3.1.3 Medical Device and Pharma Convergence

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Из курса от партнера University of Minnesota

Pharmaceutical and Medical Device Innovations

177 оценки

University of Minnesota

Pharmaceutical and Medical Device Innovations

177 оценки

Курс 3 из 5 — Specialization Healthcare Marketplace

This course in the Healthcare Marketplace specialization gives the learner an in-depth view of the intellectual property creation that is vital to creating breakthrough technologies. Included is an understanding of the strategy deployed for pricing drugs and new technologies as well as the market sizing exercise to identify where future research and development investments should be made.

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The Medical Device Industry: Bench Science to Bedside

In this module you will learn how medical device industry innovates and brings transformational products to market. The take-away messages from this module are that there are many exciting ideas that never make it off the cutting room floor of universities and research labs. Furthermore, those devices that do make it have to quite novel to compete in an increasingly crowded space. The skills gained from this module to enable a successful capstone is an appreciation of how medical devices are innovated a midst a sea of regulation and intellectual property constraints. You will be better prepared to under the features of likely successful medical device before it goes to market and competes to enhance and save lives.

3.1.1 Medical Device Industry: Regulatory Basics8:23

3.1.2 Device Failure5:07

3.1.3 Medical Device and Pharma Convergence4:30

Познакомьтесь с преподавателями

Bryana Mayer
Lecturer
Carlson School of Management, Medical Industry Leadership Institute
Stephen T Parente
Professor
Carlson School of Management, Department of Finance

This is Module 3.1.3, Medical Device and Pharma Convergence.

I'm Steve Parente and I'm professor at the Carlson School of Management.

So how are devices different from drugs?

Well, the FDA, generally,

is the first place that we stop to make the distinction.

Drugs are metabolized and devices are not.

Size of markets are quite large.

Pharma is much bigger.

Reimbursement policies are different, so devices are covered by Medicare.

Prescription drug coverage is covered by Medicare Part D, but

it's not directly paid for the same way that medical devices are and

the consumer is different.

For devices, marketing is much more focused to hospitals and physicians.

How are they similar?

That medical devices as opposed to drugs.

Both are heavily subsidized by the government for research.

Both require FDA approval to survive.

Government reimbursement policy is a critical factor in their marketing

strategy.

Both need to make a cost-savings (at best), or at least a cost focus argument

for those seeking FDA and insurance reimbursement approval.

Particularly for insurance reimbursement approval.

So one way to sort of think about future for costs is going to be

looking at different ways thing come together.

So if we're on a discovery angle and

we're talking about promoting an idea that's where we

have essentially references of health for investment.

In that case we have actually things that go off in terms of space,

defense material science is actually pretty exciting.

If we're talking about Federal policy in terms of distribution, then we have things

focused on more hospital side for construction of new hospital beds with

the help of money that's or from private insurance, Medicare and Medicaid.

If we go for discovery we try to inhibit what's going on or more regulatory body,

that's the FDA Product Liability if we're talking about medical malpractice.

If we're trying to talk about distributing these different technologies,

sort of typical need where the hospital needs to be certified,

be able to expand it's hospital beds would be critical.

Cost Containment and tech assessments work for same.

So is convergence coming between these two industries?

Basically I think convergence actually is quite likely.

It's the same regulators, in some cases they actually share staffs,

they soon have the same insurance revenues

in the sense of private insurance revenues and risk-based insurance revenues.

Medical devices are starting to look at those metabolizing

threshold what's the drug route extend.

And if drugs need devices for success then that could actually take it even further.

And finally Pharma R&D pipeline has some issues but

device enabled drugs and vice versa could provide a new product line.

The limitations, though, is that this may encourage less innovation within possible,

and there could be possible reduction of small firms enable to fund FDA trials.

And another point is that new technologies can make all approaches extinct and

capsize both technologies.

So for example, genomic research or powerful gene therapy,

personalized medicine can obviously take out the need for implantable devices.

[INAUDIBLE] The benefits of convergence.

This is a pharmaceutical benefit managers, so that is the PBMs

have national IT infrastructure date to make stable Medtronic case which we talked

about in the first course work where thing is electronically enabled,

there would be a more balanced approach to FDA.

And cost-effectiveness requirements and what we have now our device and sectors.

Kind of much more geared toward 510k process.

And can also mitigate any sort of pending pharma bubble if

there's too much over investment in the space.

This concludes Module 3.1.3.

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