Podcasts about radiological health

This month at Medtech Talk, co-host Justin Klein, co-founder and managing partner at Vensana Capital, debuts in his first episode with a discussion with Douglas Kelly, former deputy center director for science and chief scientist at the Center for Devices and Radiological Health at the FDA. Kelly talks about his time at the FDA and the fundamental changes he implemented to make a helpful impact on patients, including when the pandemic was at its peak. Kelly also shares his thoughts on the value of fostering innovation and the importance of breakthrough designation, as well as how to approach the process of advocacy and get in better alignment with shared priorities with the FDA, CMS, and other stakeholders

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world.On September 24, 2024, Ross Segan was appointed to replace Maisel as the head of medical device evaluation and quality at the FDA's Center for Devices and Radiological Health. Route 92 Medical raised $50 million in funding to support global sales of stroke devices, with a total of $82 million raised so far. A study found that recalled heart devices had limited clinical testing, with only 30 out of 157 devices undergoing premarket clinical testing. Stryker acquired Nico, adding devices for removing brain tumors and clots to their portfolio. Legacy medical devices with unsupported software pose cybersecurity threats, and experts recommend four steps to minimize these risks.Epic, a major electronic health record vendor, is being sued for alleged antitrust violations by data startup Particle Health. Senator Ron Wyden is pressuring hospitals on EMTALA compliance after reports of women being denied emergency abortions. Supply chain cyberattacks are threatening the healthcare industry, prompting the need for collaborative efforts to limit disruption. The use of artificial intelligence in healthcare is a complex issue that involves balancing innovation, efficiency, accuracy, bias, and ethics.Biogen and UCB have achieved positive lupus data after waiting for two decades, prompting them to start a large study on their medicine, dapirolizumab pegol. Bluebird is restructuring again, laying off 25% of its workforce to preserve cash amid slow uptake of its gene therapies. Metsera is promoting a long-acting GLP-1 drug for weight loss, while Novartis has struck an AI deal. Biohaven plans to seek FDA approval for a neurological disorder drug after positive data. The biopharma industry is seeing developments in long-acting obesity drugs, AI deals, and restructuring efforts to manage financial challenges.The text discusses the importance of data in cancer research and how the nonprofit Cancer Research Institute, led by Alicia Zhou, is leveraging data to pursue treatments and cures. Zhou aims to foster collaboration between industry and government sectors to improve cancer drug development. The text also highlights the importance of making biopharma more like Silicon Valley to address cancer research challenges from a multi-faceted perspective.

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.

The following question refers to Sections 10.2 of the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. The question is asked by Western Michigan University medical student and CardioNerds Intern Shivani Reddy, answered first by Mayo Clinic Cardiology Fellow and CardioNerds Academy House Faculty Leader Dr. Dinu Balanescu, and then by expert faculty Dr. Ileana Pina. Dr. Pina is Professor of Medicine and Quality Officer for the Cardiovascular Line at Thomas Jefferson University, Clinical Professor at Central Michigan University, and Adjunct Professor of Biostats and Epidemiology at Case Western University. She serves as Senior Fellow and Medical Officer at the Food and Drug Administration's Center for Devices and Radiological Health. The Decipher the Guidelines: 2022 AHA / ACC / HFSA Guideline for The Management of Heart Failure series was developed by the CardioNerds and created in collaboration with the American Heart Association and the Heart Failure Society of America. It was created by 30 trainees spanning college through advanced fellowship under the leadership of CardioNerds Cofounders Dr. Amit Goyal and Dr. Dan Ambinder, with mentorship from Dr. Anu Lala, Dr. Robert Mentz, and Dr. Nancy Sweitzer. We thank Dr. Judy Bezanson and Dr. Elliott Antman for tremendous guidance. Enjoy this Circulation 2022 Paths to Discovery article to learn about the CardioNerds story, mission, and values. Question #24 Mr. E. Regular is a 61-year-old man with a history of HFrEF due to non-ischemic cardiomyopathy (latest LVEF 40% after >3 months of optimized GDMT) and persistent atrial fibrillation. He has no other medical history. He has been on metoprolol and apixaban and has also undergone multiple electrical cardioversions and catheter ablations for atrial fibrillation but remains symptomatic with poorly controlled rates. His blood pressure is 105/65 mm Hg. HbA1c is 5.4%. Which of the following is a reasonable next step in the management of his atrial fibrillation? A Anti-arrhythmic drug therapy with amiodarone. Stop apixaban. B Repeat catheter ablation for atrial fibrillation. Stop apixaban. C AV nodal ablation and RV pacing. Shared decision-making regarding anticoagulation. D AV nodal ablation and CRT device. Shared decision-making regarding anticoagulation. Answer #24 Explanation The correct answer is D – AV nodal ablation and CRT device along with shared decision-making regarding anticoagulation.” Maintaining sinus rhythm and atrial-ventricular synchrony is helpful in patients with heart failure given the hemodynamic benefits of atrial systole for diastolic filling and having a regularized rhythm. Recent randomized controlled trials suggest that catheter-based rhythm control strategies are superior to rate control and chemical rhythm control strategies with regards to outcomes in atrial fibrillation. For patients with heart failure and symptoms caused by atrial fibrillation, ablation is reasonable to improve symptoms and quality of life (Class 2a, LOE B-R). However, Mr. Regular has already had multiple failed attempts at ablations (option B). For patients with AF and LVEF ≤50%, if a rhythm control strategy fails or is not desired, and ventricular rates remain rapid despite medical therapy, atrioventricular nodal ablation with implantation of a CRT device is reasonable (Class 2a, LOE B-R). The PAVE and BLOCK-HF trials suggested improved outcomes with CRT devices in these patients. RV pacing following AV nodal ablation has also been shown to improve outcomes in patients with atrial fibrillation refractory to other rhythm control strategies. In patients with EF >50%, there is no evidence to suggest that CRT is more beneficial compared to RV-only pacing. However, RV pacing may produce ventricular dyssynchrony and when compared to CRT in those with reduced EF (≤ 50%),

