If you're building or investing in medtech, ask one simple question: What happens when a device fails in the field? The answer tells you more than most pitch decks. thinkingkat.substack.com/p/plan-for-f...

Plan for Field Service Before Day One

Why your Go-To-Market plan must address “who fixes it, how fast, and what happens when it breaks”

thinkingkat.substack.com

FDA’s draft guidance on AI to support regulatory decision-making for drugs and biologics is a significant step toward defining what credible AI use should look like.

FDA’s April 2026 warning letter to Purolea Cosmetics Lab is an important reality check on the use of AI in regulated operations.

A commercialization plan doesn't exist in a vacuum. Payer concentration, GPO contracts, VAC reviews, provider fragmentation, and reimbursement pathways all shape what a company can realistically achieve.

Life science founders: if you're fundraising, learn how healthcare investment bankers think. Their work goes far beyond M&A. They advise on capital raises, licensing, partnerships, strategic alternatives, and exits while helping investors understand the value behind the science.

Hot take: “Not venture backable” is often code for “great business, wrong instrument.” I’ve written a new piece on alternate capital strategies for life science founders, options instead of forcing everything through a unicorn lens.

Engagement metrics ≠ evidence. Revenue ≠ repeatable. New essay on why ""impressive"" and ""investable"" are not the same thing in healthcare deals: open.substack.com/pub/thinking...

Deal Screening Mastery (Part 7 of 12): Proof, Not Motion

Telling Real Evidence from Mere Activity in Healthcare and Biotech Deals

open.substack.com

BLPN member Tim Mikhelashvili is hosting the 5th Annual Medical Innovation Olympics in NYC. Past Gold Medalist & fellow BLPN member David Mead is featured. If you're an early-stage health founder, check it out. The discount is on the homepage now. #MIO2026 medicalinnovationolympics.com

Medical Innovation Olympics

5th Annual Competition for Healthcare Champions Rockefeller Center, New York Trials: June 12, September 18 Finals: October 16

medicalinnovationolympics.com

One of the reasons I follow Deb Haas is for her relentlessly practical AI advice. She reminds us that you’re not “bad at AI.” You were just handed a complex tool with zero instructions and told to swim.

You don’t need a commercial team to have a commercial strategy. In my latest piece, I outline what “good enough” looks like at Pre-Seed, Phase 1, and Phase 2: patient journeys, a lean TPP, basic HEOR thinking, and clear partnering guardrails.

505(b)(2) isn’t a loophole—it’s a strategy. For founders working on reformulations, combos, or new delivery of known drugs, this pathway can shrink timelines and de-risk development—if you understand the rules of the game. Too many decks throw “505(b)(2)” on a slide without a real plan behind it.

Many decks talk about “reg risk” and “reimbursement” in a single bullet. This piece goes deeper: * How to test “What do regulators think you are?” * Why coding, coverage, and payment must be separate conversations * How policy (like orphan incentives or DME categories) can turn path risk into upside

Audrey Greenberg's post is her personal take on Wharton professor Tiantain Yang's research about how trust underpins success for women in business. Worth a read. www.linkedin.com/posts/audrey...

I grew up surrounded by strong women. My mother, grandmother, and great-grandmother were builders, entrepreneurs, mothers, wives. Women who carried families, created opportunity, solved problems, and…...

I grew up surrounded by strong women. My mother, grandmother, and great-grandmother were builders, entrepreneurs, mothers, wives. Women who carried families, created opportunity, solved problems, and ...

linkedin.com

Your unique value proposition isn't ""I'm good at my job."" Everyone in this field is good at their job. It's the specific combination of technical strengths, transferable skills, and differentiators that makes you the right person for a particular problem.

Geneticist Dr. Mary-Claire King's work reminds us that some of the most powerful scientific ideas start from a deceptively simple premise.

If your “Why now?” story collapses the moment someone asks about codes, waivers, or unit economics…it wasn’t a “Why now?” story. My latest article offers a four-lever framework to pressure-test timing in early healthcare and life sciences deals. thinkingkat.substack.com/publish/post...

Deal Screening Mastery (Part 5 of 12): "Why Now?" Is an Investment Question, Not a Marketing Slide

Learn How to Assess the Difference

thinkingkat.substack.com

My Thought Leader Blythe Karow is once again contributing to Med Tech startup traction with a series of interviews with former CMS Chief Medical Officer Dr. Lee Fleisher. substack.com/home/post/p-...

