Free eBook from Infera
Engineering Great MedTechin the Age of AI
Why building quality in is how teams win
As AI transforms how medical devices are used, built, and trusted, the case for treating quality as a design input rather than an after-the-fact byproduct only grows stronger. This eBook makes that case, and unpacks what it looks like when quality is built in from the beginning.
With Harry Blumsack, Co-founder & CEO and former VP of Engineering at a cleared medtech startup, and Nikki Batista, Head of Regulatory and former FDA reviewer
43%
Of recall events for FDA-cleared AI-enabled devices happen within 12 months of clearance, roughly double the rate for non-AI devices.
As AI becomes part of more devices, more of these problems will surface in real-world use, after the paperwork is done. When quality is built into development, teams find them sooner, fix them faster, and keep the trust of regulators and patients. This book makes the case for why quality is how medtech teams win.
Research letter, Johns Hopkins, Yale, and Georgetown
Contents
From a founder’s story to a former FDA reviewer’s playbook
Our best current thinking on why quality and product are one and the same in medtech, and what’s finally making that possible.
Foreword
MedTech’s Tools Haven’t Kept Up
What a team can build keeps expanding, and so does what it owes a regulator. The tools for proving it haven’t kept pace.
Chapter 1
The Infera Story
Our CEO Harry on six disconnected systems, a 400-page first submission, and realizing the answers were already in the code.
Chapter 2
MedTech Is Heating Up
Platforms, denser competition, and a rising regulatory bar are converging. The TruDi case shows what happens when they collide.
Chapter 3
Quality Was Always the Moat
The FDA’s own data shows quality pays. From Case for Quality to the Voluntary Improvement Program, and why AI raises the cost of failure.
Chapter 4
Lessons From Software Security
Software security escaped its end crunch by “shifting left.” MedTech got the same instruction in 1997 and now has the tools.
Chapter 5
The Reviewer’s Perspective
Nikki Batista on her years as an FDA reviewer, building regulatory practices at WHOOP, and three beliefs about quality done right.
Chapter 6
The End of Copy-Paste Compliance
What quality, engineering, and the whole team get back when the record keeps pace with the work.
In closing
The Tools Finally Exist
Where regulation is headed, and what it takes to build at full speed and build safely.