Capabilities

Team REV·1's proficiency is fueled by ambition, creativity and knowledge. With in-house design, prototype, laser-weld, CNC and molding equipment, your projects move quickly through all phases of the product development process.

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Engineering

The REV·1 Engineering team averages over 20 years of medical device R&D engineering experience. Our culture, ambition, creativity, engineering synergy, in-house CNC and molding equipment allow us to move at a pace others can't.
Medical Device Design and Development
Medical Device Design and DevelopmentREV·1 Engineering's comprehensive services cover every step of the product development process. Major areas include:
  • Idea Generation and Innovation
  • Intellectual Property Protection
  • Product Design
  • Prototype Creation
  • Product Development
  • Testing (in-vitro & in-vivo)
  • Risk Assessment
  • Supply Chain Development
  • Supplier Qualification and Business Risk Assessment
  • Quality System Implementation
  • Regulatory Affairs
  • Qualification
  • Verification
  • Validation
  • Project Management (including transfer to manufacturing.
NiTi Products
rev1-niti REV·1 Engineering has gained significant NiTi knowledge and experience to enable unique applications for the medical device market. With on-site furnaces and tool-making resources REV·1 is in position to rapidly iterate and hone device performance.
Injection Molded Components
rev1-injection-molded-componentExperienced, on-staff designers with extensive production mold design experience at REV·1 Engineering have developed programs with volumes as large as 26 million units / day to as low as 50 part First-In-Man runs.
Ablation and Mapping Catheters
rev1-Ablation-and-Mapping-Catheters REV·1 Engineering has developed complete AF Mapping Catheters & Ablation Systems and have mastered complex handle designs to control unique ablation tip movements - reaching anatomy others can’t.
Flex Circuitry
flex-circuitryIn a recent breakthrough project REV·1 Engineering pioneered the novel use of flex circuitry into catheter designs - years ahead of the market. This knowledge will enable REV·1 to apply this feature to new innovation for the foreseeable future.
Guide Catheter/Sheaths/RHVs and Device Delivery Systems
rev1-Guide-CatheterREV·1 Engineering’s staff has intuitively developed market-leading access systems to help clients deliver devices to anatomical targets - from “head to toe” – which were previously un-accessible.
Wound Closure
REV·1 accomplishments include large-bore vessel access & closure systems - and have fostered the industry trend to less invasive procedures in both clinical & field trauma environments.
Drug Injection, Infusion, and Fluid Filtration Systems
rev1-Drug-Injection-InfusionREV·1 Engineering has redefined Infusion/I.V. pump & control system technology for the dispensing/injection of medicines and chemicals Applying “safety or interlock” systems continues to make significant reductions in procedural errors and user-case risk profiles, for both manual and automatic systems.
Balloon & Stent Delivery Systems
balloon-stent-deliveryREV·1 Engineering staff members have designed, developed, qualified, validated, filed and launched the finest balloon & stent delivery systems in the market - spanning from simple PTCA balloons to market-leading stent delivery systems for native and graft vessels.
Orthopedic Implants
orthopedic-implantsExtensive experience in orthopedic implant technologies has enabled REV·1 to develop innovative components and systems for orthopedic surgeons and has enabled clients to distinguish themselves from the endless numbers of “screws & rods” producers in the industry.
Materials Engineering
materials-engineeringUnlike many engineering companies who outsource their materials engineering, REV·1 employs 3 full time Materials Engineers, who continually apply their material science knowledge to each REV·1 project. These engineers have had both traditional training as well as significant direct experience in the field.
Quality Engineering/Test Development
rev1-Quality-Engineering-Test-DevelopmentSuccesses in numerous full-scale design and development projects, from concept through market-launch, give REV·1 the advantage and knowledge to navigate challenging regulatory and quality system requirements – including the FDA, CE, UL, and ISO notified bodies. Staffing at REV·1 includes in-house quality engineering resources to assist in integrating with client systems – to implement a ‘right-size’, scalable system unique to the client or product.
Process Development
rev1-Process-DevelopmentREV·1’s effective on-site training assures seamless transitions between R&D and manufacturing, including a comprehensive document package detailing all the necessary processes, with client training, ahead of pilot manufacturing.
Equipment and Fixture Design/Development
rev1-Equipment-and-Fixture-Design-DevelopmentExperienced Equipment Engineers on-staff at REV·1 typically design tooling solutions to drive any product from concept to development and all the way through full-scale launch.
Remediation Engineering
Our experienced team of quality, design and manufacturing med device engineers, coupled with internal rapid process development & on-site fixturing fabrication capabilities are able to support remediation efforts at your organization and quickly implement the findings of your audit team, keeping product lines up and running and maximizing your ROI.
program-management

