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D MN! Bernie Sanders Is Finished! Look How Trump Ended Him Last Night… - Duration: 2:08.
D MN!
Bernie Sanders Is Finished!
Look How Trump Ended Him Last Night�
By Paris Swade
leased Donald Trump�s 2005 tax returns.
It was a huge mistake because in it, it proved that Trump paid a higher rate than the fake
socialist Bernie Sanders.
Donald Trump paid $38 million on $150 million made in income in 2005.
That is roughly 25% of his income.
Socialist Bernie Sanders paid 13% of his income in his 2014 tax returns.
TRUMP PAID TWO TIMES AS MUCH AS BERNIE IN TAXES!
Seriously.
Bernie people are so stupid to fall for that conman.
Finally, the fake socialist has been exposed.
Bernie Sanders is officially a fraud.
Oh and Hillary Clinton is a fraud.
Remember when she started the tax return rumor?
Hillary Clinton: �First, maybe he�s not as rich as he says he is.
Second, maybe he�s not as charitable as he claims to be.
Or maybe he doesn�t want the American people, all of you watching tonight, to know that
he� paid nothing in federal taxes.�
This is so embarrassing for Hillary Clinton.
This means that the whole nation is going to realize that she lied about the whole tax
return issue.
I mean she started this rumor the same way that she started the birther rumor.
SHARE THIS AND LET�S SHATTER THE BERNIE SANDERS MYTH!
Let�s show the entire nation that Bernie Sanders is nothing but a fraud.
He repeated the tax issue and it turns out that he pays less than our current President.
This man is a fake socialist.
He doesn�t even pay that much in taxes.
Expose him, patriots!
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Stanford Webinar: Regulation & Health-Eco Value Assess. - Two Critical Gauges for MedTech Innovation - Duration: 43:31.
Now I'd like to introduce Jan Pietzsch, who is today's featured speaker.
Dr. Pietzsch's professional and
academic work focuses on early stage technology assessment.
And strategic decision support for investors, manufacturers and
research institutions.
A primary emphasis is on evaluating the value proposition of new technologies, and
providing quantitative inputs into the selection of promising technology concepts
and their targeted development.
These includes model based assessment of the clinical and
health economic benefit from new diagnostics and therapies.
He received his academic training at the University of Karlsruhe in Germany.
And also here at Stanford University where he completed his PhD.
Dr. Pietzsch is co-founder, president, and CEO of WingTech Inc.
That's the technology consulting firm focused on health economic and
value assessment.
Previously, he'd been a research fellow with the US FDA's Office of
Device Evaluation.
Currently, he holds an appointment as Adjunct Professor of
Management Science and Engineering at Stanford,
where he also serves as a director at the Stanford Bio Center for Biodesign.
The center is located here on campus next to the medical school and
in the center of Silicon Valley, which seems fitting.
And it's a leading program in medical technology innovation.
It's vision is for
a world where health technology innovators from around the globe have immersive,
collaborative, cutting edge training that they require to thrive.
And on that note, I'm going to hand over to Jan.
>> Thank you very much Marsha.
Good morning everyone, it's a pleasure to see many of you registered here.
And it's also nice to see the interest in medical technology because it's really,
I think, one of the fields where you can combine different interest and
area competencies and expertise and really do something very meaningful
by bringing technologies to patients that really improve outcomes and
that also help to manage care, and provide services in an appropriate manner.
Which is increasingly,
as we see, important in healthcare systems around the globe.
We have two topics today that I'd like to discuss with you.
One is regulation of medical devices and the second is economic value assessment.
They are really critical for the successful bench to bedside innovation
process of medical technology and so we'd like to highlight those.
In this webinar there is also a class we will mention later that I'm teaching in
the spring time for those of you interested in taking the course online.
To set the stage let's look at a couple of medical technologies.
Starting from top left here, you see a trans-catheter aortic heat valve,
or which is a new way to place and artificial heart valve.
