Our Story

President

A chemical engineer with a specialty in polymers, Mr. Lauren  worked developing tissue-based cardiovascular devices. He started a subsidiary of Cordis Corporation in Melbourne, Australia growing  vascular grafts in sheep. His experience covers a range of engineering areas. He developed the first mass customized manufacturing system for producing dental splints, a 4-dimensional camera for capturing jaw motion with integration into dental CAD, custom in-vitro tests systems for cardiac valves, light-cure dental materials, and novel mechanochemical test equipment. 

Consultant

Dr. John Ross is widely recognized as one of the world’s leading experts in vascular access. A founding member of the Vascular Access Society of the Americas  and was given the Lifetime Achievement Award by the American Society of  Diagnostic and Interventional Radiology (ASDIN). Dr. Ross is a Fellow of  both the American College of Surgeons and ASDIN. Dr.  Ross has served as the PI on numerous industry trials, spoken at dozens of medical meetings around the world and has published on a wide variety of topics related to vascular access. In 2011, Dr. Ross founded  the Dialysis Access Institute (DAI) in Orangeburg, SC. This one-of-a-kind facility serves as a model for patient-oriented care and  hosts training for physicians, staff and administrators on a routine basis. 

Consultant 

Academically trained in biology and chemistry Kem’s scientific career  has focused primarily on the industrial research and development of  Class III biomedical devices. His accomplishments include  the invention, research, development and commercialization of a number  of world class products, including Hemashield, the first collagen coated  vascular conduit, PeriStrips, the first lung volume reduction staple  line buttressing product, MitralSeal, the first transcatheter mitral  valve prosthesis, and ArterX, a surgical sealant. Kem co-founded Tendyne Holdings, Inc., a private medical device company focused on developing  minimally invasive mitral valve replacement therapies, that was acquired  by Abbott in 2015. 

Consultant

A former Product Development Engineer with Fisher-Price, D’Arcy Development provides conceptual design and engineering input to the development process, including 3D concept modelling, 2D drawings, and graphics. 

Development Engineer

 A biomedical engineer and nurse with an extensive background in orthopedic surgery. Mr. Pitkin provides general engineering support which includes all aspects of in vitro testing and FDA documentation aligned with 21 CFR Part 820