Jay Kadakia Email & Phone Number

Silver Spring, Md

Center for Devices and Radiological Health (CDRH)/ Office of Health Technology (OHT) 6 Orthopedic Devices/ Division of Health Technology (DHT) 6B Spinal Devices/ Team of Health Technology (THT) 6B2 Extracolumnar Spinal Devices•Continually serve as an interdisciplinary engineer to independently lead reviews and evaluate scientific data submitted to the Agency by Industry to determine safety and efficacy of high level and complex orthopedic medical devices.• Review work includes experience in the following premarket programs: 510(k)s (Premarket notification), Humanitarian Device Exemptions (HDE),Investigational Device Exemptions (IDE), Premarket Approval (PMA), Q-submissions (including Breakthrough Devices).• Review work experience encompasses the following device types: total hip arthroplasty devices (constrained and semi-constrained configurations, including dual mobility systems); patient-matched cutting guides and implants; stemless humeral component for traditional total shoulderarthroplasty device; reverse total shoulder arthroplasty device; external fixators; small joint implants (including radioulnar joint and trapezium); metallic bone staples; bone plate and screw systems. • Serve as Additive Manufacturing (AM) and Magnetic Resonance (MR) expert for OHT 6• Actively participate in ISO TC150 JWG1 and ASTM F42 for the development of standards associated with additive manufacturing in surgical implant applications.• Review work includes experience in the following post-market programs: Establishment Inspection Reports (EIR), Recalls, Complaints, and Medical Device Reports (MDR).• Attained competency in AAMI Quality Systems/ISO 13485.• Participated in various conferences including Academy of American Orthopedic Surgeons, Orthopaedic Surgical Manufacturers AssociationEducational Meetings, Orthopedic Coordinated Registry Network, Current Concepts in Joint Replacement, and ASME AM Conference.

Washington D.C. Metro Area

Center for Devices and Radiological Health, Office of Surveillance and Biometrics• Research current technical standards used by Issuing Agencies (IA) that distribute Unique Device Identifiers. • Analyze qualification systems used as criteria for IA accreditation.

Indianapolis, Indiana Area

http://www.iupui.edu/~bbml/index.shtmlLoading Interaction Study• Spearheaded research project by developing scope of project and defining detailed testing procedures like identifying testing groups and quantitative methods to measure data of specific loading cycles and establishing key variables to be measured through a statistical approach.• Improved mechanical testing of bone by analyzing the effect of high impact, fatigue, and combination of both in monotonic testing of cortical beams from canine femur.• Wrote software platform to evaluate fatigue data in order to calculate important mechanical properties such as ultimate stress, ultimate force, yield stress, stiffness, modulus and displacement.• Utilized statistical analyses by running 2-way ANOVA tests on data sets thereby measuring the interaction and main effects of impact and fatigue.Osteogenesis Imperfecta (OI) Mice Fixation Study• Examined wild type (WT) and OI mice tail tendon using atomic force microscopy imaging in order to measure collagen fibril D-spacing.• Analyzed AFM images with SPIP by performing Fast Fourier Transform methodology on specific fibrils to calculate D-spacing length.• Compared D-spacing values for unfixed and fixed testing groups of WT and OI tendons using cumulative percentage frequency distribution.Raloxifene Fatigue Study• Worked with a team at the Indiana University School of Medicine to capture micro computed topography (micro-CT) images of femurs.• Obtained geometric structure and bone mineral density by leveraging imaging software like Dataviewer and CTAn as well as Matlab code.Connexin 37 Study• Observed effects of Connexin 37 knockout of mice on bone integrity.

Indianapolis, Indiana Area

Fall 2014 - Biofluid and Biosolid MechanicsSpring 2015-16 - Transport Processes in Biomedical EngineeringFall 2015 - Biomechanics• Mentored and tutored students to provide a deeper understanding of respective content, reinforce learning concepts and master assignments. • Assisted professor in gathering class statistics through activities such as grading homework and exams as well as computing and recording results. • Guided students in lab and lecture sessions through demonstrations of laboratory equipment, enforcement of laboratory rules and proctoring exams.

• Piloted a project that required the use of Aeroscout’s RFID tags and Exciters to track patients in a facility outside the main hospital.• Utilized Cisco Systems to calibrate Exciters according to various room dimensions, operated an Aeroscout System Manager to position Exciters on a virtual map and utilized Aeroscout software to calibrate RFID tags to send out signals at a certain frequency and period.• Extracted, filtered and analyzed data from Aeroscout System Manager to trace routes of patients and their interactions with clinicians.

Master Of Science (M.S.), Biomedical/Medical Engineering, 3.31

Activities and Societies: Biomedical Engineering Graduate Student Association: President March 2015 - May 2016.

Bs, Biomedical/Medical Engineering, 3.1

Education record