The case for Real World Evidence Studies

October 17, 2024 ░░░░░░

#387 The case for Real World Evidence Studies

In this insightful episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Simon Mason, President of NEST (National Evaluation System for Health Technology), to explore how real-world evidence (RWE) is shaping the future of medical device regulation.

Simon breaks down NEST's critical role in catalyzing the use of RWE to streamline submissions, accelerate time-to-market, and lower costs for MedTech companies. With a focus on post-market data, off-label use, and pivotal test cases like pediatric devices and robotic surgery, this conversation reveals the immense potential of RWE to improve patient outcomes and advance medical innovation.

Simon also touches on the evolution of NEST since its creation under the FDA's MDUFA commitment and provides real-world examples of how RWE has led to FDA clearances, including collaborations with industry giants like Johnson & Johnson and Intuitive Surgical.

Listen now:

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Key timestamps

[00:02:05] – Introduction to Simon Mason and NEST's mission.
[00:06:30] – The importance of real-world evidence in medical device submissions.
[00:10:50] – NEST's relationship with FDA and industry stakeholders.
[00:18:25] – Real-world examples: How RWE led to device clearances.
[00:25:10] – Challenges in using real-world data for submissions.
[00:32:45] – NEST's role in pediatric devices and the potential for off-label approvals.
[00:38:30] – The financial and time-saving benefits of using real-world evidence.
[00:50:00] – How companies can engage with NEST to accelerate device approvals.

Top takeaways from this episode

Latest MedTech Trends:

Real-World Evidence (RWE) Revolution: RWE is transforming regulatory pathways by utilizing data already being collected in real-world settings, reducing the need for costly clinical trials.
Off-Label Use for Approvals: NEST is helping companies harness off-label data, particularly in pediatric and robotic surgery, to expand product indications.
FDA Collaboration: NEST serves as a bridge between the FDA and industry, simplifying the regulatory process for device companies.

Practical Tips for MedTech Innovators:

Engage Early: Medical device companies should consider engaging with NEST early in their product lifecycle to identify potential RWE opportunities.
Data Accessibility: Companies should explore existing registries or datasets that could support their submissions, saving time and resources.
Clear Project Goals: When approaching NEST, companies should have a clear understanding of their product claims and the available data to support them.

Questions for Future Development:

How will the widespread adoption of RWE change the landscape for early-stage MedTech startups?
Can RWE become the default pathway for medical device approvals, replacing traditional clinical trials?
What role will AI play in streamlining data collection and analysis for real-world evidence?

References:

MDIC (Medical Device Innovation Consortium) – NEST's parent organization, which coordinates efforts between FDA and industry stakeholders.
MDIC Innovators Forum, held April 8-9, 2025 in Washington, D.C. This is the annual event discussing the latest developments in real-world evidence and device approvals.
Etienne Nichols' LinkedIn – Connect with Etienne for insights on MedTech innovation.

MedTech 101:

What is Real-World Evidence (RWE)?

Real-world evidence refers to the clinical evidence regarding the usage and potential benefits or risks of a medical device, derived from analysis of real-world data (RWD) gathered outside of traditional clinical trials. RWE is often collected from registries, electronic health records, and off-label device use, and can significantly speed up regulatory processes by leveraging data already in existence.

NEST: The National Evaluation System for Health Technology, under MDIC, is a non-profit initiative funded by FDA and MedTech companies to enhance the use of RWE for medical device regulatory submissions.

Memorable quotes from this episode

Simon Mason: “Real-world evidence has the potential to accelerate device approval and save millions in clinical trial costs. It's all about leveraging existing data to support regulatory submissions.”
Etienne Nichols: "The opportunity to use off-label real-world data to expand indications opens a whole new world of innovation for MedTech companies."
Simon Mason: “Speed is everything in business and in patient care. RWE is all about moving faster while maintaining safety and effectiveness.”

Audience Poll:

What do you think is the biggest advantage of using real-world evidence for medical device approval?

Faster time-to-market
Lower costs
More accurate data

Email your responses to podcast@greenlight.guru!

