AI-Powered Consulting for Healthcare & Digital Health

Traditional healthcare consulting from Deloitte Health, McKinsey Health, or big 4 life sciences practices runs $300,000–$2,000,000 for a full strategic engagement, with even scoped market research projects starting at $50,000–$150,000. LeanStrat delivers comparable strategic intelligence for $500–$15,000, depending on scope. A focused competitive landscape (5-10 competitors across one healthcare IT segment) starts at $1,500. A fundraising-grade market sizing with epidemiology-based TAM/SAM/SOM and payer landscape analysis runs $3,000–$8,000. A full strategic roadmap with regulatory analysis, competitive positioning, and go-to-market recommendations is $10,000–$15,000. The cost difference is structural: we use AI to process the same FDA guidance documents, CMS reimbursement tables, KLAS ratings, and HIMSS data that Big 4 analysts spend weeks reading manually.

Healthcare IT market sizing requires epidemiology-based methodology, not the top-down "X% of a $500B market" approach that fails investor scrutiny. LeanStrat uses a three-layer model: (1) TAM — defined by total patient population with the relevant condition (e.g., 37 million diabetics in the US for a diabetes management platform), multiplied by average revenue per patient if you captured 100% of addressable spend. (2) SAM — filtered by geography, care setting (inpatient vs. outpatient vs. home health), payer mix (commercial vs. Medicare vs. Medicaid), and technology adoption readiness. For a telehealth platform targeting commercially insured patients in urban markets, SAM might be 15-20% of TAM. (3) SOM — defined by realistic sales capacity, competitive density, and your GTM motion in Year 1-3. We cross-validate bottom-up models against public comp data: Veeva, Evolent, Privia, and Teladoc 10-K filings provide per-patient or per-provider revenue benchmarks. CMS claims data and IQVIA market share data anchor segment sizing. Delivered with full methodology documentation, investor-ready.

A LeanStrat health tech competitive analysis covers: (1) Competitive landscape map — direct and adjacent competitors segmented by target care setting, payer type, EHR integration depth, and customer segment (health systems, physician groups, payers, employers, or consumers); (2) KLAS and KLAS Arch Collaborative ratings analysis — the gold standard for health IT buyer perception, surfacing which vendors are winning on clinical outcomes vs. implementation quality vs. support; (3) Pricing and contracting intelligence — subscription vs. per-member-per-month vs. value-based arrangement models across competitors, including what limited public data is available from health system RFP disclosures; (4) FDA clearance and ONC certification status — which competitors have 510(k) clearances, ONC Health IT certifications, or DEA-compliant prescribing capabilities, and how long those pathways took; (5) EHR integration landscape — which Epic App Orchard, Cerner CareAware, or Allscripts developer program partnerships competitors hold; (6) Funding and strategic investor analysis — who has raised, from whom, and what that signals about competitive trajectory.

Regulatory and reimbursement research is the most underinvested area in digital health strategy. LeanStrat covers four layers: (1) FDA pathway analysis — Software as a Medical Device (SaMD) classification under the FDA's Digital Health Center of Excellence, identifying whether your product is likely exempt, De Novo, or 510(k), and benchmarking time-to-clearance against comparable cleared products in the FDA 510(k) database; (2) CMS reimbursement landscape — which CPT codes apply to your category (e.g., CPT 99457/99458 for Remote Patient Monitoring, CPT 98975-98980 for Remote Therapeutic Monitoring, G0108/G0109 for Diabetes Self-Management Training), average national reimbursement rates, and whether prior authorization is a standard barrier; (3) State telehealth parity law mapping — 43 states have telehealth parity laws, but coverage scope, modality requirements, and audio-only provisions vary significantly; (4) HIPAA and HITRUST compliance positioning — mapping what certifications your target hospital and payer buyers require as procurement prerequisites. This landscape analysis is foundational for GTM strategy, pricing model design, and fundraising positioning.

Payer strategy is where most digital health companies lose 12-18 months of runway. LeanStrat's payer landscape analysis covers: (1) Payer segmentation — ranking the top 20 US commercial payers (UnitedHealth, Anthem/Elevance, Aetna/CVS, Cigna, Humana, HCSC, Centene, Molina, etc.) by their digital health innovation appetite, existing vendor partnerships, and clinical evidence requirements for coverage determination; (2) Value-based contract landscape — identifying which payers are operating ACOs, MSSP tracks, or bundled payment programs relevant to your therapeutic area, and what outcomes metrics they track; (3) Evidence requirements benchmarking — what clinical study design (RCT vs. retrospective cohort vs. claims analysis) and HEOR (health economics and outcomes research) data each major payer typically requires before issuing a coverage determination or preferred vendor arrangement; (4) Employer channel analysis — for companies targeting self-insured employers via benefits platforms (Accolade, Quantum Health, Castlight), benchmarking what ROI thresholds and integration capabilities major employers require. This analysis prevents companies from investing 18 months in a payer channel that is structurally closed to them.