8:45 Welcome Address And Chairperson’s Opening Remarks

Quality And Risk Management

9:00 Building Quality Into Design: Risk Management And Prevention

• Planning a development process where SQA works closely with stakeholders like development teams, regulatory, project management, business analysts, sales & marketing in the early stages of a project development to avoid costly risks that eventually bring into question overall quality
• Identifying inter-department dependencies throughout the project development process
• Learning from real life work experiences of schedule slippage
• Working with a multi-layered development team
• Avoiding the trial by error design

9:45 Human Factors Engineering In Designing Software

• Integrating human factors engineering into medical devices to make them safe, effective and efficient to use
• Describing the regulations for the human factors engineering process
• Demonstrating product user interfaces for usability through a case study

Edmond W Israelski
PhD Human Factors Program Manager
Abbott Laboratories

11:15 Case Study: Demonstrating Human Factors Engineering Methodology In The Development Process

Please visit our event website for the case study description www.sdmdconference.com

Diana Gunnarson
Principal Engineer, R&D – HF/Usability
Covidien

12:00 Security And Privacy For Wireless Medical Devices

Medical devices are embracing wireless communication and internet connectivity to improve patient care and detect early warning signs. Although these devices will significantly improve care, they also bring new risks due to global computing infrastructures such as the Internet that are physically infeasible to secure. This presentation will address approaches to help companies mitigate security and privacy risks

• Mitigating risks such as disclosing patient data or inducing life-threatening situations via a wireless command
• Ensuring security and privacy of pervasive devices that must withstand determined, malicious parties
• Addressing impact of security and privacy on the 510k process

Nathanael Paul
Research Scientist, Cyberspace Sciences and Information Intelligence Research Group
Oak Ridge National Lab

1:45 Implications Of Health Care Reform In The Medical Device Industry

Congress has passed sweeping healthcare reform this year, which will reshape economic incentives in healthcare, requiring medical device companies to rethink their strategies and operations. This presentation provides those involved in the medical device industry an overview of the reform issues relevant to the industry as they navigate their companies through these changes.

• Discovering how the excise tax will be implemented and how medical device companies will be impacted
• Discussing the impact of the comparative effectiveness provisions
• Learning what you can do to prepare for these health care reforms
• Understanding how the physician payment sunshine provisions will affect medical device companies

Jennifer Hansen, Esq.
Partner
Hooper,Lundy & Bookman, Inc.

3:00 Planning Ahead For Verification And Validation Effort

• Streamlining the verification and validation process
• Implementing effective testing methodologies in the development process
• Reviewing testing tools and automation scripts for testing

Catherine Casab
Principal Quality Engineer
Velomedix

3:45 Software Product Lines: Have Your R&D Cake And Eat It Too

This session will explore the paradigm shift happening in largescale software development as it transitions from a centrally coordinated, process-centric approach to an architecture-centric, distributed approach.

• Applying this development approach medical device manufacturing
• Increasing productivity and quality based on several products sharing a common core
• Reducing time to market of new products and new features as these can be built from an existing platform

Jan Bosch
Vice President, Engineering Process, Intuit Professor of Software Engineering
University of Groningen, NL

4:30 Chairpersons Closing Remarks And Close Of Conference