4.1.1 What is a Device? What is a Drug?

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来自 University of Minnesota 的课程

Healthcare Marketplace Capstone

24 个评分

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 1: What is your Health Marketplace Innovation?

In this Milestone you will describe a new medical innovation in the context of what makes it extraordinary for investment or use in a community. Your final project for this capstone will feature 4 critical milestone components for an assessment of new innovation. Once completed, hope is that you have a body of illustrate your critical thinking to advance your career or switch careers into the healthcare market.

4.1.1 What is a Device? What is a Drug?2:43

4.3.2 Preparing a Global Health Technology ‘Dossier’6:39

5.1.4 Key Issues of the 21st Century4:04

5.3.1 Key Questions for an Innovation Valuation3:21

5.3.2 What is the Technology?2:02

与讲师见面

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

This is the Healthcare Marketplace Specialization,

Healthcare Marketplace Overview.

My name is Steve Parente and this is module 4.1.1.

What is a Device?

What is a Drug?

So what is a medical device?

We can think of lots of different things.

They could be things that can be implanted.

They can be those moments, for example, as I get older and I go through a TSA

screening machine and the guard will say something like you got some metal in you?

And well that that could fit as a device as well, particularly if it stays inside.

So fortunately, the Food and Drug Administration has a wonderful definition

and they specified that a medical device is an instrument, an apparatus, implement,

machine, contrivance, implant, in vitro reagent, or other similar or

related article that is intended in the use of diagnosis of disease, or

other conditions or intended to affect the structure or

any function of the body of man and woman, I added that by the way.

Or other animals in which it is not dependent upon being

metabolized, key word, for the achievement of its principal purposes.

And that is the keyword, metabolized meaning that your body is not going

to absorb it as either a large molecule structure the way it would for

drugs and so it's essentially there in your body.

Now, granted, there are times when some things could be drugs and devices,

but the key distinction is that metabolize function.

So the FDA makes that distinction.

Drugs are metabolized in general and devices are not.

The other thing to keep in mind is that usually the size of the market

is quite different.

Pharma is much larger as an industry and the devices.

We’ll talk more about that later when we get to the medical device and

pharma lectures and modules.

Reimbursement policies are different.

So in general, there's no direct prescription drug coverage for Medicare.

Though, if it's going through private insurers for

Medicare Part D, and/or Medicare Advantage Plans, that operates differently.

And the devices are covered by Medicare generally through hospitals.

Consumer is different.

When for devices marketing is much more focused to hospital and

physicians to convince them to use the devices because of the complexity

to get that work to happen.

Whereas drugs have a tremendous amount of direct-to-consumer advertisement.

This concludes this module on what is a device, what is a drug.

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