Podcasts about advamed

AdvaMed President and CEO Scott Whitaker sits down with just-retired U.S. Rep. Brad Wenstrup of Ohio, discussing lessons learned from the COVID-19 pandemic, illogical budgetary scoring of health care procedures, and Wenstrup's life-saving triage of U.S. House of Representatives Majority Leader Steve Scalise after a shooting. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing more than 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org.

AdvaMed President and CEO Scott Whitaker sits down with Jacob “Jake” Leach, Executive Vice President and Chief Operating Officer at Dexcom, to discuss the latest innovations from the company that provide millions of people easy ways to monitor their glucose levels. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing more than 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org.

As the Federation of American Hospitals (FAH) prepares for a pivotal year ahead, this special episode takes a moment to reflect on the progress made in health care policy and the challenges and opportunities on the horizon. Join host Chip Kahn as he sits down with retiring Executive Vice President of Policy, Steve Speil, to discuss his nearly four decades of experience in health care policy and his reflections on his remarkable 27-year tenure at FAH.Steve's career has spanned transformative decades in health care, from his early days in Massachusetts state health planning to tackling the evolving complexities of hospital policy in Washington, D.C. His insights in health care policy and the hospital community's resilience shine a light on how far we've come—and the work still ahead to ensure patients have access to 24/7 care.In this episode, Chip and Steve discuss: Steve's Career Journey Leading to FAH: From a Master in Public Health to law school and a career spanning Massachusetts state health planning, the Dukakis administration, AdvaMed, and ultimately the Federation of American Hospitals.Early Days at FAH: A look back at the early years of Steve's time at FAH, navigating key regulations like IPPS and legislation including the Balanced Budget Act.Changing Landscape of Health Policy: Steve reflects on accomplishments during his tenure and insights into how hospital policy has evolved, now facing increased burdens.Opportunities Ahead: Steve discusses the continued resilience of hospitals in the face of challenges and the critical role of organizations like FAH in supporting hospitals and the communities they serve.Guest bio: In his capacity as Executive Vice President of Policy, Steve Speil manages the Federation's broad portfolio of payment policy issues. He serves as the association's chief liaison on these issues with the Centers for Medicare and Medicaid Services and the Medicare Payment Advisory Commission. Working closely with the senior finance and policy executives in the Federation's member companies, Steve develops and carries out both issue-specific and general strategic plans designed to advance the finance and payment related regulatory and legislative interests of the FAH.Prior to joining the Federation, Steve served as Associate Vice President, Policy Coordination and Communication for the Health Industry Manufacturers Association (now AdvaMed), the national trade group representing the medical technology industry. Before moving to Washington, Steve held a succession of increasingly senior management and policy positions in Massachusetts. During his time in the Bay State, Steve served as Legal Counsel to the Lieutenant Governor, Legislative Counsel for the Executive Office of Health and Human Services, Executive Director of the Disabled Persons Protection Commission, and Legal Counsel and Policy Director in the Office of State Health Planning. Steve also taught health law and policy as an Assistant Professor at Simmons College Graduate Program of Health Administration.At the federal level, Steve served in the Food and Drug Administration's Office of Legislative and Congressional Affairs. He also worked in the Environmental Protection Agency's Office of General Counsel.Steve earned a J.D. degree from American University's Washington College of Law; a Master in Public Health degree in Health Administration from the University of North Carolina School of Public Health; and a Bachelor of Arts degree in Anthropology/Zoology from the University of Michigan.

Aimee Grossman, CFM, CBRM, COEE is AVP of Facility Management & Workplace Experience at AdvaMed, Lena Thompson, IFMA Fellow, FMP, SFP is an Adjunct Professor & IFMA Qualified Instructor while serving on the IFMA Global Board of Directors, and Sarah Burns is a Partner Account Manager at Eptura. Mike Petrusky hosted a live roundtable discussion for the Capital Chapter of IFMA called “How Evolving Systems Can Empower Facility Professionals” where the panelists discussed integrating workplace technology with the overall management of the built environment and the evolving role of FM professionals. They explored how the hybrid work model requires significant change management, including adapting to new routines and human behavior and agreed that data and reporting are critical for decision making. Tune in to get practical ideas on enhancing the user experience when implementing new strategies or technologies and hear the encouragement and inspiration you will need to be a Workplace Innovator in your organization! Connect with Aimee on LinkedIn: https://www.linkedin.com/in/aimee-grossman-cfm-cbrm-coee-51039a64/ Connect with Lena on LinkedIn: https://www.linkedin.com/in/lena-thompson-5b05a86/ Connect with Sarah on LinkedIn: https://www.linkedin.com/in/sarah-burns-6737b9202/ Check out the “On My Way To Work” video series: https://www.youtube.com/playlist?list=PLSkmmkVFvM4E39sM-pNaGhLoG0dkM947o Discover free resources and explore past interviews at: https://eptura.com/discover-more/podcasts/workplace-innovator/ Learn more about Eptura™: https://eptura.com/ Connect with Mike on LinkedIn: https://www.linkedin.com/in/mikepetrusky/  

AdvaMed President and CEO Scott Whitaker sits down with professional tennis legends Martina Navratilova and Chris Evert, who met as teen-age competitors and whose friendship of 50-plus years has deepened over each surviving cancer. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing more than 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're looking at the potential implications for the medical device regulatory sector as a result of the U.S. presidential election. This recording took place two weeks following the election results. In addition, we speak about some recurring themes that are not exclusive to the election, such as the impact of regulatory on innovation. Specifically, the following questions are addressed:Based on the fact things can continue to change, why discuss this now?Would it be possible to eliminate the FDA? What might replace it?Is there too much regulation of medical devices? Or is it just the opposite—too little? What's the sweet spot?There are some who believe the more regulation we have, the less innovation that's possible. Do you agree? Are these directly impacted by each other?Is it possible to separate regulation and politics?Other than AdvaMed, which said it was looking forward to working with the new administration for what that's worth, why isn't the FDA or industry speaking about the possible eliminations at FDA?Do you agree that safety and efficacy should NOT be a function of politics?Without naming specific people, who is the type of person you'd want heading HHS or the FDA?Does this discussion have implications related to reimbursement or CMS?If you were serving as a regulatory consultant for a company looking at what's potentially coming down the road, how would you advise them today?Any final thoughts on what's important for this discussion/topic?Listen to this discussion and see if you agree with our assessments. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want toSend us a textFor more medtech news and information, visit www.mpomag.com.

In this episode of Medsider Radio, we sat down with Steffen Hovard, CEO of Neuspera Medical, where his team is developing a novel, less invasive device that uses neuromodulation to treat conditions like overactive bladder.Previously, Steffen spent two decades at Coloplast, where he held various senior leadership roles that contributed to the company's growth, including the acquisition of a Minneapolis-based urology business in 2005. With deep expertise in the space, he has consistently driven growth and innovation across multiple functions, positioning himself as a leader of leaders in medtech, with board roles at Medical Alley and AdvaMed.In this interview, Steffen talks about confirming market fit before investing, building an early network for key hires and investors, aligning development speed with each phase, engaging with regulators early, and taking a steady, relationship-driven approach to fundraising.Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You'll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VI. If you're interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Steffen Hovard.

In this episode of the DeviceTalks Weekly Podcast, Host Tom Salemi opens by making a strong case for MedTech people to attend DeviceTalks West, which is happening on Oct. 16-17. Go to West.DeviceTalks.com to register. MassDevice Editor Chris Newmarker brings his Newmarker's Newsmakers – Women's Health, Philiips, Nyxoah, CMR Surgical, and Johnson & Johnson MedTech. Finally, Paul Grand, CEO of MedTech Innovator, introduces DeviceTalks listeners to the five finalists who will compete for the 2024 Early-Stage Grand Prize. The winner will be voted for at the AdvaMed annual meeting in Toronto. Thank you for listening to the DeviceTalks Weekly Podcast Subscribe to the DeviceTalks Podcast Network so you don't miss a future episode.

