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Toward Equitable Innovation in Health and Medicine: A Framework (2023)

Chapter: 3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity

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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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3

The Innovation Life Cycle in Health and Medicine and the Challenge of Equity


Any consideration of how the innovation system can be better aligned with equity must begin with an understanding of how technologies in health and medicine develop. This chapter provides an overview of the U.S. system for biomedical science and technology development, using a simplified conceptual model of innovation processes as they take place over time and with the contributions of multiple parties. While no single path of innovation exists, and different technologies follow variable paths of development, this generalized model can assist in identifying how and where inequities arise and how and where technological innovations in health and medicine can be better aligned with equity.

The chapter begins by presenting this conceptual model of the innovation life cycle, briefly identifying key choices and actors during each phase and illustrating them with the example of drug and vaccine development. The chapter then provides more in-depth discussion of actions during each life-cycle phase, along with analyses of how the current innovation system considers or fails to address equity. An example exploring the development of artificial intelligence (AI)/machine learning (ML) in the context of the innovation life cycle illustrates some of these alignments and misalignments.

CONCEPTUAL OVERVIEW OF THE INNOVATION LIFE CYCLE

To frame and organize its work, the committee developed a simplified conceptual model illustrating the innovation life cycle in five phases, with associated points at which decisions and choices influence how a technology progresses to the next phase (see Figure 3-1). The model is depicted as a circle rather than a linear progression to recognize that information gained from prior research, development, and use will ideally feed into and inform future innovation efforts, along with new knowledge discovery. Other sources of knowledge, including forms of community knowledge, can also play important roles in the generation and design of ideas.

The innovation process is defined by people working within existing institutions and systems, making choices at key points in each phase of the life cycle. Innovation is a process

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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FIGURE 3-1 A simplified conceptual model of the innovation life cycle. Innovation in health and medicine is a complex and variable process, involving the contributions of a wide range of actors; potential for multiple recursions within and between phases; and often iterative cycles of research and development, evaluation, and learning. This model is necessarily a simplification: In reality, the insights from multiple groups and sources of knowledge feed into the system and it is not always truly circular.

that takes place over time and that involves the contributions of a wide range of parties. The phases and choices reflected in Figure 3-1 and described in this chapter are associated with the activities necessary to translate a body of knowledge into an intervention or technology—understood as something that clinicians or other users can employ in the real world to bring about some kind of benefit. Even this simplified model involves many different actors, some of whom are able to exert greater influence over some of the choice points than others. Ultimately, the decisions and choices made as innovation proceeds reflect leverage points at which the development process can be influenced by those involved and by changes to incentive structures (discussed further in Chapter 4).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Context for the Simplified Innovation Model

Efforts to model the innovation process necessarily reflect the goals and values of those who produce the models. The technology development model used in this report is intended to capture elements of the process relevant to alignment with ethical principles, focused on equity. In reality, there is no single innovation life cycle. Innovations in health science and technology follow diverse paths from conception to funding, design, development, marketing, adoption, market success or failure, incorporation into health care, and so on. Ideas fail at different stages, and the paths taken are often recursive and the process disjointed. New technologies in the ecosystem can expand suddenly and radically, or their development can be foreclosed. Moreover, it is important to emphasize the extent to which, throughout the system, the process and governance of science, technology, and innovation are based on data—including data from prior research as well as the collection of new data—and on the human labor of researchers, patients, and members of the public who are involved in the testing, feedback, and use of products. Important as well is to recognize that considerations of equity associated with science, technology, and innovation in health and medicine involve a web of connections that link the research and development process to goals that fall outside of this process. These goals depend on the nature and distribution of the health needs in a society, the ability of health-related institutions to meet those needs, and the alternatives that are available to close these gaps.

Figure 3-1 does not explicitly convey the social and ethical context within which any innovation process exists, but it is critical to recognize the influence of values, assumptions, incentives, and historical legacies on the choices that have been and continue to be made and that can shape innovation differently. This report focuses primarily on the U.S. context for innovation, and the U.S. legal and policy environment profoundly affects the innovation process. Other countries having different historical legacies or prioritizing other values may undertake innovation and govern it differently through their respective national and regional legal and policy frameworks. Finally, the descriptions in this chapter focus primarily on describing those processes, structures, and choice points most closely associated with the development of drugs, vaccines, medical devices, and other forms of innovation in health and medicine that are regulated by the U.S. Food and Drug Administration (FDA) and are influenced by coverage decisions by the Centers for Medicare & Medicaid Services and other health insurance payers. Other forms of health innovation, including the rapidly evolving integration of AI into consumer technologies unregulated by the FDA, are discussed in less detail and may entail different processes, structures, and choices.1 Important health-related research can also advance knowledge without directly leading to new technologies and products.

Brief Descriptions of Phases and Associated Choice Points

Brief overviews of the phases are illustrated in Figure 3-1. The major actors, choices, and equity dimensions associated with each are reviewed below and analyzed in greater detail in later sections of the chapter. Equity and broader ethical considerations can be relevant at every stage of this life cycle. As a result, these phases and the associated choices made as innovation progresses offer opportunities for all involved—funders, inventors, designers, end users, and so on, from both public and private organizations—to consider whether inequi-

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1 Appendix C looks at roles and actions of the Federal Trade Commission in considering equity associated with products and technologies.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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ties have arisen, what potential actions can be taken to mitigate them, and what actions are needed to prevent new inequities from arising (discussed further in Chapters 4 and 5).

Conceiving of and Embarking on an Idea

This phase represents the earliest points at which stakeholders adopt the commitment to pursue an avenue of emerging science or develop a particular kind of technology. Idea conception and research are themselves broad categories in health and medicine, with differing implications for equity and thus differing responsibilities for awareness and action (explored further in Chapters 4 and 5). Research may involve knowledge discovery not tied to an application in human health (e.g., new tools and techniques that advance the rate, depth, or resolution of knowledge discovery, or determination of a molecular mechanism controlling gene expression); in other cases, proposals build on and apply previously discovered knowledge to health challenges, placing a direct responsibility on the research team to address the intersection of the project design with equity. Increasingly, researchers and funders are also recognizing the importance of working not only with end users, such as health care providers, but also with nonprofit patient advocacy groups and affected communities as key partners in identifying and formulating research questions and goals and designing studies.

Choices around idea conception, design, funding, and obtaining required approvals influence whether and how an area of research is pursued and its transition to the next phase of development. After the choice has been made to pursue a particular area, actions during this phase can include the formulation of relevant research questions; development of proposed research plans; application, review, and receipt of research funding; and procurement of necessary institutional approvals associated with the safe, secure, and ethical conduct of research. In addition to researchers and research-conducting organizations, significant roles are played by organizations that provide funding support (including government agencies, private philanthropy, nonprofit organizations, and the private sector).

Equity can be relevant to decisions made during this phase in several ways: (1) because, broadly, having a research and innovation enterprise that includes members with varied interests, training, and backgrounds impacts the research ideas that are proposed; (2) because who has funding and decision-making authority affects which areas of knowledge are prioritized and funded; and (3) because decisions made during this initial phase of the innovation life cycle may influence subsequent phases. Who gets to propose and decide the questions that should be pursued, the nature of the problem, the goals of the research, and who will pursue it influence research directions and methods; whether a solution is technological, social, environmental, or infrastructural; how technologies are designed and distributed, including questions of access and affordability; and whether future ideas and research questions build iteratively on or are inspired by the results.

Researching, Developing, and Assembling a Technology

This phase includes exploratory and proof-of-concept research, along with other efforts to design and manufacture a product or intervention and accumulate the knowledge necessary to use it in practice. This phase also encompasses research and development activities at different levels of advancement toward a potential product, and the nature of the research and its progress toward technological readiness influence which governance levers and actions will be most effective at supporting equity. Significant actors during this phase include academic and nonprofit research and development organizations, as well as for-profit companies, patent and licensing experts, and investors. Choices made during this

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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phase continue to affect how research and development is carried out and disseminated, as well as how resulting intellectual property is managed and whether further funding and investments are obtained.

As research progresses, the translation and scaling path for biomedical technology is complex. During this phase, assessments of the potential economic value of a technology take place. Many early-stage technologies fail, and development costs can be high. As a result, many developers seek private investment, and decisions about patents, trade secrets, and intellectual property play strong roles in procuring such investment (Budish et al., 2015; Cohen et al., 2000). Further, choices made here may influence downstream choices related to the cost and coverage of those technologies that do reach the market, including how patent expiration affects pricing (Chandra et al., 2022; Vondeling et al., 2018).

