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.

We’ve Spent Billions on Cybersecurity. We Good Now?

Details to follow.

Patents and the FDA: Powerful Strategy or Only Hope?

A patent strategy is critical for medical device commercialization. So is an FDA strategy. But a patent strategy disjointed from the FDA strategy is no strategy at all.

There are traps for the unwary in separating these two components of medical device development. By elegantly considering a regulatory strategy in view of the patent strategy and vice versa you help build up your competitive advantages, reduce risk, and help minimize obstacles typical to successful commercialization and/or securing investment.

In this talk, you will learn:

  1. Why patents should be developed in view of the regulatory pathway; the investment should be proportional and consistent with risk.

  2. Why it’s critical your regulatory strategy is consistent with your patent strategy; don’t let things to say to government agency hurt in other areas.

  3. Why coordinated patent claims that are consistent with the scope of indications of use and patient population is one way to increase portfolio value and secure your revenue model.

Break

Fast Round: Meet 4 Companies That Can Help You Right Away, Part 3

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.)

There’s a Right Way and a Wrong Way To Do User-Centered Development

User-centered development of home- and professional-use devices, IVDs, and combination products

When Did Medical Device Innovation Break Down (and How to Fix It)

Ty Hagler believes medical device innovation relies too heavily on process and neglects the skill of the practitioner. Do you agree?

He’ll explain how design thinking is an easy concept to grasp, and harder to master. What to look for.

Lunch

FDA Regulation: A Peek into AI Proposed Regulatory Framework

Artificial intelligence applications rely on diverse datasets to make informed decisions. As datasets grow, algorithms improve in sensitivity and specificity. The challenge remains, how to handle this from a regulatory perspective without hindering innovation and delaying products into the market?

The FDA is considering modifications to the Software as a Medical Device Pre-Specifications (SaMD) that would allow for changes to be made because of learning and adaptation. The FDA’s goal is to ensure that the safety and effectiveness of the software as a medical device is maintained.

In this discussion, Shawnnah will lead an overview of the Software as a Medical Device Pre-Specifications (SaMD) guidance(s) and how the proposed FDA framework allows for iterative improvements of artificial intelligence and machine learning-based software as a medical device, while assuring patient safety.