Arindam Datta

Technical Specialist, PhD (Materials Science & Chemical Engineering)

E-mail: arindam_datta@hotmail.com

Tel: +1 (908) 359-1265 (home); + 1 (908) 625-8042 (cell)


Summary

Dr. Arindam Dutta has broad experience in development, operation support and commercialization of biomaterial technologies and medical devices for repair, regeneration and controlled release for orthopedics, cardiovascular, neuro and vascular embolization, hernia, wound closure and healing, ocular and hemostat applications. He also has expertise in project management, design control, process development, material and product testing of devices made from synthetic resorbable and biostable polymers, natural polymers, composites and metals. He has also developed regulatory strategies, and supported preparation and prosecution of multiple FDA filings. He is experienced in patent drafting and prosecution, and conducted technology assessment and due diligence on various medical devices.


Work Experience

Medical Device Development Consultant (2015 – Present)

Actively involved in development of composite accommodating intraocular lens with activities encompassing material selection and process development, material and device characterization, preparation of design control and risk analysis documentation, biocompatibility strategy and testing, regulatory filings and patents.

Supporting product development in the areas of material and device characterization, process optimization to increase yield and reduce hazards and biocompatibility strategy for atrial fibrillation devices.

Supported product development of material and device characterization, processing, preparation of design control and risk analysis documentation, and biocompatibility strategy and testing for peripheral and neuro embolization devices made from polymeric composites.

Developed recommendations to eliminate redundancies and achieve a modified cost-effective ISO compliant process for existing manufacturing operations for components used in multiple trauma related orthopedic fixation devices. Made recommendations for updating design control, risk assessment, FMEA’s and leading to modifications of SOP's, assessing biocompatibility requirements, creation of new process and validation plans.

Z-Medica, Wallingford, CT (2014 - 2015)

Senior Director of R&D

Led cross-functional team for process development, process transfer to manufacturing vendors, characterization, design control, risk analysis and biocompatibility testing of kaolin based hemostats.

Led design control, risk analysis and validations, and supported BSI audits for collagen based hemostats.

Biomerix Corporation , Somerset, NJ (2002 – 2014)

Senior Director and Distinguished Fellow, Materials Technology

Led process development and validation of four FDA-approved devices (ASSURETM, REVIVE™ and RCR Surgical Mesh, Vascular Occlusion Device) and process development for stabilizing spinal annular defects and sustainable occlusion of intra-cranial aneurysm using composites of PU scaffolds with various polymers and metals.

Led cross-functional team through feasibility, development, design control, risk analysis, validation and FDA approval of PET fiber reinforced PU scaffold-based tissue regeneration device for rotator cuff repair.

Led various phases of feasibility, design control, risk analysis, verification and validation, biocompatibility and preclinical testing and regulatory filings for ventral, and inguinal hernia meshes, vascular and neurovascular embolization, spinal disc annulus stabilization, cartilage repair and wound closure based on PU scaffolds.

Led project team for development of two families of elastomeric and resilient resorbable polyester and biostable polycarbonate polyurethane 3-D tissue engineering scaffolds for bio-integrative remodeling and regeneration.

Processing technologies developed: injection and compression molding of resorbable polymers; extrusion and film coating of resorbable polymers; reinforced composite fabrication; foaming and reticulation of PU matrices.

Developed coating technologies: resorbable adhesive and surface modifications using PLGA, collagen for controlled release of active agents and specific cellular interactions, anti-microbial; growth factors on PU scaffolds

Lead test method development, method validation including detailed statistical data analysis using MINITAB.

Led mapping of the in vitro bio-mechanical, structural and analytical characterization of both biostable and resorbable devices and biomaterials; established structure/property/process/ in vivo correlations.

Assisted in planning and implementation of biocompatibility studies and pre-clinical studies with various animal models targeting multiple types of device. Oversaw various in vitro cell culture studies with universities.

Prepared Design Inputs, Product and Process specs, Design and Process FMEAs, Hazard and Risk Analysis., DHF’s.

Planned and implemented Project Plans, Design Verification and Validation, Process and Sterilization Validation.

Supported Operations in preparing GMP documentation including MI/QI, IQ/OQ/PQ, and ECR/NCR/CAR.

Supervised suppliers, vendors and labs overseeing technical assessments, pricing, audits and qualification of supplier and directing procurement, installation and / or qualification of materials, components and equipment

Supported planning, data analysis, preparation of regulatory filings and response for multiple FDA applications covering hernia meshes, soft tissue orthopedics, intra-cranial and vascular occlusion.

Analyzed and prepared several assessments of relevant technologies, competitive products and patents that impacted product development strategies, project planning, manufacturing processes and product marketing.

Ortec International, New York, NY (2000 – 2002)

Manager, Biomaterials Process Development

Project leader for multi-disciplinary product development team involved with creating strategic plans, milestone and project schedules, resource allocation and budgets, and led the implementation activities.

Developed and implemented plan for stabilizing manufacturing process, established in-process controls, improved yield and reduced cycle time for lyophilized collagen sponge for chronic wound healing.

Assisted in modifying coating process for improved transportation and controlled delivery of bio-active nutrients.

Assisted in development and implementation of validation strategies with contract manufacturer.

Ethicon Inc. (Johnson & Johnson), Somerville, NJ

Scientist / Senior Scientist (1991 – 2000)

Led injection-molding process development and device characterization from feasibility through verification and validation of injection molded resorbable fasteners (CraniosorbTM) for cranial repair.