You do not have the right to repair your own belongings because of intellectual property rights granted to corporations by Congress in 1998. In this episode, listen to the debate happening in Congress about if and how they should grant customers the right to repair and get a status update on the multiple efforts under way in the current Congress, including one with a good chance of becoming law. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via Support Congressional Dish via (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank's online bill pay function to mail contributions to: Please make checks payable to Congressional Dish Thank you for supporting truly independent media! Background Sources Recommended Congressional Dish Episodes McDonald's Ice Cream Machines Andy Greenberg. December 14, 2023. Wired. Joseph Fawbush. March 29, 2022. FindLaw. John Deere Luke Hogg. January 8, 2024. Reason. Internet of Things Updates and Maintenance Márk Szabó. August 27, 2024. WeLiveSecurity. Massachusetts Auto Repair Law Massachusetts Office of the Attorney General. DoD's Revolving Door OpenSecrets. OpenSecrets. Karl Evers-Hillstrom and Reid Champlin. June 18, 2019. OpenSecrets. OpenSecrets. Salary.com. Military Right to Repair Issues Kyle Mizokami. February 11, 2020. Popular Mechanics. Max Finkel. February 8, 2020. Jalopnik. Elle Ekman. November 20, 2019. The New York Times. Lucas Kunce and Elle Ekman. September 15, 2019. Technological Protection Measures (TPMs) Jennifer Zerkee. November 8, 2023. Simon Fraser University. Cyber Risks Sam Curry et al. January 3, 2023. samcurry.net. Apple Lawsuit Brandon Vigliarolo. December 18, 2023. The Register. NDAA Sec. 828 Jason Koebler. August 28, 2024. 404 Media. AdvaMed et al. July 30, 2024. DocumentCloud via 404 Media. Laws Bills Sec. 828 : REQUIREMENT FOR CONTRACTORS TO PROVIDE REASONABLE ACCESS TO REPAIR MATERIALS. Fair Repair Act Audio Sources May 16, 2024 Senate Armed Services Committee Witnesses: Carlos Del Toro, Secretary of the Navy Clip Sen. Elizabeth Warren: So the Navy acquires everything from night vision goggles to aircraft carriers through contracts with big defense contractors, but the contractors often place restrictions on these deals that prevent service members from maintaining or repairing the equipment, or even let them write a training manual without going back through the contractor. Now the contractors say that since they own the intellectual property and the technical data underlying the equipment, only they have the right to repair that equipment. These right to repair restrictions usually translate into much higher costs for DOD, which has no choice but to shovel money out to big contractors whenever DOD needs to have something fixed. So take the Navy's littoral combat ship, General Dynamics and Lockheed Martin considered much of the data and equipment on the ship to be proprietary, so the Navy had to delay missions and spend millions of dollars on travel costs, just so that contractor affiliated repairmen could fly in, rather than doing this ourselves. Secretary Del Toro, when a sailor isn't allowed to repair part of their ship at sea, and a marine isn't allowed to access technical data to fix a generator on a base abroad. One solution is for the Navy to buy the intellectual property from the contractors. So can you say a little bit about what the benefits are of the Navy having technical rights for the equipment that it has purchased. Sec. Carlos Del Toro: The benefits are enormous, Senator, and we've actually had tremendous success, I'd say, in the last year and a half to two years, through the taxpayer advocacy program that we initiated when I came in. There have been three examples, one, gaining the intellectual property rights for the new ACV class of ships that will replace the AAVs. The F-35 negotiations really proved themselves out in a significant way as well, too. And lastly, the 20 F-18s that the Congress authorized in ‘22 and ‘23, we were able to make significant gains in terms of the government finally getting the intellectual property rights that were necessary for us to be able to properly sustain those moving forward. Sen. Elizabeth Warren: So I am very, very glad to hear this. I like the taxpayer advocacy project and how you're training contract officers to secure technical equipment that the Navy buys, but I think you should have the support of Congress on this. Senator Braun and I have introduced the Stop price gouging the military act to give DoD more tools to get cost and pricing data so that you will be in a better position to negotiate better deals with contractors. There's also more that we can do to ensure that the Navy and the rest of the services have the rights they need to bolster readiness. So let me ask you, Secretary Del Toro, would having a stronger focus on right to repair issues during the acquisition process, like prioritizing contract bids that give DoD fair access to repair materials, and ensuring that contract officers are looking into buying technical rights early on, would that help the Navy save costs and boost readiness at the same time? Sec. Carlos Del Toro: Very much. Senator, in fact, one of the things that we have prioritized since I came in as Secretary of the Navy, given my acquisition background, is actually those negotiations need to happen as early as possible before that we even as we develop the acquisition strategy for that contract to go out to bid, and by doing so, we will reap tremendous returns. July 18, 2023 House Judiciary Committee Witnesses: Aaron Perzanowski, Thomas W. Lacchia Professor of Law, University of Michigan Law School , Legal Fellow, Hudson Institute's Forum for Intellectual Property Kyle Wiens, Co-founder and CEO, iFixit Paul Roberts, Founder, SecuRepairs.org; Founder and Editor-in-Chief, the Security Ledger Scott Benavidez, Chairman, Automotive Service Association; Owner, Mr. B's Paint & Body Shop Clips 41:25 Scott Benavidez: My name is Scott Benavidez. I'm the Chairman of the Automotive Service Association's Board of Directors. I am also a second generation shop owner from Albuquerque, New Mexico, Mr. B's Paint and Body Shop. Scott Benavidez: We do have concerns when some insurers insist on repairs that are simply cheaper and quicker, without regard to quality and safety. Repairers understand better than anyone the threat of replacement crash parts or lesser quality. We can and should have a competitive marketplace that doesn't compromise quality or safety, deciding to only cover the cheapest option without understanding implications for quality leaves collision shops and their customers in a tough position. Very few consumers have the knowledge about these types of crash parts used on their vehicles as numerous crash parts in the marketplace, such as OEM (original equipment manufactured) parts, certified aftermarket parts, aftermarket parts, reconditioned crash parts, and recycled crash parts. Repairers can make recommendations, but their customers are unlikely to hear if the insurance won't cover them. 46:45 Paul Roberts: My name is Paul Roberts, and I'm the founder of Secure Repairs. We're an organization of more than 350 cyber security and information technology professionals who support the right to repair. 46:55 Paul Roberts: I'm speaking to you today on behalf of our members to make clear that the fair access to repair materials sought by right to repair laws does not increase cyber risk, and in fact, it can contribute to a healthier and more secure ecosystem of smart and connected devices. Paul Roberts: Proposed right to repair legislation considered by this Congress, such as the Repair Act, or last session, the Fair Repair Act, simply asks manufacturers that already provide repair information and tools to their authorized repair providers to also provide them at a fair and reasonable price to the owners of the devices and to third parties that they may wish to hire to do their work. 47:35 Paul Roberts: By definition, the information covered by right to repair laws is not sensitive or protected, as evidenced by the fact that the manufacturers already distribute it widely to hundreds, thousands, or even tens of thousands of workers for their authorized repair providers. This could be everyone from mechanics working at auto dealerships to the folks staffing the Geek Squad at Best Buy. 48:00 Paul Roberts: Also, we have yet to find any evidence that the types of information covered by right to repair laws like schematic diagrams, service manuals, diagnostic software and replacement parts act as a portal to cyber attacks. The vast majority of attacks on internet connected devices - from broadband routers to home appliances to automobiles - today exploit weaknesses in the embedded software produced and distributed by the manufacturers, or alternatively, weak device configurations so they're deployed on the internet in ways that make them vulnerable to attack. These security weaknesses are an epidemic. A recent study of the security of Internet of Things devices, by the company Phosphorus Labs, or a cybersecurity company, found that 68% of Internet of Things devices contained high risk or critical software vulnerabilities. As an example, I'd like to call attention to the work of a group of independent researchers recently led by Sam Curry, who published a report, and you can Google this, "Web Hackers vs. the Auto Industry" in January 2023. That group disclosed wide ranging and exploitable flaws in vehicle telematics systems from 16 different auto manufacturers. At a leading GPS supplier to major automakers, the researchers claimed to obtain full access to a company-wide administration panel that gave them the ability to send arbitrary commands to an estimated 15.5 million vehicles, including vehicles used by first responders, police, fire and so on. Hacks like this take place without any access to repair materials, nor is there any evidence that providing access to repair software will open the doors to new attacks. 50:05 Paul Roberts: For the last 25 years, Section 1201 of the Digital Millennium Copyright Act has given manufacturers an incentive to deploy software locks widely and to limit access to security researchers. That's kind of a model what we call in cybersecurity, security through obscurity. In other words, by keeping the workings of something secret, you're making it secure. But in fact, that doesn't work, because cyber criminals are very resourceful and they're very determined, and they don't really care what the law says. 50:35 Paul Roberts: Section 1201 has also enabled what one researcher has described as dark patterns in the design and manufacture of hardware that includes everything from locking out customers from access to administrative interfaces, administrative features of the products that they own, as well as practices like part pairing, which Kyle will talk to you more about, in which manufacturers couple replaceable components like screens and sensors and cameras to specific device hardware. Such schemes make manufacturers and their authorized repair providers gatekeepers for repairs, and effectively bar competition from the owners of the devices as well as independent repair providers. 54:45 Kyle Wiens: You think about what is local? What is American? Main Street you have a post office and a repair shop. And unfortunately, we've seen the whittling down of Main Street as the TV repair shops went away when the manufacturers cut off access to schematics, as the camera repair shops went away when Nikon and Canon decided to stop selling them parts. We've seen this systematically across the economy. In the enterprise space, you have Oracle and IBM saying that you can't get security updates to critical cyber infrastructure unless you buy a service contract with them, so they're tying long term service contracts with the security updates that are necessary to keep this infrastructure secure. 56:45 Kyle Wiens: Over the last decade plus, I've been working on Section 1201, trying to get exemptions for the ability to repair products. The challenge that we've had in the section 1201 process every triennial I go back and we ask for permission to be able to fix our own things is that the exemptions we've gotten really only apply to individual consumers. They aren't something that I could use to make a tool to provide to one of you to fix yourself. So in order for someone to take advantage of a 1201 exemption that we have, they have to be a cybersecurity researcher and able to whittle their own tools and use it themselves, and that just doesn't scale. 57:45 Devlin Hartline: My name is Devlin Hartline, and I'm a legal fellow at the Hudson Institute's forum for intellectual property. 57:50 Devlin Hartline: I'd like to start with a question posed by the title of this hearing, is there a right to repair? And the answer is clearly no. A right is a legally enforceable claim against another, but the courts have not recognized that manufacturers have the duty to help consumers make repairs. Instead, the courts have said that while we have the ability to repair our things, we also have the duty not to infringe the IP rights in the process. So it is in fact, the manufacturers who have the relevant rights, not consumers. 58:30 Devlin Hartline: Right to repair supporters want lawmakers to force manufacturers to make the tools, parts, and know-how needed to facilitate repairs available to consumers and independent repair shops. And the assumption here is that anything standing in the way of repair opportunities must necessarily harm the public good, but these tools, parts and know-how, are often protected by IP rights such as copyrights and design patents. And we protect copyrighted works and patented inventions because, as the Constitution recognizes, this promotes the public good. We reward creators and innovators as an incentive for them to bring these things to the marketplace and the public benefits from the introduction of new products and services that increase competition. Thus, the right to repair movement isn't based on a pre-existing right. It's instead asking lawmakers to create a new right at the expense of the existing rights of IP owners. 1:00:45 Devlin Hartline: IP owners are merely exercising their federally protected IP rights, and this is not actionable anti-competitive conduct. It is instead how the IP system is supposed to work. We grant IP owners exclusive rights so they can exclude others, and this, in turn, promotes the investments to create and to commercialize these creative innovations in the marketplace, and that promotes the public good. Aaron Perzanowski: My name is Aaron Perzanowski. I am a professor of law at the University of Michigan, and for the last 15 years, my academic research has focused on the intersection of personal and intellectual property rights in the digital economy. During that time, the right to repair has emerged as a central challenge to the notion that we as consumers control the devices that we buy. Instead consumers, farmers, small businesses, all find that manufacturers exert post-sale control over these devices, often in ways that frustrate repair. Aaron Perzanowski: Repair is as old as humanity. Our Paleolithic ancestors repaired hand axes and other primitive tools, and as our technologies have grown more complex, from the Bronze Age through the Renaissance, to the high tech devices that we all have in our pockets here today, repair has always kept pace. But today, manufacturers are employing a range of strategies that restrict repair, from their hardware and software design choices to clamp downs on secondary markets, and we also troublingly see attempts to leverage IP rights as tools to restrict repair. These efforts are a major departure from the historical treatment of repair under the law, the right to repair is not only consistent with nearly two centuries of IP law in the United States, it reflects half a millennium of common law property doctrine that rejects post-sale restrictions on personal property as early as the 15th century. English property law recognized that once a property owner sells an item, efforts to restrain how the new owner of that item can use it are inconsistent with the essential nature of private property and obnoxious to public policy. As the Supreme Court has repeatedly recognized, IP laws' respect for the property interests of purchasers of copyrighted and patented goods was profoundly shaped by this common law tradition. In 1850, the Supreme Court recognized that the repair of a patented machine reflected "no more than the exercise of that right of care, which everyone may use to give duration to that which he owns." A century later, the Court held that the repair of a convertible car roof was justified as an exercise of "the lawful right of the property owner to repair his property." And just a few years ago, the court reaffirmed the rejection of post-sale restrictions under patent law in Impression Products vs. Lexmark, a case about refurbishing printer ink cartridges. Copyright law, not surprisingly, has had fewer occasions to consider repair restrictions. But as early as 1901, the Seventh Circuit recognized "a right of repair or renewal under US copyright law." When a publisher sued to prevent a used book dealer from repairing and replacing damaged components of books, the court said that "the right of ownership in the book carries with it and includes the right to maintain the book as nearly as possible in its original condition." A century after that, Congress itself acknowledged repair as a right that owners enjoy, regardless of copyright restrictions, when it enacted section 117 C of the Copyright Act. That provision was designed to undo a Ninth Circuit decision that allowed copyright holders to prevent third party repairs of computers. Section 117 C explicitly permits owners of machines to make copies of computer programs in the course of maintenance or repair. And finally, the US Copyright Office over the last decade has repeatedly concluded that diagnosis, repair, and maintenance activities are non-infringing when it comes to vehicles, consumer devices, and medical equipment. So the right to repair is firmly rooted in basic principles of US IP law. Aaron Perzanowski: Section 1201 of the DMCA makes it practically impossible for consumers to exercise their lawful right to repair a wide range of devices, from tractors to home electronics, even though the copyright office says those activities are not infringing, and the weakening of standards for design patents allow firms to choke off the supply of replacement parts needed to repair vehicles, home appliances, and other devices. Aaron Perzanowski: One way to think about a right is as an affirmative power to force someone else to engage in some behavior, and in some cases, that is what we're talking about. We're talking about imposing, especially on the state level, regulations that impose requirements on manufacturers. I think that's true of the Repair Act on the federal level as well. But, I think part of what we also need to keep in mind is that sometimes what you need to effectuate a right is to eliminate barriers that stand in the way of that right. So we can think about this, I think, helpfully in the context of tools that enable people to engage in repair. The state level solution has been to require manufacturers to give their own tools to repair shops, sometimes compensated under fair and reasonable terms. The other solution would be to change section 1201 to say, let's allow independent repair shops to make their own tools. I think both of those solutions have some value to them. I also think it's really important to keep in mind that when we're talking about IP rights, there are always multiple sets of interests at stake, and one of the key balances that IP law has always tried to strike is the balance between the limited statutory exclusive rights that the Patent and Copyright Acts create and the personal property rights of consumers who own these devices. And so I think a balancing is absolutely necessary and appropriate. 1:15:20 Aaron Perzanowski: I think the best solution for Section 1201 is embodied in a piece of legislation that Representatives Jones and Spartz introduced in the last Congress, which would create a permanent exception to Section 1201 for repair that would apply not only to the act of circumvention, but would also apply to the creation and distribution of tools that are useful for repair purposes that does not open the door to broad, unrestrained, creation of circumvention tools, but tools that are that are targeted to the repair market. 1:16:40 Devlin Hartline: He cited a case about where you can repair a cover on a book. That's very different than recreating the book, every single word in it, right? So there's a difference between repairing something and then crossing the line into violating the exclusive rights of IP owners in the patented product or the copyrighted book. And so the things that repair supporters are asking for is that, if somebody has a design patent that covers an auto body part, well, they have the right to exclude other people from making that part, but repair supporters say they shouldn't have that exclusive right, because, you know, we could increase competition if we just took away their design patent and now other people could make that part, and so that's competition. But that's not the type of competition that IP law and competition law seek to support. That's like saying, if we just let the Pirate Bay copy and distribute all of the Disney blockbuster movies, then that's competition, and prices would go down. But that's not the way that we do it, right? So competition means other people come up with new products and new services, and so that's what we should be trying to support. 1:26:45 Rep. Jerrold Nadler (D-NY): Repair advocates argue that section 1201, prevents non-infringing circumvention of access controls for purposes. But Congress contemplated this use when it passed the DMCA in 1998, allowing for a triennial exemption process. Is the exemption process working as intended? And if not, are there actions Congress can take to expand exemptions or make them easier to acquire? Devlin Hartline: What's important about the triennial rulemaking is that the proponent of an exemption has to come forward with evidence and demonstrate that there's actually a problem and it relates to a certain class of works, and then they can get a temporary exemption for three years. And so it is true that the Librarian of Congress, the last few rulemakings, has said that because using a copyrighted work in a way for repair, maintenance, etc, is Fair Use that they grant these exemptions. But these exemptions are quite narrow. They do not allow the trafficking of the computer programs that can crack the TPMs. And so it's very narrowly done. And the concern is that if you were to create a permanent exemption that opens things all the way up with access controls, copy controls and trafficking thereof, is now you're getting to the point of why we even have these TPMs under 1201 in the first place, and that's because they guard against piracy. And so the concern is that you're opening the piracy floodgates. You make these devices less secure, and then content owners are going to be less likely to want to put their content on these devices. Rep. Ben Cline (R-VA): How does section 1201 of the DMCA impact the ability of consumers and independent repair shops to modify or repair devices that have proprietary software and data in the consumer electronics industry? Aaron Perzanowski: Thank you so much for the question. As we've been talking about the copyright office in 2015, 2018, 2021, and they're in the process for the current rulemaking, has determined that engaging in circumvention, the removal or bypassing of these digital locks for purposes of repair, is perfectly lawful behavior, but there is a major practical mismatch here between the legal rights that consumers enjoy under federal law today and their practical ability to exercise those rights. And that's because, as Devlin was just describing, the section 1201 rulemaking does not extend to the creation or distribution of tools, right? So I have the right under federal law, to remove the technological lock, say, on my video game console, if I want to swap out a broken disk drive. How do I do that? I'd like to think of myself as a pretty technologically sophisticated person. I don't have the first clue about how to do that. I need a person who can write that code, make that code available to consumers so that I can. All I'm trying to do is swap out a broken disk drive on my video game. But you would argue that code is proprietary, correct? So I'm talking here about a third party making their own code that is simply allowing me to engage in activity that the Copyright Office has repeatedly said is non-infringing. Rep. Ben Cline (R-VA): So you want to give them a map. Is that, essentially, what you're saying? Aaron Perzanowski: Absolutely, yes, I do. Rep. Ben Cline (R-VA): Do trade secrets play a role in the right to repair debate? Aaron Perzanowski: There are occasions where trade secrets are important. I don't think in the context that we're talking about here with section 1201, that we're typically running into trade secret issues. The state-level bills that have been introduced do typically address trade secrets and often have carve outs there. And I think that's something worth considering in this debate. But I think it's important to keep in mind that just because we have some hypothetical worry about some unknown bad actor taking a tool that I use to fix my video game console -- Rep. Ben Cline (R-VA): It's not unknown. The Chinese do it all the time. Aaron Perzanowski: I don't think the Chinese are particularly worried about whether or not I can fix my video game console, and in fact, I think that point is important, but the bad actors already have these tools. All we're trying to do is get very targeted tools in the hands of law abiding citizens who just want to repair the stuff they buy for their kids for Christmas, right? If the Chinese are going to hack the PlayStation, they've already done it. 1:32:25 Aaron Perzanowski: So the 1201 process is what established the legality of circumvention for repair purposes. But when Congress created that rulemaking authority, it only extends to the act of circumvention, the actual removal. Congress did not give the [Copyright] Office or the Librarian [of Congress] the authority to grant exemptions to the trafficking provisions, and that's where I think legislative intervention is really important. 1:39:00 Kyle Wiens: One of the challenges was section 1201. It doesn't just ban repair tools, it also bans the distribution of cybersecurity tools. And so we've seen security researchers....Apple sued a company that made a security research tool under 1201 and that tool has markedly made the world more secure. It's very popular amongst government security researchers. So I think that's kind of the sweet spot is, allow some third party inspection. It'll make the product better. 1:41:25 Kyle Wiens: These ice cream machines are made by Taylor, and there is an incredibly complex, baroque set of touchscreens you have to go through. And then there's a service password you have to be able to get past in order to access the settings that really allow you to do what you want. And so, in an ideal world, you'd have an entrepreneur who would come along and make a tool to make it easier for McDonald's, maybe they could have an app on their phone that they could use to configure and help them diagnose and repair the machine. Unfortunately, the company who made that tool is struggling legally because of all these challenges across the board. If we had innovation outside of the manufacturers and to be able to develop new tools for fixing ice cream machines or anything else, you have a whole flowering ecosystem of repair tools right now. It doesn't exist. The US is like this black hole where innovation is banned in software repair. There's all kinds of opportunities I could see, I had a farmer ask me for help fixing his John Deere tractor, and I had to say, I can't do that particular repair because it's illegal. I'd love to build a cool app for helping him diagnose and fix his tractor and get back back in the field faster. We don't have that marketplace right now. It's like farmers have been forced to, like, use cracked Ukrainian versions of John Deere diagnostic software, right? Rep. Russell Fry (R-SC): So it's not just ice cream machines. I led off with that, but it's farmers, it's farm equipment, it's iPhones, it's somebody's Xbox, right? I mean, these are all things.... in your experience, what are the challenges that these customers and stakeholders face when they're trying to repair their own devices? What are some things that they face? Kyle Wiens: It's absolutely infuriating. So my friend, farmer in San Luis Obispo, Dave grows all kinds of amazing products. He has a $300,000 John Deere tractor, came to me and said, Hey, there's a bad sensor. It's going to take a week to get that sensor sent out from Indiana, and I need to use the tractor in that time. Will you help me bypass the sensor? I could hypothetically modify the software in the tractor to do that. Practically, I didn't have the legal ability, and so he had to go and rent an expensive tractor for the week. This is impacting people's lives every single day. 1:43:50 Rep. Russell Fry (R-SC): So, to pivot a little bit, what role do you see from a federal side, from legislation, and what specific measures do you think might be included in such legislation? Kyle Wiens: So we've seen the solutions being approached from two angles. At the state level, you have states saying John Deere and other manufacturers, if you have a dealership that has fancy tools, sell those tools to consumers and to independent shops, allow that competition. At the federal level, what we can do is enable a competitive marketplace for those tools. So rather than compelling John Deere to sell the tool, we can say, hey, it's legal for someone, an entrepreneur, to make a competing tool. And you have this in the car market. You can take your car down the AutoZone, you can buy a scan tool, plug it into your car, and it'll decode some of the error messages. Those tools exist on the auto market because we have a standard diagnostic interface on cars that you can access without circumventing a TPM. We don't have that for any other products. So another farmer in my town, he showed me how if he has a transmission go out on a truck, he can fix that. But if he has a transmission go out on his John Deere tractor, he can't. He can physically install the transmission, but he can't program it to make it work. I'd love to be able to make a software tool to enable him to replace his transmission. Aaron Perzanowski: So I think if we see passage of the SMART Act, we can anticipate significant reductions in the expenses associated with auto collision repairs. Estimates are that design patents on collision parts are responsible for about $1.5 billion in additional expenditures. We see price premiums on OEM parts over third party parts often reaching into like the 40% range, right? So these are pretty significant cost savings associated with that. Part of this problem, I think, does relate back to the kind of unique structure of this market. Most consumers are not paying out of pocket for collision repairs. Those costs are being covered by their auto insurance provider, and so the consumer doesn't see that the - I'm pulling this from memory, so don't hold me to this figure - but the side view mirror of a Ford Fiesta costing $1,500, that's not something that the consumer is confronted with, right? So this goes back to the question of notice. Do consumers know when they buy that vehicle that the repairs are going to be that expensive? I think in most cases, they don't. And so I think the SMART Act is a very targeted solution to this problem. I do think it's important to note that the design patent issue for replacement parts is not limited to the automotive industry. I think it's the most, I think that's the area where the problem is most pressing. But home appliances, consumer electronics, we see companies getting design patents on replacement water filters for refrigerators so that they can charge three times as much when the little light comes on on your fridge to tell you that your water might not be as clean as you want it to be. So I think we have to think about that problem across a range of industries, but the automotive industry, I think, is absolutely the right place to start. Paul Roberts: I mean, one point I would just make is that with the Internet of Things, right, we are facing a crisis in the very near future as manufacturers of everything from home appliances to personal electronics to equipment, as those products age and those manufacturers walk away from their responsibility to maintain them. So we're no longer supporting the software. We're no longer issuing security updates. Who will step in to maintain those devices? Keep them secure, keep them operating right? The manufacturers walked away. Do we just get rid of them? No, because the equipment still works perfectly. We're going to need a market-based response to that. We're going to need small businesses to step up and say, hey, I'll keep that Samsung dishwasher working for another 20 years. That's a huge economic opportunity for this country, but we cannot do it in the existing system because of the types of restrictions that we're talking about. And so this is really about enabling a secure future in which, when you buy a dishwasher with a 20 year lifespan, or 25 year lifespan, it's going to last that 25 years, not the five to six years that the manufacturer has decided, you know, that's how long we want to support the software for. Paul Roberts: My understanding is the use of design patents has increased dramatically, even exponentially, in the last 10 to 15 years. If you go back to the 90s or 80s, you know, parts makers, automakers were not applying these types of patents to replaceable parts like bumpers and rear view mirrors. Somebody had a business decision that, if you can do so, then we can capture more of that aftermarket by outlawing identical aftermarket replacements that has a huge downstream impact on car owners and on insurers and on all of us. 2:10:15 Paul Roberts: Both of the things that we're really proposing or talking about here, which would be changes to Section 1201 of the DMCA as well as passage of robust right to repair laws, would empower a market-based response to keeping the internet of things working, secure and functioning. DMCA 1201 reforms by making it clear that you can circumvent software locks for the purpose of repair and maintenance and upkeep, right? So that would take the threat of the federal crime away from small business owners as well as security researchers who are interested in, you know, plumbing that software for purposes of maintenance, upkeep and repair. And on the right to repair by making the tools available to maintain and upkeep products - diagnostic software, schematic diagrams, service manuals - available. Once again, you'll be empowering small business owners to set up repair shops and say, I'm going to keep your smart appliance running for its full 25 or 30 year lifespan, and I'm going to support my family doing that locally, and not be basically choked out of business by a company that says, Well, you don't have the right to access this product. From a cybersecurity perspective, that is really important, because one thing we don't want is a population of millions or tens of millions of out of date, unsupported, unpatched, insecure internet connected home appliances, webcams, home routers out there available to nation state actors, cyber criminal groups, to compromise and use for their own purposes. And that's something we already see, particularly around broadband routers and other types of devices, and it's a real threat going forward that I think this type of these types of changes would support. Aaron Perzanowski In a lot of instances, this conversation, and we've touched on this earlier, focuses on cost savings, right? And cost savings are an important consideration, right? Farmers aren't thrilled that they have to pay a technician from the John Deere dealer to drive maybe hours to get to their farm and connect their laptop and, you know, download these payload files to enable their equipment to work. But in the agricultural space, the thing I hear most often in the conversations I have with farmers is and Kyle touched on this a bit earlier, is a real concern about the time sensitivity of their work. If your tractor is out of commission for a week or two in the wrong part of the season, that is going to have disastrous effects, right, not only on that farm's economic outlook, but collectively, it can have an impact like, not to be hyperbolic here, but on our national food supply, and so I think it's really important that farmers have flexibility in terms of where and how they execute repairs, so that they can get their equipment back up and running. If my laptop breaks and I can't get it fixed for a week or two, I'm annoyed there will be emails that go unanswered, but like the world will continue to spin. That is not the case in the agricultural space where we, I think, have to be much more concerned. Rep. Darrell Issa (R-CA): If I remove from my BMW, at least during certain models, I remove the radio, unplug it, and then plug it back in, simply because I was fiddling around with the dash, I now have to go back to the dealer to reinstall it. Similarly, the transmission example. I've got two John Deere tractors. One's got a busted engine, the other's got a busted transmission. Currently, they will prohibit you from moving the transmission from one to the other. From a standpoint of intellectual property, where, in God's green earth or the Constitution, are any of those designed to be rights that belong to the manufacturer, rather than rights that belong to the owners of those two John Deere tractors? Devlin Hartline: So those are a bunch of different situations, and so I think there would be underlying facts that differ with each right. So we started on the iPhone, and I was going to point out that iPhone will actually give you the tool to synchronize it. In those other situations, I don't know the business justification for it. How is that an IP problem? Right? So if that's locked up with the TPM, and you have to bypass the TPM, well then that's a violation of 1201, so that's how they can that's how they can lock -- Rep. Darrell Issa (R-CA): So what you're saying is that Congress has created impediments to the right to repair. Mr. Roberts, would you say that is correct? That, in fact, the right to repair, were Congress never to have done anything since, you know, George and Thomas were our presidents, so to speak, knowing those two presidents, we'd be able to do things we're not able to do because they're now prohibited by acts of Congress. Paul Roberts: Yes, and we certainly know going back to the 50s, 60s, 70s, there was a much more you know....First of all, companies would ship products with service and repair manuals with detailed schematic diagrams with the understanding that owners would want to replace and service them. And what I would say is, yes, absolutely. I doubt very much. And I know we had members who were here in 1998 authoring the DMCA. I think if you had said to them, in 25 years time, this law will be used to prevent somebody with a broken dishwasher from getting that serviced by their local repair shop or by for fixing it themselves, this law will prevent them from doing that, I doubt very much they would have said, yeah, that's pretty much what we want. Rep. Darrell Issa (R-CA): Well, I will tell you that the I was the chairman of what is now the Consumer Electronics Association in 1998 and we did predict a lot of these items were going to be expanded beyond the scope of the original. Paul Roberts: Right now this is not an urgent issue, because most of the cars out there are older vehicles. As we move forward, as telematic systems evolve, as automakers continue their trend of moving more and more information to telematic systems, this is going to become a bigger problem. I'll point out another problem, which is the Massachusetts law is contingent on data transfers of diagnostic and repair information via the OBD or onboard diagnostic two port under the dashboard. That's only there because of federal Clean Air law. Electronic vehicles don't have that port because they don't have emissions, and so in the very near future, as we shift to electronic vehicles, that data access port will no longer be there. It will all be telematics data, and so the utility of the Massachusetts law is going to decline over time, going forward. And again, I you know, when you start talking about right to repair, you become like this crazy person who talks about right to repair every time it comes up. But one thing I try and stress to people when I talk to them about auto repair is, if you live in Michigan or California and you have taken your vehicle to the local independent repair shop, you have only done that because the voters in Massachusetts passed a ballot measure over a decade ago and then updated it in November 2020. That is the very thin thread that our right to use independent auto repair hangs by in this country. That's not the way it's supposed to be. This is something that affects vehicle owners, hundreds of millions of them in all 50 states. And it's a type of thing that the federal government needs to address with federal legislation. It should not hang by this very thin thread. 2:30:20 Rep. Hank Johnson (D-GA): Are software updates new creations, and thus copyrightable? Devlin Hartline: Software updates, yeah, they're computer programs, and so Congress said explicitly in 1980, but it was understood before then, that computer programs are literary works and they're protected, just like any other copyrighted work. Rep. Hank Johnson (D-GA): Thank you, Professor Perzanowski, do you disagree? Aaron Perzanowski: I don't disagree at all that software updates are protectable subject matter under the Copyright Act. But what I think is important to keep in mind right is the Copyright Act and copyrights exclusive rights, and all of the exceptions and limitations to copyrights exclusive rights are created by Congress, and so if you think those rights are interfering with other important issues and concerns, then I think Congress clearly has the power to make changes to the copyright law in order to best serve what you ultimately determine to be in the public interest. 2:35:30 Aaron Perzanowski: Access to firmware and other code is really essential to the functioning and repair of lots of devices. I think there's some important differences between the standard essential patent context and kind of what we're talking about here in that in the standard essential patent context, we're relying on standard setting bodies to identify technologies and to require companies to license their patents under fair, reasonable and non-discriminatory terms. We don't quite have that infrastructure in place in the copyright context, but what we do have are compulsory licenses that exist within the Copyright Act already, one of which you were alluding to earlier, the mechanical license for musical works. We also have compulsory licenses for retransmissions of satellite and broadcast content that essentially say the copyright owner is entitled to compensation of some form, but they're not entitled to prevent people from using or accessing that underlying work, and I think that could be a useful framework here for getting owners of devices access to the firmware that they need. Music by Editing Production Assistance

