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PHASE DEVELOPMENT TIMELINE

An effective strategy to bring your medical device to market, on budget and on time.

 

  • Phase Explanations

  • Next Steps & Forecasting

  • Itemized List of Deliverables

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Phase Overviews & Deliverables

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an industrial engineer illustrating a medical device. ona drawing tablet

Phase 0

Exploration 
  • Brainstorm

  • Ideation

  • Explore Competitors

  • Problem Definition

  • Market Assessment​

  • Technology Research

  • Concept Development

  • IP Strategy

  • User Research

  • Sketch Prototypes​

  • Video Animations

  • Videos Pictures Weekly

  • Weekly Prototypes

  • Database Development

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Phase 3

Design for Manufacturing
  • Design for Manufacturing (DFM)

  • CAD to DFM Files

  • Regulatory Development

  • Regulatory Costing

  • Regulatory Timing

  • Mold Flow Analysis

  • Die Mold Devleopment

  • Die Mold Manufacturing

  • Functional Prototypes

  • Pre DV Testing

  • Supply Chain Confirm

  • BOM Development

  • Design Freeze

  • DHF Files Frozen

  • DFM Files Frozen

  • Compile Documents QMS

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Phase 1

Prototyping 
  • Concept Refinement

  • Low-Fidelity Prototypes

  • Bench Testing

  • Database Refinement

  • User Assessment

  • Regulatory Pathway

  • Regulatory Risk Analysis

  • Manufacturing Ballparks

  • Business Strategy

  • Roadmap for Development

  • CAD File with Labeled Parts

  • CAD File Parts Measured

  • Business Plan & Investor Docs

  • Anatomy Animation Video

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Phase 4

Manufacturing & Regulatory
  • Design Verification Units (DV)

  • Manufacturing Documentation

  • Supply Chain Approval

  • Tooling & Small Runs

  • Dial-in Specs Small Runs

  • Verification & Validation Testing

  • 510K Regulatory Testing (3 months)

  • Quality Documentation

  • Quality Management System 

  • QMS build-out 100 documents

  • Compile Certificates

  • Sterilization Protocol

  • Engineering & Validation Runs

  • 510K Document Writing

  • 510K Regulatory Submission

  • FDA 510K Response

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Phase 2

Refinement & Testing 
  • Concept Downselection

  • High-Fidelity Prototypes

  • User Testing (UT)

  • Clinician Feedback

  • Functional Testing

  • Specification Development

  • CAD Reconfigurement with UT

  • Vendor Sourcing

  • Vendor QMS Confirmation

  • Vendor Qualification

  • Vendor Costing

  • Vendor Meetings (10+)

  • Concept Freeze

  • CAD File Freeze

  • Design History File

  • Compile Documents QMS

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Phase 5

Business Operations & Sales
  • Business Operations

  • Distribution Strategy

  • Device Commercialization

  • Production Orders

  • Sterilization Regular Runs

  • Marketing Pictures & Videos

  • Website Creation

  • Marketing Literature Creation

  • Document Control

  • QMS Management

  • Bi-yearly QMS Audits

  • FDA Complaint Handling

  • Distribution Plan

  • Warehousing Space

  • Shipping Protocol

  • Inventory Management

  • Sales Strategy

ASK US ABOUT ... DEVICE & TISSUE-TO-SKIN ANIMATIONS. 

HEADQUARTERS

3469 Lake Elmo Ave N, #304

Lake Elmo, MN 55042

(612) 500-7433

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VitaTek is an innovative, one-stop medical device development incubator, accelerator and manufacturing company that specializes in bringing ideas to market. We are dedicated to commercializing medical devices and providing innovative solutions to the healthcare industry that make a difference in people's lives. 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, FDA compliance and regulatory services, usability testing and validation, 510k submissions, tool & die molds, manufacturing, hydrophilic coating, sterilization, warehousing, distribution, marketing and sales.

© 2025 VitaTek. ISO 13485 Compliant.

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