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Clinical Feasibility Assessment & Real-World Validation

Physical Consulting
Unique Identifier: 365cf9e0-7233-40e8-8a8c-ab7202ab819f

Service Description

Who Can Benefit: - Clinical Researchers and Investigators: For gaining insights into the feasibility of proposed studies and enhancing study designs with practical clinical input. - Healthcare Institutions: To expand research capabilities by connecting with technical and clinical experts and facilities. - Research and Development Teams: For testing new technologies or methodologies in applicable clinical contexts, ensuring innovative solutions are viable and effective.

Key Features: - Technical Feasibility Assessment: Organizes and conducts comprehensive technical feasibility studies to evaluate the practicality and potential of clinical research projects. - Connection to Clinical Personnel: Facilitates collaboration between researchers and clinical experts at University Clinic Erlangen, ensuring access to expertise and resources necessary for study success. - Access to Real-Life and Laboratory Test Environments: Provides opportunities to conduct studies within associated clinics, leveraging previous experience in cardiology, neurology, and biomechanics to ensure practical and applicable results.

Possible Applications: - Project Feasibility Evaluation: Assists in determining the feasibility of clinical research projects, helping to identify potential challenges and solutions early in the development phase. - Research Collaboration: Enhances research outcomes through the integration of clinical expertise and real-world testing environments, ensuring studies are rooted in clinical reality.

Who We Are: The Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS) has established the Center for Sensor Technology and Digital Medicine (CEMDIS) in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through innovative sensor technology and digital solutions. This center focuses on integrating innovative medical technologies such as wearables and robotic systems to support medical diagnostics, patient monitoring and evaluating patient-specific therapies by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the development, integration, and validation of novel health technologies, providing companies opportunities for technological advancements. For more information, visit the Fraunhofer IIS website.

Keywords: clinical trial preparation clinical device assessment Clinical Study Design Technical Support feasibility Feasibility Assessment real-life testing
Offerings: Scientific & Medical Communication
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)
Provider Country Germany
Published Email dhs-studien@iis.fraunhofer.de

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs - Technology / Algorithm / Method Description: Detailed description of the product - Research Question / Hypothesis: Clearly defined objectives and expected outcomes fo the proposed study. - Target Clinical Domain: Specification of the relevant medical field. - Intended Use / Use Case: Description of the clinical scenario in which the technology is expected to operate. - Existing data, tests and experiments - Regulatory / Certification Status
Service Outputs - Feasibility Assessment Report: Structured evaluation of technical and clinical viability. - Study Design Outline: Preliminary study concept. - Clinical Expert Feedback and Connection: Documented input from relevant clinical specialists at affiliated clinics (Universitätsklinikum Erlangen, Universitätsklinikum Würzburg, Klinikum Nürnberg) as well as networking to relevant professionals for subsequent clinical study. - Resource & Infrastructure Plan: Overview of required test environments, equipment, and personnel for a potential follow-up study at affiliated clinics.
Service Standards
  • ISO 14155
  • ISO 14971
  • MDR
Comments - Service inputs are subject to change and can be discussed during the initiation period of the provision process -The feasibility service is designed as a low-risk entry point for organizations exploring clinical validation of new technologies before committing to a full-scale study. - Leveraging CEMDIS's co-location at Universitätsklinikum Erlangen enables rapid alignment between engineering and clinical perspectives. - Previous feasibility assessments have covered wearable sensors, robotic-assisted systems, robotics, AI algorithms and digital biomarker pipelines in cardiology, neurology, and biomechanics. - Outcomes of the feasibility phase can directly feed into a subsequent full clinical study managed via CEMDIS infrastructure (e.g., DPM-Research eCRF platform).

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