Introduction
Biomedical science has advanced in profound ways over the last couple of decades, providing earlier diagnosis, better treatments, and allowing people to live healthier and longer lives. While biomedical innovation is crucial for progress, it also presents challenges that must be addressed to support the successful translation of research into health impact. Current methods often fall short due to the complex and dynamic nature of the real-world healthcare delivery environment [Reference Austin1,Reference Hartl, De Luca and Kostikova2]. This leads to failure at the final hurdle: translating health research to improved population health [Reference Grimshaw, Eccles, Lavis, Hill and Squires3,Reference Woolf, Purnell and Simon4]. Reasons for this failure include real-world gaps in evidence, reimbursement challenges [Reference Phares, Trusheim, Emond and Pearson5], policies that slow innovation, social influencers of health [Reference Adachi, El-Hattab and Jain6], and limited system capacity. Developing effective and sustainable solutions for these challenges often requires input from multiple interest holder groups and buy-in across organizations.
The NEW Drug Development ParadIGmS (NEWDIGS) consortium has developed a methodology that supports systems thinking and collaborative innovation among multiple interest holders [Reference Eichler, Baird and Barker7–Reference Hirsch, Velentgas and Curtis9]. The range of interest holders engaged include patients, clinicians, payers, life science companies, regulators, and investors, among others. Over the last 16 years, this methodology has been applied to many different complex healthcare challenges. Although the methodology is broadly applicable, NEWDIGS has worked mainly in the later stages of translation, focusing on features of the healthcare system that slow or prevent appropriate, timely, and equitable patient access to drug therapies. It has concentrated specifically on challenges that benefit from an external innovation environment that supports pre-competitive collaboration across organizational and interest holder silos.
In this manuscript, we illustrate the application of the NEWDIGS’ methodology using three case studies where the method has been used to develop scalable solutions to complex translational challenges in biomedical innovation.
Newdigs Methodology
NEWDIGS’ stepwise methodology for translating emerging science into real-world health impact is applied in an iterative cycle and illustrated in Figure 1.
Overview including foundational setup activities and the five collaborative innovation process steps (Table 2).
Activities to consider in building a safe haven innovation
Overview of NEWDIGS setup and collaborative innovation process for each project
NEWDIGS =NEW Drug Development ParadIGmS; LEAPS = Learning Ecosystems Accelerator for Patient-Centered Sustainable Innovation; APoC = Adaptive Point of Care; FoCUS = Financing and Reimbursement of Cures in the US; ORBM = Orphan Reinsurer and Benefit Manager.
* Every project included patients or patient advocates, relevant providers, payers, and industry partners.
For each challenge undertaken, setup activities including selecting and framing the problem, identifying and engaging interest holders, building a safe haven, and developing a case-based strategy for learning, were key success drivers.
Selecting and framing the problem
To select translational problems, we focused on challenges that shared specific characteristics: our “rules of three.” First, solutions required three or more interest holders; if the challenge could be successfully addressed by one or two organizations, we determined that a consortium approach was not needed. Second, at least three organizational sponsors prioritized the challenge to the extent that they provided funding and/or time, ensuring adequate resources. Finally, the timeline to implementation was 18 months to three years, avoiding pressure for immediate results while near-term enough that solutions were still relevant.
Identifying and engaging interest holders
To identify the problem solvers to engage in solution development, we mapped interest holders impacted by the innovation challenge and any emergent solution, as well as those critical for the implementation of solutions. The group often represented a strategic microcosm of the relevant community. Engaging end users in the design process can increase the likelihood of success and accelerate the adoption of new solutions [Reference Voorberg, Bekkers and Tummers10].
Building a safe haven
Once interest holders were identified and invited to participate, we developed a safe haven to support collaborative productivity. A safe haven was differentiated from safe harbor in that there were no legal provisions; rather, safety was built via trust and co-creation of a shared culture [Reference Baird and Hirsch11]. Explicit and implicit steps were taken to facilitate cross-silo collaboration (see Table 1) and applied to support development of distinct environments depending upon project and interest holder needs.