It replaces the surgical open chest approach and
is one of the key cardiovascular innovations of the last couple of years.
It really facilitated treatment of patients that were previously not
candidates for surgery and needed to be medically managed only.
And also it's a candidate who are a technology that replaces over
time surgeries.
So very high patient value device and we get back to that later in a case study.
You see on the right, next to it, deep brain simulation.
Which is also an exciting neural simulation technology that is used for
treatment of epilepsy, for example.
For treatment of depression.
But also for treatment of Parkinson's Disease.
So a big patient impact and also, one of the medical devices.
That they contribute to reduction and the need for medication usage.
So you see a direct link actually for
medical technology also can replace pharmaceutical treatment regimens.
Next to it you see an advanced stem therapy for cardiovascular applications.
You see an imaging device for mammography or
breast cancer screening, which also has a very important field.
I mean, all of imaging and diagnostics.
You see just next to it, further below, a treatment for
obstructive sleep apnea, which is a big health concern.
I mean, obstructive sleep apnea is a condition,
because it really elevates long-term cardiovascular and stroke risk.
And in patients who don't tolerate CPAP treatment
which is a mask based treatment to treat sleep apnea.
A new device has been developed that again uses neurostimulation technology to
stimulate the tongue base at night and thereby keep the airway open.
Then you see a diagnostic device for glucose monitoring which you can
see over the counter or can purchase in any pharmacy in the United States,
certainly at the large need, or large number of users.
But their continued advancements, also with the connection to mobile health
technologies that really facilitate better management of the condition of diabetes.
Then next it, to the left, you see a new approach to actually
diagnosis lung cancer and to avoid invasive procedures.
It's a genomic marker test.
You see here a bronchoscopy being performed and
a brush that is used to take a sample which is then analyzed in a lab.
To determine the risk or the likelihood that
the patient actually does have a cancerous condition or a lesion.
And by using such new technology there
is the opportunity to reduce invasive surgical biopsy.
And you can imagine that that's really a risk reduction for the patent and
it's a benefit also for
the healthcare system in terms of avoiding costs of complex procedures.
Then a device that is a family of devices, artificial joints,
you see the hip joint here excuse me the knee joint, roughly 700,000
total knee replacements are performed per year in the United States alone.
And again, big impact on patient quality of life in patients with severe arthritis.
But also a big market for medical technology or orthopedic technologies.
And then finally, technology that's a high flow therapy respiratory support
systems that are gradually replacing more invasive respiratory support,
mordalities, such as antiobasin other wise mask based treatments.
Again, I think all of these technologies and there are many,
many more show you the wide variety of technologies and
the wide variety of opportunities to really improve patient care and
patient outcomes.
Now for all of these technologies, if you're thinking of innovations in those
spaces, right, we need to think about demonstrating
the value of these technologies to the patients or at least developing and
understanding, right, how meaningful a technology is to patients.
We also need to think about the questions of safety and
effectiveness of these technologies.
And the leading question, our lead question really is what constitutes safety
of a medical technology?
What does it take to demonstrate safety and effectiveness?
Next do we need to worry or think about the target population.
If there's a very narrow defined population that could benefit
from the therapy or the technology, or is it a larger target population.
Thinking of the knee replacement, $700,000 per year number of devices.
That's a very different to some other technology areas.
So we need to appreciate and define the target population,
because it also has an affect on the safety profile and
on the effectiveness profile and we'll discuss that in a minute.
And then finally, is this technology of value, right?
Should it be paid for, and if so, What amount would be appropriate for
healthcare systems.
And we also need to keep in mind that this value question really is stakeholder
specific, and it's country specific.
So a technology that might be of value in the United States.
Healthcare system might not be of value in other healthcare systems like the UK,
France, Spain, or Japan.
And the reason is that we not only might have some slight variations
in the underlying clinical profile.
But we have very different implementations of healthcare systems and
also different cost structures and cost profiles.
And so you see that all of these questions really directly relate to the fields of
regulation and health economics that we discussed today.
