support personalization. Drawing on digital resources, trials and experiments can be set up as "randomized studies embedded in routine care" through the use of electronic patient record databases [START_REF] Schneeweiss | Learning from Big Health Care Data[END_REF]. Through such means the duration of trials and evidence gathering will shorten, some hope. For example, with an active distributed surveillance system in place "a fullscale observational study to evaluate the association between angioedema and drugs targeting the renin-angiotensin system was designed, conducted, and completed in 11 months" [START_REF] Psaty | Mini-Sentinel and Regulatory Science -Big Data Rendered Fit and Functional[END_REF]. The perception of the need for such methods and the sense of urgency to exploit new research opportunities can be traced in part to the case of the pain killer and anti-inflammatory drug Vioxx. This medicine was licensed in 1999 and withdrawn in 2004. It took over 3 years and a number of patient deaths (disputed but probably in 6 digits [START_REF] Bhattacharya | Up to 140,000 Heart Attacks Linked to Vioxx[END_REF]) before the negative side effects were acknowledged by the makers and the drug withdrawn from the US market [START_REF] Singh | Merck Withdraws Arthritis Drug Worldwide[END_REF]. The proposition is that, with digitalized patient records, and an effective and proactive pharmacovigliance system, such a case could be identified earlier with overall less harm [START_REF] Psaty | Mini-Sentinel and Regulatory Science -Big Data Rendered Fit and Functional[END_REF].

Governance and Regulation

Research designs reflecting digitization, as described above, imply significant modifications to regulatory regimes. Regulators have been among the most active in adapting to the new world of digital drugs. The FDA, the US regulator, has made many changes in its processes to accommodate a perceived new urgency in drug approval processes including a fast-track process for 'breakthrough therapies' [START_REF] Brewer | Drug Development for Orphan Diseases in the Context of Personalized Medicine[END_REF]. There is a somewhat similar designation of 'orphan drugs' in medical areas where patient numbers are small and investments are unlikely to be made on the usual commercial basis. If and when medicines are fast tracked (a concept with a history traced back to the early period of HIV/AIDS), and are expected to have a weaker research provenance at the time of licensing, they rely more on digital resources for monitoring of "post marketing safety and effectiveness" [START_REF] Psaty | Mini-Sentinel and Regulatory Science -Big Data Rendered Fit and Functional[END_REF]. In such circumstances medicines-in-use data can serve to "raise or lower the level of concern about the overall risk-benefit profile of particular drugs", a capability that is described by the FDA as being transformational for the licensing process [START_REF] Psaty | Mini-Sentinel and Regulatory Science -Big Data Rendered Fit and Functional[END_REF]. More generally they acknowledge the ability of these new resources of data to help fulfil the FDA's role. In the own words of the FDA, it has "evolved its regulatory processes in response to -and in anticipation of -scientific developments" [START_REF]FDA: Paving the Way for Personalized Medicine -FDA's Role in a New Era of Medical Product Development[END_REF], noting how it has responded to personalized medicines and the associated growth of diagnostic products by, "collaborating in key research, defining and streamlining regulatory pathways and policies, and applying new knowledge in product reviews" [START_REF]FDA: Paving the Way for Personalized Medicine -FDA's Role in a New Era of Medical Product Development[END_REF]. Meanwhile, Australia has, arguably, the first national framework to assess personalized medicine for coverage or reimbursement decisions [START_REF] Merlin | Assessing Personalized Medicines in Australia: A National Framework for Reviewing Codependent Technologies[END_REF].

As suggested above, digitization and the availability of data generated in clinical care practices (in-use) and held in national registries, migrate from a pure research (trial) status to embody more directly various interests including of health care system managers and the payers, patients and patient groups, and the pharmaceutical industry [START_REF] Niezen | Reconfiguring Policy and Clinical Practice How Databases Have Transformed the Regulation of Pharmaceutical Care?[END_REF][START_REF] Burstin | The Journey to Electronic Performance Measurement[END_REF]. That is, research in both new and old formats, and digitalized and synthesized prospective data sets become engaged in the systems of governance and regulation that surround medicines use. Research data thus will directly feed the development of detailed and comprehensive protocols of use (and non-use) for powerful and expensive drugs, described as frameworks for 'appropriate medicines use' [START_REF] Niezen | Reconfiguring Policy and Clinical Practice How Databases Have Transformed the Regulation of Pharmaceutical Care?[END_REF]. Niezen et al. report research in The Netherlands on registries (national databases of medicines use for a specific class of patient) as digital artifacts that are both an object to be managed, and an instrument to manage with. In this way clinical work (using medicines with patients and feeding the registry) and regulatory work (setting the protocol guidelines and reimbursement rules) become closely co-constitutive and co-evolving. In their analysis they question the desirability of a regulatory system that pursues a new 'digital objectivity' where available data embodies truth -as seen in many Big Data endorsements, and captured in the idea of the 'death of the denominator' when n=All (see also [START_REF]Raw Data Is an Oxymoron[END_REF]). They contrast such digital objectivity with the more established 'regulatory objectivity', the kind of knowledge that is based on multiple evidential resources and embodies conventions and trade offs and collective expertise [START_REF] Beaulieu | Voxels in the Brain Neuroscience, Informatics and Changing Notions of Objectivity[END_REF][START_REF] Beaulieu | From Brainbank to Database: The Informational Turn in the Study of the Brain[END_REF].

