Papers and Presentations

We try to regularly publish content to help out our fellow medical device colleagues. Here you can download select papers and presentations. We are always happy to answer questions you may have!

Assurance Cases: A New Form of Requirements Traceability Matrix for Medical Devices

Scientific and medical innovations have led to great improvements and advancements in the lives of people around the world. As technology has progressed so has the complexity of the medical devices that have been created. Not only has the technical complexity increased but additionally, the user interaction with the device has also become more complex and involved. Both of these intricacies have been identified as complicating factors in the safe and effective use of infusion pumps. To this end, the FDA identified an initiative in April of 2010 to address these concerns. One outcome that was identified is the requirement to perform an assurance case. This requirement presents several challenges to practicing medical systems engineers to ensure the assurance case report is complete and assures the device is arguably wholly safe and effective.

Systems Engineering and Project Management, an Ideal Partnership

An effective partnership of the Systems Engineer and the Project Manager on a project will greatly enhance the likelihood that the system will be delivered on schedule and on budget while meeting the needs of the end user. This is a partnership where project leadership is combined, playing to the strengths of each. Systems Engineering and Project Management represent two disciplines fundamental to the underlying success or failure of developing and deploying a complex system. Each of these disciplines has a systematic view of the system, offering each a perspective not afforded to the other development stakeholders. This partnership is paramount on a project of any complexity, how could it be over-looked? Even if these elements alone are brilliant in their own execution, the end result could be a disaster if there is not an alignment and cohesive execution of the two disciplines.

A Model-based Reference Architecture for Medical Device Development

The application of systems engineering within the medical device domain must adapt to its unique challenges such-as the regulatory environment that these devices have to be designed within to ensure patient safety, and the nature of the interactions between the device and the patient. The sheer number of regulations imposed by government agencies such as the U.S. Food and Drug Administration and various international agencies adds to the complexity of designing these systems. This also presents an opportunity to implement a Model-Based Systems Engineering (MBSE) approach to capture the regulatory environment and map those specialized requirements to components within the system that address those requirements. In this study, we present a model of a reference architecture that can be used as a starting point for the system design of medical devices. Although the state of the model has not been fully matured, this approach offers the potential to more efficiently address the complex regulatory requirements, and reduce the time to design medical devices.

A Systems Approach to Medical Device Compliance with IEC 60601-1:2005

The development of electrical medical devices requires compliance with a host of regulations and standards to help ensure their safety and effectiveness. One of the most notable additions in recent years is the 3rd Edition of IEC 60601-1 (IEC 60601-1, 2005), “Medical electrical equipment – General requirements for basic safety and essential performance.” Medical devices sold to the European Community and Canada must comply with the standard in 2012, and devices in the U.S. and other countries must follow shortly thereafter. This standard represents a sea change in the way medical devices are typically developed, and includes a heavy reliance on safety risk management and usability engineering processes. This paper presents the systems engineer as the ideal candidate to lead these activities and facilitate device development; the standard impacts many areas (e.g., engineering, regulatory, human factors, and project management) and requires a methodical approach to implement in a cost-effective manner while ensuring safety and effectiveness of the device. This paper details techniques developed to efficiently comply with the standard, leveraging existing systems engineering practices and emerging methods such as Model Based Systems Engineering.