Benchmark, 2026 edition

Healthcare software development cost benchmarks 2026: 100+ solutions ranked by cost

Orangesoft estimates that custom healthcare software products cost $40,000 to $800,000+ to build in 2026, excluding integrations and add-ons. Single integrations start at $15,000 and AI add-ons at $20,000. Half of all priced scope levels start at or below $95,000 and half end below $175,000. The benchmark covers 182 scope levels of 101 solutions in 14 categories, from EHR and telemedicine to Software as a Medical Device and healthcare AI.

The ranges are Orangesoft's own estimates based on our delivery experience, not a market survey.

Each solution is priced at one to three scope levels, for example small-practice, multi-specialty and hospital-grade EHR/EMR.

. Version 2026.1.

By Tatsiana Kirimava, Co-founder & CEO, and Alex Melchanka, Co-founder.

Download CSV JSON How to cite

All price ranges, from the least to the most expensive

57% of scope levels have a midpoint between $100K and $250K; a long tail of regulated and enterprise software reaches $800K+. All ranges as a table

Select a category to highlight its scope levels. Select a line to read it.

Each line is one scope level, drawn from its lower to its upper bound; every upper bound is open (“+”).

Key findings

Six figures from the benchmark. The methodology explains how.
  • $40K–$800K+

    Healthcare software products cost $40,000 to $800,000+ to build in 2026, by Orangesoft's estimates, excluding integrations and add-ons.

    The least expensive products start at $40,000, including basic medical device companion apps, telepsychiatry visit apps and personal care and wellbeing apps. The most expensive is Software as a Medical Device (SaMD) at Class IIb / Class III. All ranges

  • $15K–$150K+

    Each healthcare integration adds $15,000 to $150,000+ to a build.

    A read-only EHR connection costs $30,000 to $55,000+, a bidirectional integration with one major EHR vendor $50,000 to $100,000+, and an interoperability layer across several EHRs $95,000 to $150,000+. All integrations

  • 15–25%

    Support after launch costs 15% to 25% of the healthcare software build cost per year.

    Support after the warranty period covers maintenance, bug fixes and platform updates; for regulated software, post-market activities are scoped separately. Methodology

  • 52%

    About half of healthcare software solutions start between $50,000 and $100,000.

    53 of 101 solutions have an entry price in that range, 21 start below $50,000, and only 3 start at $200,000 or more. Price zones

  • 1.3×–1.7×

    Regulation and validation add 1.3× to 1.7× to cost compared with the level below.

    Regulation

  • 3.5×

    A typical medical device software level costs about 3.5 times a fitness or wellness app level: a median midpoint of $283,000 against $80,000.

    By category

Healthcare software cost by category

The 14 categories are grouped by area and ordered by the lower bound within each group. Medical device software costs the most and fitness and wellness apps the least among products.
Cost range of each category, 2026
CategoryRangeSolutionsScope levelsRange on a $0 to $800K scale
Clinical systems
Telemedicine $60K–$500K+817
Core clinical and administrative software $60K–$600K+614
Laboratory software $70K–$350K+612
Administrative and financial
Healthcare analytics $20K–$300K+44
Healthcare financial software $70K–$400K+612
Patient-facing and consumer apps
Fitness and wellness apps $40K–$150K+611
Femtech (women's health) $40K–$180K+48
Mental health apps $40K–$190K+816
Connected health
Internet of Medical Things (IoMT) $50K–$450K+613
Wearable apps $70K–$300K+510
Regulated and life sciences
Medical device software $40K–$800K+412
Clinical trial software $60K–$450K+715
Data and AI
Integrations $15K–$150K+79
Healthcare AI $20K–$500K+2429
Grey bar: from the lowest to the highest bound in the category. Dots: the midpoint of each scope level.

How many solutions fall into each price zone

Entry prices and ceilings, grouped into four zones each and split by the six category groups.
  • Clinical systems
  • Administrative and financial
  • Patient-facing and consumer apps
  • Connected health
  • Regulated and life sciences
  • Data and AI
By entry price
Price zoneSolutions, by category group
Under $50K 21 (21%) Clinical systems: 0, Administrative and financial: 1, Patient-facing and consumer apps: 7, Connected health: 0, Regulated and life sciences: 1, Data and AI: 12
$50K to under $100K 53 (52%) Clinical systems: 13, Administrative and financial: 5, Patient-facing and consumer apps: 11, Connected health: 7, Regulated and life sciences: 3, Data and AI: 14
$100K to under $200K 24 (24%) Clinical systems: 6, Administrative and financial: 4, Patient-facing and consumer apps: 0, Connected health: 4, Regulated and life sciences: 6, Data and AI: 4
$200K and above 3 (3%) Clinical systems: 1, Administrative and financial: 0, Patient-facing and consumer apps: 0, Connected health: 0, Regulated and life sciences: 1, Data and AI: 1
By ceiling
Price zoneSolutions, by category group
Under $100K 10 (10%) Clinical systems: 0, Administrative and financial: 1, Patient-facing and consumer apps: 0, Connected health: 0, Regulated and life sciences: 0, Data and AI: 9
$100K to under $250K 54 (53%) Clinical systems: 9, Administrative and financial: 3, Patient-facing and consumer apps: 18, Connected health: 4, Regulated and life sciences: 2, Data and AI: 18
$250K to under $500K 30 (30%) Clinical systems: 8, Administrative and financial: 6, Patient-facing and consumer apps: 0, Connected health: 7, Regulated and life sciences: 6, Data and AI: 3
$500K and above 7 (7%) Clinical systems: 3, Administrative and financial: 0, Patient-facing and consumer apps: 0, Connected health: 0, Regulated and life sciences: 3, Data and AI: 1
Groups: Clinical systems (telemedicine, core clinical and administrative software, laboratory software); Administrative and financial (healthcare analytics, healthcare financial software); Patient-facing and consumer apps (fitness and wellness apps, femtech (women's health), mental health apps); Connected health (Internet of Medical Things (IoMT), wearable apps); Regulated and life sciences (medical device software, clinical trial software); Data and AI (integrations, healthcare AI). The entry price is the lower bound of a solution's cheapest scope level; the ceiling is the upper bound of its most expensive scope level.

