Podcasts about vascular solutions

In this episode of the Global Medical Device Podcast, host Etienne Nichols engages with Howard Root, former CEO of Vascular Solutions and author of "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed's Hit List," and Mark Duval, President and CEO of DuVal & Associates. The episode delves into the harrowing experiences of navigating severe legal battles over off-label promotions, highlighting crucial insights into maintaining innovation while managing legal risks in the MedTech field. Additionally, Mark DuVal, a noted regulatory attorney, provides his expertise on the responsible corporate officer doctrine and its implications for industry executives.Key Timestamps:[00:00:15] - Introduction by Etienne Nichols.[00:01:30] - Howard Root's background and the origins of Vascular Solutions.[00:05:00] - Mark DuVal introduces Howard Root, detailing his legal battles.[00:10:00] - Howard Root discusses the intricacies of his federal indictment and the subsequent trial.[00:30:00] - Discussion on corporate responsibility and regulatory implications in the MedTech industry.[00:50:00] - Audience Q&A session with Howard Root and Mark DuVal.[01:10:00] - Closing remarks and takeaways.Quotes:Howard Root: "We're not imposing rules at the bare legal minimum...we want to have a gray area. It's why you drive 55 in a 60 zone."Mark DuVal: "Always be truthful, fairly balanced, and not misleading when discussing device applications."Takeaways:Latest MedTech Trends:Increased scrutiny on off-label promotions highlights the need for clear regulatory strategies.Growing legal precedents emphasize the importance of corporate responsibility at all levels of operation.The role of ethical practices in sustaining innovation within the MedTech industry.Practical Tips for MedTech Professionals:Ensure thorough understanding and compliance with FDA guidelines and local regulations.Implement robust training and compliance programs for all staff, particularly in sales and marketing.Engage experienced legal counsel to navigate complex regulatory landscapes.Future Predictions in MedTech:Enhanced regulatory frameworks to better define and manage off-label use.Greater use of AI and data analytics to monitor compliance and ethical practices.Increased advocacy for legislative changes to protect innovators from aggressive legal challenges.References:Howard Root's book, "Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Fed's Hit List"Mark DuVal on LinkedInDuVal & Associates Client AlertsFDA guidelines on off-label promotions

In this episode, The Mentors Radio host Tom Loarie talks with Howard Root, founder and CEO of Vascular Solutions, and author of the book “Cardiac Arrest: Five heart-stopping years on the Fed's Hit List”. Root shares his harrowing fight—and win—against Federal Department of Justice prosecutors who abused their power beyond all imagination. That was in 2011! The Feds' unsuccessful attempt to put Root behind bars and destroy his company was ruthless. They used the justice system to distort justice and abuse individual liberties guaranteed by the Constitution. Five years later, in 2016, after shelling out $25 million in legal costs, Howard Root won a UNANIMOUS acquittal. Even more disturbing than these five years of unwarranted persecution by the Federal Department of Justice, the jurors expressed shock and outrage that these charges were ever filed against Root in the first place! After the grueling journey and ultimate victory against the Feds, Root knew the Feds could target his company again, repeat their horrific injustices and violations of Constitutional rights and he did not want to jeopardize his company or its employees. He sold the company—which, at that time, was one of the most innovative and prolific medical device companies of its kind, and pursues other interests. He also helps other CEOs unjustly targeted and pursued by the Feds whenever asked for advice. This is a modern day David beats Goliath story, and it could affect you! Now more than ever. Learn what you can do to protect yourself and your company. Find Show Notes below. Never miss an episode; subscribe here to The Mentors Radio podcast. Listen on any platform - Apple, Google, Spotify, TuneIn and more - search for "THE Mentors Radio" SHOW NOTES: HOWARD ROOT: BIO: http://www.howardroot.com/ WEBSITE: HowardRoot.com BOOK: Cardiac Arrest: Five Heart-stopping Years as CEO on the Fed's Hit List , by Howard Root LETTER: HOWARD ROOT: A LETTER TO MY PROSECUTORS - Sent on fifth anniversary (Feb.26, 2021) of Root's court victory and an EXCELLENT read! ARTICLES: "Book Review: Cardiac Arrest — A Warning to Aspiring Entrepreneurs and Society at Large"  – Catholic Business Journal “Medtech CEO rails against DOJ at industry conference”  – Med City News