The following question refers to Section 10.1 of the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure. The question is asked by Western Michigan University medical student and CardioNerds Intern Shivani Reddy, answered first by Boston University cardiology fellow and CardioNerds Ambassador Dr. Alex Pipilas, and then by expert faculty Dr. Ileana Pina.Dr. Pina is Professor of Medicine and Quality Officer for the Cardiovascular Line at Thomas Jefferson University, Clinical Professor at Central Michigan University, and Adjunct Professor of Biostats and Epidemiology at Case Western University. She serves as Senior Fellow and Medical Officer at the Food and Drug Administration's Center for Devices and Radiological Health.The Decipher the Guidelines: 2022 AHA / ACC / HFSA Guideline for The Management of Heart Failure series was developed by the CardioNerds and created in collaboration with the American Heart Association and the Heart Failure Society of America. It was created by 30 trainees spanning college through advanced fellowship under the leadership of CardioNerds Cofounders Dr. Amit Goyal and Dr. Dan Ambinder, with mentorship from Dr. Anu Lala, Dr. Robert Mentz, and Dr. Nancy Sweitzer. We thank Dr. Judy Bezanson and Dr. Elliott Antman for tremendous guidance.Enjoy this Circulation 2022 Paths to Discovery article to learn about the CardioNerds story, mission, and values. Question #15 Mrs. Framingham is a 65-year-old woman who presents to her cardiologist's office for stable angina and worsening dyspnea on minimal exertion. She has a history of non-insulin dependent type 2 diabetes mellitus and hypertension. She is taking metformin, linagliptin, lisinopril, and amlodipine. Blood pressure is 119/70 mmHg. Labs are notable for a hemoglobin of 14.2 mg/dL, iron of 18 mcg/dL, ferritin 150 ug/L, transferrin saturation 15%, and normal creatine kinase. An echocardiogram shows reduced left ventricular ejection fraction of 25%. Coronary angiography shows obstructive lesions involving the proximal left anterior descending, left circumflex, and right coronary arteries. In addition to optimizing GDMT, which of the following are recommendations for changes in management? A Anticoagulation, percutaneous revascularization, and IV iron B A change in her diabetic regimen, percutaneous revascularization, and PO iron C A change in her diabetic regimen, surgical revascularization, and IV iron D A change in her diabetic regimen, medical treatment alone for CAD, and PO iron E Anticoagulation and surgical revascularization Answer #15 Explanation The correct answer is C – a change in her diabetic regimen, surgical treatment and IV iron. Multimorbidity is common in patients with heart failure. More than 85% of patients with HF also have at least 2 additional chronic conditions, of which the most common are hypertension, ischemic heart disease, diabetes, anemia, chronic kidney disease, morbid obesity, frailty, and malnutrition. These conditions can markedly impact patients' tolerance to GDMT and can inform prognosis. Not only was Mrs. F found with HFrEF (most likely due to ischemic cardiomyopathy), but she also suffers from severe multi-vessel coronary artery disease, hypertension, and non-insulin dependent type 2 diabetes mellitus. In addition to starting optimized GDMT for HF, specific comorbidities in the heart failure patient warrant specific treatment strategies. Mrs. Framingham would benefit from a change in her diabetic regimen, namely switching from linagliptin to an SGLT2 inhibitor (e.g., empagliflozin, dapagliflozin). In patients with HF and type 2 diabetes, the use of SGLT2i is recommended for the management of hyperglycemia and to reduce HF related morbidity and mortality (Class 1, LOE A). Furthermore, as she has diabetes, symptomatic severe multi-vessel CAD, and LVEF≤35%,

Podcast: Left to Our Own DevicesEpisode: Dr. Suzanne Schwartz, FDA: What's Next in Medical Device CybersecurityPub date: 2022-09-28Dr. Suzanne Schwartz is the Director of the Office of Strategic Partnerships & Technology Innovation, at the Center for Devices & Radiological Health of the US FDA. She is one of the most prominent policymakers and leaders in medical device cybersecurity, having spent the past 12 years at the FDA advancing medical device cybersecurity for the benefit of the entire world. We sat down with her to discuss where medical device cybersecurity regulations are headed and hear her advice for women wanting to advance their careers in cybersecurity.The podcast and artwork embedded on this page are from Cybellum Technologies LTD, which is the property of its owner and not affiliated with or endorsed by Listen Notes, Inc.