Half of all solutions start at $50K–$100K. Only three start at $200K or more: HMS, SaMD and medical imaging and diagnostics software. Seven reach $500K or more: EHR, HMS, digital therapeutics, SaMD, embedded medical device software and both medical imaging products.

How the price climbs from the entry level to the top level

For solutions with more than one scope level: what the entry level costs and what the top level costs, from the cheapest solution to the most expensive.
  • Entry level
  • Top level

By default the 15 solutions with the biggest climb are shown.

SolutionEntry level and top level, on a $0 to $800K scale
Sexual and reproductive health applications education and tracking app → platform
Entry level: $40K–$90K+ Top level: $85K–$150K+
EHR/EMR integration single system, standard Application Programming Interface → bidirectional with one major vendor → interoperability layer
Entry level: $30K–$55K+ Top level: $95K–$150K+
Telepsychiatry visit app → platform
Entry level: $40K–$100K+ Top level: $95K–$180K+
Virtual health assistant / chatbot scripted → Large Language Model (LLM)-based patient or clinician assistant
Entry level: $60K–$100K+ Top level: $95K–$190K+
Healthcare payment processing patient payments module → full platform
Entry level: $70K–$120K+ Top level: $115K–$230K+
Medical device companion app basic → connected → regulated
Entry level: $40K–$90K+ Top level: $150K–$250K+
Personalized medicine solutions rule-based engine → ML-driven platform
Entry level: $50K–$180K+ Top level: $150K–$300K+
Remote Patient Monitoring (RPM) Minimum Viable Product → platform → enterprise
Entry level: $85K–$150K+ Top level: $240K–$350K+
Decentralized Clinical Trial (DCT) module added to an existing setup → platform → enterprise suite
Entry level: $140K–$250K+ Top level: $300K–$450K+
Electronic Health Records (EHR) / Electronic Medical Records (EMR) small practice → multi-specialty or multi-site → enterprise / hospital-grade
Entry level: $150K–$250K+ Top level: $300K–$500K+
Digital Therapeutics (DTx) wellness-grade → PDT pilot → regulated prescription therapeutic
Entry level: $120K–$250K+ Top level: $360K–$500K+
Embedded medical device software simple device → real-time control and safety logic → safety-critical device software
Entry level: $150K–$250K+ Top level: $380K–$500K+
Medical imaging software viewer → advanced visualization workstation → regulated enterprise imaging platform
Entry level: $150K–$320K+ Top level: $350K–$600K+
Hospital Management System (HMS) single department or clinic → multi-department hospital → hospital network
Entry level: $200K–$320K+ Top level: $450K–$600K+
Software as a Medical Device (SaMD) Class I / low risk → Class IIa / Class II → Class IIb / Class III
Entry level: $200K–$350K+ Top level: $550K–$800K+

Select a row to read its scope levels.

Sorted from the lowest to the highest cost of the top level. Bar length is the midpoint of the level's range; the label shows the full range. Higher levels add users, workflows and features, so the climb reflects more work, not a markup.

71 of 101 solutions have more than one scope level. For example, EHR/EMR costs $150,000 to $250,000+ at the entry level and $300,000 to $500,000+ at the top level.

How much regulation and validation add to healthcare software cost

12 products are priced with a regulated or validated scope level and a scope level just below it. Moving up to a medical-device regulatory scope level (an FDA 510(k), De Novo or Premarket Approval submission, an EU MDR conformity assessment, or a higher risk class) multiplies the cost by 1.3 to 1.7 compared with the level below; validation for 21 CFR Part 11 or GxP multiplies it by 1.4 to 1.7. Every range already includes the baseline security and privacy work that HIPAA and GDPR usually require.
Medical-device regulation: the scope level below against the regulated scope level
ProductLevel belowRegulatedMultipleRange on a $0 to $800K scale
Medical device companion app Connected → regulated$85K–$160K+$150K–$250K+1.6×
Embedded medical device software Real-time control and safety logic → safety-critical device software$230K–$400K+$380K–$500K+1.4×
Software as a Medical Device (SaMD) Class I / low risk → Class IIa / Class II$200K–$350K+$330K–$600K+1.7×
Digital therapeutics PDT pilot → regulated prescription therapeutic$240K–$380K+$360K–$500K+1.4×
Medical imaging and diagnostics software Research-use or internal product → regulated diagnostic product$200K–$400K+$300K–$500K+1.3×
Validation for 21 CFR Part 11 or GxP: standard scope level against the validated scope level
ProductStandardValidatedMultipleRange on a $0 to $800K scale
Clinical trial wearable technology Single study → validated platform$100K–$170K+$160K–$300K+1.7×
Electronic data capture Standard study designs → validated enterprise system$100K–$180K+$170K–$300K+1.7×
eTMF Document repository → validated system$90K–$150K+$145K–$250K+1.6×
Clinical data management Core → validated enterprise system$95K–$180K+$150K–$300K+1.6×
eCOA / ePRO Single-study app → validated platform$80K–$140K+$130K–$220K+1.6×
Electronic lab notebook Core → regulated$80K–$140K+$130K–$220K+1.6×
LIMS Single laboratory → enterprise$150K–$250K+$195K–$350K+1.4×
Grey bar: the scope level below. Black bar: the regulated or validated scope level. Higher levels also add features, such as clinical workflows or multi-site support.

Healthcare AI development cost: models and add-ons

Custom models trained from scratch
ModelRangeRange on a $0 to $800K scale
Predictive model on tabular data $70K–$140K+
Non-diagnostic computer vision $90K–$180K+
Signal and time-series $100K–$200K+
Natural language processing on your corpus $120K–$240K+
Medical imaging computer vision Includes dataset curation, training and an internal validation study$150K–$300K+
AI add-ons
Add-onRangeRange on a $0 to $800K scale
Fine-tuning an existing model on your data $20K–$100K+
AI layer over third-party models $40K–$120K+
AI agent and workflow-automation layer $80K–$160K+
Ambient documentation / medical scribe layer $100K–$200K+
AI orchestration and guardrails layer $50K–$100K+
AI model validation and clinical evidence package $40K–$80K+
AI governance and compliance setup $25K–$50K+

Not included: large-scale data acquisition and annotation.