In the first episode of the new Medtech POV series on AI in health care, AdvaMed President and CEO Scott Whitaker sits down with Troy Tazbaz, Director of the Digital Health Center of Excellence within FDA's Center for Devices and Radiological Health. The two discuss the rapid innovation in health care and the path forward as we see more AI/ML-enabled medical technologies in the doctor's office. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing nearly 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org.

Bobby Patrick, VI is the Vice President of State Affairs, Regional Government, and Alliance Development at AdvaMed, the MedTech Association. He oversees AdvaMed's state affairs work and partnerships with external stakeholders, including patient advocacy organizations and physician groups. Previously, Patrick served as the vice president of strategic growth and policy at the Medical Alley Association where he led the state and federal advocacy efforts. He also oversaw the membership work at the Association, where they experienced growth in membership revenue, engagement, and retention under his leadership. Prior to that, Patrick served as a staff member in the Minnesota House of Representatives. He holds a Juris Doctorate from William Mitchell College of Law and an undergraduate degree from Syracuse University.

Ken Reali has gained significant and varied experience in his 33-year MedTech career. He has individually contributed and then led areas including product development, global marketing, business development, commercialization, and sales of medical devices. He has a strong background in ethics and compliance, market analysis, reimbursement strategy, regulatory and clinical affairs, new product development, sales force optimization and domestic and international product commercialization. Ken has also been successful in utilizing M&A to diversify and broaden companies and has successfully led financing at both private and public companies.   As a CEO for 13 years, Reali has gained experience driving strategies to build shareholder value. He has worked with and led initiatives with medical societies, patient advocacy groups, governmental agencies, public and private insurance companies, investor relations, capital funding, strategic planning, and quality and lean production. He has led companies through sales processes to new ownership and into public markets through  IPO.   Reali started his career at two large multi-national companies, Biomet and Stryker where he held positions of increasing responsibility. Ken then gained general management experience at Smith & Nephew starting in 2006 prior to taking on his first CEO role in 2010  at TranS1 driving a turnaround strategy. Reali then led Clinical Innovations, a women's healthcare company through successful exit after five years while doubling the business size and value. In 2020 he led Bioventus through an IPO while increasing the size of the business by 80% through strategic M&A.   Reali serves on the board of directors of a broad group of companies in MedTech from orthopedics to women's healthcare. Reali also donates his time serving on the board of directors of AdvaMed, the National Italian American Foundation, and Valparaiso University  College of Business. Ken lives in Walla Walla, Washington with his wife Kristin where they started a vineyard several years ago.

AdvaMed President and CEO Scott Whitaker sits down with Steve Mapa, Executive Director of MedTechVets, to talk about the organization's commitment to supporting military veterans as they begin careers in the medtech industry. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing nearly 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org. To learn more about MedTechVets, visit: www.medtechvets.org.

AdvaMed President and CEO Scott Whitaker sits down with Nancy Brown, President of the American Heart Association to talk about AHA's 100th anniversary and the role medical technology has played in reducing cardiovascular disease deaths. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing nearly 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org. To learn more about the American Heart Association, visit www.heart.org.

AdvaMed President and CEO Scott Whitaker sits down for a conversation with Venk Varadan, co-founder and CEO of Nanowear. The two talk about Venk's journey as a medtech entrepreneur, the applications of nanotechnology and artificial intelligence (AI) in health care, and the process his startup went through to go from research and development to FDA approval. AdvaMed, the Medtech Association, is the world's largest trade association for the medical technology industry, representing nearly 500 companies around the world that are developing life-changing and life-saving medical technologies for patients. To learn more about AdvaMed, the Medtech Association, visit www.advamed.org. Learn more about Nanowear: www.nanowearinc.com

For Episode 51, MS-EPA graduate Roxy Kozyckyj joins us. Roxy is Senior Director, State Government & Regional Affairs for the advanced medical technology association AdvaMed and has spent most of her career in healthcare policy, from advocacy, to intern, to analyst, capitol hill fellow, and finally lobbyist. This experience gives her the ability to see how policy goals that serve everyone, require working, step-by-step through the interested parties. Roxy openly admits game theory plays a role in her work and backward induction seems to fit well. Think of it this way, start with a policy goal, navigate backwards solving each preceding step, the resulting path theoretically achieves the desired outcome. Sounds strategic to me. Give it a listen. 

