# Managing Clinical Data Activities

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-07-07
- Length: 24m
- Episode: 218
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities
- Listen: https://podcast.greenlight.guru/episode/managing-clinical-data-activities

## Summary

Pall Johannesson, CEO and co-founder of Smart Trial, explains how his digital platform helps medical device companies manage clinical data activities, addressing the industry's historical reliance on outdated paper and Excel-based systems. He discusses the impact of EU MDR and the pandemic on clinical trial strategies, noting a shift toward decentralized or hybrid trials and the importance of collecting clinical evidence early to avoid regulatory delays. Johannesson highlights common mistakes, such as collecting too much data without statistical rigor, and emphasizes best practices like involving statisticians early and planning for post-market surveillance from the start.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=0) Introduction: Pall Johannesson and Smart Trial
- [1:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=100) The Problem: Outdated Clinical Data Technology
- [3:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=180) EU MDR Impact and Post-Market Surveillance
- [6:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=402) US vs EU Regulatory Strategies and Real World Evidence
- [8:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=488) Pandemic-Era Trials and Decentralized Data Collection
- [14:07](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=847) Company Profiles and Device Complexity
- [15:35](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=935) AI, Machine Learning, and Wearable Integrations
- [20:08](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities#t=1208) Common Mistakes and Best Practices in Clinical Trials

## Topics

- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Smart Trial (company)
- Green Light Guru (company)
- EU MDR (other)
- FDA (other)
- Halo (product)

## 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)
- [176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski](https://hardwarepodcasts.com/podcast/lets-combinate/2025-02-19-176-the-fastest-way-to-ruin-drug-device-development-and-how-to-avoid-it-with-eri) (Let's Combinate)
- [058 - PMSR Globally, Different Clinical Roles and Risk Management with Khaudeja Bano](https://hardwarepodcasts.com/podcast/lets-combinate/2022-11-09-058-pmsr-globally-different-clinical-roles-and-risk-management-with-khaudeja-ban) (Let's Combinate)
- [038 - "Clinical Trials" with Dan Sfera](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera) (Let's Combinate)
- [094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products) (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/2021-07-07-managing-clinical-data-activities. 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.