And a point here that we should mention specifically here is that very
different from other industries like the automotive industry or
many consumer electronics fields.
Commercial success and bringing a therapy really to the patient for
commercial use means that we need to rely on approval by regulatory
authorities in the United States the Food and Drug Administration.
And we also need to obtain reasonable positive reimbursement that
actually allows us to a business in the end.
So without those third party considerations or approval by third
parties, there's no way to have a successful translation from development or
R&D to the clinical use and the patient benefit.
So that means we need to understand very thoroughly the requirements of regulatory
approval, and of reimbursement approval and value assessment.
And there's a direct link as you probably appreciate between the requirements and
the commercialization risks and rewards of the time to market, imagine for
example, a required two year followup study as opposed to six month followup.
That very much affects your time to market and
it also affects the costs of development and clinical testing.
And that leads us directly also to the funding requirement,
when you think of raising funds for a new concept or new technology.
The questions of what aspects of regulation and
reimbursement really drive heavily the funding requirement question as well.
And there's an increasing importance globally to demonstrate value in
a changing healthcare environment.
So let's talk about regulation.
Couple of years ago, we did a study at Stanford Biodesign where we outlined
the medical development process from the very early stage of need identification,
all the way through post market and you see, key activities listed here.
You see also decision gates along the way.
And what was really striking, is that more than half of the activities and
the decisions are governed by regulatory and reimbursement requirements.
Most of them actually regulatory requirements.
Second point I'd like to make here is that regulation not only relates to
the approval of medical technologies or the pre market review, as it's called.
But also to the full life cycle of a medical device.
So all aspects of surveillance in the field managing feedback that
you received from patients and providers about issues with the device.
Manufacturing, productions, all of those aspects are regulated and
governed by regulations.
And so In order to successfully manage a business, you need to be aware
of those requirements, and implement procedures accordingly.
Two important definitions that govern FDA's work when evaluating technology,
you see the legal definitions from the Code of Federal Regulations for
Safety and for Effectiveness.
And let me just read them to you.
There's reasonable assurance that a device is safe when it can be determined based on
valid scientific evidence that the probable benefits to
health from use of the device for its intended uses.
And conditions of use when accompanied by adequate directions and
warnings against unsafe use, outweigh the probable risks.
Again, in the definition of safety you see this balance of benefits and
risks, or that the benefits need to outweigh the risks.
You also see a couple of important definitions.
One is the question of what constitutes valid scientific evidence.
Is it a randomized control?
Try it, for example, with the highest level of evidence.
Or it is sufficient, for some technologies,
to use less comprehensive data to use, for example a single arm study,
and compare the results to previously published results from another technology.
So this is a very relevant and key question.
And also is actually one of the drivers
in the implementation of the regulatory process.
You may have heard about the regulatory pendulum.
That there were differences between how to administrations actually enforced
regulation.
And implemented regulation as one of the key drivers here is the question,
how much evidence is needed and what is considered to be valid or valid enough?
Another definition is the intended use.
You cannot get clearance for a technology.
For use in any patient, it's always for one specific or
several specific indications per user intended to do with this.
And you also need to be careful in describing and
specifying what is the condition of use.
Is it in an inpatient setting and an outpatient setting, who is performing or
using the device, all of those are relevant questions for
the regulatory review process.
Labeling is part of that, as well as the instructions for use.
Effectiveness, looking further below,
there is reasonable assurance that a device is defective when it can be
determined based upon again valid scientific evidence.
At any significant portion of the target population the use of the device for
it's intended use and conditions of use when adequately to the warnings against
unsafe use they provide clinically significant results.
Again definitions of valid scientific evidence.
Also definitions for intended use in a given population and
also the definition of clinically significant results that means the FDA.
For example, the European regulatory requirement FDA really evaluates
the benefit to the patient in terms of outcome, in terms of effectiveness.
It's not sufficient to agree that a technology's safe enough, but
it really needs to demonstrate a clinically significant improvement.
