No, probably not. I think what we're going to do is we're
going to try and take regulatory issues that a related to designing and,
designing and innovation. I want to try and condense those to a
very few slides. Because the problem with regulatory
issues across the world as they change from country to country.
They change not terribly dramatically. But they change significantly.
So when we look at our six constraints that we've talked about in the past, we
focus on freedom to operate. If you recall, we're thinking about three
items, one of which is legal and intellectual property which we're not
going to be covering today because we've already covered that.
And we're not going to be talking about financial reimbursement, because we're
going to be covering that. And what we want to talk about today is
regulatory. We're going to be talking about it in the
context of the United States Food and Drug Administration.
So here we go. because this is such a complex topic,
and, I don't want to spend hours upon hours on this, here are three good
references for you. this first one is a set of PowerPoint
slides that talks about the United States Food and Drug Administration, and a
little background on what it does, and some of the current issues and challenges
that they face. the second one there is a very
comprehensive discussion that you'll find in Wikipedia.
And what I like about this is not so much that the article is comprehensive, but
rather the links are comprehensive. So, if you're truly interested in the
Food and Drug Administration, and regulatory policy, and the details of how
to bring your product, service or process, through the regulatory process
in general, this is a good place to start.
it will give you some a number of of places to investigate, that are very
specific to your particular situation. And then finally in Stanford the by
design program has been kind enough to produce a few things on very, very basic
regulatory policies and procedures. let's go through the details of this
quickly, and I'm going to try and do it in somewhat memorable fashion.
step one in, in, and I'm going to look at devices primarily.
I'm not going to be talking about any, you know, pharmaceuticals and
pharmacology. And I'm not going to talk about
processes, we're going to talk about, specifically about devices.
You'll find that whatever you are trying to get through the regulatory process in
terms of Food and Drug Administration. Whether it is a pharmaceutical, or an
ethical drug, or whether it's a device, or a product, or a diagnostic.
By the way, some countries do not allow diagnostics.
pardon me, if I look, look back to patentabliity, some countries don't allow
diagnostics to be patentable. But we can, we can talk about that some
other time, perhaps. Maybe during one of our forums, we will
see. The first thing is you get, in terms of
what's the class of your device. And they're, in just broad general terms,
in three classes of devices. those devices that are exempt, those
devices that require a predicate device, and those devices that are a little bit
more difficult. and require a lot, difficult to bring to
market, I should say. They require extensive, extensive work
and analysis. And step three is putting a plan together
to to bring your product, or device, to the marketplace.
And the way in which you do that across these three different device classes is
somewhat different. Let's take a look at these class one
devices. Those are devices that are minimally of
prospective harm. Simple design.
Let's take a look at some examples. handheld instruments, gloves, tongue
depressors. cotton tipped swabs, cotton balls,
they're minimally prospective harm. Harm is not foreseeable, when used
correctly, with a simple design. We'd have to believe that a pair of
forceps is a simple design, and is indeed a scalpel.
Class two devices, they're typically non-invasive devices.
They're somewhat more complicated than class one, and they demonstrate no injury
or no prospective harm. Powered wheelchairs, and X-ray machines.
X-ray machines. It's one of those that, and now you're
beginning to see that the definition between class one, class two, and in just
a minute, class three, that that definition may be some what difficult.
Because it said, no prospective harm an X-ray machine overused though,
prospective harm. Powered wheelchairs, inappropriately used
or inappropriately trained, could indeed lead to harm.
