The Medtech Agenda for Startups — What a New U.S. Administration Means for Policy | LSI USA '25

Lishan Aklog  0:05  
Okay, good morning everyone. Good to see everyone here. I'm Lishan Aklog. I'm chairman, CEO of pabmed, and we're really excited to have this workshop today. It's been a great meeting. I was telling folks, this is, I think, my fifth consecutive LSI, and they really hit it out of the park the when we talked to Henry and Scott about having this panel, the purpose was really to try to convince folks in emerging med tech companies that it's important to pay attention as to what's going on in DC. Is there anything going on in DC right now and so. So we have a great group today. Two CEOs will do the introductions, who are run small companies but are active in admin. Advent is the our largest and most important trade association, and is extremely active in helping, helping companies across the spectrum within the industry navigate the landscape that we're facing. And a lot of small company CEOs are just focused on, I gotta get my next round. I've gotta, you know, got headaches at FDA and are not really appreciative of sort of the impact that being aware of what's going on on on a from a policy point of view, actually matters every day. You know, my ELT, we actually spend 10 minutes every every week about what's going on out there. How's it, you know, how's the FDA rule on X, Y and Z, going to affect us? And so hopefully, we'll convince you that that's something that we should all focus on, and we have some good topics to do so, so I'm going to let my colleagues here introduce themselves. I'll start with Juliana Elstad.

Juliana Elstad  1:47  
I'm Juliana Elstad. I'm CEO of vibratomedical. We are a medical device company. We use ultrasound as a therapy for peripheral vascular disease.

DeChane Dorsey  1:59  
And I'm DeChane Dorsey. I'm the Executive Director of Advamed Accel. Advamed Accel is the small company division within AdvaMed. We work with all of our small company members on a range of policy and advocacy issues, and over 70% of AdvaMed's membership are small companies.

Lishan Aklog  2:15  
So, yeah, it's interesting. You know, the that's an important statistic, I think. And it's not just the membership. One of the things that struck me when I started getting involved with AdvaMed, about just right after we licensed molecular diagnostic technology under Lucid Diagnostics, was they're not just members. They very much focus. There's a lot of attention paid to small companies. I was actually quite struck. I'm quite sure that if you go to pharma, which is the equivalent trade association for the pharma industry or bio, it's not the case. And so Juliana and I have both gotten quite involved, and we both serve on the board. We both serve on this special division that Deshaun is the executive director on of called Adam Excel. And we, you know, it's a little bit like Hamilton. We find ourselves in the room where it happens. You know, we're out of become a first name basis. Sometimes it's a bit striking, you know, with many of the large company CEOs, and we have a, you know, great understanding. So I'll just start off with that pitch. If you guys, anybody here, a member of Evan, yes, of course, Ariana a handful there. So we need we need more. We need folks to who run small companies to join adomit Excel does a great job. You know, it's our job. I'm the current chair. Juliana will be the chair next time, to make sure that issues that relate to small companies are being brought to the forefront and all of the advocacy work that that AdvaMed does includes the interest of smaller companies. If you have any other thoughts about that,

Juliana Elstad  3:49  
yeah, I think you know for us the benefit. There are three things that is really important. I think first is the community. This is the Adva Mester organization, where all of us come together, and if you think about it, issues that there are many issues that affect all of us, whether it's FDA, whether it's Medicare, whether it's NIH and grants for small companies, we can work together. And Evan represents that organization that unites people, and it's also great networking opportunity. It's again, it's big companies and small companies working together. And if we as a small business want to have our voice heard, we need to speak up. We need to be involved. Because if small companies are not at the table. Why should anyone care? Right? If we ourselves do not care enough, why should anyone else? So that's why, I think, you know, the first thing is networking and community. The second to me, I think it's very good to be on the forefront of the issues and know what's going. Going on, and de Shawn and the whole la team keeps us very informed. And I can tell you when you do a pitch to an investor and you think, like, about your next financing crowd and so on, an investor start asking you questions. Is like, oh, like, did you apply for breakthrough designation? If you can answer like, Okay, we did this, and this is what is expected. And by the way, there was hearing about this and it is expected to be there, you get credibility with those investors, and it helps you in your fundraising efforts as well. And third, I think it's important innovation, and we'll talk probably later, more about it. Reimbursement is a barrier to most innovative companies and technologies, and having a voice of a small company what it takes, because when you have on average 5.7 years between FDA approval and CMS, for many companies, it's a valley of death. But many politicians do not understand that they're not in the depths as all of you are. So I think that is another important,

