Avishek Mishra Email & Phone Number

Minneapolis, Mn, Us

Minneapolis, Mn, Us

Aurora, Co, Us

Taught a 1 credit graduate spring semester course- BIOE 5480 on International Perspectives and Regulatory Strategy for Medical Devices in the Department of Bioengineering.

Plymouth, Mn, Us

MEDIVATORS (formerly Minntech Corporation) was a wholly-owned subsidiary of Cantel Medical Corp., a leading provider of infection prevention and control products. On June 2, 2021, Cantel Medical was acquired by STERIS. • Led Cantel’s Clinical and Regulatory Affairs Team in determining clinical strategies, plans and procedures• Accelerated Cantel’s understanding of the upcoming EU MDR Regulations, in particular CER, PMS and PMCF Reports• Oversaw all Clinical Evaluation processes for Classes I & II products across Cantel’s Medical and Dental Divisions• Authored and published Clinical Evaluation Plans and Reports (CEPs & CERs) for review by Notified Bodies, FDA• Supported 20 product families through Clinical Evaluation Writing for CE Marking• Assessed 4 New Product Development projects for clinical risks as part of the product’s failure modes analysis• Directed the organization on clinical safety and efficacy of products during recalls, adverse events or health hazards• Provided direction in all aspects of the establishment, implementation, promotion, and administration of the clinical education activities, to include assessment, curriculum planning, communications and clinical skills development, and educational support• Worked closely with internal/ external stakeholders to identify clinical risks and assess regulatory marketing plans• Spearheaded the Employee‐Patient Connections (EPC) Team to drive Cantel’s culture and employee engagement• Recognized by the CEO for the EPC Team’s work and awarded the “Employee‐Patient Connections Champion Award”

Plymouth, Mn, Us

MEDIVATORS (formerly Minntech Corporation) was a wholly-owned subsidiary of Cantel Medical Corp., a leading provider of infection prevention and control products. On June 2, 2021, Cantel Medical was acquired by STERIS.

Little Falls, Nj, Us

• Collaboratively executed regulatory strategies for global registrations across China, APAC, MEA and LATAM• Led global internal and external business partners in compiling submissions for product licenses and renewals• Streamlined preparation and processing of documentation required for new/ revised product introductions• Worked with local regulatory agencies and distributors in preparation, compilation and maintenance of registrations•Identified marketing strategies across world markets and initiated innovation around a standardized registrations process• Participated on Product Development teams, providing regulatory strategy, timelines, and direction• Implemented and reviewed Change Orders and assessing regulatory impact of product changes on US and/or International regulatory strategy and submissions per standard procedures• Assessed the status of compliance across Cantel’s product portfolio to regulatory requirements like EU and China RoHS• Managed tenders and registration requests from $100,000 to $10 million across 89 countries

Minneapolis, Mn, Us

• Designed a suturing device for a “better way to make sutures in ACL graft preparation”• Achieved a 40% time reduction in ACL reconstruction procedures by simplifying the graft preparation process• Design and prototype awarded 2nd place at the University of Minnesota’s Medical Device Innovation Investor Pitch• Filed provisional patent and currently exploring opportunities to license the technology• Led all interactions with physicians and nurses across 4 healthcare institutions for clinical studies with the device• Established a “fail easy, fail cheap” design iterative process until physicians had a Minimum Viable Product• Trained 3 physicians on design, intended use, functionality, and material compatibility of the device

Minneapolis, Minnesota, Us

• Designed an Adaptive Implantable Pump for the treatment of Stress Urinary Incontinence in prostate cancer patients• Idea and prototype awarded the $25,000 by the Medical School to conduct Early Feasibility Studies• Conducted Early‐Commercial Assessments, Patent and Literature Surveys and collected Marketing Intelligence• Managed all aspects of product development from initial design specifications from 3D Printing to fiscal planning• Pitched idea to 7 physicians at the University for collaboration on an IRB‐approved clinical study• Project Co‐Ordinator on an IRB approved clinical study to understand the functional dynamics of product‐in‐market• Presented findings at the 33rd Engineering and Urology Society Annual Meeting, 2018 in San Francisco

Minneapolis, Mn, Us

• Assessed viability of new inventions ranging from biomedical, life sciences, software/ IT, and engineering• Demonstrated understanding and application of marketing principles through market analysis and customer segmentation• Published 20+ commercial assessments and patent surveys for innovative disclosures in the Healthcare/ Medical Device space• Facilitated technology commercialization across the University of Minnesota by helping STEM students, faculty and researchers develop their insights, discoveries and inventions into high potential startups •Educated Med Tech Innovators chart a course of start‐up or licensing through strategic partnerships with local medical device companies• Advised OTC Managers on clinical foundations of an innovative medical device based on intended use for patent writing

