Beyond Recruitment: A Practical ROI Model For Integrating Community Health Workers Into Medtech Trials

By Julio G. Martinez-Clark, CEO, bioaccess

The medtech industry's push into decentralized clinical trials (DCTs) has rightly focused on technology and patient diversity.¹ As part of this global shift, community health workers (CHWs) are increasingly recognized as a powerful asset for reaching underserved populations, particularly in emerging markets.² However, sponsors are making a critical mistake: they are viewing CHWs as a line-item cost for patient access, rather than a strategic investment that drives a significant multifaceted return.

This perspective is a central blind spot. The public health models often used to justify CHW programs calculate a return on investment (ROI) based on long-term healthcare savings — for example, returning $2.47 to a Medicaid payer for every dollar invested.^3,4 While valid in their own right, these metrics are largely irrelevant to a medtech sponsor whose primary goal is to get a product to market as quickly and efficiently as possible.

The industry desperately needs — and currently lacks — a practical trial-specific financial framework to build a compelling business case for CHWs. By reframing their role from a tactical cost to a strategic driver of value, medtech leaders can unlock a powerful lever for faster, more efficient, and more successful trials.

The Flaw In The Current View: CHWs As A Cost Center

Currently, the integration of CHWs into clinical trials is often framed solely around recruitment. They are considered a means to an end — a way to meet diversity quotas and access patient populations that are otherwise difficult to reach.⁵ While this is an undeniable benefit, this narrow view ignores their work's profound downstream financial impacts.

The problem is that the industry is trying to apply public health ROI models to a commercial context. The value of a CHW in a clinical trial is not measured in long-term societal health savings but in days shaved off a trial timeline and dollars saved on operational inefficiencies.

A New Framework: Quantifying The Trial-Specific ROI Of CHWs

To build a credible business case, sponsors must quantify the value of CHWs across the domains that matter most to a clinical trial's financial success. A new ROI model should be built on four key pillars:

1. Reduced Patient Dropout (Improved Retention)

Patient attrition is one of the most considerable hidden costs in clinical research. Replacing a single lost participant costs approximately $15,000 and significantly delays timelines.⁶ CHWs are uniquely positioned to mitigate this risk. As trusted community members, they build rapport and provide the social and emotional support necessary to keep participants engaged.⁷

CHWs serve as a vital link, helping patients navigate logistical barriers like transportation or childcare — common reasons for dropping out. This enhanced support directly translates into higher retention rates. Decentralized models can see retention rates up to 90%, reducing the need for costly replacement recruitment and helping keep trials on schedule.⁸

2. Higher Data Quality (Improved Adherence)

The axiom of clinical research is "garbage in, garbage out." Poor data quality resulting from protocol deviations or nonadherence to a device's use case can jeopardize a study's validity and regulatory acceptance.^9,10 CHWs provide a tangible return by offering hands-on, culturally competent training and troubleshooting for wearables and remote monitoring devices.¹¹

This direct support overcomes the digital literacy and infrastructure gaps often plaguing DCTs in emerging markets. Improved patient adherence leads to fewer data gaps, a reduced burden of data queries, and a more robust and reliable data set for regulatory submission.

3. Accelerated Timelines (Faster Recruitment And Enrollment)

While recruitment is the most recognized benefit of CHWs, its financial impact is typically underestimated. Speed to market is the single most significant driver of value in any clinical trial. Every day saved on the trial timeline is another day of patent-protected revenue.¹²

CHWs accelerate recruitment by leveraging their deep community trust to overcome historical skepticism toward research. A recent Tufts University study found that DCTs can yield a staggering 1,200% ROI for Phase 3 trials, primarily through reduced timelines and improved patient retention.¹³ CHWs are a key enabler of this acceleration.

4. De-Risked Commercial Launch (Early Market Intelligence)

CHWs function as an invaluable source of early-stage market intelligence. During their interactions, they gather unfiltered, real-world feedback on a medical device's usability, cultural acceptance, and practical challenges in real-world settings.¹⁴

This qualitative data is a goldmine for commercial teams, allowing them to de-risk product launches by identifying potential adoption barriers and refining marketing strategies long before market entry. This mitigates the risk of costly post-market design changes or commercial missteps.

