**2. Constructive technology assessment & scenario workshops**

#### **2.1. Perspectives on emerging technologies**

There are structural differences in how actors perceive and interact with novel technologies. In our modern societies there exists an asymmetry between those who develop new science and technology and those who are impacted by these developments. For one this is related to a difference in timing between the development and actual introduction of new technologies; for another it is related to differences in involvement and perspective of a variety of actors which to some extent is institutionalized in a historically grown division of labour regarding novel technologies. That is, there exists a separation between individuals and organizations involved in either the generation or the uptake – 'selection' - of technologies. For instance, technology actors have had 'a mandate' to develop new technologies and could confront society with new technologies when linked with ideals of progress. Even if this mandate is not taken for granted anymore, it has led to institutions and divisions of labour with respect to the promotion and selection or regulation - 'control' - of new technologies which cannot easily be undone [12].

basis of cost-benefit analysis, or the Food and Drug Administration deciding whether or not to grant market access to novel drugs. It can also be done by actors who are less tied to certain methods such as patients and their individual experience with specific medication. Public interest groups may act as selectors, for instance organizations which have opposed the introduction of GMOs or those who have called for more control and regulation of nanotech‐

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These different positions may, and sometimes have to, interact with each other. For instance in the case of drug delivery, firms aiming to introduce novel drugs will at some stage have to interact with the US Food and Drug Administration and/or the European Medicines Agency or other regulatory body. Firms acting as enactors of drug delivery systems will have to act with pharmaceutical companies who (then) may act as selectors, choosing between different delivery devices to be used for their pharmaceutical agent. They may also meet each other at conferences or in dedicated discussion platforms which may be set-up to foster mutual

Actors pursuing promotion activities and actors pursuing selection activities will interfere anyway, eventually. The next step then is to identify where and when these activities interfere and what happens there. That is, what do these different actors learn at these occasions from each other. How does that shape how they view the novel technology under consideration and what does this imply for their strategies regarding development or uptake of novel technolo‐ gies. Garud & Ahlstrom (1997) call such occasions 'bridging events' and discuss some

The important point here is that such bridging events can be created on purpose. This can be done by technology enactors themselves who for instance engage in market research, or by selectors such as regulatory authorities who invite sponsors of new pharmaceutical therapies to discuss their future products and how to evaluate them. It can also be done by academic researchers or more disinterested actors who are working with the perspective of Constructive

The approach of Constructive Technology Assessment (CTA) has been developed since the 1980's and has become a key methodology within the field of technology assessment. It aims to broaden design, development and implementation processes rather than only assess impacts on novel technologies [18]. In CTA, technologies and their impacts are not seen as given. "For CTA, the dynamics of the process are central, and impacts are viewed as being built up, and co-produced, during the process of technical change. Many technology studies have shown that impacts are not just passive effects of a given technology on its environment, but are actively sought (or avoided) by technology producers, users, and third actors such as governments, unions, and pressure groups alike" [18, p. 257]. Technologies and their impacts co-evolve, and actors involved try to shape this process and make assessments of what is

nologies such as the ETC Group [17].

understanding.

examples.

Technology Assessment (CTA).

happening or could happen.

**2.2. Constructive technology assessment**

For understanding actors' perspectives and interactions regarding (emerging) technolo‐ gies the actor typology developed by Garud and Ahlstrom [13] is helpful. Garud and Ahlstrom emphasize the structural difference in the ways actors assess technologies. They relate differences in views and action perspectives to two different positions: insiders and outsiders with respect to technologies. To emphasize the difference in position and style, rather than inside/outside boundaries, the terms enactors and comparative selectors have been proposed [14].

As we formulated in the yearbook Nanotechnology in Society [15], enactors, i.e. those who promote and aim to realize novel technologies "construct scenarios of progress, and identify obstacles to be overcome. They thus work and think in 'enactment cycles' which emphasize positive aspects. This includes a tendency to disqualify opposition as irrational or misguided, or following their own agendas. For nanotechnology, enactors now also anticipate obstacles similar to the ones which occurred for GMO (Genetically Modified Organisms) in agriculture and food, cf. Colvin [16]."

