SOURCE: marcus evans

May 29, 2015 10:09 ET

The Management of Risk for Medical Device Featuring SIEMENS Healthcare- Barbara Young

Interview With Barbara Young, Quality Engineer/Risk Management at SIEMENS Healthcare Diagnostics Inc.

SAN DIEGO, CA--(Marketwired - May 29, 2015) - The medical device industry is taking a more proactive approach to strategic risk management. The approach is not just about the development and design process nor solely product manufacturing, it is one that should be incorporated throughout all processes, planning, policies, procedures, analysis, evalutions, monitoring and controlling of risk.

Barbara Young, Quality Engineer/Risk Management at SIEMENS Healthcare Diagnostics Inc. recently spoke with marcus evans about key topics to be discussed at our upcoming Risk Integration and Quality Management for Medical Device July 22-23, 2015 in San Diego, CA.

How would you describe the impact of risk management in your current role?

BY: My primary responsibility is management of risk for my business unit. The role includes providing support to risk teams that are managing risk for product development and manufacturing sites, which includes providing training; reviewing the risk management process and reporting metrics to management on effectiveness; supporting audits from 3rd parties as the SME for risk management, and working with the other business units and company-wide teams on the continuing improvement of risk management processes.

How does extending risk management help to improve the thoroughness of data collection?

BY: Post-market information gathering is an essential part of the risk management process, both for maintaining commercial product safety, and for designing new product. When considering how information about our commercial products is generated, we must tap into sources that extend beyond the complaints reported by our users, as complaints may be expected to provide an incomplete picture of product safety. Social media, for example, as a relatively new information source, can be valuable in measuring our customer's perception of what constitutes acceptable risk. Also, we are tasked with understanding "state of the art" for comparable products, which requires going to sources other than complaints, to gage where and how technology is changing and the expectations for safety from present-day marketed product beyond our own products. Service technicians and information garnered at conferences and trade shows may provide different perspectives. Casting for data across multiple types of information sources ensures data collection is more comprehensive that if single sourced.

What do you believe are the most impactful mitigation effects of developing a robust risk file and threshold for action?

BY: A risk file is intended to be a complete collection of records covering the evolution of product safety through risk activities performed to manage product safety. As a product progresses through its lifecycle, there will be records of controls tried and rejected, testing schemes and data analyses that provide a baseline for performance, and improvements on product function, to name some risk file content that can be useful in establishing metrics for safety and set performance thresholds. Without ready access to preterit risk information, it is likely that past mistakes may be repeated or that functionality shift will occur over time that may put customers at greater risk. Reviewing the risk file that has information configured for easy access and setting performance thresholds for safety can provide an early warning system when performance shift is occurring. Preventive action when a threshold is approached is a more economical choice that corrective actions after problems become events.

There have been extensive innovations in medical device technology. How does Siemens Healthcare overcome barriers and idiosyncrasies among the stages of development to decrease actualized risk?

BY: Siemens recognizes the importance of uniformity in determining acceptability of product safety risk across the functional groups associated with the design, manufacture and maintenance of our products. Procedures that drive consistency in risk management practices and a set policy for risk acceptability criteria to provide a high degree of safety are implemented with extensive piloting and training to ensure consistency. Coupled with these is a proactive, comprehensive process for post-market risk management that actively feeds new information back into the risk management file with appropriate reviews and actions taken as situations posing potential and actual risks are identified.

How can systemically categorizing data allow for a more versatile application?

BY: The key to effective risk management is utilizing fully the available information. Predictive methods, such as trending, and applying the Pareto principle, are examples of statistical tools that are quite useful in monitoring information on product safety. Statistical methods offer greater sensitivity in detecting when changes are occurring, or can better direct resource allocation by indicating where the greatest potential for improvements lies. In order to take advantage of these tools, however, data must be translated into meaningful groups or categories by, for example, applying key words or coding, to facilitate the transition from mere data to information. How consistently and accurately the key words can be assigned will directly impact the quality of information derived.

What about this conference inspired you to speak? Have you spoken at marcus evans events before?
BY: I have not spoken at a Marcus Evans event before. I have been developing expertise and applying practical experience in medical device risk management for a number of years and for several companies. I am very passionate about the opportunities for driving better product safety, at stages of development, in production, and use in the field, through sound risk management practices. There are gold mines of information waiting to be extracted through applying the tools and techniques of risk management that, if utilized, can significantly improve a product's success at launch and throughout the product's lifetime. Risk management is inclusive of all stages of the product lifecycle, from cradle to grave, and constantly challenges us to product improvement. Any opportunity I have to learn and to share with others the knowledge I have accumulated, I look forward to.

Barbara Young is the Quality Engineer/Risk Management at SIEMENS Healthcare Diagnostics Inc. SIEMENS is one of the world's largest suppliers to the healthcare industry and a trendsetter in medical imaging, laboratory diagnostics, and health IT.

This premier marcus evans Risk Integration and Quality Management for Medical Device provides case study presentations that will tackle how to adopt an integrated and proactive approach to risk management and product safety. For more information, please check out the conference website or contact Monique Filardi, Marketing Coordinator, Media & PR, marcus evans at 312.540.3000 ext. 6641 or

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