Breakout

Breakout #1: Overcoming Challenges in Medical Device Design and Development

Wednesday, April 22, 2026

12:40 PM - 2:40 PM East Coast USA Time

Location: Franklin AB - 2nd Floor

Moderator(s)

Bill Brodbeck

Vice President, Regulatory Affairs
STERIS Corporation
Aaron Dunbar

Vice President of Quality Systems
Boston Scientific
John Krug

Executive Director and Site Quality Leader of Indianapolis Device Manufacturing
Eli Lilly and Company
Phil Pontikos

CEO and Principal Consultant
FDA Rescue

View Slides

Speaker(s)

Tracie Capozzio

Head of Quality Therapy Platforms, Sleep & Respiratory Care
Philips Healthcare
Benjamin Dastoli

Senior VP and Consultant
FDA Rescue
Tony Piotrkowski

Senior Director, Regulatory Affairs
STERIS Corporation

Challenges are common in medical device design and development regardless of risk classification and intended use. Global regulations and expectations are changing, increasing the complexity of moving a device from concept to market. A panel of industry experts will review some of the more recent challenges through case studies as well as address any challenges shared by the attendees and discuss potential resolutions.