Case Studies
Establishing Clinical Utility and Coverage for an MRD Assay
Client: A venture-backed molecular diagnostics company developing a molecular residual disease assay
Mandate: Define the evidence required to move from prognostic validity to demonstrated clinical utility and payer coverage.
Charrette mapped the assay’s intended use, eligible population, specimen timing, result categories, and the treatment or surveillance decisions expected to follow each result. The work separated analytical and clinical validity from decision impact, then structured a prospective evidence program around whether the assay changed adjuvant-treatment recommendations, surveillance intensity, imaging, or other clinical management.
Assay configuration, pre-analytical requirements, limit of detection, result thresholds, and failure rates were tied directly to the study design so the resulting evidence would remain interpretable and relevant to the commercial product.
Deliverables:
- Target product profile and intended use claims matrix
- Prospective multicenter decision-impact study protocol
- Endpoint hierarchy and statistical analysis framework
- Payer evidence segmentation and clinical utility requirements
- Coverage dossier and evidence-publication roadmap
Designing the Reimbursement Pathway for AI-Enabled Primary Care Screening
Client: A multinational healthcare company preparing the US expansion of an AI-based platform for image analysis, designed for disease screening in primary care settings.
Mandate: Determine the coding, coverage, payment, and evidence pathway required to move from regulatory clearance to reimbursed clinical use.
Charrette separated regulatory authorization from payment and evaluated how the service would fit within existing imaging, physician service, and site-of-care payment architecture. The analysis addressed which entity could bill, supervision and documentation requirements, eligible care settings, image-acquisition workflow, and responsibility for closing the referral loop. Medicare fee-for-service, Medicare Advantage, Medicaid, and commercial payers were segmented by benefit design and evidence requirements.
The financial model tested disease prevalence, image gradability, technician time, false-positive referrals, downstream specialist capacity, and the economics of screening in primary care practices, federally qualified health centers, and retail clinics.
Deliverables:
- Coding, coverage, and payment map by payer and care setting
- Evidence-to-claim matrix for coverage and contracting
- Payer and health system primary research
- Site-specific unit economics and budget impact model
- Prospective generalizability and post-deployment monitoring plan
Risk-Adjusting the Valuation of an AAV Gene Therapy
Client: A strategic acquirer evaluating an in vivo AAV gene therapy for a rare disease.
Mandate: Test the scientific and commercial assumptions underlying the investment thesis and establish a defensible, risk-adjusted valuation.
Charrette rebuilt the addressable market from the underlying disease biology, separating genotype-defined prevalence from diagnosed, clinically eligible, and practically reachable patients. The patient-flow model distinguished the initial prevalent pool from the recurring incident population and accounted for age, disease progression, prior treatment, neutralizing antibodies, and treatment-center capacity. Technical diligence examined the vector construct, dose, immunogenicity, manufacturing yield, comparability, and limitations on redosing.
The evidence assessment tested the durability assumptions supporting a single-administration therapy, including the use of surrogate endpoints, external controls, confirmatory studies, and long-term follow-up. The commercial model incorporated certified-center ramp, referral concentration, payer authorization, acquisition and administration economics, gross-to-net exposure, competitive entry, and potential outcomes-based contracting.
Deliverables:
- Epidemiology-based statistical analysis and patient identification model
- Technical, manufacturing, and clinical evidence assessment
- Treatment-center capacity and site-of-care analysis
- Risk-adjusted revenue forecast and valuation scenarios
- Transaction milestones and post-close value-creation priorities
Quantifying Value and Site-of-Care Economics for a Bispecific Antibody
Client: A biopharmaceutical company preparing the launch of a T-cell-engaging bispecific antibody.
Mandate: Quantify the therapy’s clinical and economic value, establish a defensible pricing range, and determine how site-of-care economics would affect adoption.
Charrette developed a patient-level total-cost-of-care model comparing the therapy with CAR-T, other T-cell-directed therapies, and later-line regimens. The analysis incorporated drug acquisition, step-up dosing, administration, hospitalization, monitoring for cytokine-release syndrome and neurotoxicity, infection management, immunoglobulin replacement, treatment duration, discontinuation, and subsequent therapy. Clinical scenarios linked depth and durability of response to progression, healthcare utilization, and treatment-free intervals.
The provider model tested inpatient and outpatient payment, buy-and-bill working capital, acquisition-to-reimbursement timing, 340B exposure, staffing, chair capacity, and the economics of administration across academic centers and community oncology practices.