Dr. Suzanne Schwartz is the Director of the Office of Strategic Partnerships & Technology Innovation, at the Center for Devices & Radiological Health of the US FDA. She is one of the most prominent policymakers and leaders in medical device cybersecurity, having spent the past 12 years at the FDA advancing medical device cybersecurity for the benefit of the entire world. We sat down with her to discuss where medical device cybersecurity regulations are headed and hear her advice for women wanting to advance their careers in cybersecurity.

Faced with increased threats from ransomware, the health care industry is growing its security priorities with technology and data. Dr. Kevin Fu, acting director of medical device cybersecurity at the Food and Drug Administration's Center for Devices and Radiological Health, discusses FDA's recently updated draft of its premarket cybersecurity guidance and how medical device developers can leverage capabilities like threat modeling to drive a proactive approach to cybersecurity.

Join me for this conversation with M. Jason Brooke, MSE, JD, CSQE, Attorney and Managing Member of Brooke Consulting LLC. Brooke Consulting is a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant. Jason and I talk about the three main pathways through the FDA: the 510(k) process, De Novo process and PMA (Premarket approval) process. We discuss the pros and cons of each pathway, and the requirements for testing and clinical data. Jason also explains the types of different types of testing such as verification and validation (bench top) testing, non-clinical animal testing, and clinical testing. But what about cybersecurity and biocompatibility which may be required for some SaMD (Software as a Medical Device) and sensors used in DTx solutions? Yes, Jason shares some insights on that as well! In this episode, we cover: Key milestones over the past 10 years for the DTx industry from a regulatory perspective Pros and cons of pursuing one of the three main pathways for FDA approval for a DTx Jason's opinion about what is currently missing with DTx SaMD regulation to uphold it to the same standard as a medical device Comparisons of the regulatory developments in the US to other areas of the world (EU, APAC) The future of regulatory frameworks for DTx Predictions and suggestions for regulators as the DTx industry moves forward Guest Links and Resources: Connect with Jason Brooke on LinkedIn FDA Information about Sofware as a Medical Device (SaMD) Visit Brooke Consulting's website About Jason: Jason Brooke brings a focused expertise in the medical device industry that combines nearly 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance. Jason has conducted scientific research (pre-clinical and clinical) and technology development in academic and industry environments as a biomedical engineer, worked within the FDA's Center for Devices and Radiological Health as a regulatory affairs program analyst, counseled clients as an attorney and consultant focused on the medical device and digital health space, and served as the chief executive officer, general counsel, and vice-president of regulatory and quality for small medical device companies.  Host Links: Connect with Eugene Borukhovich: Twitter | LinkedIn Connect with Chandana Fitzgerald, MD: Twitter | LinkedIn Connect with YourCoach.health: Website | Twitter Check out Shot of Digital Health with Eugene and Jim Joyce: Website | Podcast App HealthXL: Website | Twitter | Join an Event Season 2 of Digital Therapeutics Podcast would not be possible without the support of leading DTx organizations. Thank you to: > Presenting Partner: Amalgam Rx > Contributing Sponsors: Akili | Big Health | Click Therapeutics | Lindus Health Follow Digital Health Today: Browse Episodes | Twitter | LinkedIn | Facebook | Instagram Follow Health Podcast Network: Browse Shows | LinkedIn | Twitter | Facebook | Instagram

On this episode of InsideOut, Mike Alkire talks with Dr. Suzanne Schwartz, Director for the Office of Strategic Partnerships and Technology Innovation within the FDA's Center for Devices and Radiological Health –about steps our nation can take to address medical device shortages now and for the future.

In this Industry Talk, we speak with Mimi Nguyen, a Regulatory Health Project Manager in the Office of Strategic Partnerships and Technology Innovation in the Center for Devices and Radiological Health at the U.S. Food and Drug Administration. She helps manage and organize strategic initiatives, pilot projects, and cross-cutting working groups. Additionally, Nguyen has done work in technology transfer, strategic planning, and program building. Nguyen received a Bachelor of Science in Biochemistry and Cell Biology from the University of California, San Diego, and a Master of Business and Science with a focus in Clinical and Regulatory Affairs from KGI. 

