Top Talent Accelerant

10/13/2026

“Clean up all code.”

That was the entire description on a software change order at a wound-therapy device company that the FDA inspected this spring.

When the investigator asked what had actually changed, neither the CEO nor the President could say.

There was no verification record. Another ten more software changes had been closed without records showing they were implemented correctly. Several CAPA forms were incomplete.

That’s from one of the first warning letters issued under the FDA’s new QMSR, which took effect in February.

I’ve read through the early ones, and a pattern jumps out.

At one company, a contract manufacturer added a new intended use to a device, and the company had no record of the change. At another, the risk procedure never said who was responsible. At a third, the risk analysis hadn’t been updated since 2020, even after a Class I recall.

None of these is a paperwork problem. In each case, nobody with the right expertise owned the system.

QMSR puts risk management front and center. Since it took effect, risk management has become the FDA’s most-cited 483 observation, accounting for more than 20% of all 483 citations. And you can’t have accountable risk management without accountable people. Outsourcing the work doesn’t outsource the responsibility.

The companies that do well in these inspections aren’t the ones with the thickest binders. They’re the ones with someone in the room who can answer the question.

So, for the hiring managers here:

If FDA walked in tomorrow and asked what changed, who on your team could answer?

09/30/2026

One of my favorite scriptures is:

Luke 6:38
What we give we will receive.

I think of it every time I get a new opportunity with a partner whether it be a company or a talented candidate.

In the last month, I’ve been blessed to partner with many incredible people and receive three new professional references, that are all distinctly different.

Remarkable people and talents, and yet completely different circumstances.

The first, someone I met for the very first time that I had the opportunity to partner with for a Director of Regulatory Affairs position. I had so much fun getting to know her, supporting her through the process, and celebrating her new opportunity with her.

The second, was with someone that I’ve known for six years and helped bring talent to her team previously. Polished, respected, kind, knowledgeable, and incredibly talented. This was the first time I had the opportunity to work with her for her career interests and, likewise, it was special to celebrate her new opportunity.

The third was an impressive executive that I had professionally, but persistently pursued from a business development standpoint for three years. Finally, those efforts paid off last summer as, due to M&A activities, he had a strategic and challenging hire around RA strategy for AI, ML, cybersecurity, & PDCC.

The opportunity to partner with him did not disappoint, and it was obvious through the process why he has had such tremendous personal career success and high retention rates for his teams.

All different, however, all important to me for the same reasons. My goal is always to bring something unique to each individual that brings value whether that’s an industry insight, support in their preparation to help better position them, or simply be the right sounding board when their are unexpected challenges to the process.

Sometimes, when you are in recruiting, sales, BD…. it’s harder said than done to remember, it’s not about us, particularly when the market is compressed, and everybody is fighting for the same opportunities.

What rule, best practice, or successful memory do you keep close to your chest that helps keep you grounded?

09/25/2026

A few weeks ago I wrote about a café on Lake Como where the owner was rude multiple times and didn’t seem to care because there weren’t many options.

So, I took my business up the hill.

This month I have been in Indonesia.

Completely different world.

There's a restaurant on nearly every corner here, and business is tight. So, they fight for you. They want to know your name. They let you run a tab without a second thought.

They'll walk down the street to find something they don't have on the menu. They are, without exception, some of the kindest people I've ever been served by.

Mini (she is a sweetheart!) that runs the restaurant next to the VRBO I am renting, will make anything I want, even if it’s not on the menu! She is contantly asking me if I am happy or if I want something different.

Same industry. Same job. Opposite behavior.

In the Italy area with minimal competition, that restaurant acted like I'd always come back. I didn't.

Here, they act like every guest could walk out the door. Yes, I have tried other places but because of the relationship and incredible service, I keep coming back and have given them 70% of my business.

I have witnessed similar behaviors in MedTech hiring over the past 11+ years. When RA/QA, R&D, and Engineering talent is scarce, companies return calls same day, move fast, and are more cognizant to attract the talent versus simply interviewing.

When the market loosens, candidates tend to get ghosted more, there are more rounds of interviews, and they are treated more transactionally. Those candidates remember. And don’t think that they won’t take their talent up the hill.

