4.2.3 The 510k: Friend or Foe?

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Healthcare Marketplace Capstone

24 calificaciones

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University of Minnesota

Healthcare Marketplace Capstone

24 calificaciones

Curso 5 de 5 en SpecializationHealthcare Marketplace

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.

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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

Conoce a los instructores

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

This is lesson 4.2.3.

I'm Bryana Mayer.

And this lesson follows the 510(k) process which can be your friend or

your foe as a medical device manufacturer.

The Department of Health and Human Services houses the Food and

Drug Administration.

And you can see, within the Food and

Drug Administration, there's many different offices and departments.

This is what we're going to focus most on, the Center for

Devices and Radiological Health.

This is the body that is going to regulate medical devices.

The office of device evaluation evaluates devices

using the pre-market application, or PMA.

And also the 510(k) process that was discussed earlier.

Now the PMA process is much longer.

It's a full review of data, everything from the concept

to the design of the device, clinical testing that was conducted.

And primarily what the PMA process is looking for is safety and

effectiveness of the device.

Because typically devices that are going through the PMA process are novel devices,

and so the FDA doesn't have a lot of comparative data to review.

Included in the PMA process is a pre-approval inspection

of the manufacture site.

Now the 510(k) process, in comparison, is a much shorter timeframe.

The 510(k) process compares a specific manufacturer's device

to a predicate product,

something that is already on the market and has already been approved by the FDA.

This abbreviated review process is looking for substantial equivalence.

So, is your device equivalent

to devices that are currently on the market for the same indicated use?

And when I say equivalent I mean equivalent in terms of safety and

effectiveness for the patient.

Medical devices are classified into three classes based on risk.

The FDA considers how well they understand the product and

how well controlled the product's clinical studies are.

These Initial classifications for

risk categories started in 1976 by a panel of experts.

And there's procedures in place to move products up and down risk classes, as more

information is learned from clinical studies and post-marketing experience.

During the 510(k) process, the FDA is primarily looking in for

Substantial Equivalence.

So, this means that they are comparing a manufacturer's device

to a predicate device, and they're trying to make sure that the manufacturer's new

device has the same intended use as the marketed product, the predicate device.

And therefore the FDA can assume that the safety and

effectiveness of a new device is going to be similar to what's currently on

the market, even if the technology is different.

There are three different pathways that a medical device manufacturer can use in

the 510(k) process.

The traditional pathway is most often used when a medical device

manufacturer is marketing a new medical device for the very first time,

or when a significant change is being made to a device that's already on the market.

Because this type of review is going to take longer,

the FDA gets 90 days to review a traditional submission.

Abbreviated submissions are going to be for a less significant change to

a marketed device, so the FDA will review that process in less than 90 days.

And then the special pathway is used when there's just a small change to a device

that's already on the market, and it's the same manufacturer, the same design

controls are in place, and that type of review typically takes only 30 days.

So is the 510(k) process a friend or

a foe to the medical device manufacturer?

Well it can be a friend, allowing the medical device manufacturer to get

a product to market in a shortened amount of time by following a predicate device.

But it can be a foe to the medical device manufacturer if after the 510k

process is complete, the FDA does not feel that a new device is substantially

equivalent in terms of safety and efficacy to the predicate device.

And this means you as a medical manufacturer wasted a lot of

valuable time.

And this concludes lesson 4.2.3,

The 510(k) Process Within the Medical Device Industry.

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