Health-tech Startups & Medical Device Companies

Healthcare Software Development for HealthTech Startups, HIPAA, FDA-Ready & EHR-Connected

The SOC2 HIPAA compliant health tech outsourcing partner for digital health startups and medical device companies,  HIPAA from the first line of code, FDA compliance built into development, EHR integration that closes enterprise sales, and healthcare SaaS architecture that scales without re-engineering.

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Retrofitting HIPAA Into a Codebase That Was Not Designed for It

Deferring HIPAA compliance to a later sprint and then discovering that retrofitting HIPAA technical safeguards costs 3 to 5x a greenfield implementation, while delaying your enterprise sales process and Series B due diligence.

No EHR Integration = No Enterprise Sales

Technically sound products that cannot close health system deals because they cannot demonstrate Epic integration, satisfy the CISO's security review, or provide the FHIR API connectivity that CMS mandates require.

FDA Clearance as a Revenue Gate Without a Regulatory Strategy

Medical device software built without a documented SaMD classification, IEC 62304 lifecycle, or FDA pre-submission strategy, realizing at investor due diligence that the development history cannot support the 510(k) needed to commercialize.

MVP Architecture That Cannot Scale to Enterprise

Healthcare SaaS products built for a pilot that encounter architectural limits, scaling to 50 health system customers, single-tenant designs, monolithic applications, and manually implemented compliance controls that cannot be replicated consistently.

01What we build

What We Build for Digital Health Companies and Medical Device Startups

Four service areas from HIPAA-compliant MVP development and FDA regulatory strategy through EHR integration and scalable healthcare SaaS architecture.

01
HIPAA-Compliant Architecture, Seed Round to Scale

HIPAA compliance built into your architecture as infrastructure-as-code, version-controlled, reproducible, and audit-ready from Day 1, not assembled under pressure before the enterprise sales process begins.

  • VPC isolation, AES-256 encryption at rest (KMS-managed), TLS 1.2+ in transit, IAM least-privilege access, all as Terraform IaC
  • PHI field identification, tokenization, data minimization in API responses, and configurable retention policies
  • BAA-aligned cloud vendor configuration: AWS HIPAA-eligible service set, GCP, and Azure equivalents
  • SOC 2 Type II readiness: security, availability, and confidentiality criteria with evidence collection automation
Explore HIPAA compliance services
02
Medical Device Software Development, FDA & ISO 13485

FDA regulatory strategy and ISO 13485 QMS integrated into the development process, arriving at FDA pre-submission with a complete development history, not a retrospective documentation exercise.

  • SaMD classification, intended use definition, and regulatory pathway selection (510(k), De Novo, PCCP for AI/ML)
  • IEC 62304 software lifecycle: development plan, requirements, architecture, unit/integration/system testing
  • ISO 14971 risk management: hazard identification, control measures, and residual risk evaluation
  • ISO 13485 QMS: quality manual, procedures, design controls, and post-market surveillance, maintained as a living system
Explore medical device software services
03
EHR Integration, Epic App Orchard, FHIR R4 & CDS Hooks

EHR integration that removes the technical procurement barrier at health system enterprise accounts, so the commercial conversation focuses on clinical value rather than integration logistics.

  • Epic App Orchard development and certification: SMART on FHIR, FHIR R4, MyChart, and Epic review process management
  • Athenahealth and eClinicalWorks FHIR integration: patient data, lab results, scheduling, and clinical document exchange
  • FHIR R4 API: Patient, Observation, DiagnosticReport, MedicationRequest, Condition, US Core IG conformant
  • CDS Hooks: real-time CDSS delivery at EHR order-select, patient-view, and medication-prescribe trigger points
Explore EHR integration services
04
Healthcare SaaS Architecture, Built to Scale

Multi-tenant SaaS architecture, compliance automation, and enterprise identity management, the technical foundations that enterprise healthcare buyers require before procurement.