In Europe, the focus with the labeling, for those interested and
familiar with the European system Is to evaluate safety, and performance.
And performance means, not the clinical performance, but
that revise does what it's intended to do, but there's no long term
evaluation of outcomes as part of the regulatory process.
How is regulation implemented in the United States?
When Congress enacted medical device regulation in 1976,
following pharmaceutical regulation, which was in place since the 1930s,
with the Food, Drug, and Cosmetics Act.
Congress determined that for medical devices and, again, differential pharma,
it does make sense to consider the risk level of a device.
Because, you can imagine, medical devices like syringes.
And you see the photo here on the right, have a much different
risk profile than a intracardiac stint or catheter.
And so the three risks, one, two, three, increasing in risk level.
And the review requirement are different.
There are exempt devices that really require only the registration
of the manufacturer but no submission of clinical or other Test data.
Then there's the so-called 510(k) process.
The definition actually goes back to the Court of Federal Regulation section.
It's the typical process for Class Two devices, and it requires
demonstration of substantial equivalent to one or several predicate devices.
So as long as you can show that your technology performs similarly to
an existing technology, or uses technology components that
were previously cleared through the 510(k) process,
you can demonstrate would be upper review by FDA, you can demonstrate if
you're successful that the technology's substantially equivalent.
And therefore should be cleared to market via the 510(k) process.
Then there's pre-market approval or PMA, which is the highest regulatory process.
It's very much comparable to the new drug application process.
And medical devices always require a trial-based evaluation,
typically with several phases of clinical trials.
In addition to pre-market evaluation and clearance as I mentioned earlier,
there are regulations governing manufacturing and other aspects,
quality system regulations, R&D processes manufacturing, procurement distribution,
product surveillance and many other aspects.
FDA review was actually a paper-based review,
I mean even though lot of these papers are now electronic.
But it's not that FDA evaluates a device, takes it apart and
studies its risk profile.
Companies submit documentation of tests that were performed, and
you see how comprehensive these dockets are, this is for a PMA-type device.
And what FDA receives and then needs to review within 180 days typically.
And you can imagine that that's a tall order, and
a very comprehensive task involving biostatistics, engineering,
medical disciplines, and so on, and we expert knowledge within the agency.
As mentioned earlier,
the implementation of the regulatory review process has changed over time.
This show is a shot comes from the latest MDUFA report that FDA
published just early this year.
And it shows the pre-market approval, again the highest risk
does divides approvals, and you'll see in green the successful or
approved devices and how that's changed over the years.
And you can see, for example, with the beginning of the Obama administration
in 2008 and 2009, the approval rates for PMAs really went down significantly.
And that was the results of stricter requirements that the new administration
or the new leadership at FDA implemented at that time.
Since then it has dramatically increased again, and
FDA has been very successful actually in further improving its operations and
procedures, which is good news to everyone involved in the industry.
Now let's switch over to our second topic, health-economic value assessment,
to give you some background about the environment that we all or
anyone operating in the field of medical devices.
Now, in these two phase, you see for the United States, again,
the total federal spending is percent of the Gross Domestic Product over the years.
And you can appreciate or see here in red, the major head programs, that's Medicare
and Medicaid, primarily being the highest spending category of government spending.
Roughly 5% of the GDP and
consider that this is only the government part of health care.
When you add all of the private aspects, and
commercial insurance aspects of health care, you're currently looking at 18 or
19% of the the GDP being spent on health care in the United States,
which is roughly double what other countries in Europe spend.
And it's not only in Europe, but especially in the US it's a concern,
especially when you look at the projected future expenses,
which are driven among other factors by changes in
the age groups, for example, of patients, demographic changes.
And you can also appreciate that's just occurred or what's proposed.
If defense spending, which you see further down, is increased by $50 billion
from one year to the other at the expense of other government spending categories,
that there is even more pressure on spending on healthcare for example.
