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

Main Conference Day One

9:10 am - 9:50 am The Importance of User Experience in the Delivery of Healthcare

Moni Wolf - Principal Design Director, Microsoft Healthcare
  • Optimise your user interface to ensure a consistent experience across the globe, where clients exist within a range of demographics and competencies
  • Understand the challenges of multi-user and multi-platform devices from a usability angle
  •  Put the patient at the heart of your device by creating successful patient and client journeys 

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.

Patrick Alff

Chief Technology Officer

10:30 am - 11:00 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

11:55 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 

Lori-Ann Woodard

Medical Device Director, Compliance Practice
Lachman Consultant Services

11:15 am - 11:55 am 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

12:35 pm - 1:35 pm Networking Lunch

1:35 pm - 2:15 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

Mathieu Materne

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

2:15 pm - 2:55 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 

John Garratt

Mirada Medical

3:55 pm - 4:25 pm Networking Coffee Break

4:25 pm - 5:05 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

Jan Van Moll

Director of Quality and Regulatory

5:05 pm - 5:45 pm Round Table Discusions

The best strategies are formed through expert collaboration! Break off into small groups of 8-10 people and collaborate with your peers in these interactive roundtable discussions. Choose one of the topics below, and get stuck into the discussions and debates! 

  1. Security in Practice – Collaboratively design strategies to ensure product security and mitigate risk
  2. User Experience – Discuss the benefits of developing human-centric devices  - Maria Aranburu Arnaiz, Software Quality Assurance Engineer, KIRO Grifols
  3. EU/US Regulations – Work through the latest updates with your peers and leave with tips for effective documentation and inspection ready
  4. Total Collaboration – Reap the benefits of improved collaboration between industry and healthcare environments 
  5. 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