Meet Alexander Ballatori and Shane Shahrestani, two innovative minds revolutionizing the medtech industry with their groundbreaking company, StrokeDX. Their story is not just about technological innovation; it's a tale of resilience, determination, and a deep-rooted desire to enhance stroke care. Amidst financial hurdles and skepticism, their commitment to transforming stroke diagnosis and treatment shines through. Their episode is a must-listen for anyone intrigued by the confluence of medical technology, entrepreneurial spirit, and the profound impact of personal experiences in shaping healthcare solutions.   Guest links: https://www.linkedin.com/in/shane-shahrestani/ | https://www.linkedin.com/in/alex-ballatori/ Charity supported: Sleep in Heavenly Peace Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editing: Marketing Wise Producer: Velentium   EPISODE TRANSCRIPT Episode 027 - Alexander Ballatori & Shane Shahrestani [00:00:00] Lindsey Dinneen: Hi, I'm Lindsey and I'm talking with MedTech industry leaders on how they change lives for a better world. [00:00:09] Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. [00:00:15] Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. [00:00:28] Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. [00:00:38] Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. [00:00:42] Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. [00:00:50] Hello, and welcome back to The Leading Difference podcast. I'm your host Lindsey, and I am so excited to introduce you to my guests today, Alex Ballatori and Shane Sharasani. They are the creators and innovators extraordinaire behind StrokeDX, and I'm so excited just to talk with them, find out more about the innovation and see where they're going from here. So thank you all so much for being here. [00:01:11] Alexander Ballatori: Yeah. Thank you so much for having us. We're really excited to be here. [00:01:15] Lindsey Dinneen: Excellent. Excellent. I'd love if you two wouldn't mind starting off by just sharing a little bit about yourself, your background and, well, let's stop there. Let's do that first. [00:01:26] Alexander Ballatori: Great. I'll go ahead. So, I'm Alex. I'm originally from upstate New York, from Rochester, so very grateful to be in sunny California at the moment. Now that we're entering the winter period. But I went to the University of Rochester to study biology and chemistry. I was really interested in medtech and medicine in general. And I want to take some time before deciding what type of graduate degree I was going to pursue as well as learn a bit more about the startup ecosystem. So I ended up living in San Francisco for a few years. I really got to see a lot with respect to medtech in general, predominantly in the orthopedic in the pediatric health space, and then I ended up choosing to go to medical school where I met Shane is my first roommate in medical school and we hit it off right away started. [00:02:07] This is our 2nd business together and yeah very passionate about stroke. Stroke has impacted my family numerous times and when I saw this creative solution that Shane developed during his PhD and also just given my long lasting interest in medtech, it was a no brainer to start this company with him, but I'll let him kind of take over from there, give him some background, and then we can dive into more about our story as a company. [00:02:32] Shane Shahrestani: Thanks, Alex. Yeah, so my name is Shane Sharasani. I grew up in sunny Southern California, very different from Rochester. And I was at UCLA for undergrad. I studied neuroscience and then I did my MD PhD, my MD at USC and my PhD at Caltech. And the way they designed that is you do 2 years of med school, you do the full PhD and you come back and you finish med school. So in the first 2 years, I saw the effect that stroke had on patients. And when I went into my PhD, I wanted to develop technology that can solve that problem. Namely, having timely access to stroke care diagnosis that you receive faster treatment because time is brain. So that's where this idea came about. [00:03:13] We pivoted this tech from the aerospace industry and developed this tech for stroke detection. And when it came time to spinning out of Caltech, there was no other partner that I wanted on this other than Alex. He's my best friend and also my first roommate, as he said. So it made sense to work together and we work very well together. So since then, it's been a exciting journey since the end of 2020 when we spun out and filled with highs and lows. And we're happy to be here today on this podcast. Thank you. [00:03:46] Lindsey Dinneen: Yes, of course. Again, thank you all so much for being here. And it's just fun to hear how you guys got connected in the first place, and the fact that, you know, this roommate, which could be so hit or miss, let's be honest. And it just turned into this fantastic friendship and now business partnership. So I love hearing those kinds of background stories. So, you know, Alex, you mentioned having a personal connection to stroke, and perhaps Shane, you do as well, but I would love if you would share a little bit about your, your own experience and kind of what really motivated you all to tackle this issue and to try to make a difference in this arena. [00:04:26] Alexander Ballatori: Yeah, so, I mean, it started really close to home with my grandfather, actually, as well as a couple other uncles and great uncles, unfortunately. And, you know, my, so both my family, both my parents are clinicians by training. And so, when I saw them, and I saw the care that they received, my, my family was always, my, both my parents were very strong advocates for anyone in my family that became ill. And when I saw my family members go through stroke care, I saw that even if you have the best advocate at one of the best hospitals, there's still so many inefficiencies in the care that we can deliver. [00:05:00] And then going to medical school and seeing it firsthand when we are now. I was functioning as the provider at that point, there's just so, it's just so many issues. And despite all the advancements we've made from surgical technique and therapeutics, we haven't put a dent in stroke outcomes in multiple decades. So, you know, when we, when I first saw what this technology could do, the chain had developed at the price point that it can, also at the safety level and in the amount of time that it can deliver this information, I saw all of those problems from at my, within my family and within my medical training. That could be solved just with this simple, elegant, low cost solution. [00:05:42] Lindsey Dinneen: Yeah, that's incredible. And Shane, do you have anything to add to your own experience with stroke and what motivated you to develop this? [00:05:51] Shane Shahrestani: Yeah, of course. So I briefly touched upon the fact that I went to the PhD, I already had some experience with stroke in terms of dealing with patients in medical school and really looking at the inefficiencies there. Why are we ordering so many CTs? There has to be a better way to monitor at the bedside. And why do we not have that? Right? And now I work as a neurosurgery resident and those problems still exist. So many patients every day have to be sent back to the scanner just because something changed about their exam, and we have no idea what happened until we send them down to this big, bulky, expensive machine that requires transport. It uses radiation and there have to be better ways to solve these problems and provide the information at a point of care at a efficient cost to the patient in the hospital system. [00:06:41] Lindsey Dinneen: Yeah. And so I would love if you both or one would share a little bit about the technology itself, kind of where you are in process with approvals and all that fun regulatory excitement and just, you know, what do you envision for your company as it grows? [00:07:01] Shane Shahrestani: So from a tech perspective, there are sensors that they use in aerospace to look for cracks in airplane wings. And we have methods for non destructive detection. That's what they call it: "non destructive testing and detection" that we use every day in other fields. So what we did is, we took this technology and we optimized it for the human body, specifically for the brain and by doing so you can create a non invasive handheld, small, cheap, portable, non radiating technology that you can use anywhere to quickly assess objectively how the brain is doing in terms of its cerebrovascular health, right? [00:07:52] And the idea is it works a lot like a metal detector, right? And in stroke, you can either have too much blood in the hemorrhage or too little. And in ischemic stroke, where you're literally stopping blood flow. And if you have a metal detector that's tuned for the human body and for blood, then you can quickly assess how is the blood flow changing and what are we going to do about it? So that's the technology, and I'll pass it over to Alex to talk about the rest. [00:08:17] Alexander Ballatori: Yeah, so absolutely. So given that this technology can differentiate, localize, as well as produce an image of where the lesion is, and in stroke, again, there's two types of stroke. You need to know what type of stroke they're having. And then once they have the stroke can progress over time. So back in 2020 and 2021, when Shane was first validating this technology with an NIH funded grant awarded to Caltech and USC, we saw that it could provide all of that critical information in a very compact form and in a very low cost form. [00:08:48] So once we published that information in Nature Scientific Reports, we went out and started the company. We went out and started to raise money. And one of the, one of the things that we knew is that our basis, the basic form of our technology the common baseline principle, how it works could impact the entire stroke continuum. Right? So the stroke space has a lot of problems. So, for example, 1 out of 6 stroke patients in an ambulance goes to the wrong hospital because we can't evaluate their brain. Often stroke patients are just found down. Right? [00:09:20] So as an EMS personnel, all you want to do is get them to the closest hospital. But unfortunately, not all hospitals can manage stroke patients. So, one out of six times they're wrong, and that leads to hours in their delays in care. And like Shane said, time is brain. Every minute that passes, you lose a million neurons irreversibly. So, that's the first problem. It's kind of like the EMS. [00:09:38] Then in the emergency department, it still takes quite a while to rule in stroke, because we rely on CT scans. And there's also just a whole slew of things that have to happen for a patient in that process of getting admitted to the hospital. So stroke on average takes over two hours to diagnose from the initial symptom onset. So that's kind of the pre hospital, early hospital problem within stroke care. [00:10:01] The other big problem in stroke care is we don't have any way of monitoring patients at the bedside with a disease that's rapidly progressing. And so currently we just send patients back down to CT, on average four times for admission. And so 80%, unfortunately, these repeat scans are negative. Nothing had changed in the brain, but we require objective information to manage these patients appropriately. So we keep sending them back. [00:10:26] The other problem not to get too into the weeds with this is that most stroke patients are above the age of 65. They are enrolled in Medicare and the Medicare bundled payment system. Ever since it came out, hospitals have been losing money across the board route on stroke care, and a big contributing factors are inability to monitor and image the brain in a timely manner. So that problem also goes into the neuro rehab setting where hospitals are now pressured to push patients into neurorehab where they're getting paid, you know, per diem. And also can kind of close the DRG. [00:10:56] So you can kind of look at the stroke continuum as two problems. The early hospital, pre hospital, and then the inpatient inability to monitor this rapidly progressing disease. We have built an automated device for that second space, the inpatient and neurorehab space. Which is an automated, lightweight device that takes our sensor and has two mechanical arms that move it around the patient's head in a completely automated fashion, removing the human element to the path and the scanning path. [00:11:23] And so what that enables us to do is it enables us to put this device-- it sits right at the head of the bed-- all you have to do as a user is set them up in it, which takes less than a minute. You press go on a tablet and it scans everything and tells you all the information that's happening right at the point of care. It also enables us to leave it on and monitor patients over time, which is going to be a game changer in inpatient stroke care, where currently it takes quite a while to get patients to CT. [00:11:48] And again, 80 percent of the time it was a negative scan. So it's a completely inefficient process. That's actually we estimate to be over a 6 billion in efficiency in the U. S. alone. So we're first pursuing that, but not to say that we're not interested in the pre hospital space. We still are very interested in prehospital stroke ruling and so a lot of our diluted first round of our first round of funding, which was just about a year ago, we came to our 1 year mark, like 4 or 5 days ago, is spending a lot of time on improving our sensors capabilities, which we've improved about 3 X from what it was back in 2021. [00:12:21] So ultimately we are pursuing the inpatient space first, because there's a very clear problem for us to solve that we can solve, but it's not to say that we're not going to go for the outpatient space at a later date. We are still very actively pursuing it because our technology will be the one to solve that problem as well. [00:12:39] Lindsey Dinneen: I love it. And I love how bold and confident y'all are in your ability to do this because it's exciting to see that there are such amazing innovations and there's progress in this space. So thank you for doing the work to make that happen. I know that's going to impact so many people's lives. And also, I want to say congratulations because y'all are winning so many awards. I was looking at your LinkedIn pages and it was so fun to see, you know, post after post. So tell me a little bit about some of your recent wins, if you'd love to share that. You've been part of the MedTech Innovator Accelerator cohort for a year ish now. So yeah, just tell me about your experience and what you're celebrating. [00:13:25] Alexander Ballatori: Yeah. I mean, it's been an incredible process. MedTech Innovator is by far the most significant thing we have participated in since forming our company. The doors that were completely shut and locked and sealed that we could never potentially even knock on are now wide open because of MedTech Innovator. So yes, we've been participating for the past year and it's been a wonderful experience. First, starting off at the the pitch events at UCLA, where we pitched to the judges, where they narrowed it down. They had about 1200 early stage companies. I think a total of 1900 applications in total. And they, after those pitch events, which there were five, they narrowed it down to 61 companies total and about, I think it was 40 early stage companies. [00:14:06] So we enrolled in that program and got assigned to some incredible mentors, got to meet all of these amazing alumni that were either first time founders or seasoned, seasoned founders that have been through a lot. And we just had this complete access to this amazing network of people that we could talk to. And so, you know, it started off with Wilson Sonsini, the Innovator Summit, and the Wilson Sonsini medical device conference where we were picked to be in the top five for the vision award, which is based on the criteria, "would you invest in this company? And would you want to work for them? And do you find them inspirational?" [00:14:38] So we made it into the top five, which we're pretty surprised about, honestly, because it was a cohort wide boat. And then we had 7 minutes to pitch very similar to the finals, which I'll get to in a second. And we won that, and that was the first kind of wave of, you know, just increased interest in us, a lot more visibility for us, and a lot of validation. Our 2022 was a very very trying time for us, which we can talk about later. But anyways, that was the first big win for us. [00:15:05] And then we participated in the cohort and got to know the MTI team and our mentors and go through the value proposition program. It was so helpful for us in so many ways, and it culminated in us making it to the finals at the AdvaMed medtech conference, whereas a similar setup, we had about 7 minutes to pitch, try to explain all of the wonderful things about our technology in just a couple of minutes. After a crowd vote, we ended up winning. And so, it was really special for us because in 2022, as young innovators, you get a lot of doubt, you get a lot of no's, you get a lot of people saying you're crazy. And so to win that was really special. And I want to give Shane a moment to say anything else with respect to that too, but it was just a really sweet moment for us after what we've been through. [00:15:48] Shane Shahrestani: Yeah, a hundred percent. You know, we were two young guys in medical school, no previous business experience, trying to spin out a medtech company while also being in medical school. And the number of times we got said no to, we completely lost track. So to be able to build back up and to make it to a point where we're actually the top startup in medtech in the world was, you know, we didn't even believe it. And also, you know, a couple other things it was, Alex and I just went so much. It was awesome working together as a team over the last year and figuring out all these other problems that came up. And at the same time, at MedTech Innovator, we met so many other people going through similar problems as us. And there are so many amazing cohort companies that we got to meet who are going to change how medicine is provided in the U. S. and globally. So it was an absolute pleasure to work with all of them and to work together to solve so many problems in MedTech Innovator. It's cool. [00:16:47] Lindsey Dinneen: Yeah, that's incredible. I'm so glad that you guys had such a great experience with the cohort. And again, yeah, congratulations for winning the whole thing. That's fabulous. And I think it does speak to the innovation that y'all are bringing to the world and how important it is. And obviously you're getting some really good external validation. I mean you know the value that you're bringing, but it's always nice to have an outside person saying, "yes, we agree," you know, and to that point, I'm really curious about your 2022, because you kind of mentioned that that was a little bit more trying. So if you'd be willing to speak to that, I'd love to hear a little bit about that. [00:17:28] Alexander Ballatori: Yeah, absolutely. So like Shane mentioned, we were both full time in medical school. We were in the hospital for, I don't even want to admit how many hours. I don't think I'm allowed to say how many hours. And you know, trying to form a pitch deck. And, we're both heavy in science and research and we know how to build the presentation typically for the scientific community, right? And so, and again, we're clinicians, like, one of the reasons why I mentioned before, I think, before the recording, one of the reasons why we're so excited to come to this podcast is that this podcast is really about increasing and bringing technology to increase human health and improve human health. [00:18:05] And, you know, one of the things that we were passionate about, and still are very passionate about, is that we want to bring this product to market because we know it's going to help a lot of people. But one of the things that we had to learn is that we needed to pitch a company, right? We needed to pitch a vision and a mission, which we had the vision and the mission. It's gotten much more refined. But we had, that was our, I think our first learning curve, which we give a lot of, we have got to give a shout out to Helen McBride and Julie Schoenfeld from Caltech, as well as our lead investors at Freeflow for helping us with that one. [00:18:33] But it was tough. We were pitching during our lunch breaks and we were pitching on the weekends and we had investors lined up and then unfortunately, the day before the round of funding was supposed to come through, the markets went south and they said, "Hey, we're not investing right now. So sorry." And we were in a good amount of debt. And so, it speaks to one of the value or one of the most important things when starting a company is kind of faith in your mission and faith in your founder. [00:18:57] We were sitting and just looking at each other like, "man, what are we gonna do right now?" Like, we were still fully deep in school studying for our board exams, and we were in debt and we couldn't even build anything. And so, you know, we kept going at it and we really believed in what we could do. And we ended up finding Freeflow Ventures with David Fleck and Kevin Barrett who believed in us and, and saw our vision as well as the individuals at Caltech, and then we ended up finding quite a few other angel investors who are all directors of stroke centers, neuroradiologists, triple board certified neurologists, and you know, experts in clinical trial neuro design. [00:19:34] And they all believed in us. And so we got the money that we needed. And we've been sprinting ever since, which is why we've been able to accomplish so much in the last year. And, you know, now looking back, Shane and I were just talking about this, after we'd won MedTech Innovator finals and we were like, you know, 2022 was really tough, but it put us in a really good position because it forced us to study everything about the market, learn everything about our competitors. And really hone in on where are we going to bring this thing first? Right? Because like I said before, there's an entire continuum of stroke care where the sensor could be applied and we will apply it to all of those areas. [00:20:12] But what did we want to do first? Right? And so I think us having to go through that tough time is one of the reasons why we're so successful in such a short amount of time. So it was a tough time, but we're obviously, I think we're doing much, much better out of it. Now we can, you know, when you look back at it, we're grateful more than anything else. It's taught us a lot and definitely earned our stripes. [00:20:35] Lindsey Dinneen: It sounds like it. Shane, do you have anything to add to that? [00:20:39] Shane Shahrestani: Pressure makes diamonds. I mean, we felt the pressure. We definitely felt the pressure. It's an understatement, but you know, we learned a lot and we were able to thoughtfully revise our pitch decks, our business plans, our engineering plans with all the no's that we were getting and the feedback that we were getting underlying those no's and that's how we were just able to learn and grow. And I think there's something to be said about being young and trying to run a business. I think a lot of people don't necessarily believe in you, especially when you're asking for millions of dollars. So, we learned that we, as Alex said, earned our stripes and proved ourselves and that we were serious and we knew what we were doing. [00:21:27] Lindsey Dinneen: Yeah. And you know, what's so interesting is, when I was looking at both of your LinkedIn profiles and just seeing, I kept thinking, do you guys sleep? Do you have time to sleep? [00:21:40] Alexander Ballatori: We're sponsored by caffeine. That's actually, so Shane and I, before we even started this. We, I don't know, Shane, how many papers we published together and like 30 at least and so many conferences. And it was honestly like that, that the number of nights where we consumed hundreds of milligrams of caffeine, just working together is how we knew we were going to be great business partners. And so, you know, again, we're StrokeDX is sponsored by caffeine. [00:22:06] Lindsey Dinneen: Amazing. Can we get that official so that you actually don't have to pay for your coffee or whatever? Your caffeine of choices. Incredible. So this journey from, and obviously you probably wouldn't consider it a complete pivot or anything, but this journey from clinician to entrepreneur, and everything that entails, you know, obviously, like you said, 2022 was this huge learning curve. What would be some advice that you might have now looking back and being able to say to somebody who might be in a similar situation, maybe what's a one or two pieces of advice that you would say would be beneficial? [00:22:49] Shane Shahrestani: All right. A couple of things. One, find a co founder that you trust with your life, who is your best friend, that you'd rather be awake drinking Monsters at 3am than being asleep. That's very important. Two, every time someone says, no, that's an opportunity to learn and grow. And if you have the resilience and grit to keep your head up when you're being told no and to learn from it and to keep going forward, it will always work out. [00:23:20] Alexander Ballatori: Yeah, that's exactly, literally exactly what I was going to say. You know, someone gave us a good piece of advice. They said, expect to receive 200 no's. And so when you get your 113th, you know, you're barely, you've just barely crossed the halfway mark. Just keep going, because you should expect 200, right? And that was something that, you have to be a little crazy to do this. But also, I think, in addition, like what Shane was saying, you need to have someone that when you hit a low, you know that you can trust the person next to you and you just say, "okay, let's learn from this. Let's refine our approach. Let's , amend our deck and our plan. And let's keep going." Right? [00:23:58] And also, I think really taking the time to understand the market is really-- what you have, first of all, this is before you even get to this point-- you need to understand what you have, how it will be applied. And I think that was actually one of the one of our biggest benefits is that we work in medicine and we understand clinical utility, clinical need and as well as what we've learned that was very easy for us to learn because of we are clinicians is the whole pay/ payer system, right? [00:24:25] And, you know, price points and pricing strategies, it's all kind of coming from a clinical side. And seeing these products that I know how people use them. I've seen them use. I've used them. It just made it a lot easier for us. But yeah, ultimately boils down to having a strong partner. And and not taking things too to heart when people tell you that you're crazy. [00:24:51] Lindsey Dinneen: Yes, indeed. You know, that reminds me, I remember one time somebody saying, " when you hear no it's very rarely no forever. Never going to consider it, the end, close the door, slam it, and lock it." It's usually, "no, not right now." So if you can take that with a grain of salt, if you can take those no's with a grain of salt, eventually, you'll get to either them changing their mind or somebody else saying, no, I agree with you, you're absolutely right. [00:25:22] Alexander Ballatori: Yeah, we got a lot of "not nows." And I think it really boiled down to the fact that our first prototype was handheld. And so we were confident in our decision to go into the inpatient setting. And so now the pendulum has swung the other way. And now that we've validated that our automated device has worked in this translation, translational project of automating this technology has been successful, all of those people that were the not nows are the, "are you raising money now?" questions, which is obviously a great feeling. But yeah, no, definitely. We learned a lot. There were-- also be frank. There are many times where they ask us questions that we studied for weeks afterwards and learned so much from so all those not now is really they shaped us in such a positive way. [00:26:07] Lindsey Dinneen: Yeah, yes, I can imagine. Anything to add to that, Shane? [00:26:13] Shane Shahrestani: No, I totally agree. As Alex was saying, a lot of the previous no's are now reaching out to us. So table turn for sure, but it just takes hard work, great resilience. Got to keep your head up, keep fighting and it works out. [00:26:30] Lindsey Dinneen: Yeah. Yeah. Excellent. Out of curiosity, going back to your childhoods, could you have possibly imagined where you are now, back in the day? I mean, did you always have an interest in medicine? Is this something that sort of developed over time? Did you think you were going to be a business owner? [00:26:50] Shane Shahrestani: So ever since I was in fifth grade, I always loved the brain. I knew I wanted to do something related to the brain and now I am working in neurosurgery, but my deep passion is medtech. That's what I wake up for every day. I look forward to working with Alex and our team and solving complex problems and creating new devices that can save brain. Right? So I knew I'd be somewhere in this field, but I had no idea that I'd be able to work on a product so amazing that can really just change the paradigm and stroke care, which affects so many people every year. So, so, I never thought I'd be a business owner. I knew I'd be in the brain somewhere, but this is super exciting. [00:27:35] Alexander Ballatori: Yeah, and for me, I, so I grew up with two rockstar parents. Both came from nothing from, you know, farms in Italy, but both were very naturally gifted when it came to science and medicine. And so my parents actually met while my dad was completing his PhD at the University of Rochester. My mom was finishing up her MD. And they both saw that they had Italian last names, and then the rest is history. And then I grew up in Rochester, New York, and clouds and snow for the first 22 years of my life. But, I was very, whether it's nature or nurture, I was always very drawn to science and medicine, and both my parents actually were both entrepreneurs as well in the medical space. [00:28:13] So my dad was a pioneer in lipid and bile metabolism in the liver and developed a lot of enzymatic targets and a lot did a lot of the early work in understanding bio reabsorption. And my mom is a surgeon with multiple devices under her belt and actually is pursuing, it just gotten one of her products just got FDA cleared at the moment. They're launching right now. So I grew up in a very unique household where this is kind of dinner conversation, but I didn't know what I wanted to do. I knew I wanted to be in medtech. I knew I wanted to some sort of degree in medicine. [00:28:44] And so I took time off after I graduated and I got a degree in biology and chemistry. And so I kind of went into my time off just trying to explore as much as possible. I got my hands on so many different startups. I also got to learn from kind of the bigger medtech corporate world is getting more in respect to the orthopedic world. And so I knew it was for me, but then I was deciding PhD or MD. And for me, I liked kind of the wide breadth of knowledge that you get from the MD because there's so many problems in medicine that need to be solved. [00:29:16] And one of the things that really sticks with me is that this whole definition of "gold standard" or "standard of care," or "this is the best that we got" that I just don't, I don't like accept fully, maybe that's just kind of how I was raised or what, but I knew that I was going to, I wanted to go to medical school because I knew that there were so, there's so much more I could learn with respect to how we take care of patients that is so behind with respect to where it should be and can be, especially when you look at what's happening at some of these top universities, like a Caltech and USC and at the lab or at the benchtop. [00:29:52] So, of course, the PhD would have kind of pigeonholed me into one very specific area that I couldn't decide what I was super interested in. So to tell to go back to your question, if I, if you ask me 5 years ago, if I would be doing exactly what I'm doing right now. No, there's no way. But given my background, given my experience with stroke and then, you know, working with Shane, it just really harmoniously kind of just worked out very well. [00:30:17] And I'm really looking forward to the next few years and seeing where we can take this and then the next one as well. And the next one after that. Shane and I have a very common, one of, one of the we're I keep saying we're crazy. We kind of are in many ways where when a finish something a little bit, when we finish a task and we like finish our to-do list, the next thing we say is not like, "let's go grab lunch or grab dinner or something." It's "alright, what's next? What do we do next?" Right? And so I know the day... [00:30:40] Shane Shahrestani: I'll call Alex at like 6, 7 p. m. and be like, "Alex, I'm itching to do something. Like, just tell me something to do. What needs to be done?" He's like, "dude, you just worked a 14, 16 hour day. Why do you want more work?" I don't know. I just, it feels wrong. [00:30:56] Alexander Ballatori: I was like, Shane, go to sleep. [00:30:57] Lindsey Dinneen: It's all that caffeine. You've got your system wired, ready to go. Oh my word. Oh, that's incredible. Oh, my goodness. So out of curiosity, are there any moments or maybe one moment or whatnot that kind of stand out to you? It could be through medical school, it doesn't necessarily have to be with StrokeDX, but just a moment that stands out to you as saying, "yes, I know exactly why I'm here. This is it." It's reinforced for you: "I am in the right place at the right time doing the work that I really feel passionate about." [00:31:37] Alexander Ballatori: Yeah, you know, I think there wasn't one specific moment, but more so a process over 2022. And being told no, so so many times. And then finally battling through debt, and thank you so much to our lawyers for being very flexible with us on that. But when we finally got the amount of investors that we needed and the amount of money that we needed, everything, just we were on fire. We were so ready and we had such a strong plan. The moment the money came in, it was we were already starting to send it out the door to our engineers to start paying. And we started working that the same day that the money came in, we had a meeting with our engineers to start working. And I think just that transition point from going from trying to sell the mission to actually executing it was definitely a highlight for us. So I don't think there's one specific moment. But I think it was that kind of transition and seeing all of our incremental improvements in our sensor and seeing this device come to life. It's just been, it's, I think it's almost the whole process is really just validated that this is where I'm supposed to be. [00:32:45] Shane Shahrestani: Yeah, I think to the families of people who had a stroke and explaining to them what a stroke is and the prognosis and what's going to happen to their loved one, and then seeing people unfortunately pass because of stroke, and maybe they live too far from a hospital and their life could have been saved if they came in a little bit sooner, or they didn't know that they were having a stroke and they tried to sleep it off and woke up and couldn't move half their body. Right? And the stories go on and on. You see it in every permutation and every variation. But then, at the end of the day, these are people and their loved ones are in the hospital with them and you're trying to keep them alive and all our odds are against you and it's a function of losing brain cells and that is a function of time and efficiency, right? [00:33:41] So a big why is just so much suffering, sadness, loss can be prevented by creating new technologies that can just make healthcare more efficient for people, right? Faster, cheaper, better diagnostics, better assessment tools, better ways to monitor. And you know, that's another reason why I think Alex and I, you know, share that in common and we just work tirelessly just to create new things to just change the paradigm, change the standard of care, make things better for people. 'Cause that's just where our heart and our passion lies. [00:34:20] Lindsey Dinneen: Yeah. Yeah, absolutely. I'm very glad that you both did not let all the no's deter you. I'm glad you were willing to come back to your why and just keep at it. Yeah, that's, that takes a lot of grit and determination, but glad y'all are doing what you're doing. So, pivoting just for fun, imagine that you were asked to teach a masterclass on anything that you want. You're going to be given a million dollars for this. What would you choose to teach and why? It also doesn't have to be related to your industry at all, although it could be. [00:34:58] Alexander Ballatori: I, so my family and my my, just family events and cooking is, and my Italian heritage, is very important to me. And so I, it's, when I'm not working, I'm cooking or I'm spending, I make wine for fun. It's just it's all the traditions from my family. So I think if I had to teach a class, it would probably be sharing some of my family recipes, and also I love to cook and host all the time. So I like have had cooking classes at my house with friends and every year I make wine. It's always a big event and always have people over it. It's a really simple process. It seems so daunting, but it's quite simple, especially when you do it the old world way. And so, yeah, I guess I guess that would probably be mine. [00:35:45] Shane Shahrestani: First of all, I would go to Alex's masterclass. I'd pay however much he charged. I'd be there. His wine is like the only wine I drink now. If I had to teach a masterclass, so there's two things about me that I don't even know if Alex knows. I can identify the Latin name for any insect, any insect. And also I can classify like any saltwater fish, like tropical fish. So, somewhere between insects and tropical fish, just like, you pointed out, I'll just tell you what it is. [00:36:17] Alexander Ballatori: No way. Get out of here. We gotta go to the Galapagos. We're going on a trip. [00:36:23] Shane Shahrestani: Dude, I'm ready. We'll be the new Charles Darwins. [00:36:28] Lindsey Dinneen: Okay, so if I were to just take a random photo of a bug, I could just send it to you and you'd go, yeah, that's a... [00:36:34] Shane Shahrestani: A hundred percent. I can tell you like what order and like species that bug is. [00:36:41] Lindsey Dinneen: Amazing. [00:36:41] Shane Shahrestani: Yeah. [00:36:42] Alexander Ballatori: Incredible. [00:36:45] Lindsey Dinneen: We learn something new every day. I love it. [00:36:48] Shane Shahrestani: Just when you thought I couldn't be more nerdy, Alex. [00:36:52] Alexander Ballatori: No, so the reason why I'm laughing is because I used to do the exact same with any, you could show me any dinosaur skeleton and I knew I could do the exact same thing. I definitely can't anymore. I definitely cannot anymore. [00:37:05] Shane Shahrestani: That's so funny. [00:37:06] Alexander Ballatori: That's definitely just harsh parenting on like repeated flashcards. It was some genuine interest there, but [00:37:15] Shane Shahrestani: That's incredible. [00:37:17] Lindsey Dinneen: Amazing. I see how, you know, your, some of your childhood interests or pastimes have led you to successful careers in medicine, 'cause that amount of memorization must be daunting, but it clearly isn't because y'all have been doing it your whole life. [00:37:32] Shane Shahrestani: It's been the journey, from insects to here, you know. [00:37:38] Lindsey Dinneen: Amazing. Alright, on a slightly more serious note, how would you like to be remembered after you leave this world? [00:37:46] Alexander Ballatori: That's a great question. You know, I had a mentor at UCSF that was in a very similar position to where I kind of see myself in the later years of my career and it's very difficult to be a clinician full time and still spin technologies out, run the kind of the business end of things. And, he was someone that did it. He was someone that did both, and that's something that I also aspire at some point. And, we had this conversation where you kind of have to view it as, "do you want to be the person that takes care of the tree? And you can see the impact from your own hands on that one person? Or would you rather maintain the forest and drive things that can impact the entire forest?" It's something that sticks with me always. [00:38:35] And like I was mentioning before, just this whole concept of standard of care or gold standard, the best way to do something that I never really fully accept. So I think it's kind of not fully concrete, but I think continuing to spin out technology that these amazing technologies that are stuck at the benchtop. And through this kind of bureaucratic tech transfer process, I really see myself down the line. I would like to be remembered by our ability to take these amazing technologies and not accept that things are just the way that they are because they never are, right? We used to operate without gloves and not that long ago and wondered why our infection rates were so high. So I think for me, just down the line, I'd love to be able to be remembered by bringing new technologies and not accepting that what we currently considered the best way to do it, the actual best way to do it. [00:39:23] Shane Shahrestani: Yeah, I think, similarly, I think we all have family and friends that we love and we cherish. And I think everyone's biggest fear is losing someone that they care about. And I think we have one shot in life and my personal mission statement is just to do whatever I can just to spread positivity, happiness, ways to, to maximize that love and keep people around. Right? And I really think that medical devices and medicine and new technologies are the way to just create new solutions to problems that affect everyone. Or will affect everyone at some point in their lives. So, it would be great to be remembered as innovators, someone who can create that device that saved my brother or my mom, you know? And I think that's also a big dream or aspiration that, that we work towards every day. [00:40:26] Lindsey Dinneen: Yeah, absolutely. Yeah, and final question: what is one thing that makes you smile every time you see or think about it? [00:40:36] Alexander Ballatori: I mean, I love seeing a big table filled with food anytime, because it's, again, it's my family. We used to get together every Friday, every Sunday, no exceptions. Everyone is there, 50 to 100 people. And so every time we open a table and it's like I'm going back to upstate New York for Thanksgiving and for Christmas. And so every time I see there, I think about it, you know, we've all grown now and we're all kind of all over the place. So we don't get together as much. So anytime I think about that's definitely that's definitely my, my, what makes me smile for sure. [00:41:06] Shane Shahrestani: Lately I've been smiling, looking at that big check we won at MedTech Innovator. [00:41:16] Alexander Ballatori: Me too. Me too. Me too. [00:41:17] Shane Shahrestani: Yeah. So we'll leave it there. [00:41:20] Alexander Ballatori: And our new device rendering also makes me smile. [00:41:22] Shane Shahrestani: That's oh yeah. Yeah. That makes me smile. [00:41:25] Alexander Ballatori: It's also both of our phones screensavers. So we're smiling a lot. [00:41:31] Lindsey Dinneen: I love it. That's fantastic. It's just motivation day in and day out. You just look at it and go, "yeah, this is great. This is what we're doing." Oh my word. That is absolutely incredible. And this has just been so much fun. I really appreciate you both joining me today and sharing more about your backgrounds and your passion and all of the really exciting innovation coming out of your company. Again, thank you. Thank you for what you're doing for the world. It matters. And it's really cool to see you take the challenge and get past the no's to get to those yeses. So thanks. [00:42:08] Alexander Ballatori: Yeah, no, thank you so much for allowing us to share our story and make sure you follow us as we are moving very quickly and starting to collect clinical data. And so it's a very exciting time to, to start following us. If you aren't already, it's now is the best time to start. [00:42:22] Lindsey Dinneen: Yeah. Yeah. Yes. [00:42:23] Shane Shahrestani: Appreciate you for having us today. It's been a pleasure chatting and hopefully we do this again soon. [00:42:29] Lindsey Dinneen: Yeah, absolutely. And we are so honored to be making a donation on your behalf as a thank you for your time today to Sleep in Heavenly Peace, which provides beds for children who don't have any in the United States. So thank you for choosing that organization to support. And yeah, we just wish you continued success as you work to change lives for a better world. [00:42:52] Alexander Ballatori: Thank you so much. Thanks again. [00:42:53] Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in. Please go follow StrokeDX. Like they said, they are moving quickly and you will definitely want to be on top of that. And if you're feeling as inspired as I am, I'd love if you'd share this episode with a colleague or two, and we will catch you next time. [00:43:14] Ben Trombold: The Leading Difference is brought to you by Velentium. Velentium is a full-service CDMO with 100% in-house capability to design, develop, and manufacture medical devices from class two wearables to class three active implantable medical devices. Velentium specializes in active implantables, leads, programmers, and accessories across a wide range of indications, such as neuromodulation, deep brain stimulation, cardiac management, and diabetes management. Velentium's core competencies include electrical, firmware, and mechanical design, mobile apps, embedded cybersecurity, human factors and usability, automated test systems, systems engineering, and contract manufacturing. Velentium works with clients worldwide, from startups seeking funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.  

