Robbie Crabtree

Unseen

Unseen is building the intelligence layer for commercial real estate through a dual AI Agent workforce including data agents and CRE trained agents.

Co-Founder

Sorenborn

Strategic Communication Firm operating alongside deep tech and AI founders to craft narratives and dominate industries. Over $1 billion in capital raised and multiple companies grown from seed to Unicorn.

Co-Founder and Partner

On Deck

Program Director

Competitive Storytelling

Edtech focused on public speaking and storytelling. Exited.

Founder and CEO

Dallas County

Felony prosecutor with extensive trial experience on violent felonies and child abuse cases. 102 jury trials in my career.

Assistant District Attorney

Denton County, Texas

Growing up in commercial real estate, I did what any rational person would do...I became a prosecutor. It was my dad, the VP of real estate for a Fortune 200 company, who told me not to follow in his footsteps. 

I became an Assistant District Attorney where I tried 102 jury trials primarily focused on violent felonies (robberies, gang cases, and murders) and child abuse. 

Working in that world pushed me in ways I would have never expected and showed me the power of storytelling and persuasive communication. I left my life as a lawyer and built a tech company to transfer these skills to the masses. 

After selling that company, I began working directly with some of the most talented founders in the tech world. Through my boutique consulting firm I worked side by side to help those founders raise over a billion dollars in capital, grow from ten people to hundreds of people, and turn their early stage companies into unicorns that are growing fast to this day. 

And then life, as so often happens, pulled me back to where it all started. Commercial Real Estate. 

Together with my two co-founders, we saw an opportunity to solve the problems I'd witnessed growing up (and they'd witnessed working inside of it), especially the broken data and opaque nature of CRE.

What if the business leaders in the commercial real estate industry had access to all of their data (and market data) through a true intelligence layer so they can move faster with greater precision? 

The answer to that question isn't theoretical anymore, and the results will fundamentally change this tens of trillion of dollars industry. 

That's what we're building.

In the digital world, everything we do is a funnel. 

I have more than 20 years of experience marketing and selling enterprise business intelligence, SaaS, and AI solutions to top companies in the life sciences, financial, professional services, and manufacturing sectors. 

V2b offers an end-to-end enterprise conversion funnel that starts with a custom white paper written specifically for an audience, along with high-converting funnel pages, a professional press release, and email/LinkedIn messaging that will generate immediate results.

🟦 What we do for our clients:

▻ Content - I create powerful new content-based marketing programs
▻ Curation - I extract, reframe, and communicate the core value
▻ Community - I build actively engaged audiences from scratch
▻ Collaborations - I help establish strategic alliances with industry leaders

🟩 What we deliver to our clients:

▻ Strategy - Cost-effective content marketing suitable to all stages of growth
▻ Results - Discernable increases in client engagement, leads, and revenue
▻ Visibility - Recognized credibility and thought leadership
▻ Alignment - Lasting relationships with clients, partners, and influencers

🟩 What I promise:

▻ Honesty - I won't lie to you.
▻ Insight - I think differently.
▻ Experience - 20+ B2B Marketing E
▻ Value - I guarantee the value of my work.

How to connect** with me:

✉️ Contact me by Email:
hello@virtub2b.com

☕️ Book a Zoom Coffee with me:
https://www.virtub2b.com/zoom-coffee

**Ask me about my 🐕 Francesca for bonus points!

Sean Smith

🔥 AI Validation Risks Come Into Focus: Why Model Drift Is Shaping 2025–2026 Quality and Compliance Planning - Plus, hot picks, new events, and updates...

🧠 Quick Hits (In no special order)

- Manfred Maiers on hidden validation risks when public AI models shift without traceability or control.
- Danny Van Roijen on EU Commission findings around GenAI, regulatory compliance, and synthetic data use.
- Mike B. W. on why “minor” software updates create regulatory exposure without structured change control.
- Sigrid Berge van Rooijen on organizational readiness pillars for AI adoption in healthcare.
- Stefano Bolletta on FDA’s revised draft guidance outlining CGMP expectations for medical gases.
- Intrinsic Medical Group, LLC on evidence-based justification for omitting unnecessary biocompatibility tests.
- Matrix One on core components of production specifications that support consistent device quality.
Georg Digel on 18 essential CAPA terms that strengthen team understanding and performance.
- MedQAIR on the first four EUDAMED modules becoming mandatory in 2026 and what teams must prepare.
- Tibor Zechmeister on vigilance reporting triggers and timelines across EU, UK, and U.S. jurisdictions.
- J. David Giese on FDA’s rollout of agentic AI tools that enhance reviewer analysis.
- Edward B. on patient-safety considerations for electronic patient record software.
- Mario Gabrielli Cossellu on updated EU CAB/NB designation progress.
- Bastian Krapinger-Ruether on FDA post-market surveillance expectations and quality system alignment.
- Jose Bohorquez on the role of a Software Design Specification in FDA and IEC 62304 compliance.