Discussion Question:

With real-world evidence becoming a critical part of regulatory pathways, how do you see the future of medical device approvals evolving? Will traditional clinical trials become obsolete?

Feedback Call-to-Action:

We’d love your feedback! Leave us a review on iTunes, or send your thoughts and suggestions to podcast@greenlight.guru. Your input helps us improve and bring more valuable content to the MedTech community.

Transcript

Simon Mason: 00:00:00
So Nest was created by industry and FDA as a partnership prior to MDUFA 4 and part of the MDUFA 4 commitment.

They agreed to set aside MDUFA feeds funds coming through the FDA 2 Nest to work on a number of key initiatives and the one and the primary one we're talking about today is to catalyze the use of robot evidence.

Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Etienne Nichols: 00:00:48
With Greenlight Guru's purpose built for MedTech Quality Management System software, you can simplify your regulatory processes and bring life changing devices to market faster.

From design controls to post market surveillance, Greenlight Guru software takes the guesswork out of traceability and helps you stay compliant with FDA and ISO standards every step of the way. Visit www.greenlight.guru today and get your medtech innovations to market quicker, safer and smarter.

www.greenlight.guru Root Quality Systems understands that every company is unique. Their quality as a service provides customized solutions to fit your specific needs.

Whether it's products, process optimization or compliance support, they offer tailored services to keep your quality management on point. Discover more@rookqs.com hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode.

With me today is Simon Mason to talk about Nest, which is a part of the Medical Device Innovation Consortium.

Simon Mason is the president of Nest and Nest serves as a dual role in the medical device ecosystem as a coordinating center offering services that catalyze real world evidence, which is one of the things I'm interested in talking about today with him, but also to generate that for the medical device and health technology research sponsors and as a collaborative community comprised of representatives from across the medical device ecosystem working together to develop thought leadership and coalesce diverse stakeholders to advance innovation and understanding on initiatives of importance.

Prior to Nest, Simon has a history of building and selling private equity backed healthcare service companies and hopefully he can help make what I just said make a little bit more sense. But Simon, how are you doing today?

Simon Mason: 00:02:32
I'm doing well and I. I do intend to make it a little bit clearer.

Etienne Nichols: 00:02:36
Really appreciate you coming on the podcast. Yeah, why don't we just go ahead and dive in and tell us what Nest does and how it helps medical device companies.

Simon Mason: 00:02:43
Yeah, happy to do that.

So Nest was created by industry and FDA as a partnership prior to MDUFA 4 and, and part of the MDUFA IV commitment, they agreed to set aside MDUFA Feeds funds coming through the FDA 2 Nest to work on a number of key initiatives. And the one and the primary one we're talking about today is to catalyze the use of robot evidence.

As such, we are a nonprofit, we sit under the MDIC which is a trade based and FDA supported organization. And in fact FDA sits on the board of MDIC and sits on our governing committee, which is our board as well.

So we have very strong ties back and forth within the agency and across the industry who also sit on our boards.

And for the first period of Nest, which is really MDUFA 4, Nest invested significantly in research and development, trying to understand what are the issues within the real world evidence space, what could be done to solve for that, testing out different methods and so on. So, it was really the R and D phase, if you will.

And we have a number of other projects that are underway right now with sponsors working with us, with the FDA to, to get them over the line. So watch the space between now and the end of this year. So that's kind of roughly what we've been up to over the last six, seven years.

Etienne Nichols: 00:04:42
That's really cool. So the real-world evidence that you're helping generate, can you help me understand that a little bit better?

How is that working or how does that work?

Simon Mason: 00:04:51
Well, the simple answer is that real world evidence of course is evidence that's collected in the real world. So the challenge with it is that the theory and the promise of robot evidence is data is being collected all the time.

And instead of for when a company is getting ready to submit for approval, instead of having to run a clinical study which they have to begin and end over some period of time in the Future they can go backwards into time and look at data that's already been collected and use that as a proxy for what they might have collected through a clinical study. Now, clinical studies are timely, can be expensive and in theory, real world evidence has already been collected.

