DeviceTalks Podcast Network

In this week’s DeviceTalks Weekly, we’ll examine how governmental effort, both foreign and domestic, are hitting the medtech industry. Our guests include Tracy Eberly, CEO of Fang Consulting, a regulatory advisory group. Eberly will update listeners on what pushing back the MDR deadline could mean for medtech companies and why some companies may be less than thrilled with the decision. In our second conversation, Joy Sturm, procurement expert and partner at the DC office of Law Firm Hogan Lovells, walks us through the powers contained within the Defense Production Act invoked last week by the Trump administration. Sturm, who brings 20-years of governmental purchasing experience to the conversation, answer several key questions including: What CAN and CAN’T the government do under the act? Which federal agencies are responsible for executing the DPA? Can companies secure capital to pay for DPA-supported efforts? What player is missing on the field in the battle against COVID-19? Also, AdvaMed is also looking for direction from the Federal government. You may be surprised by the potential source of leadership. Finally, MassDevice Honcho Chris Newmarker talks DYI ventilators. Check out Mass Device's Sean Whooley's feature here. And what does the FDA say about these projects?

In this week’s DeviceTalks Weekly Podcast, hosts Tom Salemi and Chris Newmarker will detail medtech’s essential role in the escalating war against COVID-19. This week’s guests are Fluidda CEO Jan De Backer and Kevin Thornal, division president of diagnostic solutions at Hologic. The executive will explain how their new FDA tools will aid against the diagnosis and treatment of COVID-19. We also ask them how the recently invoked Defense Production Act will impact medtech’s fight against the pandemic.

Welcome to the DeviceTalks Weekly Podcast, a regular – and sometimes irregular – opportunity to visit with the editorial team at MassDevice and Medical Design and Outsourcing. This week, Chris Newmarker, Executive Editor, Life Sciences, at WTWH Media, reviews our COVID-19 coverage with Tom Salemi, Editorial Director, DeviceTalks. Tom also chats with Raj Denhoy, Managing Director, Equity Research Analyst at Jefferies, who details how the Medtech sector is fairing in this unprecedented uncertainty. While most Medtechs stand on strong financial footing, Denhoy issues a warning to investors that another correction may be coming once analysts start assessing the impact on earnings. Still, he says there are safe havens out there and identifies one in the podcast. Finally, Tom and Chris explore what impact social distancing may have on medtech in the short-term – sales and deals - and long-term – innovation.

Gary Guthart, the longtime CEO of Intuitive Surgical, tells MassDevice.com Executive Editor Brad Perriello why he's so confident about staying on top of the robot-assisted surgery heap, the company's five buckets for in-house R&D; and what he looks for in potential business partners.

DeviceTalks goes inside the union of two of the most innovative companies in the world, Google and Johnson and Johnson as they look to change the face of surgery. In this episode, we chat with Scott Huennekens, President and CEO, Verb Surgical, the robotic surgery platform spinout from Google and JNJ. Huennekens shares with us the mission of Verb, insights from his career in medical startups and why he thinks robots will be performing surgery in 50 years.

There's an old saying that Ginger Rogers did everything Fred Astaire did but she did it backwards and in high heels. For Nancy Briefs, Deborah DiSanzo and Martha Shadan, it's also a challenge they know well. These CEOs and medtech veterans have made the journey from the ranks of the medtech industry to the corner office, making them, sadly, a rarity in this industry where just 1 out of 7 women in medicine hold senior executive positions. In this panel, recorded live at our DeviceTalks Boston event features remarks from DiSanzo, IBM Watson General Manager, Ms. Briefs, CEO, InfoBionic and Ms. Shadan, CEO, Rotation Medical.

Bill Carpou took over at OCTANe 18 months ago with the mission to increase Orange County, California's image as a technology super hub. Through programs like the Medical Device Investor Forum and a new emphasis on helping local companies stay in the area, OCTANe is one of the most innovative industry council's in the medical device space. We talked to Bill about OCTANe's upcoming event, as well as its recent merger with the Orange County Technology Alliance.

Jeff Burbank started NxStage Medical in 1999 on the premise that patients with chronic kidney disease would benefit from bringing hemodialysis out of the clinic and into their homes. Now, 17 years later Burbank's hypothesis has been proven out and his Lawrence, Mass.-based company is topping more than $300 million in annual sales, while making a real difference in the lives of patients. In this interview, recorded at DeviceTalks Boston on September 28, 2016, we sit down with Jeff to discuss his business journey.

