17 - 20 February, 2020 | Mercure Hotel MOA Berlin, Berlin, Germany

Main Conference Day Two

9:15 am - 9:55 am How to Achieve Innovation and Creativity by Stopping Old Practices

  • Analyse the traditional development methodology constraints medical device manufacturers face - from the perspective of a tech company
  • Explore tech-savvy companies’ innovative software development methods: a risk based approach
  • Deep dive into the pros and cons of innovative versus traditional methods
Harsh Jain, Product Quality Engineering Manager at Google Verily Life Sciences

Harsh Jain

Product Quality Engineering Manager
Google Verily Life Sciences

9:55 am - 10:35 am Regulatory Pathways for Software Design as a Medical Device (SAMD)

        Discuss the variances in global regulatory requirements (USA/EU) and use recognised standards to demonstrate compliance with regulatory directives in the USA and Europe
        Establish the three criteria that every medical device needs for success
        Analyse the difference between Medical Device Data Systems (MDSS) and SAMD 
Diarmuid Cahalane, Co-Founder and Director of Regulatory Affairs at Metabolomic Diagnostics

Diarmuid Cahalane

Co-Founder and Director of Regulatory Affairs
Metabolomic Diagnostics

10:05 am - 10:45 am Is SOUP driving you NUTS?

        Compare SOUP vs. OTS - is there a difference?
        Delve into what IEC 62304 says about SOUP
        Unpack requirements in the new FDA guidance on OTS software
        Discuss SOUP in your SBOM - tools may be coming to the rescue!
Brian Shoemaker, Principle Consultant at ShoeBarr Associates

Brian Shoemaker

Principle Consultant
ShoeBarr Associates

11:45 am - 12:25 pm Enhancing Product Quality by Deep Analysis of Field Feedback

        Understand the value of your post-release data for enhancing product quality
        See practical examples of approaches to post-release data (deep) analysis
        Learn how to ‘close the loop’ between post-release failure data and software/product design to continuously enhance device quality
Jan Van Moll, Director of Quality and Regulatory at Philips

Jan Van Moll

Director of Quality and Regulatory

1:25 pm - 2:25 pm Roundtable Discussions

The best strategies are formed through expert collaboration! Break off into small groups and collaborate with your peers in these interactive roundtable discussions. Choose one of the topics below, and get stuck into the debate.
  • Patient Centricity – to improve risk management and clinical safety
  • Agile Software  Development for Medical Devices
  • Putting AI Theories into Practice for Better Medical Device Software
  • New Approaches for Usability & Human Factors
  • Improving Risk Management for Medical Device Software

3:15 pm - 3:55 pm Innovation in Drug Delivery Devices – Transition from Purely Mechanical Solutions to Medical Data Management

·         Discover, define and develop what is really relevant
·         Explore innovation in a highly regulated field
·         Consider the transfer to commercial development
Robert Lurf, Product Engineering Manager at Haselmeier AG

Robert Lurf

Product Engineering Manager
Haselmeier AG

Stefan Gaul, Head of Strategic Product Management at Haselmeier AG

Stefan Gaul

Head of Strategic Product Management
Haselmeier AG

3:55 pm - 4:35 pm Different Strokes - Lessons to be learned from a Non-MDS (Medical Device Software) world

·         Compare MDS &  Non-MDS : definitions, constraints and regulations
·         Examine the interplay between MDS and non MDS – how we can use MDS and Non-MDS practices and tools to assist each other?
·         Scrutinize risk management for dual purpose in MDS and Non-MDS – how is handling risk different/better/worse in MDS vs Non-MDS?
John Garratt, Product Manager at Perspectum Diagnostics

John Garratt

Product Manager
Perspectum Diagnostics

Dr Sean Pollock, Product Manager at Perspectum Diagnostics

Dr Sean Pollock

Product Manager
Perspectum Diagnostics