Enactors will identify with a novel technology and its applications such as nanotechnologyenabled drug delivery systems and may believe that the world is waiting for these products, e.g. because of its attractive performance characteristics and 'a good product sells itself'. However, for 'the world' the product is just one of many options and it may see alternatives. This group takes a position of comparing and selecting different technological options, thus act as 'comparative selectors'. While enactors may downplay considerations regarding costs and risks, selectors will often take broader evaluation frames where these considerations are put upfront [13: 40].

There can be different types of such so called 'comparative selectors'. This act of 'comparative selecting' can be done on a professional basis, such as health insurance authorities deciding which novel drugs are worth reimbursing and to be included in insurance packages on the basis of cost-benefit analysis, or the Food and Drug Administration deciding whether or not to grant market access to novel drugs. It can also be done by actors who are less tied to certain methods such as patients and their individual experience with specific medication. Public interest groups may act as selectors, for instance organizations which have opposed the introduction of GMOs or those who have called for more control and regulation of nanotech‐ nologies such as the ETC Group [17].

These different positions may, and sometimes have to, interact with each other. For instance in the case of drug delivery, firms aiming to introduce novel drugs will at some stage have to interact with the US Food and Drug Administration and/or the European Medicines Agency or other regulatory body. Firms acting as enactors of drug delivery systems will have to act with pharmaceutical companies who (then) may act as selectors, choosing between different delivery devices to be used for their pharmaceutical agent. They may also meet each other at conferences or in dedicated discussion platforms which may be set-up to foster mutual understanding.

Actors pursuing promotion activities and actors pursuing selection activities will interfere anyway, eventually. The next step then is to identify where and when these activities interfere and what happens there. That is, what do these different actors learn at these occasions from each other. How does that shape how they view the novel technology under consideration and what does this imply for their strategies regarding development or uptake of novel technolo‐ gies. Garud & Ahlstrom (1997) call such occasions 'bridging events' and discuss some examples.

The important point here is that such bridging events can be created on purpose. This can be done by technology enactors themselves who for instance engage in market research, or by selectors such as regulatory authorities who invite sponsors of new pharmaceutical therapies to discuss their future products and how to evaluate them. It can also be done by academic researchers or more disinterested actors who are working with the perspective of Constructive Technology Assessment (CTA).

#### **2.2. Constructive technology assessment**

**2. Constructive technology assessment & scenario workshops**

There are structural differences in how actors perceive and interact with novel technologies. In our modern societies there exists an asymmetry between those who develop new science and technology and those who are impacted by these developments. For one this is related to a difference in timing between the development and actual introduction of new technologies; for another it is related to differences in involvement and perspective of a variety of actors which to some extent is institutionalized in a historically grown division of labour regarding novel technologies. That is, there exists a separation between individuals and organizations involved in either the generation or the uptake – 'selection' - of technologies. For instance, technology actors have had 'a mandate' to develop new technologies and could confront society with new technologies when linked with ideals of progress. Even if this mandate is not taken for granted anymore, it has led to institutions and divisions of labour with respect to the promotion and selection or regulation - 'control' - of new technologies which cannot easily be

For understanding actors' perspectives and interactions regarding (emerging) technolo‐ gies the actor typology developed by Garud and Ahlstrom [13] is helpful. Garud and Ahlstrom emphasize the structural difference in the ways actors assess technologies. They relate differences in views and action perspectives to two different positions: insiders and outsiders with respect to technologies. To emphasize the difference in position and style, rather than inside/outside boundaries, the terms enactors and comparative selectors have

As we formulated in the yearbook Nanotechnology in Society [15], enactors, i.e. those who promote and aim to realize novel technologies "construct scenarios of progress, and identify obstacles to be overcome. They thus work and think in 'enactment cycles' which emphasize positive aspects. This includes a tendency to disqualify opposition as irrational or misguided, or following their own agendas. For nanotechnology, enactors now also anticipate obstacles similar to the ones which occurred for GMO (Genetically Modified Organisms) in agriculture

