Healthcare & medical devices

AI & software for healthcare and medical device companies

You sell to clinicians, run clinical data, or ship a product that has to be right. We build the software that carries that weight: ordering platforms, distributor portals, registries, EHR integration, and AI features inside your product. Built to support your HIPAA obligations, by an engineer who has shipped this kind of system before.

See the work
Building production software since 2005 PHI stays in your environment Strategy through implementation
Who this is for

Small and mid-sized companies doing serious work in healthcare.

Not hospital systems with a hundred-person IT department. Companies where the founder still knows every customer and the next release matters.

01

Medical device makers

Companies that need a way to sell, take orders, and support customers that looks as credible as the device itself. Including companies preparing for a raise, an acquisition, or a launch, where the platform is part of the story.

02

Medical device distributors

Distributors managing contract pricing, tiers, and accounts across many manufacturers and customers. Pricing that lives in spreadsheets and email is where margin and time quietly leak.

03

Physician-tool companies

Teams building tools clinicians use: registries, case capture, calculators, and decision support. The work has to fit a clinical workflow, protect patient data, and stay on the right side of regulation.

What we build

The systems your business runs on, and the AI that makes them smarter.

Most of this is plain, dependable software. AI goes where it earns its place: inside a workflow, behind a product feature, or across documents nobody wants to re-key.

Sales & ordering platforms

Ordering apps and sales tools your reps and customers use every day to sell to practices, surgeons, and retailers. Catalog, pricing, orders, and account history in one place that holds up as volume grows.

Distributor pricing portals

Contract pricing, customer tiers, and quoting for distributors, so the right price shows up for the right account without a phone call. Built to reconcile cleanly with your accounting.

Registry & clinical data workflows

Surgical and clinical registries, case capture, follow-up, and reporting. Designed for the clinician's workflow first, with validation and audit trails built in rather than bolted on. See what a registry needs from its software.

Document & data automation

Pull structured data from orders, forms, and records; summarize long documents; route the results. The re-keying your team does today is usually the fastest AI payoff available.

AI features inside your product

Search, drafting, summarization, and decision support inside the software you sell. We flag early whether a feature could change your product's regulatory status, before it is built.

EHR integration (HL7 FHIR / SMART on FHIR)

Connect your product to the electronic health record systems your customers already use. Standards-based, so it works across EHR vendors, with patient data handled under the controls described below.

Health data

Built to support your HIPAA obligations.

There is no official HIPAA certification for software; HHS does not issue or recognize one. What there is: a set of engineering habits that make your obligations easier to meet and easier to prove. For the vendor-neutral version written for your compliance officer, read our guide to HIPAA and AI.

PHI stays in your environment

Protected health information lives in systems you control. We work inside them rather than copying data out.

Only BAA-covered services touch PHI

When PHI is involved, every AI model and cloud service in the path is covered under a Business Associate Agreement. No exceptions for convenience.

Encryption, access control, audit logging

Encrypted in transit and at rest, access scoped to role, and a record of who saw and changed what. These are defaults, not add-ons.

Synthetic data for demos and development

We build and demonstrate with realistic fake data, so real patients are never in a test environment or a sales deck.

Regulatory awareness

Could a new AI feature make your product a regulated medical device? We ask before we build.

Some software features fall under the FDA's definition of Software as a Medical Device, and some clinical decision support is excluded from device regulation while some is not. We use the FDA's SaMD and Clinical Decision Support guidance as the map, flag the question early, and bring in your regulatory counsel before anything ships. We do not give regulatory or legal advice. We make sure the question is answered before you commit money to building it. The full walkthrough is in our guide: Does adding AI make our software a medical device?

The work

Systems that carry real revenue and real clinical data.

A few of the things we have built for companies in this space. Client names are withheld until we have permission to share them. Read the case studies →

How to start

Start with the assessment, or start with the system you already know you need.

If you are weighing where AI fits, the AI Opportunity Assessment ranks the options by value and effort in one to two weeks. If you already know you need an ordering platform, a portal, or an integration, we scope that directly. Either way, a working first version usually lands in four to eight weeks. See all services →

Questions, answered

What healthcare and device companies ask first.

Do you work with patient data (PHI)?
Yes, when the work calls for it. Protected health information stays in your environment, and when PHI is involved we use only AI and cloud services that are covered under a Business Associate Agreement. Encryption in transit and at rest, access controls, and audit logging are part of the design, and we build and demo with synthetic data. The result is software built to support your HIPAA obligations. Read how we handle sensitive and health data.
Will you sign a BAA?
Yes. When an engagement involves PHI, Skye Road signs a Business Associate Agreement as your business associate, and every AI or cloud service we put PHI through must be covered by one as well. Ask us about the specifics for your situation.
Could adding AI make our product a regulated medical device?
It can, depending on what the feature does and who relies on it. We flag this early, using the FDA's Software as a Medical Device and Clinical Decision Support guidance as the map, and we bring in your regulatory counsel before anything ships. We do not give regulatory or legal advice; we design so the answer is clear before you commit. Read our guide: Does adding AI make our software a medical device?
Can you integrate with our customers' EHR systems?
Yes. Certified EHRs in the US expose standardized HL7 FHIR APIs, and SMART on FHIR is the standard way for an outside app to launch inside the EHR and read or write data with the right permissions. We build to those standards so your product works across EHR vendors rather than against one.
We're preparing for a raise, acquisition, or launch. How does that change the work?
It raises the bar on what has to be demonstrable: a platform that runs, revenue that flows through it, security that holds up to diligence, and documentation a buyer or investor can read. We have built sales platforms for device companies in exactly that position, and we scope the work so the first version is credible, not just functional.
Let's talk

Tell us what you sell and who you sell it to. We'll tell you what to build first.

Ask our AI a real question about your product or your customers right now, or book a 30-minute working session and we'll map the first move together.

Email info@skyeroad.com