Custom IoMT software development

Healthcare IoT software development for hospitals and specialty clinics. We design, build, and launch healthcare IoT systems on a fixed-scope discovery sprint. Your CFO sees the budget before the build; your board sees the plan before the contract.

ISO 27001 + ISO 9001 certified
HIPAA-enabling architecture, BAA on request
14+ years building software for regulated industries
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You’ve been asked to evaluate a connected-care initiative – maybe remote patient monitoring for post-surgical discharge, maybe a real-time location system for the med-surg unit. The clinical case is real. But your CFO wants pricing certainty before the build. Your CISO wants HIPAA evidence from day one, and your board wants a vendor that has done this – not promised it.

IoMT projects go sideways in three predictable ways:

  • Scope creep. A defined MVP turns into an open retainer.
  • EHR integration. The integration with your EHR (electronic health records) system is harder than the sales deck suggested, and the milestone slips by a quarter.
  • Firmware security review. The device firmware fails the hospital’s security review three weeks before go-live, and the launch moves into the next budget year.

All three are preventable in discovery and we de-risk each one before you sign a build contract – and what we would actually build for a hospital like yours.

Three first-project paths – pick the one your organization is closest to

Remote patient monitoring (RPM) software development

For: Specialty clinics and hospitals discharging high-risk patients, who need continuous home vitals: cardiac, post-surgical, and COP.

Scope: Device integration (BP cuff, SpO2, scale, glucometer), patient app, clinician dashboard, EHR sync via FHIR (Fast Healthcare Interoperability Resources), alert routing.

Timeline: About 10–16 weeks from discovery exit to clinical pilot, with our AI-assisted delivery process.

Hospital RTLS software development – real-time location systems (RTLS)

For: Hospitals where equipment search consumes nursing hours and asset utilization is a measurable cost.

Scope: BLE (Bluetooth Low Energy) tag fleet, ceiling/wall infrastructure spec, location backend, asset-tracking dashboard, asset-management system / ERP integration.

Timeline: About 12–18 weeks from discovery exit to pilot, depending on facility size and infrastructure work.

Connected medical device integration software

For: Hospitals deploying new connected hardware – smart bed, IV pump, vital-signs monitor – that need to feed the EHR.

Scope: Device SDK integration, gateway, HL7/FHIR mapping, EHR routing, clinical workflow validation.

Timeline: About 8–14 weeks from discovery exit to pilot, depending on device count and protocol coverage.

SumatoSoft is flexible, efficient, and extremely good at planning and being proactive. They have also been very proactive in their approach throughout the project, seeking to understand the needs and the reasons behind them before launching into development, which has been helpful for maintaining direction and consistency, especially because the end client is regularly generating new ideas for added features.

The system has produced a significant competitive advantage in the industry thanks to SumatoSoft’s well-thought opinions.

They shouldered the burden of constantly updating a project management tool with a high level of detail and were committed to producing the best possible solution.

SumatoSoft succeeded in building a more manageable solution that is much easier to maintain.

From the early stages of the project, SumatoSoft demonstrated a proactive attitude, actively seeking opportunities to enhance the solution and anticipate our needs. They consistently took the initiative to address any potential issues, provide timely updates, and offer solutions to challenges that arose during development. This proactiveness greatly contributed to the project’s success and exceeded our expectations.

We’ve been working with SumatoSoft for a few years, starting from the initial monitoring system, so they already understood our environment quite well. At the same time, they still managed to surprise us with their professionalism.

SumatoSoft is the firm to work with if you want to keep up to high standards. The professional workflows they stick to result in exceptional quality.

Important, they help you think with the business logic of your application and they don’t blindly follow what you are saying. Which is super important. Overall, great skills, good communication, and happy with the results so far.

Working with SumatoSoft has been an outstanding experience. Their team is not only highly skilled but also incredibly responsive, collaborative, and committed to delivering quality results. I can’t recommend them enough! Thank you team SumatoSoft for bringing my vision to life.

Awards & Recognitions

SumatoSoft has been recognized by the leading analytics agencies from all over the world. Our properly set and transparent processes allow us to provide healthcare IoT development services that deliver value, not just code.
Clutch award — Top Software Developers for the Medical industry in Boston, awarded to SumatoSoft
Clutch 2026 award — Top IoT Company in Boston, awarded to SumatoSoft
Clutch 2026 award — Top IoT Company in Providence, awarded to SumatoSoft
techreviewer.co 2026 — SumatoSoft listed among Top IoT Development Companies
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How we de-risk the budget conversation

Healthcare IoT projects fail more often on budget than on technology. Here is how we make the budget defensible from day one.

