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Our Development Timeline

From the first concept to commercialization, Voltas provides a structured, end-to-end approach to medical device development. Our six-phase development process brings engineering, industrial design, regulatory, manufacturing, quality, and testing together at every stage, helping move your device from an idea to a market-ready product with fewer handoffs and fewer delays.

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Phase 0​
Exploration​

  • Problem Definition​

  • Brainstorm​

  • Ideation​

  • Regulatory Investigation​

  • Market Assessment​

  • Technology Research​

  • Concept Development​

  • IP Support​

  • User Research   ​

  • Low-Fidelity Prototypes​

  • Video Animations​

  • Videos Pictures Weekly​

  • Weekly Prototypes​

  • Database Development​)​

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Phase 1​
Prototyping​

  • Concept Down Selection​

  • Concept Refinement​

  • Higher-Fidelity Prototypes​

  • Bench Testing​

  • Database Refinement​

  • User Assessment​

  • Regulatory Pathway​

  • Manufacturing Ballparks​

  • Business Strategy​

  • Roadmap for Development​

  • CAD database​

  • Business Plan​

  • Investor One Pager​

  • Anatomy Animation Video​

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Phase 2​
Refinement & Testing​

  • Engineering Refinement​

  • High-Fidelity Prototypes​

  • User Testing (UT)​

  • Clinician Feedback​

  • Functional Testing​

  • Specification

  • Development​

  • Design for Manufacturing​

  • Vendor Sourcing​

  • Vendor QMS Confirm​

  • Vendor Qualification​

  • Vendor Costing​

  • CAD Database

  • Refinement​

  • Design History File​

  • Documentation Drafts​

  • Concept Freeze​

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Phase 3​
Design For Manufacturing​​

  • Final Design For Manufacturing (DFM)​

  • Regulatory Documentation​

  • Regulatory Costing & Scheduling​

  • Design Control Documentation​

  • Molding Design​

  • Mold Flow Analysis​

  • Die Mold Manufacture​

  • Functional Prototypes​

  • Pre DV Testing​

  • Supply Chain Confirm​

  • BOM Development​

  • Design Freeze​

  • DFM Files Frozen​

  • Oversee Tooling​

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Phase 4​
Pilot Builds & V&V Testing​

  • Manufacturing Documentation​

  • Design Verification Units (DV)​

  • Supply Chain Approval​

  • Tooling & Small Runs​

  • Assembly Line Setup​

  • Verification & Validation Testing​

  • Quality Documentation​

  • Quality Management System (QMS)​

  • Shipping Testing​

  • Biocomp Testing​

  • Performance Testing​

  • Usability Testing​

  • Aging Testing​

  • Sterilization Validation​

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Phase 5​
Production, Sales, & Distribution​

  • 510K Document Writing​

  • 510K Regulatory Submission ​

  • Creative & Marketing​

  • Distribution​

  • Commercialization​

  • Sterilization regular runs​

  • Marketing/Pics/Videos​

  • Website Creation​

  • Brochure Creation​

  • Document Control ​

  • QMS Management​

  • FDA Complaint Handling​

  • Warehousing Space​

  • Shipping Protocol​

  • Inventory Management​

  • Plug-N-Play W2 Sales Team​

  • Sales Training​

Book a Discovery Call

Ready to move your device forward? Let’s talk about where you are in the development process and how Voltas can help get you to the next stage.

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Voltas is an innovative, vertically charged medical device development manufacturing company.

 

We work worldwide with clinicians, inventors and start-up medical device companies to bring patented, or simply ‘napkin-sketched’ medical device ideas to life.

 

Our services include ideation conceptualization, research and development, prototyping, regulatory services, usability testing, hydrophilic coatings, balloon development, catheter development, tool & die molds, contract manufacturing, ETO sterilization, warehousing and distribution, marketing, and sales. Everything In House

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© 2026 Voltas. ISO 13485 Compliant.

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