Kindness gets someone through the door. Sustained quality is what keeps them. Annual Voluntary Turnover averages 25% across all industries and it’s typically the people companies can’t afford to lose.

The places that do both are the ones I enjoy coming back to, and the best teams I've worked with are the same. They treat candidates well in every market, and they back it up with a role and a culture worth staying for.

AI adoption in hiring processes the last 2 years is causing major pigeon holes; roles are staying open longer and communication is getting worse.

Executive Leadership, what do you do to take an active interest in the hiring culture at your company to attract top talent and differentiate from the marketplace to leave the best impression whether they get the offer or not?

How are you making sure humans still matter in the Age of AI, whether it’s the hiring process, regulatory & quality compliance, or operational efficiency?

Picture- some of my new friends and a picture at the top of the volcano, Mt. Agung.

09/18/2026

Medline's CAPA procedure said exactly what to do.

The data said it was time to do it.

For three quarters, nobody did.

FDA's March warning letter lays it out. Syringes were disconnecting from manifolds in the field. Medline opened a CAPA, applied a fix, and set its own effectiveness threshold: 15.98 complaints per million.

After the fix, the rate came in at 16.90. Then 16.44. Then 26.81.

The procedure said to send the CAPA back a phase or open a new one. It never happened.

Here's the part that stopped me.

Their own design FMEA listed air embolism as the highest-severity outcome for a loose connection. Their health hazard evaluation rated the risk low.

By the time of the letter: 221 complaints and 177 MDRs, including one where air was injected into a patient.

The letter doesn't say who made those calls. But this wasn't a documentation gap. The SOP was fine. What was missing was someone who'd say, "These two documents don't agree," and had the standing to be heard.

Hiring managers: when you interview quality and RA candidates, do you test whether they'd challenge a "low risk" call that contradicts their own FMEA?

09/16/2026

Before every dive, there's a CRITICAL PROCESS.

Check the tank pressure. Check the regulator. Check the BCD. Weights. Check your buddy's gear and have them check yours.

It feels slow when you're excited to get in the water. But you don't skip the check. Because underwater, there's no calling a timeout. A problem you didn't catch on the surface becomes a crisis at 60 feet.

After over 30+ years in the industry, my perspective is that Medtech companies should.

A Quality Management System isn't the exciting part of building a device for some. Neither is a rigorous hiring process for the RA and R&D talent responsible for it. Both can feel like friction when there's pressure to move fast and get to market.

But skip the check, and you don't find out until you're already underwater. That's when the FDA warning letter shows up. That's when a recall traces back to a gap in documentation, or a role filled with someone who looked qualified on paper but didn't have the judgment the job required.

Here's the thing, though — when you do it right, something special becomes possible.

On that same dive, seven manta rays appeared out of the blue (not really- I had actually been praying intentionally for them for 30 minutes!), gliding and turning together like they were choreographed. A moment you couldn't have planned for and could only be present for because everything up front had been done right.

The companies that treat quality and hiring as the foundation, not the friction, put themselves in a position for that kind of moment — the breakthrough product, the standout hire, the outcome that looks like it came easy because the hard part happened earlier, out of sight.

What's one "check" your organization refuses to skip, even under pressure to move faster?

09/15/2026

Today is an exciting day, as I sent the final manuscript and intial book cover information for my second book:

“Top Talent Accelerant: Talent Management in the Age of AI”

This was a completely different book and challenge that was an interesting project working somewhat in correlation with the buildout. As the industry continues to change rapidly and significantly relevant to , the conversations that I am have had regularly the past 2 years around the challenges AI brings to the recruiting process become more compelling.

My hope is that, like the SaaS, it brings insight and value around how important human beings are in the Age of AI. That transactional behaviors bring transactional and less valuable results whether it’s in the regulatory pathway, the QmS, the manufacturing process, the commercial launch phase, or talent management.

At some point, and I would suggest earlier in the process versus later, a human with high emotional intelligence and expertise still has to perform V&V regardless of the functional area.

The book shares the entrepreneurial journey through this lens in the Medtech industry on what the results look like relavent to risk management, warning letters, talent management, overall efficiency of process, and success versus failure while adding in real time experience and scenarios happening as AI explodes.

