REV·1 Engineering has been instrumental in the life-saving breakthroughs, market growth, leadership and acquisition at some of the country's major medical device innovators. Below are the inspiring stories from some REV·1 clients. Their success can be your success when you go 2x Faster with REV·1.
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Ablation Frontiers, Inc. is a medical device company based in Carlsbad, Calif., dedicated to helping individuals suffering from AF and other cardiac arrhythmias, and was acquired by Medtronic, Inc. in 2009.Ablation Frontiers had a family of Ablation devices used to treat Atrial & Ventricle Fibrillation. As the market adoption rate skyrocketed, there was a need to improve manufacturability, reducing the time and cost to build, as well as incorporating user interface improvements desired by customers.REV·1 Engineering evaluated the existing design and proposed five different design path solutions. Ablation Frontiers selected their preferred solution, and REV·1 developed the design through to final molded parts and development of new assembly procedures, tooling and fixturing, reducing the part count from 33 to 7 and removing nearly 5 hours of assembly time per device.
Check out this recent press release about Ablative's Peregrine System™ Infusion Catheter. Ablative Solutions, Inc., is a venture-backed, privately held clinical stage company founded in 2011 with a vision to address the significant unmet clinical need of uncontrolled hypertension.The Ablative Solutions, Inc. founder came to REV·1 with an idea for a Renal Denervation Device, but with very limited resources and a need to quickly move through development. REV·1 Engineering developed a project plan to bring the device to clinical trials. REV·1 started the project in November 2011, designing the Peregrine Renal Denervation System, managing all aspects of device development, bringing it to a First In Man device, then a larger Clinical Trial device. 510K approval came in March 2014, followed by an on-going OUS Hypertension study. Their Peregrine System™ Infusion Catheter received the CE Certificate of Authority in May, 2015.Ablative Solutions, Inc. extracted significant shareholder value in this very capital-efficient model of out-sourcing all engineering and project management needs to REV·1 Engineering.
JVC Consulting is a lean manufacturing consultant. When JVC was called in to help a large contract manufacturer ramp up production of a critical medical device, they determined that they product design itself was not optimized and had been rushed into production due to extreme market demand.JVC engaged REV·1 Engineering to visit the contract manufacturer and develop a plan to optimize the design, develop additional sizes of the product, duplicate the tooling/fixturing and production line to quadruple historic manufacturing capability... all in just 4 months!REV·1 Engineering put together a 4 month, 24/7 effort, temporarily relocating resources local to the contract manufacturer. With massive efforts and overcoming scope changes and surprises at every turn, REV·1 Engineering pulled together a collective team of more than 45 resources to drive all activities into a common direction and goal. Coordinating between REV·1's team on the west coast, REV·1's relocated team, the contract manufacturers' resources, and the JVC Consulting team, REV·1 achieved what appeared impossible.Not only was the production line capacity quadrupled, yields went from 35% to 95%, the project was completed on time and the "nice to have" milestone of making the product available in new size ranges was complete in the same timeframe. With one day to spare, JVC was able to bring the product to an international medical conference, use the product in a live human case, telecasting globally to other physicians and successfully addressing the patient's illness.
Established in 2011, OncoSec Medical Inc. is a San Diego-based biotechnology company pioneering new technologies to stimulate the body’s immune system to target and attack cancer. OncoSec approached REV·1 Engineering with a need for a new Electroporation & Genetic Payload Delivery device to reach internal cancerous tumors that could not be reached with their skin-based device.REV·1 developed multiple design solutions addressing how to access the tumors, stabilize them, and deliver OncoSec's proprietary Genetic Payload, followed by electroporating the tumors.REV·1 designed a simple hand-held unit that can be introduced in a minimally invasive out-patient setting to access tumors deep in the body. Currently in pre-clinical trials, this device, combined with OncoSec's proprietary gene therapy, will radically change the treatment of these deep-in-the-body, life-threatening tumors.
Spinal Modulation, a global medical device company, is dedicated to improving the lives of patients with chronic pain by providing the next generation of neuromodulation systems through stimulation of the dorsal root ganglion. St. Jude Medical made a $40 million equity investment in Spinal Modulation in 2013 and acquired the company in 2015 for $175 million.As a small start-up, Spinal Modulation had developed a nerve stimulation therapy which involved placing multiple electrical stimulation leads within the spinal column at specific high-density nerve bundles which transmit pain sensations. Spinal Modulation had designed the electrical lead and stimulation unit but lacked the resources to develop the delivery system required to go through the skin, navigate the spinal column space, and anchor the lead tip into the specific nerve bundles. The serious challenges in achieving this in a safe and effective manner cannot be understated, as the central nervous system could be easily damaged, resulting in an even worse outcome for a chronic pain patient.REV·1 Engineering designed and developed a miniature, simple and elegant delivery system that allowed Spinal Modulation to successfully deliver pre-clinical and eventually clinical units safely with ease and repeatability. This breakthrough delivery system was developed with materials and process never before used, allowing Spinal Modulation to successfully complete their early clinical testing and secure funding to take them through approval and commercialization. St. Jude Medical Center is now delivering chronic pain relief solutions to patients, making a major impact with an effective pain management system.
Topera, Inc. is the inspired story of one doctor’s unwavering commitment to improve the life of one patient who had undergone three failed procedures to correct his atrial fibrillation. Using his own prototype version of the Focal Impulse and Rotor Modulation mapping software, he was able to identify a rotor in an area not usually targeted for treatment. Once that rotor was eliminated, the patient enjoyed long-term freedom from AF. This breakthrough led to the development and validation of a novel diagnostic system to help identify the sources that sustain AF.REV•1 Engineering was approached by the newly-formed Topera Medical, which had licensed the inventors' intellectual property and was seed funded. Topera's new CEO's charter was to build a high-impact virtual team of medical device veterans to rapidly develop the inventors' technology into a complete system, ready for clinical trial and then commercialization.REV·1 immediately saw the powerful science behind the initial work and joined forces with Topera's virtual staff in late 2011. REV·1 developed three different 64-electrode "basket" mapping catheters introduced through a very small sheath, through the coronary vessels and ultimately into the chamber of the patient's beating heart. The basket electrode expands outward, contacting the heart tissue and sensing the rogue electrical pulses. This FIRMap basket catheter, combined with a workstation REV·1 Engineering designed and developed to run software Topera Medical's staff wrote comprises the entire system.REV·1 Engineering developed three distinct basket catheters, the workstation, integrated the software development team's work to complete the FIRMap system, and submitted for CE mark and FDA approval... in just over 20 months!REV·1 then transferred the manufacturing line/fixtures/documentation and process to both international and domestic contract manufacturers while Topera Medical waited for and successfully received approval for use of the device in humans and commercialized the system. Abbott Corporation saw the commercial and therapeutic value created and acquired Topera Medical in late 2014 for an initial $250M.