J. David Giese, Partner

J. David Giese

PARTNER

Joined: January 1, 2012

Skills

Product Development FDA Regulatory Strategy Software Engineering Cybersecurity

Bio

I help bring high-impact diagnostic medical devices onto the US market. I’ve helped develop over 40 diagnostic devices since 2012. I provide a pragmatic, cross-functional perspective, with a background in biomedical engineering, software development, and FDA regulatory consulting. 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.

Articles by J. David Giese

ArticleAI/ML

How TEMPO and ACCESS Could Support Wearable Diagnostic AI

Most diagnostic AI teams clear FDA, then stall on reimbursement. FDA's TEMPO pilot and CMS's ACCESS model take on evidence and ...

J. David Giese

ArticleRegulatory

FDA Pre-Subs: Best Practices, FAQs, and Examples

A Pre-Sub is a mechanism for requesting formal written feedback from the FDA, and (optionally) a one-hour meeting. Pre-subs are...

J. David Giese

ArticleRegulatory

Design Inputs: Best Practices, FAQs, and Examples

The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inpu...

J. David Giese

ArticleRegulatory

De Novo Requests for Diagnostic Devices: FAQs and Examples

A concise guide to the FDA’s De Novo pathway for novel, moderate-risk medical devices that lack a suitable predicate. It includ...

J. David Giese

ArticleCybersecurity

Medical Device Cybersecurity: Best Practices, FAQs, and Examples

This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. ...

J. David Giese &

ArticleCybersecurity

Medical Device SBOMs: Best Practices, FAQs, and Examples

Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerab...

J. David Giese

ArticleRegulatory

Medical-Device Software Regulations: Best Practices, FAQs, and Examples

A comprehensive FAQ for people who are interested in creating a new medical device software to learn the basics about the US re...

J. David Giese

ArticleAI/ML

PCCPs: Best Practices, FAQs, and Examples

With predetermined change control plans (PCCPs), FDA has given manufacturers a great new regulatory tool. In this article, we d...

J. David Giese

ArticleSoftware

SaMD Fund-Raising: Best Practices, FAQs, and Examples

Notes on medtech funding, covering accelerators and funding sources.

J. David Giese

ArticleNews

Why We Revisit Our Mission and Values Every Year

A reflection on how Innolitics revisits its mission and values at the annual retreat—and why that exercise sharpens judgment, s...

J. David Giese
More articles by J. David Giese