Expertise

Engineering

The REV·1 Engineering team averages over 20 years of medical device design & development experience. The combination of our culture, ambition, creativity, and engineering synergies, with our in-house capabilities in CNC machining, 3D printing, molding and fabrication allow us to move at a pace others cannot achieve.

Drug/Device Combination Products
Structural Heart
Ablation & Mapping Catheters
Balloon & Stent Delivery and Anchoring Systems
Guide Catheters, Sheaths, RHVs & Device Delivery Systems
Neuromodulation Devices
Electroporation & Gene Therapy Delivery Devices
Wound Closure and Advanced Wound Care
NiTi Products
Flex Circuitry
Materials Engineering
Engineering for Manufacture
Quality Engineering & Test Development
Remediation Engineering
Injection Molded Components

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.

Structural Heart

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

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 cannot achieve.

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 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 unaccessible.

Neuromodulation Devices

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 precise 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 for both chronic clinical and field trauma environments.

NiTi Products

REV·1 Engineering has gained significant NiTi knowledge and experience, enabling 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 NiTi device performance.

Flex Circuitry

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 enables REV·1 to apply this technology to new innovations, opening the door for breakthrough capabilities.

Materials Engineering

Unlike many engineering companies who outsource their materials engineering, REV·1 employs a team of 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·1 have an exceptional track record designing tooling solutions that 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 & development projects, from concept through market-launch, give REV·1 the knowledgible advantage 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 the integration with client systems – to implement a best fit, scalable system unique to the client or product.

Remediation Engineering

Our experienced team of quality, design and manufacturing medical device engineers, coupled with internal rapid process development and on-site fixturing fabrication capabilities deliver exceptional capabilities. Our capabilities and experience rapidly address your audit team’s findings, keeping product lines up and running, maximizing your return on investment.

Injection Molded Components

Our experienced, on-staff production mold designers have developed programs with volumes as large as 26 million units per day to as low as 50 part First-In-Man runs.

Program Management

REV·1's dedicated project management staff draws from a career's worth of project management experience. Our meticulous approach to Program Management utilizes ProChain software to drive highly efficient, timely results.

Total Management
Product Development Process
Acquisition Support
Board of Directors Support
Supply Chain Management

Total Management

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 highly skilled at modeling and driving project plans 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

REV·1 Engineering has seen two clients acquired for more than $700M since 2014. Our staff is deeply experienced presenting design and development details to corporate executives insupport of your funding or M&A plans.

Board of Directors Support

REV·1 Engineering's constant communication and weekly, 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 from scratch.

Supply Chain Management

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 seamless transitions, including S&OP, planning models and supplier audit/approval support to satisfy regulatory compliance.

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
Hi-Resolution Rendering
Animation

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

REV·1 Engineering's design team develops all of their designs within SolidWork's, employing Hi-Resolution 3D renderings using SolidWorks on board Photo View 360 rendering feature. This enables the transition from a 3D model to a fully rendered image, on-site, sidestepping the need to go to external "rendering services".

Animation

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 & Assembly

REV·1 Engineering maintains an impressive set of internal prototyping capabilities - from high speed CNC, laser machining, welding, molding equipment and 3D printing - 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 job shops needing to maximize piece runs.

Rapid Prototypes
3D Printing
Machining
Fabrication
Bench Testing

Rapid Prototypes

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.

3D Printing

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. Our latest addition to our 3D printing capabilities includes the HP Jet Fusion 3D Printer (with biocompatible materials reported to be commercially available in 2020).

Machining

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, accelerating turn times and saving money.

Fabrication

If 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

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 ROW filings and dossiers.

Preclinical

Having the right Pre-Clinical tests in place to evaluate product designs is critical for a successful development program. Recognizing this, REV·1 Engineering maintains a highly specialized skill set under one roof, in all areas of Pre-Clinical Modeling, for medical device testing.

Bench Model Development
Animal Testing
Cadaver Testing

Bench Model Development

Clinically relevant Bench Models are designed, built and validated by REV·1 Engineering's staff. In addition, we encourage evaluation participation from client Physician Advisory Board Members, or Key Opinion Leaders, in each identified "critical performance measurement area".

Animal Testing

REV·1 Engineering maintains an agile and conscientious staff to design, coordinate and conduct the development and implementation of responsible animal testing, only following the completion and confirmation of bench-top testing.

Cadaver Testing

In many cases, bench testing and animal testing 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.

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.