HIGH VELOCITY MEDICAL DEVICE SOFTWARE (SaMD/SiMD) DEVELOPMENT

We partner with overwhelmed product and innovation leaders inside MedTech companies to deliver modern, compliant software quickly and cleanly—even when your internal teams can’t.

SOUND FAMILIAR?

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    Are your innovative ideas stuck inside a regulated company?

  • Aircraft digital instrument panel displaying attitude indicator and compass.

    Internal designers not current with modern UX paradigms and patterns?

  • People in line with luggage under a boarding sign.

    Existing dev teams overwhelmed or slow to ship?

  • Illustration of a control panel with dials and gauges.

    Stuck using a Legacy QMS (Quality Management System), blocking iteration and tech adoption?

Let's chat

THE SOLUTION: RUNWAY HERO

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Blueprint of a vintage propeller airplane side view

  • We build modern, compliant software fast—no trade-off between speed and safety

  • Fully remote, senior software developers aided by AI

  • Runway Hero QMS aligned with ISO 13485, IEC 62304

  • Design, Regulatory and Quality embedded into your team

  • We deliver validated, traceable Design History Files (DHF)

  • You retain legal manufacturer status and full IP ownership

WHAT WE DELIVER

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    Ideation Sprint

    A 2-day intensive on-site workshop between our teams to produce a clickable prototype and business case with ROI to help you garner support for your ideas.

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    SaMD Web & Mobile app design and development

    We’ve built over 500 apps across various industries, including 20+ SaMDs. We take your innovative ideas and bring them to life.

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    SiMD design & development

    We partner closely with your hardware team to design and build the Software in a Medical Device of class I, II and III devices

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    Computer Systems Validation

    We help to validate your tools so that your team can focus on delivering core business value.

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    Business Intelligence / Data Lake House

    We help you make use of your data scattered across enterprise systems using a Data Lake House strategy w/ETL (Extract, Transform & Load) pipelines, AI enabled data science and reporting built using Databricks & Metabase

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    Business Process Automation

    As a leading partner of Formstack, we transform your paper-based processes into modern, EHR-integrated digital processes.

Learn More

HOW IT WORKS

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Infographic with orange arrow labeled "Design & Human Factors," and text below saying "We develop ideas into prototypes and test with users."
Flowchart arrow labeled "Build & Document" with text about ISO 13485 compliant QMS software development.
Arrow showing 'Requirements, V&V + Traceability' with list: 'User and technical requirements, risks, test plans & results, traceability matrix.'
Arrow labeled "Transfer & Support" with text below stating "• DHF transfer + optional support (including post-market surveillance)."

WHO WE SERVE

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    Digital Health startups preparing for submission

  • Icon of a stylized building or office structure with rectangular windows and a door.

    Large Pharma/MedTech companies with slow or overcommitted internal teams

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    Innovation labs needing proof-of-concepts under regulatory guardrails

Learn more
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Launch Special
Ideation Sprint

We know that getting support for your idea can be the hardest part. That’s why we offer a jumpstart package to ensure you have everything you need to make your business case.

An Ideation Sprint is a 2-day intensive on-site workshop where we start with your idea and turn it into potential business opportunities and highlight constraints (i.e. budget, timeline, regulatory, etc.). We provide design, regulatory and technical expertise. You include your product management, risk and regulatory representatives.

Deliverables include:

  • Fully articulated vision

  • Preliminary clickable prototype

  • Development and business plans (including ROI analysis)

We’re running a launch special during the month of April 2025 of just $39k (regularly $69k). This all-in price includes all travel expenses for our team to be there with you. Let’s get your idea off the ground and moving today!

PREMIER PARTNERSHIPS

  • Formstack logo with green icon and text

    Runway Hero is Formstack’s go-to partner for complex enterprise integrations, customizations and migration with expertise in Healthcare and EHR integrations.

    Learn about Formstack
  • Databricks logo with a red stacked lines icon.

    Databricks and the Data Lake House approach are taking the world by storm. Runway Hero uses it to bring together your disparate data sources, apply PII & PHI controls and prepare the date for usage across the enterprise.

    Learn about Databricks
  • Logo of The Roblox Corporation, featuring a grid of blue dots and company name.

    Metabase plugs into existing and Data Lake House data stores, making data models easy for business users to create self-service reports with robust capabilities. Runway Hero helps to get it setup and users trained for success.

    Learn about Metabase
  • Airtable logo with colorful blocks and text

    Airtable is a swiss-army knife for your project tracking needs. Runway hero has helped many businesses to streamline their processes and harness real-time reporting.

    Learn about Airtable

Meet the Founder

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Joe Schwendt

Hi, I’m Joe Schwendt, Founder & CEO of Runway Hero, and for over 30 years I’ve been building high-stakes software that works—and passes inspection. From mobile apps and SaMD platforms to full system validation and DHF delivery, I bring the rare ability to combine speed, innovation, and regulatory rigor.

Now, I’m helping those who want rapid, results-driven transformation themselves.

 

Everywhere you are

While our team is 100% remote, our Boston-based leadership is eager to meet with you. Our founder is a pilot and loves to fly.

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Get started with RUNWAY HERO today.

Ready for takeoff?