This interdisciplinary course focuses on sustainable innovation, introducing entrepreneurial students to the realities of problem identification and solution design within the complex world of healthcare.
Regulatory Issues
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來自 Duke University 的課程
Healthcare Innovation and Entrepreneurship
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從本節課中
Designing an Innovation
What approaches work best for design creation? Is "Brainstorming" an actual process? How do you select the "best fit" design from competing choices? How do you assess the operating environment? Is regulation always bad? Do you have a reimbursement plan?
與講師見面
Marilyn M. Lombardi, Ph.D.Associate Clinical Professor
School of Nursing
Bob Barnes, PhDInstructor
Biomedical Engineering
Well this is Bob Barnes, on behalf of Marilyn Lombardy.
Thank you very much for returning. Let's talk about regulatory issues for a
little while. And, this is probably going to take us,
you might as well go get a cup of coffee and a couple of sandwiches.
We're probably going to be at this for at least eight, ten, 12 hours,
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.
But, it's obvious that class two is a much more complicated and complex device
than is a class one. Class three, typically implantable
devices. Therapeutic devices, life sustaining
devices. And similar devices do not exist, or have
not, or have not been approved. Pacemakers, breast implants, replacement
heart valves. These are examples.
Let's go another step. Class one devices.
Class one devices are called exempt. There's no predicate required.
In other words, there doesn't have to be anything similar in the, in in the
healthcare world. It requires no approval.
But remember, these are minimally invasive devices that, if at all, not
invasive. They're more like tongue depressors and
gloves than not. You do have to register them with the
FDA. There's a registration process.
And if you're in other countries, you'll have to register your class one device,
or whatever designation. The device has to comply with FDA
labeling. In other words, there has to be a label
that, that, that, step-by-step, indicates how the product is supposed to be
correctly used. And that labeling, in terms of complying
with FDA, Food and Drug Administration labeling, has to be at a certain
education level. And has to be clearly and easily
understood, by a very wide group of people that may indeed use the device, or
the product. And your organization has to have a
quality control system in place, that if all it, could be demonstrated produces
the same level of high quality sterile device consistently.
Class two devices. Demonstrate similarity to an approved or
predicate device. In other words, you've come up with a
device that is in many ways similar to, acts in a similar manner, in a similar
environment, to an existing device. Now remember, we're talking about
approval by the Food and Drug Administration, we're not talking about
patentability here. Because if you have a device and it's so
similar to some other device, there's a question about whether it's patentable or
not. That is another issues all together.
We're talking about regulatory approval. Demonstrate similar to an approved
predicate device, same material, same function, same environment, same class of
clients, same disease, etc. The more similarity, the more likely you
can qualify as a class two device. It meets class one requirements.
And it has the same special controls, plus a little more.
Labeling, mandatory performance standards.
In other words, you're going to be able to demonstrate the performance is similar
to the predicate devices, or those devices that are similar.
You must also maintain post-market surveillance.
So that you can clearly demonstrate whether your device is more or less
efficacious, more or less, quote unquote, dangerous, than existing devices.
Class three device. This requires a Food and Drug
Administration pre-market approval process.
We'll talk about that in a second. And the device meets all class one and or
class two requirements. Labeling.
Post-market. The one thing that is significantly
different about class three devices, which sometimes be, will be referred to
as PMA, Pre-market Approval Process devices, is they require comprehensive
trials and demonstrations. Typically a large multi-location study.
Statistically representative and randomized clinical trials, these are
typically multi-year. They, these tests, should be
statistically significant for every market segment that you intend your
device to be applicable to. So here's good news and bad news.
You can keep your costs down if your device is only intended for one small
market, or one class of disease. That will keep your costs of your
clinical trials, the costs of that low. Which you cannot proactively market, you
cannot market that device to any group that is not in the clinical trial.
So, now we have a balancing act, from a clinic, from a healthcare or clinician
perspective, and a financial perspective. If you want it to be broadly applicable,
then your clinical trials must be broadly applicable.
This is going to cost more. We'll talk about specific costs and
duration in a minute. Any device [COUGH], that has a life
sustaining capability. Whether there's a predicate device, some
other device already exists, or not [COUGH], must goes through the PMA
process, and the clinical trials associated with it.
So in summary. When we think about regulatory approval
and regulator issues, the first step is determine what type device, what class
device you have. If it's class one, it's exempt from
testing. For this to be able to go to market,
legally, in the United States, you will indeed have to register with the FDA.
Now, that registration and that process is probably going to several weeks to
perhaps a few months. It will cost from $1,000 to $10,000,
depending upon the relative complexity of your device, or your product.
If it's a class two device or product, this goes through what we call here a
510K process. In other words, this is a process that is
not as simple as class one. Recognizes that there are other similar
devices that are already performing and have already been approved for the
application that you're seeking. And this typically takes months to maybe
a year. Maybe 18 months.
May cost between ten to 50, $10,000 hundred, several $100,000, depending on
the nature of the device or product, and the population.
And the number of predicate devices. If you have a class three device, plan on
this taking several years, a large clinical trial.
And it's going to cost between several $100,000, and perhaps several, several
million dollars. Hopefully, this cuts through a lot of the
detail, and gives you very clear idea of, here's where I am with my device, my
product. I've got a very good needs specification
to this point, which includes comprehensive market analysis [COUGH].
And I also already got my device, my product has already been through the
conceptual design process. Remember, that's if it's going to have
safety implications, it's going to have to be a class three device, and go
through this process. Good news and bad, again.
Once you have your class three approval, in many cases it's very difficult to
replicate what you have done. This may be a way for you to to build
barriers to entry for others. Think about that for a second, it's
going to cost a lot and take a long time. If you would like to have your device in
the marketplace to address health care issues promptly, and if there are other
devices that are similar in some way to yours, perhaps a 510K, a class two
approach might be more appropriate. Well, ladies and gentlemen, again, thank
you for your attention. I hope that this brief overview of
regulatory issues, dealing with the three classes of device and or product, that
you may be seeking FDA clearance and or approval for, or exemption, has been
useful. I look forward to talking to you again
some time soon. Please keep in touch.
I look forward to seeing your postings, and your interaction in our forums.
Good day.
