Our Process

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

Accelerating Value Creation Throughout the Critical Chain

Program Planning, Budgeting & Management

Early Stage Discovery

Design Refinement & Optimization - Design for Manufacture

Verification & Validation - Pre-Clinical Testing

Manufacturing Transfer

Regulatory Alignment & Support

Next Generation / Life Cycle Management

Program Planning, Budgeting & Management

1 Program Planning, Budgeting & Management

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

Following the disciplined Design for Risk Management Along the Critical Path, we identify the sequential dependencies, as well as the specific resource assignments, necessary for the completion of each developmental task. Resource allocation drives the budget process, tracking fractional engineering expenses that roll up to determine the labor budget. More importantly, this approach delivers a rational, developmental timeline that will never slow down due to resource constraints. It’s part of why we’re 2X Faster than traditional, internal development processes.

Early Stage Discovery

2 Early Stage Discovery

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 the regulatory filing strategy begin here, while continuously refining cycles of design - prototype - test brings your medical device to feasibility.

Design Refinement & Optimization - Design for Manufacture

3 Design Refinement & Optimization - Design for Manufacture

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 identifying the materials and suppliers for both testing and high-volume manufacturing your medical device will require.

With user requirements met and with an eye to the future of your device, we initiate Design for Manufacture. Through this process we minimize part counts, optimize assembly times, and strategically design your manufacturing line to maximize the profitability of your device.

Verification & Validation - Pre-Clinical Testing

4 Verification & Validation - Pre-Clinical Testing

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 necessary for your device.

Manufacturing Transfer

5 Manufacturing Transfer

As manufacturing agnostics, REV·1 works with our clients to identify the best fit solution for their manufacturing needs. Whether internal or outsourced, REV·1 designs, builds and integrates all the necessary fixturing and line equipment your manufacturing will require. We then provide full installation, conduct IQ/OQ to ensure compliance, support validation and deliver complete training to your manufacturing line operators before signing the line over to you.

Regulatory Alignment & Support

6 Regulatory Alignment & Support

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 move you seamlessly and swiftly through the regulatory approval process.

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.

Next Generation / Life Cycle Management

7 Next Generation / Life Cycle Management

REV·1 carefully monitors the advancement of technologies in the market, and are often asked to create next generation medical devices. 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.

Start Developing Your Medical Device Today!

Learn how REV·1 Engineering delivers medical devices 2X Faster than traditional, in- house design and development processes. From concept to commercialization, REV·1 delivers turn-key solutions for today’s most complex medical technologies.