3.1.1 Medical Device Industry: Regulatory Basics

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来自 University of Minnesota 的课程

Healthcare Marketplace Capstone

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University of Minnesota

Healthcare Marketplace Capstone

24 个评分

课程 5（共 5 门，Specialization 医疗市场）

In the Healthcare Marketplace specialization capstone course, key skills are engendered from the four prior courses to create an original medical innovation valuation. The first course in the specialization teaches the learner to size a population or market. The second course teaches whether the clinician will or will not find value from deploying a new innovation. The third course identifies the competitive landscape of medical technology innovations to compete or complement. The fourth course, teaches how to put a monetary value on the improvement in health resulting from a new innovation. The summary of these elements creates a document of high strategic value where the learner has demonstrated not only an understanding of the marketplace but what is required for the marketplace to advance. This is what is accomplished during the Healthcare Marketplace capstone experience.

从本节课中

Milestone 3: Regulatory and IP Status of the Innovation

Almost any new medical technology for consideration by an investor will insist on safety and efficacy approval by a government regulator like the United States FDA. Furthermore they will insist on an assessment of whether the intellectual property (IP) that the innovation operates in is not conflicting with other IP claims. For this milestone you will complete a brief assessment of how the innovation would be classified by the US FDA as well as generate a very cursory patent search for conflicting IP claims using common and free tools on the Internet such as Google patent search and the US Patent and Trademark office web site. The assessment should be 2-3 to pages in length.

1.1.3 Pharmaceutical Industry: Intellectual Property6:37

1.2.2 Investigational New Drug (Phase 1 to Phase 4)4:29

3.1.1 Medical Device Industry: Regulatory Basics8:23

4.2.3 The 510k: Friend or Foe?5:12

4.3.3 Keeping the Product Fresh and Safe in the Long Run6:51

与讲师见面

Stephen T Parente
Professor
Carlson School of Management, Department of Finance

So, this is Module 3.1.1.

We're now focused on medical devices.

Medical devices are actually a really

vital part of the landscape of a health care marketplace.

The prior two modules focused almost exclusively on pharmaceuticals.

Now, we're turning attention to the space that's actually, at least globally,

where some of the greatest innovation can come.

And, quite honestly, could actually really enhance the functional status folks

beyond a certain point.

That's what very much excites me.

And personally, I remember both my parents actually could've gotten

some of these devices, particularly some of the cardio stuff, too late.

But just knowing that there'd be options for

other people's parents in the future is quite wonderful.

So let's begin.

So on our right here we have the famous a pacemaker, a portable pacemaker,

actually, those are much smaller, that's a pretty big one right now.

And, when we talk about medical devices,

the key to understanding is the regulation space of it.

So the role of government here is essentially to focus on what is going

to be determining a safe technology, and what could be put into the market.

So government agencies are going to be determining both the approval of

these technologies, and

we'll talk about some a little bit later, their payment reimbursement.

The second important difference that people are concerned about

is that the users of these technologies generally do not pay for them.

Their health insurance company does.

So very rarely would you go to your friendly neighborhood Target and

say let me go buy an implantable cardiac defibrillator and

I'll install that later with some help from my friends coming over.

First, it's very expensive to do that.

There aren't many items at Target that are in excess of $2 or $3000,

let alone $30,000 for that little device you're seeing there.

But on top of that there is also the issue of how it would actually be deployed.

So health insurance providers are keen for this technology and

device as well as pharmaceuticals who just pop them in your hand.

So you need to understand for devices process and

also they want to plan an assessment.

When you actually do a technology assessment in preparation for

a regulatory aspect, you're gathering and

analyzing information to figure out the performance of that technology is.

Once that technology regulatory stage is passed you need to make sure your

information is actually collect it, so if you ever have to go back,

you can actually make sure that it's not necessarily lost.

