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 Understanding the Current Regulatory Landscape Around Medical Device Certification

Kate Antrobus, Clinical Advisor – Devices Clinical Team, MHRA
- Analyse the current UK regulatory landscape for Medical Device registration and safety classification and streamline your certification process
- Examine the shift from a MDD/IVDD approach to a MDR / IVDR based approach
- Spotlight: Discuss the new version of ISO 13485 and its implications

Kate Antrobus

Clinical Advisor – Devices Clinical Team

12:00 PM - 12:30 PM 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 Healthcare Organizations are Under Attack – High- Value Resources are at Risk!

Dr. Jack Lewin MD, Chairman, National Coalition on Health Care, Washington
- Examine the complex threat horizon in healthcare and the role vulnerable medical devices play in contributing to the spread of malware and ransomware in healthcare networks
- Show why all life-critical medical devices must be designed to meet the highest levels of software safety and cyber-security protecting patients and healthcare providers against sophisticated cyber exploits
- Quantify the importance and outline the substantial benefits of prioritizing device safety to the healthcare market and patient community

Dr. Jack Lewin MD

National Coalition on Health Care, Washington

2:00 PM - 2:30 PM Raising the “Software-Assurance” Bar on Cybersecurity for Connected Medical Devices

Joe Fabbre, Director, Platform Solutions, Green Hills Software
- Review and evaluate commonly used practices for incorporating cybersecurity into IoT connected medical devices
- An evaluation of current industry guidance for medical device cybersecurity software design
- Propose a new approach for designing security into IoT-connected medical devices, exceeding industry requirements while remaining cost effective and easy to use

Joe Fabbre

Director, Platform Solutions
Green Hills Software

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 - 5:15 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

5:15 PM - 5:50 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

5:50 PM - 6:00 PM Chairman's Summary of Day 1

6:00 PM - 7:15 PM Networking Drinks Reception

7:15 PM - 9:15 PM SDMD Traditional Networking Dinner