Dr. Venkat Narayan
 Medical Device Expert Witness

Medical Expert Witness - Venkat Narayan

Technical executive with extensive experience in Research & Development. Demonstrated track record of achieving stability, growth and new materials development. Strengths include conducting and coordinating innovative research and project planning as well as working in and leading cross-functional technical teams to accelerate entry to market with a range of new products. Demonstrated leadership and successful team building capabilities, sound technical communication, presentation and personnel-development skills. Innovative problem solver with proven ability to bring quick resolution to challenging situations as well as build lasting relationships with vendors and strategic partners. Experienced in characterizing and transforming materials/processes developed in the laboratory to commercial products. Lead interface between R&D and Manufacturing, Product Development, Regulatory and Marketing. Ongoing participation in regulatory discussions with FDA (U.S.), BSI (Europe) and PMDA (Japan) for device approvals. Ongoing 

contributions to business plan with creativity, analytical approach, IP generation and new developments in polymer science.

KEY ACCOMPLISHMENTS

• Developed and validated a proprietary oxidatively stable orthopedic device for commercial launch.
  • Significant improvement over current state-of-the art materials for orthopedic implants.
  •  Lead technical interface in Project Core Team for commercialization.
• Developed and implemented a wholly water-soluble UV blocking formulation for spectacle lenses.
• Developed and Core Team member for launch of tintable and tinted lens products in a range of ophthalmic materials.
• Developed and Core Team member for launch of a high refractive index progressive lens.
• Led the successful transfer and commercial scale-up of a wholly in-house developed UV curable resin formulation.
• Developed, validated and launched the synthesis and production of anionic surfactant-based leather lubricants.

TECHNICAL EXPERTISE
Hands-on experience with:

• Small molecule synthesis, characterization and modification for leather processing.
• Synthesis and characterization of engineering and high temperature stable polymers.
• Application of thermal and UV processes for optical, ophthalmic and surface coating materials.
• Design, development, characterization and processing of a variety of polymer materials for medical devices from the R&D bench top to commercial manufacture with proven manufacturing efficiencies and regulatory approval.
• Delivery of several products to the market for healthcare and other applications.

PROFESSIONAL EXPERIENCE
2018 - Present
Anthara Technologies  – Principal Polymer Consultant
McKinney, TX

• Provide expertise on polymer science and plastics technology for materials for medical device, aerospace, industrial and consumer applications to national and global organizations.
• Develop and implement polymer-based product strategies.

DePuy Orthopaedics Inc. – Research Fellow
Warsaw, IN

• Develop a technology strategy to sustain R&D pipeline with strategic business relevance.
• Collaborate with technical and business leaders cross-functionally in the implementation phase.
• Develop relationships across MD&D with thought leaders and SME’s and identify opportunities for technology and materials leverage.

DePuy Orthopaedics Inc. – Sr. Principal Scientist
Warsaw, IN

• Developed and help launch new antioxidant stabilized polyethylene for orthopedic bearings
  • Validated material through Product Development
  • Collaborated with Regulatory Affairs for FDA clearance of 510K and PMA submissions.
  • Actively worked with Sales and Marketing with training materials and surgeon interactions.

DePuy Orthopaedics Inc. – Manager, Polymer Research
Warsaw, IN

• Developed pipeline of products based on new orthopedic materials and processes
  • Oxidatively stable polymer implant material.
  • New high strength composite device.
  • High performance articulating bearing materials.

The Spectacle Lens Group, J&J Vision Care – Manager, Materials R&D 
Roanoke, VA

• Developed and implemented new materials and processes resulting in increased sales:
  • A novel water-soluble UV blocking formulation for spectacle lenses (launched).
  • Tinted and tintable lenses (launched)
  • High refractive index progressive lens product (launched).
  • UV curable resin formulation for product (launched).
  • Production equipment design (launched)
• Directed innovations in materials research with ongoing patents and invention disclosures.
  • 21 patents/patent applications & 14 invention disclosures (Materials R&D Group)
• Managed a Materials Department with responsibility for:
  • BS, MS and PhD scientists
  • Synthetic chemistry and analytical labs
  • External research contracts with companies, universities
  • Development of new materials-based products
  • Long-term strategy planning of new materials for ophthalmic lenses.
  • Support to QA and Operations for materials-related issues.

Innotech Inc., Johnson & Johnson  –  Manager, Materials R&D
Roanoke, VA

• Invented and managed synthesis and characterization of proprietary thermoplastic materials for use in optical and ophthalmic lenses.
• Conducted studies on thermal processability and melt stability on novel thermoplastic polymers for ophthalmic lenses for optimization of injection molding process conditions.
• Coordinated process development to facilitate scale-up from laboratory bench-top to manufacturing.

Innotech Inc. – Senior Research Scientist.
Roanoke, VA

• Invented and developed proprietary UV curable acrylate and methacrylate formulations for ophthalmic lenses by In-Office SurfaceCasting.
• Team Member in the launch of the in-office fabrication of mid-index ophthalmic lenses.

Chemistry Department, Virginia Tech –  Post-Doctoral Research Associate
Newtown Square, PA

• Synthesis and characterization of polyimide-siloxane block copolymers for use in gas separation membranes.

Vipaux (India) Pvt. Ltd. – Entrepreneur & Director
Madras, India 

• Responsible for development and commercial production of 200 tonnes / annum leather lubricants based on sulfited and chloro-sulfonated vegetable and marine oils.

Deccan Fibre Glass Ltd. – Market Development Officer.
Hyderabad, India 

• Responsible for identifying and growing new areas of technical and commercial applications of Glass Fiber Reinforced Plastics.

EDUCATION 
Ph.D : Chemistry
Virginia Tech - Blacksburg, Va

Master of Science: Plastics Technology 
University of Bombay – Bombay, India

Bachelor of Science: Plastics Technology 
University of Bombay – Bombay, India

Bachelor of Science: Chemistry 
University of Bombay – Bombay, India

PATENTS 

• Principal and co-inventor for 12 patents. Details available on request

PRESENTATIONS

• Over 20 podium presentations in National and International meetings and symposia. Details available on request

PUBLICATIONS

• Several publications in peer-reviewed journals. Details available upon request.

ACADEMIC COLLABORATION 

• Member, Board of Studies at Wilson College, Mumbai University, INDIA, for the development of an independent undergraduate and graduate curriculum in chemistry.
• Member, Editorial Board for G.P. Globalize Research Journal of Chemistry.
• External member on the Graduate Research Committee of PhD Candidate at Dartmouth College, Hanover, NH.
• Corporate Sponsor of research projects at the University of Rochester, N.Y.; Case Western Reserve University, Cleveland, OH; Dartmouth College, Hanover, NH; for the advancement of polymer materials for use in orthopedic devices.

AWARDS & RECOGNITIONS

• Recipient of the 2013 Johnson Medal for Excellence in Science for the ATTUNE Knee System.
• Recipient of the J&J People Inspired Award for the ATTUNE Knee System.
• Recipient of The J&J Standards of Leadership Award in November, 2003 for successful High Refractive Index Progressive Lens project implementation.
• Recipient of Innotech Presidential Award in August, 1995 for work ethics & dedication.

AFFILIATIONS

• American Chemical Society, ASTM, Orthopaedic Research Society, Association of Chemistry Teachers, India.

Contact Venkat