Agenda — Abstracts
mHealth: Enabling the revolution
Speaker: Robert Barnes
Segment Marketing, ARM
The use of mobile phone and tablet devices for self management of long term illnesses in health care is set to increase. With over 95% market share in the mobile industry ARM is ideally placed to enable mHealth building on a large software ecosystem including communication stacks and applications.
mHealth: Navigating the regulatory maze
Speaker: Frazer Bennett
Partner, PA Consulting
Why are the regulatory questions that surround mobile healthcare causing such a pickle? Surely it doesn’t need to be that difficult? Since the early days of mobile communications, the vision of mHealth has promised improved patient outcomes, greater efficiency, and reduced costs. Healthcare systems worldwide are increasingly in need of all three. Yet under the more traditional healthcare regime, the regulations surrounding mobile healthcare are often seen as disproportionate with respect to the perceived risks. Innovation and development remain restricted. We face a real challenge to overcome these constraints and ensure that the true potential of mobile healthcare is realised. The maze of mobile healthcare regulation is a difficult one to navigate. But understanding, and influencing, these regulatory issues – and the direction-of-travel of the regulation and policy makers – is becoming increasingly important. What has led us to get into a situation where we are unable to capitalise on the benefits that mobile technologies can bring to healthcare? What hope can we have that we can eventually navigate our way through this regulatory maze that we have got into?
Reduce Compliance Costs with Best Practices
Speaker: Mark Pitchford
Field Applications Engineer, LDRA
The extensive use of electronic devices in the medical industry has seen more and more dependence on embedded software. As a result the IEC 62304 standard has emerged as a global benchmark for management of the software development lifecycle. The IEC 62304 standard provides a framework of software development lifecycle processes with activities and tasks necessary for the safe design and maintenance of software for use in medical devices.
This presentation aims to share the best practices of a pioneer and global leader in automated software verification, source code analysis, and test tools covering the full development lifecycle. It will draw on experiences not only in the medical devices sector but also in achieving successful compliance with other long established industry standards in other fields, which have a great deal in common with IEC 62304.
Using practical examples, we will share key best practices such as:
The presentation pays special attention to traceability, independence criteria, testing and structural coverage analysis. Finally, we discuss how to minimize the impact on productivity following the adoption of IEC 62304.
Building Trust in Connected Medical Devices
Speaker: Jim Alfred
Director of Product Management, Certicom
Medical devices are increasingly becoming more and more connected. By taking advantage of wireless technology, devices communicate with connected sensors, backend systems as well as remote displays. Security (confidentiality, privacy and integrity) of data and of the command and control signals is critical in preventing the disclosure of private patient information. It also protects against the tampering of systems which could negatively impact a patient’s health. Other markets such as the smart metering industry have already begun to adapt security as a core requirement in system design.
This presentation describes encryption and key management techniques plus design strategies which can be applied to a wide variety of markets to protect device manufacturers, service providers and end customers from increasing cyber security threats.
Designing Safety Critical Medical Devices
Speaker: Sebastien Cuvelier Mussalian
Engineering Consultant, Team Consulting Ltd
The presentation will outline the key steps required to transition a novel lab-based concept into a robust, viable medical product which satisfies the unmet needs of the user. An overview of the commercialisation of medical technology regulatory requirement will be provided, using real case studies involving the development of class II and III safety-critical medical systems. The talk will also scrutinise phases of the medical product lifecycle, from concept design through to industrialisation, with an emphasis on the importance of meeting user needs and the development of regulatory compliant firmware and software architectures. The presentation will also look at the regulatory framework for European and US markets, followed by recommendations to optimise your regulatory submissions.
The presentation will include:
Using ISO 13485 to develop medical software for FDA & European Certification
Speaker: Stephen Bashford
Quality Manager,
MPC Data
The presentation focuses on the Product Realisation requirements of ISO 13485 and will cover requirements capture, software risk assessment, software architecture and design, use of Software of Unknown Provenance (SOUP) and Verification/Validation.
Drawing from practical experience, the session will discuss using a specialist Design History File program to assist with requirements tracking, hazard analysis, risk controls, testing and V&V. The session will describe the software development process following IEC 62304 with examples of the individual processes key to supporting this standard. In particular the focus will be on the overall software lifecycle, the importance of change management, configuration management and risk management.
In addition, the presentation will highlight the benefits of a modular architecture and how it can reduce the overhead of risk management. The use of SOUP will be discussed as well as the additional requirements for management of risks, configuration, and functionality that IEC 62304 introduces. And finally, the session will describe the process of selecting an operating system and in particular the benefits of incorporating a proven OS with a SIL3 certified kernel.
Panel Discussion: Global Trends in Medical Device Certification
Panellists: QNX, ARM, MPC Data, LDRA
Medical device certification and navigation of regulatory requirements are large and ever-evolving tasks. There are many industry trends, internationally, that feed into the guidance documents / requirements as presented by the various certification bodies worldwide. What does the inclusion of assurance cases and risk mitigation mean to the certification process? How do safety and security concerns inter-relate in medical devices? Do safety certifications — outside of traditional medical certifications — help in the process? Join our panel of experts as they explore these topics and discuss the market trends related to medical device certification abroad.
When COTS is not SOUP: Commercial Off-the-Shelf software in Medical Systems
Speaker: Chris Hobbs
Senior Developer - Safe Systems,
QNX Software Systems
In addition to the usual software delivery challenges of cost, features and schedules, medical device manufacturers must contend with specifying and validating their products’ functional safety, as well as with achieving certification by the FDA and other regulatory agencies. Many manufacturers consider COTS (Commercial-off-the-Shelf) software to reduce development times and problems, but are concerned that by using COTS they will be using SOUP (Software of Uncertain Provenance), which will invalidate their products’ functional safety claims and make certification impossible.
This presentation reviews common misconceptions about COTS and SOUP, and explains what is meant by clear SOUP. It then provides an overview of conditions that COTS software must meet in order to qualify for clear SOUP, and thus be admissible for use in a medical device. Finally, the presentation describes and explains how to evaluate key items when considering COTS software for a safety critical system: functional safety requirements, architecture, fault histories, and development and validation processes and techniques.