12 - 13 February, 2019 | Meliá, Berlin, Germany

Main Conference Day One

9:10 am - 9:50 am Revolutionising Healthcare with User Experience Design

Moni Wolf - Principal Design Director, Microsoft Healthcare
  • Adopt Design Research Methodologies and the articulation of stakeholder UX journeys to optimise the user interface of your device, ensuring a consistent experience across the globe
  • bring design thinking to multi-user and multi-platform devices: implement design thinking while exploring, evaluating and refining products and product concepts
  • Motivate and enable patients to be proactive about their health by implementing new technologies to advance disease prevention, detection and management
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Moni Wolf

Principal Design Director
Microsoft Healthcare

9:50 am - 10:30 am The Challenges of Turning Your Smartphone into a Cloud Connected Digital Therapeutics Solution

Patrick Alff - Chief Technology Officer, Voluntis
  • Discover  Digital Theraputics (DTx), how they  work and differ from traditional or embedded SaMD
  • Explore DTx architecture and discuss the challenges of implementing SaMD on a smartphone and operating a SaMD portal in the cloud.
  • Consider the long lasting DTx product lifecycles, what are the operational challenges caused by ephemeral mobile devices, a highly fragmented Android market, constant mobile OS updates and 3rd party operated cloud infrastructures.
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Patrick Alff

Chief Technology Officer
Voluntis

10:30 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 No.1 challenge

10:45 am - 11:15 am Networking Coffee Break

11:15 am - 11:55 am Understanding the Current and Future Regulatory Landscape Around Medical Device Software Regulation

Guido Fumagalli - Senior Specialist, Devices Software & Apps, MHRA (Devices)
  • Streamline your certification process by analysing the current UK regulatory landscape for Medical Device Software registration and classification
  • Explore the most recent updates on implementation of MDR and IVDR for Medical Device Software
  • What does the future hold for Medical Device Software regulation over the next few years
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Guido Fumagalli

Senior Specialist, Devices Software & Apps
MHRA (Devices)

11:55 am - 12:35 pm Harmonization of Agile Software Development and FDA Medical Device Design Control Requirements for SaMD and Digital Health Software

Lori-Ann Woodard - Medical Device Director, Compliance Practice, Lachman Consultant Services
  •  Coordinate a strategy to develop SaMD and software as part of a medical device or combination product systems in compliance with the FDA Design Control requirements
  •   Explore the 21 CFR 820.30 Design Control requirements and Agile development principles in parallel and uncover the least burdensome approach
  • Understand the importance of having a quality management system and the right resources to support SaMD development and post market maintenance 
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Lori-Ann Woodard

Medical Device Director, Compliance Practice
Lachman Consultant Services

12:35 pm - 1:35 pm Networking Lunch

1:35 pm - 2:15 pm Regulatory Awareness: Digital Health & Beyond

  • Gain insight into the new updates of the FDA’s Software Precertification Program and streamline your submission process
  •  Learn how the FDA are planning to reduce inspections based on the maturity of an organisation’s quality system with the Case for Quality Initiative
  • Emerging Issue: Explore the possible pathways for regulating artificial intelligence and machine learning for medical devices

2:15 pm - 2:55 pm Tackling the Challenges of Verification and Validation During the Development of a Mobile App (SaMD)

Mathieu Materne - IT Compliance Lead, Global Technology Officer, NewMeds and Medical Devices, UCB
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Mathieu Materne

IT Compliance Lead, Global Technology Officer, NewMeds and Medical Devices
UCB

2:55 pm - 3:35 pm MySQL for Medical Data

Mario Beck - MySQL Technical Sales Manager - EMEA, MySQL
  • Address the data requirements for medical device and healthcare applications with the MySQL Database
  • Learn to factor data security and high availability into these data requirements
  • Discover how to build, deploy, integrate, secure and manage all your healthcare cloud applications more efficiently
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Mario Beck

MySQL Technical Sales Manager - EMEA
MySQL

3:35 pm - 4:05 pm Networking Coffee Break

4:05 pm - 4:45 pm Empathic Software Design for Medical Devices

John Garratt - Analyst, Mirada Medical
  • Create human-centered products by introducing user personas to your software development
  • Make the transition from a one-way discussion about personas to advocating user’s needs throughout your agile development
  • Spotlight: Implement empathic design into your own development by utilising key strategies 
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John Garratt

Analyst
Mirada Medical

4:45 pm - 5:25 pm Recognise Factors that Influence the Introduction and Non-Detection of Software Defects

Jan Van Moll - Director of Quality and Regulatory, Philips
  • Identify the factors that influence the introduction and non-detection of software defects by hearing real-life case studies
  • Don’t waste time: gather insights on how to prevent and efficiently detect defects in your software
  • Utilise potential solutions with proven success in enduring device quality and reliability
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Jan Van Moll

Director of Quality and Regulatory
Philips

4:40 pm - 5:15 pm Round Table: Increasing the Efficiency of Design and V&V with Domain Specific Languages

Dirk Leopold - Branch Manager, itemis
Markus Voelter - Consultant in Collaboration with Itemis, itemis
Collaboratively discuss the benefits and experiences with using domain-specific languages to provide intuitive abstractions and notations. Technical and regulatory aspects of the modeling approach will be covered
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Dirk Leopold

Branch Manager
itemis

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Markus Voelter

Consultant in Collaboration with Itemis
itemis

4:40 pm - 5:15 pm Round Table: Security in Practice

Collaboratively design strategies to ensure product security and mitigate risk
Discuss the benefits of developing human-centric devices
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Maria Aranburu Arnaiz

Software Quality Assurance Engineer
Kiro Grifols

4:40 pm - 5:15 pm Round Table: EU/US Regulations

Work through the latest updates with your peers and leave with tips for effective documentation and inspection readiness

4:40 pm - 5:15 pm Round Table: Working Through IEC 62304

Overcome your own challenges with open discussion

5:55 pm - 7:30 pm Networking Drinks Reception

7:30 pm - 10:00 pm SDMD Traditional networking Dinner