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Appl Clin Inform 2024; 15(03): 456-459
DOI: 10.1055/a-2312-8621
Letter to the Editor

A Framework for Social Needs-Based Medical Biodesign Innovation

Ada Metaxas
1   Department of Chemistry, Princeton University, Princeton, New Jersey, United States
,
Sara Hantgan
2   University of Michigan School of Information, Ann Arbor, Michigan, United States
,
Katherine W. Wang
3   Trinity College of Arts and Sciences, Duke University, Durham, North Carolina, United States
,
Jiya Desai
4   The Pingry School, Basking Ridge, New Jersey, United States
,
Sarah Zwerling
5   Roslyn High School, Roslyn Heights, New York, United States
,
Sunit P. Jariwala
6   Division of Allergy/Immunology, Albert Einstein College of Medicine, Bronx, New York, United States
› Author Affiliations

Funding None.
› Further Information
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Social determinants of health (SDoH) are structural factors that influence health outcomes and contribute to health disparities.[1] These factors include: economic stability, education quality, health care quality, built environment, and community context.[1] Estimates suggest that nearly 60% of preventable deaths are caused by modifiable SDoH.[2] Adverse health outcomes caused by unmet SDoH needs are particularly exacerbated in marginalized communities. For example, chronic conditions, such as asthma and diabetes, disproportionately impact communities of color and low socioeconomic status.[3] Clinical factors are estimated to affect only 20% of the variation in health outcomes across the United States, whereas SDoH contribute to 50%.[4] Consequently, addressing unmet SDoH needs is important for addressing health care disparities.

To improve health disparities, priority should be placed on developing evidence-based interventions through social needs-based innovation.[5] User-centered design innovation involves iterative feedback cycles for developing technologies focused on equity, accessibility, and feasibility for the target audience.[6] This paper focuses on developing a framework for social needs-based medical innovation to address health disparities. We describe the implementation of this framework using a case example involving ASTHMAXcel, a mobile health application which provides interactive resources for improving asthma knowledge in patients from the Bronx, New York City, United States, a borough with a large urban minority population.

The Medical Innovation Biodesign Model

The innovation biodesign process is a systematic approach for user-centered medical innovation that involves identifying unmet health care needs through clinical observation, followed by solution mapping and prototyping for commercialization.[7] This needs-based approach empowers health care providers to address health care system shortcomings and disparities patients encounter. The biodesign process differs from the traditional linear bench-to-bedside model through which researchers seek meaningful clinical applications for newly developed technologies. In contrast, the biodesign model ensures that efforts and funding are directed toward the most relevant clinical needs. Another medical innovation model is the stage-gate model, which segments innovation into stages separated by checkpoints. The main stages include idea generation, feasibility analysis, prototyping, product validation, and postlaunch assessment.[8] This model can be useful for market-driven innovations that require consistent adaptation to fit market demands. A commonly used rapid design innovation model is Agile, which involves repetitions of sprint planning and sprints. An Agile sprint is a short, set period when a development team must achieve a specific goal that is reviewed with stakeholders.[9]

The biodesign model, which prioritizes needs identification and iterative refinement cycles, captures most of the benefits of these models. As a pioneering institution in the development of the biodesign model, Stanford University identifies three key steps: identify, invent, and implement. The “identify” phase involves needs finding through clinical immersion. The “invent” phase involves brainstorming and filtering solutions based on technical feasibility and market value. The “implement” phase involves addressing the need by developing a viable business strategy to engage stakeholders.[10] Similarly, the Johns Hopkins Center for Bioengineering Innovation employs the Spiral Model, a modified biodesign process with continuous examination of the various stages: clinical immersion, needs finding, and opportunity assessment. In contrast to other models, the Spiral Model is iterative, involving continuous technology refinement for needs addressing.[11] Considering these benefits, innovation biodesign is a well-suited approach to achieve sustained health care innovation.


 

The Framework for Social Needs-Based Innovation Biodesign

Establishing a framework for social needs-centered innovation biodesign is useful for developing technologies that reduce health disparities. This framework is broadly divided into two spaces: the “problem space” and “solution space” ([Fig. 1]). This approach has been applied for the development of mobile health applications, including ASTHMAXcel, which delivers personalized asthma education.[12]

Zoom
Fig. 1 A framework for social needs-based innovation biodesign that details the steps from the needs assessment phase to the implementation phase. These steps are divided into two areas, the problem space and the solution space, to develop solutions that help address unmet needs that exacerbate health disparities.

Within the “problem space,” we first assess a target population's health needs by identifying the unmet clinical needs, research gaps, health disparities, and clinical workflow issues. For instance, before developing ASTHMAXcel, physicians noticed that inadequate asthma education among patients, resulting in suboptimal inhaler technique, was linked to an increased risk of hospitalization.[13] In addition, postvisit patient surveys can reveal gaps in clinical care. Grouping patient feedback based on race and income levels allow identification of trends in unmet needs among patients. Second, needs screening involves filtering these needs to identify the most sustainable potential solution, such as by obtaining stakeholder feedback and conducting an evidence-based literature review, market assessment, and competitive landscape analysis. Prior existing asthma apps were found to have high attrition rates and low rates of consistent activity.[14] Thus, a market opportunity emerged for an interactive app to engage and educate asthma patients. For the initial design of ASTHMAXcel, several participatory design (PD) sessions were conducted.[15] Equitable recruitment is an important consideration.[16] Two PD sessions contained English-speaking adult patients on daily asthma controller medications at an outpatient Bronx primary care site and another session contained primary care physicians. In each session, facilitators asked participants to describe desired app features, challenges in their asthma care, and reflections post-app-use. The needs assessment and screening processes highlight barriers to care and implementation challenges. Overall, beyond unmet need identification, thoroughly understanding the context of the local community is crucial for implementing long-term changes.