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor's offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”READ MORE: https://www.wcnc.com/article/news/health/coronavirus/covid-19-breath-test-fda-authorization/507-bd965cb6-2142-49e1-9490-93d21970989eA Union County high school remembered its beloved football coach Thursday evening. Parkwood High School's Terrance Gittens died unexpectedly last week.The stadium lights at the Parkwood High Stadium didn't turn on Thursday night. Instead, candles were lit over the field where Coach Gittence once led his team."We're grieving, we're sad, we're angry," Terrence Gittens, Jr. said.He took over as head coach back in May 2020. His son, Terrence, and daughter, Mya, were overcome with support as for nearly two hours, his former colleagues, players and family shared stories of a head coach in his prime -- with a whole life ahead of him. READ MORE: https://www.wcnc.com/article/news/local/wake-up-charlotte/vigil-parkwood-high-school-terrance-gittens/275-ceed215e-e755-41b4-807b-21fda8a2c948Watch Wake Up Charlotte each weekday morning from 4:30 to 7 a.m. on WCNC Charlotte, and as always, join the conversation on social media using #WakeUpCLT! 

The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples. The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor's offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider. Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.” The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples. “InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.” READ MORE: https://www.wcnc.com/article/news/health/coronavirus/covid-19-breath-test-fda-authorization/507-bd965cb6-2142-49e1-9490-93d21970989e A Union County high school remembered its beloved football coach Thursday evening. Parkwood High School's Terrance Gittens died unexpectedly last week. The stadium lights at the Parkwood High Stadium didn't turn on Thursday night. Instead, candles were lit over the field where Coach Gittence once led his team. "We're grieving, we're sad, we're angry," Terrence Gittens, Jr. said. He took over as head coach back in May 2020.  His son, Terrence, and daughter, Mya, were overcome with support as for nearly two hours, his former colleagues, players and family shared stories of a head coach in his prime -- with a whole life ahead of him.  READ MORE: https://www.wcnc.com/article/news/local/wake-up-charlotte/vigil-parkwood-high-school-terrance-gittens/275-ceed215e-e755-41b4-807b-21fda8a2c948 Watch Wake Up Charlotte each weekday morning from 4:30 to 7 a.m. on WCNC Charlotte, and as always, join the conversation on social media using #WakeUpCLT! 

The director of FDA's Center for Devices and Radiological Health was elevated to chief digital health officer of global strategy and innovation. Bakul Patel discusses how he is tackling the office's newest priorities around promoting a diverse workforce, agility and health equity — all in the evolving medical device landscape that is incorporating more automation and software for all consumers.

In this episode of Speaking Of Medtech we're breaking out the crystal ball to give a few predictions of what could be in store this year for industry and the FDA's Center for Devices and Radiological Health. From the ongoing COVID-19 pandemic to digital devices and facility inspections, there's a lot of ground to cover. Medtech Insight article addressing topics discussed in this episode: • Happy New Year! (I Think?): Some 2022 Predictions For FDA's Device Center - https://medtech.pharmaintelligence.informa.com/MT144897/Happy-New-Year-I-Think-Some-2022-Predictions-For-FDAs-Device-Center

Following a recent cybersecurity executive order, agencies face new requirements to ensure they are protected against the evolving cyber threat landscape. Kevin Fu, acting director of medical device cybersecurity at FDA's Center for Devices and Radiological Health, dives into how the agency is developing new guidance and playbooks to guide organizations through medical device development and emphasizes the importance of threat modeling and software bills of material to combat potential vulnerabilities.

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. 