Deliverables:
- Patient-level total-cost-of-care model
- Comparator and treatment-sequencing analysis
- Price-volume and budget-impact scenarios
- Academic and community provider economic models
- Payer value framework and evidence-development plan
Positioning a Kitted IVD for Clinical and Commercial Adoption
Client: A diagnostics startup developing a kitted IVD for clinical laboratories.
Mandate: Identify the most valuable clinical use cases, establish a differentiated market position, and define the evidence required for physician and laboratory adoption.
Deliverables:
- Market segmentation and use case prioritization
- Competitive intelligence
- KOL mapping, interviews, and advisory engagement
- Virtual physician decision-making vignette study
- Laboratory buyer and workflow assessment
Advancing a Biosecurity Device Through Federal Funding and Adoption
Client: A growth-stage medical device company scaling a biosecurity and public health surveillance platform.
Mandate: Establish a pathway to professional guideline inclusion and government adoption, identify non-dilutive funding and federal partnerships, and address the intellectual property implications of government-supported development.
The engagement mapped the adoption ecosystem across relevant federal agencies, program offices, public health stakeholders, guideline bodies, and procurement authorities. It identified the evidence, field validation, interoperability, manufacturing readiness, and stakeholder support required to progress from pilot deployment to broader institutional adoption and eventual guideline consideration.
Potential funding and contracting pathways, including grants, cooperative agreements, SBIR/STTR programs, broad agency announcements, other transaction agreements, and direct procurement, were assessed according to mission fit, technology readiness, award timing, cost-sharing requirements, and follow-on potential. In coordination with legal counsel, the work also established a decision framework covering background and project-generated IP, patent rights, software rights, government-purpose rights, disclosure obligations, and subcontractor considerations.
Deliverables:
- Federal agency, stakeholder, and mission-alignment map
- Non-dilutive funding and opportunity-prioritization roadmap
- Government partnership and pilot strategy
- Federal procurement and commercialization pathway
- IP and data rights decision framework
Validating the Market and Adoption Model for a MCED Test
Client: An investment bank preparing a molecular diagnostics company for a potential strategic transaction.
Mandate: Validate the addressable market, adoption assumptions, and revenue forecast for a blood-based multi-cancer early detection test.
Charrette replaced a population-times-price estimate with a patient-flow and adoption model built from screening eligibility, age and risk segmentation, testing frequency, payer coverage, physician adoption, patient acceptance, and diagnostic follow-up capacity. The model distinguished the theoretical screening population from patients who could be reached, tested, reimbursed, and appropriately worked up following a positive result.
The analysis incorporated sensitivity by cancer type and stage, test failures, false-positive investigations, adherence to repeat testing, confirmatory imaging and biopsy, laboratory throughput, phlebotomy access, and the capacity of local systems to manage downstream findings. Commercial, Medicare, employer, health-system, and self-pay channels were modeled separately because each required a different evidence, pricing, and distribution strategy.
Deliverables:
- Incidence, eligibility, and patient-flow model
- Channel-specific market segmentation
- Laboratory-capacity and diagnostic-workup constraints
- Risk-adjusted revenue forecast and valuation sensitivities
- Transaction narrative and diligence-response materials
Establishing Drug–Test Fit for a Pharmacogenomics Platform
Client: A pharmacogenomics company evaluating the clinical and commercial fit between its test and a high-value therapeutic.
Mandate: Determine whether the underlying biology, patient population, prescribing decision, and clinical workflow supported a meaningful drug–test pairing, and build the evidence base for partnership and adoption.
The engagement began with a structured literature review covering gene–drug biology, variant function, pharmacokinetics and pharmacodynamics, treatment response, toxicity, prescribing behavior, clinical guidelines, regulatory precedent, and existing evidence of utility. The analysis distinguished biological plausibility from evidence that the test could materially improve patient selection or treatment management.
A comprehensive nationwide incidence and prevalence model combined epidemiologic, healthcare, prescribing, and demographic data to characterize the addressable population geographically. The model moved from total disease burden to diagnosed, treated, drug-eligible, and test-eligible populations, while identifying regions and clinical settings where the drug–test pairing would have the greatest relevance. These findings were integrated with test performance, turnaround time, specimen requirements, and the intended therapeutic decision. The work was then translated into two manuscripts that were developed for peer-reviewed publication.
