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


ケンブリッジコンサルタンツはアルトラン(Altran)の一員です。 アルトランは、エンジニアリングおよびR&Dサービスにおいて広く認められた世界的リーダーであり、変革とイノベーションの課題に対応する独自の価値提案をお客様に提供しています。コンセプト創造から産業化に至るまで、アルトランはお客様が明日の製品やサービスを開発するサポートをいたします。35年以上にわたり、自動車、航空、宇宙、防衛および海軍、鉄道、インフラと輸送、産業と消費者製品、生命科学、通信、半導体と電子機器、ソフトウェアおよびインターネット、金融および公共部門など、様々なお客様を支援してきました。今日、アルトランは30か国以上に50,000人を超える従業員を擁し、コンサルティング、デジタルトランスフォーメーション、テクノロジー&エンジニアリングサービスのグローバルリーダーであるキャップジェミニ(Capgemini)の中核を担っています。キャップジェミニ・グループはイノベーションの最前線に立ち、進化を続けるクラウド、デジタル及び各種プラットフォーム分野で、顧客のあらゆるビジネス機会に対応致します。キャップジェミニは、50年以上にわたり蓄積してきた優れた実績と業界固有の専門知識を基に、戦略から運用まで、一連のサービスを通じて、企業が目指すビジネスビジョンの実現を支援しています。キャップジェミニの信念は、「テクノロジーに関わるビジネス価値は人を通じて具現化される」ことであり、この信念こそが社の原動力となっています。キャップジェミニは、世界約50か国270,000人に及ぶチームメンバーで構成される多文化企業であり、アルトランを含むグループ全体の2019年度売上は、170億ユーロです。People matter, results count.(人にこだわり、成果にコミット。)アルトランの詳細は をご参照ください。

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:

  • medical technology
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