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. 3M has named William Brown as its new CEO, replacing Michael Roman who has led the company since 2018. Abbott has recalled its HeartMate LVAD communication system due to reported injuries linked to the device malfunctioning. 3M's board has approved a health spinoff, with investors set to receive shares of Solventum. An FDA panel has backed Lumicell's agent for breast cancer imaging tool, despite some risks. A report by AdvaMed has found racial disparities in care, particularly in cardiovascular procedures, and proposes solutions to address these issues. The medtech industry is seeing trends in digital health and AI applications, which are becoming more prominent in the medical device space. Cigna is capping cost increases for pricey GLP-1 weight loss drugs, showing how major players are adapting to meet high demand for these medications.Pfizer's antibody-drug conjugate, ADCetris, showed improved overall survival in patients with relapsed or refractory diffuse large b-cell lymphoma when used with rituximab or lenalidomide. The unique trial design of the study is expected to be the focus of an upcoming advisory committee meeting. Additionally, Roche presented promising mid-stage data for an investigational therapy for Alzheimer's disease, showing rapid and robust amyloid plaque reduction. Acadia Pharmaceuticals is terminating development of its antipsychotic drug after it failed to demonstrate a statistically significant improvement over placebo in a late-stage study. Merck is making a potential $1 billion bet on Pearl Bio's genomically recoded organisms. FDA updates guidelines for Alzheimer's drug development, while biopharma companies like BMS and Innovent Bio announce layoffs and site closures.Roche is focusing on its next Alzheimer's drug after setbacks, while Acadia faces a setback in a schizophrenia trial. Boehringer and Sosei Heptares have teamed up in a deal for a schizophrenia drug. Biotech stock fundings are on track for the best quarter in 3 years. ALS doctors are preparing for tough conversations with patients after a surprise trial failure, and Acadia's drug failure sets back the company's expansion plans. Other news includes the use of social determinants of health data to identify patient populations for weight loss drugs, and a deal between Boehringer and Sosei Heptares to develop medicines for neurological diseases. Publicly traded biotech companies have raised nearly $10 billion in follow-on stock offerings in January and February, driving a sector recovery according to Jefferies.The text discusses the concept of precision medicine and the All of Us research program, which aims to build a diverse health database. The program has revealed risk factors for Alzheimer's disease. The delay in the approval of Eli Lilly's drug for Alzheimer's, Donanemab, is seen as a potential opportunity to improve drug development and pave the way for a more personalized approach to treatment. Additionally, a liquid biopsy for colorectal cancer screening from Guardant Health could make precision medicine in cancer more feasible.In an upcoming webinar, marketers can learn how to execute bigger ideas in a simpler and more cost-effective way using creative automation. Many businesses struggle to balance costs, speed, and creative quality in today's complex marketing landscape. By automating creatives, marketers can accelerate digital ad production, distribution, and impact. Automation enables marketers to increase collaboration between teams, accelerate ad production, and execute bigger ideas more efficiently.Participants can register for the webinar to discover how automation can help streamline marketing efforts and drive ROI.

In this episode of the Medtech POV Podcast, host Scott Whitaker talks with Dr. Lishan Aklog, CEO of PAVmed and Lucid Diagnostics. Dr. Aklog, a heart surgeon and medtech entrepreneur, shares his perspective on the latest advancements in medical technology, the future of health care innovation, and how we can get breakthrough technology into the hands of patients. Tune in to gain valuable knowledge from one of the industry's leading voices. Don't miss out on this insightful journey into the world of medtech! Subscribe to the Medtech POV Podcast today. Learn more about AdvaMed: www.advamed.org

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, December 12, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. NeuroOne this week received FDA clearance for its neuro ablation technology. Fast Five hosts Sean Whooley and Danielle Kirsh talk about the technology, how it works and what executives think about the opportunities this device could bring to the company.  Medtronic and Cosmo Pharma are expanding their artificial intelligence collaboration for GI Genius. Learn what the goal of the collaboration will be, what GI Genius is and some of the successes Medtronic has seen with GI Genius. CMR Surgical appointed a new chief commercial officer. Hear who takes over and what some of their career history is. BCI maker Synchron has added a former Dexcom CEO to its board of directors. Whooley discusses the appointee's experience and how the diabetes tech experience will benefit Synchron.  AdvaMed picked GE HealthCare CEO Peter Arduini as the new board chair and announced it formed a new medical imaging division. The Fast Five hosts talk about the medical imaging division and what the trade organization sees for the future of that division.

In this video,, the focus is on the growing interest in digital engagement programs among FDA-regulated companies, but it also addresses the concerns raised by regulatory agencies such as the FDA, DOJ, FTC, and OIG. The discussion revolves around the risk-based review of outward-facing information shared by medical device companies. The podcast delves into seven hierarchical layers that dictate how organizations should approach compliance. These layers include:1. The Constitution (First Amendment): Highlighting the clash between First Amendment rights like free speech and FDA regulations. Emphasizes the importance of truthful and non-misleading information.2. Laws Made by Congress: Discussing how laws such as the Food, Drugs, and Cosmetics Act set the rules but can be ambiguous, potentially leading to regulatory challenges.3. Regulatory Agency Interpretation: Exploring how FDA, FTC, and OIG interpretations through regulations, guidances, and enforcement actions add another layer of compliance focus for Pharma companies.4. CIA Settlements: Examining Integrity Agreements or CIA settlements as legal precedents that set industry wide regulatory expectations for Pharma companies.5. Industry Codes: Discussing voluntary codes like Pharma or AdvaMed codes, which, while not legally binding, may influence industry standards.6. Internal Policies: Highlighting the importance of company-set policies for day-to-day operations, which are more conservative than the law but serve as prudent forms of engagement.7. Personal Risk Tolerance: Acknowledging that individual risk tolerance varies, and while policies guide the process, they won't eliminate personal risk tolerance. The podcast emphasizes the need for companies to navigate these layers carefully and stay informed and compliant. It concludes with an invitation to seek assistance in creating digital health engagement programs by contacting the speaker via email at darshan@kulkarnilawfirm.com Website: http://www.darshantalks.comLaw Firm: http://www.kulkarnilawfirm.comTwitter: https://twitter.com/darshantalksLinkedIn: https://www.linkedin.com/in/darshanku...----Disclaimers:This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice or medical advice. Listening to this video or otherwise depending on discussions in this video do not, in any way, create an attorney attorney-client relat

Tracy MacNeal is an engineer, healthcare entrepreneur and medical technology investor. She previously served as President of Diagnostics and Digital Health for Ximedica, after serving in Chief Strategy Officer and Chief Financial Officer roles at two successful medical technology companies. Additionally, Tracy served as the national Chair of Advamed's Women's Executive Network from 2019-2022 and recently joined the Executive Board of AdvaMed and the Payment Policy Committee, working alongside Materna's strategic acquirers in Washington DC on the issues that challenge all MedTech companies. Tracy received a Bachelor of Chemical Engineering at Cooper Union and an MBA from Duke's Fuqua School of Business, graduating summa cum laude. hellomilli.comhttps://www.facebook.com/himillihttps://www.instagram.com/hellomilli_/https://www.youtube.com/@hellomilli_*******************I recommend checking out my comprehensive pelvic health education and fitness programs on my Buff Muff AppYou can also join my next 28 Day Buff Muff Challenge https://www.vaginacoach.com/buffmuffIf you are feeling social you can connect with me… On Facebook https://www.facebook.com/VagCoachOn Instagram https://www.instagram.com/vaginacoach/On Twitter https://twitter.com/VaginaCoachOn The Web www.vaginacoach.com

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 26, 2023. Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast. Abbott this week reported positive data for its MitraClip and TriClip devices. Fast Five hosts Sean Whooley and Danielle Kirsh discuss the most compelling data from the results and what executives think. A Boston Scientific executive is joining the board of directors at Day Zero Diagnostics. Hear who is taking a board seat and why. Fresenius Medical Care has a Class I recall of some hemodialysis systems. Find out which devices are affected and what the company is doing to fix the issue. Ashely McEvoy's departure from Johnson & Johnson means she has to step down from her role as board chair of AdvaMed. Whooley details if the trade organization has chosen a replacement and what AdvaMed CEO Scott Whitaker had to say about her tenure. Medtronic has selected a location to manufacture its renal denervation technology if it is approved by the FDA. The Fast Five hosts discuss the manufacturing location and the reason behind the hold up of getting the technology to market.

Good morning from Pharma and Biotech Daily, the podcast that gives you only what's important to hear in the Pharma and Biotech world. In today's episode, we have several news and insights to cover. Let's dive right in.## Restructuring Efforts at Beam and Top Biopharma ConferencesBiopharmaceutical company Beam is undergoing a restructuring effort, which will lead to the layoff of 100 employees. This move is aimed at prioritizing medicines for sickle cell and alpha-1 antitrypsin deficiency. The company will also trim its plans for other programs.In other news, the top biopharma conferences for 2024 are already being planned, with a few key meetings remaining this year. While these conferences are important for networking and knowledge sharing, let's focus on the developments within the industry itself.## Ultragenyx's Exciting Venture and Worldwide Clinical Trials' Human-Centered ApproachUltragenyx, a biopharmaceutical company, is planning to spin out a new company focused on Alzheimer's gene therapy. The CEO, Emil Kakkis, believes that the findings are too exciting to ignore and describes this venture as "high-risk, high-return." This move highlights the ongoing pursuit of innovative treatments in the biopharma industry.Meanwhile, global clinical trials provider Worldwide Clinical Trials is delivering excellence in the clinical trial experience by offering a human-centered approach that combines cutting-edge science. This approach emphasizes the importance of putting patients first.## Merck's Partnership and Challenges in Biotech IPOsMerck has formed a partnership with Daiichi Sankyo to invest in antibody-drug conjugates (ADCs) for cancer treatment. This partnership solidifies the potential of ADCs in reshaping cancer treatment.On the other hand, fewer biotech companies are going public after a record run. Some companies have seen their shares lose value on the stock exchange, indicating that the public market may be becoming more selective in its support of biotech companies.## Insights in the Medtech Industry and Challenges for Biotech CompaniesMoving on to the medtech industry, Intuitive Surgical's Q3 sales missed estimates due to factors such as robot leasing and decreased demand in China. However, the company's overall procedure growth exceeded market expectations.The CEO of Advamed has warned Congress about potential supply shortages caused by regulations on ethylene oxide (ETO) and per- and polyfluoroalkyl substances (PFAS). This highlights the need for changes to regulatory proposals to ensure a steady supply of medical devices.## Addressing Affordability of Insulin and Telehealth in the Defense SectorGoodRx and Sanofi have partnered to make insulin more affordable. This partnership aims to address the rising cost of insulin, which has led many patients to ration their supply or go without. However, there are still concerns about high drug prices that need to be addressed.Amwell and Leidos have scored a defense contract worth up to $180 million, highlighting the growing role of telehealth in the defense sector. As more healthcare services are being provided remotely, telehealth is playing a crucial role.## Physician Turnover and Healthcare Worker StrikesA study has found that physician turnover is driven by a desire for increased flexibility. This highlights the need for healthcare organizations to prioritize work-life balance and offer more flexible schedules to retain physicians.Over 1,200 nurses in Pittsburgh have authorized a potential strike at Allegheny General Hospital amid ongoing contract negotiations. This is just one example of healthcare worker strikes occurring across the country, driven by concerns over working conditions, staffing levels, and wages.## Challenges in the Biotech Market and Strategies for Combating BurnoutThe biotech market continues to face challenges, with several gene therapy or editing companies laying off employees this year. Additionally, leader

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 12, 2023. Check out the show notes for links to the stories we discussed today at MassDevice.com/podcast. Novo Nordisk has announced that it acquired all shares of drug delivery device maker Biocorp. Fast Five host Danielle Kirsh and guest cohost Jim Hammerand discuss the deal, including when the acquisition talks began. Ambu named its new chief financial officer for 2024. Find out who is taking over and what some of their career history is that supports this appointment.  The FDA has approved a next-gen intrathecal drug delivery system from Medtronic. Kirsh and Hammerand talk about the technology and what sets it apart from previous iterations of the device.  Medtech Innovator announced the 2023 Grand Prize winner at AdvaMed's Medtech Conference in Anaheim. Hear who the winner is and what their technology does in today's episode.  Boston Scientific won an expanded indication for its spinal cord stimulation system. The Fast Five hosts talk about the technology, some of the features and the optimism that executives have after this approve. Bonus: Sean Whooley brings his insights from the AdvaMed Medtech Conference. His biggest takeaway from Day 2 is about building innovative business models and disruptive technologies, as well as what big companies are thinking about mergers and acquisitions. Tune in to hear what he had to say and check out the rest of his coverage on MassDevice here.

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here's what you need to know for today, October 11, 2023. Check out the show notes for links to the stories we discuss today at MassDevice.com/podcast. Hyperfine received FDA 510(k) clearance for its artificial intelligence software for improve image quality on its Swoop portable MRI system. Fast Five host Danielle Kirsh and guest host Jim Hammerand discuss the latest software development and how it updates that MRI system. Medtronic is warning on some of its previous software on some MiniMed 780G devices in Germany. Find out what the issue is and how patients could be affected. The FDA wants more testing from Philips in the ongoing recall of its Respironics respiratory devices. Kirsh and Hammerand talk about why the FDA wants more testing from Philips and what Philips plans to do to address that. Reuters is reporting that Boston Scientific is opening its first factory in China. Hear what the report said and why the company is making a major play in China. Haemonetics is strengthening its cardiology device portfolio with the acquisition of OpSens. Kirsh gives the financial details behind the deal and how OpSens' devices will improve Haemonetics' existing portfolio. BONUS: Sean Whooley is on the ground at AdvaMed's Medtech Conference in Anaheim, California this week and he gives us one major takeaway from the talks he has sat in on so far. Hear how digital health is hitting a boom.