Developing a case-based learning strategy
For each innovation challenge, we developed a learning strategy anchored in case studies that provided practical, real-world considerations for solution design and implementation planning. We defined the nature and scope of cases, as well as a portfolio of cases that allowed probing of different aspects of the challenge. Cases sometimes focused on a disease, and other times on a specific product or a product class. We used historical, synthetic, or prospective cases, depending upon availability and illustrative value, as well as willingness of interest holders to share proprietary data.
Following the setup, the collaborative innovation process steps include:
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1. Elucidate challenges – identify specific barriers to desired outcomes, including incentives, risks, and interdependencies across interest holders.
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2. Design solutions – co-create solutions to specific identified challenges through structured dialog and interactive design.
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3. Enable implementation – identify potential barriers and enablers to implementation of solutions created.
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4. Monitor and learn – track uptake of solutions in real-world settings and how they evolve in practice, identifying opportunities for improvement.
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5. Disseminate and catalyze – share learnings throughout the design process to relevant audiences to support implementation of solutions.
Table 2 summarizes application of the NEWDIGS methodology in three projects: Adaptive Licensing, Learning Ecosystems Accelerator for Patient-centered Sustainable innovation (“LEAPS”), and Financing and Reimbursement of Cures in the US (“FoCUS”). These projects were selected because they each illustrate a different type of innovation that required different strategies, indicating the diversity of application. For each project, we include an overview of the setup activities as well as steps one through three in the collaborative innovation process. Steps four and five are summarized in the Findings section.
Findings
Three lessons relevant to the application of NEWDIGS methodology across different settings were identified. First, the methodology worked best for challenges requiring interest holders to work together to find a solution meeting everyone’s needs. It became clear that the cases most benefiting from a structured collaborative innovation process were those where diverse needs required elucidation and alignment.
Second, collaboration and development of solutions were best supported by a facilitator, an “innovation steward,” to strategically steer the setup and advance innovative collaboration. The term innovation steward has been used previously in different settings with varying definitions (e.g., [Reference Domínguez-Escrig, Mallén-Broch, Lapiedra-Alcamí and Chiva-Gómez13,Reference Saner and Wilson14]). We use it to capture a specific concept; a neutral but strategic intermediary that establishes and guides interest holder collaboration. In this context, the innovation steward enabled interactive design across interest holder silos and used the collaborative innovation process to support alignment of incentives, accelerate implementation readiness, and drive impact toward shared goals.
Third, our collective skills in collaborative health system innovation were enhanced through our work together. NEWDIGS’ experience across diverse challenges helped to advance our understanding of collaborative tools, processes, and success drivers. This capacity-building work is important as the need for collaboration to tackle complex biomedical challenges grows.
In addition to methodological lessons learned, each case study had formal and informal impacts specific to the challenge, the solution developed, and the way it was implemented. NEWDIGS’ positioning as an external innovation environment limited our insight into some of these due to proprietary constraints on shared information. Due to this only the known subsets of outcomes and impacts are discussed
Regulatory innovation – adaptive licensing project
Adaptive Licensing, a staged approach to regulatory approval in global settings, was originally discussed as a potential solution under the name Progressive Licensing [Reference Yeates, Lee and Maher15]. Rather than conceptualizing the model, the challenge was advancing it to readiness for evaluation in pilot activities. Implementation barriers were significant given the complex interlocking interest holder risks that would accompany change. Earlier access to medications for high-risk subpopulations of patients meant less evidence, increasing risk for regulators and payers, plus greater potential commercial risk [Reference Trusheim, Baird, Garner, Lim, Patel and Hirsch16]. The resulting regulatory innovation was a generalizable framework for the design and implementation of the adaptive licensing paradigm. The collaborative innovation process helped move the proposed regulatory innovation from theory into action, paving the way to a European Union pilot led by the Europeans Medicines Agency (EMA) [Reference Eichler, Baird and Barker7].
This was the first NEWDIGS project in which collaborators recognized the value of a safe haven, multi-stakeholder, pre-competitive environment for rapid cycle learning and adaptation of innovative solutions. It inspired the launch of a new consortium (ADAPT-SMART) within the Innovative Medicines Initiative (IMI) to accelerate generalizable learnings from the EMA’s pilot project on Adaptive Licensing (rebranded at Adaptive Pathways) [Reference Baird and Hirsch17,18]. In the USA, NEWDIGS leadership also tracked related policy innovation in the 21st Century Cures Act [19] and were Expert Advisory Committee participants on special report by the President’s Council of Advisors on Science and Technology [20].