Enactors will identify with a novel technology and its applications such as nanotechnologyenabled drug delivery systems and may believe that the world is waiting for these products, e.g. because of its attractive performance characteristics and 'a good product sells itself'. However, for 'the world' the product is just one of many options and it may see alternatives. This group takes a position of comparing and selecting different technological options, thus act as 'comparative selectors'. While enactors may downplay considerations regarding costs and risks, selectors will often take broader evaluation frames where these considerations are

There can be different types of such so called 'comparative selectors'. This act of 'comparative selecting' can be done on a professional basis, such as health insurance authorities deciding which novel drugs are worth reimbursing and to be included in insurance packages on the

**2.1. Perspectives on emerging technologies**

504 Application of Nanotechnology in Drug Delivery

undone [12].

been proposed [14].

and food, cf. Colvin [16]."

put upfront [13: 40].

The approach of Constructive Technology Assessment (CTA) has been developed since the 1980's and has become a key methodology within the field of technology assessment. It aims to broaden design, development and implementation processes rather than only assess impacts on novel technologies [18]. In CTA, technologies and their impacts are not seen as given. "For CTA, the dynamics of the process are central, and impacts are viewed as being built up, and co-produced, during the process of technical change. Many technology studies have shown that impacts are not just passive effects of a given technology on its environment, but are actively sought (or avoided) by technology producers, users, and third actors such as governments, unions, and pressure groups alike" [18, p. 257]. Technologies and their impacts co-evolve, and actors involved try to shape this process and make assessments of what is happening or could happen.

CTA does not aim to introduce assessment – as enactors/selectors are making assessments the entire time- but rather to modulate ongoing processes of assessment and feedback into actor decisions and strategies with respect to technology development and introduction. In partic‐ ular it aims to broaden actors perspectives by offering an overview of actors and aspects involved in development and embedding of emerging technologies [19]. Second, it aims to enrich actors understanding of the dynamics of such processes, for instance the role of reimbursement in health care innovations. By broadening and enriching perspectives of actors, CTA interventions aim to support individuals and organizations in identifying their role and impacts in the overall innovation processes. This helps actors to evaluate effects of their strategies and consider what they may need to change in their activities in the present and near future in order to work towards desirable outcomes (for instance to improve chance of market success of new NDDS).

of such applications are unclear, and attempts to find out about impacts amount to social science fiction. Socio-technical scenarios capture ongoing dynamics and develop assessments of future developments. They show the effects of interactions between enactors and selectors which provides more substance to interactions in workshops as actors can draw upon the

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The use of scenarios and interactive workshops has further effects. They provide participants in workshops with competences to support anticipation and strategy articulation. Tools such as scenarios, which are based on insights in ongoing dynamics and debates during interactive workshops, provide actors with understanding of the overall situation and clues for how to take into account ongoing developments and future impacts. So, while actors will likely value anticipation of embedding as a prudent strategy relevant for their own activities, they now are

To prepare for a CTA workshop, the actual 'engagement' between stakeholders, the organizers of this event need to prepare themselves, or 'pre-engage' with the technologies and domains under consideration, in this case NDDS in the drug delivery sector. Preparing for the work‐ shops clearly includes an organizational component, such as identifying possible collabora‐ tors, preparing input documents for the workshops themselves, and interactions with participants and actors potentially interested in participating in the workshop. Preparing also requires analysis to support anticipation in a situation filled with uncertainties. This helps to focus the discussion on key issues and be more productive while at the same time the organ‐

The organizers of a CTA event need to have a thorough understanding of the emerging science & technology. What are the dynamics in its development, to what extent is there still room to change the course of technology developments and how these technologies can be integrated in business practices, and how they are perceived by regulatory authorities and further individuals and organizations in society. A second requirement is that organizers need to have a sense of various actors' willingness to anticipate future developments and tune their activities with other actors in the domain. For instance some companies may not be willing at all to engage in co-ordination activities with other companies or societal actors. A third requirement is to identify, select and position potential participants which is related to their role in the overall technology development and embedding process. For instance large pharmaceutical companies are important in the overall innovation process and should ideally be included in such an exercise. For a productive discussion the workshops benefit from an appropriate mix of participants with an enactor or selector perspective toward the technologies under consid‐ eration [19]. Finally, the organizers should be aware of broader dynamics which may not always be immediately obvious to actors involved in developing novel technologies. In the case of the drug delivery sector, one may consider involving health insurers as they may be not directly involved in developing new options, but will definitely be important when new

scenarios for inspiration.

also provided with some skills to fill in such strategies.

izers should remain open for other themes and questions.

pharmaceutical options are introduced on the market.

