Innolitics Medtech Newsletter

Subscribe: https://innolitics.com/articles/

Over 750 active readers are now tuning into the biweekly Medtech Newsletter that I curate for Innolitics.

With each issue, I'm realizing there's a growing need for clear guidance on bringing medical software to market safely and effectively. The newsletter covers common strategies and tips for success with FDA regulatory submissions for Software as a Medical Device (SaMD).

How This Started

Shout-out to Yujan Shrestha, MD for trusting me with this opportunity to share Innolitics' insights and reach founders and physicians who need them most.

Innolitics is an FDA regulatory consulting firm that specializes in AI/ML Software as a Medical Device. They've helped dozens of companies navigate the 510(k) process, and I realized there was a ton of institutional knowledge that wasn't being shared publicly.

So I started writing.

What the Newsletter Covers

The goal is practical, actionable guidance for SaMD founders:

• 510(k) submission strategies — What actually works, what doesn't
• Predicate device analysis — How to read between the lines of your competitor's clearances
• AI/ML-specific guidance — PCCP strategies, clinical validation requirements
• Common mistakes — Things we see founders do that slow them down
• Regulatory news — FDA guidance updates, MDUFA fee changes, policy shifts

One Actionable Tip

Here's something I share with founders all the time:

Before developing medical software, check out previous 510(k) regulatory submissions.

You can read between the lines to infer why your competitor made certain design decisions, saving you from making similar mistakes. The FDA's 510(k) database is public — use it.

DM me if you'd like help analyzing these.

The Impact

What started as a content marketing experiment has grown into something I'm genuinely proud of:

• 750+ active readers and growing
• 15% increase in monthly website traffic to Innolitics
• Direct inbound leads from founders who found us through the newsletter
• Speaking opportunities and partnership conversations

More importantly, I've heard from founders who said the newsletter helped them avoid costly regulatory mistakes. That's the real win.

Why I Care About This

I've spent my career at the intersection of healthcare technology and product development. At Georgia Tech's MBID program, I wrote 510(k) submissions as part of my coursework. At TargetRWE and VivoSense, I saw how clinical data workflows intersect with regulatory requirements.

The SaMD space is exploding — AI/ML applications in radiology, pathology, cardiology, dermatology. But a lot of founders are building without understanding the regulatory landscape. They burn months (and money) on approaches that were never going to work.

This newsletter is my way of helping them avoid that.

Sample Topics I've Written About

• How to identify the right predicate device for your 510(k)
• Understanding FDA's AI/ML action plan and what it means for your submission
• The difference between 510(k), De Novo, and PMA pathways
• When (and when not) to request a pre-submission meeting with FDA
• MDUFA fee changes and how they affect your submission timeline
• Clinical performance testing requirements for AI/ML SaMD

Subscribe

If you're building medical software and want to understand the regulatory landscape, subscribe here: https://innolitics.com/articles/

Or reach out directly — I'm always happy to chat with founders navigating this space.