This week's episode is dedicated entirely to the 10 Finalists of MedTech Innovator's Pitch Competitions. The final winners will be selected by the audience on Oct. 10 at the upcoming AdvaMed annual meeting. The finalists for MedTech Innovator's grand prize of $350,000 are listed below. Click on the link to watch their 1-minute pitch video. Dr. Tom McClellan - Fingy3D - https://www.youtube.com/watch?v=KCoj_ZALf3c Amanda French - IFPx - https://www.youtube.com/watch?v=8B3j2weOkNo Jay Shah/Vivek Ganesh - Neurava - https://www.youtube.com/watch?v=lyUB9WCLeww Dr. Alex Woods - Newrotex - https://www.youtube.com/watch?v=MEhP_Ack32c Alex Ballatori/Shane Shahrestani - StrokeDx - https://www.youtube.com/watch?v=tdkl5QyDfD8 The companies listed below are vying for MedTech Innovator's Execution Award. The winner will receive $25,000. Click on the link to watch their 1-minute pitch video. Harlee Sorkin - InterShunt Technologies - https://www.youtube.com/watch?v=QPi5FSRSjUQ Michael Ebner - Hypervision Surgical - https://www.youtube.com/watch?v=oTz-AXfwJgw Lori Arakaki - Opticyte - https://www.youtube.com/watch?v=AECmlLpv0hE Joanna Nathan - Prana Thoracic - https://www.youtube.com/watch?v=myjUp3Gg4mQ Dushyanth Surakanti - Sparta Biomedical - https://www.youtube.com/watch?v=wvS9PwpkT_c DeviceTalks's Tom Salemi and Kayleen Brown visited with the founders and CEOs of each of the 10 companies. We'll run through those interviews with Paul Grand, CEO of the MedTech Innovator program. Thanks for listening to the DeviceTalks Weekly Podcast Subscribe to the DeviceTalks Podcast Network on any major podcast application.

Dr. Peter Schneider, Professor of Surgery in the Division of Vascular & Endovascular Surgery at the University of California San Francisco, and Dr. Justin Klein, AdvaMed board member and co-founder at Vensana Capital joined AdvaMed's Scott Whitaker to talk about a recent New York Times story about atherectomies and peripheral artery disease (PAD) and the impact the story could have on patients seeking treatment for this condition.

About Pierre Leurent:Pierre Leurent, President of Aptar Digital Health, is the CEO and co-founder of Voluntis, a leading digital therapeutic company acquired by Aptar Group in 2021. Pierre has over 20 years of experience in digital health in the United States and Europe. Prior to starting Voluntis, he worked at GE Healthcare, in its medical imaging software division, and at HealthCenter Internet Services, a vendor of EMR solutions based in Silicon Valley. He is a founding Director of the Digital Therapeutics Alliance, of which he served as Chairman and a member of Advamed's Digital Health Executive Leadership Group. Pierre previously co-chaired the digital therapeutics task force of the Personal Connected Health Alliance, a member of HIMSS, and chaired the eHealth France Alliance. He holds an MS from Ecole Centrale Paris. About Sai Shankar:Sai has more than 20 years of experience across the pharmaceuticals, medical devices, and digital health business verticals. He has been an intrapreneur at Aptar, building the Digital Health division. Prior to joining Aptar in 2017, Sai worked for 15 years at Allergan and Sanofi.As the President of Aptar Digital Health, Sai is responsible for the overall P&L of the business. In addition to the organic growth of the connected devices business, he has overseen the acquisition of digital health companies (Voluntis and Cohero Health) as well as equity investments in various startups like Propeller Health, Sonmol (China), and Navia (India). Things You'll Learn:Voluntis was acquired by Aptar last year, a big investment on their part in the digital space.Aptar is a publicly traded company that makes technology to optimize the effectiveness and adherence of drugs across many therapeutic areas.Aptar Digital Health falls under the pharma segment of the Aptar organization.Digital technology can guide patients to help them self-manage and be more connected with their healthcare team remotely.Making data available to care teams remotely brings clinical benefits and generates savings for the healthcare system.Aptar Digital Health has one of the largest portfolios of collaborations in digital therapeutics in the global pharma market.Enhancing patient experiences lead to better engagement and in turn, outcomes. Resources:Connect with and follow Pierre Leurent on LinkedIn.Connect with and follow Sai Shankar on LinkedIn.Follow Aptar Digital Health on LinkedIn.Discover the Aptar Digital Health Website.

In this episode we'll speak with two leaders of Ronovo Surgical, a Shanghai-based surgical robotics company that's looking to challenge Intuitive and all comers to the massive surgical market in China. CEO John Ma and CTO Ying Mao describe the benefits they see in Ronovo Surgical's unique modular system design. The pair bring experience from Intuitive, Auris, and other medical device companies. Why does Ronovo see its Carina system as a more attractive alternative to legacy MIS systems? And how does it intend to tackle the China market and beyond? Chris Newmarker, executive editor of life sciences, delivers his Newmarker's Newsmakers after Host Tom Salemi bemoans the uncertain fate of his family's Kia Rondo. Newsmakers include Silicon Valley Bank, Abbott, CVRx, AdvaMed, Johnson & Johnson and Medtronic. You can find MassDevice Tip Line here. https://www.massdevice.com/massdevice-medtech-layoffs-tips-line/ Thanks for listening to the DeviceTalks Weekly Podcast. You can subscribe to the DeviceTalks Podcast Network on any major podcast player. Don't miss future episodes of DeviceTalks Weekly, IntuitiveTalks, StrykerTalks, and now Boston Scientific Talks.

➡️ Like The Podcast? Leave A Rating: https://ratethispodcast.com/successstory   ➡️ About The Guest⁣ Bill George is a senior fellow at Harvard Business School, where he has taught leadership since 2004. He is the author of four best-selling books: 7 Lessons for Leading in Crisis, True North, Finding Your True North, and Authentic Leadership, as well as True North Groups. His newest book, Discover Your True North, was published in August of 2015 along with its companion workbook, The Discover Your True North Fieldbook. Mr. George is the former chairman and chief executive officer of Medtronic. He joined Medtronic in 1989 as president and chief operating officer, was a chief executive officer from 1991-2001, and was board chair from 1996-2002. Earlier in his career, he was a senior executive with Honeywell and Litton Industries and served in the U.S. Department of Defense. Mr. George currently serves as a director of Goldman Sachs and The Mayo Clinic. He has recently served on the boards of ExxonMobil, Novartis, Target Corporation, and Minnesota's Destination Medical Center Corporation. He is currently a trustee of the World Economic Forum USA. He has served as board chair for Allina Health System, Abbott-Northwestern Hospital, United Way of the Greater Twin Cities, and Advamed. ➡️ Show Links https://twitter.com/Bill_George/  https://www.linkedin.com/in/williamwgeorge/  https://billgeorge.org/  ➡️ Podcast Sponsors HUBSPOT - http://hubspot.com/successpod/  ➡️ Talking Points⁣ 00:00 - Intro 01:45 - Bill George's origin story 04:33 - How many people pursue careers that they're not fulfilled or happy with? 06:24 - The concept of True North 10:49 - How to effectively action authentic leadership in an organization 12:28 - Leading an organization 30 years back vs now 15:24 - How and when should a leader take a stand? 17:32 - When should a CEO take a social stand? 20:10 - Advice for people who want to expand their business overseas 22:35 - Bill George on leading without True North 24:57 - What is Mark Zuckerberg trying to accomplish as a leader? 27:05 - Is there a place for a leader to be charismatic? 31:05 - Challenges leaders are going to experience in the next ten years 34:29 - What businesses are actually making a difference in the world? 35:56 - What can the new generation of leaders learn from the last generation of leaders? 37:57 - Advice for emerging leaders 39:41 - Where can people connect with Bill George? 40:47 - What does success mean to Bill George? Learn more about your ad choices. Visit podcastchoices.com/adchoices

AdvaMed's Scott Whitaker sits down on the latest episode of the MedTech POV podcast with Dr. Lucy Frasier to discuss the recent news about ethylene oxide (EtO), the real risks caused by the naturally occurring chemical, and what would happen to health care delivery if the chemical was banned as a sterilizer of medical devices and component parts.

Cary Vance, President and CEO of Titan Medical, joins AdvaMed's Scott Whitaker to share his experience leading a small medical device company through the regulatory process as they transition from design to manufacturing.

Key retirements, important changes in leadership, and some surprising new faces. Now that the dust has almost settled, leaving just one Senate run-off and several House seats still to be settled, what does the election's outcome mean for the medical device industry, both in terms of prospects for the rest of this year and for the new Congress in 2023? MDMA's Mark Leahey and Advamed's Greg Crist offer their perspectives on this podcast with Market Pathways editors Stephen Levin and David Filmore.

In this week's episode, we'll visit with CL Tian, co-founder and CEO of Phiex Technologies, Medtech Innovator's 2022 Grand Prize winner chosen by attendees at this week's AdvaMed conference in Boston. Tian details the pending problems facing the medtech industry due to concerns about current sterilization practices and shares how Phiex could help alleviate the problem. At the start of the episode, co-hosts Tom Salemi and Chris Newmarker are joined by Associated Editor Sean Whooley and Pharma Editor Brian Buntz to revisit the high points of last week's DeviceTalks West conference in Santa Clara. Thanks to all of our speakers, sponsors and attendees! To read the report mentioned in the podcast go here. https://www.bcg.com/publications/2022/us-ahead-in-medtech-regulation You can find ongoing coverage at MassDevice. Thanks for listening to the DeviceTalks Weekly Podcast. Subscribe to this podcast on every major podcast player.

Just a short visit today. Paul Grand of the Medtech Innovator introduces us the five finalists of his start-up program. They'll compete for the top spot at AdvaMed's meeting next week. in Boston. Remember to join us at DeviceTalks West THIS week. Register at DeviceTalks.com.

Mick Farrell, ResMed CEO and member of the AdvaMed board of directors, joined AdvaMed's Scott Whitaker on the MedTech POV podcast to discuss how an agile company with skilled staff and a clear mission can pivot sharply as the market demands, from scaling up ventilator production at the outset of the COVID-19 pandemic to informing semiconductor chips manufacturers of their product's critical importance to the medical technology industry.

Derek Herrera, former Marine and current Board President of MedTechVets, Founder and CEO of Bright Uro, joined AdvaMed's Scott Whitaker on the MedTech POV podcast to talk about his experiences, from his paralysis by a sniper's bullet in Afghanistan to his subsequent career as a medtech entrepreneur, and what he sees for the future of the industry. Watch a heartwarming video of Derek standing up from his wheelchair for the first time in front of his two young sons using exoskeletal medical technology. https://www.youtube.com/watch?v=pCTBn2SSUjg

Market Pathways editors Steve Levin and David Filmore discuss important medtech regulatory and policy developments they are looking for in 2022. In this episode, they delve into the US picture, including what to expect from Congress, FDA, and CMS. Check out the second part of the conversation, where they discuss the environments in Europe and Asia, in the next episode. Read more about the topics discussed in these Market Pathways articles: Pathways' Picks for 2022: 7 Medtech Policy Issues to Watch https://bit.ly/3JNdRUS Q&A: AdvaMed's Scott Whitaker on Partnering, Advocacy, and the Medtech Policy Year Ahead https://bit.ly/3LSDx3U Device User Fee Talks Stalled as a Deadline Approaches https://bit.ly/3p86G1A

Lishan Aklog, MD, Chairman and CEO of PAVmed joined AdvaMed's Scott Whitaker on the Medtech POV podcast to talk about the way the reimbursement system works for medtech companies and the impact it has on raising capital and getting life-saving medical technology to patients.

Lisa Earnhardt, Executive Vice President, Medical Devices, at Abbott joined AdvaMed's Scott Whitaker on the Medtech POV podcast to discuss how innovation and technology are helping patients manage diabetes, allowing them to live fuller and better lives.

Mike Mussallem, Chairman and CEO of Edwards Lifesciences joined AdvaMed's Scott Whitaker on the Medtech POV podcast to talk about changes to federal policy that could speed up the process of getting life-saving medical technology to patients.

In this important episode, Haleh is riveted by her conversation with Tracy MacNeal, President and CEO at Materna Medical, a medical device company devoted to improving women's pelvic health through technology and empowerment. The two discuss the historical lack of medical research specifically done on women, the embarrassment associated with pelvic conditions, and the role technology is playing to transform women's health care. Do you know the signs of woman having a heart attack? Listen and learn, because it is not the same as a man's symptoms! Holding a BE in Chemical Engineering from The Cooper Union and an MBA from Duke, Tracy has over 20 years in pharmaceuticals, digital health and medical devices. A deep believer in the importance of contribution and collaboration within our shared healthcare ecosystem, she also serves as national Chair for Advamed's Women's Executive Network, amplifying the voices of women leaders who are creating the future of healthcare. Did we mention she's a North Carolina native…born and raised?

“We were forced to collaborate with such speed and collective work, and collective passion, and the results were very good. That's going to shape how we think about public policy I think from this point on.” Scott Whitaker, president and CEO of AdvaMed, didn't have “respond to a global pandemic” on his five-year strategy plan when he took the helm of the powerful device industry trade association in 2016. The unexpected challenges have been steep, with the industry he represents at the center of the pandemic narrative. But Whitaker has been heartened by industry's ability to rally to the challenge. And he believes that his work, the work of government advocacy, has been strengthened by the experience. The need for industry to work with policymakers in new ways to achieve quicker action in response to the emergency has enhanced appreciation for productive partnerships on both sides, he says. He thinks that dynamic will be lasting, beyond pandemic policies. More productive government-industry partnerships would certainly help over the next months, and year, as the device industry's DC representatives face having to start from square one following CMS' recent repeal of the Medicare Coverage of Innovative Technology program, bringing challenging user fee negotiations with FDA to a close, and engaging in what could be a very active congressional session for medtech in the mix of election-year politics. Whitaker talks about those issues and more with Market Pathways Executive Editor David Filmore. Relevant articles: MCIT Rule May Be Toast, But There's More on the Medicare Menu: https://bit.ly/3i1SiEj Capitol Hill Staffers are Impatient for Device User Fee Deal: https://bit.ly/2ZDJdM9 Pathways' Picks November 17: Big Week in Washington, Aussie Reclassifications, China Picks, and More: https://bit.ly/3xLOvSs View the latest issue of Market Pathways: https://bit.ly/3uSbUzS View more podcast episodes: https://bit.ly/3ai8nBy About Market Pathways Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com

Nadim Yared, President and CEO of medical technology startup CVRx recently joined AdvaMed's Scott Whitaker on the Medtech POV Podcast to discuss his expansive career in medtech – from engineer to CEO – and how his work to improve communication between the Food & Drug Administration and the medtech industry has vastly changed over the years.