**2.3. Workshop design and preparation**

While CTA events are an intervention, they are also a tool to understand what is happening in a particular domain of technology. They provide an entrance point to elicit perceptions of enactors and comparative selectors in an interactive setting. As we formulated it [15], it is creating and orchestrating spaces where interactions occur, even if the interactions between citizens/consumers and technology developers and promoters will always be partial (because of their difference in perspective). There will be "probing of each other's realities" (as Garud and Ahlstrom (1997) called it), with more or less contestation.

The CTA workshop which convenes stakeholders in a particular domain, is a micro cosmos which reflects parts of the macro cosmos, in this case the drug delivery sector, through participants' interactions and their assessments of the force fields in which they find them‐ selves. The workshops provide a space in which actors with different socio-cognitive positions, which I summarized as enactors and comparative selectors, can interact. Thus, the temporary space is a bridging event, and is designed as a bridging event.

Within this general framing, CTA workshops are tailored towards stimulating actors' antici‐ pation of embedding through broadening and enriching actors' assessments of ongoing dynamics, and actors' articulation of possible embedding strategies. Facilitating interactions, especially mutual 'probing', between enactors and selectors is one of the mechanisms. At the same time, interactions between enactors and selectors offer insights into what is happening in a domain. Supported by careful preparation – 'pre-engagement' [20] – CTA workshops then provide a 'window on the world' to the participants; their world as it is, and might be in the future. The articulations in this micro cosmos then will offer a view of potential developments in the domain. On the other hand, the temporary (and protected) space of the workshop will not fully reflect the force fields in the macro cosmos. Still, the patterns that are found in actors' articulations and their assessments of force fields affording actions, offer good indications. One reason is that participants probe into or comment on each other's positions and consid‐ erations, introducing checks on what happens in the drug delivery sector.

In interactive workshops, probing and commenting can be supported by socio-technical scenarios. In the case of nanotechnologies, socio-technical scenarios are necessary to address their doubly fictional character [15]. Many of the expected applications enabled by nanotech‐ nologies (and nanosciences) are still envisioned, part of 'science fiction'. The eventual impacts of such applications are unclear, and attempts to find out about impacts amount to social science fiction. Socio-technical scenarios capture ongoing dynamics and develop assessments of future developments. They show the effects of interactions between enactors and selectors which provides more substance to interactions in workshops as actors can draw upon the scenarios for inspiration.

The use of scenarios and interactive workshops has further effects. They provide participants in workshops with competences to support anticipation and strategy articulation. Tools such as scenarios, which are based on insights in ongoing dynamics and debates during interactive workshops, provide actors with understanding of the overall situation and clues for how to take into account ongoing developments and future impacts. So, while actors will likely value anticipation of embedding as a prudent strategy relevant for their own activities, they now are also provided with some skills to fill in such strategies.

#### **2.3. Workshop design and preparation**

CTA does not aim to introduce assessment – as enactors/selectors are making assessments the entire time- but rather to modulate ongoing processes of assessment and feedback into actor decisions and strategies with respect to technology development and introduction. In partic‐ ular it aims to broaden actors perspectives by offering an overview of actors and aspects involved in development and embedding of emerging technologies [19]. Second, it aims to enrich actors understanding of the dynamics of such processes, for instance the role of reimbursement in health care innovations. By broadening and enriching perspectives of actors, CTA interventions aim to support individuals and organizations in identifying their role and impacts in the overall innovation processes. This helps actors to evaluate effects of their strategies and consider what they may need to change in their activities in the present and near future in order to work towards desirable outcomes (for instance to improve chance of market

