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Requirements Engineering in Robotic Surgery

Supporting the structured validation of clinical, technical and infrastructural requirements for automated instrument exchange in minimally invasive surgery
SME / Company Symphera
Service Provider CEED - Charité Healthcare Services GmbH
Disease / Clinical Domain Surgery
Product / Solution Automated instrument exchange system
Validation Needs Requirements Engineering

About Symphera

Symphera develops intelligent automation solutions for minimally invasive surgery, with a focus on automated instrument exchange, robotic end effectors and connectivity solutions for handheld surgical devices. The company aims to improve surgical workflows, reduce manual workload and support more precise, efficient and data-enabled procedures.

The Challenge

Symphera needs a structured requirements analysis to validate key clinical, technical and infrastructural assumptions, reduce development and adoption risks, and support evidence-based next development steps.

The Story

The collaboration started with an initial workshop and developed into a BMFTR project focusing on structured requirements engineering for Symphera’s automated instrument exchange technology.

The project addresses key challenges in surgical robotics, including high development pressure, implicit assumptions, unclear weaknesses of existing systems and the risk of misaligned product development. CEED supports the project through a phased requirements analysis, moving from hypotheses to clinically grounded development decisions. The work includes structured discussions with Symphera, rapid validation with robotic surgery experts, targeted deep-dives, clinical workshops and internal alignment sessions.

The aim is to identify real clinical problems early, reduce development and adoption risks and create a reliable basis for the next development steps. In addition, CEED contributes surveys, expert interviews, workshops on surgery, OR infrastructure and data integration, as well as data-based analyses using existing hospital data to quantify clinical and organizational requirements.

Further activities include iterative evaluations of tool-change prototypes, preparation of a test concept, support for the ethics application and the planning, execution and analysis of preclinical evaluation activities. The project supports Symphera in translating clinical, technical and health-economic requirements into structured development guidance, including documented requirement classifications, use contexts, requirement IDs and a simple traceability matrix.

Services Used

Healthcare Problems Addressed

  • Manual instrument changes and limited workflow integration in robotic surgery.
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