Right, and that means also, there needs to be significant scrutiny,
and funds should be spent wisely on technologies or
aspects of healthcare that really are meaningful and contribute value.
And that's the environment we live in and
that we are increasingly facing going forward.
Therefore, not only in the United States but globally,
any healthcare system, regardless of their ability to spend, and
the absolute amount of spending on health care.
All health care systems face the issue of improving or
the desire to further improve patient outcomes,
while also managing costs, controlling costs, in some cases, reducing costs.
And so technology really can contribute significantly to helping
resolve these issues, right?
We just need to make sure that the technology we're bringing forward
really address one or two of these concerns.
Ideally both of them, right,
in outcome improvement and overall same or reduced cost.
Now when we look further at value,
we need to appreciate that there are different stakeholders involved.
It's not sufficient to only look at Medicare, for example, and
show that Medicare expenses, even though that's very important and relevant, right?
If Medicare expenses are reduced with the introduction of a new technology,
it might be that it comes at increased cost, or lower revenue margins for
the hospitals, right?
And so, from a hospital perspective, from a pure financial perspective,
that would mean that it's not of value to adopt a new technology.
And so keeping in mind that the argument driver should always be
an improvement in patient outcomes, but on the financial side, we need
to be aware of those ramifications, and be aware of different stakeholders.
We need to think about demonstrating incremental improvement,
compare the status quo.
Which also means that we need to identify and
very carefully appreciate how technologies are currently, or
how patients treated with existing technologies, right?
And we need to identify the incremental changes.
We need to have a focus on cost and outcome,
demonstrate the long term perspective.
And consider not only the episode of care, but
also the longer term implications in terms of costs and outcomes
So from a patient perspective, again, going back to the clinical objectives of
any new technology, we need to be able to demonstrate either a reduction
mortality survival improvement, or a reduction in patient morbidity,
or a improvement in patient related quality of life.
In some technologies, actually,
we're able to address all of them, but keep in mind that
these are the three drivers really that drive the value proposition to a patient.
And we need to be able to demonstrate a viable economic profile,
a therapy needs to be either cost-saving or cost-effective to be of value.
And that is measured through the cost-effectiveness ratio,
on the right-hand side you see a graph where you see at the zero point or
the cross of the axis, the existing approach and
technology, how a patient might be treated and given an indication, and
we are looking at The difference in costs.
There's our costs on the y axis.
And the difference in outcomes or
effectiveness of measured in quality adjusted life here is to the right.
And you can appreciate that there might be technologies
that lead to better patient outcomes at higher overall costs.
And up to a certain willingness to pay threshold that is defined by individual
healthcare systems, the technology might be considered to be of good value,
to be cost effective.
And that means it should be adopted.
There are also technologies that hopefully in the future,
more technologies that improve patient outcomes.
But also reducing overall cost to the healthcare system, and
it would be in the quadrant on the lower right.
When we think of developing technology that leads to higher costs, and
many, many, increased effectiveness that lie above the willingness to pay threshold
here, then you can appreciate that they're not considered to be of good value, and
would be very hard to actually get a successful adoption of those technologies
in the future.
So the implications continued here we need to again, appreciate all of
the requirements and how agencies like in the UK, the National Institute
of Clinical Excellence, how they evaluate technologies and
we need to collect data in a prospective way from the very early stage of
development all the way through clinical and be aware of those requirements.
Let me briefly go through a case study for TAVR, transcatheter aortic valve
replacement, remember that we looked at this technology on the very first slide.
And, I'd like to briefly discuss with you the safety effectiveness and
value assessment, based on this real world technology.
Brief background about the medical condition aortic valve disease.
The aortic valve is actually the most important.
All of the heart valves are important, but the most important valve or
highest pressure valve, actually between the left ventricle and the aorta and
the main body artery vasculature.
And in many patients,
aortic stenosis in older ages leads to a narrowing of this valve.
In the old days and up to now,
the main treatment approach was open heart surgery, which is the on top here.
