Let’s Talk Medtech (Informa Markets)

In this episode of Let's Talk Medtech, Babson Diagnostics CEO David Stein discusses the company's progress toward commercialization. Babson has developed a model for diagnostic blood testing that maintains a high standard of accuracy, yet requires only one-tenth the sample size of traditional venipuncture methods. Babson also uses a proprietary blood collection device to collect the sample at a participating pharmacy, then the sample is processed back at Babson's labs.

Jijo James, MD, chief medical officer of medtech and global external innovation at Johnson and Johnson, talks with MD+DI News Editor Amanda Pedersen about medical device safety. He talks about the shift from reactive approaches to patient safety to a proactive approach. He also talks about how to handle situations where a use-related error is causing a safety concern, and how even those errors are the responsibility of the device manufacturer.

Scott Nelson, one of the medical device's top insiders, stops by to discuss the trends in the industry and to give tips to entrepreneurs looking to jump into the world of medtech. Nelson is the co-founder and CEO of FastWave Medical, a medical device startup developing intravascular lithotripsy systems for cardiovascular disease. Additionally, he’s the founder of Medsider, where he interviews founders and CEOs of promising, early-stage medical device and health technology companies. 

maxon's Peter van Beek delves into the latest miniaturization trends in medtech.

Dr. Jim Mault, BioIntellisense CEO, breaks down the rise of remote patient monitoring and explains why it’s time to drop the term. He also speaks about his time at Microsoft and Qualcomm.

It's no secret that Dexcom is on the rise. From commercials during the Super Bowl, to blockbuster products on the horizon, the company is reaching a new height of popularity in the continuous glucose monitoring space.

Kevin Sayer, Dexcom CEO, talks about the company's new position the space and all the hype surrounding the upcoming G7 CGM sensor. He also gives his thoughts on where CGM technology is headed in this incredible, can't miss conversation.

Naomi Schwartz, the Senior Director for Cybersecurity Quality & Safety at Medcrypt, a medical device cybersecurity specialty firm, shares some interesting tidbits about FDA's upcoming Refuse-to-Accept (RTA) policy for Cyber Devices and Related Systems. The policy is effective Oct. 1 and Schwartz breaks down what the RTA will mean for medical device manufacturers and their FDA submissions.

It's been a little more than a year since ZimeVie was launched from Zimmer Biomet. The dental and spine specialist has had to overcome some tough obstacles and find its footing. ZimVie's CEO, Vafa Jamali returns to Let's Talk Medtech to discuss the company's growth, tribulations, success, and why Europe has become a fertile market. You don't want to miss this exciting episode of Let's Talk Medtech.

Penumbra CEO Adam Elsesser joins Let’s Talk Medtech to discuss the company's newest mechanical thrombectomy devices (Lightning Flash and Lightning Bolt), an ambitious revenue projection, and why failure is an acceptable option at his company.

How is medtech holding up in this tough economy? Are supply issues still a problem in the industry? What's the next big market for growth? Is medtech still healthy? EY's Jim Welch answers these questions and talks about the company's latest Pulse of the Industry report in this brand-new episode.

Ruby Gadelrab, CEO and founder of MDisrupt, stops by Let’s Talk Medtech for a candid conversation about digital health, diversity, and working to create an atmosphere of inclusion in the space. Plus, she shares her professional experience.

Elucid is changing the way we think about cardiovascular health. To do this, the Boston-based company has appointed medtech veteran, Scott Huennekens as chairman of its board.

Scott along with Elucid's CEO Blake Richards joins us for this episode to talk about how the company is changing the way we view cardiovascular health.

Plus, Scott discusses his incredible career in this can't-miss episode.

Dr. Lishan Aklog wears multiple hats. He's the CEO of both PavMed and Lucid Diagnostics. Being a CEO of two companies during the pandemic can be tough at times, but Dr. Aklog's biggest challenge is getting out the awareness of how some instances of GERD can lead to Esophageal Cancer.

Dr. Aklog stops by for an amazing conversation on how Lucid Diagnostics is making an impact in the detection of Esophageal Cancer.

GE HealthCare started off 2023 by becoming a fully independent company. The company then wasted little time making acquisitions. Most recently, GE HealthCare was in the spotlight because of developments in Alzheimer's treatments that could potentially drive up the demand for the firm's imaging equipment.

Jan Makela, President and CEO, of Imaging at GE HealthCare, joins us to talk about the company's success and how it plans to finish out the year, in this exciting new episode.