It's "In the News..." the only LIVE diabetes newscast! Top stories this week: FDA hints on 2021 D-tech timeline, the Freestyle Libre 2 app is approved, interchangeable insulin to cost less, an "astonishing" type 2 teen study and a big fall-off in use of metformin in people with type 2. Join us on Facebook live every Wednesday at 4:30pm EDT This week I was on the road, at the Podcast Movement convention. Sorry about the setting! Back in the home studio next week. Check out Stacey's book: The World's Worst Diabetes Mom! Join the Diabetes Connections Facebook Group! Sign up for our newsletter here ----- Use this link to get one free download and one free month of Audible, available to Diabetes Connections listeners! ----- Get the App and listen to Diabetes Connections wherever you go! Click here for iPhone      Click here for Android Episode Transcription below: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and these are the top diabetes stories and headlines of the past seven days.  I'm on the road – again! This time I'm at podcast movement a big convention going on in Nashville.. so apologies if the audio and video are a little bit off but I think we're good enough. And As always, I'm going to link up my sources in the Facebook comments – where we are live – and in the show notes at d-c dot com when this airs as a podcast.. so you can read more when you have the time. XX In the News is brought to you by Real Good Foods! Excited to have them back as a sponsor – we're big fans. Real Food You Feel Good About Eating. XX Our top story this week… a brief comment about diabetes devices at the FDA might give a hint to some timelines we're all watching. FDA Center for Devices and Radiological Health head Jeffrey Shuren says COVID-19 remains a source of uncertainty. "Goal is to be back to normal as we roll into 2022," Shuren said. "But there are a lot of variables that could impact that… don't know if we'll get hit with another tsunami of submissions for full marketing authorization for a lot of the COVID products. Getting back on track, everything is moving for the diabetes submissions." Products in front of the FDA expected by year's end: Medtronic's 780G and Zeus CGM, Insulet's Omnipod 5, Tandem's bolus by phone and it's expected that Dexcom's G7 will be submitted soon. https://seekingalpha.com/news/3715640-fda-devices-head-says-progress-being-made-on-diabetes-devices-backlog XX The FDA did clear one diabetes product this past week.. Abott's Freestyle Libre 2 iOS app. The Libre 2 hardware was approved last year.. this is the app for Apple phones.. it gives users optional real time high and low alarms – still have to scan to see the actual values. It updates every minute – only CGM that does – and it lets caregivers remotely monitor. Freestyle Libre 2 has a 14 day wear.. no exact date on when the App will be available or when it'll be available for android users.   https://finance.yahoo.com/news/abbotts-freestyle-libre-2-ios-130000861.html XX Other side of the coin, Abbot will pay $160 million to resolve claims that two of its units submitted false claims to Medicare. The Justice Department said free glucose monitors were provided to get patients to order more testing supplies, and the companies routinely waived copayments. They were also accused of charging Medicare for ineligible patients and for more than 200 patients who were actually dead. https://www.reuters.com/business/healthcare-pharmaceuticals/us-says-abbott-units-pay-160-mln-resolve-alleged-false-medicare-claims-2021-08-02/ XX Back to the FDA.. for the first time, they're allowing a less expensive brand name insulin to be substituted for the original. Semglee – approved last year – is basically the same as Lantus but it's a lot less expensive. Semglee is now is the first-ever to earn the “interchangeable” designation Trusted Source, meaning it's fully approved to be substituted for Lantus at the pharmacy. No need to get permission from the doctor. This is the second copycat of Lantus; the first was Eli Lilly's Basaglar, launched in 2016. There is some new branding and labeling needed here, so expect a relaunch of Semglee by the end of this year. FYI the pens are a little different even if the insulin in them is the same. It's always a good idea to know what your doctor is prescribing and what your pharmacist is giving you.. even if it costs less. XX Big new studies focusing on children and teens with type 2 diabetes.. showing how different the disease can be in younger people. The studies, published July 29 in the New England Journal of Medicine, showed that within 15 years of a Type 2 diabetes diagnosis, 60% of participants had at least one diabetes-related complication, and nearly a third of participants had two or more. These Texas researchers call it astonishing and say it appears type 2 in youth is much more aggressive than in older people. These researchers say more treatment options are needed for younger people because lifestyle changes don't seem to be enough. The study also showed a lot of families don't have regular access to medication or health care providers. They say it was a diverse study representative of teens and kids in the US. https://medicalxpress.com/news/2021-08-young-adults-complications-diabetes.html   XX More to come, including new about people with diabetes who stop taking a very commonly prescribed medication..  but first, I want to tell you about one of our great sponsors who helps make Diabetes Connections possible. Real Good Foods! We've been fans for a long time – Benny especially likes their ice cream. Real Good Foods makes delicious food you'll feel good about eating; high in protein, grain free and always made from real, nutrient dense ingredients. The labels are easy to read – because the ingredients aren't chemicals and fillers. Whether it's waffles or burrito bowls or stuffed chicken or the pizza that started it all.. I think you'll really love Real Good Foods. Learn more with the link in the FB comments or as always at d-c dot com. Back to the news…   XX Interesting research using artificial intelligence to catch diabetes eye issues earlier – when they're easier to treat. Changes in the blood vessels in the retina cause diabetic retinopathy, the most common diabetic eye disease and a leading cause of blindness in US adults. There are several studies and institutes looking at the use of A-I here, but these folks at the Indiana University School of Optometry say they're using information that is often ignored for diagnosis and it's making a big difference. The National Institutes of Health's National Eye Institute funded the work. https://www.futurity.org/biomarkers-diabetic-retinopathy-blindness-vision-2604812/ XX Nearly half of adults prescribed metformin after a new diagnosis of type 2 have stopped taking it by 1 year. The fall off is most dramatic during the first 30 days. These researchers say it didn't matter how long the prescription was written for and most who discontinued still had A1C's high enough to still need glucose lowering medication. They say as physicians quote - A lot of times we're quick to prescribe metformin and forget about it...Physicians might write a script for 3 months and three refills and not see the patient again for a year...We may need to keep a closer eye on these folks and have more regular follow-up, and make sure they're getting early diabetes education." https://www.medscape.com/viewarticle/955893 XX That's In the News for this week.. if you like it, please share it! And quick note this is our 400th episode. I've been busy with some behind the scenes stuff and it caught up to me! A huge thank you to all of you.. incredible support from this community. Six years and 400 episodes is an accomplishment that I've only reached because of you. And join me wherever you get podcasts for our next episode -Tuesday –  I'm talking to Eoin Costello the host of his own diabetes podcast – about staying active or starting getting more fit with type 1. This week's interview – the one that's out right now – is a look at the features of Omnipod 5 – the newest hybrid closed loop system in front of the FDA. Thanks and I'll see you soon    

