Medical Device Development Manufacturing
Everything. In-House
About Voltas
Voltas is a full-service medical device development and manufacturing company dedicated to helping innovators bring products to market faster. By bringing engineering, prototyping, regulatory support, manufacturing, sterilization, and commercialization together under one roof, we simplify the development process and keep projects moving efficiently.
From concept to commercialization, our experienced team works alongside every client to deliver innovative solutions, exceptional quality, and a seamless development experience.
Everything. In. House.
Our A-Z Vertically Charged Services
ONE TEAM. ONE FACILITY. ONE DEVELOPMENT PROCESS.
IDEATE → DESIGN → PROTOTYPE → TEST → REGULATORY → MANUFACTURE → STERILIZE → PACKAGE → DISTRIBUTE
Our Development Timeline
Phase 0 - Exploration
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Problem Definition
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Brainstorm
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Ideation
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Regulatory Investigation
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Market Assessment
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Technology Research
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Concept Development
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IP Support
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User Research
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Low-Fidelity Prototypes
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Video Animations
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Videos Pictures Weekly
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Weekly Prototypes
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Database Development)
Phase 1 - Prototyping
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Concept Down Selection
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Concept Refinement
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Higher-Fidelity Prototypes
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Bench Testing
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Database Refinement
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User Assessment
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Regulatory Pathway
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Manufacturing Ballparks
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Business Strategy
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Roadmap for Development
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CAD database
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Business Plan
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Investor One Pager
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Anatomy Animation Video
Phase 2 - Refinement & Testing
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Engineering Refinement
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High-Fidelity Prototypes
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User Testing (UT)
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Clinician Feedback
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Functional Testing
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Specification
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Development
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Design for Manufacturing
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Vendor Sourcing
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Vendor QMS Confirm
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Vendor Qualification
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Vendor Costing
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CAD Database
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Refinement
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Design History File
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Documentation Drafts
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Concept Freeze
Phase 3 - Design For Manufacturing
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Final Design For Manufacturing (DFM)
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Regulatory Documentation
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Regulatory Costing & Scheduling
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Design Control Documentation
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Molding Design
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Mold Flow Analysis
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Die Mold Manufacture
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Functional Prototypes
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Pre DV Testing
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Supply Chain Confirm
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BOM Development
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Design Freeze
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DFM Files Frozen
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Oversee Tooling
Phase 4 - Pilot Builds & V&V Testing
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Manufacturing Documentation
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Design Verification Units (DV)
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Supply Chain Approval
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Tooling & Small Runs
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Assembly Line Setup
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Verification & Validation Testing
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Quality Documentation
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Quality Management System (QMS)
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Shipping Testing
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Biocomp Testing
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Performance Testing
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Usability Testing
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Aging Testing
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Sterilization Validation
Phase 5 - Production, Sales, & Distribution
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510K Document Writing
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510K Regulatory Submission
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Creative & Marketing
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Distribution
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Commercialization
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Sterilization regular runs
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Marketing/Pics/Videos
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Website Creation
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Brochure Creation
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Document Control
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QMS Management
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FDA Complaint Handling
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Warehousing Space
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Shipping Protocol
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Inventory Management
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Plug-N-Play W2 Sales Team
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Sales Training
Device Specialties
At Voltas, we specialize in developing and manufacturing a broad range of medical devices across multiple specialties. From minimally invasive technologies and vascular devices to orthopedic implants and advanced imaging systems, our team brings the expertise and capabilities needed to move innovative products from concept to commercialization.
Ablation Catheters
Catheters designed to precisely target and treat abnormal tissue through minimally invasive procedures. Supporting a range of therapeutic applications.
Bone Plates
Implantable plates used to stabilize and support fractured or damaged bones during the healing process.
Implantable Screws
Used to secure fixation and stabilization within the body. They are used across a range of surgical applications to support healing, reconstruction, and long-term structural stability.
Diagnostic Imaging Systems
Advanced systems that capture detailed images of the body to help healthcare professionals diagnose and evaluate medical conditions
Endovascular Grafts
Implantable devices used to reinforce weakened or damaged blood vessels and restore proper blood flow.
Fluoroscopy Systems
Imaging systems that provide real-time X-ray images, allowing physicians to visualize anatomy and guide minimally invasive procedures.
Laparoscopic Instruments
Specialized surgical instruments designed for minimally invasive procedures through small incisions, helping surgeons access and treat internal anatomy.
Medical Balloons
Expandable devices used to dilate vessels, deliver treatments, or assist with a variety of minimally invasive medical procedures.
Neurostimulation Devices
Devices that deliver controlled electrical stimulation to targeted nerves or areas of the nervous system to help manage neurological conditions.
Patient Monitoring Systems
Systems that continuously track vital signs and other physiological measurements, helping clinicians monitor a patient's condition.
Radiography Systems
X-ray imaging systems used to produce detailed images of bones, organs, and other internal structures for diagnosis.
Stent Delivery Systems
Catheter-based systems designed to safely position and deploy stents within blood vessels or other anatomical structures.
Thrombectomy
Specialized devices used to remove blood clots from blood vessels, helping restore blood flow and treat vascular blockages.
Tissue Expanders
Implantable devices used to gradually stretch and expand tissue, commonly used to prepare areas for reconstructive or restorative procedures.
Vascular Catheters
Flexible, minimally invasive devices designed to access blood vessels for diagnostic, therapeutic, or interventional procedures.
Featured Projects
Address
8200 97th Street
Cottage Grove, MN 55016
Contact
(651) 677-0675
Follow Us
Operational Hours
Mon - Fri
9:00 am – 5:00 pm
