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REV•1 Engineering has been instrumental in developing life-saving, breakthrough technologies at remarkable speed and with world-class efficiency. We invite you to read our Case Studies that illustrate the value creation REV•1 consistently delivers to our clients.

Drug/Device Combination Product - Life Cycle Management of Infusion Catheter for Treating Hypertension

The Challenge

Founded in 2011, Ablative Solutions, Inc. is a venture-backed company that developed I.P. for a Renal Denervation Device, but with limited resources and the need to move quickly, they came to REV•1 for the development of their combination product.

The Solution

REV•1 initiated the engagement in November, 2011, with the development of a project plan to bring the device to clinical trials. REV•1 was charged with managing all aspects of the development of the Peregrine System™ Infusion Catheter.

The Results

REV•1 delivered it as a “First In Man” device, then on to broader Clinical Trials, and 510(k) approval in March, 2014. The device received the CE Certificate of Authority in May, 2015. Ablative Solutions continues to work with REV•1 today, developing their second-generation device.

Gene Therapy/Device Combination Product - Electroporation Delivery for Oncology

The Challenge

Founded in 2011, OncoSec Medical, Inc. is pioneering gene therapy technology to stimulate the body’s immune system to attack cancer. OncoSec required an innovative Electroporation and Genetic Payload Delivery device capable of accessing cancerous tumors that are beyond the reach of their skin-based technology.

The Solution

REV•1 developed multiple design solutions capable of accessing tumors deep in the body, stabilize them and deliver OncoSec’s proprietary Genetic Payload within the tumor through electroporation.

The Results

REV•1 delivered a simple, hand-held device that can be introduced in a minimally invasive, outpatient setting to access tumors deep in the body. Currently in pre-clinical trials, this combination product will radically change the treatment of deep-in-the-body, life-threatening tumors.

Cardiac Ablation Device for Treating Atrial and Ventricle Fibrillation

The Challenge

Ablation Frontiers’ family of Cardiac Ablation devices experienced high market adoption rates and rapid growth in sales upon launch. As demand skyrocketed, excessive manufacturing complexity and resulting lead times, the Cost of Goods Sold, and the need to improve the devices’ clinician interface threatened continuous growth and profitability.

The Solution

Applying our rigorous approach, REV.1 evaluated the existing design and proposed five alternative design path solutions. In only six months, REV.1 executed the selected design through to validated, molded parts and the creation of new assembly procedures, tooling and manufacturing fixtures.

The Results

Our approach reduced the part count from 33 to 7, and decreased assembly per device time by nearly five hours. Ablation Frontiers was acquired by Medtronic in 2009.

Cardiac Mapping for Rotor Modulation/Atrial Fibrillation

The Challenge

Topera, Inc. was a startup endeavor that had licensed technology for Focal Impulse and Rotor Modulation mapping software and had secured seed funding. The CEO was charged with creating a virtual team of medical device veterans to rapidly develop and commercialize the technology.

The Solution

Starting in late 2011, REV•1 developed three different 64-electrode, “basket” mapping catheters that were deployed through a very small sheath, capable of navigating the coronary vessels to reach the chamber of the patient’s beating heart. Once within the heart, the basket electrode array expands outward, contacting the heart tissue, sensing and relaying the rogue electrical pulses. In just over 20 months, REV•1 developed three distinct basket catheters, the workstation that runs the software and controls the device, and positioned Topera for regulatory submissions for CE mark and FDA approval. REV•1 also developed and transferred the manufacturing line fixtures, documentation and procedures to international and domestic contract manufacturers.

The Results

Topera successfully received approval for the device in humans and commercialized the system. Topera was acquired by Abbott Corporation for $250 million in 2014.

Neuromodulation for Pain Management

The Challenge

As a small start-up, Spinal Modulation had developed a nerve stimulation therapy designed to interrupt the transmission of pain sensation. The device required placing multiple, electrical stimulation leads within the spinal column at specific, high-density nerve bundles. The company had designed the leads and stimulation unit, but lacked the resources to develop subcutaneous delivery, lead navigation and anchoring technologies critical to patient safety and device efficacy.

The Solution

REV•1 designed and developed an elegant, miniature, integrated delivery/navigation/anchoring system that enabled Spinal Modulation to successfully navigate both pre-clinical and clinical studies, and secure additional equity financing. The novel, breakthrough device employed materials and processes that were first of kind, adding strength to the company’s I.P. portfolio.

The Results

In 2013, St. Jude Medical infused a $40 million equity investment in Spinal Modulation and acquired the company for an additional $175 million in 2015.

Engineering for Manufacture

The Challenge

Due to surging demand for a critical medical device, JVC Consulting, a Lean Manufacturing consultancy, was contracted to ramp up production at a contract manufacturing organization. Upon evaluation, JVC concluded the device itself had been rushed into production and not optimized for manufacturing quality or efficiencies.

The Solution

Provided with a four month delivery date, REV•1 was contracted to develop a plan to refine the design, develop additional product configurations, scale the tooling/fixturing and production line to quadruple manufacturing capabilities. REV•1 embedded engineering and technical resources onsite and orchestrated a collective team of 45 resources to work to solve the challenges.

The Results

Production was quadrupled while yield rates went from 35% to 95%. Four additional product sizes were also introduced in less than four months and released for human use.

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