From Idea to Prototype
We turn bold concepts into functional, testable prototypes—fast. As a lean, high-performance innovation studio, we specialize in the early phases of MedTech development where uncertainty is highest and speed matters most. Our engineers and designers work side-by-side with founders, clinicians, and R&D teams to de-risk ideas, compress timelines, and deliver the kind of validated form factors that unlock first-in-human milestones. We don't just imagine what's next—we build it.
Trusted by MedTech innovators worldwide
Our Services
Comprehensive solutions to bring your medical device concepts to life, backed by our trusted consortium of experts.
Concept Generation
- Identify user needs through clinical insights
- Harvest and refine innovative ideas
- Create detailed storyboards to define your vision
Product Development
- Preclinical design and engineering
- Rapid prototyping and iteration
- Simulated use testing to validate concepts
Therapeutic Focus
Who Our Customers Are
From venture-backed startups to individual innovators, we partner with visionaries who want to transform healthcare through rapid prototyping and expert guidance.
Venture-Backed Startups
Early-stage MedTech teams seeking rapid prototyping and lean paths from idea to preclinical proof.
Incubators & Accelerators
Programs supporting startups in need of plug-and-play development resources or specialized prototyping capabilities.
Individual Innovators
Physicians, clinicians, and inventors turning concepts into functional prototypes without full R&D teams.
"Have an idea to improve patient care? Whether you're a physician, engineer, or entrepreneur, Mountain's 11 can help you bring it to life."
Why Choose Mountain's 11?
Our unique approach delivers exceptional results for your medical device innovation needs.
Strict Client Confidentiality
Your intellectual property is completely protected. We maintain the highest standards of confidentiality through comprehensive NDAs, secure communication protocols, and strict internal policies. Share your most sensitive MedTech innovations with complete confidence—your ideas remain yours throughout our partnership and beyond.
Comprehensive NDAs
Secure Communication
IP Protection Protocols
Unrivaled Materials Experience
Our material integration capabilities help you solve the most challenging problems in implantable device development.
Advanced Alloys
Deep knowledege in design with both self & balloon expandable alloys custom suited for your product application.
Biocompatible Solutions
Expertise in materials that meet the highest biocompatibility standards for long-term implantation.
Durability Testing
Comprehensive fatigue and failure analysis to ensure your devices perform reliably over decades.
How It Works
Our streamlined process takes your medical device from concept to validated prototype in weeks, not months.
Engage
Safely share your MedTech idea through our confidential consultation process. We assess feasibility and define project scope within 48 hours.
Innovate
Our experts deliver customized solutions using rapid prototyping, materials innovation, and rigorous testing protocols.
Succeed
Receive a validated prototype with comprehensive documentation, positioning you for design freeze, verification, regulatory approval, and market entry.
Accelerating Medical Device Innovation
Mountain's 11 Innovation Studio is a lean R&D partner accelerating early-stage implantable device innovation. Based in Flagstaff, AZ and powered by a network of elite MedTech professionals with decades of experience, we transform your ideas into validated prototypes.
Cody Hartman
Head of Studio
With over 25 years of experience in implantable medical device development, Cody is passionate about improving patient lives by accelerating the path from concept to clinic. As a hands-on engineer and strategic partner, he combines deep expertise in prototyping, bench testing, and failure analysis with advanced computational modeling to help clients transform early ideas into functional, testable prototypes. His approach reduces technical risk through rapid iteration, enabling faster validation and smarter decisions in the face of uncertainty.
Ed Shaw
Head of Innovation
Ed is a Senior Medical Device Development Engineer with demonstrated skills as a creative problem solver and over 500 patents worldwide. His hands-on approach has gained followership as a team leader who can convert concepts into reality by utilizing rapid prototyping techniques and sound engineering principles. By collaborating with experts in many fields, he has been successful in identifying customer needs and translating them into tangible prototypes which address business objectives.
Our Values: Integrity and Transparency
At Mountain's 11 Studio, we prioritize ethical practices in everything we do. Our conflict of interest policy prohibits engagements that could interfere with our commitment to our clients, and we maintain open communication to address any potential conflicts swiftly, ensuring our work is always in your best interest.
The M11 Consortium
Access our trusted network of independant product development experts to streamline your path to market. Our consortium scales capabilities beyond prototyping to include regulatory strategy, quality systems, and First-in-Human support.
Expert Network
Ben
Materials Science & Device Development Expert
25+ years
Materials science expert with 25+ years at W.L. Gore, specializing in novel technology integration for complex clinical problems.
Tina
Commercial Transactions Attorney
25+ years
Seasoned attorney with expertise in medical devices, gene therapy, and strategic commercial transactions.
Alex
Patent Agent
15+ years
Patent preparation and prosecution specialist supporting start-up companies and individual inventors.
Stay Updated
Subscribe to M11 Innovation Studio Insights for the latest trends, case studies, and prototyping techniques.
Client Success Stories
Real results from real partnerships. See how we've accelerated innovation for MedTech leaders.
"That's awesome! Look at you breaking one of the universal laws of the business 🙂"
Redefining MedTech Innovation
Mountains 11 Innovation Studio is redefining MedTech innovation. By partnering with clients like you, we're building a foundation to expand our impact—creating solutions that transform patient lives worldwide.
Contact
Mountain's 11 Innovation Studio is located in Flagstaff, AZ, America's 1st STEM City. Contact us today to transform your MedTech vision into reality.
Flagstaff, AZ
Have questions or want to discuss your project? Reach out to us and we'll get back to you as soon as possible.