AskVenkats London, UK

CEO and Founder Oct 2023 – Present

Management consultant helping startups and mid size companies with product positioning, launch strategy and regulatory compliance

• Provided product positioning, launch strategy, and regulatory compliance consulting for startups and mid-sized companies.
• Supported Lovu.health’s platform migration, customer onboarding, and customized configurations. Program managed LLM models to be incorporated for AI based healthcare planning
• Technical Program Lead for Autogen AI model for Livia.AI, a chat based recommendation engine
• Raised £230k in seed funding for 3 Gen AI-based startups, developing financial models and product strategies.
• Built and launched eCommerce websites and platforms using PHP, HTML5, and NodeJS.
• Mentored startups through regulatory compliance processes (GDPR, HIPAA, ISO, SOC).
   

AMAZON UK  London, UK

Senior Manager, Product Oct 2021 – Sep 2023

Lead multiple projects to increase customer retention and selection for Amazon Retail and Amazon Healthcare using Gen AI

• Product owner for a multi-year project to enable third party deliveries (240M USD per year opportunity) to Amazon Pick-up-Points Worldwide (WW) with Pilots launched in EU5 (UK, DE, FR, IT and ES)
• Developed new algorithms for optimizing cold storage utilization, route optimization and in-time delivery of pharmaceutical products based on pick-up time data of customers and locker usage; set up dashboard for continuous improvement based on 12 different monitored KPIs
• Led the customer and clinician support, including customer care SOPs, for Amazon DTC COVID-19 test kit (4 star customer rating on amazon.co.uk) that generated $1.4MM in revenue in 3 months
• Ideated and Strategized implementation of 3P Clinician Support in UK for 1P DTC Diagnostic Devices by collaborating with R&D, Quality, Regulatory and Global Tech Teams
• Strategized and communicated decisions on WW launch strategy (& 3-year plans) including Legal, Accounting and Tax strategies. This involved dial down of pilots using defined metrics and negotiating new contracts with external carriers
• Increased availability and selection for Amazon Locker customers by onboarding 3507 new sellers and ~35K products
• Implemented 3 different feature upgrades to existing Dx customer support (CS) tool to help drive better customer experience (reduced customer contacts by 23%) by eliminating pain points for both customers and CS agents
• Conducted 3 ideation sessions and competitive audits of Wellness Tests and STI Tests in UK to finalize UI/UX requirements, CX Journey, Health Agency Reporting (HAR) and Clinician workflows for DTC Dx Products
• Onboarded new diagnostic test supplier using new data on demand forecasting, manufacturing capability and testing efficiency
• Onboarded 170+ sellers and delivered 25K+ orders in 4 months including a peak volume of 350 orders per day; customer satisfaction >95%

COMPLIANCE GROUP INC ($200M Niche solution provider for Pharma/Med Device Industries) New York, USA / London, UK

Senior Director and Head of Product – AI May 2021 – April 2022

Converted product development process from legacy to cloud based digital system; started a new 10% CAGR YoY business

• Incorporated modern SDLC (SAFe Agile) methodologies in client’s product development process with minimal impact to daily activities; Ideated extensively using Miro and Figma; ran sprints using Asana and JIRA
• Managed career development and team goals including promotions to Engineer Managers and Associate Directors
• Developed training material and trained ~500 employees including certifying future trainers
• Recruited and built a team of 5 analysts and managed Sub-C level client relationships to deliver Quality Management Systems for SaMD, SiMD development including strategy to incorporate AI/ML technologies

MU SIGMA INC (Largest pure play analytics management consulting firm, Unicorn evaluation) New York, NY

Head of Product and Director - Healthcare Oct 2019 – May 2021

Lead India and US based teams of 50 analysts and managed C-level client relationships to deliver descriptive, inquisitive, prescriptive, and predictive insights for a 1.2 B portfolio of products. P&L responsibility for accounts totaling 5M+ revenue