Is CMS Killing Breakthrough MedTech? A View from the Other Side

This article is part one of a three-part interview series with Dr. Lee Fleisher, former Chief Medical Officer of CMS, on what the breakthrough device coverage problem looks like from CMS's point of vi...

substack.com

VERVE 101 is often framed as a cool gene editing story; I see it as a stress test of our cholesterol model. If a single base edit in PCSK9 can durably lower LDL in primates and now early human trials, that’s a potent confirmation of the LDL receptor axis we’ve been building toward since the 1970s.

MECHANISMS is one of the clearest explanations I have seen of why medical neurotech gets stuck between lab, clinic, and market—and what it would take to fix the system. www.linkedin.com/posts/sharen...

Mechanisms in Medical Neurotech: A Systems Account | Sharena Rice, PhD posted on the topic | LinkedIn

What the Mech is going on? This came alive in a NASA Inventor's Notebook. For years, I was carrying observations I could not yet name, patterns I kept seeing across training, quality, connections, ca...

linkedin.com

In my latest Deal Screening Mastery article, I introduce Founder Problem Fit (FPF) as a practical way to answer: “Why is this team uniquely qualified to tackle this specific problem, at this moment, with these execution risks?” thinkingkat.substack.com/publish/post...

Deal Screening Mastery (Part 4 of 12): Founder-Problem Fit

Moving Beyond the “Great Team vs Great Idea” Trap

thinkingkat.substack.com

Most founders don’t think seriously about risk until something goes sideways. Investors do. If you’re building in life sciences, your broker shouldn’t just be a policy salesperson—they should be a strategic partner helping you protect value, manage burn, and show you run a disciplined company.

I’ve been writing a lot about AI in healthcare lately, and a new report from Intelligence Ventures just dropped that’s worth your time: The State of AI Healthcare 2026. It’s a real look at what’s actually getting built at pre-seed and seed. report.intelligencevc.com

If you've ever thought "I want to invest in startups but I don't even know where to start"—this one's for you. I'm a Portfolia investor, and here's why that decision made sense for me as a woman building in life sciences. info.portfolia.com/women-in-wea...

Founders building in women's health — this one's for you. NFX's Women's Health 2.0 FAST funding window is open now through April 9th. Every applicant gets feedback. No ghosting. No idea is too early. fast.nfx.com/womens-healt...

Women’s Health 2.0 FAST

$150K Uncapped SAFE or $1M-$3M SAFE for 15% - 25%. Investing in founders revolutionizing human longevity. No idea is too early. Apply by April 9th.

fast.nfx.com

Early stage founders and new fund managers are staring at the same problem from opposite sides of the table: what actually counts as a “great idea”? thinkingkat.substack.com/publish/post...

Deal Screening Mastery (Part 3 of 12): Fund Fit, Moats, and Milestones

A Qual‑and‑Quant Playbook for Picking Better Deals

thinkingkat.substack.com

Women’s health founders and funders: if policy is not part of your strategy, you’re leaving impact and enterprise value on the table. Do you want a high-impact way to contribute? The photo shows my local women’s health advocates! womenshealthadvocates.org

The healthcare innovation confidence gap is real: what vendors promise doesn’t always survive real-world deployment. I break down the warning signs and share the three-question framework founders need to bridge this gap—before capital gets burned. thinkingkat.substack.com/publish/post...

The Healthcare Innovation Confidence Gap

Why Hype Outpaces Reality—And How to Close the Gap

thinkingkat.substack.com

Your insurance broker should be a strategic partner — not just a form-filler. Join me for a practical workshop on using smart risk management to protect valuation, manage burn, and signal investor-ready governance. Mar 10 | 9–10am PT 🔗 www.eventbrite.com/e/smart-risk... #LifeScience #Biotech

#Investors, how do you evaluate a #Startup Team? If you are not using a simple, scorable rubric you can defend in LP #diligence, consider the alternative in my #ThinkingKat newsletter this week. open.substack.com/pub/thinking...

Deal Screening Mastery (Part 2 of 12): Stop Winging It on Team Quality

A Practical Framework for Spotting “Great Teams” in Life Sciences

open.substack.com

Stress‑test life sciences deal terms in seconds. Ambrosia’s calculator gives data‑driven benchmarks for upfronts, milestones, and royalties for the two most active therapeutic areas in biopharma licensing. www.linkedin.com/feed/update/...

Dealmaking deserves better tools, not precedent valuations | Issa K. posted on the topic | LinkedIn

We trust data to pick which molecules to develop, then price the deals on precedent and gut feeling. Same asset. Same phase. Same indication. Three different banks, three different valuations. Tha...

linkedin.com