Healthcare software development cost: all 182 ranges

Every solution and scope level in the benchmark, in US dollars at a blended rate of $65 to $180 per hour. Open a category to see its solutions, or search across all of them. Each solution name is a link to its row.

101 solutions, 182 priced scope levels in 14 categories

Clinical systems

Telemedicine 8 solutions, 17 scope levels $60,000–$500,000+
Chronic disease management software Application or system $80,000–$250,000+
Chronic disease management software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single condition: tracking, education, care-team messaging$80,000–$140,000+
Multi-condition platform: device data, clinician dashboard, care protocols, CPT billing codes, EHR/EMR integration$130,000–$250,000+
Acute care applications Application or system $90,000–$280,000+
Acute care applications: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Care coordination app: triage, escalation, on-call routing$90,000–$160,000+
Full platform: real-time vitals, clinical protocols, hospital system integration, audit trail$150,000–$280,000+
Digital Therapeutics (DTx) Application or system $120,000–$500,000+
Digital Therapeutics (DTx): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Wellness-grade: non-regulated behavioral program$120,000–$250,000+
PDT pilot: prescription digital therapeutic pilot with clinical study support$240,000–$380,000+
Regulated prescription therapeutic: full clinical trial support, FDA submission, prescribing and reimbursement flows$360,000–$500,000+
Teleneurology apps Application or system $80,000–$250,000+
Teleneurology apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Teleconsultation: video visits, intake, clinical notes Hybrid approach$80,000–$140,000+
Platform: standardized assessments and device or imaging data review Hybrid approach$130,000–$250,000+
Stroke treatment solutions Application or system $120,000–$350,000+
Stroke treatment solutions: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Care coordination: alerting, stroke-team workflow, time-to-treatment tracking$120,000–$200,000+
Platform: imaging triage and hospital system integrations$190,000–$350,000+
Primary care apps Application or system $70,000–$200,000+
Primary care apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Telehealth visits: booking, video, notes, payments Hybrid approach$70,000–$120,000+
Full platform: care plans, laboratory orders, eRx, insurance, EHR/EMR integration Hybrid approach$115,000–$200,000+
Physical therapy and rehabilitation apps Application or system $60,000–$180,000+
Physical therapy and rehabilitation apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Exercise app: exercise programs and adherence tracking$60,000–$100,000+
Platform: motion tracking or connected devices and a therapist dashboard$95,000–$180,000+
Home health and home care software Application or system $70,000–$220,000+
Home health and home care software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Documentation app: scheduling and documentation$70,000–$120,000+
Platform: visit routing, care plans, compliance documentation, payer integration$115,000–$220,000+
Core clinical and administrative software 6 solutions, 14 scope levels $60,000–$600,000+
Electronic Health Records (EHR) / Electronic Medical Records (EMR) Application or system $150,000–$500,000+
Electronic Health Records (EHR) / Electronic Medical Records (EMR): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Small practice (ambulatory): single specialty, core charting, scheduling, documents, basic reporting Hybrid approach$150,000–$250,000+
Multi-specialty or multi-site: role-based workflows, billing, lab and imaging orders, patient portal Hybrid approach$200,000–$400,000+
Enterprise / hospital-grade: inpatient workflows, custom modules, interoperability layer, migration from a legacy system$300,000–$500,000+
Healthcare Customer Relationship Management (CRM) Application or system $80,000–$200,000+
Healthcare Customer Relationship Management (CRM): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Configuration of an off-the-shelf CRM: patient and lead pipelines, campaigns, sync with the EHR/EMR Hybrid approach$80,000–$150,000+
Custom build: proprietary data model, contact center workflows, care-coordination automation, analytics Hybrid approach$140,000–$200,000+
Medical billing and coding software Application or system $100,000–$250,000+
Medical billing and coding software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Module: charge capture, coding assistance, clearinghouse integration Hybrid approach$100,000–$180,000+
Full platform: multi-payer rules engine, denial management, automated coding suggestions, reconciliation Hybrid approach$170,000–$250,000+
Hospital Management System (HMS) Application or system $200,000–$600,000+
Hospital Management System (HMS): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single department or clinic: registration, scheduling, staff, basic inventory$200,000–$320,000+
Multi-department hospital: inpatient, pharmacy, laboratory and billing modules, EHR/EMR integration$300,000–$480,000+
Hospital network: central data layer, per-site configuration, analytics, legacy migration$450,000–$600,000+
E-prescribing (eRx) platform Application or system $70,000–$180,000+
E-prescribing (eRx) platform: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Core: prescription creation, pharmacy routing through a network, drug database Hybrid approach$70,000–$120,000+
Advanced: controlled-substance prescribing, clinical checks, formulary and benefit data, prior-authorization flow Hybrid approach$110,000–$180,000+
Patient portal Application or system $60,000–$180,000+
Patient portal: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Basic: appointments, results, secure messaging, documents$60,000–$110,000+
Full patient engagement platform: payments, digital intake, telehealth, care plans, EHR/EMR integration, web and mobile$100,000–$180,000+
Laboratory software 6 solutions, 12 scope levels $70,000–$350,000+
Laboratory Information Management System (LIMS) Application or system $150,000–$350,000+
Laboratory Information Management System (LIMS): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single laboratory: samples, workflows, instruments, reporting Hybrid approach$150,000–$250,000+
Enterprise: multi-site, GxP (good clinical, laboratory and manufacturing practice) validation, instrument fleet, Laboratory Information System (LIS) and Enterprise Resource Planning (ERP) integrations Hybrid approach$195,000–$350,000+
Laboratory Information System (LIS) Application or system $150,000–$350,000+
Laboratory Information System (LIS): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Clinical core: orders, results, quality control, reporting Hybrid approach$150,000–$250,000+
Enterprise: multi-site, EHR/EMR and billing integration, regulatory reporting Hybrid approach$240,000–$350,000+
Electronic Lab Notebook (ELN) Application or system $80,000–$220,000+
Electronic Lab Notebook (ELN): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Core: experiments, templates, search, electronic signatures Hybrid approach$80,000–$140,000+
Regulated: GxP and 21 CFR Part 11 compliance, review workflows, LIMS and instrument integration Hybrid approach$130,000–$220,000+
Laboratory instrument integration Application or system $70,000–$200,000+
Laboratory instrument integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
A small set of instruments: drivers, parsing, data upload$70,000–$120,000+
Middleware: many instrument types, bidirectional control, monitoring$115,000–$200,000+
Clinical Data Management System (CDMS) Application or system $95,000–$300,000+
Clinical Data Management System (CDMS): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Core: data cleaning, queries, medical coding, exports$95,000–$180,000+
Validated enterprise system: multi-study, Clinical Data Interchange Standards Consortium (CDISC) standards, audit trail, integrations$150,000–$300,000+
Laboratory billing software Application or system $80,000–$200,000+
Laboratory billing software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Module: test pricing, claims, invoices$80,000–$130,000+
Full revenue platform: payer rules, prior authorization, denial management, LIS integration$125,000–$200,000+