Claire Smith, VP of global strategic marketing for Nevro, shares how the company's HFX iQ technology is using artificial intelligence to help treat chronic pain. Smith also shares some of her experiences in medtech sales and how the role of a medtech salesperson has changed over the years.

Interested in designing medical device products? Want to know the do's and dont's of medtech design? Then you must listen to this all-new episode of Let's Talk Medtech featuring BlackHägen Design's Philip Remedios and Renee Bailey. Both will talk about what you need to have in mind when building device and breakdown how Contextual Inquiry is changing how we think about medtech design.

Foley & Lardner LLp's, Nathaniel Lacktman joins us for this episode of Let's Talk Medtech to give insight on whether the telemedicine boom the industry saw at the beginning of the pandemic still exists.

In this episode of Let's Talk MedTech, Omar chats with Jijo James, Chief Medical Officer for Johnson & Johnson MedTech and Interventional Oncology. James shares insights into J&J's commitment to patient safety, discussing how the company combines clinical safety, safety science, and bioethics to ensure safe and effective outcomes for patients. He highlights the importance of the operator in medical device procedures and how J&J is improving safety through innovative tools like the device briefing tool. James also discusses the challenges of device-related interruptions during surgeries, emphasizing the need for better communication and proactive strategies to avoid complications. This is a fascinating conversation for anyone interested in healthcare innovation and patient safety in the medtech industry!

ZimVie's CEO Vafa Jamali joins Let's Talk Medtech in an exclusive interview about how the company is poised to transform the dental and spine markets.  The company has now been completely spun out from Zimmer Biomet and is trading on the Nasdaq. With strong leadership and a strong product portfolio, ZimVie is poised to be one of the breakout companies of the year in medtech.

Nicole Black, Phd., Vice President of Biomaterials and Innovation, at Desktop Health, drops by to discuss how new technological developments are transforming 3D printing from a method primarily used for prototyping into a reliable manufacturing method for end-use medical devices. Black is also a keynote speaker at BioMEDevice Boston, an event showcasing emerging technologies and trends from the medtech market, set to be held Sept. 20-21 at the Boston Convention & Exhibition Center.

In this Let's Talk Medtech Special, recorded at the IME West manufacturing tradeshow in Anaheim, CA April 12-14, 2022, we explore all aspects of the global supply chain crisis. You'll hear from multiple manufacturing experts who were at the show, in one succinct, narrative-style podcast episode.

European Union states greenlit a measure to regulate artificial intelligence. The sweeping law is the first of its kind and will have a definitive impact on any companies that employ the use of AI.

Anne-Gabrielle Haie, a partner with Steptoe LLP, answers questions about the AI Act and discusses its potential impact on the medical device industry in this all-new episode of Let's Talk Medtech.

Varian is changing the way we look at and treat cancer. Dr. Deepak 'Dee' Khuntia joins us for an incredible conversation about Varian's strategy in the fight against cancer.

Tissium's co-founder and Chief Innovation Officer, Maria Pereira chronicles her journey into medtech and how a plan to mend heart tissue led to the formation of a company. Pereira co-invented Tissium's technology while she was a PhD student at Prof. Jeff Karp’s Laboratories. She has been recognized for her research by MIT Tech Review’s “35 Innovators Under 35” in 2014, as well as Forbes in its “30 under 30” selection in healthcare in 2015.

The Massachusetts Medical Device Industry Council (MassMEDIC) has launched the Why Medtech campaign to build awareness of the medical device industry. MassMEDIC's Brian Johnson and Rachel Robinson joins us for this episode to discuss how people can take part in this campaign and why everyone has medtech story.

Omicron has caused quite a disruption in both pharma and medtech. Derron Stark EY-Parthenon Partner, Principal, Strategy Transactions, speaks about these supply chain issues.

Volta Medical is a company that has developed AI software solutions to assist cardiac electrophysiologists in treating atrial fibrillation (AF). Its technology focuses on mapping abnormal regions in the heart during AF procedures and providing cues to optimize the ablation strategy. Unlike other mapping technologies, Volta Medical takes a data-driven approach and aims to replicate the clinical expertise of physicians using machine learning and AI.

The company recently completed enrollment for the TAILORED-AF clinical trial, which is a large-scale international trial involving multiple centers and physicians in five countries. The trial enrolled 374 patients who will be followed up for one year. The primary endpoint is freedom from AF after one procedure, with several secondary endpoints related to freedom from arrhythmia.

