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?

  • Illustration of a light bulb crossed out by red diagonal lines

    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

Illustration of an airplane propeller with a radial engine blueprint.
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

  • white background

    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.

  • blank white background

    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.

  • Solid white background with no discernible objects or features visible.

    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

  • White background with no visible objects or text.

    Computer Systems Validation

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

  • Large white zero on a white background

    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

  • Document icon with gear symbol

    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

Arrow labeled "Discovery & Alignment" pointing to text about aligning with QMS and Regulatory Affairs expectations.
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

  • Simple icon of a house in dark gray and light gray shades, with a gabled roof and a chimney.

    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

  • Illustration of a combination wrench

    Innovation labs needing proof-of-concepts under regulatory guardrails

Learn more
Illustration of an airplane taking off

Jumpstart Your Idea with a 2-Day On-Site
Ideation Sprint

Struggling to turn your concept into a winning business case? Our Ideation Sprint embeds on-site for two days at your location and delivers the clarity and momentum you have been waiting for.

Workshop Overview

  • Kick off with your current concept - We outline business opportunities and key constraints (budget, timeline, regulatory).

  • Collaborate with your team - We work side by side with your product management, risk and regulatory reps.

  • Leverage our expertise - You get design, regulatory and technical insights in real time.

Deliverables Delivered Within Two Weeks

  • Crystal clear vision and product roadmap

  • Clickable Figma prototype illustrating the primary user journey

  • Development plan with milestones, cost estimates and risk mitigation

  • Business plan including ROI analysis and a reality check of your current approach

These assets give you a rock-solid foundation to build internal buy-in and demonstrate measurable value quickly.

Investment

$69,000 all inclusive (travel and expenses covered, anywhere you choose).

Ready to Get Going?

Let us know your preferred dates and we will confirm resource availability. Contact us today to schedule your Ideation Sprint and turn your idea into a strategic advantage.

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

A smiling man wearing a light gray blazer and a checkered shirt standing in a modern office environment with glass walls and office chairs.

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.

Light aircraft parked on a runway at sunset, with trees in the background.

Get started with RUNWAY HERO today.

Ready for takeoff?