When Jeffery McCaulley took the reigns at Smiths Medical, the company was in a slump. Several years of flat growth and a potential merger that didn’t go through, had sapped the winning spirit of the Twin Cities, Minn.- based company. However, with McCaulley’s arrival, came a renewed sense of what was possible for Smiths Medical. The medtech veteran employed several new initiatives, honed at companies like GE to rebuild the company’s culture and move it back on a path to growth. In this podcast, we discuss McCaulley’s playbook when it comes to fostering a winning culture in the medical device industry.

This interview, recorded live on June 6, 2016 in St. Paul, Minn. at DeviceTalks Minnesota, is one of the funniest, most enlightening and interesting discussions we've ever had at DeviceTalks. Teleflex CEO Benson Smith takes us through his career from door-to-door salesman to CEO of 1 of the top performing medical device companies in the past five years. Listen all the way to the end to hear an unforgettable tale of going all out to get the job.

Dr. Paul Walker speaks to MassDevice about his efforts to take on endotoxins and sepsis at the head of Spectral Medical, his history with the deadly condition and what’s next for the burgeoning Canadian medical device firm.

Innovative Trauma Care, a San Antonio, TX-based startup, has found a new way to stop the bleeding. The company's flagship product, the iTClamp is a hemorrhage control device for use in the extremities, scalp and neck. The device, which looks like a hair clip, seals the edges of a wound closed to stop further blood loss until the wound can be surgically repaired. We spoke to CEO Joe Brennan about the device and how it can help improve survival rates in trauma incidents.

Novocure, the St. Helier, Jersey-based medical device company, which raised more than $158M in an IPO last year, is trying to change the way we fight cancer. Company officials say its proprietary tumor treating fields technology, marketed under the product name Optune, are a new tool in the war against some of the deadliest forms of cancer. MassDevice publisher Brian Johnson recently caught up with Doyle to discuss the technology, the company's origins and how its current concentration on glioblastoma is just the beginning.

Patrick Daly, CEO, Cohera Medical talks to MassDevice Executive Editor, Brad Perriello about starting up the absorbable surgical adhesives and sealants company, how he raised one of the largest seed rounds in history and why he's moving the company to Raleigh, NC. This episode was recorded on February 29, 2016 at DeviceTalks Raleigh.

On this episode of DeviceTalks we dive into life in the corner office with Bill Hawkins, former CEO of Medtronic and chairman of Immucor. Hawkins shares his experiences on the front lines of medicine where he has spent 25 years leading companies as diverse as start ups to the world's largest medical device company.

Martin Fitchet is responsible for R&D at JNJ's medical device unit, a tall task for anyone but appropriate for this former surgeon. In this episode of DeviceTalks, we talk about what innovation means to a behemoth like JNJ and what areas he sees in medicine that are ripe for disruption.

Clostridium difficile or C. diff. is a growing crisis in the U.S. with over 29,000 deaths and 500,000 cases annually, according to the CDC. The disease, which CDC officials warned can kill people in less than 30 days, is characterized by severe diarrhea, fever, and loss of appetite. Sadly, many elderly and infirmed patients are among the most vulnerable. Roseville, Minn.-based Rebiotix is one of a handful of companies looking to harness the human microbiome into a treatment for recurrent C. diff, which impacts about 20-30% of patients, where there are currently no approved drugs to treat patients with two or more recurrences. Rebiotix is currently in Phase 2 clinical trials for the treatment, which harnesses gut microbiota and turns them into therapies. The company hopes recurrent C. diff is just the 1st in a pipeline of treatments than can be derived from the microbiome. On this episode of DeviceTalks we discuss C.diff with Reviotix CEO Lee Jones. What personal stories led her to this mission; How powerful the human microbiome will be in the future of combating disease and the differences between running a medtech company and a biotech company.

For a man who took a private company from $17 million in sales to a $4.5 billion publicly traded juggernaut, John Brown is a remarkably humble man. However, he is, by all intents and purposes, the man who put Stryker on the map. Today, the Kalamazoo, Mich.-based medical device company nets nearly $10 billion in annual sales. In this episode of DeviceTalks, recorded at the recent AdvaMed 2015 conference, Brown spoke to us about how he built such impressive results during his tenure at Stryker, including the lessons he learned along the way.