As these research and development efforts are designed and conducted, developers and investors make decisions related to cost, speed, and complexity that can intersect with equity. For example, the desire to produce a technology as quickly as possible and maximize the time for which it receives patent protection can result in practices that widen knowledge gaps among potential treatment subpopulations; such gaps increase the risk that inequities may emerge later when a technology is used more widely (Kimmelman and London, 2015; London and Kimmelman, 2016, 2019). Researchers and developers must also continue to comply with relevant federal and institutional regulations and practices for responsible conduct of research. Research involving human participants is governed by a variety of requirements, including extra scrutiny on studies in certain marginalized populations, such as those who are incarcerated or are considered to have diminished competence to consent. Research involving human subjects is also subject to, for example, approval from institutional review boards (IRBs), although there are currently limited requirements for IRBs to include members of affected communities or for clinical trial investigators to consult these populations.2 As described in Chapter 4, the FDA is currently taking action to increase racial and ethnic diversity in clinical trials.

Evaluating a Technology’s Performance

This phase includes subjecting the technology to late-phase, confirmatory testing to generate the evidence necessary to justify claims of safety and efficacy before widespread public use. Choices during this phase involve the collection and assessment of sufficient performance information to support widespread use, as well as the processes used in making regulatory decisions and issuing market approvals. Contract research organizations are assuming growing roles in the conduct of clinical trials and other late-stage testing on behalf of principal investigators, and this market is projected to reach more than $60 billion globally in 2030 (Getz et al., 2014; Research and Markets, 2022). Patient advocacy groups are also playing a growing role in recruiting participants for clinical trials (Merkel et al., 2016).

Many biomedical technologies considered to be higher risk, such as new drugs, must be evaluated by expert scientific reviewers and receive regulatory authorization before they can be marketed legally. This requirement does not apply to all technologies relevant to health and medicine; it excludes, for example, those deemed to be lower risk, such as dietary supplements. Regulatory agencies, such as the FDA, often determine what testing is required before marketing, while agencies such as the Federal Trade Commission (FTC) influence consumer technologies available to the public.

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2 See 45 CFR §46.107 for information on IRB membership (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/revised-common-rule-regulatory-text/index.html#46.107; accessed June 30, 2023), although, for example, IRB review for research involving incarcerated individuals includes at least one prisoner-focused member.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Equity considerations during this phase include decisions about the populations in which performance is assessed, including how representative they are of the range of potential end users. The desire to complete trials quickly can lead to recruitment of homogeneous study populations or those with characteristics that represent the most favorable case for clinical benefit, even if those populations are not representative of the population of patients likely to use the technology in practice (Sharma and Palaniappan, 2021). Recent guidance on the inclusion of participants with a wider range of skin tones (FDA, 2022a) or on the appropriate inclusion of participants who are pregnant or lactating illustrates the continuing evolution of practices in this area (NASEM, 2022b).

Accessing and Using a Technology

Broadly speaking, the technology developer, who may own some of the intellectual property, or firms that license the intellectual property decide when, how, and where the innovation is deployed and how much it will cost.3 These decisions are often made through some form of market analysis and are sometimes made in response to pressure from public and private payers, including Medicare, Medicaid, and private health insurance providers. Health insurance providers themselves sit within a complex legal and regulatory landscape that informs the cost and coverage of medical technologies, and the eventual cost to the patient. Further, payer decisions may or may not be influenced by information on the comparative effectiveness of the technology among different groups of people.

The choices made during this phase intersect with equity, justice, and fairness primarily with respect to how and whether a patient population that would derive benefit from a given technology can actually access it and receive its benefit. Decisions on marketing, cost, health care adoption, and insurance coverage for a technology may be made without considering the range of factors that influence certain patients’ ability to access and use it (such as income level, employment or insurance status, age, geographic location, disability status, or internet access).

Learning from a Technology’s Deployment

Information on a technology’s performance in the market is necessary for feedback and system learning, identifying new types of questions or research directions that could be pursued, and informing changes or adjustments to the technology itself or to governance mechanisms in light of the technology’s real-world implications. Problems with a technology may also become apparent only after it is widely available.

This phase encompasses the commitment to ongoing monitoring of a technology’s performance after it has entered the market, as well as the public’s responses to the technology. Choices during this phase include the types and extent of postmarket performance analyses that are required by regulatory agencies and/or conducted by the company, and whether or how information on experience with the new technology is collected and assessed. Equity considerations during this phase include how and in which populations a technology’s performance is monitored, the distribution of risks and benefits associated with the technology’s use, whether and how postmarket data are collected and used, and whether and how action is taken based on the results of such postmarket surveys and studies (London et al., 2012).

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3 For university-based technologies, determinations on technology licensing are often made through institutional technology transfer offices and may involve limited decision making by the scientist or engineer. In other cases, a technology licensee, such as a private company, makes decisions on deployment and pricing.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Illustrating a Development Trajectory: Drug and Vaccine Development

Health and medicine encompass such a range of potential technologies and products that the brief explanations given above are necessarily at a very high level. An example development trajectory for drugs and vaccines provides a more granular look at this process, with the caveat that some drugs and vaccines may follow a different path, and the development trajectories for medical devices and consumer health technologies may be similar in some ways and different in others.

In this example, the first step often begins with government funding for basic research, which generates scientific insights that point to promising opportunities for medical innovation (Azoulay et al., 2019; Li et al., 2017). The contribution of public funding to drug development can be substantial. For example, a recent paper reports that during “2008–17, about 25 percent of small-molecule drugs and 42 percent of biologics had direct connections to public funding, even when in late-stage development,” and that extensive federal funding for the discovery and development of anti-HIV drugs has led to debates and ongoing litigation over related intellectual property rights and the high drug prices being charged (Tessema et al., 2023). Another analysis found greater public-sector influence (government funding and public-sector patents) associated with drugs that received FDA priority review approvals (Sampat and Lichtenberg, 2011), a designation for drugs that offer significant improvements.

Scientific insights may be taken up for further development and commercialization. One route is for an entrepreneur, who may be the academic behind an idea, to form a start-up company in an attempt to translate this opportunity into a marketable product. Indeed, an analysis of new drug approvals found that half of drugs addressing an unmet medical need or considered scientifically innovative were initially discovered in universities and biotechnology companies rather than large pharmaceutical companies (Kneller, 2010). This is the point at which venture capital (VC) investors may enter the picture, providing funding needed by the entrepreneur to support the research and development necessary to create a viable product. The VC investor and company also may need to license the technology from the university that holds key patents for the idea. In other cases, a technology may be picked up or licensed by a large firm that aims to commercialize it.

Before being allowed to sell a drug or vaccine, companies must demonstrate the product’s safety and efficacy and obtain approval from the FDA (or from other regulatory bodies if they wish to sell the product in other countries). This is a complex and expensive process that often takes a decade or more to navigate. Until a drug or vaccine has been approved to enter the market, it generates no revenue for the company, and the funding to support its development comes from the company itself and investors. The incentives and choices that guide investors are often about extracting a return beyond what was invested in development, and such profitability choices do not always align with equitable health outcomes. VC investors typically exit the process (and receive a payout, or not) when one of three things happens: the technology or company fails, the start-up company is acquired by a larger pharmaceutical company, or the start-up company moves to an initial public offering (IPO). From this point forward, company shareholders benefit from any profits generated through the product’s commercialization.

It is worth noting that the cycle of medical innovation described in this report, particularly the role of VC investors, is largely an American industry (Chandra et al., 2022). Basic research funded by the U.S. government generates a large share of the research insights that lead to patents, and investors and companies based in the United States account for many of the medical technologies commercialized worldwide. The global engine for medical research and development is largely concentrated in limited geographic areas, including

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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the San Francisco Bay area, Boston, and several other locations (Chandra et al., 2022). This concentration of actors can lead to inequities, although innovation clusters also provide potential opportunities to influence research, investment, development, and deployment decisions to advance equity.

