About Us
The Hub Medical Device Group's mission is to help medical device OEMs, inventors, doctors and companies of all sizes turn their medical device ideas into reality.
The Hub Medical Device Group, Inc., is a one-stop-shop medical device group that provides clients:
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Industry Specific Design and Engineering Services
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Affordable Rapid Prototyping
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Regulatory Consulting and Guidance
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Manufacturing Resources (in-house and outsourced)
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Device History Record and Revision Control
We provide these services for the development of single use and reusable medical devices for surgical procedures (including orthopedic, spine, trauma, CMF, joint replacement and bone fixation), clinical testing, and research and development. Our group is made up of medical device professionals with decades of design, engineering, regulatory and manufacturing experience.
Industry Expert Engineering & Design
Whether it’s a brand new concept, a project stuck in neutral with deadlines looming, or an existing product revision, we can help. We can provide complete project management, expert design for manufacture consulting, and fast prototype design. Services include:
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Design Conceptualization
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CAD Design & 3D Design Modeling
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Design Verification & Mechanical Testing
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Design Control and Documentation
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Design for Manufacturing
Rapid Prototype
Before design verification comes design demonstration. That’s when the client gets to physically interact with the new medical device. Getting to design demonstration needs to happen fast, but you can’t cut corners on quality. Our team knows all of the nuances of rapid prototyping so we can help you meet your client’s expectation. Services include:
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3D printing - SLA, SLS, DMLS, FDM
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Metals, thermoplastics
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CNC Machining
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Injection & Vacuum Molding
Production Manufacturing
Small, Medium & Large Volume
We can handle everything from individual parts to fully assembled, multiple component medical devices. Don’t settle for ever increasing prices and lead-times! No job is too big or too small. Capabilities include:
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Surgical Instruments, MIS, soft tissue
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Blades, drills, taps, reamers
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Implants, plates, screws
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Cases and Trays
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Titanium, carbon fiber, stainless, aluminum, thermoplastics
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3D Production
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Coatings, laser marking, graphics
Napkin Sketch thru Production Manufacturing
and all points in between
Regulatory Consulting
Domestic & International
Top notch regulatory guidance from the very beginning can save time and money. Our regulatory team has decades of US and International regulatory experience including 510K submission and CE marks. Services include:
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Regulatory Strategy and Submissions
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Design Control and Documentation (Master Device Record)
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Product Risk Assessment and Management
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Packaging Design & Development
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Product and Process Validation
Contact Us
Need help with your medical device idea? Give us a call today.
at The Boatyard
60 River St
Beverly, MA 01915
USA
844-284-3482