Case Study
Project Overview
An EU-based deep medical technology startup sought to bring its first medical innovation to the EU market.
The breakthrough technology, which originated from a university research project, had concluded its preclinical stage, and the prototype device was entering the clinical evaluation phase.
Client Needs
The client required support in evaluating the results of the preclinical investigation and designing for clinical evaluation and investigation. Alongside clinical design, the client needed assistance defining the site requirements and selection criteria for the clinical investigation site.
The development phase coincident with the transition period to MDR (EU) 2017/745, and the prototype device, initially classified as a risk class IIb active therapeutic device according to MDR (EU) 2017/745 regulations, needed confirmation alongside the clinical evaluation.
Client Challenges
As an emerging medical technology, the client’s device had no equivalent devices regarding technical, biological and clinical characteristics and properties.
The clinical evaluation had to be designed in the context of the general safety and performance requirements (GSPR) – as stipulated by the MDR (EU) 2017/745 – the intended clinical benefits to patients must be determined with clinical outcome parameters.
In addition, the MDR (EU) 2017/745 increased the requirements for the amount and quality of data needed to generate sufficient clinical evidence.
Project Initiation & Key Objectives
The client decided to leverage inXso’s expertise in developing emerging and breakthrough medical technology to support their development transition from the preclinical to the clinical phase.
The project scope included:
- Analysis and validation of preclinical study results
- Design for clinical evaluation plan (CEP) and clinical evaluation report (CER)
- Design for clinical investigation plan (CIP), clinical investigation report (CIR), and clinical development plan (CDP)
- Clinical investigation site(s) requirements and selection criteria
inXso Approach
inXso assessed the client’s research and development plans and analysed gaps with the regulation (EU) 2017/745 compliance and relevant ISO/IEC standards.
inXso provided specialised training on the key clinical evaluation and investigations requirements under regulation (EU) 2017/745, sponsor responsibilities, and relevant ISO/IEC standards.
Together with the client, inXso created an implementation roadmap tailored to the client’s development needs.
inXso Solution
inXso supported the medical technology startup in the following activities:
- Creation of statistical analysis methods to validate results from preclinical studies to ensure that the prototype device is ready for the next phase.
- Creation of templates and documentation for clinical development plan, clinical evaluation plan and report in compliance with MDR (EU) 2017/745.
- Creation of templates and documentation for clinical investigation plan and report in compliance with MDR (EU) 2017/745.
- Design of clinical trials to generate clinical evidence and demonstrate general safety and performance requirements.
- Analysis of requirements for clinical trial site selection criteria and identification of appropriate sites and their performance.
Project Achievements
inXso supported the medical technology startup in successfully transitioning their active therapeutic device from the preclinical to clinical phases.
inXso delivered:
- Enhanced methodology for medical technology assessment and analysis.
- A clear and systematic approach to plan and carry out clinical trials successfully.
- High-quality documentation to meet the regulatory requirements.
- Improved compliance based on inXso guidance.
Outcomes for the Client
The medical technology startup team gained a cohesive understanding of regulatory and standardisation aspects regarding clinical evaluation and investigation.
After the assessment of combined properties, the client’s active therapeutic device was reclassified to risk class III.
The client selected several sites in the EU to conduct clinical trials based on site profile, qualifications, facilities, equipment, and access to the patient population.
The client’s clinical evaluation and investigation consider real-world evidence, diversity and inclusion to ensure therapy effectiveness in diverse patient populations.
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