Fixed-scope discovery sprint

The healthcare IoT discovery sprint runs one to three weeks at a fixed price. You leave with a written technical scope, an architecture diagram, a compliance plan, a risk register, an integration plan, and a fixed-price build proposal. You own every artifact – including the right to shop the build to other vendors. If we are not the right partner for the build, you have lost a sprint, not a quarter.

ROI model we build with you

We do not promise a specific ROI percentage. Anyone who does is guessing. In discovery, we build the model with your finance team using your real cost drivers – nurse-hours saved per shift, readmission cost avoidance and billing-cycle improvement. Sensitivity ranges are built in so your CFO can stress-test the assumptions. If the math does not work for your hospital, we say so in discovery. You spend a sprint instead of a build budget.

Milestone-based build, not retainer

The build phase is priced per milestone – typically four to six milestones across a 10–16 week first-IoMT MVP. You approve and pay per milestone. If the scope grows mid-build, we re-price openly before continuing. Nothing slips into the retainer.

Compliance cost is scoped in discovery

The compliance plan is a discovery deliverable. HIPAA, EU MDR (Medical Device Regulation), and security-review work is priced before you sign the build contract.

HIPAA-enabling, ISO 13485 expertise, IEC 62304 – built in, not bolted on

Pillar 1 – Data protection

IoT security and compliance runs through every pillar below. We deliver HIPAA-enabling IoT software. HIPAA-enabling architecture with BAA on request. Protected health information (PHI) is handled per HHS Security Rule. AES-256 encryption at rest, TLS 1.2+ in transit. Role-based access control (RBAC) and multi-factor authentication (MFA) are mandatory across every interface. Immutable audit logs are forwarded to your SIEM (security information and event management) system.

Pillar 2 – Quality systems

Our healthcare software development follows formal quality systems. Expertise in implementing ISO 13485 (medical device quality management), IEC 62304 (medical software lifecycle), and ISO 14971 (risk management). We are ISO 27001 and ISO 9001 certified. 21 CFR Part 11 documentation supports your FDA submission when applicable – we support the submission package, we do not file 510(k) ourselves.

Pillar 3 – Device security

Unique device certificates and secure boot on every endpoint. Signed over-the-air (OTA) updates with integrity verification. Firmware-level attestation before connection. Cryptographic key storage in hardware security modules (HSMs) or gateways, never in application code.

Pillar 4 – Cloud & infrastructure security

Isolated environments per Client. Network segmentation between the ingestion, processing, and EHR zones. Infrastructure is defined as code and version-controlled. Regular third-party penetration testing, with findings tracked to closure.

Pillar 5 – Continuity & incident response

Encrypted, tested backups with defined recovery-point and recovery-time objectives. A documented disaster-recovery runbook. Breach-notification readiness aligned to the HIPAA Breach Notification Rule. Defined service level agreements (SLAs) for incident response.

Your devices, your EHR, one architecture

We build and maintain integrations for the major US electronic health records (EHRs) – medical device integration software and HL7 FHIR integration services that connect device data to clinical systems. Integration scope is confirmed against your environment during discovery, never assumed.

Integration we work with

  • EHR systems: Epic, Oracle Health, MEDITECH, athenahealth
  • Cloud platforms: AWS, Microsoft Azure, Google Cloud
  • Device connectivity & gateways: BLE / RFID gateway hardware
  • Alerting & messaging: Twilio, Firebase Cloud Messaging, APNs
  • Identity & access: Okta, Microsoft Entra ID, Auth0

Protocols and standards

  • HL7 v2
  • FHIR R4
  • DICOM
  • BLE
  • MQTT
  • OPC UA

AIoT in healthcare connects devices, data, and clinical workflows, and our AIoT development brings AI-driven processing into that flow. Connected medical devices and wearables stream telemetry through a secure device-connectivity and gateway layer. Data lands at IoMT ingestion APIs, where a processing and alert engine applies clinical rules. Outputs branch into four destinations – a clinician dashboard, a patient app, an analytics and reporting layer, and the EHR via FHIR or HL7. A security and compliance control plane – encryption, RBAC, audit logging – runs across ingestion, processing, and EHR integration.

IoT software for smart medical devices scheme
IoT software for smart medical devices scheme

Talk to our Healthcare IoT experts.

Find out more how your healthcare organization can benefit from IoT.

Nine phases. Each one is boardable.

