Session Panelitsts
Regulatory Strategies and Risk road Mapping for Medtech Success
This expert panel will explore the latest developments in domestic and international regulatory frameworks and how medtech innovators can build effective, risk-informed development roadmaps. Panelists will discuss designing pathways that identify and mitigate clinical and regulatory risks. The emphasis will be on holistic, cross-jurisdictional strategies that support efficient product development and timely market access, and include considerations around early clinical evaluations, including FIH studies.
Kelli Anderson ,CEO, Tech2Med, LLC
Kelli Anderson is a seasoned regulatory and compliance professional with over 20 years of experience across the medical device industry, including orthopedics, active implantables, computer-assisted surgery, and imaging devices. Throughout her career, Kelli has authored numerous regulatory submissions, including 510(k)s, PMA supplements, Annual Reports, EU Technical Documentation, and Health Canada License Applications.
Kelli has supported global compliance efforts by participating in FDA, Notified Body, and PMDA audits—managing both front and back room activities. Her experience also includes recall tracking, CAPA investigations and closures, MDR/Vigilance reporting, and 483 response support.
Recognized for her collaborative style, Kelli is known to foster strong cross-functional partnerships within organizations and engage effectively with regulatory authorities to ensure compliance and drive operational success.
Lindsay Klee, Founder, Intent Venture Management
Lindsay advises investor, IP, R&D, life science/medtech, healthcare, and payor clients nationwide. She specializes in Intent’s Integrated Reimbursement & Regulatory Planning services and directs investment activities. Her experience spans consulting with Belle Michigan GP, leading innovation and technology transfer initiatives, and managing multi-million-dollar funding programs. Lindsay has supported pharma, device, diagnostic, and software companies with revenue growth, reimbursement, funding, FDA submissions, and compliance.
Previously with PricewaterhouseCoopers’ Healthcare-Life Sciences division and a scientist at Pfizer, she also consults on trial readiness, M&A strategy, IP deal structuring, QMS preparation, and audit readiness (ISO13485, 19011 Lead Auditor Certified). Lindsay holds a master’s in healthcare management with a focus on finance.
Nicholas Werner, Director of Regulatory Affairs, CooperVision
Nicholas Werner is the Director of Regulatory Affairs, Portfolio Compliance for CooperVision, where his current expertise is in Regulatory Intelligence and Advocacy. He is a former FDA medical device reviewer and postmarket analyst. Prior to his current role, he has also held positions at Stryker Instruments and numberous consulting agencies, working in total product lifecycle regulatory and with companies of all sizes and maturity level. He received his Bachelor's degree in Bioengineering form the University of Pittsburgh.