Conference Day 1

8:15 AM - 8:45 AM Welcome Coffee and Registration

8:45 AM - 8:50 AM Pharma IQ Welcome Address

8:50 AM - 9:10 AM Chairman's Opening Remarks

9:10 AM - 9:40 AM FDA Digital Health Precertification Program

- Examine the ongoing digitisation of the Health Care Continuum
- Discuss the rapidly evolving regulatory landscape for medical devices: Digital Health Foundational Policies and 21st Century Cures Act
- Envision a new digital health paradigm with FDA pre-certification

9:40 AM - 10:10 AM Regulatory Awareness: Digital Health and Beyond

Pat Baird, Head of Global Software Standards, Philips
- Analyse the FDA’s Software Modifications Guidance(what is it, key takeaways)
- Map the FDA’s Case for Quality initiative (what is it, history & next steps)
- Predict the Future: Artificial Intelligence & Machine Learning (how are these new approaches different than what we are used to, and how do we validate something that we don’t understand?)

Pat Baird

Head of Global Software Standards

8:00 AM - AM People Bingo

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 #1 challenge

10:30 AM - 11:00 AM Networking Coffee Break

11:00 AM - 11:30 AM Taking a Human Factors Approach to Medical Software Design

Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi
- Understand the importance of and challenges in designing medical software to meet the needs, desires and expectations of diverse user populations
- Learn how to design the user interface to enable user customisation and support users throughout the user experience
- Utilise appropriate human factors evaluation methodologies to achieve a user-centric approach and control use-related risks

Molly Story

Head, Global Usability Engineering and Risk Management

11:30 AM - 12:00 PM GDPR and Healthcare Data for Medical Device Software

Celestina Bianco, Quality Assurance and Regulatory Affairs Director, Systelab Technologies
This presentation will guide the audience through an introduction of GDPR and a roadmap example for SW Developers and Manufacturers.
- Gain an understanding of how to define “Health Data”
- Create an overview of the main changes in the regulation and concepts such as Privacy Impact Analysis, One-stop-Shop, Data Protection Officer, Transparency and Consent
- Understand the application of GDPR on Art 9 and Health Data Collection
- Examine the extent of the “scientific research” exemption for GDPR obligations – how does this interact with secondary utilisation of data for development purpose?

Celestina Bianco

Quality Assurance and Regulatory Affairs Director
Systelab Technologies

8:00 AM - AM The Challenge of Interoperability and Scalability in Software Design

Ionut Alexandrescu, Senior Consultant, The Qt Company
- Understand the importance of considering scalability and interoperability in software design
- Identify your design weaknesses – how to ensure a true software experience when operating across a number of different systems
- Challenge your design framework – ensure your software is agile and scalable

Ionut Alexandrescu

Senior Consultant
The Qt Company

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:00 PM Connectivity and Medical Devices: Data Creation and Utilisation

Dimitar Baronov, Chief Technology Officer, Etiometry
- Utilise ‘Cloud Connectivity’ as a means of shortening your software development timeline
- Create cloud based teamwork – how moving towards a cloud based approach can foster teamwork and software development innovation
- Manage your exposure - understanding the broader security concerns with cloud based approaches

Dimitar Baronov

Chief Technology Officer

2:00 PM - 2:30 PM Micro Agile – Insights into Agile Transition For a Small Organisation

Neil Stevenson, Software Development Manager, Mirada Medical
- Hear experiences on applying Agile in a small enterprise environment compared to a large organisation transition and how micro agile teams can be effective
- Explore what ‘being agile’ vs ‘doing Agile’ means and how to avoid killing productivity with your improvement measures
- Learn ways to combine lean, scrum and UX practices effectively and when to break the rules in order to get the improvement of the whole system

Neil Stevenson

Software Development Manager
Mirada Medical

2:30 PM - 3:30 PM Vendor Showcase

3:30 PM - 4:00 PM Networking Coffee Break

4:00 PM - 4:45 PM Campfire Round Table Discussions

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…with a twist!
A campfire theme gives these round tables an intimate and open feel, with campfire snacks provided to get everyone in the mood! Warm your hands and your imagination.
Topics Will Include:

- Cyber Security and Remote Access – The existing regulations and where to next? Key landscape challenges and strategies to stay ahead.
- Software for Med-Devices: DevOps and Tooling - discuss continuous software integration methodologies and build automation practices
- EU vs US Regulations – The updates and how to stay compliant and inspection ready
- Motivating the Team – how do you get the best out of your people and keep them thinking outside the box?

4:45 PM - 5:25 PM Maximise Your Impact by Increasing Usability Through User Experience

Doug Kanter, Senior Manager, User Experience Strategy, Dexcom
- Understand the importance of usability and human factors, and how it can vastly improve the value of your products
- Discuss how to effectively set up your design process to incorporate Human Factor Methodologies
- Maximise your software design through greater understanding of user related safety and efficiency concerns

Doug Kanter

Senior Manager, User Experience Strategy

5:25 PM - 5:30 PM Chairman's Summary of Day 1

5:30 PM - 6:45 PM Networking Drinks Reception

6:45 PM - 8:45 PM SDMD Traditional Networking Dinner