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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EngineeringThe 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.
Drug/Device Combination Products
REV·1 Engineering’s experience with combination products, disciplined and transparent Program Management and meticulous attention to documentation accelerate speed to revenue for sophisticated products requiring parallel CDER/CDRH submission.
With our extensive background in minimally invasive cardiac technologies - from trans-septal access to cardiac mapping and transcatheter valve replacement, our exceptional team of mechanical engineers has produced multiple successful structural heart solutions.
Ablation & Mapping Catheters
Balloon & Stent Delivery and Anchoring Systems
REV·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.
Guide Catheters, Sheaths, RHVs & Device Delivery Systems
Rev.1 has designed stimulation leads and advanced delivery systems for placement to targets throughout the nervous system including Spinal Cord Stimulation (SCS), Peripheral Nervous Stimulation (PNS), & Deep Brain Stimulation (DBS).
Electroporation & Gene Therapy Delivery Devices
As minimally invasive technology advances into cell and gene therapy, Rev.1 is the premier team to translate your science and research to the clinic and deliver the most advanced and sensitive biological therapies.
Wound Closure and Advanced Wound Care
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.
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.
In 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.
Unlike 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.
Engineering for Manufacture
Experienced, on-staff Equipment Engineers at REV·1have an exceptional track record designing tooling solutions to drive products from concept to development and all the way through full-scale launch. Our team also coordinates documentation transfer and the requisite training to ensure compliance throughout scale up.
Quality Engineering & Test Development
Successes 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.
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 ManagementREV·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.
REV·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
REV·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.
REV·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
REV·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
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.
3D CAD DesignREV·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
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!
Since 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".
REV·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 & 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.
Whether 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.
As 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.
Because 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.
If your contract manufacturer of choice is a limiting factor REV·1 often bridges customers DV&V production needs with in-house fabrication capabilities.
REV·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.
PreclinicalHaving 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
Clinically 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".
REV·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.
In 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.