Box 3-1 provides an example of how this process played out in the case of the pharmaceutical company Moderna. The company’s story is similar to that of other health technology developers in that considerations of equity were largely separate from and subordinate to other drivers behind the technology development and commercialization process. Nevertheless, the company made decisions around the location and enrollment for its COVID-19 vaccine trials aimed at improving the representation of people of color (Hill et al., 2023). Its resulting COVID-19 vaccines and boosters saved millions of lives (Watson et al., 2022).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

The case of the drug sofosbuvir for treatment of hepatitis C (see Box 3-2) provides several further lessons on the opportunities and limitations of medical innovation to address health needs in alignment with equity.

ASSESSMENT OF THE EXISTING INNOVATION SYSTEM

This section focuses on identifying opportunities for a coordinated governance framework to embed equity more systematically in emerging technology development and innovation in health and medicine. To this end, it analyzes U.S. practices, policies, and structures that govern innovation in health and medicine in greater detail; how ethical principles including fairness, justice, and equity are addressed during this process; and how the current system fails to systematically align innovation with equity.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Conceiving of and Embarking on an Idea

How a problem is defined and funded and who is involved in research design have downstream implications for what research is done, how it is undertaken, and how researchers assemble a technology for the next phases.

Which Problems Are Addressed and By Which Actors

Problem conceptualization and early-stage research build on the discovery of new knowledge; existing knowledge and gaps, needs, and opportunities; and insights from prior research, development, and innovation activities. Subsequent technological advances can arise from research questions developed through a discovery-based approach, as well as research directions driven by hypothesis. Further, the conception and pursuit of a research question can occur at as small a scale as a single investigator or single-team initiative, or can arise from large, mission-driven initiatives at the organizational or governmental level. In some cases, an avenue of research to pursue is selected in response to the identification of a health or social challenge for which the knowledge base is underdeveloped and that could benefit from investment of resources. In other cases, this commitment arises when stakeholders regard the knowledge base in an area as being ripe for translation into a novel technology, tool, or intervention or because actors believe it is potentially lucrative. In still other cases, new avenues of research are driven by curiosity, without direct consideration of future applications.

This early stage often takes place in nonprofit settings, such as universities, although private-sector companies and research conducted by government scientists are involved as well. Numerous considerations shape what research areas are prioritized and how funding decisions are made. Equity has sometimes been among these many factors, but the alignment of proposed research with equity is often not explicitly considered or required for the research to be initiated.

The Research Workforce and Efforts to Diversify It

Researchers study what interests and is important to them, and if the research workforce includes a narrow range of human experience, the questions asked will be similarly narrow. While Chapter 2 makes clear that diversity is not synonymous with equity, which researchers and teams conceive of and embark on an idea and get credit for resulting publications and intellectual property is an important contributor to equity. For the most part, institutions of higher education, government research facilities and national laboratories, businesses and other private entities, and nongovernmental and other nonprofit institutions include and rely on a highly educated workforce and leadership team responsible for developing research directions and business plans, applying for and securing funding, and conducting the research (Funk and Parker, 2018; NSF, 2020). Long-standing demographic disparities in science, technology, engineering, and mathematics (STEM) participation are well documented, ranging from undergraduate and PhD degree attainment, to receipt of substantial research grants such as National Institutes of Health (NIH) R01 awards, to faculty employment at major research-conducting universities, to the private-sector STEM workforce (NIH, 2021; NSF, 2019). This situation directly influences who generates the research questions that are ultimately pursued and translated to technological advances, and results in disproportionate access to funding and resulting intellectual property.

Potential solutions and recommendations for addressing these long-standing challenges to diversifying the workforce of investigators and innovators have been proposed (NASEM,

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

2023), and would contribute to advancing equity in innovation. Beyond traditional research pathways, small-scale and grassroots efforts have also been undertaken to experiment with generating solutions for problems identified at the community level, including by patient advocacy groups. These efforts can also include “do-it-yourself” biology and biohacking approaches. One example is the Open Insulin Project, which is seeking to develop community-centered, low-cost insulin to address an identified cost and access gap (see Chapter 4).

The Role of the U.S. Federal Government in Setting Research Priorities and Funding Early-Stage Research in Health and Medicine

The U.S. government plays an important role in generating the knowledge base that serves as the foundation for medical innovation opportunities. For example, an important breakthrough in oncology stems from understanding the role of the PDL1 ligand and PD1 receptor in the immune checkpoint system. NIH support helped create the knowledge needed to understand the roles of these molecules in the development of certain cancers. Unlocking these insights created the context in which for-profit companies were willing to embark on research into immune checkpoint inhibiters (Bardhan et al., 2016).

One of the roles of the government is creating, maintaining, and improving the social institutions that support the health and well-being of Americans. Market failures in investments to address the health needs of marginalized or underserved populations can result from immaturity of the knowledge related to health needs common in these groups. Government thereby has a responsibility to produce the information needed to close such gaps between the needs of its citizens and the ability of their individual and public health systems to address those needs effectively, efficiently, and equitably. This responsibility is grounded in the fact that whether U.S. health-related institutions can fully understand the health needs of all Americans and provide safe and effective prophylactic or therapeutic measures to meet those needs depends on the maturity of the information available about these needs and measures.

Government influences the direction of research through its control over funding. Substantial early-stage biomedical research is funded by federal agencies including NIH, the National Science Foundation (NSF), and the U.S. Department of Defense (DoD). One analysis of drug development, for example, found that 54 percent of basic science milestones were supported by public funding, while private-sector funding was dominant in subsequent drug discovery and development phases (Chakravarthy et al., 2016). The criteria used by agencies and other funders to allocate research dollars thus influence the distribution of scientific efforts and the probability that new discoveries will be made, as well as the probability that others will embark on technologies that build on these efforts. To the extent that research develops the knowledge base on which private actors later build, decisions about how to invest resources in the early phases of innovation play a role in shaping the development activities of private firms.

A number of factors influence how a funding organization allocates its resources. What research is supported by agencies such as NIH is influenced by the faculty and other investigators who submit proposals, serve on peer review panels, and assist agencies is identifying knowledge gaps and priorities. As a result, who has decision-making roles as members of funder advisory boards and review panels, as program managers, and in other decision-making positions influences the innovation system. There have been long-standing concerns about underrepresentation on peer review panels (by race, gender, research institution, and other factors [Volerman et al., 2021]), as well as calls for greater involvement by patient representatives and others.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Patient advocacy organizations can also play important roles in shaping research agendas, as affected by the capacity of patient and community organizations to engage meaningfully in these processes. Not all diseases or communities are associated with large or well-funded advocacy organizations, and in some cases, smaller organizations, including the Chordoma Foundation and Castleman Disease Collaborative Network, have also had success in advancing research in their area of interest. The Chan Zuckerberg Initiative is now funding a network of 50 rare disease organizations, modeled after the success of these and other rare disease groups, called the “Rare as One” Project.4

Agencies can also use such measures as the health burden of a disease to help guide funding levels and priorities, For example, NIH funding can be correlated with burden (measured as disability-adjusted life years), although some conditions, such as cancer and HIV, have received greater-than-predicted support while others, including migraine and chronic obstructive pulmonary disease, have received less (Gross et al., 1999; Moses et al., 2015). These decisions can have downstream equity implications when the knowledge base for a condition that substantially affects an underserved group remains understudied.

Health Care Organizations and Providers

Health care organizations are also interested actors during problem formulation and the definition of potential use cases. Many medical technologies, from updated dashboards in electronic records to new diagnostic tests and treatments, are used within the context of health systems. Health care organizations can influence choices in this innovation phase by leveraging their gatekeeper roles in approving research, making funding and resourcing decisions to support research, and intentionally involving care providers (technology end users), patients, and communities (users and beneficiaries) in problem definition. The response of San Francisco General Hospital and the University of California, San Francisco to the HIV/AIDS epidemic provides an example of the influence of health care organizations in defining research directions. The establishment of Ward 86 and Ward 5B in 1983—the first dedicated clinics for HIV/AIDS—produced standards of care for patients with HIV/AIDS, and ensuing work by the hospital’s and university’s researchers contributed to medical breakthroughs in HIV/AIDS treatment and prevention (HIV.gov, 2023).