Lishan Aklog  6:15  
yeah, we actually have a voice. It's really quite striking. Again. Never really expected it when, we honestly our company, we signed up for, I've told this story before. We signed up for AdvaMed as a way to get a discount to the med tech conference. And so check here if you want to pay, I think it was 400 or $500 at the time. And within weeks, me and my CEO were down in DC meeting with, you know, very, you know, high powered experts on reimbursement, because we had just licensed the technology in an area that we didn't have a lot of experience with. And I, just from day one, had been, been amazed at the access we have to to folks. I had a colleague of mine who runs a med tech company, small med tech company, that is struggling with the CPT codes. Right now, there's a battle going on at the AMA, and, you know, Tara and her group on the payment group are all over it. And this is not, you know, Abbott or some other big company. It's a small company, and it's quite remarkable. And just to give a example of how we have a voice, you know, when the we'll get into the into some of the issues on reimbursement, when, when there was an opportunity for to actually get in front of Congress and lobby for small companies on behalf of this breakthrough bill that guarantees CMS coverage for breakthrough device companies, they trotted me out to to FDA, to in front of Congress at the Hearing, and I was able to tell that story of why this is important for Medtech innovation, why it's important for small companies directly, not through, through sort of the high power, you know, larger, larger company folks. So we're going to cover, try to cover at least three areas today, and then we'll leave it open to whatever other folks. This is intended to be a workshop, I think, is the first year that that that LSI is doing this. So we're hoping that this can be interactive. I think there are mics around. So, yeah, there's a mic there, so people can come up and and ask questions. And we'll try to keep this as as interactive as possible. So we'll definitely cover regulatory, FDA issues, reimbursement issues. There's a lot going on right now with grants, SBIR grants and other sources of government, non dilutive financing, which is being affected by some of the things that are going on, and that will leave it open for other other, other areas. But before that, I just thought maybe de Shawn, maybe you could just touch on a little bit more from as as executive director at AdvaMed, about the kinds of activities from advocacy work, from just maybe a little bit of a flavor of what your team does every day on behalf of this industry.

DeChane Dorsey  8:49  
Sure. Thanks. Lishan, so AdvaMed Accel, as I mentioned earlier, is the small company division. We are what I consider to be a small but mighty team comprised of basically three people, but we work alongside our colleagues in the other divisions and departments to really ensure that our members are getting the full bang for their membership dollar. And what I mean by that is we work to make sure that they are plugged in on all the advocacy and policy issues that are directly impacting their day to day operations and helping their products to be viable and to hopefully go from inception to one day the marketplace and into the hands of the patients who need them. I also co lead our work on women's health and health equity. So all very hot issues these last several years and issues that we continue to see a lot of evolution and change on, especially under this current administration, one of the things that we work quite closely with our colleagues across departments and divisions on are issues that impact the coverage and payment environment for the small companies, especially because when you go to the Hill, when you go into agencies, people generally will think of med tech and med device, and they will immediately default to very large multinational companies like Edwards and Abbott and Zimmer and Stryker and. Don't really fully understand the small company landscape, the small company ecosystem, or how that ecosystem feeds into the M and a pipeline and creates a lot of the technologies that eventually get into the hands of doctors and are impacting patient lives in this current ecosystem. The other thing that we do well is we work with our small companies on what I call small company specific issues. So many of our small companies are heavily reliant on federal grant funding programs. We make sure that those programs are reauthorized. We work with stakeholders and policy makers and legislators to advance re authorization of programs like SBIR and STTR. We also work with these same folks on issues around taxation policy. So we know a lot of people ran into hurdles when the tax cuts and Jobs Act, which we affectionately call tcja, modified the R and DE expensing provisions in the Internal Revenue Code A few years ago, and that has created tax burdens that were not anticipated by several of our small companies, and makes it a little bit harder for them to have that capital available for other use, and now they are paying tax bills with it. So we are working quite heavily on an anticipated tax package to ensure that that change is modified this year and that hopefully in years going forward, if we can't have it made retroactive, that that ability to expense when the need occurs and when the expense is encouraged instead of amortizing, is made available. And then we also have just been working on a lot of issues around the investment. A lot of you are here seeking investment because of investment needs, and we work with our companies through a variety of work groups and webinars and other engagements and opportunities with investors at our med tech conference to make sure that people understand current trends, what the landscape is, and to also connect investors more closely to our member companies in the industry through inviting them, not only to our med tech conference, but also now having established what we call an investor Advisory Committee, which my colleague, Patrick Brennan, Who is in the room somewhere. There he is, runs on behalf of avimed, and that's really our opportunity to pull in venture capitalists and other investors who work with portfolio companies, to have their portfolio companies plugged in, but also to make sure that we are hearing current, relevant information and insights from those investors about how the ecosystem and the environment for investment is changing, and what those trickle down impacts are for our small member companies. 

