18 - 19 February, 2020 | Berlin, Germany

Main Conference Day One

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

  • 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
Moni Wolf, Principal Design Director at Microsoft Healthcare

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

  • 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.
Patrick Alff, Chief Technology Officer at Voluntis

Patrick Alff

Chief Technology Officer

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

  • 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
Guido Fumagalli, Senior Specialist, Devices Software & Apps at MHRA (Devices)

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

  •  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 
Lori-Ann Woodard, Medical Device Director, Compliance Practice at Lachman Consultant Services

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 at UCB

Mathieu Materne

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

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

  • 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
Mario Beck, MySQL Technical Sales Manager - EMEA at MySQL

Mario Beck

MySQL Technical Sales Manager - EMEA

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

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

  • 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 
John Garratt, Analyst at Mirada Medical

John Garratt

Mirada Medical

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

  • 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
Jan Van Moll, Director of Quality and Regulatory at Philips

Jan Van Moll

Director of Quality and Regulatory

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

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
Dirk Leopold, Branch Manager at itemis

Dirk Leopold

Branch Manager

Markus Voelter, Consultant in Collaboration with Itemis at itemis

Markus Voelter

Consultant in Collaboration with Itemis

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

Collaboratively design strategies to ensure product security and mitigate risk

4:40 pm - 5:15 pm Round Table: User Experience

Discuss the benefits of developing human-centric devices
Maria Aranburu Arnaiz, Software Quality Assurance Engineer at Kiro Grifols

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
Georg Heidenreich, Director Healthcare IT Standards at Siemens Healthcare

Georg Heidenreich

Director Healthcare IT Standards
Siemens Healthcare

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

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