Opportunities for companies to engage with FDA during the development and review of new devices have grown over the years. And if Jeff Shuren, Director of the agency's Center for Devices and Radiological Health, has his way, there will be even more fundamental change in the years to come. In this conversation, Shuren talks about the evolution of FDA-sponsor interactions that has occurred over his tenure, the “real-time” engagements during COVID-19, and CDRH's proposal for a TPLC Advisory Program (TAP), which Shuren says will be a game-changer, allowing companies unprecedented access to FDA, payors, providers, and others along the development route. View the full article: https://bit.ly/2USj8Gi 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

Windows XP went end of life on April 8th, 2014, but it's probably running on more than one BioMed device at your health system.Can you think of an area more needing for Cybersecurity focus than BioMed devices?  Well, the FDA has finally moved to address this gap.FTA:The Food and Drug Administration recently named Kevin Fu as the agency's first Acting Director of Medical Device Cybersecurity in its Center for Devices and Radiological Health.The newly created position is designed as a 12-month post, which began on January 1, 2021. Fu will lead the FDA's ongoing efforts to ensure the safety and effectiveness of medical devices, including pacemakers, insulin pumps, hospital imaging machines, and other electronic devices.----If you want to know where he is going.“You can't simply sprinkle magic security pixie dust after designing a device,” Fu explained to the University of Michigan. “Whether for manufacturers of the Internet of Things or medical devices, we're not providing the necessary level of security engineering training that companies need.” Dust off your bio med device security playbooks.  I would be shocked if they have much dust on them, but get them out and turn to page ... 

Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third CEO to lead BIO, the world’s largest biotechnology advocacy group, since its founding in 1993. She previously served as Global Head of Evidence Generation for Medical Device Companies, Vice President of Global External Innovation, and Global Leader for Regulatory Sciences at J&J. Back in 2008, Dr. McMurry-Heath was a member of the Obama-Biden transition team, which tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies. President Obama then named her Associate Science Director of the FDA’s Center for Devices and Radiological Health under Commissioner Margaret Hamburg. Michelle McMurry-Heath takes command of BIO during a tumultuous time and amidst unprecedented challenges. In this podcast we discuss BIO´s role supporting companies now producing mRNA vaccines against COVID-19, as well as how US-based biotech, particularly in California and Massachusetts, has been the key player driving the global growth of the biopharmaceutical industry over the last several decades. Repeated technological triumphs notwithstanding, we also highlight the mounting regulatory challenges regarding pricing and access at a time when science is targeting ever smaller populations and more personalized treatments, which require innovative approaches that under current regulatory structures are not always appropriately supported. Lastly, Michelle McMurry-Heath also outlines what priorities are key to ensuring the viability of the biotech sector at the state level.

Dr. Shah welcomes Dr. Suzanne Schwartz, director of FDA’s Office of Strategic Partnerships and Technology Innovation at the Center for Devices and Radiological Health, for a discussion on personal protective equipment and its critical role in helping to reduce the spread of COVID-19.

Bakul Patel, Director of Digital Health at the FDA Center for Devices and Radiological Health, talks about conducting clinical trials over digital devices.

Dr. Shah welcomes Bakul Patel, the director of Digital Health at FDA’s Center for Devices and Radiological Health, to discuss telemedicine, digital health tools, and FDA’s new Digital Health Center of Excellence.

The tenth installment of Ropes & Gray's podcast series, Non-binding Guidance, focuses on FDA regulation of COVID-19 diagnostic tests, with a particular focus on employee testing. In this episode, chair of Ropes & Gray's FDA regulatory practice, Greg Levine, interviews Lauren Silvis, a former FDA official and currently Senior Vice President of External Affairs for Tempus, a clinical molecular technology company, to hear her input on the role employee testing can play in maintaining a safe workplace. Topics covered include the role of antibody tests, testing of asymptomatic persons, pooled sample testing, and evolving technologies such as Next Generation Sequencing (NGS). Prior to joining Tempus, Lauren spent a number of years at the FDA, first as deputy center director for policy in the agency's Center for Devices and Radiological Health, and subsequently as the FDA chief of staff, where she was responsible for overseeing the daily management of the agency and leading the agency's activities on major initiatives. Additionally, Lauren co-authored several reports and articles on COVID-19 – most recently, “How Businesses Can Keep Employees Safe From Coronavirus.”

Dr. Anand Shah, FDA's Deputy Commissioner for Medical and Scientific Affairs, welcomes Toby Lowe, the Associate Director of the Office of In Vitro Diagnostics and Radiological Health, to discuss the basics of diagnostic tests for COVID-19.

