We are Medical Device AI Experts

We have decades of collective experience and bring an engineering, clinical, and FDA regulatory skillset to your team.

Our Leadership

Yujan Shrestha

CEO, PARTNER

Joining Date: January 1, 2012

Skills

AI/ML Algorithms FDA

Bio

I am a physician, software engineer, AI/ML expert, and regulatory consultant. I have been developing medical device software for 10 years. I have helped startups and Fortune 500 companies write medical grade software and secure regulatory clearance. I was born in Nepal, came to the states when I was 4, and learned to code BASIC when I was 8. I graduated with a BME degree from UT Austin and a MD degree from UT Houston. I am passionate about decreasing barriers to translating medical devices from the lab to the clinic for the benefit of patients and physicians alike.

Hobbies

Snowboarding, Mountain Biking, Video Games, Ukulele, and Parrots

J. David Giese

PRESIDENT, PARTNER

Joining Date: January 1, 2012

Skills

Regulatory Strategy Software Engineering Writing

Bio

I live in Austin, Texas with my wife and daughter. I’m a biomedical engineer, a software developer, and now a regulatory consultant. I run Innolitics with Yujan, my old friend and business partner.

Hobbies

I enjoy reading, thinking, and writing about classic literature, philosophy, history, and religion. My personal website is goodlifeodyssey.com.

Our Team

Bimba Shrestha, Software Engineer

Bimba Shrestha

SOFTWARE ENGINEER

Joined: January 4, 2021

I’m a software engineer with 6+ years of experience who is passionate about making the world of medical devices better....

Ethan Ulrich, Software Engineer, AI/ML

Ethan Ulrich

SOFTWARE ENGINEER, AI/ML

Joined: June 15, 2022

I am a software engineer with 10 years of experience developing medical image processing software. I have experience with DICOM,...

George Hattub, Senior Regulatory Affairs Project Manager

George Hattub

SENIOR REGULATORY AFFAIRS PROJECT MANAGER

Joined: July 10, 2024

I am a certified medical device professional with over 30 years experience. I have successfully achieved almost 70 FDA 510(k)...

Ilya Spivakov, Software Engineer

Ilya Spivakov

SOFTWARE ENGINEER

Joined: January 10, 2022

I’m as full-stack software engineer with experience in medical and aerospace industries. I enjoy learning and solving problems.

Jim Luker, Senior Regulatory Affairs Project Manager

Jim Luker

SENIOR REGULATORY AFFAIRS PROJECT MANAGER

Joined: September 19, 2022

I see myself as a husband, father and friend. I have been married for 30 years to my best friend’s...

Joshua Tzucker, Senior Software Engineer

Joshua Tzucker

SENIOR SOFTWARE ENGINEER

Joined: July 12, 2021

I’m a full-stack software engineer that enjoys being a generalist, but also leans towards web development. I’m self-taught (my degree...

Juan Pablo Centeno, Software Engineer, AI/ML

Juan Pablo Centeno

SOFTWARE ENGINEER, AI/ML

Joined: April 10, 2023

I am an AI/ML Software Engineer specializing in the medical field. My expertise lies in developing and implementing AI/ML algorithms...

Kris Huang, Senior Software Engineer

Kris Huang

SENIOR SOFTWARE ENGINEER

Joined: October 7, 2024

Kris Huang, MD, PhD, is a physician and biomedical engineer with extensive experience in medical device software development and regulatory...

Mary Vater, Director of Regulatory Affairs

Mary Vater

DIRECTOR OF REGULATORY AFFAIRS

Joined: April 29, 2024

I am a Medical Device Quality and Regulatory Affairs consultant with a history of working on diverse products within the...

Matt Hancock, Software Engineer

Matt Hancock

SOFTWARE ENGINEER

Joined: September 11, 2023

I’m a software engineer with expertise in machine learning, image processing and analysis, mathematics, and data engineering. Prior to my...

Meri Martinez, Regulatory Affairs Project Manager

Meri Martinez

REGULATORY AFFAIRS PROJECT MANAGER

Joined: February 13, 2023

I'm a biomedical engineer and regulatory professional. My journey began in a medical device startup, where I got to wear...

Mihajlo Grčić, Director of Admin/Finance

Mihajlo Grčić

DIRECTOR OF ADMIN/FINANCE

Joined: January 20, 2023

I'm a general and theoretical physicist with three years of experience as an expert associate for physics in EdTech companies,...

Miljana Antić, Ops Admin

Miljana Antić

OPS ADMIN

Joined: February 28, 2023

I’m originally a visual artist majoring in fine arts, very passionate about visual and graphic design. My professional journey has...

Nicholas Chavez, Software Engineer

Nicholas Chavez

SOFTWARE ENGINEER

Joined: September 16, 2024

I am a biomedical engineer who has worked across diverse software domains such as network traffic optimizers, 4D image acquisition/analysis...

Pablo Hernandez-Cerdan, Software Engineer, AI/ML

Pablo Hernandez-Cerdan

SOFTWARE ENGINEER, AI/ML

Joined: February 13, 2023

I am a seasoned software engineer with a rich background in research and a strong advocate for open science. Holding...

Quinten Sodia, Junior Software Engineer

Quinten Sodia

JUNIOR SOFTWARE ENGINEER

Joined: September 20, 2021

I am a software engineer specializing in Matlab and Python code, as well as Graphical User Interface coding. I have...

Reece Stevens, Director of Engineering

Reece Stevens

DIRECTOR OF ENGINEERING

Joined: May 26, 2016

I am a biomedical engineer with 9 years of experience in software development. I’m passionate about building safe, effective, and...

Russell Kan, Software Engineer

Russell Kan

SOFTWARE ENGINEER

Joined: June 20, 2023

I’m a software engineer who is passionate about medical software as a tool for patients and providers. I do mostly...

Sam’an Herman-Griffiths, Junior Software Engineer

Sam’an Herman-Griffiths

JUNIOR SOFTWARE ENGINEER

Joined: February 21, 2022

I started my engineering journey at 22 by quitting my job as a Kitchen Manager and joining a software engineering...

Shelley Kellum, Finance/HR Admin

Shelley Kellum

FINANCE/HR ADMIN

Joined: July 29, 2019

Valeriia Zakrasniana, Admin Assistant

Valeriia Zakrasniana

ADMIN ASSISTANT

Joined: October 30, 2024

I’m a mathematician with five years of experience in operations and administrative assistance, complemented by a strong passion for organization...