Program Ends (kind of)

It’s true, the two day-long program has concluded.

But the new relationships you formed are just beginning!

If you go back to work and don’t keep in touch with the people you met, well, why’d you come in the first place?

Go. Cement relationships. Build your network of medical device professionals on whom you can rely.

Many of today’s guests hail from my most trusted MDG Premium network. We meet weekly. Perhaps joining us is a good place to start.

You can join us at

MDG Premium here. And if you attended, I probably gave you a secret code for a discount. 🙂

You’re a 10x alumnus now! You can call me anytime, for anything.

I’m happy to know you.

Closing Thoughts

A little real-time feedback from you:
• What were your major takeaways?
• What did you love?
• What can we improve for next time?
A special discount toward future 10x Medical Device Conferences will be available only at this time as a thank-you to those to stay until the end for the feedback session.

Concentrated Consulting

Something we did with much success last year: Invited two audience members in front of the room to discuss their greatest challenges. The audience, filled with experts in every discipline, gave their thoughts with lots of “have you considered…” and “I know someone you should meet. Talk with me later.”

You know, family stuff. 😇


Fast Round: Close and Personal with 4 Guests

Click here to apply for one of the limited Fast Round spots.
This is how a ‘Fast Round’ works:

  • It’ll be just you and Joe onstage, both sitting on bar stools.
  • Joe will ask questions, the kind he’d ask if he walked up to your trade show booth.
  • Joe won’t prepare in advance. In fact, the less he knows, the better.
  • Joe will start with this question: “So who are you and what do you do?”
  • Questions will flow naturally from there.
  • Joe may also ask (so be prepared): “Teach us something about your work (but not in any way self-promotional) that you believe the average guest in our audience may not know.”
  • If you choose to bring something onstage, it will be small enough for you to carry on and off the stage.
  • You’ll need to fill out a simple one-page template. During our time, we’ll project it onscreen to aid visual learners. It will also appear in show photographs (and can subsequently be used for your social media efforts).
  • It will be recorded and professionally edited for your later use, however you see fit.

It’ll be fun, casual, and a real crowd-pleaser. Starring you!

A sample Fast Round, below, with the balance here on YouTube. Should we feature you too?
(A modest additional charge assessed to cover production costs.)

Actually Using AL/ML to Improve RA/QA Performance Today

Details to follow.

Place Your Bets: The Quality Management System Horserace

How to make those pesky procedures and regulations make sense for your company, who needs to understand and use the procedures, and how to make continuous improvement work for you.


Cybersecurity Panel: The New Bare Minimums For Your Business

Details to follow for this panel discussion.

Why Did FDA Reject Your Rationale for No Usability Testing?

If anyone can explain why, it’s Rob. He writes, “90% of usability testing submitted to the FDA is unacceptable and the root cause is simply a failure to understand the human factors process.”

And continues, “Unlike CE Marking technical files, the FDA does not require a usability engineering file for all products.

Instead, the FDA determines if usability testing is required based upon a comparison of your device’s user interface and a competitor’s user interface (i.e. predicate device user interface). If the user interface is identical, then usability testing may not be required.

Instead, your company should be able to write a rationale for not doing usability testing based upon equivalence with the predicate device. If there are differences in your user interface, you will need to provide use-related risk analysis (URRA), identify critical tasks, implement risk controls, and provide verification testing to demonstrate the effectiveness of the risk controls.

Even if your device is “easier to use” or “simpler”, you still need to provide the documentation to support this claim in your submission. The FDA also does not allow comparative claims in your marketing for 510(k) cleared devices. Comparative claims require the support of clinical data.”

Rob will show you the 10 steps to deliver what you need to FDA and proceed without nasty surprises.