II. Opportunities and Challenges Presented by Advanced Biopreservation Technologies

Emerging science and technology focused on extending the timescales over which viable biological materials can be preserved and reused — collectively referred to here as advanced biopreservation technologies — is opening up transformative possibilities.Reference Wolf⁶ These include extending the usable time window of viable human tissue and organs,Reference Giwa⁷ protecting and preserving non-human species and tissues,Reference Angeles and Catap⁸ and preserving the biological sources of food supplies,Reference Kumari, Maurye, Pandey and Parhi⁹ for instance through biopreservation focused on aquaculture. These emerging capabilities have the capacity to substantially extend time limitations that currently constrain the use and usefulness of biologically preserved biological materials. In doing so, these technologies are opening up possibilities that include greater access to replacement organs and tissues, preservation of endangered species, and protection of biodiversity.

However, advanced biopreservation techniques are also potentially disruptive technologies. If successful, they are likely to challenge societal, policy, and governance systems, as well as norms and expectations surrounding biopreservation.¹⁰ Beyond the benefits of being able to extend the viable window of, say, a living heart, or preserved seeds, the ability to “extend time” within preserved biological samples holds the possibility of upsetting the delicate balance of systems that have been built around clear time constraints. The result is a growing ecosystem of technologies that, while beneficial in principle, could threaten the status quo in ways that may jeopardize their long-term socially and economically beneficial development and use.

This potential for disruption is seen clearly in the systems, processes, procedures, and regulations surrounding access to vital organs for transplant.Reference Pruett¹¹ While the number of organs available for transplant in the United States falls far short of the number of patients requiring heart, liver, lung, and kidney transplants, established systems are in place that ensure predictable and tested pathways between donors and recipients so that transplants are safe and ethical. However, substantial perturbations within this system — such as greatly extending the time-window within which an organ is usable — have the potential to upset the balance in what is a complex sociotechnical system, to the point where the potential benefits of seemingly positive advances cannot be realized in practice.

Such perturbations are likely to impact the governance norms, systems, and practices that surround the use of biopreserved materials — not just in organ transplantation, but wherever systems for managing biological materials have been established that depend on constrained and well-defined timescales. If care is not taken, new biopreservation capabilities will disrupt existing processes, infrastructure, and economics in ways that will raise novel and challenging barriers to progress. Such barriers — for instance, where advanced biopreservation substantially extends viability and thus the availability of vital organs in ways that threaten the smooth operation of existing systems — represent threats to progress that lie outside many conventional approaches to risk assessment and management.

Navigating this complex “risk landscape” requires an early understanding of emerging risks and opportunities by researchers, developers, companies, policy makers, and others. Given the complex coupling between societal and technological systems, this will need to encompass an understanding of the social, political, and economic context within which advanced biopreservation technologies are developed and deployed. It will also require applying theories and practices guiding advanced technology transitionsReference Maynard and Dudley¹² to help ensure that advanced biopreservation technologies lead to long-term societal good. These include concepts that draw from responsible innovationReference Owen, Macnaghten and Stilgoe¹³ and participatory technology assessmentReference Kaplan¹⁴ as well as anticipatory governance,Reference Guston¹⁵ agile governance,¹⁶ and soft-law approaches to the governance of emerging technologies.Reference Marchant and Allenby¹⁷ Undergirding all these areas is a need for practical insights into how key stakeholders — including organizations developing advanced biopreservation techniques — understand and navigate an increasingly complex emerging risk landscape.

III. A Risk Innovation Approach to Supporting Positive Societal Impact

In this exploratory study we considered the application of Risk InnovationReference Maynard¹⁸ — an approach to guiding risk-informed actions developed by the Risk Innovation Lab at Arizona State University. This approach was formalized through the Arizona State University-based “Risk Innovation Nexus” in 2019.¹⁹ It is an approach that has previously been applied in the context of single companies — primarily startups. This is the first study to test the approach in the context of a community of multiple and diverse entities collaborating in the development and application of a new and emerging technology. The goal of applying the Risk Innovation approach in this study was to see if it could help ATP-Bio stakeholders —public and private organizations, as well as individuals — to identify perceived risks and navigate the emerging risk landscape around advanced biopreservation technologies.