Deliverables:
- Drug–test fit and evidence assessment
- Structured scientific and clinical literature review
- Nationwide incidence, prevalence, and addressable population map
- Evidence gap and biopharma partnership strategy
- Two manuscripts developed for peer-reviewed publication
Building the Institutional Case for Metagenomic NGS in CNS Infections
Client: An academic medical center evaluating whether to establish in-house metagenomic NGS for suspected central nervous system infections.
Mandate: Build the clinical, operational, and financial case required for institutional approval and controlled implementation.
Charrette defined the patients for whom metagenomic sequencing could add value after routine microbiology, targeted molecular testing, imaging, and clinical assessment. The pathway specified specimen requirements, test-ordering criteria, infectious-disease and neurology consultation, contamination review, confirmatory testing, result interpretation, and communication of potentially actionable findings.
The economic analysis compared in-house testing with send-out testing and incorporated instrument acquisition, validation, sequencing reagents, batching, laboratory personnel, bioinformatics, confirmatory testing, turnaround time, reimbursement, and required test volume. Potential value was evaluated through incremental diagnostic yield, changes in antimicrobial or antiviral management, time to targeted therapy, avoided testing, invasive procedures, isolation, and hospital utilization. Governance requirements included CLIA validation, result-review procedures, quality controls, data storage, and oversight of pipeline updates.
Deliverables:
- Clinical eligibility and test-ordering pathway
- Value Analysis Committee evidence dossier
- Throughput, budget-impact, and break-even model
- CLIA validation and quality-management roadmap
- Pilot protocol and institutional success measures
Evidence Generation
Market Fit Optimization
Aligning Product with Market Demand
A growing company approached us with a strong product but limited traction. Through in-depth market analysis and customer segmentation, we identified key gaps in positioning and messaging.
By refining the value proposition and aligning it with customer expectations, we helped the organization improve market fit, increase engagement, and strengthen its competitive position.
Project conducted by: Randy
Client: One of the largest US biotech companies
Objective: Determine whether company should enter the heart and lung post-transplant monitoring space.
Randy identified the most appropriate KOLs to collaboratively conduct studies with, negotiated and closed relevant contracts, designed the respective studies with the clinical operations team, and co-led data analysis.
Other Deliverables:
- Market research
- Competition analysis
- Ad boards
- Upstream marketing, market fit
- Financial forecasting
- Product positioning, marketing collateral, clinical adoption potential
Outcome: Company entered the post-transplant monitoring space for both heart and lung and has been executing well in this space.
Market Entry Strategy
Navigating New Market Opportunities
A client looking to expand into a new market needed a tailored market entry strategy. Our team conducted in-depth market research, competitor analysis, and customer segmentation to guide the entry process.
We crafted a roadmap that outlined the optimal entry strategy, identified potential partners, and evaluated key risks. This helped the client successfully enter the market, build brand recognition, and establish a foothold in a competitive space.
Project conducted by: Randy
Client: A digital pathology startup
Objective: Provide an SaMD client (AI biomarker prediction → precision therapy) a clear reimbursement strategy and detailed implementation plan.
Randy evaluated critical decision points that can lead to a delay to market, as related to FDA (pre-)submission, CLIA lab buy-borrow-build, pursuance of ADLT status, and AMA CPT coding.
Other Deliverables:
- In-depth HCP (oncologist/pathologist/Lab Director/COO) interviews
- Advised on CLIA/no-CLIA reimbursement strategy after engaging the key government regulator
- Financial modelling for purchase incentivization of hospital central labs
Outcome: Client pursued the recommendations to (1) raise additional VC funds, (2) build a 2-year go-to-market plan, (3) tailor their sales strategy, and (4) pursue a hospital billing pathway.
Product Launch Execution
Driving Early Adoption and Momentum
We supported a client preparing to launch a new product in a competitive market. Our role included defining go-to-market strategy, optimizing messaging, and identifying key distribution channels.
The result was a structured launch that generated early traction, accelerated adoption, and positioned the product for long-term growth.
Project conducted by: Randy
Client: A Fortune 50 multinational pharmaceutical company
Objective: Broadening the use of a point-of-care test – from emergency use authorization (EUA) to an in vitro diagnostic, submitting a 510K; the context was differentiating two communicable respiratory infections.
Randy performed economic and clinical outcome analyses on the client’s data, and created value messaging for the three key stakeholders necessary for broad adoption– patients, healthcare providers, and payers. These analyses informed a nationwide product launch campaign.