Lishan Aklog  12:52  
Okay, our pitch is done, so get involved. Get involved with Adam Ed. Sign up for AdvaMed Excel. It's a few $100 I think it's still a few $100 and please get involved. This is, as Juliana said, this is the industry. Is really a network. It's a family. We can all work together to help each other out. So let's dive in. Let's dive into the weeds. Let's start with regulatory, with FDA related issues. So how many, how many folks here in the room are, in some way, either planning, active, pre sub waiting some way engaged with with FDA right now. Yeah, not, not a big surprise, how many of you are concerned about some of the things that we're hearing about going on in DC as it relates to staffing furniture? I think there was a furniture issue this week, right like and other other related things. So, so let's see if we can flesh out sort of what's going on, and our adamant kind of perspective of what's going on. And frankly, what Adam at is doing to try to try to try to help out that situation. So maybe, maybe de Shawn, you could start with because that is an immediate concern about the issues around staffing and concerns around the time. How might, how might it affect the review process? How might it affect the time to clearance and things like that? 

DeChane Dorsey  14:16  
Absolutely. So I think many of you are probably familiar with a lot of the changes that have been going on via Executive Order since the new administration took office, and one of those changes happened about three and a half, four weeks ago now, where there were a series of firings of probationary status employees. Why that matters to us is that probationary status employees, for some people, it's one year, for some people, is two years probationary status, technically, does not mean you are new to an agency. It could mean that you were in an agency for many years, got promoted into another position, and now are starting to go through a probationary period as it relates to that new job transition. So in the midst of this, many of you familiar with MDUFA. MDUFA. It's the medical device. 

Lishan Aklog  15:01  
Let's talk about it, because I didn't know what MDUFA was when it sounds like a alphabet soup

DeChane Dorsey  15:05  
Medical Device User Fee Agreement, and it's negotiated every three to five years. And what MDUFA does is this an agreement between FDA and manufacturers that's initiated through legislation and the industry. Us, avamed, our member companies, you all, if you are in an organization like avamed, agrees to pay user fees to the FDA. What those user fees are used for is to ensure that FDA has sufficient staff to make sure that when you submit applications, 510, K, PMA, otherwise to FDA that there are reviewers on staff and on team to do those reviews in a timely and effective and efficient manner. How these user fees work is that we collect user fees from our members. Those funds are then dispersed to the FDA. They then use the funds to independently hire people to take on new tasks and roles within the agency. And this meant, in the context of the last medufa agreement, which was medupa Five, FDA brought on several people in their review teams to handle issues that are emerging, like AI, to handle a lot of issues that are currently in ohts throughout the agency, and then also to staff people for their total product life cycle Advisory Program, affectionately known as tap, even though a few letters are missing from the acronym, to help shepherd people through The FDA approval process. So really working with companies directly from the time they have an application and for breakthrough designation all the way through the FDA approval process. And

Lishan Aklog  16:52  
Let's touch on MDUFA Real quick, because I think that's an that's something that before we move on to what happened to three weeks ago, because they're there, they're very much intertwined. This actually affects you. So the the time it takes to, you know, from a submission, either an FDA days, which is sort of a, you know, an FDA days, not the same as when the when the Earth turns around the sun, or in actual, real days, that those numbers that really, really obviously affect all of us. It affects, you know, that's unpredictable. It affects the ability of our investors to have confidence in in the pathway. And there was something very unique about this current the last medufa, maybe Juliana, maybe talk a little bit about, from our from our perspective, how that matters with regard to having some predictability around timelines and investing resources to make sure that they're under certain timelines.

