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

For more than a decade, REV·1 Engineering has demonstrated their market validated, world-class Development & Innovation process. A process proven to accelerate speed to revenue, while simultaneously mitigating risk, in the medical device sector. Our comprehensive approach optimizes engineering efficiencies while delivering exceptional efficacy at launch, in terms of clinical, regulatory and business objectives.

REV·1 INTRO Initial Design Consultation

Our process initiates with a conversation designed to identify critical risk factors and project fit criteria based upon our expertise and capabilities. It is imperative to us that we deliver exponential value creation to our customers and ensure they’re on the right trajectory. Getting a client only partway to the finish line is not a win.

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 device’s development process, REV•1 focuses on clearly determining user requirements, including Human Factors and usability, 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
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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.

CLINICAL STUDIES THROUGH COMMERCIALIZATION

As you approach Clinical Studies and initiate scale, REV•1’s extensive experience in Engineering for Manufacture ensures a smooth transition from development to commercialization. Whether you’re bringing your device in-house or looking to outsource manufacturing, our on-staff Equipment Engineers can design tooling solutions to drive any product from short-run clinicals all the way through full-scale launch. Our team also oversees document transfer, Quality Systems’ alignment and the requisite training to maintain compliance.

CLINICAL STUDIES THROUGH COMMERCIALIZATION

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.

We can also work with you in an adjunct capacity, maintaining your access to our knowledge, facilities and team in a cost effective manner.

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

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