Regulatory + Quality Assurance | Michelle Lott | lean RAQA

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Regulatory Strategy

Michelle is a "no shit" expert in helping start-up companies with FDA. She sits on an FDA advisory committee, helped inform FDA's thinking on a classification, and has team members who specialize in a variety of medical devices.

  • Dr. Mark Adkins
    Founder
    AK Collaborations

Why is regulatory strategy important?

Many medical device companies see “everything regulatory” as a burden.

That’s a matter of perspective.

I see regulatory strategy, done right, as a competitive advantage. So do my clients.

Are there lots of forms? Sure, and you can delegate most of that to me or someone else.

But the thinking, the planning, the strategizing?

That’s very much worth your time and talents. You’re even more effective when you engage someone who lives regulatory all day long.

And researches it.

Even enjoys it.

Project work varies greatly around here at Lean. Some clients “just have a question.” They “just like knowing they can call me” whenever the need arises.

Others have an audit in two weeks(!!) ??? and are gonna ? unless I call them back right now!!!

The reason for your visit to my site today (thank you) probably falls somewhere in the middle. And statistically, if Google Analytics is to be believed, you’ll likely visit a few pages and not email me or use my calendar.

But why, I always wonder.

You’re looking for something specific and I probably have it.

Are you afraid I’ll put you on some big list and try to sell you all the time?

Well, newsflash: Nobody has time for that antiquated nonsense. You don’t. And I definitely don’t.

So, if you’ve got a ? about regulatory strategy, just ask me already.

Why you need a strong regulatory strategy

First, you’re going to do regulatory something anyway. It’s unavoidable.

So if you’re doing it anyway, do it smartly. With me, with someone else. But do it smartly and in the least burdensome way.

Beat your competition while you’re at it.

Second, a strong regulatory strategy lets you:

  • Get money. Investors like knowing what they’re investing in. If you can’t effectively project costs, timelines, and testing, you ain’t getting the money. Sorry about that.
  • Skirt death. Come to Arizona, buy me a glass of wine, and I’ll tell you about the clients who should have called me sooner.Because when you get caught being out of compliance, you’re already in a ditch. I can help you out of the ditch, sure.

    But you’ll need shovels to cover up that huge hole. Probably a landscaper too. All could have been avoided, just sayin’.

  • Expedite clearance. Without a strong regulatory strategy, your submissions risk getting sucked into a bureaucratic vortex. Oh, the time wasted going back and forth for a change here, an edit there. It adds up and pushes your launch back further and further.

Contents of a strong regulatory strategy

You’ll see. This isn’t so bad. And I can help you with each.

  • Clear intended use and indications statement
  • Product type determination
  • Product code determination
  • Product classification
  • Identification of any exemptions
  • Itemization of applicable recognized consensus standards
  • Itemization of applicable FDA guidance documents
  • Analysis, costs, risks and recommendation for submission options
  • Analysis and recommendation for test strategies based on standards and guidance documents
  • Review of changing regulations, policies, or politics that may affect product clearance
  • Quality Management System requirements, costs, and resources post commercialization

Help has arrived

Pick an open half hour on my calendar.

Maybe I can lighten your workload!

+ Michelle +