Establishment of a Medical Advisory Board and the Appointment of Three Industry Leaders | Press Release
AddUp, Inc. has announced the establishment of the AddUp Medical Advisory Board, aimed at providing a comprehensive and unbiased perspective on the medical industry’s utilization of metal 3D printing technologies.
CINCINNATI, OH – April 17, 2023 – AddUp, Inc. announces 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 utilization of metal 3D printing technologies as a means of serving the medical community.
The company is excited to also announce the appointment of three members to the advisory board each bringing a wealth of 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 innovative engineering and global thought leader in disruptive technology evaluation, accelerating the commercialization of 3D printing, with specialization in healthcare applications and digital customer delivery models. Mr. Onukuri is focused on engineering global equity and sustainability and brings extensive international experience spanning Europe, Asia, North and South America. Mr. Onukuri was most recently the Global Head and Senior Fellow for Johnson & Johnson’s 3D Printing Innovation and Customer Solutions divisions.
Jan Triani is 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. Ms. 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 3D printed polymeric permanent implants. Ms. Valdant is the Chief Commercial Officer for QuesTek Innovations LLC and was recently the President at Oxford Performance Materials, Inc.
Commenting on the appointments of Mr. Onukuri, Ms. Triani, and Ms. Valdant, AddUp, Inc. CEO, Rush LaSelle stated, “We are honored to welcome three industry veterans to our newly formed Medical Advisory Board. These professionals have proven track records of leveraging additive 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 orthopedic care.”
Founding Medical Advisory Board Members
Scientific Advisor | Healthcare Innovator | 3D Printing Health Innovation | Medical Device Development | Front-end R&D | Global Health Equity Thought Leader
Sam has over 30+ years of experience in R&D & Commercialization of medical devices and an extensive background as a material scientist in his career. He is currently engaged in advancing innovation with various Industry thought leaders, healthcare practitioners and 3D printing technology providers.
Previously, As the Head of Johnson & Johnson 3D Printing Innovation and Customer Solutions, Sam Onukuri led the integration of 3D printing across various businesses and evolved the way we create and deliver products and solutions.
He and his dedicated team advanced new materials and 3D printing technologies to innovate the design, manufacturing and delivery ecosystem. Sam worked closely with R&D, Supply Chain, Commercial, Quality, Regulatory, Legal and IT to drive 3D printing initiatives across J&J’s medical device, consumer and pharmaceutical businesses. Those initiatives include bioprinting, point of care solutions, precision medicine, electronics and sensors, advanced metals and ceramics, polymers and natural materials and 3D enabled innovative designs.
Prior to Johnson & Johnson roles include Advanced/Front-end Technology leadership for Medical Devices and Senior Fellow within the Ethicon family of companies. Prior to Johnson & Johnson, Sam worked at General Electric and Baxter Healthcare.
Sam holds a BS in Mechanical Engineering from Anna University and a MS in Engineering from Northern Illinois University.
Sam currently resides in Cincinnati, Ohio with his wife Jeanne and 2 dogs (Guinees & Shamrock).
Quality Management System SME | QA/RA Advisor | Compliance Expert | Medical Device Product Development | FDA Audit Leader
Jan is an accomplished quality assurance and regulatory affairs leader with 20+ years of experience in the medical device industry. Jan has worked for large medical device manufacturers and two start up medical device companies. Over the last six years she has run her own consulting business with a focus on being her client’s interim QA/RA Director. On the quality side, she advises teams on complaint handling, CAPA and elements in the QMS.
In addition, she wrote two complete quality management systems, and has been the SME in five FDA inspections. With respect to regulatory affairs, Jan authored herself or ghost authored over 20 FDA submissions; four HDE supplements and advised on various custom and compassionate use cases. She also has authored design dossiers and achieved 13485 certification with BSI for a former startup. Her strong work ethic and relatable personality makes her a great fit for teams of various sizes.
Throughout her career, Jan has been recognized for her ability to balance compliance and innovative product development projects with a variety of management styles. She believes people, especially patients, should be the focus of an organization’s strategic roadmap – from concept to commercialization. Empowering functional roles outside of QA/RA to have a “compliant” mindset in all that they do, is a passion of hers. Jan believes there’s always room for improvement and strives to say, “yes we can!” to innovative ideas.
Jan holds a BS in Materials Science & Engineering from Lehigh University and a MS in Technology Management from Stevens Institute of Technology.
Jan lives in Ridgefield, Connecticut with her husband Ryan, 3 children, and 2 bernedoodles.
Business Leader | ICME Expert | 3D Printing Innovator | Digital Material Development | Medical Device R&D
Severine is an experienced business leader who is passionate about technology and the individuals who make technological advances a reality. Her entrepreneurial spirit, love for STEAM, and strong people skills have enabled her to build long lasting relationships with industry partners and lead companies through challenges and transformational stages.
Severine Valdant is the Chief Commercial Officer at QuesTek Innovations since August of 2022, where she is building the team and leading all activities relating to commercializing the company’s proprietary Materials by Design® technology. Prior to joining QuesTek, Severine spent over 20 years in the field of high-performance materials, medical devices, and 3D printing, with over 15 years in leadership positions ranging from operations management, advance manufacturing, business planning, financial reporting, to capital formation. In her last position at Oxford Performance Materials, Inc. (OPM), as President, she led the company through its transformation from a polymers company into an additive manufacturing and medical device company, becoming the first company to receive FDA approvals for 3D printed polymeric implants.
Throughout her career, beyond the fascinating technology she helped developed with industry partners, she most enjoyed building and mentoring the team that led the company through its transformation as a medical device OEM.
Severine holds a master’s degree in Chemical Engineering from French engineering school Ecole Nationale Supérieure des Industries Chimiques and a bachelor degree in Industrial Engineering from Ecole Nationale Supérieure en Génie des Systèmes Industriels.
Severine lives in Miami with her husband Nick and their English Bulldog Fifi.