The co-founder of Volta Medical, Theophile Mohr-Durdez, joins this episode of Let's Talk Medtech to talk about the company's technology, long-term goals, and the unique skillset he brings to the table thanks to his experience on stage.

Upma Sharma joins us for this episode of Let's Talk Medtech to discuss how Arsenal Medical is developing biomaterials that are changing the way medicine is practiced. Sharma also discusses her evolution from a researcher to CEO of a medtech company.

Surbhi Sarna began her journey into medtech when she had a health scare at the age of 13. The ordeal led her to founding nVision, a company focused on the detection of ovarian cancer. nVision was eventually acquired by Boston Scientific.

Sarna joins us shortly before her keynote at BIOMEDevice Silicon Valley to discuss her journey into medtech and what it takes to be an entrepreneur in the industry.

EY’s John Babbitt and Jim Welch join us for this episode to dive deeply into the Pulse of the Medtech Industry Report. We’re talking about deals, IPOs, the hottest segments, and more in this incredible episode of Let’s Talk Medtech.

It's hard to believe it's been more than 10 years ago since FitBit pioneered the fitness wearables market. As the technology has advanced, the lines between what is a consumer wellness device and what is a medical-grade wearable have begun to blur, with a number of companies sitting at the intersection of consumer wellness and medical-grade wearables. One such company is Movano.

John Mastrototaro, CEO at Movano, joins the latest episode of Let's Talk Medtech to discuss that intersection of consumer and medical-grade wearables, and why he joined Movano. The Pleasanton, CA-based company is creating consumer products designed to deliver medical-grade data. Founded in 2018, the company recently announced that its first product will be a fitness ring designed specifically for women that measures heart rate, heart rate variability, sleep, respiration, temperature, blood oxygen, steps, and calories.

Movano is currently conducting clinical trials with its radio frequency-enabled technology and developing algorithms to add medical data, including non-invasive glucose monitoring and cuffless blood pressure, to its core product in the future. The company plans to execute accuracy studies to pursue FDA clearances on its vital signs monitoring capabilities including heart rate, SpO2, and respiration rate.

The Movano Ring is expected to be available through a beta release in the second half of 2022.

MD+DI's Senior Editor, Amanda Pedersen joins us for this episode of Let's Talk Medtech to look at what 2023 was for the medical device and diagnostics industry. The veteran journalist also dives into what the future might hold in 2024 for the industry.

PwC's Glenn Hunzinger stops by to discuss the  Pharmaceutical and life sciences deals insights: 2021 midyear outlook report, showcasing the PLS sector returned to normal deal activity with strong deal volume. Plus, Omar Ford, MD+DI's Managing Editor gives his take on the controversial Illumina/Grail merger.

Paul Grand, MTI's CEO and Glenn Synder, Deloitte's Principle medtech practice leader discuss startups.

Don't miss Cordis CEO Shar Matin talking about building a new company from a storied brand, M&A, and what to expect from Cordis now that it is privately owned and solely focused on medtech.

MD+DI Editor Daphne Allen speaks with the team behind MasksOn.org, a nonprofit that set out to transform a full-face snorkel mask into a face shield for clinicians who don’t have access to typical PPE. Allen speaks with Sanjay Vakil, executive director for MasksOn.org, Devon Campbell (Founder of Prodct LLC), Jon Speer (Founder and Vice President of QA/RA, Greenlight Guru), and Ken Block, president of Ken Block Consulting. 

In this episode of Let's Talk Medtech, Kevin Thornal, Hologic's Division President, Diagnostic Solutions, discusses with MD+DI Editor Daphne Allen the company's efforts to expand the reach of its diagnostics offerings as well as to address unmet needs in oncology and more. He also explains the company's slogan, "The Science of Sure," and why it is important to keep patient needs in mind every day. Hologic was MD+DI's 2020 Readers’ Choice Company of the Year.

Galen Robotics's CTO and co-founder Dave Saunders explains why true artificial intelligence in healthcare doesn't exist...yet. 

Benjamin Zegarelli, counsel with Mintz, gives some important regulatory updates surrounding laboratory-developed tests, artificial intelligence, and software. Oh yeah, we talk about a little thing called EU MDR in this new episode of Let's Talk Medtech.

One of the current trends in the medtech industry involves companies expanding digital solutions. While digital innovation can be slow to progress in regulated industries like healthcare, GE Healthcare is changing the game with Edison Digital Health Platform, a vendor-agnostic hosting and data aggregation platform with an integrated artificial intelligence (AI) engine.  