Which requires a very invasive procedure, open chest, and you can increase the.
Now what that means in terms of length of stay, in terms of quality of life impact,
of the mortality impact in fact.
And transcatheter aortic valve replacement is a new technology that has been
introduced over the last decade to average
patients that are not candidates for surgery because they're too sick,
too ill, and wouldn't survive or possibly survive surgery.
And increasingly, this approach is also used to replace surgeries and
candidates that are at intermediate risk.
And you can see on this image here on the right-hand side how the valve is actually
implanted through the catheter without opening the chest of the patient.
So now if we look through the regulatory or the value lens again,
it's starting with the question of general evaluation of TAVR,
we probably should compare this TAVR approach against surgical treatment,
in patients that are candidates for surgery.
In patients previously not candidates for surgery, we need to compare
against the existing paradigm for these patients, which was medical management.
So again it shows that we need to carefully present and
understand what the patient population that we're looking at when
evaluating the technology, and also what the current paradigm of treatment.
Because that drives our incremental differences in terms of patient outcome,
and in terms of cost.
How should we evaluate the effectiveness?
Well it's the long term survival that really is the most meaningful factor here.
So we need to appreciate not only the procedural success or
maybe six month follow up outcome but ideally the remaining lifetime of
the patient and how survival is affected by this new technology.
We also need to think about events like strokes and
heart attacks that might be affected by the use of the technology.
And to assess those outcomes, ideally, we would want to see one year or
two year outcomes from a trial to be able to evaluate that.
There are also factors like six minute walk test and
other approaches to evaluate the functional ability of a patient.
All of those factors in sum really drive effectiveness and
do have an impact on the quality of the That we're measuring and Analysis.
What cost elements do we need to consider when comparing TAVR and surgical AVR?
So the main stay treatment, open chest surgery.
We need to consider, for example, the number of intensive care days
that are required after one versus the other procedure.
We need to consider length of stay.
And we need to consider certainly the cost of the wealth,
a transcatheter aortic heart valve actually costs around $30,000
in the United States versus maybe 6,000 for a surgical belt.
And you can imagine how that factors into the cost equation and
the cost difference equation.
So what clinical data are needed to support cost calculations?
As I mentioned earlier on the effectiveness side,
there are parameters like stroke rates, and heart attack rates that might
also be influenced by the use of this different technology.
And certainly we want to capture those also on the cost side as the treatment
of this drug has immediate cost implications and long term implications.
More data sources could be used to support a cost assessment
where we could do a micro-costing approach during the trial.
That there's also extensive literature or
publication based data available that discuss the cost of a stroke treatment or
to discuss the cost of an ICU aid, intensive care aid.
But there are a number of sources we can rely on when performing these
health economic value assessments.
My therapy difference is between that groups of patients, absolutely.
So again it shows that we need to be aware of the specific
target population that we're evaluating, not only from a regulatory perspective but
also from the health economic perspective.
And you think of high risk patient or extreme risk patients for example,
versus intermediate risk patients, the safety profile and
the health economic profile could look very different.
And you should also appreciate that when going back to the benefits
outweighing the risks equation, right.
Or the scale here that we saw earlier that certainly the risks in patients that
are at extreme risk are much different than patients at intermediate risk.
Right, so keep that in mind.
If you're interested in reading more about the health-economic evaluation of
a transcatheter aortic heart valve,
there's an interesting study by Reynolds and
colleagues that was published last year and they give you the reference down here.
But it shows what we just looked at this plane of cost and
effect, and the likelihood that
the technology actually would be cost-effective when considering
a threshold of 50 to $150,000 per college supply period in the United States.
And the conclusion of that study was even though technology costs more from a health
care system perspective, the improved outcomes actually
lead to a very favorable health-economic profile,
willingness to pay off the society as stated in the United States between 50 and
150,000 Means that this should be adopted, even if it's higher cost.
There are also a couple of interesting regulatory documents.