  • Multi-tenancy: schema-per-tenant, database-per-tenant, or row-level-security, with PHI access controls per tenant
  • Compliance automation: HIPAA control validation on every deployment, PHI anomaly detection, automated access review reporting
  • Enterprise SSO: SAML 2.0, OIDC, and SCIM 2.0 for automated user lifecycle management in health system environments
  • Observability and SLA: distributed tracing, availability monitoring, 99.9% uptime SLA documentation for enterprise contracts
Explore digital health platform services
02Outcomes

What HealthTech Startups and Medical Device Companies Get Back

✓
HIPAA-compliant architecture and SOC 2 Type II that satisfy health system IT security reviews
✓
FDA clearance on schedule, development history in place, not assembled retrospectively before submission
✓
Epic App Orchard listing that removes the EHR integration question from enterprise procurement
✓
Architecture that scales from 5 pilot customers to 100 enterprise customers without re-engineering
✓
Enterprise SSO and compliance automation that meet health system IT procurement requirements
✓
FDA PCCP pathway for AI/ML models, enabling post-clearance model updates within approved bounds
03Case studies

Proof From HealthTech and Medical Device Engagements

ISO 13485 Compliant AI-Powered Wearable
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Scalable Employee Wellness SaaS
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Frequently Asked Questions

When should a digital health startup address HIPAA, and what does it cost to defer?
HIPAA compliance should be addressed at the architecture design phase, before code is written. Starting correctly at the MVP stage costs approximately 10-15% more engineering effort. Starting at the enterprise sales stage, when the architecture must be refactored, typically costs 3 to 5x a greenfield build and delays commercialization by 6 to 12 months. The specific decisions that make compliance retrofits expensive are data model design, cloud service selection, IAM architecture, and the lack of PHI audit logging at the application layer.
What is the FDA pathway and realistic timeline for medical device software (SaMD)?
Class II SaMD typically requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. FDA's nominal review time is 90 days from acceptance, but the total time from pre-submission Q-Sub through clearance is typically 9 to 18 months, including document preparation, acceptance review, interactive questions, and any additional information requests. Novel SaMD with no predicate requires a De Novo request, adding 3 to 6 months. AI/ML SaMD can use the PCCP pathway to obtain FDA clearance for model updates without a new 510(k).
What does Epic App Orchard certification require, and how does it help close enterprise sales?
App Orchard listing requires Epic's technical review (FHIR API usage, SMART on FHIR authentication), security review (HIPAA documentation, penetration test results, BAA terms), and interoperability review (FHIR resource profiles, Epic FHIR server compatibility). Commercially, it removes a procurement barrier: health system IT departments typically require App Orchard listing before allowing third-party connectivity to Epic. Without it, each customer requires a custom integration project, adding 3 to 6 months to the sales cycle.
What do enterprise health system procurement teams evaluate beyond product functionality?
Five areas: security and compliance (HIPAA BAA, SOC 2 Type II, penetration test, security questionnaire in VSAQ or CAIQ format); EHR integration (Epic App Orchard listing, SMART on FHIR, compatibility with the health system's Epic version); data governance (data processing agreement, residency options, deletion and portability on BAA termination); operational resilience (uptime SLA, disaster recovery RPO/RTO, incident response, reference customers at comparable health systems); and contract terms (PHI breach indemnification, liability caps, termination for cause provisions).
04Related solutions

Explore the Underlying Solutions

Digital Health, IoT & Security

HIPAA architecture, FDA compliance, ISO 13485, and PHI masking, the technical foundations for your product.

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Data Interoperability & Integration

FHIR R4, HL7, and Epic App Orchard, the integration layer that closes your enterprise deals.

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Clinical Intelligence & AI

CDSS, analytics, and population health platforms for startups building clinical decision support products.

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Ready to Build a Healthcare Product That Passes Procurement and Scales?

Tell us your product, target buyer, and compliance stage. We will scope the build.

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