Many of us wear wireless, battery-powered medical sensors on our wrists in the form of our smartwatches or fitness trackers. But someday soon, similar sensors may be woven into our very clothing. Harry's guest this week, Nanowear CEO Venk Varadan, explains that his company's microscopic nanosensors, when embedded in fabric and worn against the skin, can pick up electrical changes that reveal heart rate, heart rhythms, respiration rate, and physical activity and relay the information to doctors in real time. And that kind of technology could move us one step closer to a world where we're far more intimately connected to the medical system and doctors can catch health problems before they turn into disasters.Nanowear's leading product is a sash called SimpleSense that fits over the shoulder and around the torso. Last month the company won FDA approval for the software package that goes with the SimpleSense sash and turns it into a diagnostic and predictive device. It's currently being tested in a network of clinics as a way to monitor and manage congestive heart failure.Varadan trained in biochemistry at Duke, earned an MBA at Columbia, and spent about a decade in pharmaceutical sales and marketing and technology investment banking before co-founding Brooklyn, NY-based Nanowear in 2014. His father Vijay Varadan, MD, PhD, now an emeritus professor in the Department of Engineering Science and Mechanics at Penn State, is the other co-founder and the company's chief innovation officer. "Nanowear's technology was actually the culmination of his life's work," Venk says.Please rate and review The Harry Glorikian Show on Apple Podcasts! Here's how to do that from an iPhone, iPad, or iPod touch:1. Open the Podcasts app on your iPhone, iPad, or Mac. 2. Navigate to The Harry Glorikian Show podcast. You can find it by searching for it or selecting it from your library. Just note that you'll have to go to the series page which shows all the episodes, not just the page for a single episode.3. Scroll down to find the subhead titled "Ratings & Reviews."4. Under one of the highlighted reviews, select "Write a Review."5. Next, select a star rating at the top — you have the option of choosing between one and five stars. 6. Using the text box at the top, write a title for your review. Then, in the lower text box, write your review. Your review can be up to 300 words long.7. Once you've finished, select "Send" or "Save" in the top-right corner. 8. If you've never left a podcast review before, enter a nickname. Your nickname will be displayed next to any reviews you leave from here on out. 9. After selecting a nickname, tap OK. Your review may not be immediately visible.That's it! Thanks so much.Full TranscriptHarry Glorikian: Hello. I'm Harry Glorikian. Welcome to The Harry Glorikian Show, the interview podcast that explores how technology is changing everything we know about healthcare.Artificial intelligence. Big data. Predictive analytics. In fields like these, breakthroughs are happening way faster than most people realize. If you want to be proactive about your own health and the health of your loved ones, you'll need to learn everything you can about how medicine is changing and how you can take advantage of all the new options.Explaining this approaching world is the mission of my new book, The Future You. And it's also our theme here on the show, where we bring you conversations with the innovators, caregivers, and patient advocateswho are transforming the healthcare system and working to push it in positive directions.Everyone's used to the idea that if they're being treated in a hospital, they'll probably get wired up to sensors that track their heart rate or respiration rate or blood oxygen level.We've talked on the show before about a new generation of portable medical sensors for everyday life, like continuous glucose monitors for people with diabetes.And some people even wear medical sensors on their wrists in the form of their Fitbit or Apple Watch. Some of these devices can go beyond fitness monitoring to alert wearers to problems like cardiac arrhythmia.But what if medical sensors were woven into your very clothing? My guest this week is Venk Varadan, and he's the CEO and co-founder of a company called Nanowear that's taken a big step in that direction. Nanowear has developed a way to put microscopic nanosensors inside clothes .If that cloth is worn against the skin, it can pick up electrical changes that reveal heart rate, heart rhythms, respiration rate, and physical activity and relay the information to doctors in real time. Nanowear's leading product is a sash called SimpleSense that fits over the shoulder and around the torso. And last month the company won FDA approval for the software package that goes with the SimpleSense sash and turns it into a diagnostic and predictive device.But Varadan says that in the future the nanosensors and the software could be put into even more places, like headbands, conventional clothing, or bed sheets. That's just one example of the explosion in mobile health technology that's putting more power into the hands of patients. And it's also one of the topics in my book The Future You, which is available now in Kindle ebook format. You can get your copy by going to Amazon.com and searching for "The Future You," by Harry Glorikian. The book grows partly out of conversations like the ones I have here on the podcast with medical researchers and entrepreneurs. But it goes even deeper into the impact of wearable sensors, AI, and so many other technologies that have the potential to help us live longer, healthier lives. So I hope you'll check it out.And now on to my conversation with Venk Varadan.Harry Glorikian: Venk, welcome to the show.Venk Varadan: Thank you, Harry.Harry Glorikian: So, look, we all know that with with technology startups, there's always this sort of chicken and the egg question what what came first in the mind of the inventors: the market need or the product that needs to address it. You know, ideally they come together simultaneously and there's a back and forth dialogue between founders and potential customers. And you end up with what the startup community calls--what is it?--product-market fit, if I talk to my, you know, my Silicon Valley nephew of mine. So in the case of Nanowear, you know, did you start to think about the problem and how to solve it? Or did you start out with the technology? Which in your case involves a way to embed these tiny nano-pillar sensors into cloth and then look at ways to make it sellable. So which one was it for you?Venk Varadan: Great question, Harry, and again, thanks for having me on the podcast. We were squarely the latter and I think most entrepreneurs are the former. But we had this great advanced material, a cloth based nanotechnology that could pick up really, really high fidelity clinical grade biomarker data off the body. And we didn't really know what to do with it. Do we start as a consumer company? Work on fitness, B2B, sports? Do we think about industrial safety, military use cases? They've been trying to figure out smart textiles forever. Or do we go into health care? And I think stubbornly so, and a little bit of altruism, we chose the harder route, which was health care. But I think it was probably more premised on that we believed in the quality of the sensor. It was doing something from a quality and quantity standpoint that no other on body sensor or non-invasive sensor out there could do, whether it was consumer grade off the shelf or health care based electrodes. So all we really knew when we started is that we wanted to be a health care company, but we didn't know the right application to start with.Harry Glorikian: Yeah, I was going to say, let's, let's pick the hardest one and see if we can get over that hill. So let's back up here and talk about like the medical need you're trying to address. I mean, at a high level, why is portable diagnostic sensing so important for people's health?Venk Varadan: I think it was always important because of an access issue, right? Not everybody can go see a physician or can do high cost diagnostic tests that require a facility or diagnostic tools in person. And there's a cost even to running a blood pressure cuff or checking your heart with a stethoscope or running a hemodynamic monitor, all the way up to more expensive tests like sleep studies and sleep labs. So I think it started, remote diagnostic needs started with an access issue, and it's not like we haven't had telemedicine in the past. But even that was sort of limited due to access issues. You needed a broadband network, you needed particular devices, you needed smartphones, and there were a lot of industry, I guess, pressures holding this sort of need to sort of push health care out into the more wide stream for those that have access issues. And we all said that this was going to happen one day. Virtual care, telemedicine, remote monitoring at home, replacing offices at home. And it was a nice sound bite. And COVID kind of forced the issue and I think completely accelerated that 10 year frame on the need, right? Because folks were still sick. Folks still have chronic disease. Folks still needed acute procedures. But you weren't really able to do a lot before, during and after, if you had to have these people camped out in the hospital or in outpatient clinics or acute surgical centers. So that's when while everybody thought it was cool and one day I'll employ these digital technologies, it really took COVID to shut their business down or they didn't have any patients, to force them to adopt. So I think a lot of our, companies like us, we were all doing the right thing. And we also are the first to admit that we got fortunate that the pandemic sort of accelerated the need for our solutions.Harry Glorikian: Yeah, I mean, I remember I put together, god, it's got to be like 15 plus years ago, I put together a distributed diagnostics conference, because I was like, "This is going to happen." And, well, OK, eventually. But so let's talk about, let's step back for a minute and talk about some of the specific medical conditions where continuous, high resolution, high fidelity data is useful. Like, I know we need to probably start with congestive heart failure.Venk Varadan: Yes, so that's where we actually started before COVID. That was the sort of market need where our technology, our ability to sort of simultaneously and synchronously look at biomarkers from the heart, from the lungs, the upper vascular system in a sort of contiguous way and sort of map the trends over the same period of time as you would with a stethoscope or blood pressure cuff and electrocardiogram or hemodynamic monitor if they were all in one platform. That's really what we're replacing as part of our solution and our device-enabled platform. But the economics of heart failure and the business need were really what was pulling us there in the sense that there were penalties from CMS to avoid that next hospitalization within 30 days. And many of these patients are, one in four are being readmitted within 30 days. One in two are readmitted within six months. So this isn't a problem that we can just medicate our way out of. We have to understand when decompensation of the heart is happening before symptoms show up, because once symptom show up in fluids accumulating in their lungs, it's already too late. So I think there was a good product need for us, as well as the economic need with reimbursement and solutions for something that can be done outside the body that a patient could be be using at home.Venk Varadan: And then I think, you know, COVID hit and the market applications really just exploded beyond heart failure. Heart failure is still on our roadmap. Our clinical study to prove that ALERT algorithm of, we take all these data points, send it into the cloud, do a risk based predictive algorithm to predict worsening heart failure or decompensated heart failure weeks before fluid accumulates in the lungs. That's still firmly on our roadmap. We've just got to restart the study that was halted due to COVID. But the same product that does the same parameters with a different sort of algorithmic use cases opened up a lot of other applications that now have a business need and economic need to use us. So the two that we're starting with is pos-procedural or post-surgical follow up in an acute use case setting. And the second is outpatient cardiology longitudinal care for someone who unfortunately probably has to see a cardiologist for the rest of their life.Harry Glorikian: And if I'm not mistaken, congratulations are in order because of an FDA approval.Venk Varadan: Yes, so we actually got our third 510K just two days ago. September 21st, sorry, September 22nd, we got our third 510K. This is actually an example of our of our first digital-only clearance. So our first two clearances, our first clearance in 2016 was primarily around the advanced material, the nanotechnology, to get FDA comfortable in its safety and efficacy profile. The second was for our product, which is the SimpleSense shoulder sash, which simultaneously and synchronously captures data across the heart, lung and upper vascular system biomarkers, feeds that data through a mobile application and into the cloud. And then this clearance is sort of for an end-to-end digital infrastructure that circularly includes ingestion of our 85 biomarkers and then analytics circularly across our spectrum that continues to sort of process and then has the ability to push insights or algorithmic alerts down. So that last part is not included. But if you think about it, Harry, we kind of had a strategy before we got to the AI part. Now everything we submit with FDA has nothing to do with the device, has nothing to do with software infrastructure, has nothing to do with what would be MDDS or what wouldn't be. We can simply send in statistical analysis on the AI algorithms based on the inputs that we've already cleared and then looking retroactively on the outcomes. So it was it's a nice win for us to kind of show that we're not a device company, we're a device-enabled platform. But I think what it's really exciting the market on is that we're ready for AI diagnostics. We hope to have a first one and our fourth 510K, I guess here with FDA pretty soon in the complex chronic disease state. So really exciting times for us.Harry Glorikian: Yeah. And I mean, as an investor, I mean, I, you know, I've been in diagnostics forever and I, you know, I'm so focused on Where's the data? Show me the exponential nature of the data and then what we can do with it and really like blow that up, right? That's where I see the value in these platforms and technologies. But there are technically other methods that had been used, right, that you might say you might or might not say are competitive in some way. But one of them is called a Holter monitor, right? Which people put on their skin to monitor, you know, electrocardiogram and EKG rhythms outside the hospital. And I don't want to say the name wrong, but I think it's SimpleECG for yours and then the SimpleSense vest, [how does it] compare to that. What are the alternatives? How long do you wear it and how do you compare it to the existing status quo?Venk Varadan: Sure. So, you know, a Holter monitor has a specific use case. It's looking at your electrocardiogram rhythm to see if you have a rhythm or abnormality, right? So we one of the metrics we capture is an electrocardiograph, right, and we do multiple channels of that. So it's not a single lead. So we could certainly compete against that application and just look at rhythm abnormalities in the same way. Companies like iRhythm have that, and Apple Watch has that 30 second feature on it. We are not playing in that space. And the difference between us, even though our signal quality, we would argue, is much cleaner than a Holter monitor that's using standard electrocardiographs, with those you have to shave your chest, you have to stand the dead skin down. You have to put gel on for the electrode to get a conductive signal. We don't have to do any of that because of the nanotechnology. But what the nanotechnology also affords, in addition to a better experience and better quality, is the ability to do more than just a Holter monitor, right? So imagine if that same Holter monitor wasn't just looking at rhythm abnormalities, it was also looking at the acoustics of your heart and your lungs, the sounds of your heart in your lungs. It was looking at the flow characteristics. The blood injection times, the fluid accumulation in your lungs. It was looking at your breathing rate, your breath per minute, your lung capacity, your changes in lung capacity over time, if it was looking at your pressure related issues at the aorta, systolic and diastolic blood pressure. In addition to being a better experience in all of these and sort of kind of replacing a Holter monitor and a stethoscope and what have you, the real value is being able to do all of that at the same period of time over the same period of time. So even if I'm monitoring for, our use cases are about 30 minutes to an hour in the morning, 30 minutes or at night. And because we're getting such dense quality and quantity of data over that time period, we can actually see trends across the cardiopulmonary and upper vascular complex, which is actually the first company and platform that can do that. And that may not have been important before COVID. But COVID, I think, was revelatory in the sense that COVID may have started as a respiratory disease, but it affects the heart. It affects the upper vascular system. You can get a DVT from it. And I think it opened the world's eyes into understanding. We're not looking at all of these systems, the heart-lungs-upper-vascular system that all work together and work uniquely in each of our own bodies. We're only getting a risk based signature on just cardiac rhythm or just breaths per minute or just the sound murmurs of your heart, whereas we're doing it now.Harry Glorikian: Yeah. So for a guy like me, like, I'm like, Oh my god, how do I get one of these? I want one of these right now. I'm thinking like, Oh, I could use it right after I work out. And I'm, you know, forget the I'm sick part of it. I want to use it as a wellness monitoring and sort of to see, get a baseline. Tell me where I'm going, right, over time. That's what I'm always discussing with my my physician is we need a baseline because I don't know how it's going to change over time. If I only look at it at that point in the future, I don't know what it was. So, but the other side, I think to myself, there are physicians listening to this show that are probably all excited about this. And there are physicians going, "That's a lot of different data points. How in the hell am I going to make sense of that?" And so I'm I'm assuming what you're going to tell me is you've got this amazing software that lets you visualize, you know, and make sense of all these different parameters together.Venk Varadan: And that's exactly right. You know, we were actually stubbornly annoying to our KOLs, our clinical teams, as well as our original customers in beta rollouts, because Harry, we agreed with you. We looked at where Gen 1 and Gen 2 sort of digital health companies struggled in health care. Health and wellness is a little bit different right? I mean, to each their own, right. I mean, if you market well, you'll find that pocket of people that want to be overwhelmed with data or what have you. But we really listened to what digital health was doing for the provider and patient relationship. There were some good things there and there were other bad things, and the bad things we realized actually wasn't monolithic between clinics. Some people thought that bad things were "I'm alerted too often." Others wanted to be alerted all the time. Some were like, "This is noisy data. It's too unclean." Others were saying, "I just need, you know, 70 percent C-minus level data," right? And then we were thinking about all of those aspects which we couldn't get consensus on. How do you bring all of those aspects that gives control to the provider so the provider can say, how often are they alerted, how much data and the raw signals do I want to look at, how much do I not want to look at? And really, with the thesis of building the platform on them, spending less time than what they do before? Because I think Gen 1 and Gen 2 products unfortunately actually added more time in adjudication and frequency of the provider being notified, and also cause some anxiety for patients as well because they were looking at their screen and their data at all times.Venk Varadan: So we really tried to be sponges of all of those different devices that were tech enabled and sort of moving from hundred-year-old devices to now Gen 1, Gen 2, pushing into the cloud. And really listened on... And I'll tell you, it was mostly from staff. It wasn't necessarily from the physicians and the surgeons themselves. It was mostly from triage nurse, from health care staff, the people that are running around coordinating the follow up visits, coordinating the phone calls from patients that were doing poorly or feeling bad after feeling sick after a procedure. And I just think we just kept our ears open and didn't go in saying, we know what you need. We were asking, What do you?Harry Glorikian: All right, so let's talk about the technology itself, the  SimpleSense wearable sash. How does the cloth sensor in the garment work? I mean, on a microscopic level, what are the kind of changes that this nano pillar detects and how?Venk Varadan: Yeah, so not to get to sort of, you know, granular into the physics, although I'm happy to Harry, if you if your audience ends up sending me some questions. But think about our ability to just detect a difference in potential action potential from point A to point B. And it's an oversimplified way of describing what we do, but the reason we can do it better than anybody else with any other sensor -- and that's what really feeds the cleanliness and the quality of our data and allows us to derive so many biomarkers that other others can't, which obviously feeds the ability for AI -- is because we've got these billions of vertically standing nano sensors per centimeter of surface area. The differential or the potential difference that we can find because our signal quality so clean is so narrow. Whereas other sensors that might be treated as noise, we can consistently see deltas from point A to point B and know exactly what caused those deltas, right? And that's unique to us and our vector orientation. And it's probably a little too wonky here, but if you have a vector across the largest slice of the heart, across the largest slice of the lungs, across the upper vascular system in its entirety, with that finite ability to get really microscopic level changes in potential, irrespective of what signal you're looking at. Because once you we know what signal we're looking for, we just set the frequency bands for those, right? Right. And that's really, in a nutshell, how it works across the multiple parameters that we can capture from a biomarker standpoint.Harry Glorikian: So you said 85 biomarkers, right? We're not going to go through all of them because we'll be at the end of the show. But what are the kinds of, let's say, physiological data that you're pulling in and that you're differentiating on?Venk Varadan: Sure. So I probably summarize it into several different buckets that each have maybe 20 or 30 derivatives under it. But, you know, cardiopulmonary biomarkers. So the coupling between the cardio and pulmonary complexes, impedance cardiography, thoracic impedance and then looking at not only the means and the median trends across those metrics, but the standard deviation. So one of our board members famously said, Nadim Yared, the CEO of CVRx, You will learn so much more from the standard deviations than you will from the trends. Don't just look at the sort of the trend. So that's an example. Cardiopulmonary: We look at the electrical signals of the cardio complex and electrocardiographs. We look at a combinatorial methodology of cardiographs, acoustics, BMI, height and weight. And then we tie activity, posture, movement. What is your sleep orientation? Are you sleeping on your left side? Are you sleeping on your right side? All of these sort of things together actually enable some really interesting insights from a machine learning standpoint. And again, the beauty of our ability to sort of understand them and see more biomarkers. Eighty-five is where what we know right now, what we've validated. There's probably a lot more that we will discover under certain disease states. But what we're able to sort of mesh together from all of those are really cool aspects like blood ejection times. That's not a physical, raw metric we're getting. That's a derived metric and combining a lot of these aspects cardiac output, stroke volume, you know, these are things that could only have previously been done with an arterial line in your body and in a hospital system. So I don't know if that answers your question.Harry Glorikian: Well, no. I mean, listen, I mean, this is why I invest in this space because, you know, theoretically, as I get older, I may be a patient and you know, the better these technologies get, the better off I'm going to be. But so let's talk about for a second, where did where did this originate from? And I think your dad, your father had something to do with this, if my research is correct.Venk Varadan: He sure did. This may be a little bit of a long winded answer, Harry. But but for your audience, I'll tell the story because it's important for dad to be happy at all times, even though I'm 40 years old. So, Dr. Vijay Vardhan is our co-founder and Chief Innovation Officer. My father, 40 plus year academic researcher in the fields of materials, research and biomedical engineering and this was actually, Nanowear's core technology was actually a culmination of his life's work. Back in the 80s and the 90s when I was still a young pup and he was convincing me to go be a doctor, he was doing research in this field, and it wasn't even called nanotechnology back then. There wasn't a term for it, but he was doing defense related projects in the ability to detect very minute signals at very, very, very, very difficult detect detection environment. So an example is submarine coating, right? Submarines when they're below water are picking up their external environment information through sonar. The deeper they get in the ocean, the harder that sonar frequency is to be able to differentiate. Is that a a school of plankton? Is that a whale? Is that a thermal geyser that's sending me the signal? Or is it a Russian sub, right? And his thesis was, if I have a really big footprint of sensors and exponentially higher surface area of sensors and not just one sensor or two or one hundred but billions across the hull, I can start to differentiate over time the nuanced differences between the sonar a whale emits, the sonar a thermal geyser emits, or oh, by the way, what are our friends in the USSR emitting, right? And that's an example in really, really hard to detect environments. He did the same with observatory jets and missile defense systems at 75,000 feet, you know, the opposite, very high frequencies at very high speeds. So that original thesis, the human body is also a very complex environment and hard to detect environment as well, right? So long story short, he kind of took that same thesis over many years of playing around in the lab and publishing papers and doing great work for our government and our Department of Defense, but also with an eye to the future on what could this do in the human body one day?Harry Glorikian: Right. Well, that's great. I mean, it's I'm sure he's very happy that you two are working together to bring this to market.Venk Varadan: He's not as disappointed in me about not going to med school anymore. Let's put it that way.Harry Glorikian: Yeah. Keeping parents happy is is a is a difficult thing. I know many people are like, Are you going to be a doctor or are you going to be a lawyer? You know, I know the I know the joke. So you've got FDA approval for a number of, as you said, you're building on top of, this layering that you've been doing from an FDA approval standpoint. What did it take to get them to sign off? What sort of evidence did they need to see?Venk Varadan: Yeah, it's a great question. I think that we kind of had to create our own playbook with them. I'm sure if they're listening, they don't want to hear this because you're not supposed to sort of commend and compliment the agency. They're just supposed to be there as sort of the gatekeepers. But we used to hear just a lot of horror stories like, "Oh man, you know, working with the agency, it's really tough. You know, they're really tough on this." I mean, we always looked at them as our partners, you know, we were bringing a novel technology to the world. We chose to go into a regulated environment because we believed in the promise of saving patients. We were not taking a sort of anti-regulation attitude that I can fix this, government get out of my way. I'm a patient first. I like living in a country with FDA where something is scrutinized that I have to take when I'm sick. And I think that attitude and going into it from us as a product and R&D team, first of all, helped in clarifying our understanding of FDA's processes because it's a lot, and you really need to dig through the guidance in that. But I would say this is really hats off, Harry, to our founding engineers. I mean, they went from being engineers to really understanding process, and that's really what FDA is. Our first clients we met with, we went down to Washington 11 times in person to demo to ask questions continuously. And "Hey, we read this part of the guidance. Does this make sense for us?" And we shut up and listened when we didn't agree with them. We said, "But what do you think about this? Doesn't this solve it?" We weren't trying to go around them, and so we were trying to develop sort of new understandings of it.Venk Varadan: And I think collaboratively we put together a good playbook with FDA to clear a material that they had never seen before. Right? It would be one thing if we use the standard electrode like all Holter monitors do and combined it with something, and did different things on the software side. That would be somewhat straightforward because they know the data that's being generated is often the standard electrode. But for us, we had to do a lot of different and in many cases, much more rigorous testing, which that was painful. Don't get me wrong, but totally worth it, right? I mean, our sort of boundaries and our understanding of what FDA put us through, it turned out to be a boon in disguise. I mean, our whole team can sort of run through the needs now of FDA and we feel very experienced and very well equipped on how they think. And now that they're comfortable with the sort of data we capture, all the great things we can do on the AI side, which is still scary to a lot of people. You just say I've got a black box and I'm combing electronic medical records, and here's what the unsupervised learning tells me. I was a regulator. I'd be like, Wow, I'm not touching that with a 10-foot pole, you know? So it's different with us, right? I mean, we can define everything that's coming in and we can define the outputs. Yes, the AI in the middle is the magic, but we're not sort of defining everything until the outcomes, right, which is where I see a lot of companies got into trouble. So I think it was worth it with the FDA.Harry Glorikian: Well it's funny because, I mean, I always say to people, I'm like, Listen, they're not the enemy, actually. They can make your life easier because and I say, people tell me, "Well, I'm not going to go until I'm absolutely done." I'm like, If you wait that long and they tell you you're wrong, you just spent a whole lot of money for "and you're wrong." Right? So you should look at them as your partner. Right. And I'm assuming you went to, you worked with the digital health group at the FDA.Venk Varadan: We worked predominantly, consistently we work with CDRH [the Center for Devices and Radiological Health] and now actually as a as a board member on Advamed, sitting on the executive leadership group for digital health, Advamed is a trade association that helps with FDA and with CMS on on industry innovation. CDRH does have its own sort of digital health group within it that's focused on a lot of these issues that we're talking about A.I., data privacy, cybersecurity, which in this sort of next decade, I think is going to be the main sort of frontier for the industry government relationship that we all sort of signed up for when we decided to go into health care, because even the most sleepy widgets right that we use consistently, they're all tech enabled now. Everything is digital, you know?Harry Glorikian: So yeah, and I mean, they're they've been creating that from the ground up. I remember talking to the the gentleman that runs it and he's like, I feel like I'm running a startup because, right, most of the stuff that we're, you know, we need to figure out has never been done before at the regulatory agency. And so we're sort of creating it from scratch, right? So I mean, in a way that that's good because he understands the pains that the companies are having to go through in creating something that hasn't been done before.[musical interlude]Harry Glorikian: Let's pause the conversation for a minute to talk about one small but important thing you can do, to help keep the podcast going. And that's to make it easier for other listeners discover the show by leaving a rating and a review on Apple Podcasts.All you have to do is open the Apple Podcasts app on your smartphone, search for The Harry Glorikian Show, and scroll down to the Ratings & Reviews section. Tap the stars to rate the show, and then tap the link that says Write a Review to leave your comments. It'll only take a minute, but you'll be doing us a huge favor.And one more thing. If you like the interviews we do here on the show I know you'll   like my new book, The Future You: How Artificial Intelligence Can Help You Get Healthier, Stress Less, and Live Longer.It's a friendly and accessible tour of all the ways today's information technologies are helping us diagnose diseases faster, treat them more precisely, and create personalized diet and exercise programs to prevent them in the first place.The book is now available in Kindle format. Just go to Amazon and search for "The Future You" by Harry Glorikian.And now, back to the show.[musical interlude]Harry Glorikian: So let's go back for a second to, you know, 2020 in the first wave of coronavirus pandemic, right? You partnered with some medical centers in New York and New Jersey to start using it to monitor patients. And what did you learn from those studies and how did the device help improve treatment?Venk Varadan: There were two things I think. One, it was all anybody was talking about, and there were so many unknowns about it that we recognized that this was a, you know, a virus that was affecting the cardiopulmonary complex. Those that were getting sick and we're going to the E.R. had issues there, and that's what we were doing. And so in the same way that we're looking at potential use cases with the ultimate goal of assessing someone's risk, right, which is really what we're what we're doing as a remote diagnostic company or a remote hospital at home patient monitoring company, we went into COVID with that same thesis in doing so. And obviously in our backyard in New York, we got punched in the mouth first in the USA. With that, pretty much everybody I know was infected in March. We were all riding the subway together, you know, up until the last day as sardines. So it was not escapable here. And we're a dense city, right? We all sort of live on top of each other and our hospitals almost in a week. There were patients in the cafeteria. They were we were making tent villages for additional beds in Crown Heights, Brooklyn. It was completely overwhelming. And so we really feel it felt like we wanted to do something about it now. We would have gotten on patients right away, but. We did have to go through the IRB processes, which would take time, unfortunately, but we learned a couple of things and the two things actually that we learned are is that we're not necessarily super helpful in a acute virus that hits you really fast.Venk Varadan: The patients that this is sending to the ICU, it's doing so very quickly. It's rare that someone is sick for three or four weeks. They progress so badly that then they go to the ICU. They have a drop pretty quickly when it happens. So what we found was, our study was really to go on patients while they were in the general ward, and the endpoint would be when they were transferred to the ICU because they had gotten so sick a morbidity event or they were discharged. And I think we were unable, to be candid, we were unable to find the lead up to that point because we just simply didn't know what patients were coming in. I would have loved data on them from 48 hours beforehand. Right? We could have learned so much, even very basic functions that Fitbit and the Apple Watch are trying to market. "I saw a spike in heart rate from the all patients that got infected with COVID 48 hours before." That is the premise of where I would have loved to go with our granular data, but we're not the type of device that somebody just wears at all times, whether they're sick or not, right? So I think that was a learning experience for us that if there's an unknown of when something's going to hit, it'll be challenging. Venk Varadan: For infectious disease that becomes chronic disease, I think we're going to be in much better shape, and I think we could definitely do a longitudinal study for the long hauler community, right> You know, the folks that have been infected with COVID and have literally seen symptoms for a year or two, I think there's a lot we can learn longitudinally from there. And that's really where I think our study with our with our great partners at Maimonides Medical Center in Brooklyn and Hackensack, New Jersey and others across the country would, we would be more than happy to to participate in some of those longitudinal studies because, you know, we don't know what the long hauler is going to look like in five to 10 years, right? Or even people that have been infected before the vaccines now. That's still a let's figure it out type thing. So it's not you have to balance sort of running a sales product business versus a research part, but with the right resources and the right partners we would love to continue that work in COVID because it's not going anywhere as you know.Harry Glorikian: Well, listen, I actually want you to put it into a T-shirt and send me one so that I can wear it and monitor myself. But let's talk about where this technology is going in the future, right? The SimpleSense sash looks, you know, comfortable, convenient, way more comfortable than, say, a Holter monitor. But you'll correct me if I'm wrong, but it's still a specialty device. It isn't made from off the shelf materials, et cetera. But do you think there's like we're moving to a day where you can sort of embed these sensors in, as I said, a T-shirt, familiar cloth items. I'm looking at digital health and saying it has the ability to monitor me and sort of help identify problems before they come up so I can get ahead of them. And so that's how I'm thinking about this technology, because those sensors look pretty small and thin, at least from what I could see visually in the picture.Harry Glorikian: We're the first to say we don't know when we don't know, Harry. I know the market wants you to always have an answer for everything. A lot is going to depend on the additional aspects that we all use in technology stack. Where does 5G take us? Where does increased broadband take us? You know, 10 years ago, we didn't realize everyone in the world would have a smartphone, right? Villages in India and Africa, they have these now, you know what I mean? They may not have running water, but they've got, you know, a Samsung device, right? And so we may have never thought that monitoring in remote places like that because we couldn't find an economic model to sell shirts or bed sheets for a dollar out there. But maybe with the volume and with the right partners, that's where we could go. We certainly built our our stack with that sort of dream in mind. We filed IP and got patents awarded to embed in clothing and bed sheets and upholstery on cars and seatbelts and on the steering wheel and. You know, this could be in the gloves of a pilot one day. You know, this could replace your sort of neurological monitoring. We've got a prototype of a headband that's calculating all your EEG and EOG signals could replace an 18 lead one day. I think when you throw in real good advances in automated supply chain and 3D printing, there's a lot that can be done in this space and it's going to be done through partnership. We're not going to do it all on our own.Harry Glorikian:  No way. I was going to say Venk, get to work, man! What are you doing? Like, you're using this in a in a medical application, but I really want to understand: so especially if, you must have believed in it because you filed the patents, but do you think that this sort of sensor technology could just be a normal part of preventative health care in healthy patients?Venk Varadan: I think that was always the goal, Harry. What can we do to really help a physician provider and ultimately a payer understand someone's risk without them coming in to a hospital or doing a visit? Because really the only people you should be seeing in person are people that need to be seen, not me, for an annual physical. Not you for an annual physical. Not, you know, somebody in the villages in Africa who really just needs to understand why they have a fever, whether there's something really wrong inside them. That's where I think this should go. It always was that case. We never knew what the right problem was to start to build a business around it. But this should replace your your annual physical, your annual checkup for healthy people. This should replace the follow up visit for your post-surgical, whether you get a knee replacement and angioplasty or a stent in your heart and should replace your chronic disease visits. If you have sleep disorder or heart failure where you know, do you really have to go get a $10,000 test every three months to see if you're regressing, improving or if you're staying the same? I think that this can democratize all of that in some way, and it's cloth. We all wear clothes every day, right? So yeah.Harry Glorikian: I mean, I look at I've looked at all these technological advances and I look at them as deflationary in a sense right. We're allowing people to get higher quality care from these technologies because of the information that comes off of it and then utilizing AI and machine learning and, you know, different forms of data analytics to sort of highlight trends and problems or hopefully, no problems, and then if one comes up, it sort of sticks out like a sore thumb, but it gives you a longitudinal view on that patient. And that's where I see all of this going, I mean, COVID has just pulled everything forward a lot faster than. You know, anybody could have guessed, and I agree with you, if you look at 5G and all these things coming together, it's just it's going to take it one more leap forward that much faster. I mean, I can imagine a partner for you would be Apple or Google thinking about, you know, clothing. Or Lululemon, for that matter, I guess. But somebody that that can incorporate this into their into their materials and make it more available. Because I got to believe that there's a consumer application that somebody could take advantage of rather than just a hardcore medical need, if that makes sense.Venk Varadan: No, you're absolutely right, and again, this sort of went through our strategic thinking when we were thinking about what we wanted to be when we grew up. And we think that the our unique cloth nanosensor technology, which good luck trying to replicate and copy that for anybody who's interested, I mean that again, this was 40 years of work that sort of how to create it and we're bulletproof, protected from a from a patent standpoint. But we think this can enable all of those markets. Our thesis was always, Harry, if we could start in health care we'd have the need-to-have population. The people that don't have a choice, right? I mean, I can go out for a jog or I don't need to go out for a jog, right? I can run with a monitor but I don't need to. But there's a good percentage of the population that doesn't have a choice. They must be monitored. If we could start with that, need to have population and prove it, prove that it works, that it's changing outcomes. Why would the nice-to-have market use something that you know, is already working for for sick people, right? And that was kind of always our thesis. We don't really have a timeline on when we're going into the consumer market, but because, you know, there are different aspects that are involved there from a business standpoint, customer acquisition marketing are the obvious ones, but sexiness, fit, we did not focus on "Do we look cool?" We were focusing on, you know, design is important on everything, don't get me wrong, but we first started with "make it work." We didn't start with "It has to be this big" and then figure it out, right? We started the other way around.Harry Glorikian: Well, and if you think about all the existing wearable technologies, they incorporate a sensor that everybody understands very well, right? There's no question that temperature monitoring, there's no question that, you know, if you can have a CGM on you, you can sort of understand what foods affect you positively or negatively. You're right. We need the scientific publication to prove that the technology that you built does what it needs to do, and it's probably all the time going to give you new information. You're going to be like, I didn't know we could figure that out, right? Which is the beauty of having 85 biomarkers. You're going to find something new all the time, but you could easily see that certain applications would then become accepted and then make its way into mainstream.Harry Glorikian: Yeah, absolutely. And I think the more that folks are using and the cool thing or not, maybe not cool, maybe it bothers some people, I'm sure, but technology goes one way. It does not go backwards, right? And COVID sort of shifting virtual care into the forefront, which is what technophiles did before. "Oh, I just talked to my doctor on the phone." I would have laughed. I was like, What can they do with that right before I started Nanowear, right? But that's not going back right. If you don't have to go see your position in person and you've got an alternative now that replaces it, why wouldn't you do that right? So. Yeah, I think as people get more accustomed with devices, they'll understand how to differentiate from them. You know, I'm not taking shots at our friends in Cupertino, but there's only so much you can do on the wrist, righHarry Glorikian: Absolutely.Venk Varadan: If you're not going across the heart, across the lungs, across the brain, you're going to be limited in what you can do if you just have an armband device that's picking up your pulse rate and your skin temperature, you're limited in what you can do, right? So I think what we're excited about, maybe not just on this form factor in this product, but understanding its application around the body. You can't put a smartwatch around your body, but you can put a cloth around your body. You can put a sheet around your body, right? I think that hopefully the understanding is going to come that there is a delineation between something that's great for the consumer and something that's great for, you know, the health care population. And where does that nexus come together? I think that's going to be driven by patients. I don't think it's going to be driven by us. I don't think it's going to be driven by the provider or the payer. I think the patients are going to demand, you know, as they are doing now, right? I mean, the reason providers are buying our solution right now is because the patients are demanding it right. The payers are kind of demanding it. To some extent, cardiologists would love to see 40 patients a day in their office again. They were really used to that, right?Harry Glorikian: Yeah. This is a longer debate over a beer at some point.Venk Varadan: It is Friday!Harry Glorikian: Listen, it was great to talk to you. Healthy congratulations on the on the latest approval and look forward to seeing other approvals as as you're taking this thing forward. And you know, I can only wish you great success. I mean, obviously since I'm an investor, I have a soft spot in my heart for every entrepreneur out there.Venk Varadan: Thank you, Harry, and thank you for the opportunity to spend some time with you and and your audience. Hopefully, it's the first of many and I can come back and give an update in a year or so. And hopefully by then, it's not just about FDA approvals, but I'm showing we really built sales here because I know investors care about that. Just selling our product in the enterprise for the first time this month in September, and early numbers are great. So it's a really exciting time. I think six and a half years into the journey and being able to do it starting with dad has been pretty special. So so thanks for having us and appreciate you following our progress going forward. Harry Glorikian: Excellent.Thanks for participating.Venk Varadan: Thanks, Harry.Harry Glorikian: That's it for this week's episode. You can find past episodes of The Harry Glorikian Show and MoneyBall Medicine at my website, glorikian.com, under the tab Podcasts.Don't forget to go to Apple Podcasts to leave a rating and review for the show.You can find me on Twitter at hglorikian. And we always love it when listeners post about the show there, or on other social media. Thanks for listening, stay healthy, and be sure to tune in two weeks from now for our next interview. 