Administrative and financial

Healthcare analytics 4 solutions, 4 scope levels $20,000–$300,000+
Reporting and dashboards on existing data Integration or add-on $20,000–$40,000+
Reporting and dashboards on existing data: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Business Intelligence (BI) tool setup, standard report pack Hybrid approach$20,000–$40,000+
Custom analytics application Application or system $60,000–$110,000+
Custom analytics application: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Own data model, role-based dashboards, exports, embedded reporting$60,000–$110,000+
Healthcare data warehouse and analytics platform Application or system $150,000–$300,000+
Healthcare data warehouse and analytics platform: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Multi-source pipelines, data governance, self-service analytics$150,000–$300,000+
Predictive and prescriptive analytics add-on Integration or add-on $80,000–$160,000+
Predictive and prescriptive analytics add-on: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Risk models, forecasting, model monitoring$80,000–$160,000+
Healthcare financial software 6 solutions, 12 scope levels $70,000–$400,000+
Medical billing software Application or system $100,000–$250,000+
Medical billing software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Core: charge capture, claims, patient statements Hybrid approach$100,000–$170,000+
Full platform: multi-payer rules, denial management, analytics, EHR/EMR and clearinghouse integration Hybrid approach$160,000–$250,000+
Revenue Cycle Management (RCM) software Application or system $150,000–$400,000+
Revenue Cycle Management (RCM) software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Module set: eligibility, claim submission, payment posting Hybrid approach$150,000–$250,000+
End-to-end platform: automation, denial prediction, contract management, multi-entity Hybrid approach$200,000–$400,000+
Insurance claims management software Application or system $100,000–$300,000+
Insurance claims management software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Core: intake, validation, adjudication support Hybrid approach$100,000–$180,000+
Enterprise platform: payer rules engine, fraud checks, appeals, integrations Hybrid approach$170,000–$300,000+
Prior authorization software Application or system $80,000–$250,000+
Prior authorization software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Request tool: forms, payer routing, status tracking$80,000–$140,000+
Automated platform: payer rules library, document assembly, AI extraction, EHR/EMR integration$130,000–$250,000+
Healthcare payment processing Application or system $70,000–$230,000+
Healthcare payment processing: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Patient payments module: payment provider integration, statements, receipts Hybrid approach$70,000–$120,000+
Full platform: payment plans, cost estimates, refunds, multi-entity reconciliation, compliance Hybrid approach$115,000–$230,000+
Patient financing platform Application or system $80,000–$250,000+
Patient financing platform: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Application flow: application, scoring integration, lender handoff$80,000–$140,000+
Full platform: underwriting, servicing, provider portal, compliance and reporting$120,000–$250,000+

