Technical Specialist, PhD (Materials Science & Chemical Engineering)
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.
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.
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.
• 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.
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)