With Talent Management, regardless of how much AI is involved up front, at some point a person is going to have to verify and validate the skills, interest, and fit at the company and for the role. As AI creates less efficiency in recruiting, scenarios where candidates feel lest respected or valued, and a higher % of candidates are actually not real, the industry faces an interesting level of inefficiency as critical postions stay open longer.

My hope is that the book brings focus into how important the right people are while the SaaS brings a process that proves it.

Thank you for all the companies and candidates that have been an integral part of this journey over the past 11.5 years. None of this could’ve happened or would’ve mattered without you and I sincerely thank you and our following from the bottom of my heart.

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08/26/2026

The first day at MedTech World Asia was fantastic with a great conversation about the conference, the industry, and the value being brought to the ecosystem by Dylan Attard MD, MRCSI, MEnt. and his phenomenal team.

There is simply a remarkable energy around this event and the Medtech World team; genuine, sincere, and fun. Thank you Shara Layton and Yulia Yurevich for your efforts and support.

The cultural aspect of today’s adventures were fantastic and created a fun, relaxed environment to learn while networking, sharing ideas, and industry insights. The feedback and insight on the TTA has already been invaluablel!

Great dinner and awards ceremony tonight! I can’t wait for tomorrow’s panels, presentations, and networking opportunities.

Great start to this amazing conference!

Blue Goat Cyber
Lars van den Broek
Simon Terhürne
Rafael J. Veraza, PhD, MPH
Patrick Nowlin

08/21/2026

https://www.linkedin.com/posts/medtech-hiring-leadership-ugcPost-7496632820354854912-Lv7i?utm_medium=ios_app&rcm=ACoAAAI4XFYBg8pLaKJwURzLEETjVV9jpbBAiAM&utm_source=social_share_send&utm_campaign=facebook

Hiring the wrong person for a critical MedTech role can become an expensive mistake. Consider what happens next. Time has already gone into recruiting and interviewing. The new hire needs to be onboarded and trained. If the fit is wrong, the company has to address the disruption, reopen the position...

08/21/2026

Today is a day that I will enjoy for a while and never forget.

A candidate I helped make a strategic career move last year just found out she's being promoted to Fellow.

Let me back up.

Last year, I had the opportunity to support a VP of RA at a top-15 global MedTech company with a challenging problem. Their RA team wasn't broken — it was the opposite. A decade-long track record, 95% retention. The kind of team most companies would love to just… leave alone.

But a new technology acquisition changed the ground under them. They needed RA talent who understood , , , and PDCC well enough to build submission and compliance strategy — and to sit across the table from the FDA and hold their own on all of it.

That combination of experience barely exists in the market. Real talk: I could count the qualified candidates on one hand within a commutable distance, and it was hybrid.

The VP that I was partnering with made one thing clear from the start: culture mattered as much as capability. He wasn't going to protect a 95% retention rate by hiring someone who didn't fit the team.

In a niche area, we were able to find the right talent, and the entire process was 4 weeks.

She was moving from Class II to Class III devices — a real career leap — and what pulled her in wasn't the title. It was the culture. She could feel, even through the interview process, that this was a team worth joining and an opportunity to be mentored.

One of the main topics we discussed when she accepted the offer was who she could become professionally over the next few years and how that would benefit her personally!

Fast forward: last year she earned the highest annual review the company gives out.

And today, she's a Fellow!

I've known this was coming since April. Sitting on that secret for months made today's congratulations even sweeter.

She did the work. Over the years, the VP built a team worth staying for. I just got to be the person who made the introduction and managed the process to help her join the team.

This is the part of recruiting I love most — getting to be a part of a strategic hiring strategy and then having the opportunity to celebrate the results.

To the hiring managers developing and protecting a team like this one- how do you evaluate the ability to perform the technical aspects of the position versus the cultural fit?

08/20/2026

Thank you Blue Goat Cyber for having me on the podcast to talk about talent management in the age of , the Top Talent Accelerant, Inc. , and the importance around risk management in Medtech for AI, ML, and cybersecurity.

I love your passion for helping others and bringing solutions that prevent the disasters that effect patient safety physically and from a personal data standpoint, as well.

When Candidates and Companies Both Use AI