J. David Giese
CEO & CO-FOUNDER
Joined: January 1, 2012
Bio
I live in New York City with my wife and daughter. I’m a biomedical engineer, a software developer, and now a run a Innolitics with Yujan, my old friend and business partner.
Hobbies
I enjoy reading, thinking, and writing about classic literature, philosophy, history, and religion. I see these activities as ends in and of themselves, however, I'm especially interested in how to apply their wisdom as a means to living the good life. My personal website is goodlifeodyssey.com.
Articles by J. David Giese
- Why Are you Wasting Time Building Your Medical Device?
- SBOMs: Best Practices, FAQs, and Examples
- 2023 Final FDA Cybersecurity Guidance - Redline
- How Frequently Can you Release Medical Device Software?
- Off-The-Shelf Software: Best Practices, FAQs, and Examples
- Medical Device Threat Modeling: Best Practices, FAQs, and Examples
- Medical Device Cybersecurity: Best Practices, FAQs, and Examples
- Get to Market Faster with Software-Savvy Regulatory Experts
- The Ultimate 510(k) Checklist
- “It’s the Workflow, Stupid” - Lessons Learned Bringing Radiology AI/ML to Market
- Powerful Debugging Techniques: A Real-World Example
- Striking the Right Balance: Determining the Ideal Granularity for IEC 62304 Software Items in Medical Devices
- Can We Work on our SaMD After Submitting our 510(k)?
- One Way to Speed Up Software 510(k) Submissions
- Why Notion is the Best Traceability Tool for Medical Device Startups
- Unresolved Anomalies: Best Practices, FAQs, and Examples
- Quick Introduction to User Needs and Requirements
- How to Grow a 10x Team with Code Reviews
- Design Inputs: Best Practices, FAQs, and Examples
- Socratic Dialogue about Software Maintenance
- How to Grow a 10x Team with Code Reviews
- Medical Software Deployment and HIPAA: Cloud, Native, or Hybrid?
- A Brief Introduction to the United States Medical Software Regulations, for Developers
- Get More Out of Your Annotated Medical Images with Self-Supervised Learning
- How to Use Online Chat Effectively
- Most Makefiles Should .DELETE_ON_ERROR
- 2018 FDA Draft Guidance - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Graduate from Sed and Sort to Lnav, the Logfile Navigator
- Commentary on Code Complete: Refactoring
- Decorating Async JavaScript Functions
- Advanced BASH Exercises
- Software's Hidden Demon: Poor Code Quality
- Database Pools
- The Business of Programming Languages
- 2002 FDA Guidance - General Principles of Software Validation
- 1997 FDA Guidance - Design Control Guidance for Medical Device Manufacturers