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 KremliovskyDirector of Medical Devices and eHealth
9:55 am - 10:35 am Continuous Integration and Testing in 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 AmabileQuality Assurance & Regulatory Affairs Manager
Massimo PanonziniSoftware 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!
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 AnderssonSenior Quality Manager
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 SchooenderwoertPrincipal Consultant
Lean Agile Partners
1:35 pm - 2:15 pm Optimising Remote Patient Care
• 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 WeberDirector Program Project Management - Global R&D - Therapy Program Home
Fresenius Medical Care
2:15 pm - 2:55 pm Organs & Org Charts
• What do Biologists, Lawyers, Makers and Users have in common?
• Systems Design & Systems Thinking
• What tools & techniques can we bring back to our teams as soon as this talk is over?
Matt KreyFounder and CEO
3:25 pm - 4:05 pm Innovation in Drug Delivery Devices – Transition from Purely Mechanical Solutions to Medical Data Management
4:05 pm - 4:45 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 GarrattProduct Manager
Dr Sean PollockProduct Manager
4:45 pm - 5:25 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