Software Articles & Videos

Practical tips for medical-device software engineers, process, and tips

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FeaturedArticleAI/ML

AI/ML in Digital Pathology and the Software-as-an-IVD Paradigm: 2026 Snapshot

Fifty-one FDA-authorized pathology AI devices through April 2026, only seven of which are whole-slide imaging algorithms. This ...

Yujan Shrestha

FeaturedArticleAI/ML

Frustrated with Slow AI Adoption? Here’s why.

AI-assisted medical device development is FDA-compliant when done right. The obstacle isn’t regulation. It’s the messy codebase...

Yujan Shrestha

FeaturedArticleAI/ML

Medical Imaging AI/ML Engineering Guide: Best Practices and Examples

A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orien...

Yujan Shrestha

FeaturedArticleRegulatory

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

FeaturedArticleAI/ML

FDA Strategy for Foundation Models, Gen AI, LLMs, AI Scribes, and Beyond

Ideas on how to get foundation models and generative AI FDA cleared.

Yujan Shrestha

ArticleAI/ML

The First AI Otoscope: What TytoCare's De Novo Means for AI in ENT

TytoCare's De Novo cracked open ENT, a specialty with just five prior AI/ML clearances, and dropped a 510(k) on-ramp for everyo...

Yujan Shrestha

ArticleAI/ML

How to Get Your AI-Generated, Vibe-Coded Medical Device FDA-Cleared

From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, C...

Yujan Shrestha

ArticleRegulatory

How to Build a Medical-Device Timeline You Can Actually Trust

Are your medical device timelines slipping despite a smart team and lots of effort? This article explains Innolitics’ practical...

J. David Giese

ArticleAI/ML

What Your First 510(k) Actually Costs You

Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of...

Yujan Shrestha

ArticleRegulatory

Quality Work Doesn’t Mean Quality Service

To provide quality service to our clients, we need to do more than produce quality work.

J. David Giese

VideoRegulatory

10x Coffee Talk: Review of FDA's Latest Draft AI Guidance

The discussion in the transcript revolves around the FDA’s Draft Guidance on AI in Medical Devices, focusing on regulatory cons...

Matt Hancock

VideoAI/ML

10x Coffee Talk: Image Processing Toolbelt

Kris Huang led a discussion on key image processing techniques in medical imaging, focusing on CT and MRI scans. Topics include...

Kris Huang

VideoAI/ML

How to get AI/ML SaMD FDA cleared - Presentation by: Yujan Shrestha

Discussion covered key takeaways from the RSNA conference, balancing safety with speed, and setting risk thresholds. Topics inc...

Yujan Shrestha & 2 others

VideoSoftware

Medical Device Recalls - Software Related

The discussion outlines the evolution of FDA regulations, common violations, and the enforcement structure. It emphasizes the i...

George Hattub

VideoAI/ML

10x Coffee Talk: Generative AI and FDA Guidelines

The discussion explores generative AI (GenAI) in medical devices, focusing on FDA's considerations for regulation, risks, and t...

Yujan Shrestha & J. David Giese

VideoCybersecurity

Coffee Time: Medical Device Cybersecurity Threats

We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufactu...

Yujan Shrestha & J. David Giese

VideoAI/ML

Coffee Time: Is FDA Doing a Good Job with AI?

Yujan and David discussed the topic of FDA's performance in regulating AI medical devices, focusing on the ideal regulatory sit...

Yujan Shrestha & J. David Giese

ArticleSoftware

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

Notes on medtech funding, covering accelerators and funding sources.

J. David Giese

VideoAI/ML

10x Talk: Intro to Prompt Engineering

A 10x talk exploring the basics of prompt engineering, followed by an open-ended discussion.

Nikko Chavez

ArticleDICOM

How To Integrate With the VA VistA PACS

A practical guide for integrating software with VistA, the VA’s PACS. This guide is based on our experience working through the...

Bimba Shrestha & Quinten Sodia

ArticleSoftware

SMART on FHIR: Is it a Good Fit for your Medical Device Software?

Overview of SMART on FHIR and when it’s a good approach to integrating your software into the clinical workflow. It includes a ...

Russell Kan

ArticleRegulatory

Off-The-Shelf Software: Best Practices, FAQs, and Examples

An in-depth guide to navigating the use of off-the-shelf software (OTS) in the medical device industry. OTS software is general...

J. David Giese

ArticleCybersecurity

Can Your Software Diagrams Slow Down Your FDA Submission?

A short article that attempts to explain why badly made diagrams will confuse FDA reviewers and slow down your submissions. Inc...

J. David Giese

ArticleAI/ML

User Needs vs Requirements

What is the difference between user needs and requirements?

Yujan Shrestha

ArticleRegulatory

To Rewrite or Not: From Prototype to FDA-Compliant Software

This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code...

J. David Giese

ArticleRegulatory

Why Are you Wasting Time Building Your Medical Device?

If you’ve ever been working on a medical-device and have thought, “this is a waste of time,” this article is for you. It will p...

J. David Giese

ArticleRegulatory

How Frequently Can you Release Medical Device Software?

Medical-device software release frequency is a common question, particularly from software engineers familiar with agile develo...

J. David Giese & Jim Luker

GuidanceRegulatory

2023 FDA Guidance - Off-The-Shelf Software Use in Medical Devices

This guidance document explains how medical device manufacturers can incorporate off-the-shelf software (OTS) into their device...

Imran Shehzad

ArticleSoftware

Get to Market Faster with Software-Savvy Regulatory Experts

This article explains why regulatory consultants who understand software can save your engineers time and help get your medical...

J. David Giese

VideoSoftware

Powerful Debugging Techniques: A Real-World Example

Learn from a real-world MedTech OS software bug and explore various debugging techniques that can help you navigate through sof...

J. David Giese

VideoRegulatory

Why Notion is the Best Traceability Tool for Medical Device Startups

What is traceability? How does Notion help you handle it? How does Notion's flexibility empower medical device startups in ways...

J. David Giese

VideoSoftware

How to Grow a 10x Team with Code Reviews

This video explains why code reviews are essential for growing a 10x software engineering team and how to do code reviews well.

J. David Giese

Get To Market Faster

Medtech Insider Insights

Our Medtech tips will help you get safe and effective Medtech software on the market faster. We cover regulatory process, AI/ML, software, cybersecurity, interoperability and more.