The Risk Innovation approach conceptualizes risk as a multifaceted threat to value and is designed to provide key stakeholders with a subjective, but informative, understanding of a threats-based landscape that potentially stands to inhibit progress toward goals²⁰ — in this case, the successful development and application of advanced biopreservation technologies. By helping enterprises understand areas of agreement and disagreement with key stakeholders on the creation and protection of value, the Risk Innovation approach should allow the enterprise to reduce or avoid risks associated with value misalignment or clashes. Building on this, the approach was initially constructed as a way of helping individuals and organizations to better understand how to navigate risks they may otherwise neglect in achieving their goals. It was also developed for use by small groups with a common focus and vision and has previously been applied within single organizations.

Risk Innovation as a tool was conceived from the outset as complementary to more-established risk analysis and decision-making tools available to organizations such as Enterprise Risk Management; Strengths Weaknesses Opportunities and Threats analysis (SWOT), and standards-based approaches such as ISO 31000²¹ (Risk Management). While these and other tools provide important frameworks for addressing more conventional risks, the Risk Innovation approach was designed to foster a risk-based mindset that was attuned to less conventional risks.

In this study, we explored whether the approach could allow organizations within a community of stakeholders to identify and navigate potential risks. Applying the Risk Innovation approach within such a community would make it potentially valuable to initiatives such as the ATP-Bio ERC. The Risk Innovation approach respects the expertise of stakeholders involved in development and application of a technology, by giving them a structured way to identify the areas of value they are seeking to promote and risks that are easy to overlook. This kind of systematic, upstream reflection early in the development and use of emerging technology can increase the likelihood of successful development and positive societal impact.

By working with stakeholders developing advanced biopreservation technologies in the domains of human health, food supply systems, and biodiversity, our study explored the utility of Risk Innovation approaches to aid the successful development and beneficial use of advanced biopreservation technologies.

IV. Applying Risk Innovation to Advanced Biopreservation Technologies

The theory and practice of Risk Innovation frame risk as a threat to value, and thus help individuals and organizations make pragmatic decisions on how to navigate risks that are hard to quantify but that nevertheless present substantial barriers to success.²² In this framing, “value” can take on any dimension that is relevant to an individual or organization. For instance, in a conventional risk assessment, “value” may refer to human health or well-being, environmental well-being, or fiscal security. Yet in reality, “value” may also extend to less conventional and less-easily quantified dimensions, including human flourishing, an equitable society, mental well-being, social and individual identity, autonomy, and dignity. These and similar dimensions are rarely quantifiable and are often ignored in formal risk assessments, and yet are frequently pivotal to the success of new endeavors.²³

In this respect, advanced biopreservation technologies are no exception. Researchers and companies developing these technologies have specific ambitions that depend on the success of the technologies they are developing. These may include turning a profit. But for many, their ambitions extend to advancing human flourishing, whether this means saving lives, improving quality of life, increasing access to transplant services, ensuring resilience through biodiversity, or accomplishing other goals. These are all areas of value that, if threatened, could prevent emerging biopreservation technologies and the organizations that develop and deploy them from succeeding.

The Risk Innovation approach also recognizes that organizations developing advanced technologies do not operate in a vacuum but are part of a network of influential stakeholders. Because of this, actions that an organization takes that potentially threaten what is of value to key stakeholders also represent potential risks. For instance, if the actions of a company deploying advanced biopreservation techniques are perceived as unethical, this “threat to stakeholder value” becomes a threat to the success of that organization and potentially others deploying the technology. Likewise, if an emerging biopreservation technology undermines established supply chains (and, by extension, organizations with a financial interest in maintaining them), this may pose a risk to organizations developing the new technology.

Because of this interplay between threats to value and stakeholders, the Risk Innovation approach considers both threats to areas of value that are important to an organization — referred to as the “enterprise” — and threats to areas of value that are important to key stakeholders. Both may lead to risks that need to be navigated, as illustrated in Figure 1 .

Figure 1 A schematic representation of the Risk Innovation approach to identifying and navigating risk as a threat to value within a multi-stakeholder environment.

Many areas of value addressed in the Risk Innovation approach are not quantifiable. This is precisely the type of challenge that the Risk Innovation approach was designed to address. Building on the framing of risk as a threat to value, the Risk Innovation approach identifies 18 “orphan risks” across three domains (social and ethical factors, unintended consequences of emerging technologies, and organizations and systems) that potentially threaten the preservation of existing value or the growth of new value ( Table 1 ).²⁴ The term “orphan risks” refers to the tendency of organizations and individuals to ignore such risks, despite their importance in informing strategic decisions. The 18 orphan risks were developed by drawing on the types of challenges that emerging technologies startups and founders in particular struggle to address. The list is not exhaustive, and there are many risks — for instance, the “risk” of hype and overblown claims of benefits, or the “risk” that may be posed by political or ideological agendas and narratives — that are captured implicitly in the list but not explicitly named.

