# Bridging the Gap between Medical Devices and Clinical Data

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2022-04-20
- Length: 50m
- Episode: 255
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data
- Listen: https://podcast.greenlight.guru/episode/bridging-the-gap-between-medical-devices-and-clinical-data

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=0) Introduction: Adam Steadman and SMART-TRIAL Overview
- [2:53](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=173) EDC Adoption in Medical Devices vs. Pharma
- [4:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=250) EU MDR Impact: Post-Market Effectiveness and Data
- [5:13](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=313) Five Key Data Streams for Medical Device Manufacturers
- [11:45](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=705) Data Collection for Mechanical and Orthopedic Devices
- [16:17](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=977) EU MDR Fallout: Notified Bodies and SKU Rationalization
- [19:43](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=1183) Decentralized Trials and Remote Patient Monitoring
- [24:03](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=1443) Medical vs. Lifestyle Wearable Data and Regulation
- [25:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=1525) Algorithm Development and Software as a Medical Device
- [32:33](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=1953) Best Practices: ISO Standards and Avoiding Shortcuts
- [37:36](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=2256) Global Clinical Trials: South America and Data Acceptance
- [43:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data#t=2601) Impact of US-Centric Trials on European Research

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Pricing, margins & unit economics](https://hardwarepodcasts.com/topic/pricing-and-unit-economics)

## Most relevant to

early-stage companies

## Mentioned

- SMART-TRIAL (company)
- Greenlight Guru (company)
- True Quality 2022 (other)
- EU MDR (other)
- ISO 14155 (other)
- ISO 20916 (other)
- FDA (other)
- NICE (other)

## Related episodes from other shows

- [059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-16-059-literature-review-eu-mdr-cers-and-being-problem-driven-with-ethan-drower) (Let's Combinate)
- [099 - Medical Device vs. Medicinal Product Reviews in the EU, Working at MHRA, Notified Bodies, EU MDR, ICH Q6 and Writing All About It with Janine Jamieson](https://hardwarepodcasts.com/podcast/lets-combinate/2023-08-23-099-medical-device-vs-medicinal-product-reviews-in-the-eu-working-at-mhra-notifi) (Let's Combinate)
- [054 - "EUDAMED" with Richard Houlihan](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-12-054-eudamed-with-richard-houlihan) (Let's Combinate)
- [021 - "Options" with Karandeep Singh Badwal](https://hardwarepodcasts.com/podcast/lets-combinate/2022-02-23-021-options-with-karandeep-singh-badwal) (Let's Combinate)
- [015 - "Would You Use it on a Family Member?" with Monir El Azzouzi](https://hardwarepodcasts.com/podcast/lets-combinate/2022-01-19-015-would-you-use-it-on-a-family-member-with-monir-el-azzouzi) (Let's Combinate)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-04-20-bridging-the-gap-between-medical-devices-and-clinical-data. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.