Engaging with Communities

Engaging with those who will use and be affected by technologies is important during problem identification and formulation. It is increasingly recognized that meaningful involvement of the voices of marginalized and underserved communities may produce different paths for research and development from those that might be conceived in the absence of their engagement. This approach to community engagement has been defined by NIH as “the process of working collaboratively with and through groups of people affiliated by geographic proximity, special interest, or similar situations to address issues affecting the well-being of those people.”5 The rationale is that those directly impacted by potential inequities bring their own unique perspectives and understandings of such issues and often more nuanced and locally informed insights into how those issues can best be addressed.

The goals of such community engagement are to build trust, enlist new resources and allies, create better communication, promote sustainability, and ultimately improve health

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4 See https://chanzuckerberg.com/science/programs-resources/rare-as-one/ (accessed May 16, 2023).

5 See https://www.nih.gov/health-information/nih-clinical-research-trials-you/community-engagement (accessed June 30, 2023).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

outcomes. Without such community input, the overall effectiveness of interventions and programs addressing identified needs may be limited (Barnes and Schmitz, 2016). Engagement efforts have long been embedded in social science and public health interventions, often relying on tenets of participatory action research, including bidirectional engagement, the equitable exchange of ideas and values to drive interventions that reflect mutual benefit, and a shared commitment to health equity. Over the last three decades, such approaches have also been embraced by health care delivery organizations, research funders, philanthropic organizations, and advocacy groups, which have championed active engagement with the communities their services or programs are intended to benefit in order to drive the development and implementation of more successful solutions.

The Patient-Centered Outcomes Research Institute (PCORI) is an example of a research organization that recognizes engagement with patients and community members as essential and requires funded projects to engage those concerned in program development.6 NIH has similarly been making efforts to ensure that projects—particularly research aimed at addressing complex, multifaceted problems such as health disparities—engage relevant communities. Examples include the Clinical Translation Science Awards (CTSA) program and the precision medicine All of Us Initiative (see also Chapter 4). Community–academic–health system partnerships have also demonstrated the value of participatory action research in building trust and accelerating innovation. During the COVID-19 pandemic, for example, a community-based initiative codesigned with San Francisco’s Latino Task Force succeeded in understanding and overcoming vaccine hesitancy in the Mission District of San Francisco, where many Latinx people live and work (Marquez et al., 2021).

Central to all engagement initiatives is recognition that there is no one-size-fits-all approach, and that research approaches and engagement strategies need to be tailored to unique needs and circumstances. There are numerous ways to conceptualize “community” and “engagement” at different levels of complexity and cocreation (see Figure 3-2). As the level of community involvement increases from outreach and consultation to collaboration and shared leadership, patients and community members become more than objects of research; they become partners in a research process bolstered by earned trust, with power and decision-making authority of their own. Yet despite such initiatives, the majority of technologies are still developed with limited involvement from those who are their intended targets, consumers, or beneficiaries. As a result, instead of being driven by community needs, interests, and concerns, product development efforts can remain disconnected from the people they are intended to serve.

Researching, Developing, and Assembling a Technology

Activities and governance during this phase influence how research is carried out; how research results are reported and disseminated; how intellectual property is managed and licensed; and what technologies are selected for further investment and development, often by private investors and companies.

Research Pipeline

Early-stage biomedical research often takes place within universities. In 2019, universities performed the largest proportion of basic research in the United States (46 percent) (NSF, 2022). This research is funded by sources that include the federal government, state and local

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6 See https://www.pcori.org/ (accessed June 30, 2023).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Image
FIGURE 3-2 Varying levels of community engagement.
SOURCE: Clinical and Translational Science Awards Consortium, 2011.

governments, institutional funds, and business. In 2021, federally funded research and development at universities surpassed $49 billion, accounting for 55 percent of total research and development by academic institutions. The U.S. Department of Health and Human Services (HHS) was the largest federal source of research and development support to higher education institutions ($27.5 billion, representing 56 percent of federally funded research and development). HHS funds supported more than $24 billion in life sciences and more than $1 billion in engineering research and development expenditures (Gibbons and NCSES, 2022).

The primary means of disseminating knowledge generated from these research investments is publications in scientific journals. As a result, what gets published has a major influence on which findings are ultimately adapted for applications. Factors recognized as limiting the ability to maximize the collective benefits of research investments include the lack of mechanisms and incentives for publishing “negative” findings, along with barriers to accessing, sharing, and reusing data (Bauchner et al., 2016; Matosin et al., 2014; Zuiderwijk et al., 2020). In addition, studies that employ unconventional methodologies, as is sometimes the case with community-based research, may face greater barriers to journal publication, limiting the dissemination of their findings. This landscape may be evolving, however, with increasing use of preprint servers and open-source publishing, as well as recent guidance on public access to federally funded research (OSTP, 2022).

Private-sector companies and investors play key roles in funding efforts to translate basic research findings into commercial products. In selecting which technologies to bet on, companies and investors necessarily select from the options available. Where there are gaps or biases in the types of discoveries made and the types of insights entrepreneurs are working to translate into medical technologies, these gaps and biases are likely to be echoed in the investments of VCs and companies. For example, if NIH funding were to disproportionately favor diseases that affect men, it follows that more discoveries would be made about these diseases, more medical technologies would be developed based on those discoveries, and a disproportionate number of start-up companies would form to capitalize on those technolo-

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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gies. On the flip side, the pipeline for technologies benefiting disfavored groups (women, in this example) would be weaker, and the array of start-ups pitching to VCs or available for acquisition by larger companies thinner.

Intellectual Property Management

Whether the research in question is publicly funded, privately funded, or a mix of both, intellectual property management questions are likely to loom large. Even when earlier-stage work is publicly funded, key downstream patents may be owned by a private-sector firm, a situation that can arise when earlier-stage research leads to a publication that a private-sector patent builds upon. One study that examined data on patents linked to all NIH grants awarded over the period 1980–2007 found that while only about 10 percent of NIH grants resulted directly in a patent, about 30 percent of grants generated articles that were subsequently cited in a patent (Li et al., 2017).

In addition to patents, trade secrets can be important in innovation. For the biologics interventions that constitute almost half of biopharmaceutical spending in the United States (IQVIA, 2020), for example, if key information regarding FDA-required manufacturing processes is protected by trade secrecy, competition necessary to lower prices may be difficult to achieve (Price and Rai, 2016). Because trade secrecy requires demonstrated investments in efforts to maintain actual secrecy, it tends to be a private-sector regime.

Given the importance of private-sector intellectual property and likelihood that it will be managed in a manner that furthers market-driven goals, it is important for analysts concerned about equity to assess how the government confers intellectual property rights. Patents have long played a crucial role in the U.S. innovation system. The Constitution confers upon Congress the power to award patents to inventors as an incentive for “promoting the Progress of...the Useful Arts.” The framers of the Constitution were, however, wary of extended monopolies, and the Constitution specifically states that patents are supposed to be awarded for “limited times.” The laws that established a patent bureaucracy, now the U.S. Patent and Trademark Office (USPTO), for evaluating patent applications are similarly circumspect. They have long required that a patent application be granted only if it covers an invention that is novel, useful, not obvious, and sufficiently described to allow other scientists and technologists to replicate it. If USPTO’s technically trained examiners determine that the invention meets these criteria, a patent is granted, giving the inventors the exclusive right to commercialize their technology for a limited period of time (currently 20 years).

The law on the ground has not, however, always matched the law on paper. As comprehensive empirical studies have shown (Frakes and Wasserman, 2017; GAO, 2016), USPTO examiners lack both incentives and time. As a result, patent holders have been able to claim patent protection over technical areas beyond their actual invention, which can create monopolies that limit research and raise costs over a wide swath of technologies (Parthasarathy, 2007; Trooskin et al., 2015). Inventors have also been able to obtain patents on small, often obvious changes to a technology that allow them to extend the term of monopoly power, a practice pejoratively known as “evergreening.” One analysis found that for each of the 12 top-grossing drugs in the United States, companies attempted to secure an average of 38 years of patent life (i-Mak, 2022).