Table 1 Orphan risks as used in the Risk Innovation methodology.

One of the most basic tools in the Risk Innovation portfolio is the Risk Innovation Planner.²⁵ This was initially developed to guide new thinking with users who have limited time to devote to this process, and yet need to increase their awareness of orphan risks and identify approaches to navigating them. The Planner consists of a 2-page online worksheet that can be completed within 1 – 2 hours, and takes users through a process of (1) identifying key areas of value to their enterprise, investors, customers, and the communities associated with them and their products; (2) mapping areas of value onto orphan risks; (3) exploring how threats to enterprise and stakeholder areas of value potentially lead to hurdles to progress; and (4) identifying next steps in navigating the resulting risk landscape. The process is intended to catalyze thinking, rather than providing definitive solutions.

The Risk Innovation Planner is foundational to a more extended approach that is designed for groups exploring emerging risk landscapes. This is the approach used in this study. The extended approach we employed takes a small group of stakeholders through a workshop process of identifying key areas of value relevant to a specific enterprise or sector, mapping these to orphan risks to produce a risk innovation landscape, and exploring strategies for navigating these risks.

Given the potential of advanced biopreservation technologies and the uncertainty associated with their successful development and use, we were interested in the use of the Risk Innovation approach to generate a subjective, but informative and actionable, assessment of barriers to progress that might otherwise be overlooked.

V. Methodology

In this study we used established Risk Innovation approaches but extended them to working with diverse stakeholder groups within three specific domains of advanced biopreservation technologies. As this was a novel extension of an approach that was originally designed as a guide to decision-making within an organization, the study was meant to explore the utility of the approach as much as it was designed to develop insights into the successful and socially beneficial applications of advanced biopreservation technologies.

To develop a clearer understanding of the risk landscape around emerging advanced biopreservation technologies using a Risk Innovation approach, we developed and convened three 90-minute workshops. We invited ATP-Bio Partners (described below) to each workshop. We specifically invited Partners in three areas of application: food systems, human health, and biodiversity. Each workshop was devoted to one of those areas, with Partners involved in the area being invited to the relevant workshop. The protocols followed were approved by the Institutional Review Boards (IRBs) of Arizona State University and the University of Minnesota, the home institutions of those researchers directly involved in the workshops (A.M., M.S., T.T., S.W.). In each workshop the two leaders (A.M. and M.S.) took participants through a 2-step protocol based on the Risk Innovation Planner. This was designed to draw on participant insights to identify key areas of value for enterprises, investors, customers, and communities associated with advanced biopreservation technologies in each of the workshop focus areas.

Invitees and participants in each workshop were drawn from the member Partners of ATP-Bio. NSF defines Partners as (1) industrial Partners — companies that help build an industrial constituency within the center; and (2) practitioner Partners — organizations that support research and will use the outcomes in the delivery of services. The member Partners within ATP-Bio include large, small, and start-up businesses; non-profit organizations; government agencies; and museums. At the time of the study, ATP-Bio had a total of 36 Partners. Eighteen organizations were invited to send a representative to the workshops, based on their alignment with the focus areas. Sixteen organizations participated. The number of participants and the sectors represented in each workshop are shown in Table 2 .

Table 2 Number of participants in each workshop, and sectors represented by participants.

All the organizations, except for one, sent a single individual to participate in a session. One organization sent two individuals representing different functional areas of the organization, giving a total of 17 individual participants from a total of 16 Partners. Overall, this represents an 89% participation rate from the invited ATP-Bio member Partner organizations (16/18). Each workshop had between 4 and 8 participants. All participants consented to participation and use of their de-identified data.

Each workshop was conducted using the same protocol. Prior to each workshop participants were encouraged to access various Risk Innovation resources on the Risk Innovation website,²⁶ including a description of the Risk Innovation approach and orphan risks. These included downloadable Risk Definition cards and a Risk Innovation Landscape template. In each workshop, participants were initially given a brief introduction to the Risk Innovation approach and process. This included a description of risk as a threat to value, the concept of orphan risks, how to construct a visual risk landscape that matches perceived areas of value to perceived orphan risks, plus a short case study from the field of artificial intelligence (AI) demonstrating the application of the approach.