Nadim Yared, President and CEO of medical technology startup CVRx recently joined AdvaMed's Scott Whitaker on the Medtech POV Podcast to discuss his expansive career in medtech – from engineer to CEO – and how his work to improve communication between the Food & Drug Administration and the medtech industry has vastly changed over the years.

Nadim Yared is a medtech CEO who is not afraid of digging into the details—the regulatory details; the nooks and crannies of Medicare coverage, coding, and payment; the finer-points of p-values and novel clinical trial designs. He has dug in deep on these matters and more during his 15 years at the helm of CVRx Inc., which as recently transitioned to a commercial phase, public company with its Barostim Neo heart failure device. And he has also done so as part of his very active role in cross-industry endeavors on the boards of AdvaMed, the Medical Device Innovation Consortium, and, most recently, the CRO NAMSA, where is currently the board chair. In this conversation, Yared talks about the evolution and what to look for next at FDA, CMS, and in the clinical research realm. One update note: During the interview, Yared discusses the Medicare Coverage of Innovative Technology (MCIT) program at CMS. After the conversation took place, CMS issued a proposed rule to repeal MCIT before it takes effect in December and the agency stated plans to pursue new rulemaking. In a follow-up phone call with Market Pathways, Yared called this a “stunning reversal” from CMS. View Market Pathways' updated insights on MCIT and what's to come at CMS: https://bit.ly/3i1SiEj View our recent feature article on CVRx's reimbursement strategy: https://bit.ly/3zCrhx8 View the latest issue of Market Pathways: https://bit.ly/2UEqmO9 About Market Pathways Your premium guide to global medical device regulation, reimbursement and policy. Market Pathways delivers incomparable intelligence exploring the people, challenges, and opportunities impacting the global medtech regulatory and reimbursement community. View the latest issue of Market Pathways on MyStrategist.com

On the podcast this week is Dr Jonathan Sackier, MB, ChB, FRCS, FACS who is an internationally renowned surgeon, technology innovator and entrepreneur. Trained in Britain as a surgeon and recruited to the USA in 1989 he helped lead the laparoscopic surgery revolution. As a Professor at George Washington University in Washington, DC, he founded, and funded the Washington Institute of Surgical Endoscopy, a center for education, research & innovation. He is a Visiting Professor of Medicine & Surgery at the University of Virginia and his activities in basic and clinical research funded by multiple grants have led to many publications, chapters and books. He has served multiple journals as editor or reviewer, has been involved in medical societies at the highest level and has been honored for his work in many countries. Jonathan's collaborations with the pharmaceutical and medical device industry have resulted in technologies that have been brought to market with partners like Valleylab, Pfizer, Karl Storz, Applied Medical and Pall. In 1984 his team at Genethics discovered and patented a line of amniotic stem cells and then licensed the rights to a publicly traded British drug discovery company. He helped develop and bring to market the AESOP robot with Computer Motion, who had a successful IPO in 1997 and has also started a medical products contract sales organization, a locum medical agency and a communications company. He has consulted to many companies including Aventis, Cook, Integra Neurosciences, Bayer, Cryocath, Novartis and ConvaTec and has worked with the financial community on enterprise financing, mergers & acquisitions and due diligence. A frequent commentator in the media, Jonathan has been a guest on radio and television many times to discuss various healthcare issues. In the mid-1990's he hosted a television health magazine program “Health and Wellness” aimed at a senior audience for the Goodlife Cable TV network and served the communications company Spotlight Health with their celebrity featured outreach including the hugely successful Carnie Wilson web-cast which drove increased attention to bariatric surgery as an option for the management of morbid obesity. Jonathan has served the National Committee of the Steppenwolf Foundation, is a Trustee of the First Star Foundation, the Virginia Hillel Board and previously chaired the Board of the Larry King Cardiac Foundation. He has sat on the Associate Board of AdvaMed (the medical device industry trade association) and on several corporate and scientific advisory boards.

Nelson Mandela's granddaughter, South African writer, and activist, Zoleka Mandela, has joined the humanitarian organization, Global Access to Cancer Care Foundation (GACCF) as an Ambassador to raise awareness about lifesaving global cancer education and treatment programs. Two-time cancer survivor, Zoleka promotes GACCF's work in low and middle-income countries (LMICs) and educates the public about GACCF's mission to educate medical specialists who work in the oncology field.              Tonya Steiner is Executive Director of GACCF. Prior to joining GACCF, Steiner worked for AdvaMed, the Advanced Medical Technology Association, where she served as Director of Strategic Partnerships overseeing revenue generation and strategy for the organization's conferences and educational events. In her role, Steiner leads efforts to build lasting relationships with key supporters, identify and recruit new sponsors and funding sources, manage sales and revenue as well as strategic planning for future growth. Tonya also served as the Director of Sales for HR Tech software in New York City and Director of Customer Services at DEI, an online education company. After receiving her B.A. in Communications and Business, Steiner remains stay active in the University of Colorado Soccer and Crew programs. She has lived and worked around the world supporting innovative technologies for health and child welfare. She has held numerous leadership and mentorship positions both locally and internationally for health, wellness and youth charities. Tonya is passionate about reducing the education gaps in radiation therapy and increasing resources to provide effective treatment solutions. We'll speak with Tonya, but won't mind if Zoleka Mandela calls in too! Learn more! https://globalaccf.org/