• Led the team creating Angular™ based Market Tracking, Patient Journey and Payor Metrics platform saving the client $6M dollars annually. Managed the complete project lifecycle, including UI/UX, and delivered with 99% client satisfaction; merged data from 6 different databases
• Helped launch subscription video training products for surgeons and ophthalmologists including internal data platforms for customer analysis
• Implemented multiple scalable, re-deployable, distributed modeling solutions on quarterly refreshing real-world data (RWD) using Tableau, Alteryx, PowerBI, MySQL, Python and Excel Macros. Deployed on AWS Redshift & Azure platforms
• Strategized and solved for a requirement to utilize claims data for patient/HCP segmentation by interpolating biomarkers. It involved clearing regulatory and legal hurdles. Utilized algorithms like super learner, neural networks & random forest. 
• Spearheaded Reproducible Research initiative for R&D analytics; 26 Jupyter notebooks created for ADS creation, Analyses like Propensity score matching, Cardinality matching and visualization of KM curve and Sankey
• Collaborated in two different initiatives including predicting demand for elective surgeries post COVID-19 and white field optimization using multiple data sources
• Project manager for strategic regulatory assessment of SKUs in the allergy category for global consumer care (OTC) company, resulting in label and ingredient change recommendation of 5 different products
• Crafted and executed strategy to grow engagement by 20% in 1 year, involved interfacing with multiple C-Level and Sub C-level leaders across medical device/Pharma R&D value chain

BAYER CONSUMER CARE Memphis, TN / Toronto, ON / Morristown, NJ

Senior Associate Director – Engineering and Product Mar 2017 – Jun 2019

Built a cross functional team of 8 colleagues for a year and built Class II and Class III Medical Devices with Bluetooth functionality; responsible for go-to-market strategy for multiple B2B and B2C products, received clearance for Medical Devices through 510K and de-novo pathways 

• Developed multiple electro mechanical devices with mobile application and created data platforms (UI/UX) for SaaS and subscription services
• Authored technical file and design history file for 3 different medical devices (US and EU), and successfully e-filed
• Researched and analyzed existing patents and technologies; presented new innovative idea for migraine treatment to Local Innovation Steering Committee (LISC); finished prototype and created business plan for a potential market of 3 million customers with $45M revenue potential
• Collaborated on a capability building initiative focused on optimizing/stream-lining assessment, development, launch and maintenance of next-gen digital products. Recommendations approved by sr. management and implemented for allergy, pain and contraceptive franchises
• Advised Canadian business on strategies to improve infrastructure and processes for launching SaMD and Medical Devices compliant with Health Canada standards including CE certification
• Managed multiple external partners and vendors in multiple countries and sites for development activities including Software, Agency (UI/UX, VoC), Mobile App and Firmware Development

PERKIN ELMER, INC. ($2.8B firm focused on innovations/market insights within key health-related industries) Memphis TN

Engineering Manager – Assignment: Merck Consumer Care  Jun 2014 – Mar 2017

Performed Failure, Gap-fit, Risk Analyses and ran Design Thinking workshops across multiple teams and projects; resulted in efficient resource allocation for the division; developed and managed Performance Goals, KPIs and reporting

• Led design, method and process validation for a one-of-a-kind automated Allergy Chamber (Class II) to study Human Immunological response to air dispersed pollen; perform comprehensive financial analysis illustrating the ROI 
• Appointed to 8 member highly selective, confidential project for new marketing claims; implemented and executed unique methods and proprietary technology to conduct human trials in a controlled exposure chamber
• Project increased division profitability by ~$2M per year
• Hired analysts and established new lab processes and standard operating procedures for 2 key labs; provided training to 100 employees
• Worked on OTC monographs, Rx-OTC switches and 3 new-drug applications in allergy, pain, and skin health categories. Authored technical and regulatory documents to be submitted to FDA, Health Canada and EMA

• Invited speaker in 3 different marketing and product webinars in 2022 organized by Strategy Insights and Products that Count
• Obtained PMP certification, SCRUM coach and SaFE AGILE leader, Certified Product Owner, Medical Device Regulatory Strategy and Certified Quality Auditor
• Received Bayer’ Excellence Award for Leadership and Flexibility for performing multiple roles on a project 
• Authored 4 different 510Ks (US), 4 CE marked Devices (UK, EU, Japan and China), 1 PMA (US) and 1 DeNovo (US) including new device applications to MHRA (England) and EU MDR (Rest of EU)
• Expert in GAMP 5, GxP, 21 CFR, ISO 14971 & 13485, MHRA, EU MDR, Brazilian ANVISA, MDSAP, IEC 60601 & 62304 (International Standards applicable to Pharma/Med Device Industries)

References Available on Request