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 JainProduct 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 CahalaneCo-Founder and Director of Regulatory Affairs
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 ShoemakerPrinciple Consultant
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 MollDirector 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
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 GarrattProduct Manager
Dr Sean PollockProduct Manager