And an understanding of this whole process, for development, and

a reimbursement is necessary to prevent any mistakes, really,

from occurring, so that you can go into market as quickly as you can.

So how do we actually go and make it into a market?

So, this applies to drugs as well.

And we talked about this actually, in the first course, but just to review,

we're going to take it, we're going to go much more specific in devices in,

just a slide or two.

The idea is that there's going to be Four Key Steps.

These are going to vary by country to country, and innovation to innovation.

First step that's key is to obtain a patent, we call the patent it

grants exclusive rights to sell the product for about 20 years.

And that the next step is to go for regulatory approval from the FDA or

whatever government agency in different countries you might be looking at say.

And this process of getting approval for something that is safe and

also effective could be a very long multi-stage process.

Then, number 3, you need to get payers publicly prior agree to cover that drug or

in this case device.

You need to make sure that you are meeting the standards of different payers, and

then Medicare's particular standard is reasonable and necessary.

And providers must persuaded to then use

that technology to make sure it can get to markets base.

So to create a patent, anywhere from 6 months to 2 years for

the patent office to grant it as Brandon said earlier, what's the determination?

Anyone who invents or discovers any new and useful process, machine, manufacture,

or composition of matter, or any new and useful improvement thereof,

may obtain a patent.

The standard is novel and non-obvious, 20 years.

And you can get some extensions.

The medical devices are different in the FDA approval process.

Brandon talked a lot about how things go through there differently with

investigational new drugs.

In this case what you have to go is for either the pre-market approval,

otherwise known as PMAs, or pre-market notification, known as 510(k)s,

by the statute that they're associated with.

So, the FDA receives about 50 to 70 of these really brand new,

breakthrough technologies, these PMAs, per year, and about 4,000 510(k)s.

The agency for the FDA responsible for approval of the devices is the Center for

Devices and

Radiological Health, which is just tucked away in many different parts of the FDA.

So one thing to keep in mind is that's the definition of what is a medical device

basically it is this apparatus simple machine

contrivance agent there's the point which is

recognized by the United States it has far more associated with it.

It is intended for an initial use of a disease or condition or mitigation or

presentation of a disease, and

the key thing is that it is not dependent

upon being metabolized for the achievement of its primary intended purposes.

So what we see over here is a stent.

And a stent is put into an artery once it's cleaned out by

angioplasty to keep it open.

You can coat that stent with a drug, otherwise known as drug-alluding stents.

And that would actually be a combination.

But most medical devices are not dependent upon metabolization.

So different Medical Device Classes, we have Class I,

the most basic one that's out there.

This is really just for Band-Aids, tongue depressers,

anything that's going to be momentarily in the body, but generally pretty safe,

is low risk and that's subject to pre-market approval.

Then we get to Class II.

These are usually things that are cleared through the 510(k) process.

These pose either a low or moderate risk.

And then finally we get to Class III, PMA, Pre-Market Approval.

These have higher risk, they're breakthrough products, and

they have a much more expensive application process.

My general criteria when people ask me and they have new ideas and

technologies is that are you leaving it in the person.

So here's our person, there, there, and they're smiling.

So if you're actually putting something inside and they're going to stay, I don't

know 10 to 15 to 20 years, that usually is the criteria if it's the first time that

technology's ever been developed that way for that purpose as Pre-Market Approval.

Now, if it's something that has been around, like a pacemaker, for awhile, then

it could fall to class two because it's already been cleared for that technology.

So the agency that examines the data that's there.

They look at very simple products,

like tongue depressors, adhesive strips, before allowing them on the market.

30% of all devices are Class I.

60% fall into Class II, the dominant form, 10 percent for

the extraordinarily new technologies in Class III.

And then all these devices are subject to General Controls, marketing,

properly labeling and monitoring performance.

And anything that's radiation emitting, laser pointers as well as

different technologies, face additional controls to minimize radiation risk.

This concludes Module 3.1.1, looking at Medical Devices and the Market Space.

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