Minneapolis And St. Paul, Minnesota, Us

Learnt the core principles behind Implicit Bias and Viewpoint Neutrality Assisted with the hiring of general and non-deliberating members of the Studet Service Fees CommitteeHeard and deliberated on student group operations requests for fundingHeard and deliberated on media group requests (including Minnesota Daily, Radio-K, etc)Heard and deliberated on 40-60 student group programming requests per semesterCoordinated recordkeeping for sub-committeeCommunicated with student group applicants and assisted with information sessions

Minneapolis And St. Paul, Minnesota, Us

Participated in hearing presentations for Administrative units on campus for Student Fee AllocationDeliberated through a parliamentary procedure on allocation of funds for admin unitsSat on the Appeals Committee for the SSF allocation for academic year 2016-17

Minneapolis, Mn, Us

TA for EE 3005: Basic Electrical Engineering ( Fall 2014)TA for EE 3115: Analog Electronics (Spring 2015)TA for EE 2361: Introduction fto Microcontrollers ( Summer 2015, Fall 2015, Spring 2016)Teaching undergraduate students, especially with a non-electrical background

Minneapolis, Mn, Us

• Worked at the department’s 3D Micro and Nano Engineering Science Group in collaboration with the Minnesota Nano Center• A futuristic project titled “Self-assembly of Micro-cubes using Graphene Sheets” for targeted cancer therapy• Successfully optimized fabrication mechanisms and improved yield of these micro-cubes by five-fold (100μm, 250μm, 1000μm)• Extensive use of clean room technology including Electron Microscopy, Photolithography, Etching, Sputtering Deposition• Co-authored a review paper on Biological and Artificial 3D Sensors in the Small Journal

Minneapolis, Mn, Us

• Developed a working prototype for “A better way to access the heart for catheter lab procedures”• Achieved a 60% reduction in error occurrence during heart catheterization procedure through femoral artery• Obtained, analyzed and summarized key customer needs through: Voice of Customer (VOC) and Voice of Business (VOB) practices; active engagement of key opinion leaders, current and potential customers, and internal stakeholders; and third‐party market research• Represented voice‐of‐customer and marketing/strategy on project teams to ensure unmet needs are accurately communicated and prioritized for development of the device• Developed comprehensive business plans to identify and evaluate the business opportunity; assessed market opportunity through detailed market modeling, defined the unmet need and value propositions, monitored competitive landscape• Pitched the idea as an internal start‐up venture for Medtronic’s next set of bundled medical devices in the CRHM space

Golden Valley, Mn, Us

• Published market capability briefs for the Cardiac Active Implantable devices owned by MN‐based companies• Collected data on Global and Minnesota based companies‐ Research assets, Development support assets, Manufacturing and Operations, and Companies and Products for an extensive capability brief• Campaigned at trade shows and talked about Minnesota’s place in the healthcare industry

Rueil Malmaison, Paris, Fr

• Supported design work for a Ministry of Energy, Govt. of India sponsored initiative to study the possibilities of using Aluminum over Copper in electric busbars• Developed ANSYS simulations for a comparative analysis of Aluminum and Copper busbars at different current ratings that is now used as prerequisite knowledge by the Govt. of India

Kolkata, West Bengal, In

PI: Dr. Amitav GhoshDevelopment of prototype synchronization mechanism for traffic controlInterface between ARM processor and sensors connected to the track

Charlotte, North Carolina, Us

• Worked on integrated automation and software solutions for public buildings- Tata Medical Center, Quest Mall and Acropolis Mall• Assisted the AutoCAD teams in bringing in together their wide product portfolio in sensing and controls to secure these facilities• With the help of Honeywell Building Management Systems, I tested CAD designs for final debugging and closures on THREE building projects with the aim of conserving energy and the environment

PI Link: http://cori.pes.edu/group/003Conceptualized and designed an Obstacle Avoider using Atmega16Line Following, Obstacle Detection, Grid Solving applications and designing several other prototypes of robotsSuccessfully engineered and fabricated a “Library Robot” for the college library to sort books

Bengaluru, In

Quality assessment and testing of Electrical accessories in the Center for Military Air-worthiness and Controls(CEMILAC)Detailed analysis of the anti-icing valves in jet engines and its repair and overhaul process for several Indian Air Force jets

Master Of Science - Ms, Medical Device Innovation

Harvard Catalyst- Harvard Clinical & Translational Science Center, Medical Device Development

Master Of Science - Ms, Electrical And Computer Engineering

High School Diploma

Middle School Diploma

Education record