Pre-Conference Workshop Day
9:30 am - 11:30 am RISK MANAGEMENT WORKSHOP: Incorporating Recognised Standards for Risk Assessment into Software Design for Software as a Medical Device
In a rapidly evolving medical environment it is very important to establish the nature of the software that is being developed: is it a medical device, and if so what level of risk could it pose to patients? With the ongoing developments in Medical Device Data Systems, and also the forthcoming FDA regulation on Clinical Decision Support Software, it is imperative that the most appropriate regulatory strategy is followed when developing software as a medical device.
The proliferation of “big data” type systems as a result of the enormous cost reduction in sequencing costs has led to huge opportunities for machine learning type systems, but also created the potential for enormous risk. This workshop will help to explain how rapid developments in big data analytics and machine learning can be harnessed for the benefit of patients with as little risk to patient safety as possible.
· Identifying an unmet medical need for a proposed device
· Determining the classification of a device based on a risk based approach to patient safety
· Identifying the nature of the software application: customisable, configurable, bespoke
· Applying recognised standards (IEC: 62304) to software development
· Relating ISO:14971,and ISO:13485 to software design as a medical device
· Understanding the difference between Information Systems Infrastructure Qualification (ISIQ) and Software Validation well as how this is particularly relevant to cloud based systems
· Analysing recognised industry guidelines such as Good Automated Manufacturing Practice (GAMP)
· Identifying the nature of your software application: is it a medical device, or a medical device data system (MDSS) and the different regulatory approaches
· Covering an introduction to the US Food And Drug Administration, (FDA) and the European Commission’s approaches to regulation of software as a medical device
· Exploring the Software Development Lifecycle (SDLC) Approach To Software As A medical Device development
Diarmuid CahalaneCo-Founder and Director of Regulatory Affairs
11:30 am - 1:30 pm AGILE SOFTWARE DEVELOPMENT WORKSHOP: The Tortoise and the Hare – How Efficiency Works in an Agile Business
There is plenty of folk wisdom about how slow and steady wins the race, how a stitch in time saves nine - yet we continue to operate in organisations the way businesses did a century ago when time and motion studies were the latest thing. When Agile methods are used well, efficiency just doesn’t look like it did when work was mostly visible and mostly manual. 21st century companies have to combine creativity, technology, and keen understanding of customers. Agile practices do this extraordinarily well, but they seem counterintuitive.
In this workshop we will look behind the surface and help you understand the inner workings and how to best support your organisation as it moves through a deep self-transformation.
Key points of discussion:
· True Agility demands collaboration across disciplines - helping identify safety risks and blind alleys early
· Frequent end-user feedback keeps development focused, especially if the marketplace is changing
· Agile can "build in" the generation of required documentation and conduct of reviews
· Some Agile teams may save time by exploring multiple solutions early
· Also counterintuitive is mob programming - how can multiple employees working on one item be efficient?
· Learn what to do when it appears your Agile team isn’t as efficient as you believe they should be
· Establish how to answer management concerns about resource utilisation
· Understand when planned parallel activities are not wasteful
· Discover what “deciding at the last responsible moment” means and how it benefits your development work
· Uncover how to make risk management and human factors support efficiency rather than compete with it
· Gain ideas for building documentation into the flow of development
Nancy Van SchooenderwoertPrincipal Consultant
Lean Agile Partners
Brian ShoemakerPrinciple Consultant
1:30 pm - 2:30 pm Networking Lunch Break
2:30 pm - 4:30 pm SOFTWARE DESIGN WORKSHOP: Design Patterns for Remote Patient Monitoring Systems
Remote patient monitoring (RPM) systems use digital technologies to monitor patients outside of conventional clinical settings, such as in the home, and electronically transmits that information securely to their health care providers.
Smart, connected medical products offer exponentially expanding opportunities for new medical services, far greater reliability, much higher product utilization and capabilities that cut across and transcend traditional boundaries of a single medical product.
When it comes to remote patient monitoring, capabilities are evolving and expanding, but there are challenges to widespread adoption. The interconnectivity of various different medical and non-medical devices found a system which poses completely new challenges for manufacturers and operators.
This workshop is aimed to understand the different components of which a typical RPM system is composed of.
In interactive group sessions the participants will be challenged to run risk assessments and to find the right mitigations for various different challenges in a RPM environment.
· Framing a regulatory strategy in the context of a RPM system
· Understanding risk components, risk statements, risk severity and derived security design controls
· Understanding aspects of Post Market Surveillance tasks for a RPM system
· Exploring design patterns for smart concepts to operate RPM systems
· Understanding value drivers for commercialization and scale considering the different user groups of a RPM system
Thomas WeberDirector Program Project Management - Global R&D - Therapy Program Home
Fresenius Medical Care