Strategic Evidence for Smarter Decisions and Measurable Results

We help health innovators, mission-driven organizations, and legal and medical professionals navigate the full evidence lifecycle. Our four practice pillars — Regulatory Science & Evidence Strategy, Pediatric Neuro & Med-Legal Consulting, Evidence & Impact Analytics, and Acquisition & Funding Strategy — work together to de-risk decisions, win critical resources, and deliver results that stand up to scrutiny

What we Do

Imara means solid, firm, or fortified in Kiswahili — a name that reflects our commitment to steadfast, evidence-driven solutions.

Imara Strategic Advisors is a minority-owned, woman-led consultancy co-founded by siblings Dr. Mwanatumu Mbwana and Kassim Mbwana, MPP. We operate at the intersection of regulatory science, clinical insight, and strategic growth, delivering integrated, cross-disciplinary expertise to health innovators, public health agencies, and mission-driven organizations.

Our four practice pillars — Regulatory Science & Evidence Strategy, Pediatric Neuro & Med-Legal Consulting, Evidence & Impact Analytics, and Acquisition & Funding Strategy — work together to guide clients from concept to approval to measurable impact. Our extended team includes experts such as Dr. Juma S. Mbwana, a board-certified pediatric neurologist and biomedical engineer who advises on pediatric neuro device innovations and high-stakes medico-legal cases.

We help founders, government agencies, nonprofits, and legal teams de-risk decisions, secure resources, and deliver results that stand up to the scrutiny of regulators, payers, courts, and funders.

Let us guide you

  • We guide health-tech founders, diagnostics developers, and innovators through the full regulatory evidence lifecycle — from early product concept to market clearance. Whether preparing a 510(k), pursuing a De Novo classification, or planning a PMA, we align your technology, study design, and evidence package with current FDA expectations.

    Our team integrates regulatory foresight with real-world evidence (RWE) and clinical trial strategies, ensuring your submissions are scientifically rigorous and decision-ready. We also position you competitively for non-dilutive capital — including SBIR/STTR and other federal research funding — by embedding regulatory and evidence plans into winning proposals. From pre-submission strategy through final approval, we serve as your embedded regulatory and evidence partner, de-risking decisions and accelerating time to market.

  • We bring rare, dual-discipline expertise to pediatric neurology consulting — combining clinical leadership with biomedical engineering insight. Our work supports medical device innovators, legal teams, and healthcare systems in high-stakes cases where safety, efficacy, and usability intersect.

    From human-factors validation and workflow integration to independent medical examinations (IMEs) and expert witness testimony, we help clients ensure that devices and interventions are clinically sound, regulator-ready, and defensible in legal or reimbursement settings. For pediatric neuro device innovators, we provide early design input, evidence planning, and risk assessment to position your solution for approval and adoption.

  • We measure what matters — turning clinical, operational, and program data into decision-grade insights that improve performance and strengthen your standing with regulators, payers, funders, and policymakers. Our team designs mixed-methods evaluations, builds performance measurement frameworks, and applies advanced analytics to track outcomes, cost-benefit, and equity impact.

    Whether assessing a post-market device, evaluating a multi-site public health program, or producing evidence for grant renewals, we translate results into clear, actionable findings. Our work ensures that impact is not only demonstrated but understood and valued by the audiences that matter most.

  • We turn proven value into competitive advantage — helping clients secure multimillion-dollar grants, high-value federal contracts, and strategic partnerships. Our capture strategies combine market intelligence, stakeholder engagement, and compelling evidence narratives to position you for success in competitive funding environments.

    From SBIR/STTR applications to large-scale procurement bids, we integrate your regulatory and evidence assets into proposals that are compliant, compelling, and backed by measurable impact. We don’t just chase opportunities — we help you win the right ones, then prepare you to deliver and scale.

Our Approach

  • Evidence Lifecycle

    Strategic Evidence for Smarter Decisions — Across All Four Pillars

    At Imara Strategic Advisors, every engagement follows our Evidence Lifecycle  — a structured process that turns complex questions into clear, defensible, and actionable answers. Whether you are navigating the U.S. Food and Drug Administration (FDA), scaling an innovation in pediatric neurology, competing for high-value funding, or measuring the real-world impact of a program, this lifecycle ensures we deliver both speed and substance.

