Expertise

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.

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.

REV.1 Engineering is uniquely positioned to support your disposable endoscope design, development and manufacturing needs. Long an acknowledged leader in the engineering of complex, minimally invasive, catheter technologies, REV.1 brings its unique expertise in single-use, First of Kind technologies to endoscopy.

Strategic Manufacturing is a highly coordinated, compliant and innovative approach for medical device startups seeking an innovative, flexible solution for early manufacturing demands. Moving from V&V builds, to various study demands, through to First in Man and beyond, startups often struggle to find a partner that can work with them through this highly variable process. REV.1 has built a solution that scrubs risk and accelerates the manufacturing path, all tailored to the unique demands and constraints facing startups today.

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.

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.

REV·1 has designed stimulation leads and advanced delivery systems for placement to targets throughout the nervous system including Spinal Cord Stimulation (SCS) and Peripheral Nervous Stimulation (PNS).

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.

REV.1 offers its unique experience in the design and development of highly complex, artificial organ systems to today's leaders in regenerative medicine, critical intervention and "Out of the Body", artificial organ development. In fact, the design and development of First of Kind devices makes up the majority of REV.1's day-to-day workflow.

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.

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.

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.

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.

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.

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.

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.

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.

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".

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.

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.

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.