Patient-facing and consumer apps

Fitness and wellness apps 6 solutions, 11 scope levels $40,000–$150,000+
Workout and exercise apps Application or system $50,000–$150,000+
Workout and exercise apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Tracking app: content library and tracking$50,000–$90,000+
Platform: personalized plans, wearables, social features, subscriptions, multi-platform$85,000–$150,000+
Activity tracking applications Application or system $60,000–$100,000+
Activity tracking applications: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Tracking, goals and wearable sync$60,000–$100,000+
Diet and nutrition apps Application or system $50,000–$130,000+
Diet and nutrition apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Food logging: database, barcode scanning, goals$50,000–$85,000+
Platform: photo recognition, meal plans, coach chat, wearables$80,000–$130,000+
Running and cycling apps Application or system $50,000–$120,000+
Running and cycling apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Core tracking: Global Positioning System (GPS), routes, statistics$50,000–$85,000+
Endurance platform: training plans, device ecosystem, segments, social features$80,000–$120,000+
Yoga and meditation applications Application or system $40,000–$110,000+
Yoga and meditation applications: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Class library app: class library$40,000–$70,000+
Full platform: programs, live classes, personalization, multi-platform$65,000–$110,000+
Personal trainer applications Application or system $60,000–$150,000+
Personal trainer applications: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Trainer-client app: plans, messaging, progress$60,000–$100,000+
Marketplace platform: payments, scheduling, video, analytics, web and mobile$95,000–$150,000+
Femtech (women's health) 4 solutions, 8 scope levels $40,000–$180,000+
Pregnancy and childbirth apps Application or system $50,000–$160,000+
Pregnancy and childbirth apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Tracking app: pregnancy tracking and content$50,000–$90,000+
Maternity care platform: clinician connection, remote monitoring, risk flags, EHR/EMR integration$85,000–$160,000+
Personal care and wellbeing apps Application or system $40,000–$120,000+
Personal care and wellbeing apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Tracker: cycle and wellbeing tracking$40,000–$70,000+
Personalized platform: insight models, wearables, optional telehealth$65,000–$120,000+
Sexual and reproductive health applications Application or system $40,000–$150,000+
Sexual and reproductive health applications: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Education and tracking app: education content and tracking$40,000–$90,000+
Platform: fertility algorithms, clinician consultations, laboratory and test-kit integration$85,000–$150,000+
General female healthcare solutions Application or system $60,000–$180,000+
General female healthcare solutions: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single-service app: one care service$60,000–$110,000+
Multi-service platform: telehealth, pharmacy, diagnostics, care programs$105,000–$180,000+
Mental health apps 8 solutions, 16 scope levels $40,000–$190,000+
Telepsychiatry Application or system $40,000–$180,000+
Telepsychiatry: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Visit app: scheduling, video, notes, payments Hybrid approach$40,000–$100,000+
Platform: measurement-based care, prescribing, risk protocols, EHR/EMR integration Hybrid approach$95,000–$180,000+
Mindfulness and meditation apps Application or system $40,000–$120,000+
Mindfulness and meditation apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Content-based: library, player, subscriptions$40,000–$70,000+
Platform: personalization, structured programs, wearables, content management tooling$65,000–$120,000+
Stress and anxiety management apps Application or system $50,000–$140,000+
Stress and anxiety management apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Self-guided: exercises and tracking$50,000–$85,000+
Program-based platform: adaptive programs, coach chat, outcome measures$80,000–$140,000+
Self-help and Cognitive Behavioral Therapy (CBT) apps Application or system $50,000–$150,000+
Self-help and Cognitive Behavioral Therapy (CBT) apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Program app: modules, journaling, tracking$50,000–$90,000+
Clinically oriented platform: evidence-based protocols, clinician oversight, outcome measurement$85,000–$150,000+
Mental health tracking apps Application or system $40,000–$120,000+
Mental health tracking apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Tracker: mood and symptom tracking$40,000–$70,000+
Platform: passive data collection, analytics and clinician sharing$65,000–$120,000+
Addiction recovery apps Application or system $50,000–$150,000+
Addiction recovery apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Support app: milestones, journaling, basic community$50,000–$90,000+
Platform: coaching, telehealth, care-team integration, medication support$85,000–$150,000+
Peer support and community apps Application or system $40,000–$130,000+
Peer support and community apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Community app: groups, feeds, basic moderation$40,000–$75,000+
Moderated platform: moderator tooling, safety escalation, AI moderation, scale$70,000–$130,000+
Crisis management apps Application or system $60,000–$190,000+
Crisis management apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Support app: safety plan, hotline routing, check-ins$60,000–$100,000+
Response platform: risk detection, escalation to clinicians or emergency services, 24/7 operations tooling$95,000–$190,000+

Connected health

Internet of Medical Things (IoMT) 6 solutions, 13 scope levels $50,000–$450,000+
Remote Patient Monitoring (RPM) Application or system $85,000–$350,000+
Remote Patient Monitoring (RPM): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Minimum Viable Product (MVP): one device type, patient app, clinician list view$85,000–$150,000+
Platform: multiple device integrations, thresholds and alerts, clinician dashboard, CPT billing codes$140,000–$250,000+
Enterprise: large device fleet, 24/7 monitoring operations, EHR/EMR write-back, analytics$240,000–$350,000+
Assisted living solutions Application or system $100,000–$300,000+
Assisted living solutions: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Basic app: basic sensors and alerts$100,000–$170,000+
Full platform: fall detection, multi-sensor environment, caregiver and facility portals$160,000–$300,000+
Chronic care management apps Application or system $80,000–$250,000+
Chronic care management apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Basic app: tracking and care plan$80,000–$140,000+
Platform: device data and care-team workflows$130,000–$250,000+
In-home monitoring and automation Application or system $100,000–$300,000+
In-home monitoring and automation: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Hub and app: monitoring hub and mobile app$100,000–$170,000+
Platform: multi-protocol devices, automation rules, provider integration$160,000–$300,000+
Medication tracking and management software Application or system $50,000–$150,000+
Medication tracking and management software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Reminder app: reminders and adherence tracking$50,000–$85,000+
Platform: smart dispenser integration, pharmacy and eRx integration, caregiver and clinician views$80,000–$150,000+
Hospital automation solutions Application or system $150,000–$450,000+
Hospital automation solutions: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single process: asset tracking or one workflow automation$150,000–$250,000+
Platform: assets, staff, beds and logistics with hospital system integrations$240,000–$450,000+
Wearable apps 5 solutions, 10 scope levels $70,000–$300,000+
Proactive health management Application or system $80,000–$220,000+
Proactive health management: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Companion app: wearable data and health insights$80,000–$140,000+
Platform: multiple wearable sources, risk models, coaching, provider view$130,000–$220,000+
Connected rehabilitation apps Application or system $70,000–$200,000+
Connected rehabilitation apps: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Exercise app: wearable-guided exercises$70,000–$120,000+
Platform: sensor fusion, progress analytics, therapist portal$115,000–$200,000+
Chronic disease management with wearables Application or system $80,000–$220,000+
Chronic disease management with wearables: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single-condition app: one condition$80,000–$140,000+
Platform: clinician workflows and alerting$130,000–$220,000+
Clinical trial wearable technology Application or system $100,000–$300,000+
Clinical trial wearable technology: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single study: data capture for one study$100,000–$170,000+
Validated platform: Title 21 Code of Federal Regulations Part 11 (21 CFR Part 11) compliance, audit trail, multi-site, eCOA integration$160,000–$300,000+
Laboratory wearables Application or system $90,000–$250,000+
Laboratory wearables: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Data collection app: data collection$90,000–$150,000+
Platform: instrument and Laboratory Information Management System (LIMS) integration$145,000–$250,000+

Regulated and life sciences

Medical device software 4 solutions, 12 scope levels $40,000–$800,000+
Software as a Medical Device (SaMD) Application or system $200,000–$800,000+
Software as a Medical Device (SaMD): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Class I / low risk: limited claims, lightweight Quality Management System aligned with ISO 13485 and the FDA QMSR$200,000–$350,000+
Class IIa / Class II: 510(k) or De Novo for FDA; notified-body review for EU MDR$330,000–$600,000+
Class IIb / Class III: FDA PMA or EU MDR notified-body review; clinical validation$550,000–$800,000+

AI-enabled functions do not change the class: FDA regulates them by risk class like other software, and most reach the market through 510(k) or De Novo. AI adds validation, bias testing and change-control planning, which are priced separately under Healthcare AI.