Once several health needs are identified and assessed, the next steps fall within the “solution space” involving invention, implementation, and validation. To develop a product, additional stakeholder feedback is needed to improve the user interface and the intellectual property must be protected. To guide ASTHMAXcel's implementation, patients—stakeholders and technology end users—were interviewed to iteratively refine user-facing features. Field testing was conducted by administering the Questionnaire for User Interface Satisfaction (QUIS) and the Unified Theory of Acceptance and Use of Technology (UTAUT) questionnaires at baseline and 4 weeks to 28 English-speaking adult patients on daily asthma controller medications from three Bronx outpatient primary care sites. QUIS was used to assess satisfaction with user interfaces. UTAUT was administered to measure the likelihood of technology acceptance. At week 4, telephone interviews were conducted with the eight patients using the app the least often and eight patients using it the most often to refine usability and accessibility.[17] Overall, this cycle of moving an unmet health need from the problem to solution space is repeated until a viable solution is reached that addresses the relevant health disparity. The resulting ASTHMAXcel mobile platform is an inexpensive, scalable mobile application that has improved asthma outcomes. A group of 40 English-speaking adult patients from the Montefiore Asthma Center, on daily controller medications and demographically representative of the Bronx (with majority Hispanic, 52.7%, and non-Hispanic Black, 41.8%, individuals, whose highest education level was mostly a high-school diploma, 45.5%), were found to have asthma control test scores that increased significantly at 2 (p = 0.038), 4 (p = 0.02), and 6 months (p = 0.003) after baseline.[12] There were also significant decreases in asthma-related emergency department visits at 6 months (p = 0.02). In a follow-up study, analysis of 99 adult patients from three Bronx primary care sites showed a significant increase in ACT scores in the intervention group between baseline and 12-month visits (p = 0.005), whereas this difference was nonsignificant in the control group,[18] highlighting ASTHMAXcel's success in improving asthma management. The outlined ASTHMAXcel use case in a diverse population with high chronic disease burden emphasizes the success of the established framework in addressing health disparities.


 

Implementation of Social Needs-Based Innovation Biodesign

Serving the poorest county in New York City with a poverty rate of 26.4%, the Montefiore Innovation Biodesign Program was launched in 2020 to address unmet SDoH needs in the Bronx.[19] While other biodesign programs stress the importance of needs finding, this program focuses on addressing chronic conditions and health disparities and has created 12 mobile health applications since 2020.

A fundamental component of the social needs-based medical innovation approach is engaging stakeholders to develop transformative, patient-oriented health technologies. To best engage stakeholders and implement the social needs-based biodesign framework, the program holds monthly Innovation Biodesign seminars. Fifty-five medical centers and universities, over 135 industry partners, and over 40 Montefiore divisions participated in the program across the 28 seminars. Engaging stakeholders has been useful for the subsequent adaptation of ASTHMAXcel to other cities. For example, adult patients and asthma physicians from the Bharati Hospital in Pune, India were recruited for PD sessions to adapt ASTHMAXcel for this new setting. After applying the social needs-based innovation biodesign model to redesign the mobile application for this new city, an increase in Asthma Knowledge Questionnaire scores among the 57 asthma patients in the ASTHMAXcel intervention group (p = 0.0001) was found.[20] When applying the framework for social needs-based innovation to different geographic areas, engaging diverse community perspectives was essential for identifying heterogeneous unmet SDoH needs and finding avenues for implementing solutions.


 

Summary

In a recent survey, 38% of U.S. health care system CEOs reported no digital components in their strategic plan,[20] suggesting a need for increased health technology innovation. This manuscript serves as a call-to-action for the adoption of social needs-based innovation biodesign in medical centers. Our findings suggest that innovators can focus on identifying unmet clinical needs in marginalized populations, followed by employing our social needs-based biodesign framework to develop a user- and stakeholder-centered product. Furthermore, educating physicians about SDoH is key for improving awareness about unmet SDoH needs and gaining novel perspectives for innovation.[21]


 

 

Conflict of Interest

None declared.

Protection of Human and Animal Subjects

This study was performed in compliance with the World Medial Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects and was reviewed by the Albert Einstein College of Medicine Institutional Review Board.



Address for correspondence

Sunit P. Jariwala, MD
Division of Allergy/Immunology, Albert Einstein College of Medicine
3411 Wayne Avenue, 2nd floor, Bronx, NY 10467
United States   

Publication History

Received: 31 October 2023

Accepted: 23 April 2024

Accepted Manuscript online:
24 April 2024

Article published online:
12 June 2024

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Zoom
Fig. 1 A framework for social needs-based innovation biodesign that details the steps from the needs assessment phase to the implementation phase. These steps are divided into two areas, the problem space and the solution space, to develop solutions that help address unmet needs that exacerbate health disparities.