The U.S. patent system relies on other innovators and competitors to litigate if the scope of a patent is too broad, its term too long, or its disclosure insufficient, but litigation is very expensive, and the incentives of these competitors may be skewed. Equity is rarely front of mind among economic competitors. As a result, technologies can become unaffordable or inaccessible for those who need them most. Ensuring that USPTO and other institutions have

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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the incentives and resources to keep intellectual property regimes within their proper boundaries is critical to aligning innovation with equity. For patents that arise from public funding, additional legal levers may come into play. The Bayh-Dole Act, signed into law in 1980 (P.L. 96-517, Patent and Trademark Act Amendments of 1980), granted universities, not-for-profit organizations, and small businesses the right to retain title to inventions that emerged from federally funded research. Motivating the legislation were the ideas that research is key to new technologies, that technological change fosters productivity gains, and that growth in productivity supports long-term economic growth. Bayh-Dole was conceived to strengthen the first link in that chain—the transfer of knowledge from laboratory research to new technologies. Although both patents and trade secrecy represent important intellectual property for private-sector biomedical technology developers, universities usually rely on patents. Unlike trade secrecy, patents promote transparency and shared understanding of innovative science and technology, but they do so by giving inventors an extended opportunity for exclusive use of the invention in exchange for disclosing its workings.

Universities can realize significant financial gain from patenting and licensing (Mowery et al., 2001; Thursby and Thursby, 2002), although these activities can in some cases be counter to the public interests—for example, if they impede access to research materials and tools (Eisenberg, 2003; Eisenberg and Rai, 2004; Wadman, 2005). Universities and their associated technology transfer offices make key decisions about whether and when to assert intellectual property rights over the biomedical research conducted by members of their community. As an effort of collective governance to meet university needs while advancing science and the public interest, 11 research universities and the Association of American Medical Colleges in 2007 released “In the Public Interest: Nine Points to Consider in Licensing University Technology,” which includes “recommended clauses” for contracts on issues that range from limiting licensing exclusivity to making medical technologies accessible to developing countries.7 The guidance recommends, for example, reserving rights in exclusive licensing contracts that could enable universities to issue additional licenses to address unmet health needs. This guidance has since been endorsed by more than 100 institutions. Adoption of the “Nine Points” document appears to have had a significant effect on the use of clauses such as reservation of rights for education, research, and materials transfer (Contreras, 2022). However, an assessment of 220 publicly available university licenses found that the “Nine Points” language on access has not been widely adopted (Contreras, 2022).

Intellectual property looms particularly large for the small firms that often bring breakthrough products to market and provide key research and development inputs to larger firms. Consistent with economic theory holding that patents facilitate “markets for technology” (Arora et al., 2004), patents undergird interest in small-firm technology among large firms, as well as VCs and other sources of private funding (Farre-Mensa et al., 2016). Intellectual property barriers also provide “pull” incentives for investment by offering the promise of quasi-monopolistic pricing once the technology reaches the marketplace, a practice that long has caused many stakeholders to raise equity concerns (Arno and Davis, 2001; Rai, 2001). These equity concerns also motivated a patent lawsuit brought by the American Civil Liberties Union (ACLU) against Myriad Genetics over its patents on genes linked to breast and ovarian cancer. While the U.S. Supreme Court invalidated the ability to patent human genes as they exist in the body, Myriad Genetics’ initial patent-based control prevented others from researching and developing competing detection tests in the late 1990s and early 2000s (Rai and Cook-Deegan, 2013). Moreover, the libraries of gene variants amassed during

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7 See https://autm.net/about-tech-transfer/principles-and-guidelines/nine-points-to-consider-when-licensing-university (accessed June 30, 2023).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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the process perpetuated the company’s effective monopoly (McElligott et al., 2012), as trade secret law protects a patentee’s market power over data generated by patented inventions even when the patent expires or is invalidated (Simon and Sichelman, 2017). The past decade has seen a legislative effort to restore patent protection for human genes that would reverse the Supreme Court’s Myriad decision and related subsequent legal developments and that, if passed, could have negative implications for equity. Such efforts underscore resistance in the innovation system to reforms that reduce profits but may better align such elements as patent regimes with the public interest.

The default approach to patents invoked by universities after the Bayh-Dole Act has been exclusive licensing. From the financial standpoint of universities, exclusive licensing is often perceived as more lucrative than nonexclusive arrangements, and universities can point to exclusive licensing as important for incentivizing investment in developing the technology and promoting start-up formation. Indeed, both universities and faculty inventors may have financial equity interests (such as stock ownership) in the start-ups (Contreras and Sherkow, 2017). Bayh-Dole has allowed some universities to accrue significant revenue from licensing. The 197 universities that responded to the Association of University Technology Managers (AUTM) 2020 survey reported filing 17,738 new patent applications and being issued 8,706 new patents that year. In 2009, universities derived total licensing revenue of $2.4 billion or approximately 4 percent of the systems’ research expenditures (AUTM, 2010). For example, Columbia University and the inventors received approximately $800 million from licensing patents on how to introduce DNA into eukaryotic cells, techniques that arose from federally funded research and became important in biotechnology (Colaianni and Cook-Deegan, 2009). A small number of universities, however, account for the majority of licensing income, and many do not reap such significant financial rewards (Marcus, 2020).

Economic Viability: The Key Driver for Investment and Development

Private funders (mainly VCs or VC investors) and the companies that develop medical technologies play a central role in translating research insights into practical medical innovations. It is critical to recognize that economic viability is the key driver for both private funders and the companies that develop and market medical innovations. Because economic viability influences every decision made by investors and companies, any attempt to influence the decisions of these actors needs to connect in some way to the ultimate financial returns that may be generated.

VC investors act as both enablers and gatekeepers in the medical technology development cycle, primarily through their investments in start-ups seeking to turn research insights into successful products (Chandra et al., 2022). VC investments come at a critical point in the development cycle, and these investors therefore have an influence on everything that happens subsequently. When investing in biotechnology start-ups, VC funders attempt to identify which medical innovations are likely to succeed, make it to market, and make a profit, and which entrepreneurs are likely to succeed in this process. A VC investor typically enters at the early phases of a start-up’s existence (through seed, Series A, and Series B investments), and the investor’s exit typically comes when the start-up is either acquired by an existing large, publicly traded company or moves forward with an IPO to become a publicly traded company in its own right. For their part, the role of companies or technology developers takes two main forms. The first comes into play early in the development process, when companies use private funding to conduct research and development to create a product. The second comes into play later as the product nears approval and commercialization, when (typically larger, publicly traded) companies invest in bringing the product to market. In both roles,

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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companies must continually determine when to keep investing in a product in the hope that it will eventually generate revenue, and when to stop and cut their losses.

It is also possible that investors or companies can amplify biases and inequities that arise upstream of where they enter the innovation process. For example, investors or developers may disproportionately favor or disfavor technologies benefiting certain groups or entrepreneurs who are members of certain groups, although this is an area not well studied. In any case, inequities rooted primarily in earlier-stage research are unlikely to be addressed by placing a primary focus on investors, and inequities rooted upstream of commercialization are unlikely to be addressed by focusing solely on development and manufacturing companies playing key roles later in the innovation process. This feature helps to highlight the importance of developing a systemic framework for aligning innovation with principles such as equity.

For VCs and companies, the incentive driving participation is profit. In deciding whether to invest in a given start-up—and how much to invest—VC investors calculate how likely they are to make a profit in the end and how big a payoff they can expect. Many factors go into this calculation, but three questions loom large: How many people will use this product? How much would they pay for it? and How long, uncertain, and costly will the development process be? Wealthier people might be willing to pay a very high price for a new cure, but if it cures a disease that is extremely rare, the market size may be too small to yield much profit. Conversely, a product that would benefit millions of people may be unprofitable if the people who would benefit cannot pay a high enough price for it. In addition to calculating the expected market size, investors consider what it will take to get the product to market and the likelihood of failure along the way. These considerations include, for example, what types of clinical trials will be needed and their likelihood of success, what the overall technology ecosystem looks like, what constraints or opportunities the regulatory environment might hold, and the track record of the company leadership.

It is a complex calculation and a risky bet, in which a successful outcome depends on such factors as scientific risk, technical risk, execution risk, policy risk, and economic risk. While some investments in medical technology start-ups generate tremendous returns (2000 percent or more), the median return for this industry in the years after an IPO is negative, meaning that most investments will lose money even after a successful IPO (Cleary et al., 2021). The huge gains reaped occasionally at the top end of the spectrum essentially carry the losses that are far more frequent. The prospect of high returns provides the incentive for VCs to keep investing, but the high level of uncertainty provides a counterbalancing disincentive. To succeed in the long run, investors must be choosy. There are limited profit incentives for private investors and companies to advance innovations that would be accompanied by lower prices or that would largely benefit populations in lower-income settings or countries.

