Mike Luloh

AI training for R&D leaders in regulated industries.

Practical skills for the tools your company actually allows.

The gap

Picture the senior engineer on your team with 20 years' experience. Right now they're quietly avoiding Copilot because the one time they tried it, the output was wrong in a way they couldn't trust. So they went back to doing things the way they always have.

It isn't one thing. Copilot is crippled in their environment — locked down by IT, no Claude, no ChatGPT, features most users don't know exist. And nobody taught them how to work effectively with AI in the first place — when to use it, when not to, how to catch the confident-sounding wrong answer before it becomes a problem.

Multiply that by every senior person in your org and you have a pretty good picture of where most of the unrealized value is hiding.

That gap — between the AI mandate and the reality on the ground — is where I work.

What I offer

1:1 sessions

For directors and senior engineers who want to build AI fluency or think through their own strategy. Live, one hour, billed by the session. No minimum commitment.

$250 per hour
Small-group cohort sessions

Live, two hours, typically four to eight people. Good for directors who want to train a team or for peers who want to learn together.

$150 per person per session

All sessions are live. Nothing is pre-recorded. You ask questions, we work through your actual problems, you leave with something you can use Monday.

Who this is for

R&D directors and senior engineers at FDA-regulated companies — medical devices, pharma, life sciences.

You're under pressure to show AI fluency. Your IT department has locked you into Microsoft Copilot. Your team is making it work at the margins and not much more. You don't need an AI evangelist. You need someone who knows what your environment actually looks like.

About me

30 years building safety-critical medical device software. My work at Alcon includes real-time laser shot-pattern control for LASIK surgical instruments and novel vibration-cancellation methods for high-speed optical metrology of intraocular lenses — systems still in production use today. I also serve as a voting member on the AAMI SM/WG 01 committee that maintains IEC 62304, the international standard for medical device software.

I'm not an AI researcher. I'm an engineer who has spent the last three years figuring out where AI actually fits in regulated product development, what the real risks are, and how to implement it without creating compliance exposure. That's what I teach.

Get in touch

Tell me a bit about your team and what you're trying to solve. I'll respond within a day or two.