Hardware Podcasts

Bridging the Gap between Medical Devices and Clinical Data

Global Medical Device Podcast · 20 Apr 2022 · 50m · Episode 255

What this episode covers

Adam Steadman, Chief Commercial Officer for SMART-TRIAL, explains how Electronic Data Capture (EDC) software bridges the gap between medical device development and clinical data requirements, particularly under the EU MDR. He details the necessity of collecting five distinct data streams—algorithm, proof of concept, regulatory, payor, and physician adoption data—to ensure market success and reimbursement. Steadman highlights that the EU MDR has forced manufacturers to prove ongoing effectiveness, leading to SKU rationalization and a shift in clinical trial strategies from Europe to the US. He warns against taking shortcuts in clinical trials, such as conducting 'first-in-human' studies without proper risk assessment, and emphasizes adherence to ISO 14155 and ISO 20916 standards for patient safety and regulatory compliance.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
SMART-TRIAL, Greenlight Guru
Also
True Quality 2022, EU MDR, ISO 14155, ISO 20916, FDA, NICE

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