Cambridge Consultants congratulates its client Saranas, Inc. on reaching a series of significant milestones. The Saranas Early BirdTM 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.

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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.”

Notes to editors

캠브리지 컨설턴트(Cambridge Consultants)는 혁신적인 제품을 개발하고, 지적 재산권을 창출 및 라이선스하며, 전 세계 고객을 대상으로 기술 중심 문제를 해결하는 비즈니스 컨설팅 서비스를 제공합니다. 캠브리지 컨설턴트는 60년 이상 기업고객이 신기술을 도입하여 업계 최초로 제품을 출시하거나, 새로운 시장에 진출하거나, 기존 시장을 확장하거나, 사업기회를 상업적 성공으로 전환하도록 지원해 왔다. 엔지니어, 과학자, 수학자 및 디자이너를 포함한 900명 이상의 인원이 캠브리지(영국), 보스턴(미국), 도쿄(동경), 싱가포르(싱가포르)의 연구소에서 의료 기술, 산업 및 소비자 제품, 디지털 보건, 에너지 및 무선 통신 등 다양한 업종에 걸친 솔루션을 제공합니다.더 많은 정보를 원하시면, www.cambridgeconsultants.com를 방문하세요.

케임브리지 컨설턴트(Cambridge Consultants)는 캡제미니 그룹의 혁신 컨설팅 브랜드인 캡제미니 인벤트 (Capgemini Invent)의 소속입니다. 캡제미니 인벤트는 CxO가 조직의 미래를 계획하고 구축할 수 있도록 지원합니다. 30개 이상의 오피스와 25개 이상의 창의적인 연구소를 보유하고 있습니다.  캡제미니 인벤트의 7,000 여개의 팀들은 창의적인 설계, 깊은 산업 전문 지식과 통찰력을 바탕으로 미래의 새로운 디지털 솔루션 및 비즈니스 모델을 개발합니다. 

캡제미니 인벤트는 그룹의 핵심적인 부문으로, 기술력을 바탕으로 고객사의 비즈니스를 혁신하고 관리하는 데 있어 기업과 협력하는 글로벌 리더입니다.  캡제미니 그룹은한 포용적이고 지속 가능한 미래를 위하기술을 통해 인간의 에너지를 촉발하려는 목적에 따라 매일 발전됩니다. 거의 50 개국에서 270,000 명의 팀원으로 구성된 책임감 있고 다양한 조직입니다. 우수한 50 년 전통과 깊은 산업 전문성을 갖춘 캡제미니는 빠르게 진화하고 혁신적인 클라우드, 데이터, AI, 커넥티비티 소프트웨어, 디지털 엔지니어링 및 플랫폼에 힘입어 전략 및 설계에서 운영에 이르기까지 비즈니스의 전체 폭을 해결할 수 있도록 고객사로부터 신뢰를 받고 있습니다. 캡제미니 그룹은 2020 년 글로벌 매출이 160 억 유로라고 보고했습니다.
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About Saranas

Saranas is a privately held Houston-based medical device company focused on improving patient outcomes through early detection and monitoring of internal bleeding complications. The company’s patented Early Bird Bleed Monitoring System for vascular access procedures enables physicians to mitigate downstream consequences by addressing bleeding complications immediately, improving patient outcomes and lowering healthcare costs. For more information, please visit: www.saranas.com

  • medical technology
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