Ultimately, equity is typically an afterthought during the research, development, and assembly phase of technology development, if it is considered at all. Rather, activities during this phase are concerned primarily with the validity of the research and the eventual viability of a resulting technology. As innovation progresses through this phase, economic drivers and returns on investment become key motivating factors and incentives that spur advancement. Still, certain norms and practices that are embedded in this phase, including those around ethical matters guiding the responsible conduct of research, provide insight into the types of opportunities for embedding equity into this phase of technology development.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

Evaluating a Technology’s Performance for Widespread Use

Developers of medical technologies are subject to external governance in the generation and assessment of the evidence used to determine whether a product’s performance, particularly its safety and efficacy, is sufficient to support public marketing. Many clinical studies of novel medical products are governed by regulatory controls, such as FDA application and issuance of an investigational new drug (IND) approval or an investigational device exemption (IDE).8 Regulatory agencies such as the FDA can strongly influence the design and conduct of clinical studies intended to evaluate the performance of a product to support regulatory review.

These agencies provide opportunities for public comment, and such comments often have an impact (as was seen in the case of AIDS activists, and ALS and Alzheimer’s patient advocates pressuring the FDA to approve drugs) (AlzForum, 2008; Epstein, 1998; IOM, 1991; Specter, 1989). At the same time, these agencies are often sensitive to concerns that they are bowing to political pressure. Race-based inaccuracies with devices such as the pulse oximeter (see Box 2-1 in Chapter 2) generated a warning notice from the FDA only after multiple studies had shown problems; there appears to be little proactive consideration of these kinds of issues (Brodwin and St. Fleur, 2021; FDA, 2021).

Developers of medical technologies typically choose the approach to generating clinical evidence for their products. For example, a drug or device developer decides on the type and design of clinical studies intended to generate the evidence required for evaluating its performance. Most testing focuses on establishing the safety and efficacy of the technology, but there is some attention to testing in diverse populations in terms of gender and race/ethnicity9 (see also the discussion of Moderna vaccine trials in Box 3-1 in Chapter 3). Informed consent is a critical ethical component of the generation of evidence from trial participants, and the selection of trial participants, procedures for obtaining informed consent, and what that consent entails have equity ramifications. An IRB is responsible for ensuring that the informed consent obtained meets applicable standards (FDA, 1998).

Inequities in the current systems for pre- and postmarket performance evaluation derive from the challenges of evaluating product performance in a way that is representative across a large population of diverse individuals. The location of many trial sites in urban locations and concerns about added economic costs may deter companies from evaluating the performance of technologies across a diverse population, including those in rural communities (Chaudhry et al., 2022). The infrastructure and tools used by medical technology developers for a clinical study also affect the likelihood that the study will be appropriately representative of diverse groups of patients. For example, tools that allow study activities to be conducted remotely may permit the participation of those who live far from traditional clinical study sites (e.g., in rural areas) (Washington et al., 2023).

Beyond the important ethical reasons for limiting the size of certain types of studies, clinical trials often are also very costly on a per-participant basis (Moore et al., 2020), incentivizing medical technology developers to minimize the number of participants. Advances in the methods and infrastructure needed to improve the efficiency of generating premarket clinical evidence are important for improving the effectiveness of the medical innovation

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8 See https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application and https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process (accessed June 30, 2023).

9 For example, inclusion of women and members of racial and ethnic groups is mandated for NIH-funded clinical research as appropriate to the question being investigated (42 U.S.C. §289a-2; see also https://grants.nih.gov/policy/inclusion/women-and-minorities.htm; accessed June 30, 2023), and the FDA is developing new guidance on diversity in clinical trials (FDA, 2022a).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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system and could also contribute to equity. Increasingly, companies focused on the science and technology of generating clinical evidence play an important role in more advanced types of clinical studies, including those using novel data sources. Decisions by these companies can affect the capabilities and design of clinical studies, how risks and benefits are distributed across groups, and the bandwidth of information such a study is likely to generate (London and Kimmelman, 2019). These companies can also focus on tools for engaging with consenting research participants.

Currently, some segments of the population are unable to benefit from new technologies because they are inadequately represented in clinical research (NASEM, 2022a). Increasing the diversity of participants in clinical research is an important aim that can improve the generalizability of research findings, produce new biologic insights and therapeutic strategies, and increase patients’ interest and confidence in effective new treatments (Schwartz et al., 2023).

Altogether, the evaluation of a technology’s performance is conducted through layered, multidirectional interactions and communication among developers, regulators, and research oversight bodies, as well as the patients, providers, and organizations involved in clinical trials and evaluation studies. These evaluations rely on applicable guidelines and standards related to safety and efficacy and the involvement of human research participants, but they are often incomplete with regard to the full scope of equity considerations set forth in Chapter 2. This incomplete consideration of equity arises from various factors, including cost pressures and other economic factors, as well as the system’s inherent structure of balancing rigid, prescribed methods of assessment (including assessments of ethical considerations) with flexible means of evaluation according to the specifics of a given technology.

Accessing and Using a Technology

For many health technologies, consumers do not directly purchase a product; access is often mediated by health care organizations and insurers. The decisions of health care organizations about purchasing and using new technologies thus affect access to and the cost of those technologies, representing a choice point for equity. However, health care organizations currently have little incentive to prioritize equity in these decisions since doing so has a limited ability to benefit their bottom line, even though it fundamentally impacts their core function of delivering health care services to all patients. Care providers, as employees of health systems, have limited ability to influence choices at the organizational level, while patients, as consumers of health care, may have more influence. Both providers and patients can contribute to the pressure required to drive change.

While health insurance organizations are not technically gatekeepers of health technology, technologies that are not covered by insurance are typically so expensive that most people cannot afford them, making these payers de facto gatekeepers. Their decisions about coverage therefore play a large role in patients’ ability to access and use health technologies. Private payers may have substantial flexibility to limit coverage based on comparative effectiveness information. Government payers in the United States (e.g., Medicare and Medicaid) may be more limited in their ability to condition coverage on information about the performance of a medical technology; Medicare generally conditions coverage for medical technologies on the statutory “reasonable and necessary” requirement.10 The Inflation

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10 See Notices, Federal Register 68(187) for Friday, September 26, 2003 (https://www.cms.gov/Medicare/Coverage/DeterminationProcess/Downloads/FR09262003.pdf; accessed June 30, 2023).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Reduction Act of 2022 also includes provisions that enable the government to negotiate prices for some types of drugs (with exclusions) (Cubanski et al., 2023).

Private health insurance and employer-based health insurance are largely creations of the post-Depression and post–World War II eras and were strongly influenced by the cost-containment measures adopted in the 1970s—for example, by the creation of health maintenance organizations (HMOs) (Hickey, 2022). One possibility for creating system changes toward equity draws on power at the level of individual states, which have the authority to mandate coverage for specific services or to ensure some aspects of equitable access. While not a comprehensive power, such state authority has been used in the past, for example, to mandate coverage for certain fertility services, breast cancer treatments, or hearing aids.11 States were given the power to set coverage rules for Medicaid, usually using various cost-containment methods that continue to this day under the Affordable Care Act; in addition, states have some authority to require coverage for particular services as a condition of selling insurance policies within the state (subject to some exceptions). Together, these authorities give states power to determine that equity requires coverage for certain services, or for certain forms of services.

One approach that has been suggested is for states to adopt a “vulnerability” theory to undergird their insurance policies. In the context of contraceptive access, one proponent describes this approach as follows:

A better approach to establishing state responsibility for family planning would reframe state involvement as proactive, positive, and supportive rather than punitive and reactionary. Vulnerability theory begins with the recognition that, as embodied beings who are constantly susceptible to changes in our physical and social well-being, we are all universally vulnerable. The severely restrained state can play only a limited role in protecting the autonomous, independent, and self-sufficient legal subject from any constraint on the exercise of her autonomy. In contrast, vulnerability theory requires a responsive state that affirmatively addresses the vulnerability of its subjects. It does so by providing its citizens with the resources needed to maintain resilience in all life stages in a just and equitable manner. (Hickey, 2022, p. 99)

Stated more generally, a vulnerability approach would task states with identifying those services that are ill suited, logistically challenging, or otherwise inappropriate for meeting the needs of underserved populations, and mandate coverage for alternate therapies or delivery methods that could address unmet needs. Such an approach, of course, would require political will and decision making to enact measures at the legislative and administrative levels of state government.