Juliana Elstad  17:46  
So when you raise capital, you investors. They want certain timelines, they want you to execute. And if you deal with lack of predictability, it doesn't matter how good you are at execution. You need you know there are things outside of your control. So to make the FDA process more predictable, there were some milestones and performance metrics that were established, essentially AdvaMed and others in negotiating MDUFA with FDA said, okay, the industry will pay the users fees for the decision, but we need ufda commit to certain milestones that included the time for the decision making, that including having the staff and again, Dushan mentioned briefly, but you know this probation staff that was laid off and then re hired. These were the people specifically for innovative technologies. Because very often, you know, people who've been with FDA for 2030, years, they might not be the best experts on AI or digital health in general, or whatever new, really transformative innovation that all of you guys are working on. So those were the critical people. And it was through medufa that, you know, we as an industry, say, like, Okay, we're going to pay the user fees, but we need certain things, and that gave us leverage in all of that. And so then when layoffs happened, you know, as you heard, many of these people were re, hired back, and the main reason is because in the medufa negotiation, it was laid out that if FDA doesn't have appropriate staff, then the funding from the industry, whatever is lack will be a credit against the future fees. So essentially, when FDA realized like and all this Efficiency Initiative, realized they're not going to save any money by laying off these people, that was, you know, the madufa negotiation that AdvaMed did so masterfully. I was the force behind to have these people coming back.

Lishan Aklog  20:05  
And this is all new, you know, again, if you've been involved in this for more than three years, you know, going back four or five years, that was not true, that there was no accountability, that the FDA had no accountability to the industry. If the industry says, I think it's up to $2 billion collectively, the industry pays to support FDA activities. It went from about a billion to two, and as part of that increase, for the very first time in the history of the FDA, there is accountability. There are metrics as to what are the time timelines? They're focused, I believe, on 510, Ks and PMS. But there that's tracked when you know and the board, we get those reports every time a board meeting. You know, how's FDA doing with regard to that their track, with regard to the time, as well as regard with regard to hiring metrics. So it actually became, I don't say was easy, but it was a very straightforward argument when, when these 200 folks were, were about 200 folks were, were laid off, to say, You guys are not saving any money here, and you're actually going to lose going to lose money because you're not going to hit your target, and we're going to be able to claw back user fees. That was would not have happened in medufa Four, which was, you know, three, four years ago. So, yeah, great. Go ahead Leslie,

Audience Question  21:14  
because this is, I think important, one thing that you guys to haven't shared. So I was an adamant whenMDUFA was initially negotiated, and Lee used to submit a 510, K, and it might take a year. Yeah, like, this is real, like, 18 months for 510, K, a, PMA, easily would take you two years. And so that's really what madufa Did it transform that? And so what he's saying is, you know, it took the things you can get a 510, K back, Count 90 days if you've done it right, and work for the agency well. So in terms of predictability and investment, it's been transformational. And yes, when all those people got laid off, those of us that have been around for a long time jumped on the phones were scared to death, because nobody wants to go back to that world where it's taking years right to get something clear. So I just wanted to make sure that you guys understood, when they're talking about these timelines, what that mean, like in real timelines, you're talking about from 90 days to 100 I mean, to 300 or 450 days. And that's transformational when you're trying to build a business. 

Lishan Aklog  22:22  
Thanks. Leslie, 

Audience Question  22:22  
yeah. Do so after med really made, you know, a difference in a huge way for the industry, when they created MDUFA

Lishan Aklog  22:28  
it's a deep incentive. They're hiring people. And if you if they don't reach these targets, that's, I don't think we had a slide, but let's, let's just, we can talk about it the the average, right now, time, actual days, right? Earth turns around the sun-days, not FDA days is for 510K is about 

DeChane Dorsey  22:46  
138 days 

Lishan Aklog  22:47  
138 days

DeChane Dorsey  22:48  
to Leslie's point is significantly lower than it used to be. And really does keep FDA aligned with our industry guard targets, so that we are able to really, oh, my slide, yeah, yeah. So, yeah, it keeps FDA on track, and really makes sure that industry is getting what they need out of these agreements, and are able to really get through that process and get things,

Lishan Aklog  23:13  
I think for PMAs, it was 300 or so, something like that, which is within the target. So 120 days is basically 30 days above the minimum 90 FDA days. So that's that includes probably one round of a request for more information. So that's actually pretty reasonable, and again, much better than the dark old days that Leslie was referring to. I'd really love to open it up to any buddy who's ha. So actually, before we get to that, can you talk a little bit about how those folks who were fired were back in five days? That's actually not typical of