And more...
Sean 🐝

Founder & Publisher | MedTech, Life Sciences, HealthTech | MDR/IVDR, QA/RA | Leading Voice Program | Worker 🐝

MedTech Leading Voice | Issue 141 AI Validation Risks Come Into Focus: Why Model Drift Is Shaping 2025–2026 Quality and Compliance Planning - Plus, ho

Open article: Hidden Validation Risks of AI in MedTech Manufacturing: Why Model Drift Matters for 2025–2026 by Sean Smith • 5 min read

Hidden Validation Risks of AI in MedTech Manufacturing: Why Model Drift Matters for 2025–2026

Hey gang, meet Elizabeth Wellwood. Director of Quality Services and Operations at ClariMed, Inc.

As you may know, I’ve unofficially declared December Human Factors Awareness Month. (There was no vote. I just did it. Felt right.)

And last week’s conversation with Liz Wellwood reinforced why this theme deserves its own season.

Liz has spent 14 years inside real quality systems. She’s seen devices move from sketch to submission to “why are we getting so many complaints about this button?”

🔥 And in the middle of that conversation, she dropped a line that stuck with me: “To me, human factors is already part of the quality system.”

Once you hear that, it stays with you.

It reshapes everything from user needs to labeling choices to risk files to those moments when a CAPA reveals something you really wish had been caught earlier.

Liz also pointed out something that matters for every RA/QA team heading into 2026: “With the FDA adopting ISO 13485, this work becomes part of the foundation of the QMS.”

That framing has weight.

- It changes how teams think about design.
- It changes how they interpret user behavior.
- It changes how they prepare for downstream consequences that pile up when HF is treated like an afterthought.

So this Friday at 11 a.m. ET, Liz is leading a different kind of session — the kind where everyone shapes the output together. A working map of where human factors lives inside the QMS, built with the room.

We’ll look at HF touchpoints across design, risk, labeling, training, CAPA, PMS, and everything in between.

👉 We’ll close with a Monday-ready checklist you can walk straight into your next project review.

Think of it as a collaborative HF workshop for anyone who wants clarity on how this work strengthens quality from the inside out — and yes, it will be fun. (Quality people have fun. I’ve seen it. I have proof.)

Details are in the comments.

Candid photo of Liz Wellwood, Director of Quality Services and Operations, ClariMed, Inc.

With QMSR and the FDA emphasis on ISO 13485 fast approaching, December is (unofficially) Human Factors Awareness Month. Here are just a few highlights from my recent conversations with HF experts from ClariMed, Inc. 

Read the full article, featuring insights from Kelley Kendle, Annmarie Nicolson, Leya Bergquist, Kay Sim, Jessica Parry (C.ErgHF), Wendy S., Louisa Harvey, and Merrill Zavod, PhD.

#humanfactors #medicaldevices

🔥 MedTech Leading Voice and ClariMed Present: The Human Factors Usability Prep Kit Human factors remains one of the least understood disciplines in M

Open article: 5 Ways Human Factors Sink FDA Submissions by Sean Smith • 5 min read

5 Ways Human Factors Sink FDA Submissions

As a business owner, I am always inspired by talking with other founders, especially in the MedTech space. Recently, I had the pleasure of hosting Laura Van Vaeck and Rob Bedford on MLVx to discuss their new CRO venture, Franklyn Health.

In case you missed it, here's a quick recap and interview.

A MedTech Leading Voice Profile of Franklyn Health CRO When Rob Bedford and Laura Van Vaeck decided to launch Franklyn Health in October 2024, they kn

Open article: Why Two Clinical Research Leaders Built Franklyn Health CRO in 2025 by Sean Smith • 8 min read

Why Two Clinical Research Leaders Built Franklyn Health CRO in 2025

🔥 Last week’s Friday in Focus felt alive.
We had more than 100 auditors, consultants, notified body veterans, clinical folks, and quality leaders all in the same room — swapping stories, challenging ideas, and pushing Rob Packard with nonstop questions.

The chat was running so fast we could barely keep up.

Leonard, Rocío, Susan, Darrin, Sandi, Eckhard, David, Catherine, Tianna — the whole group brought real field experience to the conversation.

This two-minute highlight reel captures a couple of the key moments:

✅ What qualifies an auditor in practice — training, observed audits, and the repetition that builds judgment
✅ How better questions change the tone of an audit
✅ The art of choosing the right records and sampling with intention
✅ Building credibility through documentation, continuing education, and a clear track record
✅ Growth areas Rob is watching: ISO 27001, cybersecurity, clinical studies, algorithms, and combination products
✅ The reminder that successful auditors help teams improve, not just complete reports

It’s a quick watch, and it says a lot about where MedTech quality work is heading.

Upcoming In-Focus Calls

This Friday — Dec 12: Integrating Human Factors into the Quality System with Elizabeth Wellwood (ClariMed, Inc.) - Together, we’ll map the touchpoints where HF strengthens reliability, usability, and system performance — and we’ll build a shared checklist together. A working session, not a lecture.

Next Friday — Dec 19: Honing Your MedTech Message in Two Minutes with Tino Chow (Giant Shoulders). A workshop for founders, consultants, and technical leaders who want to stand out and be remembered.

And one more for the auditors in the group:
Rob’s SaMD Lead Auditor Masterclass is scheduled for Dec 17. It’s a clean pathway for anyone preparing for QMSR, MDSAP, or deeper SaMD responsibilities.

Two more Friday in Focus calls left in 2025.
Watch the recap — links in comments. 🐝 

#MedTech #Quality #RegulatoryAffairs #QMS #MedicalDevices #MLVx

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