Our Process

 

REV·1 Engineering Medical Device
Product Development Process

INTRO

  • Project Plan
  • Budget
  • Regulatory Strategy

EARLY STAGE DEVELOPMENT

  • Design Concept
  • Preclinical Model
  • Feasibility

DESIGN REFINEMENT

  • Product & packaging specs
  • BOM/ASL
  • Design-Prototype-Test cycle

VERIFICATION & VALIDATION

  • Pre-clinical studies
  • Oversee testing
  • Regulatory compliance

REGULATORY FILING

  • Present to FDA/CE
  • Ramp up Manufacturing
  • Clinical Trial Prep

NEXT GENERATION

  • Sustaining Engineering
  • Add Features or Sizes
  • Develop Next Generation Device

REV·1 Engineering Medical Device
Product Development Process

All companies follow a product development process... what makes REV·1 Engineering different? From the very beginning, REV·1 Engineering considers the entire lifecycle of your medical device from initial idea through market maturity, not just the technical aspects. With minimal resources, REV·1 Engineering develops your new medical device from napkin sketch to marketability 2x Faster than a start-up in-house staff.

REV·1 INTRO Initial Design Consultation

You say "yes" and the REV·1 medical device engineering team is prepared to get started... often within hours of your agreement. And, while REV·1 always creates a plan to take your medical device to commercialization, production feasibility can be your only contractual obligation, simplifying the process and better meeting the needs of each funding stage.

Project Plan & Budgeting
Initial Regulatory Strategy REV·1 creates a regulatory strategy from the first meeting, to ensure design choices match the regulatory and market goals of your medical device.

EARLY STAGE DEVELOPMENT

In the early stages of your medical devices development process, REV•1 focuses on clearly determining user requirements, which guide the design concept. Preclinical model development and regulatory filing strategy begin here, while continuously refined cycles of design - prototype - test bring your medical device to feasibility.

Design Concept
Development
Preclinical Model
Development
Intellectual Property
Development REV·1 builds upon your initial ideas, providing additional parallel ideas that we assign to your company due to our engagement.
Feasibility
  • Technical feasibility
  • Market feasibility
  • Regulatory feasibility
  • Reimbursement feasibility
Developing & Formalizing
User Requirements
  • Device classification
  • Product market claims
  • Regulatory strategy
  • Test methodology
  • Preclinical model development

Ongoing Project Management & Budgeting

  • Weekly updates
  • Project status
  • Network updates
  • Schedule
  • Budget
  • Fever charts

DESIGN REFINEMENT

With feasibility established, REV·1 refines the medical device design to perfectly meet user requirements, quality assurance, and regulatory standards. At this stage REV·1 designs packaging and sterilization requirements, as well as identifies materials and suppliers for both testing and high-volume manufacturing of your medical device.

VERIFICATION & VALIDATION

REV·1 oversees every step of your medical device product development process, including preclinical studies to verify and validate your new medical device. REV·1 has established relationships with top quality labs that excel in medical device testing, and works closely with them to establish the specific test methodology for your device.

REGULATORY FILING

REV·1's regulatory strategy starts in our very first engagement with you, determining early on the classification and claims of your medical device. This mitigates your financial risk, ensuring the medical product design development and testing methodologies used move you smoothly and swiftly through the regulatory approval process.

Presentations to Regulators REV·1 is your R&D team with deep experience answering the hard technical questions. Our well-equipped facility is ready to impress both regulators and potential funding sources.

Supply Chain Development Build Design History File Manufacturing Ramp-up REV·1 works to find the best manufacturer, builds your supply chain, and goes through the rigors with suppliers to ensure they will be approved.

NEXT GENERATION DEVICE DEVELOPMENT

REV·1 carefully monitors the advancement of technologies in the market, and are often asked to create your next generation medical device. Depending on the significance of the change, you may be able to leverage much of the first generation work. If the device looks very different or has different indications for use, REV·1 uses our intimate knowledge of your medical device and the market to build your next-generation medical device.

Our work on your solution can begin...
tomorrow (really)