  • 1. Plan

    Regulatory Science & Evidence Strategy  Define regulatory pathway and evidence needs.

    Pediatric Neuro & Med-Legal Consulting Frame clinical and legal questions for precise investigation.

    Evidence & Impact Analytics Choose evaluation designs and outcome metrics.

    Acquisition & Funding Strategy  Target funders and design win-ready narratives.

  • 2. Generate

    Regulatory Science & Evidence Strategy – Build trial protocols, real-world evidence (RWE) plans, and validation studies.

    Pediatric Neuro & Med-Legal Consulting Gather clinical observations, imaging, and human-factors data.

    Evidence & Impact Analytics Link datasets, conduct surveys, and analyze program performance.

    Acquisition & Funding Strategy Develop market intelligence and competitive insights.

  • 3. Decide

    Regulatory Science & Evidence Strategy – Pre-submission reviews, label/claims positioning.

    Pediatric Neuro & Med-Legal Consulting Differential diagnosis and clinical interpretation for device or legal cases.

    Evidence & Impact Analytics – Interim evaluation dashboards for adaptive decision-making.

    Acquisition & Funding Strategy Bid/no-bid analysis and capture strategy refinement

  • 4. Implement

    Regulatory Science & Evidence Strategy – Author and file submissions. Draft compliance plans.

    Pediatric Neuro & Med-Legal Consulting Integrate devices into clinical care pathways.

    Evidence & Impact Analytics – Support program delivery and fidelity monitoring.

    Acquisition & Funding Strategy – Lead proposal development and partnership formation.

  • 5. Prove

    Regulatory Science & Evidence Strategy Support responses to regulator queries.

    Pediatric Neuro & Med-Legal Consulting Deliver expert testimony or validation data.

    Evidence & Impact Analytics  Publish evaluation reports and visualizations.

    Acquisition & Funding Strategy  Demonstrate past performance and impact in funder reports.

  • 6. Scale

    Regulatory Science & Evidence Strategy – Reuse submission modules across product lines.

    Pediatric Neuro & Med-Legal Consulting Apply successful device validation to new conditions or settings.

    Evidence & Impact Analytics Scale proven interventions to additional populations.

    Acquisition & Funding Strategy Build on wins for larger and longer-term opportunities.

Our Services

Regulatory Science & Evidence Strategy

We serve med-tech and diagnostics innovators, health-tech startups, and research teams bringing regulated products to U.S. and EU markets

  • Identify the optimal FDA pathway, define endpoints, and prepare Q-sub packages that align with current guidance and review expectations.

  • Draft and compile 510(k), De Novo, and PMA submissions with integrated RWE and clinical trial data to strengthen your case.

  • Develop study protocols, statistical analysis plans, and data strategies tailored for regulatory acceptance.

  • Produce regulator-ready assessments to address safety, usability, and claims validation.

  • Integrate regulatory and evidence plans into SBIR/STTR and other non-dilutive funding proposals.

Pediatric Neuro & Med-Legal Consulting

We serve medical device developers, law firms, insurers, and healthcare systems addressing pediatric neurology challenges in product design, clinical validation, and litigation.

  • Evaluate device safety, efficacy, and usability with both clinical and biomedical engineering perspectives.

  • Assess real-world clinical environments to ensure pediatric neuro devices fit seamlessly into care delivery.

  • Provide expert, impartial evaluations for medico-legal cases involving neurological injury or impairment.

  • Deliver clear, defensible opinions in high-stakes litigation, supported by robust clinical and technical evidence.

  • Identify regulatory, clinical, and market adoption risks early in device development.

Evidence & Impact Analytics

We serve public health agencies, non-profits, health systems, and mission-driven programs that need to prove and improve their outcomes to regulators, funders, and policymakers.

  • Build mixed-methods frameworks to assess outcomes, cost, and equity across programs and interventions.

  • Create monitoring tools and dashboards that track progress toward strategic goals.