Coordinated process transfer activities between internal client and external manufacturing vendors. Prepared specifications, protocols and process FMEA's. Assisted in implementing validation strategies and wrote reports.

Project leader for developing novel, high performance resorbable screws for trauma related to intermediate load applications based on injection molding and multi axial extensional solid-state drawing of high Mw PLLA and PLGA.

Led materials and process development and testing of multi-component co-extruded resorbable urological stent.

Developed resorbable polymeric spray coating formulation and process and conducted in vitro analytical characterization of release rates for controlled drug delivery for coronary stent.

Led the injection molding process development and validation of PLLA based PanalokTM orthopedic suture anchor.

Led injection molding process development and validation for PDS based Lapra-TyTM surgical suture clip

Process development, characterization, and verification and validation support for extruded PDS and PET sutures.

Conducted thermal, rheological, mechanical, in vitro testing, and structure-property-process correlation


Additional Experience

Technical

Experience with development of implantable devices delivered via endoscope, catheter or open procedures.

Broad expertise in polymer processing techniques such as injection molding, extrusion, co-extrusion, composite fabrication, thermoforming, coating technologies for controlled release of active agents and microspheres.

Broad expertise with biostable polymers (polyurethane, polyolefin, polyester, silicone, etc.) for devices.

Broad expertise with resorbable polymers (PLLA, PGA, PCL, PDS), collagen, alginate for device and drug delivery.

Worked with metallic (Nitinol, platinum) medical device and inorganic kaolin for hemostats.

Tissue engineering scaffold processing techniques such as reticulated foam technology and lyophilization.

Broad expertise in invitro characterization techniques such as Mechanical testing (tensile, compression, fatigue), Thermal Analysis (DMA, DSC, TGA), Rheology (stress, strain, capillary), SEM.

Extensive experience with planning and implementation of ISO10993 biocompatibility and extractable testing

Analysis and interpretation of FTIR, GC/MS, LC/MS, ICP/MS, control release and drug elution.

Assisted in protocol development and implementation of multiple in vivo pre-clinical studies with external labs.

Assisted in planning, statistical data analysis, writing applications and responses for regulatory filings covering hernia meshes, orthopedic repair and regeneration, wound closure, neuro and vascular, and ophthalmic devices.

Intellectual Property including drafting and prosecution of patents, encompassing materials, devices and processes.

Quality

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Design control: Planning, Design Input, Product and Process specs, Design Verification, Risk and Hazard Analysis, Design and Process FMEAs, Process and Sterilization Validations, Preparation of Protocols and Reports, DHFs.

Operations support in preparing QSR and ISO compliant GMP documentation including Manufacturing protocols, Quality Instructions as well as procuring equipment and conducting IQ/OQ/PQ and preparing ECR/NCR/CAR.

Test method development, method validation, statistical data analysis using MINITAB and establishing specifications for various types of materials and finished devices both internally and at external vendor locations.

Prepared documents for regulatory audits and management reviews for polymer, collagen and composites devices.

Extensive experience in working with ISO 13485, 14971, 11979 and 10993 as well as various ASTM testing.


Professional Highlights

• Actively involved with development of material and process, preparing design control and risk analysis, strategy and implementation of biocompatibility testing and assisting regulatory filings of accommodating intraocular lens.

• Immersed in material and process development, design control, biocompatibility of atrial fibrillation device

• Led cross-functional team through feasibility, preclinical, development, design control, risk analysis, validation and FDA approval of fiber reinforced polyurethane scaffold-based tissue regeneration device for rotator cuff repair.

• Led feasibility, process development, materials and device testing, design control, risk analysis, biocompatibility, validation, preclinical testing, FDA filings for hernia meshes, neuro and vascular embolization devices.

• Led process development, risk analysis and validation of multiple FDA approved injection molded and extruded devices for orthopedic soft tissue repair, wound closure and cranial fasteners using resorbable PLGA polymers.

• Led cross-functional team for process development and characterization, biocompatibility testing, design control documentation, risk analysis and validations and regulatory submissions of kaolin and collagen-based hemostats.

• Led cross-functional team that stabilized manufacturing and bi-cellular coating process, improved yields and introduced verifiable process controls for lyophilized collagen scaffolds for chronic wound healing device.

• Led cross-functional team for developing two families of novel biostable and resorbable elastomeric polyurethane 3-D reticulated fully open pore foam matrices for bio-integrated tissue regeneration and regenerative medicine.

• Developed processes for resorbable PLGA coatings for controlled release in cardiovascular stents; developed for PU scaffolds - PLGA coatings for controlled release and collagen coatings for specific cellular interactions.

• Led process development and preclinical testing for spinal annular stabilization and cartilage repair devices.

• Led development of multi-axial high strength resorbable devices for intermediate load bearing orthopedic repair.

• Led method development and validation of bio-mechanical, structural and analytical characterization of biostable and resorbable biomaterials and devices; managed multiple ISO compliant biocompatibility and pre-clinical testing.

• Supported USFDA and European regulatory filings for multiple polymeric, composites and collagen devices.

• Led multiple technology and patent assessments that helped in development of business strategies and resulted in formulating product development plans and support for corporate funding for different implantable devices.

• Inventor with claim to 20 US patents.


Education

Virginia Tech, Blacksburg, VA, USA
Ph.D. (Materials Science & Chemical Engineering)

Southern Illinois University, Carbondale, IL, USA
M.S. (Thermal Engineering)

Indian Institute of Technology, Kharagpur, India
B.S. (Chemical Engineering)