Healthcare CoP: Risk Management in the Life Sciences Industry

Bruce Fieggen

A certified Project Management Professional since 1999, with over 30 years in the medical device and pharmaceutical industries, Bruce has managed projects from $100k validations to $10 million in new product developments.

Bruce conducts on-site Project Management Assessments and develops customized solutions to improve clients’ Project Management maturity, conducting training, setting up PMOs, and creating PM Guidebooks. He has trained and mentored thousands of project managers and helped hundreds achieve their certifications within his PMP Boot Camps.

Bruce has planned hundreds of projects in the Life Sciences industry using an efficient rapid project start-up methodology. He has conducted numerous Project and Portfolio Prioritization sessions to ensure that the organizations are running the right number of high-priority projects given the number of resources at their disposal.

Bruce is currently President of Round Table Project Management, a consulting firm servicing the Medical Device, Biopharma, and Pharmaceutical industries.

Risk Management in the Life Sciences Industry

Project risk management is concerned with the overall objectives, scope, and requirements of the project. Key elements of project risk management include resource availability, the project schedule, and the project budget. How should we handle risk in the Life Sciences Industry? Are there unique challenges the Healthcare space faces?

During this session you will learn:

• Where our company should be on the continuum from ignoring the risk to risk analysis paralysis
• The difference between Hazard Analysis and Risk Management
• An efficient way to identify 100 risks in five minutes
• A ten-minute method to categorize risks
• Using individual vs. group think to efficiently build on other people’s ideas
• The right way to document risks, so that they can be properly evaluated for likelihood and severity
• A better way to qualify risks than the DFMEA chart we borrowed from the Automotive Industry
• The difference between Avoiding, Transferring, and Mitigating risks
• The proper threshold to stop trying to fix risks and accept them
• How to request a contingency budget and schedule from Management to account for risks
• A tool to ensure risks are followed up on and the solutions are implemented