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

- Discuss the reality of patient need in paralysis cases: how can medical technology assist in primary communications
- Analyse the solution – creating a distributed braincomputer interface (BCI) with the consideration of cost-benefit analysis
- Understand the requirements of successful device development – mapping patient usability needs with the needs of the caregiver and the cost to the manufacturer
- Ensure interactivity with additional software and medical devices to create an interoperable device

Matthias Hohmann

Research Assistant and PhD Candidate in Neurotechnology
Max Planck Institute for Intelligent Systems

9:40 AM - 10:20 AM Confessions of a Software Verification Manager

Andrew MacCormack, Engineering Manager - Software Test and Continuous Improvement, Optos
- How I learned that verification is about getting useful feedback as quickly as possible
- Mistakes were made along the way and how to learn from them
- Why you will never only have to do something once

Andrew MacCormack

Engineering Manager - Software Test and Continuous Improvement
Optos

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 ‘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

12:10 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 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

8:30 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

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

10:50 AM - 11:30 AM Creating a Flexible Implementation Strategy for Effective Rapid Prototyping

Irene Kaashoek, Mechatronic System Engineer and Head of the MDB competence group – Macawi Medical Systems, Demcon Group
- Discussing development strategies from the perspective of a rising medical device company
- Cherry picking the MBD workflow for optimal efficiency
- Rapid prototyping: from breadboard to final design
- Risk reduction by test-driven development

Irene Kaashoek

Mechatronic System Engineer and Head of the MDB competence group – Macawi Medical Systems
Demcon Group

11:30 AM - 12:10 PM 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

12:10 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 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