Discovery runs one to three weeks. A first-IoMT MVP build runs about 10–16 weeks with our AI-assisted delivery process. Each phase has a fixed exit criterion, a named risk and mitigation, and a defined commitment from your team. That commitment is typically about four hours per week from your clinical or IT subject-matter expert (SME). No invented “compresses delivery by X percent” claims. The mechanic is the answer.

1
Discovery sprint
  • Risk: the candidate use case is not viable.
  • Mitigation: discovery surfaces in week one, before any build commitment.
2
Architecture & compliance plan
  • Risk: compliance requirements surface late and inflate scope. 
  • Mitigation: the compliance plan is a discovery deliverable, not a build-phase surprise.
3
UX & clinical workflow design
  • Risk: the design does not survive contact with the real clinical workflow. 
  • Mitigation: workflow validation with your clinical SME before build starts.
4
Prototype
  • Risk: stakeholders disagree on scope once they see it working. 
  • Mitigation: the prototype is cheap to change; scope locks only after sign-off.
5
MVP build (milestones 1–N)
  • Risk: scope grows mid-build.
  • Mitigation: milestone-based pricing – scope changes are re-priced openly before continuing.
6
Integration & QA
  • Risk: EHR integration is harder than expected.
  • Mitigation: the integration plan and EHR access are confirmed in discovery, not assumed.
7
Security & compliance validation
  • Risk: the hospital security review finds blockers near launch. 
  • Mitigation: security validation runs as its own phase, before pilot.
8
Pilot rollout
  • Risk: real-world device behavior differs from the lab. 
  • Mitigation: the pilot is scoped to one unit or population, so issues surface small.
9
Production launch + joint ops
  • Risk: knowledge gaps when your team takes over. 
  • Mitigation: a written transition plan and a defined joint-operations period before handover.

When SumatoSoft is the right fit (and when it isn’t)

Right fit

  • A funded first IoMT project with executive sponsorship
  • Want a partner who scopes before they build
  • Value milestone-based pricing
  • US, UK, or EU healthcare operations

Not the right fit

  • Projects under roughly $50,000 – start with a proof of concept instead
  • Need a body-shop staffing model
  • Need 510(k) submission filed for you (we support documentation; we partner with regulatory firms for filing)
  • Need on-shore-only US developers (we are US HQ + Warsaw development center)
98
%
User satisfaction rate
350
+
Successful projects
25
+
Countries
70
%
Senior engineers
3
+
Years of Clients’ engagement
14
+
Years on the market

FAQ

What is IoMT, and how is it different from IoT?

The Internet of Medical Things (IoMT) is the subset of the Internet of Things (IoT) applied to healthcare – connected medical devices, wearables, hospital sensors, and the software layer that routes their data into clinical workflows. IoMT software development carries regulatory requirements tied to healthcare operations, including HIPAA, HL7, FHIR, DICOM, and, where the device qualifies as software as a medical device, FDA and EU MDR oversight.

What does healthcare IoT software development cost?

Cost depends on product complexity, compliance requirements, and integration depth, which is why we do not quote a number without discovery. A fixed-scope discovery sprint defines the build budget in one to three weeks. You leave discovery with a written fixed-price build proposal or a written explanation of why the project is outside the current operational or financial scope.

How long does it take to build a hospital RPM system?

From discovery exit to clinical pilot, remote patient monitoring (RPM) software development for a first MVP typically runs about 10-16 weeks with our AI-assisted delivery process. Hospital security review windows and EHR integration complexity drive most of the timeline variance. We size both during the discovery sprint, so the timeline is committed before the build starts.

How do you support HIPAA compliance?

We sign a Business Associate Agreement (BAA) on request, design HIPAA-enabling IoT software and architecture from day one, and enforce role-based access control, multi-factor authentication, AES-256 encryption at rest, TLS 1.2+ in transit, and immutable audit logging. PHI access is scoped per least privilege. We support your HIPAA posture; your organization remains the covered entity.

Working with the UK or the EU healthcare organizations?

We design software that supports NHS Digital DTAC requirements and EU Medical Device Regulation (MDR) pathways for software as a medical device. Data handling is aligned with the EU General Data Protection Regulation (GDPR), with EU data residency in Poland. Compliance specifics differ by jurisdiction. Request a UK or EU briefing tailored to your project.

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      Please be informed that when you click the Send button Sumatosoft will process your personal data in accordance with our Privacy notice for the purpose of providing you with appropriate information.

      Vlad Fedortsov (Account Manager)
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