Vignesh Shetty, Senior VP & General Manager of Edison AI And Platform at GE Healthcare, discusses why the digital platform is a difference maker.

In this Let's Talk Medtech episode, you'll get to know the editorial team at MD+DI as we discuss industry trends and predictions for the year ahead.

Rachel Hall, EY's US Consulting Digital Health and Smart Health Experience Leader, joins us for this episode as we peel back the layers of digital health.

Rachel will give her take on the landscape and how each player, patient, physician, and healthcare firm fit into the ecosystem.

We also talk about something that's been on everyone's minds lately - and that's artificial intelligence.

So join us for this episode of Let's Talk Medtech as we "crack" the digital health code.

EY Americas Leader for Health Technology, Dr. Kaushik Bhaumik joins us for this episode of Let's Talk Medtech to discuss COVID-19's impact on the healthcare system.

While the virus accelerated the adoption of technology in healthcare, it also illuminated existing gaps in digital care and leveraging patient data. And if not addressed, these gaps, along with other pressing healthcare issues like nursing shortages and the Great Resignation, will only further exacerbate healthcare’s existential problem. 

Dr. Bhaumik speaks about the true nature of the problem and gives some insight into potential solutions.

BIOMEDevice Boston is fully loaded in 2022! Adrienne Zepeda, Group Event Director at Informa Markets - Engineering, gives us the scoop on why this is the show's biggest year ever!

Guardant Health's Co-Founder and CEO Helmy Eltoukhy discusses the company's growth and sheds light on the rapidly changing field of liquid biopsy.

News Editor Amanda Pedersen talks with Sandra Nagale of Boston Scientific about the evolution of digital healthcare and the role that COVID-19 has played in that evolution this year.

Hyperfine's President & CEO Maria Sainz tells us how and why Swoop is changing the way we think about MRI's. Plus, she discusses her career in the medtech industry.

A look at what's in store for medtech deals this year. Will 2022 be known as the year of Medtech M&A? Looks like it. EY's John Babitt joins us for a riveting conversation about EY's Annual M&A Firepower Report.

Ethan Drower, co-founder and Operating Partner of CiteMed drops by to talk about how his consulting firm is helping medtech companies navigate European Union Medical Device Regulation (EU MDR). Plus he gives some stellar tips on device regulation in other geographies too.

It's all about surgical robotics as AiM Medical Robotics, Founder & CEO Gregory Fischer, PH.D. joins us for this episode of Let's Talk Medtech. Dr. Fischer talks about the surgical robotics landscape and all of the cool things AiM Medical Robotics has been up to.

Plus, he gives a preview of his upcoming keynote at BIOMEDevice Boston titled, "From Concept to Commercialization: It’s not brain surgery, or is it?"

EY's Jim Welch stops by to discuss the EY Pulse of the Industry report and to discuss the state of M&A in medtech.

Something amazing is happening right now in the world of medtech. Devices are becoming mainstream and more consumer-friendly. With this new development, medical device companies have to think of a more consumer-friendly approach toward getting the message out about technologies. Nicole Osmer, Health+Commerce's CEO and founder, joins us for an insightful conversation on medtech branding.

Jennifer Samproni, CTO of Flex, discusses the importance of human-machine interface innovation and strategies for medical device designers and manufacturers.

MD&M West is a tradeshow that boasts some of the best speakers in the medical device industry - and Let's Talk Medtech has snagged its keynote speaker, Jennifer Samproni for this can't miss episode.

Jennifer is the Chief Technology Officer, of Health Solutions at Flex, and drops by to shed some light on her keynote speech - Transforming the Future of Patient Care with Human Machine Interfaces. She'll also talk about how artificial intelligence is changing healthcare; why contract manufacturing is booming; and give tips on navigating the medical device industry in this season opener of Let's Talk Medtech.

Ha Hong, Chief AI Officer at Medtronic Endoscopy, joins us to talk about how the company is embracing artificial intelligence. He'll also discuss the trends he's seeing with AI in the medical device industry on this brand-new episode of Let's Talk Medtech.

Dana Brown, iCAD's president, chairman and CEO, shares how the company is changing the way we think about breast cancer detection. Brown gives us an update on the partnership with Google. Plus, she talks about her time at Susan G. Komen and how cancer detection has changed throughout the years. She also gives some tips for aspiring medtech professionals in this new episode of Let's Talk Medtech.

Omar : How are you?

Dana: Great. Thanks for having me.