So there's a lot of sunk costs built into that which will not be repeated.

The challenge with that is that, you know, if, if the data were collected in the past sufficiently equivalent to what is being collected in the study, we would have no issues. But obviously the data that's collected in the past in many cases wasn't collected with the, the, with a submission in mind as an example.

Etienne Nichols: 00:05:51
Clean data.

Simon Mason: 00:05:52
Yeah, exactly. Yeah. So, it's going to have potential challenges associated with it.

They may not have collected enough of it, you know, so all these things have to be put together. But, and, and so that's essentially what, what real world evidence is and where some of the challenges come from.

And I'm happy to talk through and a little bit more on the, what we do to solve that.

Etienne Nichols: 00:06:09
I'll read back to you what I'm kind of hearing myself. So, the real world data, that's what's generated all the time.

Real world evidence is generated from that real world data, kind of extracting the clean and the usable information from that real world data. Is that accurate or.

Simon Mason: 00:06:24
Well, the, I mean neither the data or the evidence are necessarily clean.

The evidence is the, you know, the evidence is the information in the data that actually supports a claim, supports a specific use of a product or, and in many cases that, that can be off label use.

So if, if it's being used off label that, you know that it's being recorded, that's an opportunity to get that product on label in the future by using that data set of having to go off and collect more data. But you know, it cleanliness is, is, is in the eye that will hold it when it comes to this.

And ultimately, we have to make sure that we measure up to what the FDA's definition of cleanliness is.

Etienne Nichols: 00:06:59
Absolutely. And cleanliness might not even be the right word. Controlled or you know, relevant, accurate. Yeah, it's a really good point.

So those are important clarifications. Can you explain how NEST access that neutral conduit between the industry and the FDA?

Simon Mason: 00:07:14
Well, we do that largely by how we were formed.

So, you know, NEST was originally put together between FDA leadership and the industry representatives that were involved in MDIC and in the MDUFA negotiations. It was agreed that we would be set up and created a specific way, so we are, as I mentioned, a nonprofit.

The funding does come through grant from the FDA but uses MDUFA fees to pay for it. So, in other words, the industry are the investors, they give it to the FDA and the FDA then provides it to us through the grant mechanism.

And our governance structure is quite well prescribed in terms of containing industry representatives, FDA representatives, patient advocates, institutional representatives and so on. So that we have a broad range of stakeholders that are committed to us.

But what is, I think, unique about us is that we have FDA sitting on our governance committee and as well as industry and everybody else. And so we're able to create a sort of a neutral ground where we operate with all of those folks.

And each group has a vested interest to bring us inside their organization.

So either working directly within the sponsors organizations to help them figure out how a particular project might work or not work, but FDA equally steps up and provides us with unparalleled access to the organization to help get these projects through and help teach and educate as it comes to real world evidence.

Etienne Nichols: 00:08:46
Okay, so if I'm a medical device company or I'm working in a early stage medical device company, I'm assuming early stage would be the ones that would get a lot of benefit from this, but maybe not. At what point in the design and development life cycle would they engage with Nest? What does that look like?

Simon Mason: 00:09:04
Well, I think there's a couple things that, and not necessarily early stage we do have. We work with big companies, we work with small companies, it doesn't really matter.

I think obviously the projects are going to be more complex in terms of Class 2, Class 3 products likely in the space because otherwise they wouldn't need robot evidence to get it across the line. They're probably going to know whether or not they're a good candidate.

And by that I mean they're aware of potentially data that exists out there today that could be used to support a submission and it could be data that's being collected off label that I mentioned.

Pediatric use, of course, is one enormous example of that, where they have an approved product in the adult population, but they know it's being used off label in pediatrics.

It could be data that exists in other parts of the world that they might have used for an approval or they're where it's available in the registry or something like that. So, they're probably going to be, they're probably going to know more about the opportunities.

And that's why we see a lot of companies coming to us, bringing opportunities to us because they say Listen, this data's here. You know, we have some concerns about this, that and the other how can we work through this process to get it done.