In general, this phase of innovation has seen remarkable changes throughout U.S. history (see also Appendix B). It is driven by interwoven policies related to health care access, distribution, and reimbursement, which are created in various political, historical, and judgment-based contexts. Notably, the lack of federal or state policy on a given topic also plays a role in affecting access and use—for example, as pertains to direct-to-consumer and do-it-yourself markets for some technologies. Accordingly, equity as a consideration is often present only when a particular policy governing access enables equity or reflects the values that promote it. Otherwise, equity is unlikely to be embedded systematically in this phase.

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11 See, for example, state-mandated coverage of infertility treatments at https://www.kff.org/womens-health-policy/state-indicator/infertility-coverage/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Location%22,%22sort%22:%22asc%22%7D or mandated coverage for hearing aids at https://www.asha.org/advocacy/state/issues/ha_reimbursement/ (accessed May 31, 2023).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Learning from a Technology’s Deployment

Existing governance systems for medical technologies include regulatory requirements to evaluate performance in the postmarket context.12 In addition, payers exert control to the extent that they may condition reimbursement or payment for medical technologies on the generation of follow-up data. Regulators of medical products and producers of new medical technologies, often companies, also influence what postmarket follow-up is conducted after a product is released for widespread use, particularly if companies are responsible for meeting the requirements for postmarket evaluation of regulators or payers.

Companies and health care organizations engaged in health care delivery, such as health systems, are also critical to this phase because they interact directly with the medical technologies and the patients and consumers using them, can collect information about performance, and can make this information accessible with appropriate privacy and security protections. Companies engaged in health care delivery may also be incentivized to participate in postmarket performance evaluations to the extent that they depend on reimbursement by payers that is conditioned on such performance data.

Reporting by Patients and Users

The postmarket public response to a new drug or technology from patients, patient advocacy groups, and users has an impact on its overall success, adoption, public perception, and legacy. The primary actions and choices of patients and patient advocacy groups here revolved around reporting, either to regulatory agencies such as the FDA or directly to the general public. This is a phase of innovation in which the involvement of marginalized communities can be very important in illuminating performance or access concerns.

Patients and patient advocacy groups can voluntarily report serious adverse events, product quality problems, product use errors, or therapeutic failures that they suspect are associated with the use of an FDA-regulated drug or device via MedWatch, the FDA’s public-facing medical product safety reporting program (FDA, 2023). While MedWatch was developed to assess potential safety concerns related to drugs or devices, however, it was not designed to assess equity concerns related to the real-world use of products.

Through its research, guidance, and regulatory actions, the FTC serves as another forum for assessing the deployment and implementation of health technologies. Additionally, nonprofit consumer watchdog organizations provide a voice for consumers and taxpayers, playing a role similar to that of patient advocacy groups in both health- and nonhealth-related sectors. These organizations use the levers of education, research, lobbying, litigation, and funding to advance their members’ interests, which in more recent years have expanded to include calls for equity. Patients and patient advocacy groups can also appeal directly to their target audience (pharmaceutical companies, technology companies, health care organizations, funders, or policy makers, for example) through the press and popular media, impacting postmarket outcomes after a technology has been deployed.

What Gets Reported in the Postmarket Period

Fairly well-developed mechanisms exist for assessing issues with the safety of drugs and medical devices, but these mechanisms do not currently extend to how technologies may reinforce or exacerbate inequities and injustices. Additional postmarket data are needed to

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12 See https://www.fda.gov/drugs/guidance-compliance-regulatory-information/postmarket-requirements-and-commitments (accessed June 30, 2023). However, not all requested postmarket studies are completed.

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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capture a broader picture of the patient experience and offer insights necessary to better monitor and evaluate health equity–related outcomes. The generation and analysis of such data may involve different or additional actors. At present, for example, safety reporting often comes from doctors and hospitals, which may not be best positioned to identify equity considerations and metrics, while reporting from patient and community groups may offer additional contributions.

Postmarket data collection mechanisms include Phase IV studies, regulator-supported systems (e.g., Sentinel, Medwatch, the FDA Adverse Event Reporting System [FAERS], and the Vaccine Adverse Event Reporting System [VAERS]), payer-supported systems (e.g., claims databases), independent systems (e.g., National Poison Control Center, National Coordinating Council for Medication Error Reporting and Prevention), information from electronic health record (EHR) systems, clinical registries, and patient- or disease-based registries. Data collected through these mechanisms include adverse events, longitudinal use or exposure, and morbidity/mortality.

Postmarket reporting systems have faced criticism for being too narrowly focused or hampered by incomplete data, lack of data standardization, and issues with data quality (Pisac and Wilson, 2021). Furthermore, these programs are likely to identify only a fraction of the total number of adverse events that occur (Ross, 2015). Passive surveillance is undermined by voluntary reporting of frequently inaccurate, untimely, unverified, and/or biased data, whereas active surveillance is expensive, slow, and often narrow in scope. While these mechanisms, however flawed, are reasonably well designed to assess problems with the safety of drugs and devices, they do not currently extend to how drugs or devices might reinforce or exacerbate inequities and injustices in the real world. It is also important to remember that not all health-related innovation is subject to FDA regulation, limiting requirements and constraints around how products are tested and for which types of users before and after marketing. Ultimately, use of real-world data and real-world evidence in postmarket surveillance will be needed to strengthen existing safety monitoring, as well as to enable equity monitoring in the future. These efforts can be augmented by the addition of a Unique Device Identification System integrated with multiple data sources (including EHRs, administrative claims data collected by payers for billing purposes, and clinical registries), allowing the FDA to conduct large-scale, proactive surveillance of devices (Rising et al., 2014). Real-world data on patient characteristics and health outcomes associated with the use of technologies would allow the FDA to better identify patterns of inequity related to access, efficacy, and unintended consequences. Many equity concerns can be revealed only when the experiences of some individuals or groups are contrasted with those of other groups. To the extent that an equity concern is revealed only in analyses at the population level, it cannot be addressed in systems designed to report on individual occurrences. Thus, combining multiple sources of real-world data can offer additional insights about equity.

Additional issues in postmarket data collection and analysis involve challenges with the “data substrate,” particularly the availability and quality of data from real-world clinical practice and other sources needed to monitor performance, including aspects of performance related to equity (Tang et al., 2023; Zhang et al., 2022). Significant advances are also needed in the ability to collect, characterize, and analyze nontraditional sources of data, including data on social determinants of health, geographic variables, and social vulnerability. Companies focused on the science and technology of generating clinical evidence can be critical actors in follow-up because the methods and technical infrastructure for analyzing data on the real-world performance of medical technologies are still at a relatively early stage.

The development of the infrastructure, methodology, scientific consensus, and community and public support needed to apply these types of evidence sources to decision making

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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(e.g., governance decisions around a technology) represents a significant opportunity to advance equity in health innovation. As with premarket performance evaluation, appropriate incentives and resources will need to be dedicated to producing useful evidence that can help in better evaluating aspects of equity. Incentives during this phase can be shaped by regulatory requirements, payers, and other levers. Without these levers, equity issues may not be explicitly considered unless driven by demand among those for whom inequities are at play. To inform and support these choices, better methods and metrics are needed to measure how inequities arise in different contexts and in relation to the types of equity described in Chapter 2, as well as to capture and assess the impacts of any actions taken to enhance the alignment of an innovation with equity.

Artificial Intelligence/Machine Learning Technologies in Health Care: An Illustrative Example

Box 3-3 provides a case study of equity concerns associated with the development and use of AI and ML in health care, an area that has been receiving increasing attention. It helps illustrate the rapid pace of technology evolution; potential tensions between innovation and nuanced equity considerations; the need for actors across the technology life cycle to discuss and align technology development and governance with aims such as equity; and the need for guidance to address equitable development, evaluation, and deployment of AI-based innovations.

FAILURE TO ADDRESS EQUITY HOLISTICALLY IN THE CURRENT SYSTEM

An important purpose of emerging science, technology, and innovation in health and medicine is to help people live longer, healthier lives. But as this chapter illustrates, the current system is often shaped by goals promoting the rapid advancement of technology and the influence of incentives such as profit making. Considerations relevant to equity can arise throughout the innovation life cycle, but alignment with equity is often an afterthought and subordinate to other considerations.

