Cambridge Consultants’ partner Saranas secures de novo classification from US FDA

Cambridge Consultants congratulates its client Saranas, Inc. on reaching a series of significant milestones. The Saranas Early Bird^TM Bleed Monitoring System has been granted de novo classification by the United States Food and Drug Administration (FDA), becoming the first and only device on the market for early bleed detection during endovascular procedures. In addition, Saranas released a study of the first human results, which shows that the device is effective in the early detection of internal bleeding. Finally, the company has seen its first commercial use cases in the United States.

Cambridge Consultants has been a partner to Saranas since their startup origins. Beginning in 2015, the two companies embarked on a design journey with the goal of moving from a technology concept to a coherent system. Since then, Cambridge Consultants has been one of a small group of partners that supported Saranas through the many challenges of medical device development and regulatory approval.

Saranas chose to partner with Cambridge Consultants as it has all of the required capabilities and disciplines under one roof, from mechanical engineering to human factors and industrial design. Cambridge Consultants is a multi-disciplinary partner with decades of development experience in the medtech space, even providing a simulated operating room where technologies can be tested in a realistic environment.

From the beginning, Cambridge Consultants’ approach was to frame the design challenge from a holistic point of view, focusing on feasibility, usability, desirability and viability. By designing the product to meet these competing needs it was possible to maintain the integrity of design when additional specialist partners were engaged to continue the development process.

The team used an integrated design approach to gather user needs and set requirements. This led to a design that could deliver the hardware and software functionality needed to perform bleed detection, while also being elegant and unobtrusive to clinicians. The technology, design language and Saranas brand were all considered simultaneously as the design evolved to its final form, allowing it to meet both technical and commercial goals.

Zaffer Syed, President and CEO of Saranas, Inc. commented: “Cambridge Consultants has been a vital partner as we moved from a technology capability to a commercial product. Their laser focus on user needs and systematic approach ensured that design integrity was retained throughout our journey to commercial launch.”

Serge Roux, Associate Director at Cambridge Consultants, commented: “We share the pride that Saranas, Inc. is feeling at securing de novo classification from the FDA, and congratulate the Saranas team, which has shown great determination and a singular focus on improving patient outcomes through the early detection of internal bleeds. Bringing a new, regulated medical device to market is amongst the most difficult challenges that a startup can take on. It requires vision, determination, investment and of course selection of the right development partners.”