Ketan M. Email & Phone Number

United States

Cambridge, Massachusetts, Us

Building a digital ecosystem (sw) with wearables (hw) in regulated space to support OSA diagnostic, monitoring, and adherence.

Cambridge, Ma, Us

As a leader in product strategy and execution, I drive the development of AI-ML clinical decision support products for early screening of cardiovascular diseases using ECG data. I collaborate with various teams, including engineering, design, clinical, regulatory, quality, marketing, and business.In this role, I work closely with the clinical team to shape trial designs, EDC, and partner with regulatory and quality teams to develop documentation for AI-ML model submissions. I also collaborate with engineering and program management to drive roadmap development, design input, and product discovery (VOC, interviews etc.). Key achievements:- Drive product strategy and roadmap- Define and drive EHR integration for CDS- Deployment of solution at Mayo, Duke, Stormont Vail, Mercy etc.- Device partnership - FDA approval for LowEF - https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232699.pdf- Contribution to multiple SaMD DHFsMy goal is to deliver innovative solutions that enhance patient outcomes and advance cardiovascular disease screening. #HealthTech #ProductDevelopment #Innovation

Paris, France, Fr

Lead engineering and analytics for SaMDs product for the companyLed the engineering team, consisting of internal team members and external contractors (multiple vendors), managed the budget, plan releases, collaborated with the program, portfolio, and all external functions (quality, regulatory, medical, finance, legal, privacy, cybersecurity, pharmacovigilance, and human resources). Set up internal competency, align with various internal teams, support and build various SaMD products.Key achievements:- Stabilized team against various challenges, re-aligned priorities, managed vendors and delivered on team's commitment- Spearheaded group transition from one business unit to another

Paris, France, Fr

Worked with business and global leadership to help affiliates understand and scale the deployment of digital products. Digital therapeutics are innovative solutions for the business (sales and marketing). Key achievements:* Scaled product adoption in Mexico by 4x, Improved HCP's prescription behavior in Algeria* Setup multiple global and country level KPI dashboards for commercial and clinical outcomes* Supported real world data analytics activities and publications

Cambridge, Ma, Us

(Formerly Luminopia), role and responsibilities aligned with roles called out as director of engineering. Odin become a new venture with new vision in consumer healthcare space.Leading engineering team through technical and product development. Involved with product planning, requirement, specification, design, and development. Responsible for leading verification (V&V) and quality system at Luminopia. Worked on building and delivering mental health solution built using Flutter for Mobile and Backend using Firebase

Cambridge, Massachusetts, Us

Leading engineering team through technical and product development for DeNovo device designed for amblyopia. Involved with product planning, requirement, specification, design and development, V&V and quality system.Trials:* https://clinicaltrials.gov/ct2/show/NCT03608150* https://clinicaltrials.gov/ct2/show/NCT02782117Publication:* https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239850/Developed a quality system for the company ensuring compliance with 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971 with keeping a pace of startup development. Worked on pre-submissions, QMS and supporting clinical trial activities. Currently (2020) working on DeNovo submission. On technical side, my responsibility included building and delivering SaMD solution to solve a problem in behavioral health and amblyopia for pediatric population.Tech Stack: * Mobile product - iPad Mobile App (Flutter and Dart), Backend (React, Node.js), and web portal (React, Typescript) along with Dev-ops (AWS, Terraform etc.).* VR product - Android App (Unity, C#, C++), Front-end (React, TS, and Node.js), Backend (React) on AWS using Terraform

Cambridge, Massachusetts, Us

Member of the founding team at Luminopia, which scaled to 12 people and raised ~10m to build a SaMD (software-as-a-medical-device) solution to address an unmet need in amblyopia. Identified the appropriate technology (virtual reality) to build an optimal solution to address amblyopia treatment. Helped formalize concept, vision, and needs into design inputs, setup tools, and infrastructure, recruit a team, and later transitioned to project management/planning and setting up quality systems and regulatory compliance.Key achievements:* Led design of the product.* Authored native audio video rendering infrastructure to stream video (NDK MediaCodec, OpenGL, OpenSL and Unity toolchain) in VR performing real-time image processing (80x80 sized blur, blending and masking).* Recruited and retained talent to build the product* Setup a QMS (Quality Management System), authored multiple SOPs, Work instructions in collaboration with external consultants and prepared package for DeNovo submissionOverall exciting time to build new product and take it to the market. Fun of startup enables working on multiple areas!

Paris, France, Fr

Sanofi’s MedTech team was the first internal incubation team tasked to develop regulated software in-house, which made the group behave like a startup. Worked in various roles and functions to ensure that team can build and deliver the first internally developed product for 510k clearance. Conducted building backend services using Java and Play framework. Mentored and led a team in building a web portal for physicians using AngularJS and Material Design. Key achievements:* Built a product from concept to 510k approval under 18 months* Deployed a product in trial* Led external analytics projects with MGH and DukeReceived 510k clearance for My dose coach in March https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163099.pdf

Zoetermeer, Olanda Meridionale, Nl

Served as rendering lead and managed all existing rendering technologies at Vital Images. Developed and maintained multiple GPU and CPU-based volume-rendering engines integrated into multiple products with close collaboration with vendors (ATI, Nvidia).Key achievements:* Responsible for all rendering technology used across multiple products* Extensive optimization for CPU (SSE2 etc.) and GPU (Caching, Texture management)* Managed relationship with Nvidia and ATI to improve their driver performance for our products* Single rendering engine supported high-end workstation and client-server products with different performance and scalability needs.Lot of experience in design and support of various enterprise deployment stacks (virtualized and non-virtualized). Selected recent work includes auto-stereoscopic support, volumetric clipping, multi-volume fusion, surface rendering and early stage research.

Minnetonka, Minnesota, Us

Developed scalable rendering solution using CPU and GPU. Built scalable CPU engine for virtualization and accelerated GPU based engine for render nodes. A major contribution has been designing new renderer and improving existing rendering performance, scalability and adding features like shader framework, embedded geometry, subtraction, negation rendering etc.Primarily use C++, OpenGL and SSE for implementation and VTune, gDEbugger etc for performance tuning.

Mississippi State, Ms, Us

Completed MS in Computer Science and Engineering with focus on computer graphics with focus on information and scientific visualization.Research topic is to find novel techniques by combining scientific and information viz techniques to solve the problem of exploring temporal and spatial tensor and vector data for Nematic Liquid Crystals.Thesis: http://vis.cse.msstate.edu/publications/theses/Mehta-2006-NTV

Bangalore, Karnataka, In

Worked in Medical device area. Conceived and developed the solutions for medical device space. Worked on MRI, CT and Incubator software.

Ms, Computer Science - Graphics Concentration

Bcse, Computer Science & Engineering

High School