Orange County-based medical diagnostic company Fluxergy has taken the next step toward getting a high-speed test for COVID-19 available for use.  Fluxergy submitted an emergency use authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s test system as a COVID-19 diagnostic at the point-of-care. Advanced rapid point-of-care tests for COVID-19 may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy’s on-site sample- to-answer test for COVID-19 requires a very small sample, typically a nasal swab, which is mixed with a reagent solution, loaded onto a card and inserted into the analyzer in a two-step procedure.   In this episode of DeviceAlliance’s Medtech Radio we with speak CCO of Fluxergy, Dr. Ali Tinazli.  He also serves as Business Partner & Strategy Advisor with Immunaccel, and is a Member of the Strategic Advisory Board of InnVentis Ltd.  Join us as we discuss Fluxergy's goal to make laboratory testing accessible everywhere, the challenges facing current labs, and how our current environment is acting as a catalyst for the next generation of medical device innovation.

Many people might not think of connected medical devices as critical infrastructure but they are. And new cybersecurity holes keep opening up in medical devices. The latest ones have the attention of two agencies: The Food and Drug Administration and the Department of Homeland Security. To explain more about this topic, Federal Drive with Tom Temin spoke to Dr. Suzanne Schwartz, FDA deputy director of the Office of Strategic Partnerships and Technology Innovation in the agency's Center for Devices and Radiological Health; and Boyden Rohner, associate director for Vulnerability Management in DHS' Cybersecurity and Infrastructure Security Agency.

In episode 18, ADHD parenting coach discusses the FDA’s approval of eTNS device to treat ADHD. It has been approved to treat children from 7 to 12 who have been diagnosed with ADHD and are not currently on ADHD medication. Carlos Peña, Ph.D., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said of the device in the press release. “This new device offers a safe, non-drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind. Today’s action reflects our deep commitment to working with device manufacturers to advance the development of pediatric medical devices so that children have access to innovative, safe and effective medical devices that meet their unique needs.”  (https://www.medpagetoday.com/neurology/adhd-add/79346) The eTNS (external Trigeminal Nerve Stimulation) system is a nerve stimulation treatment that delivers low-level stimulation to branches of the trigeminal nerve. The pulse is delivered via a patch on the child’s forehead. The belief is that by stimulating the Trigeminal nerve, signals are sent to the brain controlling the areas that control function, which is one of the areas in which ADHD children struggle. According to the manufacturer, the device is as big as a cell phone, and the treatment is administered overnight. It is not currently covered by insurance and costs about $1,000. When new ADHD treatment options become available, it’s easy to get really excited about what the new treatment means. One of the concerns with the approval of the eTNS is that we don’t know the long-term effects of the device.  The trial period of this device was only four weeks and involved roughly 60 kids. They did see a reduction in treating ADHD with minimal side effects. With that length and sample size, we don’t know what long-term effects of sending electrical pulses to the brain will be. This new device is just one of the non-medication treatment options available to ADHD children. Other options include the behavior skills available on Smarter Parenting. 

In April 2019, I was invited to host a panel at the International Conference on Cyber Engagement in Washington DC, to discuss "Securing the Software Supply Chain". On the panel were four of the top voices in software supply chain management: - Edna Conway, Chief Security Officer, Global Value Chain, at CISCO - Joyce Corell, Assistant Director, Supply Chain and Cyber Directorate, National Counterintelligence and Security Center, US Office of the Director of National Intelligence - Bob Kolasky, Director, National Risk Management Center, Cybersecurity and Infrastructure Security Agency, US Department of Homeland Security - Dr. Suzanne Schwartz, Associate Director for Science & Strategic Partnerships, Center for Devices & Radiological Health, US Food & Drug Administration This episode of the DevSecOps Podcast is the full session from the conference. It is an extended session, running an hour and a half, significantly longer that our usual broadcast. I think you'll find it worth the time. Thank you to the ICCE for allowing rebroadcast of the panel. Pull up a chair, sit back, and listen in as we discuss Securing the Software Supply Chain.

In this episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss the FDA’s letter from March 15, which provided a statement from FDA Commissioner Scott Gottlieb, M.D., and Jeffrey Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions. Specifically, we address a number of questions, including: What were the main contents of this announcement with regard to the evaluation of materials by the FDA? Are there certain materials they are expected to target early in this review process? What are technology-specific guidances and how do they relate to this effort? Will the FDA ban specific materials if they do not meet a certain criteria or have too high an incidence of reactions among patients? Will this effort ultimately lead to a regulatory pathway to approve materials for medical device manufacture? Does having a review process for materials that would be approved for use in medical devices run counter to allowing for a broad selection of materials for a given device and ultimately limit options for innovation?Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting. Medtech Insight articles addressing topics discussed in this episode: • FDA Device Center Reorg Set To Roll Out This Week https://medtech.pharmaintelligence.informa.com/MT124798/FDA-Device-Center-Reorg-Set-To-Roll-Out-This-Week • Neuro Devices Panel Skeptical On Alzheimer’s Treatment https://medtech.pharmaintelligence.informa.com/MT124823/Neuro-Devices-Panel-Skeptical-On-Alzheimers-Treatment

