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

Main Conference Day One

9:15 am - 9:55 am From Cyber-Physical Systems to Intelligent Agents: The Future of Medical Device is Now!

        Understand the driving forces behind evolution of cyber-physical systems
        Discuss the systems architecture of an Intelligent Agent and Types of Agents
        Explore validation of Intelligent Agents and the struggle of software architects and regulators alike
        Analyse ethically aligned design for autonomous / Intelligent Systems in Health (IEEE Initiative)
Michael Kremliovsky, Director of Medical Devices and eHealth at Bayer

Michael Kremliovsky

Director of Medical Devices and eHealth

9:55 am - 10:35 am Healthcare Software Development: The Inpeco Approach to Agility

•          Gain insight into Inpeco’s Software development in a regulated environment
                    Learn how to transition away from waterfall
•          Uncover the full automation key to agility and traceability
Giorgia Amabile, Quality Assurance & Regulatory Affairs Manager at Inpeco

Giorgia Amabile

Quality Assurance & Regulatory Affairs Manager

Massimo Panonzini, Software Development Manager at Inpeco

Massimo Panonzini

Software Development Manager

10:35 am - 10:45 am People Bingo: Interactive Speed Networking

A highlight of Pharma IQ events, now at SDMD! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers and add to your contact pool. There is a prize in it for the winner so get networking!
Please Share:
1. Who you are
2. The scope of your job role
3.What you plan to achieve from attending this event
4.Your #1 challenge

11:15 am - 11:55 am A User-Centric Approach to Risk Management and Clinical Safety

  • Discover Sectra’s history of user obsession
  • Explore the agile approach to risk management
  • Dive into the industry's challenge of finding relevant clinical knowledge
Peter Andersson, Senior Quality Manager at Sectra AB

Peter Andersson

Senior Quality Manager
Sectra AB

11:55 am - 12:35 pm Flow For Enterprise Transformation - FLEX

  • Discover a new extensible framework for using Lean and Agile practices company-wide
  • Learn how FLEX gives a clear starting point based on your situation and is just right when SAFe is overkill
  • Explore how FLEX is modular and flexible, so is easy to incorporate into your regulated process

Nancy Van Schooenderwoert, Principal Consultant at Lean Agile Partners

Nancy Van Schooenderwoert

Principal Consultant
Lean Agile Partners

        Explore modular software architectures in Remote Patient Care environments
        Factor MDR and GDPR compliance processes in Remote Patient Care environments
        Discuss cybersecurity risk management in Remote Patient Care environments, including post market surveillance
        Evaluate the benefits and risks to patients and care-givers considering Human Factors in Remote Patient Care environments
Thomas Weber, Director Program Project Management - Global R&D - Therapy Program Home at Fresenius Medical Care

Thomas Weber

Director Program Project Management - Global R&D - Therapy Program Home
Fresenius Medical Care

2:15 pm - 2:45 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

3:25 pm - 4:05 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

4:05 pm - 5:05 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