Actors across the ecosystem for emerging science, technology, and innovation can take a wide range of actions to recognize and address inequities, biases, or unfairness, with research and development organizations, companies, patient and community groups, federal and state government agencies, funders, investors, care delivery and payer organizations, and others having particularly impactful roles at different phases of the innovation life cycle. However, the varied and fragmented nature of the system and the lack of a holistic, systems-level view of equity may limit the impacts of individual actions.

One mechanism by which actors and governance bodies can understand the implications and effects of a technology is through technology assessment methods. Current processes for technology assessment in the United States do not necessarily include equity-related impacts, and traditional technology assessment also has not involved substantial community input (see Appendix B). The development of enhanced forms of technology assessment through the work of such institutions as the Government Accountability Office’s (GAO’s) Science, Technology Assessment and Analytics team13 (the organization that has assumed the mission of the former congressional Office of Technology Assessment), academic institutions, involved communities, and others developing deliberately democratic models, such as participatory

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13 GAO also published a Technology Assessment Design Handbook (GAO, 2021).

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×
Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

technology assessment, are continuing to innovate in this space, inclusive of the need to evaluate equity in the innovation system (Ada Lovelace Institute, 2021; Kleinman et al., 2007; Tomblin et al., 2017; Weller et al., 2020). Enhancing technology assessment methods in health and medicine to better identify and incorporate equity-relevant metrics and impacts across innovation phases provides a useful opportunity to engage diverse stakeholders and to collaborate both within the United States and internationally on shared ideas, needs, practices, and tools.

Government plays a crucial role in the development and use of science, technology, and innovation, yet this role is distributed across agencies with different areas of jurisdiction, missions, authorities, budgets, and priorities. In general, there are two drivers of government activities promoting aspects of equity in innovation: direct mandates provided by Congress or legislatures that are focused, targeted authorizations of activity (but are not necessarily identified as an effort toward “equity”); and top-down directives by government leaders to incorporate explicit efforts on equity within a preexisting agency authorization. In response to these drivers, agencies deploy varied approaches with varied intensity or resources and directed toward varied points along innovation pathways. Approaches taken can include financial, regulatory, and process-related practices promoting equity in innovation. Financial mechanisms can be upstream (e.g., in research grants) or downstream (e.g., procurement specifications supporting equity-relevant processes or outcomes). Process-related practices can include targeted outreach related to agency programs; collaboration with nongovernmental organizations; technical assistance for government programs and funding; and the inclusion of equity factors in grant reviews and decisions, such as evaluations of equity in research participation or in outcomes associated with the use of technology. Examples of how authorities and responsibilities for considering equity have been implemented at NIH, FTC, and additional federal agencies are described in Appendixes B and C.

Each government agency intersects with and exercises influence during only certain phases of the innovation life cycle, and may have a limited view of the overall innovation ecosystem and how to align it with equity. In the absence of an explicit mandate from Congress, some agencies may not consider themselves to be legal authorities for addressing equity. The politicization of discourse around equity may also lead some agencies to shy away from explicit efforts to address equity so as to avoid becoming embroiled in controversial issues.

Even when government agencies explicitly seek to address inequity, the roles of agencies active during a particular phase of the technology development life cycle can overlap with the purview of other agencies, which may use different definitions and processes and devote different levels of attention, effort, and resources to these concerns. Some agencies have an organizational structure that places their explicit work on equity in discrete offices. Others embed equity throughout their structure and operations, typically through a set of guiding principles or an internal ethos—all of which may vary in intensity and enforcement. Agencies also differ in how they interpret and deploy definitions of “equity,” often using such terms as “health disparities,” “diversity,” “equality,” and others to capture equity-related work (see Appendix C), and potentially overlooking such issues as topical equity, evaluation equity, and contextual equity (as described in Chapter 2). Further, some agency efforts aligned with advancing equity are not necessarily “branded” or identified as such; for example, the FTC’s activities around the use of AI technologies have implications relevant to equity even though equity is not necessarily seen as a primary driver of these activities. There are also inconsistencies in agencies’ approaches to collecting and analyzing data related to equity. All of this variation can lead to fragmentation of efforts across government bodies and agencies.

Another pervasive challenge in the ecosystem for emerging science, technology, and innovation is a lack of sufficient mechanisms for engaging and empowering groups that

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
×

have historically been marginalized or structurally disadvantaged, and that are thus not well served by the current system and may not view themselves as “stakeholders or rights holders” within that system. As a result, innovation and stakeholder needs can be misaligned. In addition, data collection and analysis undergird existing and potential efforts on equity in innovation, but gaps exist in the capacity to operationalize such data. These include gaps in what data are collected, as well as gaps in the workforce, digital infrastructure, and organizational structures, procedures, and systems used to process and analyze the data and apply them to make informed policy decisions.

A lack of coordination and coherence across the full landscape of emerging technology development and governance exacerbates such gaps and points to a need for systems thinking. Some combination of top-down governance from policy makers, funders, and regulators and bottom-up pressure from patients and affected communities, consumers, providers, and technology developers is likely to be required to create incentives in the system, ensure appropriate engagement, and collect and use data to drive change toward a more holistic approach to centering equity in the innovation ecosystem.

CHAPTER CONCLUSIONS

This chapter describes the life cycle of innovation in health and medicine, including the types of actions taken and the choices and considerations arising at each life-cycle phase. From this description, it is clear that the U.S. ecosystem for emerging science, technology, and innovation in health and medicine is dynamic and diverse but does not currently prioritize alignment with equity, leading to the following conclusions.

Conclusion 3-1: Pathways of innovation in health and medicine are varied, nonlinear, and difficult to map. Nonetheless, every technology’s development progresses through phases from idea conception to postmarket learning and is shaped by the actions and choices of multiple participants across sectors—including funders, researchers, developers, regulators, users and affected communities, health care organizations, and many others.

Conclusion 3-2: With limited exceptions, the current system of innovation in health and medicine is not sufficiently aligned with values such as promoting equity.

  • The current governance model prioritizes speed and efficiency of technology transfer; the incentivizing roles of patenting and profit in innovation; and the use of narrow, targeted incentives to promote fairness, justice, and equity, which remain subsidiary concerns.
  • Emerging science and technology assessments can be updated through commitments to studying inequities and expanding keystone values and tenets, to include broadening participation and sharing responsibility for aligning innovation with equity, justice, and fairness.

Conclusion 3-3: Crucial equity considerations arise at every phase of emerging science, technology, and innovation. Ongoing efforts to enhance equity include increasing the diversity of the science, technology, engineering, and mathematics (STEM) workforce, incorporating patient input, addressing discrimination and the rights of patients and research subjects, and increasing access to new technologies. Aligning innovation with equity requires continued attention to these areas while going further to embed equity throughout the innovation process. An equity-aligned

Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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system for the development and governance of innovation will require new processes that shift and diversify the traditional innovation life cycle by incorporating new considerations and a wider array of stakeholders from communities that offer specialized expertise, such as marginalized communities and social scientists and humanities scholars with expertise in equity. These new processes include drawing on the priorities and knowledge of underserved communities to shape ideation; valuing the contributions of people whose data and biological materials inform research; evaluating design, performance, and deployment according to a technology’s implications for the full range of users; enhancing equity assessments; and learning from the resulting information to improve the system iteratively.

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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Suggested Citation:"3 The Innovation Life Cycle in Health and Medicine and the Challenge of Equity." National Academies of Sciences, Engineering, and Medicine and National Academy of Medicine. 2023. Toward Equitable Innovation in Health and Medicine: A Framework. Washington, DC: The National Academies Press. doi: 10.17226/27184.
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Advances in biomedical science, data science, engineering, and technology are leading to high-pace innovation with potential to transform health and medicine. These innovations simultaneously raise important ethical and social issues, including how to fairly distribute their benefits and risks. The National Academies of Sciences, Engineering, and Medicine, in collaboration with the National Academy of Medicine, established the Committee on Creating a Framework for Emerging Science, Technology, and Innovation in Health and Medicine to provide leadership and engage broad communities in developing a framework for aligning the development and use of transformative technologies with ethical and equitable principles. The committees resulting report describes a governance framework for decisions throughout the innovation life cycle to advance equitable innovation and support an ecosystem that is more responsive to the needs of a broader range of individuals and is better able to recognize and address inequities as they arise.

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