***Apologies! The wrong episode audio was incorrectly uploaded previously***   Dr. Francisco Delgado, or Frank, has worked as a postdoctoral researcher at the University Florida under Dr. Kevin Otto’s laboratory for a little over two years. As he plans to move on and pursue his career with the Food and Drug Administration, he reflects back on what he received as working in the Otto lab. Not only does he offer advice to future postdoctoral researchers, he also points out how they can receive the most from their experience as well. Top Three Takeaways: Postdoctoral careers are necessary to become an academic but less necessary to work in industry. Candidates should try out possible postdoctoral laboratories before making a commitment to ensure it is what they want to do. Mistakes are not failures but ways to view gaps of knowledge to improve upon. [0:00] Frank explains how he feels odd on his last day and explains how everything is ending and coming together. [2:00] Frank describes how he is going to the Food and Drug Administration with two offers: one from the Center for Tobacco Products and one from the Center for Devices and Radiological Health. [3:45] Frank and his girlfriend agreed to move on and find new positions as soon as a clear endpoint arrived in their work. [5:30] Frank explains how working as a postdoc, he had to put his papers and publications on hold in order to work with DARPA; he was also able to help many people get their projects started. [7:15] A postdoc career often takes one in may unexpected directions. [9:00] Frank recommends for postdoc students to volunteer in whatever lab they may choose to work in for a week to ensure it is a good option for them. [11:30] Frank shares how sometimes he feels postdocs are not helpful because they are irrelevant to many industries; one needs to do a postdoc if they wants to become an academic. [12:40] Frank’s postdoc gave him more confidence in what he could do than his PhD program. [14:00] Frank describes the pressures of possibly making mistakes in someone else’s laboratory. [15:30] Frank had to apply his past experiences from his graduate career to be able to learn new tasks quickly. [18:00] Franks shares his viewpoint that people need to be willing to make mistakes in order for progression. [20:00] Frank strikes down the notion that mistakes are equivalent to failure. [21:30] Scholarly papers should move towards publishing the mistakes along with the positive results.

In this edition of Cyber Chat with Sean Kelley, Sean sits down with Dr. Suzanne Schwartz, associate director for Science & Strategic Partnerships at the Center for Devices and Radiological Health, and Christopher Butera, deputy director for Cyber Threat Detection and Analysis at the National Cybersecurity and Communications Integration Center.

In partnership with IEEE EMBS. Virtual reality, prosthetics, biomedical engineering and research are just a few of the areas in which Dr. Heather Benz works on a day-to-day basis. As a biomedical engineer working as a Medical Device Staff Fellow at the FDA Center for Devices and Radiological Health, Dr. Benz experiences the sci-fi excitement that comes with working in new technology as well as using that technology to help people in need; her two passions. In this IEEE Brain podcast episode, Dr. Benz shares what it's like working with the FDA to improve the lives of patients, how she came to be a biomedical engineer and what it's like to be a woman in her field.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a recent Editor's Letter that appeared in the March 2017 issue of MPO. In it, I wrote about a blog Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, authored regarding findings of recent hospital inspections as related to medical device reporting. Suffice to say, changes are needed with regard to the reporting of incidents by those involved in healthcare. How might we resolve the issue? Listen to this episode to hear what suggestions are made. Listen to the podcast streaming via the player or get the podcast on the Medtech Matters channel via your preferred vendor of podcasts, such as Apple Podcasts (iTunes) or Spotify. Once you’ve had a chance to listen to the podcast, if you have any questions or comments you’d like us to discuss or share with other Mike on Medtech listeners about this topic or any other topic we’ve addressed, or you have a suggestion for a future topic for us to cover, email me at sfenske@rodmanmedia.com and we’ll try to respond in an upcoming Mike on Medtech podcast.

Tubing misconnections are a significant threat to patient safety. The accidental connection of different delivery systems—through which patients receive medication, nutrients and other fluids—can result in serious patient harm, even death. A number of organizations, including AAMI, and federal regulators have banded together to work on a new initiative that aims to reduce that risk through the development and use of new small-bore connectors and standards. The FDA’s Scott Colburn and Pamela Scott, both with the Center for Devices and Radiological Health, join Thomas Hancock, with the Global Enteral Device Supplier Association (GEDSA), and Tricia Otstot, a nurse whose mother died as a result of a tubing misconnection, to talk about this important issue. Sponsored by GEDSA. http://www.stayconnected2015.org/   Produced by AAMI in partnership with Healthcare Tech Talk  

Safe & Sound: Episode 134: Cell Phone Radiation: Daniel Kassiday from the U.S. Food and Drug Administration Center for Devices and Radiological Health joins the show to talk about the amount of radiation that you are exposed to when talking on your cell phone, and tells us facts and fiction about some celebrities’ claims that talking on their cell phone gave them tumors.