While CTA events are an intervention, they are also a tool to understand what is happening in a particular domain of technology. They provide an entrance point to elicit perceptions of enactors and comparative selectors in an interactive setting. As we formulated it [15], it is creating and orchestrating spaces where interactions occur, even if the interactions between citizens/consumers and technology developers and promoters will always be partial (because of their difference in perspective). There will be "probing of each other's realities" (as Garud

The CTA workshop which convenes stakeholders in a particular domain, is a micro cosmos which reflects parts of the macro cosmos, in this case the drug delivery sector, through participants' interactions and their assessments of the force fields in which they find them‐ selves. The workshops provide a space in which actors with different socio-cognitive positions, which I summarized as enactors and comparative selectors, can interact. Thus, the temporary

Within this general framing, CTA workshops are tailored towards stimulating actors' antici‐ pation of embedding through broadening and enriching actors' assessments of ongoing dynamics, and actors' articulation of possible embedding strategies. Facilitating interactions, especially mutual 'probing', between enactors and selectors is one of the mechanisms. At the same time, interactions between enactors and selectors offer insights into what is happening in a domain. Supported by careful preparation – 'pre-engagement' [20] – CTA workshops then provide a 'window on the world' to the participants; their world as it is, and might be in the future. The articulations in this micro cosmos then will offer a view of potential developments in the domain. On the other hand, the temporary (and protected) space of the workshop will not fully reflect the force fields in the macro cosmos. Still, the patterns that are found in actors' articulations and their assessments of force fields affording actions, offer good indications. One reason is that participants probe into or comment on each other's positions and consid‐

In interactive workshops, probing and commenting can be supported by socio-technical scenarios. In the case of nanotechnologies, socio-technical scenarios are necessary to address their doubly fictional character [15]. Many of the expected applications enabled by nanotech‐ nologies (and nanosciences) are still envisioned, part of 'science fiction'. The eventual impacts

and Ahlstrom (1997) called it), with more or less contestation.

space is a bridging event, and is designed as a bridging event.

erations, introducing checks on what happens in the drug delivery sector.

success of new NDDS).

506 Application of Nanotechnology in Drug Delivery

To prepare for a CTA workshop, the actual 'engagement' between stakeholders, the organizers of this event need to prepare themselves, or 'pre-engage' with the technologies and domains under consideration, in this case NDDS in the drug delivery sector. Preparing for the work‐ shops clearly includes an organizational component, such as identifying possible collabora‐ tors, preparing input documents for the workshops themselves, and interactions with participants and actors potentially interested in participating in the workshop. Preparing also requires analysis to support anticipation in a situation filled with uncertainties. This helps to focus the discussion on key issues and be more productive while at the same time the organ‐ izers should remain open for other themes and questions.

The organizers of a CTA event need to have a thorough understanding of the emerging science & technology. What are the dynamics in its development, to what extent is there still room to change the course of technology developments and how these technologies can be integrated in business practices, and how they are perceived by regulatory authorities and further individuals and organizations in society. A second requirement is that organizers need to have a sense of various actors' willingness to anticipate future developments and tune their activities with other actors in the domain. For instance some companies may not be willing at all to engage in co-ordination activities with other companies or societal actors. A third requirement is to identify, select and position potential participants which is related to their role in the overall technology development and embedding process. For instance large pharmaceutical companies are important in the overall innovation process and should ideally be included in such an exercise. For a productive discussion the workshops benefit from an appropriate mix of participants with an enactor or selector perspective toward the technologies under consid‐ eration [19]. Finally, the organizers should be aware of broader dynamics which may not always be immediately obvious to actors involved in developing novel technologies. In the case of the drug delivery sector, one may consider involving health insurers as they may be not directly involved in developing new options, but will definitely be important when new pharmaceutical options are introduced on the market.

