InnovaMed Solutions

Realizing Innovations.

Enhancing Lives.

We translate clinical ideas into validated, market-ready medical devices.
Your vision, our execution - powered by global expertise.

Whether you're just starting or seeking market launch, we support every stage.
From concept to commercialization, we are strategic and clinician-centric.

Our Mission

To empower clinicians and medical innovators by transforming their visionary concepts into viable medical devices, equipped to make a real-world impact. 

Delivering Comprehensive Expertise:

Offering specialized development services, from feasibility testing to regulatory pathways, tailored to address every stage of medical device development.

Navigating the Innovation Pathway:

Guiding clinicians through the intricate journey from concept to market, ensuring their ideas have the strategic support to succeed.

Bridging the Gap in Medical Innovation:

Simplifying the complex engineering and regulatory landscape, so clinicians can focus on what they do best—improving patient outcomes.

Industry Challenges

  • Medical device development can take 3–7 years from concept to market, often lagging behind fast-evolving healthcare needs and technological advancements.

  • Although 80% of physicians have device improvement ideas, less than 1% can bring these to market, largely due to time constraints from administrative and clinical duties.

  • Only 15% of healthcare innovators have direct ties to the medical device industry, with limited access to technical expertise and prototyping resources posing a major barrier

  • Regulatory hurdles like the FDA's 510(k) process and limited funding avenues add significant obstacles to medical device commercialization.

Our Services

    • Idea Evaluation: Brainstorming sessions to refine initial concepts and identify core clinical needs.

    • 3D Modeling: Creating CAD models to visualize early-stage ideas and iterate designs quickly.

    • Sample Prototyping: Developing physical prototypes using 3D printing or CNC machining for hands-on evaluation.

    • Provisional Patent Filing: Assisting in the preparation and submission of provisional patents to protect early-stage concepts.

    • FEA (Mechanical) Simulation: Conducting finite element analysis to validate the structural integrity and safety of the device under various conditions.

    • Design Optimization: Iterating designs based on simulation results to enhance performance, durability, and manufacturability.

    • Prototype Iterations: Building and testing updated prototypes to ensure they meet initial design specifications and performance criteria.

    • Simulation Analysis Report/Manuscript: Generating detailed reports or manuscripts that document simulation results, aiding in both regulatory submissions and potential publication.

    • Regulatory Assessment & Pathway Strategy: Evaluating the appropriate FDA pathway (510(k), PMA, De Novo) and developing a comprehensive regulatory strategy.

    • Market Analysis: Conducting detailed market assessments to identify opportunities, competitive landscape, and potential demand for the device.

    • Funding Proposal Review: Reviewing and refining funding proposals to ensure they align with investor requirements and highlight the device's commercial and clinical potential.

    • Business Pitch Development: Assisting in the creation of compelling business pitches that articulate the device’s value proposition, market potential, and development plan to attract investors.

    • Regulatory Strategy and Design Control Implementation: providing a comprehensive regulatory pathway assessment, integrating ISO 13485 and 21 CFR 820.30 design controls into the medical device development lifecycle

    • Design Control implementation: Defining user needs, design inputs and outputs, verification and validation strategies, and documentation to ensure FDA compliance and streamline market approval.

    • Intellectual Property Management and Market Entry Strategy: Protecting innovations through patent searches and filings while preparing medical devices for market entry by aligning development milestones with market demands and potential acquisition criteria

Past Projects

  • Reverse Shoulder Implant Development

    - Concept Development
    - 3D CAD Modeling
    - Prototyping
    - Biomechanics Cadaver Study
    - Market Analysis and Funding

  • Tracheobronchial Stent Development

    - Existing Research Review
    - FEA Analysis
    - Design for Manufacturing
    - Prototyping
    - FDA Regulatory Pathway Strategy

  • Surgical Tool Prototyping

    - Unmet Clinical Needs Gathering
    - Clinician-led design
    - 3D printing
    - User validation studies
    - Market Validation Report

  • Mechanical Testing and FEA

    - Cyclic Testing
    - Wear Testing
    - Stability Testing
    - FEA Simulations
    - Biomechanics Studies

  • IP Strategy and Patent Filing

    - Competitor IP Analysis
    - Patent Claims Review
    - Provisional Patent Filing
    - Non-provisional Patent Filing
    - Legal Team Collaboration

  • FDA Regulatory Pathway Strategy

    - 510(k), De Novo Pathway Reviews
    - FDA Database Search
    - Reimbursement Code Planning
    - 21 CFR 820.30 Design Controls
    - Regulatory Requirements for Testing

Testimonials

  • What I appreciated most was their strategic approach. We iterated fast, they gave me straight answers, and they handled the FEA and prototype development without needing hand-holding. They’re not only technical but they also get the clinical side, which is rare.

    Dr. Brian Cole, MD, MS
    Knee Surgeon

  • I’ve had this surgical tool idea for years, but never knew where to start. Innovamed walked me through every step. They were thoughtful, responsive, and honestly felt like part of my team. It was refreshing to work with engineers who actually understand surgeons.

    Dr. Melissa Grant, MD
    Emergency Medicine

  • As a startup, you want partners who move quickly and don’t create noise. Innovamed delivered. They understood the pressure we were under and became an extension of our internal team. We were able to hit our investor deadlines because of them

    Jason Lee
    CEO, Novo Care

  • I had an idea for a device that could improve how we manage endoscopic procedures, but I didn’t have the bandwidth to figure out the engineering. Innovamed translated my sketches into prototypes and handled the technical side easily.

    Dr. Jordan Caro, MD
    Gastroenterologist

About Us

InnovaMed Solutions is a medical device consultancy led by engineers with hands-on experience bringing real products to market. We've worked across startups, corporates, and research institutions - contributing to technologies now generating multi-million-dollar revenue.

We help surgeons and clinician-innovators turn ideas into validated, market-ready devices by offering tailored support in design, testing, regulatory strategy, and commercialization. With deep domain expertise and global vendor partnerships, we deliver high-impact solutions without the overhead of an in-house R&D team.

Get in touch.

Have an idea you’ve been meaning to develop? Whether you're in the early stages or preparing for the market, we're here to help. Reach out to explore how Innovamed Solutions can support your vision with expert guidance, technical execution, and a physician-centered approach. Let’s build something impactful, together.