Chris Lyle, M.S.

Chris Lyle, M.S.

Vice President, Evidence Strategy, DuVal & Associates

Chris focuses his consulting practice on the intersection of clinical evidence, regulatory requirements, and payer coverage policies to support product approval requirements and demonstrate value to payers and providers. A biostatistician by training, Chris has successfully negotiated study designs with FDA and several OUS regulatory agencies.

Chris has over 25 years of experience in the medical device industry and has supported the development of medical devices, biologics, and pharmaceuticals. Prior to joining Duval & Associates, Chris was a Partner at the JD Lymon Group, a Minneapolis-based reimbursement and market access consulting firm, where he focused on evidence development initiatives to support positive coverage arguments. He spent the prior 12 years at a Minneapolis-based device CRO where he held various executive positions including roles overseeing corporate operations, biostatistics, and market access.

Chris holds a B.S. in Mathematics from St. Olaf College and an M.S. in Applied Statistics from Florida State University. He speaks routinely on evidence strategies and clinical study design to support pre- and post-approval requirements and has served on the community faculty of both Metropolitan State University and the St. Cloud State Masters of Regulatory Affairs program. He is a co-founder and Board member of JDL Access, LLC, a prior authorization and patient appeals firm based in Minneapolis.