Your AI works in the demo. Production runs on FHIR, GxP, and 21 CFR Part 11.

Clinical research data is the most underbuilt foundation in life sciences. CRO and tech-vendor service costs grew from $10.4B in 2000 to $78.6B in 2020 (Tufts CSDD), but the data still lives in disconnected EDC systems, unmanaged spreadsheets, and ad-hoc R packages. A typical Phase III trial generates 200-500 tables, listings, and figures (TLFs), each requiring double-programming validation that adds 20-40% to timelines. Protocol amendments now hit 3.3 per study on average, with each substantial Phase III amendment costing roughly $535K and adding ~260 days from internal approval to ethics-committee sign-off.

Real-world evidence is the regulatory tailwind. FDA's RWE program now appears in 23-28% of supplemental drug approvals expanding labeling, with the final medical device RWE guidance industry-operationalization deadline hitting February 2026. ICH M14 (July 2024 draft) and the 2024 final guidance on EHR/claims data further codify acceptability. Companies with clean OMOP CDM, CDISC SDTM/ADaM, and FHIR-linked claims+EHR datasets file faster and defend their submissions better. Companies without that foundation watch their AI roadmaps stall in IT.

We build the integration layer. ETL/ELT pipelines from Veeva Vault Clinical, Medidata Rave, Oracle InForm, and proprietary EDC systems into harmonized analytics environments. CDISC mapping and Define-XML automation. eTMF inspection-readiness. RWE platforms that link claims, EHRs, registries, and patient-reported outcomes. The same data engineering pattern that works in manufacturing and energy, with the validation rigor life sciences requires.

Roughly 30 AI-discovered or AI-enabled drug candidates have entered human trials by late 2025, with zero FDA approvals to date. Insilico Medicine's rentosertib is the most advanced (Phase IIa positive in idiopathic pulmonary fibrosis). Schrödinger and Takeda's zasocitinib is in Phase III. Major partnerships are real money: Isomorphic Labs combined ~$3B with Lilly and Novartis (January 2024), Recursion-Roche up to $12B, BenevolentAI-Merck $594M, and NVIDIA's $1B BioNeMo co-innovation lab with Lilly announced at JPM 2026. The platforms work. The drugs are mostly still in trials.

For biotech and pharma teams in the $100M-$500M range, the question isn't whether to use AI in discovery. It's how to integrate AlphaFold 3, ESM3, NVIDIA BioNeMo, generative chemistry models, and proprietary target-ID models into existing R&D workflows without breaking GxP, IP boundaries, or scientific reproducibility. FDA's January 2025 draft guidance on AI in drug development establishes a risk-based credibility framework based on context-of-use. CDER has handled more than 500 submissions with AI components since 2016. Teams that document their model lifecycle clearly file faster.

We build the engineering scaffolding. Pipeline orchestration on Nextflow or Cromwell. Foundation-model serving with proper observability. Experiment tracking that survives an FDA audit. Vector databases for chemistry and biology embeddings. Integration between commercial platforms (Schrödinger, OpenEye, Benchling) and proprietary models. We don't sell drug discovery. We build the infrastructure that lets your scientists actually use the models you've licensed.

FDA has cleared more than 1,200 AI/ML-enabled medical devices through end-2025, with 295 new authorizations in 2025 alone, a record year. About 76% are radiology. 62% of 2025 clearances are SaMD. 97% used the 510(k) pathway. But a 2024 JAMA Network Open systematic review found only 3.6% of cleared devices reported race/ethnicity in validation cohorts and fewer than 2% linked to peer-reviewed performance studies. The bar is rising fast.

Three regulatory shifts converged in late 2024 and 2025. FDA's December 2024 final guidance on Predetermined Change Control Plans (PCCPs) lets manufacturers ship AI model updates without re-clearance, provided they document the change protocol up front. About 10% of 2025 AI/ML clearances included a PCCP. FDA's September 2025 final guidance on Computer Software Assurance replaces decades of CSV practice with a risk-based, vendor-leveraged approach. The QMSR final rule incorporating ISO 13485:2016 takes effect February 2, 2026. The EU AI Act's high-risk medical-AI obligations apply August 2027, with overlap on MDR/IVDR conformity assessment.

We build the engineering systems that make this manageable: model lifecycle infrastructure with full audit trails, automated validation pipelines that satisfy CSA's risk-based expectations, change-control automation for PCCPs, and 21 CFR Part 11 compliant electronic records. We've shipped compliance-heavy infrastructure for the Department of Defense (MEPCOM) and utility companies (SDG&E), both of which demand the same rigor FDA-regulated software requires.

Modern genomics generates petabytes per year. Cost-per-genome dropped from $95M in 2001 to under $200 today (Illumina NovaSeq X, Complete Genomics DNBSEQ-T7, Ultima UG100), three orders of magnitude in two decades. The bottleneck isn't sequencing anymore. It's the pipelines, the storage economics, and the integration between LIMS, ELN, instrument data, and downstream analytics.

Diagnostics labs run Nextflow, Cromwell, and Snakemake on managed cloud genomics services (AWS HealthOmics, Google Vertex AI for Life Sciences, Azure Genomics). Cell and gene therapy manufacturers need eBR and MES configured for ATMPs, where every batch is functionally a small clinical trial. Multi-omics integration projects (genomics + proteomics + transcriptomics + clinical) sit half-finished in most mid-market biotechs. Benchling powers more than 1,300 biotech companies but stops at the ELN boundary; the rest is custom integration work.

We build the connective tissue. LIMS-to-cloud pipelines that survive instrument firmware upgrades. Genomics workflow orchestration with proper resource economics. Multi-omics data lakes with FAIR principles built in. Custom applications that integrate Benchling, Geneious, Schrödinger, and your in-house pipelines. The engineering skill is the same as data infrastructure work in any industry. The compliance overlay is the part most consulting firms underestimate.

Telehealth stabilized at 5.7-7.0% of E&M visits by 2024, well below the pandemic peak but roughly ten times the pre-pandemic baseline. Behavioral health is the standout: 43.8% of E&M visits in high-use specialties are now telehealth. Remote patient monitoring is reimbursed by Medicare and 42 state Medicaid programs, with new CPT codes 99445 and 99470 effective January 1, 2026. The new Medicare DMHT codes for digital therapeutics were used for only 446 patients across 897 visits through Q3 2025. Adoption remains thin even after the Pear Therapeutics bankruptcy and Akili pivot reset the category.

Ambient AI scribes are the runaway healthcare AI story. The NEJM AI randomized trial (Nov 2024 to Jan 2025, 238 physicians across 14 specialties) confirmed clinically meaningful reductions in documentation time and burnout for both Microsoft DAX Copilot and Nabla. KLAS forecasts 93% of U.S. health systems will be in moderate-to-deep adoption within six months. Abridge raised $300M Series E at a $5.3B valuation in June 2025. Then Epic launched native AI Charting on February 4, 2026, threatening every standalone scribe vendor. Doximity released a free scribe in 2025. The category is consolidating fast.

For HealthTech vendors, the engineering problem is integration depth and defensibility. Epic Pal and Toolbox certification. SMART on FHIR app development. Cigna's October 2025 auto-downcoding moves create billing-defense engineering work. We build the integration layers, the workflow logic, and the validated AI infrastructure that makes a HealthTech product survive contact with enterprise health systems. We've built large-scale public-facing communications platforms (SDG&E wildfire safety, scaled from 5,000 to 150,000+ notifications per activation). The architecture pattern transfers cleanly to digital front door, RPM, and patient engagement work.