Conference Day 2

8:30 AM - 8:50 AM Registration and Welcome Coffee

8:50 AM - 9:00 AM Chairman’s Recap of Day One

9:00 AM - 9:40 AM An Evaluation of Model Based Planning Adoption

Nolan Wanner, Principal System Engineer , Hill-Rom
- Achieve a balance between model cost and process efficiency
- Create a framework for feature set inclusion and plant model fidelity optimisation
- Examine the challenges of plant model integration into full system level models

Nolan Wanner

Principal System Engineer
Hill-Rom

9:40 AM - 10:20 AM The Connected World – Exploring the Relationship Between Mobile Medical Applications and Medical Device Software

Brian Shoemaker, Principal Consultant, Shoebar Associates
- Understand the implication of a growing ‘medapp’ culture for software development
- Discuss where the responsibility for human interaction and interpretation lie with reference to medical-personal device communications
- Examine how the medical mobile app model is a perfect example of the challenges of design vs. human factor and agile development

Brian Shoemaker

Principal Consultant
Shoebar Associates

10:20 AM - 10:50 AM Networking Coffee Break

10:50 AM - 11:30 AM Creating an Agile and ‘Pro-Active’ Risk Analysis Model in the Agile Development Cycle

Patricia Krantz-Zuppan, Standards Manager, Cardiac Rhythm and Heart Failure, Medtronic
- Put risk management at the beginning of the process – the benefits of embedding a risk management approach within your software development methodology
- Define role responsibilities – ensure that your team understands their process risks and work together to be risk adverse throughout your team
- Create a framework for ongoing analysis and real-time risk management in the move towards continuous risk analysis

Patricia Krantz-Zuppan

Standards Manager, Cardiac Rhythm and Heart Failure
Medtronic

11:30 AM - 12:10 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
MHRA

1:10 PM - 1:50 PM Networking Lunch

1:10 PM - 1:50 PM Round Table Discussions

1. Understanding your User Experience – your usability strengths and weaknesses
2. Achieving Effective Documentation Preparation
3. Maximising Agile Adoption Benefits – how to optimise your process
4. Creating a Connectivity Chain – Software and Connected App Interactions
5. Connectivity and the Cloud – weigh up the opportunities and security risks with the shift to cloud based systems

1:50 PM - 2:25 PM ‘Cyber Threat’ – Considerations for Risk Management in the Product Lifecycle

Hannah Murfet, Founder and Vice Chair, CQI Next Generation Network, The Chartered Quality Institute
With increasing cybersecurity threats, should this prompt new questions on the safety and effectiveness of medical devices? In this session discover how risk management of cybersecurity can be considered throughout your product lifecycle, including:
- Developing an understanding of key regulatory sources that include management of cybersecurity risk.
- Gaining an insight into original research into cybersecurity risk management practices for medical devices, including safety and effectiveness considerations.
- Debriefing on findings from the related conference workshop, and learning how others are considering cybersecurity in their product lifecycle.

Hannah Murfet

Founder and Vice Chair, CQI Next Generation Network
The Chartered Quality Institute

2:25 PM - 3:00 PM Intuitive Software Design for Diagnostics – Understanding the Human Factor Impact

Lori-Ann Woodard, Sr Manager Quality Compliance Combination Products , Teva
- Utilise predictive software –incorporating human factors and analytics in the move towards ‘smart’ software
- Ensure you have the software for the real market – effectively test your software across all user demographics and avoid generation gaps
- Understand the user risks – ensure that the our devices minimise human errors in data interpretation

Lori-Ann Woodard

Sr Manager Quality Compliance Combination Products
Teva

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

3:30 PM - 4:10 PM Managing Product Quality for Software Medical Devices

Jan Van Moll, Head of Quality Management System, Audits & Compliance, Philips
- React Proactively – how to respond to increasingly strict regulations while ensuring product quality and compliance
- Rethink your approach to product quality – becoming more agile and responsive in your problem identification and resolution
- Discuss the best approach to minimise the challenges of design verification & validation

Jan Van Moll

Head of Quality Management System, Audits & Compliance
Philips

4:10 PM - 4:50 PM Becoming Agile – An Implementation Timeline

- Discover how to scale agile methodologies from team to company implementation to create a truly Agile organisation
- Learn how to use Lean-Agile values to drive innovation and decrease time to market
- Utilise your agile framework to react quickly and effectively to market changes.

4:50 PM - 5:30 PM Innovate Your Teamwork to Advance your Software Design – a Mob Programming Approach

Nancy Van Schooenderwoert, Principal Consultant, Lean Agile Partners
- Understand the value in Mob Programming as a means of innovating your software
- Recruit the team– how to communicate your software development strategy to inspire rather than exclude
- Give yourself the competitive edge - discover the benefits of team programming to maximise output and innovative thinking

Nancy Van Schooenderwoert

Principal Consultant
Lean Agile Partners

5:30 PM - 5:35 PM Chairman's Summary and Closing of Conference Day 2