Omar: I'm doing well, just a bit sleep-deprived with a newborn at home, but otherwise, all good.

Dana: Congratulations.

Dana: Thank you. So, Dana, it's been over a year since you took the reins at iCAD. How has the journey been so far?

Dana: Better than I expected, honestly. I joined ICAD's board over two years ago, initially thinking it was my dream role. But I saw an opportunity to contribute more directly given my background in cloud technologies and breast health. Jumping in has been fantastic—the team is great, and seeing our solutions in action, not just on paper, has been incredibly rewarding.

Omar: That's wonderful to hear. Before we dive into iCAD, let's talk about your time at Susan G. Komen. Can you share about your role there?

Dana: Sure, at Susan G. Komen, I served as the chief strategic and operations officer for nearly five years. My focus was enhancing direct patient engagement, ensuring initiatives like helplines, financial aid, and support resources were impactful and accessible. It was about making sure Komen's efforts directly benefited patients throughout their breast cancer journey.

Omar: How have your experiences at Komen influenced your approach at iCAD?

Dana: Three main takeaways: continuous learning, particularly in management and collaboration; leveraging technology like EMRs and research registries to enhance patient care; and fostering a culture of innovation, crucial for developing effective solutions in breast health.

Omar: It sounds like a wealth of knowledge to bring to iCAD. Speaking of which, let's touch on iCAD's use of AI in breast cancer detection. How is AI reshaping mammography?

Dana: AI has revolutionized mammography by enhancing accuracy and efficiency. Unlike human eyes, AI processes data at a granular level, making it a reliable second opinion for radiologists. Beyond cancer detection, we're exploring applications like detecting breast arterial calcification, offering a more holistic view of a patient's health.

Omar: That's impressive—AI as a precision tool in healthcare. Is it making mammogram results more understandable for patients?

Dana: Currently, AI primarily aids clinicians by providing trusted decision support. However, patients are becoming aware of AI's role and its potential to offer them clearer, faster insights into their health—a promising development we're exploring further.

Omar: Moving forward, iCAD has partnered with Google Health. What can you tell us about this collaboration?

Dana: Our collaboration with Google Health spans two key initiatives: integrating our technology into Google's cloud infrastructure for seamless healthcare operations, and jointly developing advanced AI algorithms. This includes creating an AI-powered second reader for mammograms, aiming to streamline diagnosis and reduce turnaround times, addressing the shortage of radiologists globally.

Omar: That's a significant step forward in leveraging technology for healthcare efficiency. While we await regulatory clearances, how do you see AI influencing patient care in the future?

Dana: AI is empowering patients with knowledge and enabling more informed healthcare decisions. It's part of a broader trend towards patient empowerment, where individuals actively engage in their health management—a positive shift we're committed to advancing at ICAD.

Omar: Your...

Sometimes as a company grows and matures, the corporate identity it started out needs to change. Memic Innovative Surgery is the perfect example as the company has changed its name to Momentis Surgical. In addition the company has also changed the name of its technology from the Hominis Surgical System to Anovo Surgical.

DVir Cohen, CEO of Momentis Surgical, discusses the name change and how the Anovo Surgical system stands out in the surgical robotics space.

David Perry, chairman and co-founder of Better Therapeutics, spoke with Let’s Talk Medtech about the company’s efforts and going public through a Special Purpose Acquisition Corporation Merger (SPAC).

Embecta is now fully independent from Becton Dickinson & Co. Devdatt Kurdikar, Embecta's CEO talks about what that means going forward and his plans for the company.  With its rich pedigree and newly-independent status, Embecta is truly the new/old kid on the block in diabetes care.

A look at what means to be a person of color in the medtech industry.

Marissa Fayer is a decorated veteran of medtech. Hear how she broke into the industry and how she founded HERHealthEQ to fight for women's health.

It's been more than a month since Elizabeth Holmes, Theranos's founder and CEO, was found guilty on three counts of wire fraud and one count of conspiracy to commit wire fraud for lying to investors. There's no doubt that she has a mystique surrounding her that invites conversation. Hulu even recently released a limited series starring Amanda Seyfried as Holmes, which documents the rise and fall of Theranos.

A special panel of medtech veterans discusses the mystique surrounding Holmes and the implications the trial could have on the industry in the future. Plus the panel gives some tips to entrepreneurs on how to avoid a "Theranos-like" situation.

It's American Heart Month & Cleerly's Dr. James Min shows how the company is using artificial intelligence to change the way we diagnose cardiovascular disease.