DeChane Dorsey  23:46  
and my clicker worked that time. So I went to my next slide, which really just shows the Oh HTS and how they are performing. But if you look at those Oh HTS on the screen, the ohts that were most directly impacted by the firings were in vitro diagnostics, digital health, which is contains the Radiological Health, which also contains the digital health reviewers and then cardiovascular so three of the ohts that really see a lot of activity in terms of reviews. How this played out is essentially people were terminated on a Friday evening, our CEO, Scott Whitaker, eventually sent out something to via LinkedIn, and we had touch points within the administration to raise the point that Lee Shawn so eloquently made regarding the fact that you don't save money when you Fire people that are working essentially with outside funds, funding their salaries. And then there was a re extension of job offers to some of those persons who were terminated. We still remain not completely sure of how many people have come back some of their other extenuating factors, as such as requirements for. People to return and work in person during the last several years, as you all know, since COVID A lot of people started working remotely, and some of these people were hired remotely to work in their reviewer roles. It allowed FDA to really tap into a much more sophisticated skill set of potential employees who were willing to work for the government. I don't even work for the government, but I was a government employee most upon times a lawyer. And they don't make a lot of money, but they do great work. And so remote hiring became a great vehicle, much like if you think about qsbs for attracting talent through a stock offering, but to bring in talent to work at the government. And so some people, we suspect, will not be returning because of that, but we have understood that many people who had pros, who had reviews underway, have been contacting their reviewers. And you know, many of those people have returned, but.

Lishan Aklog  25:57  
I think the word is that 85% we think, are back, and that was a fairly remarkable from a timeline point of view, fairly remarkable switch. I would really be curious if anybody here who has an active engagement with FDA has had any particular challenges over the last month or two, as it relates to some of this,

Audience Question 2  26:18  
We talk about the layoffs and everything, but Jeff Shuren, Bill Murzell, new commissioner, so the leadership has changed, 

Lishan Aklog  26:19  
Correct. 

Audience Question 2  26:20  
And the last year, I would say, believe it or not, FDA was been friendly, been having these interactive conversations you could have in person. Now I'm just kind of curious, is that still the same or

Lishan Aklog  26:37  
Yeah, so we don't know, right? So new commissioner, new new secretary. Dr Tarver is still in the leadership role in place she was Dr Shuren's successor. 

DeChane Dorsey  26:37  
And, um you know, Dr Marty McCarry, who is currently on staff at Hopkins, is the person who is nominated as the incoming Commissioner, he's had a couple of confirmation hearings so far. His confirmation is not completely firmed up as of yet. During one of his confirmation hearings, he did express interest in continuing to make sure that FDA was working on things like telehealth. FDA was focused on making sure that they were responsive to industry needs. However, you know it does remain to be seen. Some of you may be aware that there's a communications freeze that's been in place since very early February. That Freeze has started to lift in just the last couple of days. And is our understanding from speaking with our team internally, that you can have those conversations again, at least with the staff that is there. So I would encourage people who do have folks at FDA that you have reached out to historically and you have questions about issues, to please try to resume those communications. My understanding that people are now, as of this week, actually able to respond, but we are watching that issue very closely, to your point, to see how we can work with the new the new administrator, the new commissioner in that role, and see how we are able to continue what we think was a really good relationship with FDA and the CDRH team. 

Lishan Aklog  28:19  
I didn't think anyone who's been in the signature while would think that we would be praising the FDA, but it really is actually things have gotten quite a bit better with regard to those interactions. And I think folks are hoping that that stays where it is. It's a bit of reading tea leaves, but I think, and maybe both of you can confirm this, I think the general sense is that we are not in the cross hairs. The cross hairs are targeting food, at least at the HHS level. It's targeting food and pharma and that we, you know, hopefully, are, you know, fit a bit within some of the philosophical leadings of the current would you, would, you agree with that. It's, again, it's just a bit of tea leaf reading. We don't know for sure, but that's a set

DeChane Dorsey  29:00  
I would, I would. And if we wanted to say the same thing about CMS, you know, we've also been monitoring the hearings for Dr Mehmet Oz. And same thing in his confirmation hearings, he expressed support for ongoing understanding of the role that Medicaid and Medicare play in ensuring the health care of underrepresented populations. He spoke a lot to those topics. He spoke a lot about coverage reform and the ongoing need for coverage reform. So we are hope 

Lishan Aklog  29:35  
time is right. Let's dive into reimbursement unless there's anything urgent about because I realize we're way way, close to the end here. So let's talk about reimbursement. So from the point of view of emerging, smaller companies, maybe Juliana, you already sort of hinted at it. Could talk about the importance of these efforts around m, set and T set and breakthrough bills and all of that. Why that's so important. For us, within the within Med, within the Medtech industry.