Conclusion

In this paper we introduce the new concept of digital drugs as the intensified integration of digital services, data resources and algorithms into the practices of medicines. We anatomize it to reveal some of the main components (use, regulation, research) and mechanisms and relations using the lens of assemblage. The digitalization efforts that characterize the movement towards digital drugs are for the most part undertaken in the name of understanding, best practice, precision, and certainty. The individual initiatives and innovations described here can be seen individually as the expression of some regular and rational plan or policy to enhance the efficacy and efficiency of health care. Our view, our conceptual repertoire, and our chosen lens of assemblage, however, suggest something else or at least a different account of motivations and mechanism. As proposed here, digitization (digital mediation of drugs) is pursued as a means to address the organic quantum of chemicals in the body. However, the complexity and multiplicity of elements that converge in or constitute a digital drug and its 'use/reuse' suggest that it need not, and perhaps should not, be seen as a pursuit of a certain or specific outcomes. Digital drugs are manifest as diverse, distributed, cumulated and dissected events and incidents across and between domains. They also permit multiple outcomes as data resources grow, algorithms learn and reconfigure, and virtual phenomena take new roles. Such multiplicity and instability is a price paid for the desired outcomes, for example in the case of in-use experimental designs or big data driven protocols (digital objectivity). Markus and Saka introduce assemblage as a technique of collage and "something that generates enduring puzzles about 'process' and 'relationship'" and "[offers] an odd, irregular and time-limited object for contemplation" [START_REF] Marcus | Assemblage. Theory[END_REF]. Applying it in these terms to medicines, this paper raises issues that might be assessed against a wider understanding of digitalization.

First, is the idea of digital drugs themselves, or more generally of movement (reconfigurations) towards a digital materiality that attaches to and 'takes over' classes of artifacts. In this it recasts them ontologically away from an artefactual existence to one of assemblage -found in a complex ecosystem of data, algorithm and temporally unstable conjunctions, actual, real, virtual or simulated.

Second, and embedded within this perspective, is the question of the 'mechanisms' of the digital as rational processes of improvement, as (digital) controllers, as sensemaking, and as generative forces. Our case, and the examples in Table 1, suggests that there is opportunity here for useful fundamental categorizations of this digital agency through artefactual and assemblage conceptualizations.

Third and finally, is the question of knowledge processes (research designs) as embedded in these phenomena. The methodological arsenal of the evidence based community (that of innovators, regulators and evidence-based practice) is changing and adapting. Event and transaction are at the core, able to be inspected, accumulated and animated in ways that were not possible in earlier eras. This reconfiguration is core to the phenomena of interest. But can the IS community reconfigure its research agendas and methods to meet this challenge?

Table 1 .

 1 A sample of contemporary digital hybrids in medicines use

	Concept	Definitions	Digital mechanisms
	Electronic
	prescribing
	(EP)

In this paper we use the word medicines and drugs almost as synonyms. We recognise however that they offer slight but significant shifts of emphasis. 'Medicine' evokes the practice of medicine and hence the practices of medicines, while drug evokes the manufactured product and its chemical character/materiality. Thus in this most basic sense the thing we address has an inherent multiplicity. The US National Library of Medicine thesaurus (MeSH -Medical Subject Heading) avoids this tension in its own way using the term Pharmaceutical Preparations -"Drugs intended for human or veterinary use, presented in their finished dosage form" (NLM -Medical Subject Headings -2014 -Unique ID D004364 -

The average NNT (Number Needed to Treat) for a licensed drug used in secondary care is well over 5, and for a prophylactic drug (e.g. aspirin for prevention of stroke) it may be well over 1000; that is over 1000 persons need to receive the drug, including paying for it and suffering possible side effects, for one to obtain a therapeutic benefit[START_REF] Chatellier | The Number Needed to Treat: A Clinically Useful Nomogram in Its Proper Context[END_REF]. As a point of contrast everyday paracetamol (acetaminophen) which a dentist may give you after an extraction has an NNT of

around 4.5 for post-operative pain[START_REF] Toms | Single Dose Oral Paracetamol (Acetaminophen) with Codeine for Postoperative Pain in Adults[END_REF].

Omics: a neologism used to describe a range of scientific fields (proteomics, genomics etc.) studying important biomedical aspects about a patient or patient group for subsequent use in personalised or stratified medicine; used also to refer to a person's characteristics in terms of molecular components and biological pathways (e.g. transcriptomic, proteomic, metabolomic).

http://www.nice.org.uk/guidance/index.jsp?action=bytreat-ment&TREATMENTS=Drug+treatments Last accessed 15 September 2014

Acknowledgements. We would like to thank the colleagues with whom we have discussed various ideas and aspects of this work and the anonymous reviewers who offered insightful comments on a previous version of this paper. We also acknowledge the research grant EP/L021188/1 (2014-2016) awarded by the Research Councils UK Digital Economy Theme to support this work.