In this episode of The Mentors Radio, host Tom Loarie and mentor Howard Root, former CEO of Vascular Solutions and author of “Cardiac Arrest: Five heart-stopping years on the Fed's Hit List” , deliver a riveting interview. Hang on to your seat as you learns about Root's harrowing fight—and win—against Federal Department of Justice prosecutors who abused their power beyond all imagining.... and based on, literally, nothing. No evidence. No case based in facts. No nothing! The Feds used bully tactics, threats and more, frustrated and trying to "justify" what became a massive, costly "hunt" for something that did not exist. The Feds trampled over individual liberties guaranteed by the Constitution. Five years after $30 million in legal costs and a UNANIMOUS acquital, jurors said they were concerned that these charges were ever filed. This is a modern day David beats Goliath story, and it could affect you! Learn what you can do to protect yourself and your company. Find Show Notes here. Never miss an episode of THE Mentors Radio --available on EVERY podcast platform -- by subscribing here to podcast (free).

You and I in a series of getting and staying healthyAdvanced Vascular Solutions Phone: (772) 581-8900Email: jad@avsmedicalgroup.comAddress: 13100 US Highway 1 Sebastian, FL 32958 Find us on FACEBOOK  Our  mission:To provide quality arterial, venous, and wound care to all its patients while ever striving for the efficiency of healthcare within our own business and beyond.Dr. Shalhoub, D.O., FACOS BOARD CERTIFIED VASCULAR & GENERAL SURGERY“I love it when I have patients come back to me and express how their lives have greatly improved from the result of the work that we do.”Jennifer Lang, PA-C PHYSICIAN ASSISTANT“Being a PA is about touching patients' lives, and I find it very fulfilling. The greatest reward is when the patient says thank you!”https://www.facebook.com/AdvancedVascularSolutions/https://avsmedicalgroup.com/YOUR VISION IS OUR FOCUS Exceptional eye care in a professional, caring, & friendly environment. C.J. Cannon's Restaurant Located at the Vero Beach Airport, where the only thing we overlook is the runway!

Dr. Gershony was the Founder of Vascular Solutions, Inc. (Minneapolis, MN), which had a successful IPO in 2000, and for which he served as Chief Medical Officer and a member of the Board of Directors from 1996-2002. Dr. Gershony was the principal inventor of the DuettTM Vascular Sealing Device manufactured by Vascular Solutions. Dr. Gershony was also the Co-Founder and Chief Medical Officer of AngioScore, Inc. (Fremont, CA), a medical device company devoted to developing unique angioplasty scoring balloon catheters to address a variety of important clinical needs during coronary and peripheral interventional procedures. He was a member of the senior management team from 2003 until AngioScore’s successful acquisition in 2014. Dr. Gershony has served on the adjunct faculty of the Stanford Biodesign Innovation Program. He also completed an Executive Program in finance and accounting (FANFE) at the Stanford Graduate School of Business in 2007. Dr. Gershony is the author of 10 issued medical device patents. He has been a member of the scientific advisory board or a consultant to numerous medical device companies and venture capitalists in the Bay Area and elsewhere. Dr. Gershony is an active early-stage MedTech company investor and mentor, a member of Life Science Angels Medical Device and Digital Health Committee, and a member of the Band of Angels.

On this show guest mentor Howard Root, healthcare founder and CEO of Vascular Solutions and author of “Cardiac Arrest: Five heart-stopping years on the Fed's Hit List” , shares with host Tom Loarie an insider's view of his harrowing fight—and win—against Federal Department of Justice prosecutors. Root faced Department of Justice prosecutors who abused their power in their unsuccessful attempt to put him behind bars and destroy his company. They used the justice system to distort justice and abuse individual liberties guaranteed by the Constitution. Five years after $30 million in legal costs and a UNANIMOUS acquital, jurors said they were concerned that these charges were ever filed. This is a modern day David beats Goliath story, and it could affect you! Learn what you can do to protect yourself and your company. Find Show Notes here. Episode link will be posted after its airing Saturday morning. Never miss an episode by subscribing here to podcast (free).