Medical device companion app Application or system $40,000–$250,000+
Medical device companion app: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Basic: pairing, data display, cloud sync$40,000–$90,000+
Connected: Bluetooth Low Energy (BLE) protocol work, firmware interaction, alerts, cloud backend$85,000–$160,000+
Regulated: part of the device regulatory file, IEC 62304, cybersecurity documentation, clinical workflows$150,000–$250,000+
Embedded medical device software Application or system $150,000–$500,000+
Embedded medical device software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Simple device: sensor acquisition, connectivity, basic user interface$150,000–$250,000+
Real-time control and safety logic: device-to-cloud data path$230,000–$400,000+
Safety-critical device software (FDA Class II or III; EU MDR Class IIb or III, depending on the device): redundancy, IEC 62304 software safety class C documentation, full verification and validation$380,000–$500,000+
Medical imaging software Application or system $150,000–$600,000+
Medical imaging software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Viewer: DICOM viewer and Picture Archiving and Communication System (PACS) integration$150,000–$320,000+
Advanced visualization workstation: 3D reconstruction, segmentation, measurements$200,000–$380,000+
Regulated enterprise imaging platform: clinical validation, vendor-neutral archive, hospital-wide deployment$350,000–$600,000+
Clinical trial software 7 solutions, 15 scope levels $60,000–$450,000+
Clinical Trial Management System (CTMS) Application or system $150,000–$400,000+
Clinical Trial Management System (CTMS): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single sponsor or site network: study setup, milestones, monitoring visits, documents Hybrid approach$150,000–$260,000+
Enterprise: multi-study portfolio, finance, integrations with EDC, eTMF and safety systems, regulatory reporting Hybrid approach$250,000–$400,000+
Electronic Data Capture (EDC) Application or system $100,000–$300,000+
Electronic Data Capture (EDC): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Standard study designs: form builder, edit checks, exports Hybrid approach$100,000–$180,000+
Validated enterprise system: complex designs, randomization, coding dictionaries, 21 CFR Part 11 validation package Hybrid approach$170,000–$300,000+
Randomization and Trial Supply Management (RTSM, IRT) Application or system $100,000–$300,000+
Randomization and Trial Supply Management (RTSM, IRT): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Randomization module: standard algorithms, blinding, emergency unblinding$100,000–$180,000+
Full system: supply forecasting, depot and site logistics, expiry management, multi-country$170,000–$300,000+
Electronic Trial Master File (eTMF) Application or system $90,000–$250,000+
Electronic Trial Master File (eTMF): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Document repository: structure, metadata, permissions, audit trail Hybrid approach$90,000–$150,000+
Validated system: inspection readiness, review workflows, completeness metrics, integrations Hybrid approach$145,000–$250,000+
Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-Reported Outcome (ePRO) Application or system $80,000–$220,000+
Electronic Clinical Outcome Assessment (eCOA) and Electronic Patient-Reported Outcome (ePRO): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single-study app: questionnaires, reminders, exports$80,000–$140,000+
Validated platform: licensed instruments, multi-language, device provisioning, 21 CFR Part 11$130,000–$220,000+
Decentralized Clinical Trial (DCT) Application or system $140,000–$450,000+
Decentralized Clinical Trial (DCT): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Module added to an existing setup: televisits and ePRO$140,000–$250,000+
Platform: televisits, eConsent, ePRO, wearables, direct-to-patient logistics$200,000–$380,000+
Enterprise suite: multi-study, multi-country, validated, full integration set$300,000–$450,000+