The design of a CTA workshop can take different shapes, see also [19, 21], but will often be geared toward eliciting actors' perspectives on societal embedding of emerging technologies and to stimulate broadening and enriching of understanding of dynamics in development and future introduction of these technologies. To do so the workshop can be structured around two themes which will be recognizable for participants: (1) identification of challenges, opportunities and directions for development of emerging technologies in a specific domain; (2) identification of ways to cope with challenges and opportunities of these technologies. These are broad themes in order to simulate actors to articulate linkages between emerging technologies like NDDS and aspects of societal embedding and prevent too early lock-ins into particular options or strategies. Such open-ended character will often be unavoidable consid‐ ering the emergent character of the application of technologies. It was intentionally openended in order to allow for open discussion

drug delivery sector, then, is an intersection of two product value chains involving the 'primary manufacturing' of the active pharmaceutical ingredient (API) and the 'secondary manufac‐ turing', i.e. the formulation (including drug delivery systems) and packaging. Both stages of manufacturing can occur within one (integrated) firm or be outsourced to contractors [24].

participants anticipatory competences by enhancing their insights on what happens

**<sup>21</sup>**2-3 grounded in understanding of ongoing dynamics in a domain

at the level of a domain.

Please replace figure 1 on page 9 with:

Delivery systems suppliers

Suppliers of materials

> Pharmaceutical manufacturers , brand owners

Knowledge institutes

**Figure 1.** Organizations in the drug delivery sector

Contract Research Organizations

Active Pharmaceutical Ingredient suppliers

**<sup>21</sup>**3-5 contribute to the further development of

**20** 32 foregrounded highlighted

Developments related to nanotechnologies more

**20** 29 Aspects aspects during the development of

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These broader discussions

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nanotechnology-enabled products.

support articulation of anticipatory

509

strategies and decision making

**20** 26 with its associations of both promises and

risks

generally

**20** 26/2 7

**20** 33 different

Dynamics in the sector then come from both chains and their intersection, but also from the broader health care environment in which these chains are embedded. For embedding new drug delivery systems, enactors, e.g. business entrepreneurs, not only need to deal with business dynamics in the world of pharma, but also with broader developments in health care such as overall pressures on cost reduction of treatments, debates on reimbursement. In addition to firms, there are knowledge institutes, clinicians, patients, governmental actors and health insurers. Figure 1 offers a (simplified) overview of actors in the drug delivery sector.

**21** 10 will have effects will already have effects

Distributors, Wholesalers

Authorities Patent Offices

professional associations Consortia

The development and introduction of nanotechnologies plays against a backdrop of increasing difficulties of pharmaceutical companies to develop and market new drugs [25, 26]. Nano‐ technology-enabled drug delivery systems promise new solutions. The application of nano‐ technologies which has attracted the most attention is the promise of releasing drugs at a particular target. While there are other targeting approaches, nanotechnology engineered delivery systems are considered to be particularly promising. In a conventional delivery system, the drug is distributed systemically across the body, but this may not always be

Branch organizations &

Clinicians, Pharmacies

Regulatory

Patients

Public & private health insurers

> NGOs & patient interest groups

> > 3

Some reduction of the open-ended character of these two discussion themes will be important in order to have a productive meeting and attract participants. In CTA workshops this is often done by means of a preparatory document which will be given to all participants, justifying and framing the meeting. To link up with interests of potential participants, such a document can identify key issues and dilemmas which will be recognizable to at least part of the participants. In addition the document will contain the scenarios about future developments. These scenarios depart from major challenges in the present situation and explore strategies to overcome them, including the possible responses of actors involved, for scenario method‐ ology see also [15, 20, 22]. In this way the scenarios help to make anticipations of future developments concrete and can support actors in their formulation of strategies.

Finally, to stimulate an open discussion and overcome possible concerns regarding confiden‐ tiality, a CTA workshop can be held under the 'Chatham House rule'. This rule is as follows: "When a meeting, or part thereof, is held under the Chatham House Rule, participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed" [23]. By adopting this workshop rule, the organizers aim to create an informal atmosphere and stimulate an open discussion.

Before I will discuss the results of the workshop discussions I will briefly introduce the drug delivery sector and nanotechnology.