Big things sometimes come in small packages. For Sirtex Medical, the big thing comes in a really small package. The Australian medical device company’s flagship product - the SIR-sphere - is made up of 30 to 60 million microspheres about the size of a grain of sand, which are injected into the hepatic artery and flow into the liver where they kill tumors from the inside. In this episode of DeviceTalks, MassDevice.com publisher Brian Johnson talks with Mangano about the company, the learning curve he had of moving from a traditional medical device company to an oncology company and why the cancer market may be ripe for other medtech companies to enter.

Colon cancer is one of the most preventable cancers, yet it is also one of the deadliest forms of the disease. In this episode, we speak with Graham Lidgard, the Chief Science Officer, Senior Vice President of Research and Development at Exact Sciences, a Wisc. -based company that has developed a non invasive test to detect colorectal cancer without having to undergo a colonoscopy. We talk to Graham about the Cologuard test and his 40 year career developing breakthrough medical technology.

Before Stephen Ubl departed for a job as the chief lobbyist for the pharmaceutical industry, medtech's main man in Washington D.C. sat down with us to reflect on his time as CEO of AdvaMed. In this episode of DeviceTalks, we go deep into Ubl's background, the fights over the medical device tax, forging a new partnership with the FDA and more.

Marie Johnson turned tragedy into a mission. In 2002, the CEO of Aum Cardiovascular lost her husband to a sudden heart attack, despite the fact that he was, by all accounts, a perfectly healthy man. Fast forward 13 years and her company has commercialized a non-invasive test designed to quickly detect significant coronary stenosis called the CADence. Johnson hopes the pre FDA-approved device, which is on the market in Germany, will eliminate needless death due to coronary artery disease. In this interview, recorded live at our DeviceTalks Minnesota event, touches on Johnson's incredible story.

Dr. Manny Villafana is one of the most successful men in the history of medical innovation, having founded four companies, including CPI/Guidant Corp. and St. Jude Medical, Inc. His most recent venture, Kips Bay Medical was supposed to be his best work yet. However, problems with the FDA and shortfalls on funding doomed the company, which shut down in September 2015. Recorded live on September 23rd at DeviceTalks Minnesota, just one day after he resigned as CEO of Kips Bay Medical, we discuss failure with Dr. Villafana. How does someone who has had so much success deal with the opposite? What comes next for this serial entrepreneur?

Stephen Marsh has more than 70 patents to his name but his most recent endeavor, the Airing device, may make him a household name. The Airing is a hoseless, maskless, disposable micro CPAP machine, which could one day change the game in sleep apnea. However, Marsh and company have already made quite the mark on medtech by running one of the most successful crowdfunding campaigns ever. The company has raised more than $1 million on Indiegogo, more than 10 times its initial goal. In this episode of DeviceTalks, we talk to Marsh about the Airing device, inventing technology that sticks and how the company pulled off such a successful crowd funding campaign.

Ten years after it was spun out of MIT, Invivo Thereapeutics and its neuro scaffold treatment for traumatic spinal cord injuries is moving closer to a reality. The company has completed enrollment of its 5 patient pilot study, which has made headlines around the world and is looking to push forward on adding more patients. In this episode of DeviceTalks, we talk to new CEO Mark Perrin about the company and why there has been so little movement in the fight against paralysis.

In this episode of DeviceTalks, recorded live at our DeviceTalks Boston event at Boston Scientific's corporate headquarters, we sit down with CEO Mike Mahoney to discuss the company's recent turnaround. Mahoney, who joined the company as its CEO in 2012, sat down with MassDevice's Brian Johnson to take us inside how the company has improved its performance.

Reshape Medical recently received FDA approval for its Duo balloon system for obesity. The company bills the device as an alternative to bariatric surgery for the majority of patients suffering from this global epidemic. In this episode we dig into the obesity epidemic and how ReShape Medical is looking to change the paradigm of care for patients needing to lose a significant amount of weight.

In this episode we catch up with LifeScience Alley CEO Shaye Mandle about doing business in Minnesota's world class medical device cluster. We delve into why the medical device and life sciences community clustered in the Twin Cities, what trends are developing in funding, m&a and technology in the area and, of course, where to go for a power breakfast in the area.

In this episode of DeviceTalks, we delve deeply into emotion and how teaching computers to recognize emotions led to a potentially major breakthrough in medical technology with MIT scientist and entrepreneur Rosalind Picard. Listen to hear the backstory behind her book Affective Computing, her work with artificial intelligence and pioneering wearable technology.