Each participant was then given 15 minutes to complete an initial online worksheet where they identified key stakeholders in the following categories, along with key perceived areas of value of relevance to them: (1) enterprises associated with advanced biopreservation technologies (participants were asked to consider their own enterprise, or enterprises that they considered important to the domain); (2) investors in the enterprises they had previously identified; (3) enterprise customers; and (4) communities potentially impacted by the identified enterprises. Participants were provided with 73 pre-identified types of value as they filled in the worksheet (see Appendix 1). They were encouraged to either use these or write down other areas of value as they saw fit.

Participants were subsequently provided with a more complete description of orphan risks. They were then given 15 minutes to complete a second online worksheet that asked them to visually align areas of value identified for each stakeholder category with the orphan risks as described in Table 1 .

After each workshop, the collected data for each workshop were de-identified, cleaned up, and aggregated with respect to areas of value and orphan risk. As participants used a variety of methods and shorthand notes to complete the worksheets, cleanup included transferring responses from each worksheet to a separate document where they were reformatted and, where necessary, articulated in complete and coherent sentences.

To create an aggregated risk landscape for each workshop, identified areas of value for each stakeholder category were manually clustered into groups by identifying common themes and foci. These in turn were summarized using language that captured the essence of each cluster. Following the Risk Innovation approach typically used with organizations, we used participant feedback to identify areas of value and orphan risks that particularly stood out. This is an intentionally subjective process that is designed to avoid “paralysis by analysis” when working with organizations by forcing them to focus on a small but relevant number of areas of value and associated orphan risks.

Using this approach, we identified 3–5 areas of value for enterprises, investors, customers, and communities, around the development and use of advanced biopreservation technologies in food systems, human health, and biodiversity. We also identified a subset of orphan risks associated within each stakeholder category that particularly stood out: For each category, orphan risks were clustered according to the number of times they were identified within a workshop, and the stand-out orphan risks noted. To reduce the chances of analyst bias, the identified areas of value and orphan risks were checked by three researchers who were present in each workshop.

The processed data were then used to construct visual summaries of identified areas of value and orphan risks for each advanced biopreservation technology domain ( Tables 4–7 ). These tables reflect the manner in which areas of stakeholder value and orphan risks are typically presented when using the Risk Innovation approach. The relative frequency with which each orphan risk was identified as relevant in each workshop was further noted. These frequencies are shown in Figure 2. Tables 4–6 and Figure 2 reveal participants’ perceptions of areas of value and associated orphan risks. As the workshop participants were stakeholders familiar with advanced biopreservation in organizations that were established ATP-Bio Partners, the data offer an initial indication of types of value and risk within the three domains of food systems, human health, and biodiversity. They also indicate areas of potential convergence and divergence across these domains.

Figure 2 Relative frequency with which each orphan risk was identified as a risk in each of the three workshops: A) Food Systems, B) Human Health, C) Biodiversity.

VII. Analysis

B . Areas of Value vs. Orphan Risks

Tables 4–6 show orphan risks identified for each stakeholder group in the three workshops. The format of the tables mirrors that used in the Risk Innovation approach, and provides a visual representation of the “risk landscape.”

In each table, the orphan risks associated with the enterprise represent risks that directly threaten the areas of value associated with the enterprise. In Table 4 (Food Systems) it can be seen that “black swan” events, governance and regulation, and organizational values and culture, were considered as some of the more prominent threats to maintaining and growing value for the enterprise.

In contrast, the orphan risks associated with investors, customers, and communities represent potential threats to value associated with these specific stakeholders, and not directly with the enterprise. Thus, in the Food Systems workshop ( Table 4 ), ethics, “black swan” events, and governance and regulation were identified as potential threats to value for investors, while threats to value for customers were “black swan” events, loss of agency, and standards. Orphan risks for communities included social trends, perception, health and environmental impacts, and reputation and trust.

Where an enterprise engages in behaviors and actions that threaten areas of stakeholder value through these risks, there is an elevated chance that it will encounter barriers to success. Of course, not every orphan risk identified with a stakeholder will be relevant to the enterprise. But the maps shown in Tables 4–6 indicate potential orphan risks that developers and users of advanced biopreservation technologies may want to be aware of. We should note that the single orphan risk that cut across all stakeholder groups in a given workshop was ethics. Table 5 shows that participants in the Human Health workshop saw ethics as an orphan risk germane to areas of value for all four stakeholder groups — the enterprise, investors, customers, and communities.