The pre-market approval PMA summary of the Transcatheter Heart Valve
device is available under this link at the agency and
you find all of the documentation of the clinical studies and
pre clinical studies that were performed, so it's very educational.
Similarly as I mentioned the cost effectiveness article.
So to briefly summarize without regulatory approval there's no market access The key
criteria for approval in the United States are safety and effectiveness.
We need to determine early on,
how the product will be regulated because that drives the regulatory requirement.
We also need to appreciate detailed requirement with regards to
clinical testing and so on for each of the FDA pathways.
And FDA online resources are available again if you want to study further.
We can also learn from published documents of prior approvals and
panel meetings that are published on the FDA website, a trove of evidence and
information that really is very helpful.
And as discussed and then a population appropriate comparative predicate
endpoints can be gleaned from those publications.
QSR, good laboratory practices, and good manufacturing practices,
as discussed, are additional important elements of regulation.
On the health economics side, we have seen that health economic evaluation
increasingly is a critical requirement.
Any health care system that wants to make meaningful decisions about the adoption of
devices and their reimbursement price needs to evaluate
the healthcare benefits and the patient benefits and the cost of the technology.
And that means for us, from a innovator perspective,
that we need to be aware of those requirements.
We need to actually collect information during the trial and during development,
already collecting evidence that we can use to demonstrate the value proposition.
We also need to appreciate what are the key value drivers of a new therapy,
very early on in development.
And we need to appreciate that it's not only the episode of care or
episode of implantation, but
the long-term implications and effects of the therapy that we need to consider.
Value is defined by incremental changes from current status quo, so we need to
appreciate what are the current therapies, what are the outcomes, and the cost.
And, again, we have differences between individual countries.
Useful resources for health economics are HTAs or
health technology assessment reports that are published and publicly available
as well as cost effectiveness studies in the published literature.
So, with that, I'd like to briefly say a few sentences about 256,
which studying this year actually has lifted bioengineering course,
bio e256 tech assessment and regulation of medical devices.
It's a course that is given Fridays, 1:30 to 3:20, nine sessions total
available through SCDB Lectures include guest speakers from industry and the FDA.
And also, a hands on team based class project investigating
a real world medical technology report from the regulatory perspective but
also on the health-economic value perspective.
And you can find details on the website which is given here.
Thank you very much.
>> Thank you very much that was a great presentation.
And now, I'd like to hand back over to so
he can answer some of the questions that you've been sending through.
>> Thank you Marsha.
Thank you for all of your questions.
We did receive a couple of them that are listed here.
And let me just go into them step by step.
One of you asked about the designed thinking process or concepts and
how they have been used and applied in the medical technology field.
And some of you that are not familiar with designed thinking, it's a process
that was defined at Stanford and at IDO Evaluating or using concepts of
use identification, by observation and those contents have been implemented,
mainly in the process, taught at the center,
that mentioned earlier Her fellowship is offered that emphasizes
heavily the early phases of the process of medical technology innovation,
where we try to have the fellows spend time in the actual clinical studying.
And observe processes, to identify needs, and then in a very careful manner and
process narrow the needs down into the most important needs that then
lead to the next step which is actually innovation or inventing technologies and
then figuring concepts down to one final product or product idea.
So, the design thinking process is really,
we think, very aptical with medical technology and has been used for
50 years in the prior designed program very efficiently, and effectively.
But, how do you prove, next question,
how do you prove value on something like preventative medicine?
A very good question, and indeed there are important programs that are supported by
technology also where you try to avoid or improve the long-term patients outcome for
things, for example, with weight management and obesity.
You can think of cardiac risk factors.
If you manage them effectively, you can influence the long-term outcome and
the benefit of the technology.
Are evaluated prospectively and sometimes in modern day assessment.
So, you try to appreciate how behavior and certain parameters
like blood pressure or weight are affected with the use of such program.
And then, you can project the likely long term impact and
evaluate whether it would be meaningful, both in terms of outcome, but
also in terms of cost, so a very good question and
there are many technologies actually that focus on the parantative field.
