Chris is the CEO and co-founder of Galen Data, Inc., a configurable, scalable, FDA-Compliant software platform that enables connecting medical devices to an FDA-compliant cloud.
Chris has over 25 years of experience developing sophisticated technology in the medical device industry including Cyberonics (LivaNova) and the aerospace industry including NASA and Iridium.
Chris has been a project manager and principal software engineer for a venture-funded FDA Class III medical device company responsible for executing key software projects through a formal design control, verification, and validation process in compliance with FDA regulations.
Chris has been involved with numerous Class III medical startups in various roles and started the commercially successful Life Science Division at Tietronix Software, Inc.
Chris co-authored and submitted seven U.S. patents covering patient management and threshold optimization software applications for implantable medical device systems (four patents issued to date).
Chris initiated and led the effort to achieve ISO 13485 certification, for two separate companies, which included building from scratch a compliant ISO 13485 (Medical Device – Quality Management System International Standard) and ISO 14971 Risk Management system.
Chris has a master’s degree in Electrical Engineering with a focus on intelligent software and a FAA certified flight instrument instructor (CFII).
Galen Data makes it easy and affordable to connect medical devices to an FDA compliant cloud platform.
The Galen Data team come from FDA Class III medical device companies. Our expertise includes medical device software, quality management systems (Galen Data is ISO 13485 certified). We have all been part of early-stage medical device companies and have a strong passion for all things medical device.
The COVID-19 pandemic has increased global awareness of the lack of medical device connectivity. We live in a connected world; why aren’t our medical devices connected? Galen Data is changing that. We are seeing firsthand the increasing demand for medical device connectivity.
We’re really excited about our product roadmap, that includes: EHR (electronic health records) integration, expansion of our current support for artificial intelligence and machine learning for medical devices, and electronic prescriptions. It’s an exciting time to be on the forefront of these technology enhancements for the medical device industry.
I think one needs to lead by example, be honest, don’t be afraid to make mistakes, and find ways to maximize the strengths of your team members. The ongoing challenge is working within today’s limited resources while planning for tomorrow. All the folks at Galen Data are smart, multi-talented, and bring a passion for medical devices. The basic idea is to set the course and then let the team excel at their core competencies. It’s a beautiful thing when we all work together to achieve a common goal.
The best advice I have received is: “You learn more from your failures then your successes; it’s how you deal will failure that will set you apart.” If we are not failing, then we are not pushing hard enough. The trick is to not make the same mistake twice or make a catastrophic failure.
The worst advice I have received: “Chris you are crazy to go work for a small company — it’s way too much risk.” I responded, “didn’t IBM just layoff a thousand engineers a few weeks ago?” If I would have followed that advice, I would not have entered the medical device industry or started Galen Data.
The most rewarding moment in my career was when a patient said our medical device saved his life. There were six engineers in that conference room when he shared that with us, I was just one of many. I still see his face to this very day – and on that day is when I decided to use whatever engineering and entrepreneurial talents I have in the service of furthering medical device innovation.
Simple, to grow Galen Data, furthering our mission to connecting all the worlds medical devices.
A piece of chocolate, a glass of bourbon, and a good book!
I’m looking forward to meeting more like-minded folks that have a passion for all things medical device related, and I know the Medical Alley community shares that same passion.