Data and AI

Integrations 7 solutions, 9 scope levels $15,000–$150,000+
EHR/EMR integration Integration or add-on $30,000–$150,000+
EHR/EMR integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single system, standard Application Programming Interface (API): one EHR/EMR, read-only or limited write, HL7 FHIR$30,000–$55,000+
Bidirectional with one major vendor: write-back, vendor certification, sandbox-to-production path$50,000–$100,000+
Interoperability layer: multiple EHR/EMR systems, mapping engine, Health Level Seven version 2 (HL7 v2) and FHIR, monitoring, many sites$95,000–$150,000+
Laboratory integration Integration or add-on $20,000–$55,000+
Laboratory integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
LIS / LIMS order and result exchange$20,000–$55,000+
Payer and claims integration Integration or add-on $35,000–$70,000+
Payer and claims integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
X12 Electronic Data Interchange (EDI) transactions 837, 835, 270/271$35,000–$70,000+
Medical device and wearable data integration Integration or add-on $20,000–$40,000+
Medical device and wearable data integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Per device family, including vendor cloud APIs$20,000–$40,000+
Pharmacy and eRx network integration Integration or add-on $20,000–$65,000+
Pharmacy and eRx network integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Prescription routing network, formulary and benefit data$20,000–$65,000+
Payments and eligibility integration Integration or add-on $20,000–$40,000+
Payments and eligibility integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Payment provider, real-time eligibility and cost estimates$20,000–$40,000+
Identity and access integration Integration or add-on $15,000–$30,000+
Identity and access integration: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Single Sign-On (SSO), SMART on FHIR, role mapping$15,000–$30,000+
Healthcare AI 24 solutions, 29 scope levels $20,000–$500,000+
Data pipelines and healthcare data platform AI service $80,000–$160,000+
Data pipelines and healthcare data platform: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Extract, Transform, Load (ETL), Health Level Seven Fast Healthcare Interoperability Resources (HL7 FHIR) normalization, data warehouse or lakehouse$80,000–$160,000+
Machine Learning Operations (MLOps) platform AI service $60,000–$120,000+
Machine Learning Operations (MLOps) platform: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Training pipelines, model registry, deployment, drift monitoring, retraining$60,000–$120,000+
Synthetic and de-identified data tooling AI service $30,000–$60,000+
Synthetic and de-identified data tooling: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
De-identification pipeline, synthetic data generation, re-identification risk testing$30,000–$60,000+
Computer-vision model trained from scratch AI service $90,000–$300,000+
Computer-vision model trained from scratch: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Non-diagnostic: visual analysis such as wound tracking, movement and posture, test-strip reading$90,000–$180,000+
Medical imaging (radiology, pathology, dermatology): dataset curation, training, internal validation study$150,000–$300,000+
Text and Natural Language Processing (NLP) model trained from scratch AI service $120,000–$240,000+
Text and Natural Language Processing (NLP) model trained from scratch: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Clinical notes, entity extraction, coding on your own corpus$120,000–$240,000+
Predictive model on tabular data trained from scratch AI service $70,000–$140,000+
Predictive model on tabular data trained from scratch: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Risk scoring, readmission, deterioration, no-show prediction$70,000–$140,000+
Signal and time-series model trained from scratch AI service $100,000–$200,000+
Signal and time-series model trained from scratch: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Electrocardiogram (ECG), continuous glucose monitoring, vitals streams$100,000–$200,000+
Fine-tuning an existing model on your data AI service $20,000–$100,000+
Fine-tuning an existing model on your data: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Vision or language, evaluation harness included Hybrid approach$20,000–$100,000+
AI layer over third-party models AI service $40,000–$120,000+
AI layer over third-party models: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Retrieval-Augmented Generation (RAG) assistant over your documents, guidelines and records Hybrid approach$40,000–$120,000+
AI agent and workflow-automation layer AI service $80,000–$160,000+
AI agent and workflow-automation layer: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Documentation, intake triage, prior authorization, back-office processes Hybrid approach$80,000–$160,000+
Ambient documentation / medical scribe layer AI service $100,000–$200,000+
Ambient documentation / medical scribe layer: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Speech recognition, summarization, structured write-back to the EHR/EMR Hybrid approach$100,000–$200,000+
AI orchestration and guardrails layer AI service $50,000–$100,000+
AI orchestration and guardrails layer: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Prompt and model management, evaluation harness, Protected Health Information (PHI) redaction, audit trail, human-in-the-loop review Hybrid approach$50,000–$100,000+
Medical imaging and diagnostics software Application or system $200,000–$500,000+
Medical imaging and diagnostics software: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Research-use or internal product: Digital Imaging and Communications in Medicine (DICOM) pipeline, viewer, model serving, no regulatory submission$200,000–$400,000+
Regulated diagnostic product: clinical validation, Quality Management System (QMS), U.S. Food and Drug Administration (FDA) 510(k) or De Novo submission support, or European Union Medical Device Regulation (EU MDR) technical documentation$300,000–$500,000+
Personalized medicine solutions Application or system $50,000–$300,000+
Personalized medicine solutions: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Rule-based engine: guideline-based personalization$50,000–$180,000+
ML-driven platform: genomic or multi-omics data$150,000–$300,000+
Clinical Decision Support System (CDSS) Application or system $150,000–$400,000+
Clinical Decision Support System (CDSS): development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Rule-based: guideline logic, alerts, EHR/EMR integration$150,000–$260,000+
ML-driven: predictive models, explainability, performance monitoring, regulatory path$200,000–$400,000+
Virtual health assistant / chatbot Application or system $60,000–$190,000+
Virtual health assistant / chatbot: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Scripted: Frequently Asked Questions (FAQ), booking and triage flows$60,000–$100,000+
Large Language Model (LLM)-based patient or clinician assistant: RAG, safety guardrails, EHR/EMR integration, multilingual Hybrid approach$95,000–$190,000+
Medical coding and billing AI Application or system $60,000–$180,000+
Medical coding and billing AI: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Code suggestion from clinical notes, audit trail and confidence scoring$60,000–$180,000+
Clinical trial matching AI Application or system $80,000–$160,000+
Clinical trial matching AI: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Patient-to-protocol matching against eligibility criteria$80,000–$160,000+
Medical document processing AI Application or system $60,000–$120,000+
Medical document processing AI: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Optical Character Recognition (OCR) and data extraction from referrals, faxes, laboratory reports and insurance forms Hybrid approach$60,000–$120,000+
Population health risk stratification Application or system $80,000–$160,000+
Population health risk stratification: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Cohort models, risk registries, care-gap detection$80,000–$160,000+
Drug interaction and pharmacovigilance AI Application or system $90,000–$180,000+
Drug interaction and pharmacovigilance AI: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Adverse-event detection, signal detection, case triage$90,000–$180,000+
Voice and speech AI for healthcare Application or system $70,000–$140,000+
Voice and speech AI for healthcare: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Voice intake, contact center analytics, quality monitoring Hybrid approach$70,000–$140,000+
AI model validation and clinical evidence package AI service $40,000–$80,000+
AI model validation and clinical evidence package: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Retrospective performance analysis on your dataset, bias and fairness testing, and a documentation draft for regulators. Prospective and multi-site clinical studies are not included.$40,000–$80,000+
AI governance and compliance setup AI service $25,000–$50,000+
AI governance and compliance setup: development cost by scope level, 2026 (USD)
Scope levelEstimated cost (USD)
Model cards, audit logging, alignment with the Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR) and the EU AI Act$25,000–$50,000+

Type. A solution is a type of software, module or service that Orangesoft builds. Each solution is marked as an Application or system, an Integration or add-on, or an AI service.

Hybrid approach. Marked where part of the solution can be delivered by configuring an existing product (for example an EHR platform or a CRM) instead of building it from scratch. This can lower the cost; license fees and vendor dependency apply.

What moves the price inside a range

Two projects of the same type can land at opposite ends of one range. These factors explain most of the gap.

Scope

The number of user roles, workflows, languages and markets.

Integrations

How many external systems, and whether they are standards-based (HL7 FHIR) or legacy and custom.

Regulatory path

HIPAA and GDPR compliance only, or a medical device class with IEC 62304, a quality management system, clinical validation and an FDA or EU MDR submission.

Data

For AI projects: whether labeled, representative data already exists, and its quality, volume and licensing.

Platforms

Web only, or iOS, Android, tablet, wearable and embedded targets.

Non-functional requirements

Uptime, latency, scalability, security certifications and auditability.

Legacy migration

The volume, quality and structure of the data to be moved.

