Paper and Presentation: Wide Angle Agile: A Compliance-Integrated Approach to Regulated Product Development
Abstract: Traditional project management waterfall methodologies often prove less effective in environments characterized by high uncertainty and frequent iteration, where rigid planning and sequential execution can hinder responsiveness and timely decision-making. This presentation shares how agile principles were adapted for use in preclinical research at a medical device company, starting with a series of preclinical studies.
The session outlines the creation of a hybrid project management framework that replaced legacy practices with agile elements such as twice-weekly stand-ups, two-week sprint cycles, and structured retrospectives. These changes improved team coordination, responsiveness, and delivery timelines.
Key takeaways:
- How to tailor agile practices for regulated or research-heavy environments
- Techniques for piloting agile in small teams to build organizational support
- Lessons learned from sprint planning, retrospectives, and iterative delivery
Attendees will gain practical insights into introducing agile in settings where traditional methods dominate and flexibility is essential.
PMI Talent Triangle: Ways of Working
Biography: Danielle Filipkowski has over 15 years of experience in the medical device industry, specializing in research and development, cross-functional project leadership, and process improvement. She holds both a Bachelor’s and Master’s degree in Biomedical Engineering and is a certified Project Management Professional (PMP). Danielle is passionate about applying adaptive project management methodologies to complex technical environments and driving collaboration across multidisciplinary teams.
