Venkat Narayan Email & Phone Number

Mckinney, Tx

Principal consultant to a number of clients in the medical device space for the technology development and regulatory clearance of polymer materials

Warsaw, In

Lead/mentor team of up to eight scientists at various levels within Polymer Research group. Review technology readiness of external proposals for potential business acquisitions and licensing. Provide inputs to Quality and Regulatory departments on product quality and compliance issues. Manage $3MM+ annual research budget. Provide technology strategy and roadmap for establishing sustainable research pipeline. Active participant in global, enterprise-wide team of senior scientists exploring beyond organizational silos to leverage in-house technology capability for advantageous and collaborative product development. Develop technology strategy to sustain R&D pipeline with strategic business relevance. Advise Management Leadership Teams on Product Strategies and Pipeline and review of Technology Roadmaps. Develop relationships across MD&D with thought leaders and SME’s and identify opportunities for technology and materials leverage. Collaborate with technical and business leaders cross-functionally in implementation phase.Contributions:• Developed technology strategy and roadmap for sustainable product lifecycle management addressing osteoarthritis with changing patient demographics that generated approval for implementation.• Partnered with Marketing, Regulatory Affairs, Quality Assurance and Operations in successful product launch of ATTUNE ™ Knee System in over 30 countries.• Reviewer of external technology, start-up concepts/proposals in decision-making and recommendations for licensing and acquisitions. • Key member of panel of Subject Matter Experts in supplying technical assessment reports, recommendations, and opinions that enabled Legal Department to respond successfully to several product-related complaints and lawsuits.Honors:• J&J People Inspired Award for successful market launch of ATTUNE Knee System.• Johnson Medal for contributions to innovation of ATTUNE Knee System with development of Antioxidant Stabilized Polyethylene, AOX.

Warsaw, In

Supervised and reviewed research group of up to seven scientists at various levels within Polymer Research group.• Provided technical education to Sales and Marketing groups apart from presentations to surgeons; participated in creation and technical review of marketing literature and provided inputs to Device History File. • Validated material via Product Development. Collaborated with Regulatory Affairs for FDA clearance of 510K/PMA submissions.Contributions:• Developed and led launch of new antioxidant stabilized polyethylene AOX™ for orthopaedic bearings.• Polymer Expert in Project Core Team for implementation of commercial launch of ATTUNE™ Knee System.• Generated and implemented specifications and acceptance criteria for materials and processes to be used in ATTUNE™ Knee System to ensure Manufacturing, Quality, and Regulatory requirements. • Secured clearances from national and global regulatory bodies, such as FDA (USA) for 510(K), PMA (Supplement) and BSI for EU mark certification, as well as PMDA (Japan), CMDE (China), and ANVISA (Brazil) for commercialization of ATTUNE™ Knee System.

Warsaw, In

Managed team of eight junior to senior research scientists with $3-5M annual budget accountability.• Reviewed/led projects into long-term research programs internally and externally. Created and maintained polymer testing center of excellence for J&J. Ensure compliance for lab operations to support testing, validations, and troubleshooting polymer products for orthopaedic bearings.Contributions:• Developed pipeline of products based on new orthopaedic materials and processes, i.e. Oxidatively stable polymer implant material, new high-strength composite device, and high-performance articulating bearing materials.• Initiated research into new generation of polymer bearings with superior performance and biological and toxicological safety. Delivered oxidatively stable polymer bearing; tested and characterized for functional and biological performance.• Reviewed various technologies/programs to perform technology feasibility assessment. Polymer bearings that demonstrated significant improvement in these characteristics and addressed anticipated clinical problems are expected to disrupt existing commercial dynamics and provide market superiority. Technology feasibility assessment performed on novel UHMWPE systems and other engineering polymers, such as polyether ether ketone (PEEK).

Roanoke, Va

Managed Materials Department (Synthetic chemistry and analytical labs) consisting of up to seven BS, MS, and PhD scientists for US Corporate Research with $1M budget/annually in development of new materials-based products. Formulated long-term strategy planning of new materials for ophthalmic lenses.  Created and managed external research contracts with companies/universities. Provided support to QA and Operations for materials-related issues.Contributions: Developed and launched high refractive index Definity® progressive lens to minimize chromatic aberrations and peripheral astigmatic distortions. Successfully transferred/commercialized scale-up of wholly in-house developed UV curable resin formulation. Realized 15% incremental business and increased ASP validated through $3MM annual sales in test market area. Directed innovations in materials research with ongoing patents and invention disclosures, including 21 patents/patent applications and 14 invention disclosures (Materials R&D Group). Developed and implemented wholly water-soluble UV blocking formulation for spectacle lenses. Reduced raw material costs by over 60% and cosmetics inspection and manual intervention by 80%. Developed and launched tintable and tinted lens products in range of ophthalmic materials. Projected incremental business of 3 ~ 5% validated through increased sales volume and ASP.

Bsc, Chemistry

Bsc(Tech), Plastics Technology

Msc(Tech), Plastics Technology

Ph.D, Polymer Science