Module 15 Presentations

4/15/2024

Early Stage CER

What is the State Of The Art ? • Current knowledge in this medical field? • What are the Therapeutic Alternatives? • Strengths / Weaknesses/ unmet need? • Risks (potential clinical hazards) / Benefits with Therapeutic Alternatives? What current public data is available? • From appropriate literature from benchmark/similar devices • Known/anticipated Adverse Events (types and frequency) • Performance endpoints? in each indication? • Safety endpoints (risks)? What evidence do we need to produce? • Risks to go into FMEA (ISO 14971:2019) • Design V&V activities (bench testing, biocompatibility, sterilization…) • Can I use an equivalence strategy? • Clinical performance vs clinical benefit

7

© NAMSA 2021

7

From the Early Stage CER

• Prevents too late discovery of inadequate relevant clinical data • Prevents underestimating timelines and costs of necessary activities for full V&V • Provides input to the Risk Analysis • Provides input to the V&V activities • Positions the device among alternatives(SOTA) • Provides inputs on appropriate comparator devices (equivalent or similar or different) • Provides data to determine your Clinical Strategy (especially high risk devices) • Provides inputs on available clinical data to contextualise Safety and Performance requirements

8

© NAMSA 2021

8