We are excited to have Howard Root, founder of Vascular Solutions and author of Cardiac Arrest on our show. Howard’s story is incredible. He founded Vascular Solutions in 1997, took it public in 2000, and then sold it for $1 billion to Teleflex in 2017. Howard Root is most known for his recent five-year battle with the Department of Justice. After a lying whistleblower went to the DOJ with a false story about Vascular Solution, Howard ended up spending $25 million on 121 lawyers to stay out of prison.    More Notes: Read Howard Root’s book, Cardiac Arrest Some advice: No matter your innocence, ask to speak to your lawyer before dealing with prosecutors. 40:35 – Quick fire questions. THIS WEEK: Work on the way you speak. Find videos online to provide guidance; complete some speaking exercises.

When the feds thought Vascular Solutions would be a good target for a fraud investigation, CEO Howard Root thought it was merely a shakedown. He was wrong. Howard Root is author of Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds' Hit-List. See acast.com/privacy for privacy and opt-out information.

It’s a dangerous trend—federal prosecutors have the power and authority to destroy a person’s company and reputation, but are falsely accusing innocent people of crimes they didn’t commit. To discuss growing concerns of “over-criminalization,” prosecutorial misconduct and the overall lack of accountability in the system, we’re joined by Cyril H. Wecht, M.D., J.D., an expert in forensic medicine and practicing forensic pathologist for the past 40 years, and Howard Root, retired CEO of Vascular Solutions, Inc., and author of the book, “Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List.”

Howard Root started Vascular Solutions, a medical device company, from scratch. Fifteen years later, his Minnesota company had created over 500 American jobs and developed more than 50 new medical devices that saved and improved lives.But in 2011, the federal government accused Howard of marketing medical devices for unapproved uses – a practice prohibited by the FDA. Howard professed his innocence from the beginning but, when prosecutors set their sights on Howard and his company, there was no guarantee that he would save his company from closing or himself from prison.5 years, 121 attorneys, and $25 million in legal fees later, his life’s work and freedom rested in the hands of 12 strangers in a San Antonio jury room. Would Howard and his company be vindicated by the verdict, or had he made the biggest mistake of his life by challenging the federal government?Featuring:- Howard Root, Former CEO of Vascular Solutions, Inc.Visit our website – https://RegProject.org – to learn more, view all of our content, and connect with us on social media.

In the last year, the Department of Justice lost three major cases against Fed Ex, Vascular Solutions and Warner Chilcott. Critics argue that each case was an example of over-enforcement by DOJ and overcriminalization by Congress. Proponents assert that it is a critical role of government to police and dissuade bad acts by private citizens and corporations. Are there too many federal agencies, giving prosecutors too much power over individuals and corporations? Is it good policy to prosecute individual employees of a corporation, as suggested in the Yates memorandum? Panelists, including lawyers in each of these three cases, will discuss the limits of federal criminal law and prosecutions. -- This panel was held on December 8, 2016, at the National Press Club in Washington, DC. -- Speakers: Cristina C. Arguedas, Partner, Arguedas, Cassman & Headley LLP; Leslie R. Caldwell, Assistant Attorney General for the Criminal Division, The United States Department of Justice; Ben Hatch, Partner, McGuireWoods; John Richter, Partner, King & Spalding; and Joseph Savage, Partner, Goodwin Proctor. Moderator: Stuart S. Taylor, Contributing Editor, National Journal.

For as long as I can remember, at every company meeting I’ve ever been to, the topic of off-label promotion is always covered. Whether it was new-hire orientation, a national sales meeting, or some other large commercial event, the dissemination of off-label information was always presented as not only a fireable offense, but something that could get you...[read more]Related StoriesHow Will These 2 Major Healthcare Changes Affect Medical Device Companies?Substantial and Sustainable – 2 Words That Medtech Companies Should Get Used ToSocial Media Best Practices for Marketing Medical Devices

After five years and $25 million, Vascular Solutions CEO Howard Root watched a jury confirm what he knew all along. His company had done nothing wrong. In this interview, Root and Mark Duval, who is advising companies in this area but didn’t work with Vascular Solutions, explain what all this means for Medtech executives.

A recent jury decision cleared Vascular Solutions of charges of improper off-label marketing. Former Acclarent CEO Bill Facteau discusses his indictment in a similar case, the coming court case, and the support he has received.