And the only thing stopping us from being completely overwhelmed with opportunities because we do get a lot of opportunities brought to us is that not enough companies know about us. So it's despite the fact we're in the MDUFA commitment ladder, which I don't think everyone reads every day.

But you know, it's, it is, it is, it is using venues like this that we, we want to get the word out.

Etienne Nichols: 00:10:30
Okay.

It would be a company that's most likely post market, they already have a product on the market, it's already being used and potentially like you said, that off label use and to expand those label indications. That's one of the goals or one of the, the real uses here.

Simon Mason: 00:10:46
Yeah, no, I mean it that’s, that's one opportunity. I mean premarket is always a possibility of data exists for one reason or another. So it's going to vary a little bit.

I mean there's, you know, there's, it runs the gamut, but if it's a novel product that's not existed before and is not available anywhere else, then likely it's, you know, they're not going to be using this real world evidence approach.

But they might be able to collect real world evidence concurrently and use that as a, you know, as a support to their existing submission and things like that as they move forward.

Etienne Nichols: 00:11:15
Okay, do you have any examples of, of companies or products that have gone through this process and how you've been able to help them?

Simon Mason: 00:11:23
Well, we have, we have test cases which if you go to our website, there is a description of each of the test cases on there.

Now none of those actually got through to a submission, but so since that time we have the two that we talked about, the one with Johnson & Johnson that was an approval last year and the woman Intuitive Surgery, which is in the robotic surgery space, which was a clearance this year. So those involved usage of the product in, in different settings that was able to be converted over and then used to support the process here.

The intuitive one, which I think is what you guys picked up on is in the robotic surgery space, in the prostatectomy space, the device is being used, it's not approved in that specific window and they were able to use the data that was, that was available out there today to convert and get a clearance based upon that.

So it's, but the pediatric space is something we're really interested in because a Lot of companies see pediatric off label use as a, as a particularly challenging avenue. Obviously the device is being used and therefore revenues are coming in, but they can't support the use of the product in that space yet.

The regulators often are quite a bit more concerned about when they see pediatric submissions.

And so this is one way that if we can lower the barrier of cost and effort in use of real world evidence, we hope that more companies will actually pursue the pediatric angle.

And in fact our governing committee also contains pediatric patient advocacy representatives who are helping us to sort of motivate the marketplace and move it forward. Because I think it's really the one area where we can make a difference and it's part of our mission to make sure we do that.

Etienne Nichols: 00:13:06
I mean, I could imagine the savings from using real world evidence as opposed to a traditional clinical trial or maybe the time savings. But do you have an idea of the impact there?

Simon Mason: 00:13:19
We're actually just started working on some of the sort of ROI analysis based upon this.

But the, you know, all things being equal, a real world evidence study is going to be quicker, cheaper to actually perform and it's going to get the product to prove quicker. So you know, so there's a couple of different variables we're working with here.

Number one, the cost of running a clinical study is generally in the millions and you know, doing real world evidence study is under a million and could be, could be significantly less depending on the work that's being done.

Two, if the approval happens quicker then depending on what the product is, it may, it may see increased usage, it may see 100% increase in usage, it all depends. And therefore, that turns into potential revenue for the organization.

So if you, but we've also had case studies that, where sponsors have told us that if they had not gotten that approval in the time that we were talking about, the competitive situation was set, that they were going to see market erosion. So, they were actually protecting against market erosion.

Which at the end of the day, you know, not the most exciting thing that you're not, you're not showing a massive increase, but you are showing no decrease or a limited decrease. And that could be quite significant.

And one of the, one of the case studies, they estimated that this was probably going to save them about 2 to $300 billion in market erosion.

If, and of course if they had waited and gone through the traditional process by the time they got the approval, they perhaps wouldn't have seen some, it wouldn't have seen some of that, that slowdown in erosion.

Etienne Nichols: 00:14:48
You got me curious about the fact that Nest is funded through the MDUFA fees. What would you say to medical device companies? What do they need to bring you to really properly utilize your services?

Simon Mason: 00:14:59
Well, we're not, we're not the solution to all.