Design maturity

Whether a design system and brand guidelines already exist, and how complex the interface is.

Specific compliance requirements

Baseline obligations are included in every range; requirements specific to your product or market add to the estimate.

Methodology and data

Where the numbers come from

The ranges are Orangesoft's estimates, built from our delivery experience on 300+ projects since 2011 at a blended rate of $65 to $180 per hour. Each of the 101 solutions is priced at one to three scope levels, 182 in all, in US dollars. They are not a market survey.

For Software as a Medical Device, our ranges cover software development and regulatory documentation: IEC 62304 lifecycle files, an ISO 14971 risk management file, quality system artifacts, cybersecurity documentation, verification and validation protocols and submission support.

What the estimates include

Discovery and requirements, user experience (UX) and user interface (UI) design, development, quality assurance (QA), DevOps and release engineering, project management, and a post-release warranty period.

What the estimates do not include

  • Third-party licenses and subscriptions: EHR/EMR vendor programs, imaging libraries, licensed clinical instruments, commercial AI model APIs.
  • Cloud and infrastructure running costs.
  • Clinical studies, notified-body and regulatory agency fees, legal and regulatory consulting. For reference, FDA user fees for fiscal year 2026 were $26,067 for a 510(k), $173,782 for a De Novo request and $579,272 for a PMA; check the current fee schedule.
  • Large-scale data acquisition and annotation, content production, translation and marketing.
  • Support after the warranty period typically costs 15% to 25% of the build cost per year and covers maintenance, bug fixes and platform updates. For regulated software, post-market activities such as complaint handling, vulnerability management and quality system upkeep are scoped separately.

How to read a range

Low end
The minimum scope that defines the scope level, as described in its name.
High end
The same scope level with the cost drivers listed above pushing the estimate up.
“$X+”
The upper bound is open: scope beyond the scope level description costs more.

Terms used in this benchmark

First release
The first version released to real users or, for a regulated product, ready for regulatory submission.
Scope level
A defined level of scope within one solution, for example small practice, multi-specialty or enterprise. Each scope level has its own range.

How the derived figures are calculated

  • Midpoint of a scope level: (lower bound + upper bound) / 2. The open upper bound is not extrapolated, so midpoints understate the cost of large projects.
  • Scope level ratio: midpoint of the top level divided by the midpoint of the entry level, for the solutions whose scope levels step up. It selects the 15 solutions shown by default in the scope levels chart.
  • Regulation multiple: midpoint of the regulated or validated scope level divided by the midpoint of the level just below it in the same product, for 12 products: Medical device companion app, Embedded medical device software, Software as a Medical Device (SaMD), Digital therapeutics, Medical imaging and diagnostics software, Clinical trial wearable technology, Electronic data capture, eTMF, Clinical data management, eCOA / ePRO, Electronic lab notebook, LIMS.
  • Price zones: a solution counts by the lower bound of its cheapest scope level (entry price) and by the upper bound of its most expensive scope level (ceiling).
  • Categories are grouped by area and ordered by the lower bound within each group.

Off-the-shelf plus custom

In many healthcare projects the fastest and cheapest route is a hybrid approach: proven off-the-shelf products (EHR/EMR platforms, CRM systems, telehealth video kits, LIMS, cloud AI services, payment and identity providers) configured together, with custom software only where the market does not cover the clinical workflow, the differentiation or the compliance requirements. In our projects, a hybrid approach has reduced the cost of a full custom build by 20% to 40%. The ranges in this benchmark are for a custom build.

Important notes

  • These are indicative ranges for planning. A binding estimate is produced after a discovery phase.
  • Figures are in United States dollars (USD) at a blended rate of $65 to $180 per hour. They assume a dedicated team delivered by Orangesoft.
  • Nothing here is regulatory, clinical or legal advice. Device classification and the regulatory pathway must be confirmed with a qualified regulatory specialist for your market and intended use.
  • AI accuracy and clinical performance depend on your data and are confirmed only in a proof of concept.
  • Payer-side FHIR APIs required by CMS-0057-F from January 1, 2027, including the Prior Authorization API (drugs excluded), are not included. Compliance dates vary by payer type.
  • Whether decision support or wellness software is regulated as a device depends on its intended use; see FDA's guidances Clinical Decision Support Software and General Wellness: Policy for Low Risk Devices, both reissued in January 2026.

Who published this

Published by Orangesoft, a healthcare software development company founded in 2011, with a development center in Poland and clients in the US and Europe. Orangesoft has delivered 300+ projects, is ISO 9001:2015 certified and builds HIPAA- and GDPR-compliant software, including AI components for healthcare products. Prepared by Tatsiana Kirimava, Co-founder & CEO, and Alex Melchanka, Co-founder.

Versions

Updated

Data and citation

Free to cite with attribution. Download the data as CSV or JSON, no sign-up required.

CSV JSON

Cite as

Orangesoft. “Healthcare software development cost benchmark 2026.” orangesoft.co/benchmarks/healthcare-software-cost, version 2026.1, updated October 19, 2026.

Quick answers

How much does healthcare software development cost in 2026?

Custom healthcare software products cost $40,000 to $800,000+ to build in 2026, by Orangesoft's estimates, excluding integrations and add-ons. Single integrations start at $15,000. Medical device software is the most expensive product category and fitness and wellness apps the least expensive. Source: Orangesoft healthcare software cost benchmark, October 2026.

How much does HIPAA compliance add to the cost?

Every range in the benchmark already includes the baseline security and privacy work that HIPAA and GDPR usually require, so it is not a separate line. Compliance also depends on your own policies, business associate agreements and hosting. Requirements specific to your product add to the estimate; for example, AI governance and compliance setup for HIPAA, GDPR and the EU AI Act costs $25,000 to $50,000+. Source: Orangesoft healthcare software cost benchmark, October 2026.

How much does healthcare software maintenance cost per year?

Support after the warranty period typically costs 15% to 25% of the build cost per year and covers maintenance, bug fixes and platform updates. For regulated software, post-market activities such as complaint handling, vulnerability management and quality system upkeep are scoped separately. Source: Orangesoft healthcare software cost benchmark, October 2026.