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?

  • Are your innovative ideas stuck inside a regulated company?

  • Internal designers not current with modern UX paradigms and patterns?

  • Existing dev teams overwhelmed or show to ship?

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

Let's chat

THE SOLUTION: RUNWAY HERO

  • 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

  • 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.

  • 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

  • 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

  • Business Process Automation

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

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HOW IT WORKS

WHO WE SERVE

  • Digital Health startups preparing for submission

  • Large Pharma/MedTech companies with slow or overcommitted internal teams

  • Innovation labs needing proof-of-concepts under regulatory guardrails

Learn more

Featured Clients and Projects

  • The Hermitage Club

    Architected a complete refresh of resort-wide network, security camera infrastructure, device management, collaboration tools and end user devices with a focus on supportability, end user experience and security.

  • Rx-360

    Transformed a paper-based supplier assessment questionnaire into advanced digital forms with logic and validation, simplifying data entry and evaluation through the use of Runway Hero’s Formstack Forms Modules Suite.

  • Crothall Healthcare

    Created a content management system for Crothall’s SOPs and procedures, enabling real-time updates and seamless use on mobile and desktop devices.

  • Bestie Defense

    Designed and implemented a highly complex custom e-commerce solution for selling personal defense products across numerous sales channels.

  • Equifit

    Helped to select and establish a new ERP system to reduce reliance on a parent company’s systems.

  • Broomstones Curling Club

    A complete overhaul of all systems including a new website, retail POS, networking, broadcast streaming, collaboration, digital signage, payment processing, etc. Broomstones is now able to live broadcast 4 simultaneous HD streams every day.

  • AliMed

    Created a strategy for revamping e-commerce systems and provided guidance for team structure to support it.

PREMIER PARTNERSHIPS

  • 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 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

  • 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 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

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.

Get started with RUNWAY HERO today.

Ready for takeoff?