Building The Business Case: A Practical ROI Calculation

Sponsors can construct a simple but powerful financial model by focusing on these four domains. While a complete analysis is complex, an illustrative calculation can highlight the potential return.

Consider a hypothetical trial where the cost to replace a dropped patient is $15,000 and the projected daily revenue of the device at market is $100,000:

Inputs:

• Annual cost of a CHW program (e.g., three CHWs): $210,000

Value Drivers:

• Value from retention: If CHWs prevent just 10 patients from dropping out over the year, the direct savings are (10 patients × $15,000) = $150,000
• Value from acceleration: If their impact shortens the trial by just one week (seven days), the value is (7 days × $100,000/day) = $700,000

Calculation:

• Total value generated: $150,000 (retention) + $700,000 (acceleration) = $850,000
• Net benefit: $850,000–$210,000 = $640,000
• Return on investment (ROI): ($640,000 ÷ $210,000) = 3.05:1 or 305%

This simplified model, which doesn't even include the value of higher data quality or de-risked commercialization, demonstrates a clear and compelling financial return, aligning with studies that have shown CHW programs can generate an ROI of over 2:1.¹⁵

Strategic Implementation: Maximizing CHW Value

To realize this ROI potential, medtech companies should consider these implementation strategies:

• Partner Selection: Select clinical research organizations (CROs) with established CHW networks and proven track records in community engagement. The right partners understand how to integrate CHWs effectively into clinical protocols while maintaining regulatory compliance.¹⁶
• Training Investment: Invest in comprehensive training programs that equip CHWs with the technical knowledge and communication skills necessary to support patients and clinical teams. This up-front investment pays dividends in improved data quality and patient retention.
• Technology Integration: Leverage mobile health (mHealth) platforms that enable CHWs to collect, transmit, and track patient data efficiently. Smart mobile devices can significantly augment CHW performance in low- and middle-income countries.¹⁷
• Cultural Competency: Ensure CHWs receive cultural competency and health literacy training to effectively communicate complex medical device instructions and address community-specific concerns about clinical trial participation.

A Strategic Imperative For Medtech Innovation

Medtech leaders must evolve their thinking about community health workers. CHWs are not a tactical expense to be minimized; they are a high-return strategic investment in clinical trials' speed, efficiency, and ultimate success. The evidence is clear: properly implemented CHW programs can deliver ROI exceeding 300% while improving patient outcomes and data quality.

By moving beyond outdated public health metrics and adopting a trial-specific ROI framework, sponsors can build a robust data-driven business case for integrating CHWs. This shift in perspective is essential for companies serious about conducting faster, more effective, and more equitable clinical research globally.

As the medtech industry continues its push toward decentralized and patient-centric trial models, those who recognize and harness the strategic value of community health workers will gain a significant competitive advantage in bringing life-changing innovations to market.

References

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5. American Public Health Association. Community Health Workers. Policy Statement Database 2009.
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13. Tufts Center for the Study of Drug Development. Impact Report: Decentralized Clinical Trials - Cost Analysis and ROI Projections. Tufts CSDD 2023.
14. Cadzow A, Craig K, Allen J. Community Health Workers provide a bridge between researchers and community. University at Buffalo News 2025.
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16. Higa C, Vega-Sandoval T, Altamirano-Diaz L, et al. Community Health Worker-Led mHealth-Enabled Diabetes Self-management Education and Support Intervention in Rural Latino Adults: Single-Arm Feasibility Trial. JMIR Diabetes 2022;7(4):e39742.
17. World Health Organization. Global strategy on human resources for health: Workforce 2030. WHO Technical Report Geneva: World Health Organization; 2016.

About The Author:

Julio G. Martinez-Clark is co-founder and CEO of bioaccess, a market access consultancy that works with medical device companies to help them do early-feasibility clinical trials and commercialize their innovations in Latin America. Julio is also the host of the LATAM Medtech Leaders podcast: A weekly conversation with Medtech leaders who have succeeded in Latin America. He has a bachelor's degree in electronics engineering (BSEE) and a master's degree in business administration (MBA).