Clinical innovation – Adaptive Point-of-Care platform
NEWDIGS built on the historic precedent for clinical point-of-care data collection, analysis, and integration into decision-making [Reference Chen, Liang and Zhang21] by facilitating the engagement in the Adaptive Point-of-Care (APoC) design process. Based on this work, a pilot of APoC use in Rheumatoid Arthritis was proposed to enable scalable evidence generation for regime optimization. Results were disseminated via peer-reviewed publication [Reference Hirsch, Velentgas and Curtis9] and the clinical innovation functioned as a learning health system strategy influencing subsequent research design efforts led by our collaborators.
Business innovation – orphan reinsurance and benefit manager model
Cell and gene therapies face reimbursement challenges due to high costs and clinical uncertainty. One of several new payment models developed by interest holders at NEWDIGS included Orphan Reinsurer Benefit Managers (ORBM), designed to address the financial risks of high cost, potentially curative cell and gene therapies for small insurance companies and self-insured employers. Careful innovation stewardship was required in guiding interest holders to determine the scope of implementation planning work. While some interest holders wanted to co-develop a business plan within NEWDIGS, others felt that this might constrain adoption to a single interest holder group. Ultimately, the decision was to stop short of a business plan and instead to allow the marketplace to adopt and adapt the ORBM model.
Discussion
Biomedical science is advancing rapidly, and collaborative innovation is essential to enhancing our ability to translate these advancements into health impact. NEWDIGS’ methodology provides a structure and process that could be adapted for use across a range of innovations. NEWDIGS is known for blending key elements to enhance capacity for innovations that require system change for success:
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external innovation environment for collaboration across organizations and interest holders,
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safe haven for fostering pre-competitive collaboration,
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neutral third party serving as innovation steward, and
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proven structured methodology to enable interactive design.
For those interested in leading or stewarding cross-functional innovation environments, it is important to know that the setup and the collaborative innovation process are critically important to successful solution development. Together they push the boundaries of multi-interest holder collaboration to drive meaningful collective impact.
Organizational leaders may consider whether particular innovation efforts are more likely to succeed within an internal or external environment. By sharing our experience, we hope to enhance understanding of types of innovation challenges that might benefit from a multi-interest holder approach within an external safe haven. The details provided may also help to inform assessment of conditions under which collaboration value may outweigh proprietary risk.
The biggest limitation of this work is that to date our application of the methodology has been narrowly focused on addressing system barriers to the appropriate and timely real-world use drug therapies. In the future, application could be expanded to include life science products (e.g., diagnostics and medical devices), integration of new technical tools and capabilities into healthcare (e.g., digital health), and future state systems (e.g., clinical care and public health). It could also be expanded to other fields that would benefit from a structured and stewarded pathway to collaborative innovation.
Another limitation is the absence of a framework for measuring collective impact. We have recently begun to develop a metrics framework, involving interest holders to ensure metrics are meaningful to them and capture relevant information, including costs as well as health outcomes [Reference Hirsch, Phares and Barlow22]. The framework will provide generalized principles that will be tailored to project context and goals.
Our capacity for scientific innovation far outpaces that of healthcare system innovation, and there are a growing number of transformational biomedical products that are entering a market that is unprepared for them. We believe that our collaboration methodology is a dynamic way to address complex challenges in healthcare at a time of tremendous opportunity. While its use has been focused on biomedical products, its potential to provide a platform for innovative solution design could have a much broader reach.
Author contributions
Marisha E. Palm: Conceptualization, Methodology, Visualization, and Writing – original draft; Sharon Phares: Conceptualization, Data curation, Methodology, and Writing – review and editing; Gigi Hirsch: Conceptualization, Data curation, Funding acquisition, Investigation, Methodology, and Writing – review and editing.
Funding statement
Drs. Palm, Phares, and Hirsch and received support from the NEWDIGS consortium under the Tufts Center for Biomedical System Design.
Competing interests
The authors report no competing interests.
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