I mean the, you know, the MDUFA fees are paid by all companies and go into the FDA and then the FDA has to use those fees not only to, to take care of the submissions that are coming through, but they also have, you know, they have a responsibility to improve across the board in terms of understanding real world evidence and many other. So there are, you know, there's a certain subset of fairly large subset of companies that can benefit from what we do.

What do they need to bring us is, is really in the opportunity is, is a couple of things we look for in any project. We look for a patient benefit number first and foremost.

So we, we want to see that we're having an impact on the patients’ lives as a result of this, whether it's getting a product more readily available or simply approved. Second thing is we want, you know, ideally a knowledge of where data might exist to support this.

You know, we'll work with the sponsor to go out and identify additional data sets if that's not sufficient. But it's often much easier.

They say that we come in and we've been working with for example this registry group and they've got this data, and we think we can use it. But you know, we see some challenges. Third is they obviously have to claim that something they're looking to do, right?

I mean, I know that sounds like a silly question, but trust me, we have conversations with companies where they're just spit balling on different ideas. We need them to be a little bit more prescribed in terms of what they're looking for.

And then fourth, we look for ways in which we can use the information, the project to test something like a particular element of the process. A new data set that we haven't worked with before, a new therapeutic area that we haven't worked in so that we can show that it has broader approach.

Right now we have worked with cardiovascular on the OHT surgery, some discussions with orthopedic potentially coming up diagnostic tests. So, there are other areas there that we're looking for that if a company comes to us and says, okay, we'd like to try that area, we're interested.

Neurology is the latest area we're talking to now.

Etienne Nichols: 00:16:49
Okay, what's the most exciting potential? I mean you already kind of hit on some of the different specifics in the industry.

But what do you think are some of the most exciting potentials of real-world evidence? Advancing medical technology and improving patient care?

Simon Mason: 00:17:02
I mean, speed is really the biggest, the biggest point here. I mean, it's all about the speed. After all the R and D process took place.

And when I got in last year, I worked with the team, and the team is mostly new.

We reformed the organization based around that mentality of running like a business, which in the nonprofit space is actually starting to become more in vogue. To demonstrate returns and other things that people normally look for in a business out of a nonprofit organization is not always appropriate.

But in our case, it's specifically appropriate because industry wants to see the success. But we took a look and said, okay, well, what are the challenges now facing the industry as it relates to this?

And we found really three things that were problematic. Number one was the fda. Number two are the sponsors themselves, and number three is the data.

You know, FDA has, you know, it's very hard for them to, to deal with what evidence they get data thrown at them from all different angles. They're not sure, you know, how it's collected.

They've told stories about high school kids being enrolled to collect data in, you know, on, on the, as part of a sponsor submission and things like that. That's true, but it, it, you know, they, it makes it very difficult for them to support this.

As a result, companies don't see this as a viable pathway because they see it too risky and they don't want to proceed down this path, spend 6, 912 months, you know, a smaller investment, not be successful or still be in a position where they're still going through the process and have to then kick into a clinical study which they could have started six months earlier. It's going to cost them more, but they would have, they wouldn't have sunk the cost on the RWA.

And then solving for data is the biggest issue because the collection of data in the real-world environment. And I'll quote Rob Califf, FDA commissioner, he was at our public forum last year and he'll be there again in September this year. It's a mess.

So it's not done in a way that, you know, that is conducive to what we're trying to achieve here. So, we have solved for the first two issues.

We have worked with FDA to develop the nest mark process, which is our process for marking the data as fit for purpose and then fit for evidence support. As a result, industry starting to pay attention to say, wow, that that actually makes a difference.

Because if we can go through that, you know, we can. People like to say fail fast, I like to say succeed quickly.

But they can move down a path and get a point and say, okay, you know what, we tried, or it's working. And therefore, they can, you know, they feel much more confident about the process. We're still solving for data, but all of this leads to speed.

And in business, speed is everything. In patience, speed is everything.

Etienne Nichols: 00:19:37
So when you say you're still solving for the data, does that mean you're really still trying to establish for this industry or the. And when I say industry, you mentioned the urology or cardiovascular or orthopedic, pediatric. What does it mean to be solving for the data?