  • Apply statistical modeling, causal inference, and data visualization to derive actionable insights from complex datasets.

  • Monitor safety and performance of approved devices using real-world data sources.

  • Translate evaluation findings into clear stories that support renewals, scaling, and policy influence.

Acquisition & Funding Strategy

We serve innovators, research institutions, and social impact organizations competing for non-dilutive funding, federal contracts, and strategic partnerships.

  • Identify, qualify, and position for high-value grants, contracts, and cooperative agreements.

  • Manage end-to-end proposal processes, ensuring compliance, competitiveness, and compelling narratives.

  • Leverage impact data and regulatory assets to strengthen win themes and differentiators.

  • Align technical, regulatory, and business cases for SBIR/STTR and other non-dilutive funding sources.

  • Develop performance tracking and reporting systems to meet funder requirements and support future growth.

Meet the Team

  • Dr. Mwanatumu Mbwana, PhD, RAC

    Co-Founder; Chief Regulatory & Evidence Officer

    Regulatory science leader and PhD-trained epidemiologist with 20+ years guiding medical devices and health technologies through FDA and global regulatory pathways. Former Associate Director of Evidence Generation at NESTcc (MDIC), where she partnered with FDA/CDRH to advance national RWE standards, and Regulatory Affairs leader at Meso Scale Discovery. She specializes in real-world evidence generation, ISO-compliant systems, and market access strategies, helping innovators align with regulatory expectations from pre-submission through post-market surveillance.

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  • Kassim Mbwana, MPP

    Co-Founder; Chief Strategy Analytics & Funding Officer

    Shipley-trained strategist and program evaluation expert with 15+ years securing $350M+ in federal, state, and nonprofit awards. He has also positioned clients on federal acquisition vehicles valued at $500M+. At Summit Consulting, he led multi-million-dollar wins and advanced high-impact initiatives for USDA, SBA, HUD, NASA, and the American Heart Association. He blends expertise in mixed-methods evaluation, outcome measurement, and strategic positioning—bridging acquisition strategy with evidence analytics to help clients secure resources, deliver results, and demonstrate measurable impact.

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  • Dr. Juma Mbwana, MD, BS

    Consulting Partner – Pediatric Neuro & Med-Legal Consulting

    Board-certified child neurologist and biomedical engineer specializing in pediatric neuro device consulting, high-stakes medical-legal cases, and clinical leadership. Medical Director at Children’s National Hospital and Associate Professor at George Washington University, he oversees multidisciplinary neurology programs across inpatient, outpatient, and regional settings. Juma consults to Imara Strategic Advisors supporting expert witness services and real-world evidence strategies to support neurotechnology innovation and regulatory readiness.

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  • Dr. Oswaldo Urdapilleta, PhD

    Consulting Partner, Evidence & Impact Analytics

    Evaluation leader with 20+ years directing large-scale federal studies for CMS, USDA, SBA, and DOL. Principal Research Associate at Optimal Solutions Group and Former Director at Summit Consulting, he has led evaluations such as the multi-state CMS demonstration projects. A highly cited researcher and published author in peer-reviewed journals, he is recognized for shaping evidence-based policy and improving program performance across health and social policy. He serves as an advisor strategically extending the firm’s evaluation capabilities and expertise.

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  • George C. Tagg, Jr.

    Consulting Partner, Acquisition & Funding Strategy

    Founder of GTC 360 Advisors, George is a government affairs and business development strategist whose capture leadership has delivered over $800M in competitive contracts and grants from agencies including the U.S. Economic Development Administration’s Tech Hubs. Former NATO Policy Advisor at the U.S. State Department and Senior Advisor at the Department of Defense, he has also led the Government + Public Sector practice at Hill+Knowlton. He extends Imara’s Acquisition & Funding Strategy pillar with coalition-building, positioning, and win-theme development for high-value pursuits

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Let’s talk about your next project

Ready to take the next step? Schedule your consultation and tap into decades of experience in navigating regulations, securing funding, and building evidence that drives results. We’ll listen, ask the right questions, and give you clear, practical recommendations you can act on right away.