AddUp Inc, Cincinnati, Ohio, USA, has announced the establishment of the AddUp Medical Advisory Board. The board’s mission is to provide AddUp with a non-biased and holistic view on the medical industry as it relates to the development and utilisation of metal Additive Manufacturing technologies as a means of serving the medical community.
The company has also announced the appointment of three members to the advisory board, each bringing experience from different corners of the healthcare and medical device community. Founding members include Sam Onukuri, Jan Triani, and Severine Valdant.
Sam Onukuri is an engineering and global thought leader in disruptive technology evaluation, accelerating the commercialisation of Additive Manufacturing, with specialisation in healthcare applications and digital customer delivery models. Onukuri is focused on engineering global equity and sustainability and brings extensive international experience spanning Europe, Asia, North and South America. Most recently, Onukuri was the Global Head and Senior Fellow for Johnson & Johnson’s 3D Printing Innovation and Customer Solutions divisions.
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Jan Triani is a said to be an industry leader in the areas of regulatory compliance and is a subject matter expert for FDA audits. She has authored 510(k)s, HDE, complete Quality Management Systems, 483 and Warning Letter responses. She also helped foot and ankle start-up businesses sell to larger MDM, developed and established initial QMS for two startup medical device companies, successfully led Stage I and Stage II assessments with BSI, and achieved 13485 certification with no major non-conformities. Triani is the founder of Triani Consulting and was recently the Director of Qualify Assurance and Regulatory Affairs, Patient Specific for Paragon 28.
Severine Valdant is passionate about technology and the individuals who make technological advances a reality. She took OPM through its evolution from a polymers company to an additive and medical device manufacturer, becoming the first and only remaining company to receive FDA approvals for additively manufactured polymeric permanent implants. Valdant is the Chief Commercial Officer for QuesTek Innovations LLC and was recently the president at Oxford Performance Materials, Inc.
“We are honoured to welcome three industry veterans to our newly formed Medical Advisory Board,” stated Rush LaSelle, CEO, AddUp. “These professionals have proven track records of leveraging Additive Manufacturing technologies in safe and reliable manners to improve patient care. Mr Onukuri, Ms Triani, and Ms Valdant will provide unique perspectives in advising AddUp, Inc as we continue advancing our metal 3D printing technologies, software, monitoring suites, and service offerings to empower companies to accelerate the adoption of additive manufacturing and all its benefits in delivering safe and affordable orthopaedic care.”