Rotation Medical is changing the game when it comes to treating rotator cuff disease, one of the most prevalent orthopedic conditions that people suffer from. We talk to CEO Martha Shadan about Rotation Medical's revolutionary biologic treatment and how the orthopedic world is changing.

Tal Medical's roots go back to a serendipitous discovery at McLean Hospital where patients suffering from bi-polar disorder reported feeling better after MRI. In this episode of DeviceTalks, Jan Skvarka, CEO, Tal Medical tells us about how that discovery could one day lead to a new clinical pathway for care for patients suffering from acute depression.

In this DeviceTalks podcast, we talk with Merit Medical founder and CEO Fred Lampropoulos about starting the Utah-based medical device company, his thoughts on leadership and his experience as a musician opening for The Doors and The Beach Boys.

Medtech entrepreneur, patient safety advocate Joe Kiani, CEO, Masimo Corp. talks about building the company from scratch. In addition, he discusses his mission as the founder of the Patient Safety Movement Foundation, recorded at DeviceTalks West on November 19, 2014. Also featured, B. Braun CEO Carroll Neubauer.

MassDevice publisher Brian Johnson interviews Caroll Neubauer, CEO, B. Braun Medical about the medical device tax, Obamacare, patient safety and the current state of the medical device industry.

One day, Second Sight Medical CEO Robert Greenberg, may be considered one of the most important figures in the fight against blindness. On this episode of DeviceTalks, he discusses the journey to bring sight to the blind with the Argus II "Bionic Eye. "

Manny Villafanna, founder, St. Jude Medical, Guidant and Kip's Bay Medical, joins medtech CEOs Brian Concannon, Duane DeSisto, Charles Carignan and Carmichael Roberts for a discussion on leadership.

This CEO panel was recorded on July 15, 2014 at DeviceTalks Boston, hosted by MassDevice.com. It features CEOs from BIOM, Insulet and Carmichael Roberts, founder MC10, Arsenal Medical and 480 Biomedical.

MassDevice publisher Brian Johnson interviews Haemonetics CEO Brian Concannon about the company's history, its present and the future of blood management and blood donation. The interview was recorded at DeviceTalks Boston on July 15, 2014.

Panel discussion recorded at June 24th DeviceTalks Minnesota event featuring Nadim Yared, Deb Rectenwald, Philip Ebeling.

This MassDevice podcast featuring Covidien's Stacy Enxing Seng was recorded live on June 24th at DeviceTalks Minnesota.

Glooko CEO Rick Altinger and MassDevice's Brian Johnson discuss Glooko's mobile diabetes management app. Altinger describes the economics behind the Glooko platform, as well as the app's ability to foster easy communication between diabetes patients and healthcare providers.

MassDevice’s Brian Johnson and CeQur's CEO Jim Peterson discuss Peterson’s personal connection to diabetes, and how that personal connection has impacted the company’s direction.

MassDevice reporter Brad Periello speaks with CEO and founder of NxStage Medical Jeff Burbank, Zoll CEO Richard Packer, ConforMIS CEO Philipp Lang, and Ocular Therapeutix CEO Amar Sawhney about what it takes to keep companies on the cutting edge, as well as their ups and downs as heads of major medtech companies.

Johnson & Johnson's Global Medical Solutions Group Worldwide Chairman Karen Licitra talks about her role within Johnson & Johnson and how she thinks the economics of healthcare and the medical device industry need to change in order to accommodate the future.

Former Kinetic Concepts CEO Catherine Burzik takes you inside the $6.1 billion merger of Kinetic Concepts with Apax Partners in 2011, the largest leveraged buyout since the fall of Lehman Brothers.

Medtronic CEO Omar Ishrak sat down with MassDevice's Brian Johnson to talk about his two years on the job at the Minneapolis-based medtech company. Ishrak shared his experiences, as well as the insights he has gained as Medtronic's CEO.

Semprus BioSciences Corp. hopes to reduce the 60,000 deaths and $11 billion in costs related to "surface failures" of vascular catheters with its Sustain technology for coating medical devices.

William Hawkins, former chairman and CEO of Medtronic Inc., dishes on mergers and acquisitions, the Food & Drug Administration and healthcare reform.

Dr. Thomas Fogarty, the founder of the Fogarty Institute for Innovation, discusses the investment climate for medical innovation, venture capital and explains why his passion for winemaking is actually an extension of his medical career.

Capsule Tech's newly appointed North America president Stuart Long tells MassDevice about the company's surging growth and what it means to be a "middleware" service provider.