There's one question about transcarotid back replacement here I mentioned
the roughly $30,000 cost that is published in publications in the United States.
And the question is what is the price?
There are some variations.
And again, just going back public domain information in European countries.
According to publications It's in the range of 20,000 Euros.
Again, variation within those countries but yes, there are global differences.
But we need to also keep in mind that healthcare in general and
healthcare systems costs are very different in these other markets.
And certainly,
pricing of technologies impacts the value proposition of the technology as well.
These are all very intertwined aspects.
And we just look at the next question here,
how will the changes in development of medical device regulation in Europe and
in Asia affect the development of innovative medical devices?
For a long time, Europe was seen,
from a regulatory perspective, more innovation, and that still is the case.
But there are some changes in regulation on the way,
currently need to be approved by the European Parliament,
to be implemented, but especially for high risk devices.
The requirements are now suppose to be a little bit more stringent and
also to the PMA evaluation in the United States.
In Asia there are changes, in Japan it was significant.
There were significant issues with a review process in that it
took a very long time.
And you can imagine that very long review time means also delayed patient exits.
And the Japanese had their authorities that worked hard in improving
a more rapid review while maintaining high levels of safety and effectiveness.
But certainly those factors of global regulatory systems also influence
companies' strategic decision-making about initial markets to access and
gain clinical experiences with, and commercialize.
And I think there's one more question here about doctor regulations can be,
would I talk a little bit more about doctor regulations.
Certainly, when you look at the technologies we've evaluated, or
looked at, early on, deep brain stimulation,
heavily driven by doctor right when you think of an ECG machine, or
even this mammography device that we looked at, software plays a big role.
And FDA has guidelines for software regulation, and for software testing, and
for failure modes and effect analysis.
So they are a key cornerstone of the review process, certainly not an easy one.
And I think their continued efforts to study better or develop
better approaches to evaluate software and determine how much radiation and
testing do you need to do of doctor to make sure that it's reliable enough.
Something that is not only limited to the health care industry,
but also to other industries like automotive and
aerospace where you face the same issues of software reliability.
>> I'll jump in with one that came in a little bit later, but start-up companies,
is it critical to consult with the FDA ahead of time to prepare for approval?
If so, how to establish the connections?
Perhaps with your you might have some experience with that.
>> So it is always a good idea to first use the published resources.
And I mentioned the FDA website with a lot of useful information.
So, once you've done with a company the homework and evaluated as good as you
can the resources, I think it's always a good idea to reach out to the agency and
have an early dialogue.
But you increase the likelihood of success for
outcome if you have done your homework internally beforehand.
It's also a center at the FDA that's called DICE, division for industry and
consumer education, which has a hotline and provides free advice to companies.
And so I think the first step, in terms of FDA interaction,
aside from the typical regulatory review branch, context and division context
is to make use of that free advice through the center, again it's D-I-C-E
at the agency and they provide webinars and also a telephone hotline.
That might be a good first segue, especially for
small companies who experience this process for the first time.
>> Great, well thank you again for the talk,
Jan, and also being able to give really helpful details on today's questions.
Thank you everyone who sent them in.
I'm afraid we didn't have a chance to get through all of them because of the time.
But hopefully you found a lot that's useful to take away from that.
And enjoy the rest of your day.
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Ghost in the Shell For more infomation >> Ghost in the Shell-------------------------------------------
Evil Pony-The Spring is Coming ft. Dayl Pezer (SUBTITLED) - Duration: 1:56.
The birds are out and singing
the birds are loudly saying
F**K
The birds are out and singing
How the world soon is ending
We are fine, all we do is Love
The birds are lonely singing
But we still keep pretending
Its fine, its fine
All we say is love
Define
Love-Divine
Love - Divide
Do we really Love?
The birds are out and singing The birds are loudly saying
How The World soon is Ending
The birds are out and singing How the world soon is ending
How the World soon is Ending
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