Juliana Elstad  30:04  
Well, every investor, when they invest, they want their money back at some point, right So, and they want it sooner rather than later. And so, if you think about it, you know, like FDA process over the last 10 years improved, but CMS process still lacks some predictability, accountability, transparency, and so this is important for all of you investors. You know, they watch it too. The reason, there is a reason why at the Met has an investor group, because politicians want to hear from investors sometimes, and investors want to know, because all the companies are impacted by reimbursement issues. So once you get your FDA approval, if it takes you a long time to take, to be covered, to be paid, that's a problem, right? And if there is uncertainty, even if you are going to get paid. That's a problem. How does that translate? You know, if you think about pharma biotech, they can do their IPOs way earlier than med tech right now, if you're a med tech company, you probably need to be 50 million in revenue to do an IPO, or at least close to that in the near future, while some pharma biotech can do IPO before FDA approval, why is that? Because their reimbursement process is more predictable, it's less riskier, and that makes a big difference for small companies. Just imagine if you could have access to public markets way earlier. How would that change financing, speed of innovation for med tech and other things? So I think again, reimbursement is a big topic we can talk

Lishan Aklog  31:52  
yeah, let's go through the alphabet soup. So MCED was introduced in the two administrations ago. What's MCED?

DeChane Dorsey  32:00  
MCED is the med innovative technologies legislation. It was really a process whereby a device would get automatic coverage upon receiving FDA approval, which was geared towards expediting the ability of people to get products into the hands of their patients and providers, and also to make the process more predictable for breakthrough for breakthrough devices, that was ultimately rescinded at the start of the Biden administration, took several years T set, so we got t set, total transitional coverage for emerging technologies, which is still a breakthrough, Paul breakthrough coverage pathway, however, T set, which was finally finalized last year, had a much more limited set of coverage. It was limited to five products per year, and that was based on some numbers that CMS determined to be reasonable, given staffing constraints and given

Lishan Aklog  32:58  
a really watered down it's essentially a lottery by the year. So, I mean, it's essentially became a lottery, and it was limited to by, oht, right, you started. They started with, I think cardio, them, diagnostics, for example, were not, were not included. So it was really watered down from what MCED was, essentially, was, you know, not that useful for us. The good news is there is some hope that we may go back to the more liberal interpretation of how we encourage reimbursement and drive the kind of transparency that so maybe a little bit about, 

DeChane Dorsey  33:35  
right? Yeah, there is an opportunity, potentially, to revisit andor resurrect and sit, and then there has been ongoing activity on what we call the breakthrough legislation bill, which is a bill that has been in Congress and had a lot of bipartisan support last session, but just did not make it across the finish line. But that bill really goes back to a more MCED like structure, where there are not limitations on the number of products that come through this automatic coverage pathway program.

Lishan Aklog  34:06  
I mean, TCET was better than nothing, but it really didn't accomplish what you were what you were hinting at in terms of increasing transparency and predictability. 

Juliana Elstad  34:14  
Look five companies out of the whole industry, none of you investors will believe you will be one of those five, regardless of what you say. Because, again, as Lishan said, that's a lottery, right? But I think it's important what Dushan was saying. So right now, as an industry, we pursue dual path. There is a legislative path, which is called Breakthrough legislation, 1691 where it does talk about automatic coverage for technologies that have breakthrough device designation, and that is in the process. And then there is another path through resurrecting kempsit, with a lot of talk in the current administration how whatever they did was great and whatever the Biden administration did was not so great. And. Maybe we can capitalize on that and say, Okay, let's go back to M set, which was approved in the last 90 days of so