Program Management

REV·1's dedicated project management staff draws from a career's worth of project management experience - and in most instances this qualified team utilizes ProChain software to achieve timely results.
Total Management
rev1-Total-ManagementREV·1 Engineering manages all projects, (clients and internal) using Theory of Constraints and Prochain Software. These extremely practical and proactive approaches have established themselves as the best project management toolset in the market.
Product Development Process
rev1-Product-Development-Processt-02REV·1 Engineering's Principle Project Managers are very skilled at modeling & driving a project plan forward using our in-house Product Development Process (PDP) or our client's PDP, eliminating painful Quality System Transfers as commercialization approaches. This Product Development Process is FDA, CE and ISO compliant.
Acquisition Support
Acquisition SupportREV·1 Engineering has seen two clients acquired for more than $700M since 2014. Our staff is very comfortable presenting design and development details to corporate executives to support your funding and acquisition plans.
Board of Directors Support
Board of Directors SupportREV·1 Engineering's constant communication and detailed presentations can be "cut and pasted" to provide most of the reports you will need for your Board of Directors... saving you an enormous amount of time creating presentation materials.
Supply Chain Development
rev1-Supply-Chain-Development Sourcing risks can result in potential supply interruptions. REV·1 has certified staff on-site to fully assess supplier QS risks and business risks – to fully uncover conditions requiring risk mitigation or alternative sourcing arrangements.REV·1 continually develops partnerships with key suppliers – to minimize risk and enable a seamless transition - including S&OP, planning models and supplier audit/approval support to satisfy regulatory compliance.
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3D CAD Design

REV·1 Engineering maintains licenses for SolidWorks Premium & Professional design & analysis workstations as the design tool of choice, including past and current versions.
Finite Element Analysis and Simulation
rev1-Finite-Element-Analysis-and-Simulation REV·1 Engineering's capabilities include a powerful set of tools for simulating linear & nonlinear materials, in both static & dynamic load scenarios. Additional capabilities in Mold Flow Analysis, Thermal Performance and Fluid Dynamic performance simulations are in-house toolsets, ready when needed!
Hi-Resolution Rendering
rev1-Hi-Resolution-RenderingSince REV·1 Engineering's design team develops all of their designs within SolidWork's, with HI-Resolution 3D renderings using SolidWorks on board Photo View 360 rendering feature, the transition from a 3D model - to a fully rendered image - is done on-site, and without the need to go to external "rendering services".
Animation
rev1-animationREV·1 Engineering uses a variety of features within Solidworks to animate the design function. If further animation of "clinical demonstrations" or "marketing media" is required, REV·1 Engineering maintains several partnerships with graphic medical experts that yield amazing audio & video representations of the interaction of their designs with the human anatomy.

Prototyping, Fabrication & Assembly

prototyping-fabrication-assemblyREV·1 Engineering maintains an impressive set of internal prototyping capabilities - from high speed CNC, laser machining, welding and molding equipment - to simple hand-operated assembly fixtures. With in-house equipment and programmers REV·1 is not at the mercy of long lead times due to the job shops trying to squeeze every dime out of their equipment.
Rapid Prototypes
rev1-rapid-prototypeWhether 3D printed, plastic rapid prototype or high-speed, machined (plastic or metal) prototypes, REV·1 internal capabilities and strong external partnerships provide for very short prototype lead times - measured in hours and days, not weeks and months.
3D Printing
3D PrintingAs 3D printing is embraced by the medical device industry, REV·1 is staying ahead of the game with the latest 3D technology, in-house and ready to speed your project through various development stages.
Machining
MachiningBecause new medical devices are developed quickly and refined through many iterations, REV·1's machine shop includes a variety of CNC machining for small-scale and micromachining, allowing our staff to control the machining process, saving time and money.
Fabrication
rev1-fabricationIf your contract manufacturer of choice is a limiting factor REV·1 often bridges customers DV&V production needs with in-house fabrication capabilities.
Bench Testing
rev1-bench-testingREV·1 Engineering provides bench-test development and test-method validation services for its clients during the development process and typically performs all Design Verification & Validation testing used to support US and OUS filings and dossiers.
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Preclinical

Having the right Pre-Clinical tests in place to evaluate product designs against is critical for a successful development program. Recognizing this, REV·1 Engineering maintains a highly specialized skillset under one roof, in all areas of Pre-Clinical Modeling for medical device testing.
Bench Model Development
bench-model-developmentClinically relevant Bench Models are designed, built and validated by REV·1 Engineering's staff who encourage evaluation participation from client Physician Advisory Board Member, or Key Opinion Leaders, in each identified "critical performance measurement area".
rev1-animal-testingREV·1 Engineering maintains an agile and conscientious staff to design, coordinate and conduct the development and implementation of responsible , only following the completion and confirmation of bench-top testing.
Cadaver Testing
rev1-cadaver-testingIn many cases bench testing and has its limitations. Should Cadaveric testing be required, REV·1 Engineering is well-versed in what it takes to design, manage and perform this testing. REV·1 Engineering also maintains an active database of teaching institutions supporting Cadaveric testing.