Simon Mason: 00:19:52
This side, we have a couple of initiatives in play. Our Nest Marketplace and Nest Window. What we're trying to do through those is to, is to make data more accessible.

And the first the marketplace is really what we're doing is we're working with all data providers, whether commercially based or institutional based, to really understand what's out there and make it easier for companies that come to us and work with us to quickly see what's out there. Now, from their limited window, especially a small company, for example, they're not going to have vast resources.

They can actually come with us and just consult and ask about the data sets that we've worked with because all of the providers come to us and many of them are actually under agreement with us to participate in providing more information about their, their data sets. We have on our website, again, we have a list of all the institutional network providers.

It reads like a who's who of, of the institutions out there today. We work very closely with all the commercial services providers and so on.

The Nest Window is really designed conceptually because we're still, still building that. And that's something that any sponsor that comes to us can help us make it better.

But the concept in Nest Windows, you look through the window and you can see what's there.

And the idea is that it's not going to give you detailed access to the data, it's not going to give you the ability to query the data or that sort of thing necessarily in any detail.

But what it does is say if you're sitting with a project in front of you, you believe data is out there, you want to quickly identify it, you can do it through this process and then you can make a decision. Go, no. Whether you go this approach today, that is a challenging process. You can go to a commercial Services organization that consolidates data.

But they're going to have a, you know, obviously still a limited slice of what's available out there. You can ring up institutions and see what, you know, try to get them to, to participate and provide information back.

It's, you know, that piece there is why most people just don't even bother and just keep moving on with the, the clinical study. So those are the attempts we're trying to make to, to fix that.

And because of our, you know, our position as a nonprofit between all these groups, everybody is willing to work with us because, you know, it's not like I'm a commercial service provider and asking you to have an institution sign up. It's, you know, it's, they're willing to do it because they understand and are and have a stake in our outcome.

Etienne Nichols: 00:22:05
So I'm just trying to wrap my head around this because it's actually really cool. So I mean, when you say those service providers, are you talking about EPIC or the healthcare, all the different ones that are.

Everything that happens in a hospital, potentially like through a surgery, for example, maybe there's a medical device company that wants to improve arthroplasty outcomes or something like that, and they're not sure what data is collected even, or maybe they have an idea.

But you would have better window into all of those things because of your relationships with the, which service providers and how does that, how does that work?

Simon Mason: 00:22:39
So that, that actually, that points more to the, the nest window process. Now you know, EPIC and companies like that, you know, don't, don't sell the data. So they, you know, so they, it.

So it would be companies, either the underlying institution that has the data and has developed a method for, for making it available or not for that, for that matter, because we can work with the, you know, there are institutions that have developed their own data organizations that are responsible for commercializing their data, making it available. So those would be examples of that. So that's more of the nest window side.

Then there are commercial services providers which are the companies that are out there working with Medtech today in either selling them data like a Health Verity or companies like that, they, providing the clinical study capabilities.

There's a lot of those organizations and we work with all of them to, to better understand our process so that they can actually provide that to their clients and have their clients come back into them. So that would be more of the nest mark process, which is the process for marking the, the entire, you know, data and evidence.

The window is much more to the Data providers, and we work with a number of organizations out there too. And to be clear, Window is in, is in concept stage at this point.

After last year's evaluation of the challenges, we focused first on getting FDA in industry to a place where they were comfortable to start to move forward and, and, and try things. Which was enormously successful on both sides, very supportive both within the FDA and within the industry.

But at the end of the year we still realize that even with both sides comfortable, if there's not an easy access to good looking data, you know, they're challenged to get an outcome that is going to be satisfactory. So that's when NEST Window was born and we're now, that's something we're really focused on now. Ideally it's a, it's a buy versus build.

Now I don't have a huge budget because as I mentioned, I get paid through the MANUFA phase.

But we're hoping to take advantage of underlying capabilities that are already out there today such that we can provide that access to the data quickly and so people can understand what's there.