Lishan Aklog  35:08  
think about that. You got automatic. We didn't. We weren't running out of time, so we weren't able to get into the TAP program. But there is an there is an element within FDA right now where there's a interest in pursuing breakthrough device designation, not just so you can brag about it, but it actually has a actually has an impact. And if you think of if you had, if you if you knew in advance that, okay, we're going to, we know FDA has told us what we need to get breakthrough clearance through this breakthrough pathway. We know that upon clearance or approval, that we will have at least transitional covers from FDA, from from CMS. I mean, that's that's the the landscape that we're trying to, trying to accomplish here. And I'm sure how many folks here are, are dependent on CMS or other governmental agencies with regard to the reimbursement for their products. It is a lot. I know some people are entering spaces where there's already established reimbursement, but many of us are not, and there's even issues around category, category. You know, you may be innovating in an area where there isn't a clear category, there's certain diagnostic screening tests, for example, where there is not a category and you're stuck, you may have a great technology that can help patients, that can have an impact. Have an impact, that you've demonstrated, but to get CMS reimbursement, essentially, literally requires an act of Congress, because they don't have the statutory authority to actually give you coverage there. And that's that's also part of part of this initiative,

Juliana Elstad  36:34  
yeah, so as part of AdvaMed work, like there is a working group that talks specifically for Excel companies that we meet on a zoom call every two weeks to really discuss the issues that impact small businesses as it relates to reimbursement. So that when de Jon and her colleagues go and advocate on the behalf of the industry, the voice of small companies and the issues that we have with reimbursement policies the way they're at now, are properly presented to politicians.

Lishan Aklog  37:07  
So sadly, we're almost at the end of our time, so I do want to make sure we spend at least a minute or so on federal funding. So again, how many folks here in the room are have received SBIR grants or other sources non deleted financing as part of their, of their, of their journey. Yeah. I mean, there's a decent number. Maybe Deshaun, if you could give us a quick snapshot, we don't have time to go through a lot of depth here as to what's going on and the uncertainties around SBIR and Sir, other sources

DeChane Dorsey  37:36  
Quick and Dirty on SBIR STTR reauthorization. So the legislation expires at the end of this fiscal year, and we are currently in the process of working alongside our government affairs team to get that legislation reauthorized. There was a small business committee meeting before last where there was a lot of bipartisan support, not only for reauthorization of SBIR STTR, but also for making the program permanent. What that permanency would do would be to make this program permanently locked in place so we wouldn't have the inconsistency or the concerns about reauthorization. There's also some current legislation that Senator Joni Ernst has author, authored that is also modifying the SBIR program, and is talking about potential caps on Lifetime numbers of SBIR grants and potential caps on the dollar amounts. We are working closely with our members to get feedback on what those impacts would mean to them, because we know that some companies do rely quite heavily on SBIR. The other thing we've been looking into quite closely are some of the freezes that have been put in place.

Lishan Aklog  38:43  
Anybody, so anybody here have challenges with accessing grants that they already that they already have? Yeah, this is where we have a survey out, I think, which

DeChane Dorsey  38:53  
We had a survey out that showed what those slaps is and grant funding would mean for our members. Many people had freeze notices that they received when they put in for disbursements from federal agencies, and those have been cleared up. But right now, a huge point of concern of the NIH changes, which are also problematic, and we're working to resolve those, 

Lishan Aklog  39:14  
Especially those that are in tranches where you might have already received. We have an NIH grant where we've received half. I'm quite, quite sure we're not going to get the second half. So we've had to to to navigate that accordingly. And if any of you are actually having those challenges, I would encourage you to contact admin. I know of some examples of folks who've contacted their through advice from the folks at Advent, contacted their congressmen, senators, so forth, and it actually been able to reverse individual cases where there's been where there have been tyre so, you know, get involved in that. It'd be helpful. Unfortunately, I can't believe we are 40 minutes here, but this has been great. If you want to do a pitch for the Medtech conference,

DeChane Dorsey  39:55  
Medtech conference, October, fifth through eighth in San Diego. I.

Lishan Aklog  40:00  
A really a great supplement to this conference. This meeting is obviously very much focused on small companies. The Medtech conference is industry wide, so we have, we have a seat at the table there, but it's an opportunity to engage with larger companies as well as strategics and investors and so forth. And this has really evolved, I think, at the very complimentary.

Juliana Elstad  40:16  
And some people ask about FDA leadership, and what's the overall feeling. So traditionally, FDA comes to this to the med tech conference, and you can hear it directly. Last year, Michel tower, who was, who is the Commissioner of our day, she came, she talked about her strategy, like, what is important, what are her priorities? And so we anticipate that this year will have the same insightful comments and talks.

Lishan Aklog  40:43  
All right, thank you all for your time. Really appreciate it. Hopefully this is helpful. Thank you. Thanks.