Clinical Advisory board Member of KERANOVAHélène Lamielle

MD, MBA
Dr. Lamielle is currently offering consulting services with a special interest in strategic guidance and execution for startup companies including overall development strategy, organization, clinical and regulatory planning, to bring innovative products to patients.

After practicing clinical and surgical ophthalmology in France, Dr. Lamielle joined the Medical Device Industry where she served in senior positions VP in R&D, Clinical Research and Regulatory Affairs. She relocated to the US in 1999 as Director of Development for Chiron Vision, and then moved into increasing senior positions in R&D, Clinical and Regulatory for Bausch & Lomb. Dr. Lamielle joined Starr Surgical as head of Clinical, Regulatory and Development in 2002, where her responsibilities included product design and innovation, clinical development, and product registration. After PMA approval of a breakthrough and still most implanted phakic IOL worldwide, Dr. Lamielle joined in 2005 Glaukos Corporation as Global Head of Clinical, Regulatory and Quality Affairs, where she designed and executed the clinical strategy leading to successful PMA approval of Glaukos landmark iStent®. She then moved to Rox Medical, a start-up in the vascular/pulmonology field, and from 2012 to 2015 Dr. Lamielle worked at Allergan in Clinical Development then in Regulatory Affairs for Aesthetic Medical Devices (Dermal fillers, Breast Implants).

Since 2015, as an independent consultant, Dr. Lamielle has accompanied development of preeminent start-ups mostly in the ophthalmological field, including refractive surgery, glaucoma, innovative IOLs, retina, with focus on strategic continuum for access to the market in US and integrating the new MDR requirements in EU.

Dr. Lamielle is a clinical ophthalmologist from University of Lyon, France, and former ophthalmic surgeon. She has served for 25 years in the Medical Devices field as Head of Development, Clinical, Quality Insurance and Regulatory Affairs, in both publicly traded companies and startups. In addition to her M.D. and training in ophthalmology, Dr. Lamielle is an ISO 13485 certified auditor, and she holds a Master in Business Administration (MBA) from UC Irvine (2003).

Advisory board

Arthur Cummings
Scientific Advisory Board of KERANOVAArthur Cummings
Christophe Baudouin
Scientific Advisory Board of KERANOVAChristophe Baudouin
Ralph Chu
Scientific Advisory Board of KERANOVARalph Chu
Damien Gatinel
Scientific Advisory Board of KERANOVADamien Gatinel
Dominique Monnet
Scientific Advisory Board of KERANOVADominique Monnet
Mark Packer
Scientific Advisory Board of KERANOVAMark Packer
Pavel Stodulka
Scientific Advisory Board of KERANOVAPavel Stodulka
Michael Brownell
Strategic advisory board of KERANOVAMichael Brownell