Other Deliverables:
- HEOR-based pricing model
- Marketing collateral and storyboards
- Real-world evidence report
Outcome: Client proceeded in the advised direction and is on path to secure broad distribution and market acceptance (including coverage by commercial payers).
Coverage & Integration Strategy
Expanding Reach with Operational Alignment
An organization seeking expansion faced challenges in integrating new operations across multiple markets. We developed a strategy focused on coverage optimization and operational alignment.
By streamlining processes and improving coordination, the client was able to expand efficiently while maintaining consistency and performance.
Project conducted by: Randy
Client: A leading US clinical laboratory
Objective: Provide a clinical laboratory/test developer evidence to support both reimbursement and broad primary care integration for a drug-drug interaction (adverse drug event) test.
Randy led a 500+ physician market research study, a decentralized clinical trial, and a pilot study (with one of the largest US primary care systems) to produce physician decision-making and real-world outcomes data.
Other Deliverables:
- Evidence generation planning – AV (analytical validity), CV (clinical validity), and CU (clinical utility)
- Multiple high-impact publications
Outcome: Client expanded their commercial and CMS coverage for the product, the primary care system adopted the test at all nationwide facilities, and client is in development of a next-generation product.
Product Harmonization
Product Harmonization
A company with multiple product lines needed to unify its portfolio. We helped harmonize product positioning, streamline messaging, and align internal processes.
This resulted in a more cohesive brand presence and improved operational efficiency across the organization.
Project conducted by: Randy
Client: A global life sciences company
Objective: Improve operational efficiency by reducing product redundancy.
Company sought to determine how to streamline and harmonize their somewhat redundant HLA genotyping products, and what the financial effect on the business would be. Jonathan performed a comprehensive assessment and developed a rationalization plan.
Other Deliverables:
- Met with primary company customers to discuss potential discontinuation impact
- Projected financial outcomes for various SKU reductions
- Devised a clear (SKU-by-SKU) rationalization plan and generated relevant marketing messaging
- With the company Operations team, collaboratively developed an implementation plan
Outcome: Rationalization plan was executed. Loss of revenue was minimized as company achieved clarity with all key customers about their migration plan ahead of rationalization. Discontinuing underperforming products boosted division profitability by streamlining operations across QA, QC, manufacturing, technical support, marketing, product management, supply chain, and bioinformatics.
Business Strategy Development
Building a Scalable Growth Framework
We worked with a leadership team to redefine their strategic direction. Through structured analysis and planning, we developed a roadmap that aligned business goals with market opportunities.
The outcome was a clear, actionable strategy that supported growth, improved decision-making, and strengthened long-term positioning.
Project conducted by: Randy
Client: A leader in developing genomic tests and platforms
Objective: Create an enterprise strategy.
Randy co-led the process of forming a 3-year strategy for a company operating in transplant diagnostics. He collaborated with dozens of stakeholders, and then convened the key internal company executives to obtain an actionable enterprise-wide strategy.
Other Deliverables:
- Identified business challenges and opportunities, resulting in reprioritization of internal projects
- Assessed high-priority needs and required capacity, creating a pragmatic timeline for multi-project launches
- Evaluated changes to FDA & CMS guidelines, creating a plan to capitalize on changes relative to competitor
Outcome: Streamlined processes, consolidated resources, and developed consensus, building energy among team members, and aligning goals with practical steps forward.
M&A Intelligence
Supporting High-Stakes Decision Making
A client evaluating a potential acquisition required detailed insights to guide their decision. We conducted comprehensive analysis, assessing financial, operational, and strategic factors.
Our work provided the clarity needed to evaluate risks and opportunities, enabling the client to move forward with confidence.
Project conducted by: Randy
Client: A leader in developing and manufacturing molecular diagnostic tests
Objective: Plan portfolio and evaluate acquisition targets.
Randy led M&A intelligence, closely advising the CEO, CBO and other stakeholders on technical product analysis, financial modeling, and reimbursement potential, leading to investment recommendations backed by supporting evidence.
Other Deliverables:
- Performed technical due diligence and held discussions with company founders
- Assessed product’s fit with company’s current portfolio
- Evaluated various reimbursement pathways
Outcome: After assessing over a dozen companies, advised the company CEO and CBO to pursue a tender offer for one target. To minimize risk, the company made a conservative bid based on Jonathan’s valuation of the asset. A competitor overpaid for the product and struggled to gain market share. Leveraging insights gained from this, the company independently developed its own technology.