Etienne Nichols: 00:24:44
Really exciting. I appreciate all the work that you're doing in all of this.

I'm curious if there's one key message that you would want our listeners to take away from the NEST and the power of real-world evidence. What would that one message be?

Simon Mason: 00:24:56
I think it's really to have another look at Nest or have a look at Nest. I think that's the most important thing.

Nest in its first iteration worked with a lot of companies in terms of the testing and so on, but they perhaps didn't see what the potential outcome of that was. You know, in, in the last, you know, we're just entered the second year of MDUFA 5 funded.

We've had enormous success in actually getting submissions done, which ultimately is what companies want. And that's what they wanted from us, you know, all along. And so, we're very heavily supportive of that.

You know, I often go to conferences, and I ask everyone in the room to put their hand up if they've heard of NEST and all the hands go up. I then ask them to keep their hand up if they know what NEST does. And most of them go down.

So you know, we're trying to get that message out there through, through attending conferences and venues like this because they really need to take notice and take a look at their situation and say, okay, how many real world evidence potential projects do we have within the organization?

How many of we have passed over just because we understand the complications and, and if we knew there was a way to get it done more efficiently, would we take that path? And we're evolving the process. The NEST mark originally started last year.

We, you know, we had one partner that we worked with to help us develop and deliver because we're a very lean organization. You know, we're, we outsource everything to make sure that we keep our costs down.

And then sponsors obviously have to cover the cost of the outsourcing that relates to their particular project, which is fair because we don't want MDUFA fees to go to pay for an individual company. It pays for our R and D that benefits all companies.

But as we move forward we're looking to make that load lighter and lighter and lighter to ultimately where we can work with a company on a very light touch basis and they can use the NEST mark going into their submission and then ultimately into FDA such that the FDA sees it and says okay, well if you know, I have 100 checkboxes I have to go through on a, on my review process. Ten of them are already checked by the NEST bark being there now that's a gross oversimplification.

But, but you know those 10 checkboxes on the data can be the difference between, you know, 6, 12, 18 months’ worth of negotiations in a submission.

So if we can solve for that piece right up front, then it gets down to the actual claim and the validity of the claim which of course we don't get involved in. But we do stay with the projects that we work all the way through post submission to make sure that we're providing all the support we can.

And that does speed things up too.

Etienne Nichols: 00:27:18
We'll include in the links or in the show notes different links to get a hold of Simon but also to be able to get a hold of the Nest and learn more about this. But Simon, where were the best place for people to go to learn more about you and about the program?

Simon Mason: 00:27:33
Well, our website which I believe is still nestcc.org so that's or mdic.org, which is our parent organization that we sit underneath.

We're sort of a self-contained operating unit within those we have our annual public forum in D.C. great way to come and we do that, MDIC does that every year and we participate and actually this year FDA is, is actually doing their public forum as part of the MDUFA commitment within the public.

Our annual public forum which is great because we're combining the two and you it's a great opportunity to meet with all the FDA folks and also with us on our website as well. So, I think those are probably the best way to do this.

And then I think you will probably put our standard Nest email address at the in the contact details when you when you post this.

Etienne Nichols: 00:28:17
Yeah, absolutely. Very, very good. Thank you so much. Really appreciate all of the information. Thank you for coming on and sharing all of this.

Thank you so much for listening. Really appreciate it. We look forward to seeing you next time. Take care.

Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never. Done that before, but if you're listening. On the phone, we look at the iTunes app. Scroll down to the bottom where it says leave a review.

It's actually really easy.

Same thing with computer. Just look for that leave a review button. This helps others find us and it lets us know how we're doing.

Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only. Way I'm going to get better. Thanks again for listening and we'll see you next time.

About the Global Medical Device Podcast:

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The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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Etienne Nichols

Etienne Nichols is the Head of Industry Insights & Education at Greenlight Guru. As a Mechanical Engineer and Medical Device Guru, he specializes in simplifying complex ideas, teaching system integration, and connecting industry leaders. While hosting the Global Medical Device Podcast, Etienne has led over 200...