Table 5 Areas of value versus orphan risks identified for advanced biopreservation technologies in the domain of human health.

This mapping of risks to areas of value is at the heart of the Risk Innovation process. When working with individual organizations, the map will be unique to the person or organization carrying out the exercise and will act as a guide to areas that they may need to pay closer attention to. In this study, the mapping aggregates across multiple persons and organizations in a particular domain of application for ATP-Bio technologies. Our process demonstrates how bringing together a community of stakeholders can begin to identify areas requiring attention that may otherwise remain obscured.

C . Relative Importance of Orphan Risks Across Domains of Advanced Biopreservation Technologies

Figure 2 plots the relative frequency with which each orphan risk was identified by participants in each of the three workshops. Data have been normalized between the workshops (given the different numbers of participants in each workshop) to enable direct comparison between them.

Care needs to be taken in interpreting these data, as risks are aggregated across the stakeholder groups for each workshop. However, the distributions provide insights into the risks that participants considered to be most relevant in each of the three domains of food systems, human health, and biodiversity.

Looking for commonalities across the workshops, the 5 orphan risks that have a relative frequency of at least 5 in each of the workshops (the midway frequency) are ethics, perception, “black swan” events, governance and regulation, and reputation and trust. With the exception of “black swan” events (which participants may have considered a catch-all category for risks they could not foresee) these are all risks that are associated with societal behavior or policy. This cluster of orphan risks underlines the importance of engaging with stakeholders to understand and navigate a complex societal and policy landscape between potentially transformative ideas and positive social impact.

Contrasting participant perspectives across the 3 workshops, 3 risks have a frequency greater than 5 in the Food Systems workshop (perception, “black swan” events, and governance and regulation). This compares to 10 in the Human Health workshop (ethics, perception, social justice and equity, “black swan” events, health and environment, loss of agency, product lifecycle, bad actors, governance and regulation, and reputation and trust); and 8 in the Biodiversity workshop (ethics, “black swan” events, co-opted tech, health and environment, product lifecycle, bad actors, governance and regulation, and reputation and trust). There is less variation in frequency across orphan risks in the Human Health and Biodiversity workshops when compared to the Food Systems workshop (where there is subjectively greater variation in the frequency with which different risks are identified), indicating a wider range of orphan risks being considered relevant by participants. Here it is worth noting that, because Figure 2 represents all identified risks across all stakeholder groups, there are differences in the number of times a particular risk appears in Tables 4–6 (which show only a subset of risks as described above), and in Figure 2 .

Table 6 Areas of value versus orphan risks identified for advanced biopreservation technologies in the domain of biodiversity.

Comparing the data in Figure 2 from the Human Health and Biodiversity workshops, ethics is identified in both cases as being important to the success of advanced biopreservation technologies, as is reputation and trust, and governance and regulation, while the behavior of “bad actors” (organizations that give the technology a bad name) is a clear threat. Health and environmental impacts also rank high. In contrast, the risk of co-opted technologies (those that are used for purposes for which they are not intended) ranks higher in the Biodiversity workshop than in the Human Health workshop, while privacy is flagged as being more important in human health applications.

These comparisons in risks identified across the 3 workshops reveal 2 threats to value with scores above 5 across all three domains of application for advanced biopreservation technologies — “black swan” events, and governance and regulation. This suggests the importance of (1) building “safety net” strategies to deal with unexpected threats in developing new technologies such as advanced biopreservation, and (2) engaging early with problems of governance and with potential regulators.

Comparing identified risks across the three workshops also reveals those risks seen as more relevant to specific application areas. For instance, privacy is a lower concern for biodiversity than human health and food systems, as are social trends, while co-opted tech is indicated to be a higher concern for biodiversity. Similarly, concerns around loss of agency are indicated to be more important in the domain of human health than the other two domains. These differences indicate that the perceived risk contours within different application domains of advanced biopreservation technology are not convergent, and that advanced biopreservation should not be approached as a monolith when considering potential barriers to success.

Our data and analysis suggest that a Risk Innovation approach can have considerable utility in helping bridge innovation and application in areas where advanced technologies face a complex array of orphan risks. While further research is needed to fully explore the utility of this method, both with advanced biopreservation technologies and for a wider range of emerging technologies, we conclude that Risk Innovation approaches should be considered an important set of tools to help support the development and application of new technologies to secure social benefit — particularly within the context of the National Science Foundation’s Gen-4 ERCs.