The 7investing Podcast

Given the rise of exciting new therapeutic modalities ranging from mRNA to gene editing, investors would be forgiven for overlooking opportunities in medical devices. They might be worth a closer look though. In this episode of the 7investing podcast, the team's health-care trio provide a high-level overview of the regulatory environment for medical devices, describe why and how genetic tests are regulated as medical devices, and provide three examples of companies in the space and how they fit within the regulatory landscape. Medical devices are regulated by the U.S. Food and Drug Administration (FDA) within three categories: Class I devices are the simplest and least likely to pose safety risks. Examples include bedpans or medical gauze. These require regulatory clearance. Class II devices are more complicated and require more data within their regulatory submissions to ensure the safety and effectiveness of the device. Examples include X-ray machines or knee braces. These require regulatory clearance. Class III devices are the most complicated and pose the greatest potential risk to patients, such as life-supporting, life-sustaining, or implantable devices. Examples include liquid biopsies, pacemakers, or implantable contact lenses. These require regulatory approval. Although Class I and Class II medical devices can be submitted through the 510(k) process and only need to show equivalence to a predicate ("existing") device, Class III medical devices must be submitted through the more rigorous premarket approval (PMA) process that often requires a clinical trial. Unlike a drug candidate that requires at least three separate clinical trials (phase 1, phase 2, and phase 3), a Class III medical device often only requires a single clinical trial. It seems odd, but genetic tests and liquid biopsies are also regulated as medical devices. These product candidates are categorized into one of the classes above, which typically impacts how and where they can be used. The three designations of genetic tests include: Research use only (RUO) products cannot be used as diagnostics and don't require a regulatory submission. RUOs can form the basis of a more advanced diagnostic product from the originator or its customers. These serve an important role, but generally have the smallest market opportunity. Laboratory developed tests (LDT) must be designed, manufactured, and processed by a single CLIA-certified laboratory. These tend to be Class II medical devices and require a 510(k) filing. LDTs are often used with centralized business models, where patient samples are shipped to a centralized facility. Examples include genetic screening tests. These have the largest volume potential, but low to moderate pricing and insurance coverage. These have moderate to large market opportunities. In vitro diagnostics (IVD) are more robust tests and can be shipped to the point of care, which means placed in the hands of doctors, oncologists, and medical facilities. Because these are not self-contained within CLIA-certified labs, they're often classified as Class III medical devices and require a PMA filing and clinical trial. IVDs are often used with distributed business models, where patient samples are processed at the point of care. Examples include liquid biopsies. These have both large volume and high price potential, which results in the largest market opportunities by monetary value. Finally, the podcast concludes with three different examples of medical device companies: 7investing Lead Advisor Dana Abramovitz discusses Inviate (NYSE: NVTA). 7investing Lead Advisor Maxx Chatsko discusses Nano-X Imaging (NASDAQ: NNOX). 7investing Lead Advisor Simon Erickson discusses STAAR Surgical (NASDAQ: STAA)

Investors hear a lot about genomics these days, but what does it all mean, exactly? 7investing Lead Advisors Simon Erickson and Maxx Chatsko team up to discuss what investors should look for in pre-commercial drug developers. To provide practical examples, they discuss how continuous improvements in DNA sequencing have created various technological offshoots now loosely called "genomics," including exciting new opportunities in precision oncology and liquid biopsies. Finally, they provide a high-level overview of DNA editing tools and approaches, including base editing and prime editing. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

America's health care bill may cost us $4 trillion a year. But at least we're getting more efficient. Technological advances are improving several of health care's most serious issues. Oncology diagnostics are now able to detect earlier-stage cancers before patients even begin showing symptoms. Remote monitoring is taking vital signs of the elderly without them ever needing to step into a hospital. The COVID vaccine is renewing our focus on mRNA, genomic sequencing is unlocking personalized treatments, and spatial biology is quickly capturing the full attention of the medical community. But due to heavy regulations and the specialized nature of the work, isn't the health care industry also notoriously slow to embrace innovation? Will these exciting new technology improvements actually pay off for forward-thinking investors? To help us answer those questions, we've brought in a health care expert. Nina Deka is a senior analyst for ROBO Global, where she contributes to the firm's health care technology index that carries the ticker "HTEC". Nina has spent her career either working in or covering the health care industry, and she is well-versed in the ways of how technology can improve it. In an exclusive interview, Nina spoke with 7investing CEO Simon Erickson about several of health care's most important developing trends and the specific companies that investors might consider as opportunities. Publicly-traded companies mentioned in this interview include Akoya Biosciences, Exact Sciences, Illumina, Invitae, Moderna, Pacific Biosciences of California, Teladoc, and Vocera Communications. 7investing's advisors or its guests may have positions in the companies mentioned. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

There are a lot of exciting new frontiers hitting the headlines of today's financial media. 7investing lead advisors Steve Symington and Simon Erickson are joined by CryptoEQ founder Spencer Randall to break down the most important things to watch for as investors.  Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

It’s beginning to look a lot like Christmas at least as far as many retailers are concerned. The holiday season has crept into October so some players are offering Black Friday-like deals before Halloween has even passed. It’s also going to be an interesting year with “supply chain” being both a real problem and a ready excuse. Dan Kline looks at how investors should view the season on the episode of 7investing Now. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

Esports is quite rapidly taking the entire world by storm. Nearly half a billion people now tune in to watch competitive tournaments between the most talented global teams. Popular games like Riot Games' League of Legends or Activision Blizzard's (Nasdaq: ATVI) Overwatch are attracting live audiences in numbers that rival the Super Bowl. And because most of these tournaments are broadcast digitally, there's a flood of data available for advertisers to digest about their audience's demographics and interests. So how should investors play this massive and developing trend? Are there game developers who are banking on the popularity of their best-selling titles? Are there broadcasting platforms who are winning the lion's share of advertising? Are there progressive companies who are tuned-in and placing the right bets on sponsorship? To help us answer these questions and more, we've brought in an Esports expert. Chris Buckner is the founder and CEO of Mainline.GG, who is unlocking the value of Esports for everyone. His company set up tournaments for companies and universities -- including the University of Texas, Texas A&M, and Louisiana State University -- helping them manage, monetize, and market their Esports programs. In an exclusive interview, Chris spoke with 7investing CEO Simon Erickson about why Esports is such an important developing trend. He described what games are the most popular for tournaments and which developers are at the forefront of the movement. He also explained how the Esports gaming industry makes money and why certain broadcast platforms and advertisers are uniquely positioned to benefit. Chris also describes what Esports tournament events are really like, as well as what China's recent regulations on gaming could mean for the industry. Publicly-traded companies mentioned in this interview include Activision Blizzard, Amazon, Audi, and Chipotle. 7investing's advisors or its guests may have positions in the companies mentioned. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

Tesla has managed to largely avoid the production problems that have impacted the rest of the automotive industry. That’s not to say it has been clear sailing -- the company has had some delivery delays -- but its vehicle delivery numbers for the quarter are impressive. Anirban Mahanti joins “7investing Now” to look at any potential problems he sees for the company as well as how it stacks up again other automakers. We’ll also look at the upcoming Rivian IPO and talk about what it means for early backer Amazon as well as its expected $80 billion valuation. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

Not too long ago, software was sold with perpetual licenses. Often, software was bundled with hardware. In some cases, an annual maintenance contract was added to the perpetual license, which provided the buyer with software updates and patches. This sales motion meant significant upfront costs for the purchaser. Every few years, a new major upgrade landed, and the whole process repeated itself. Subscription software changed all this with the arrival of the Software as a Service (SaaS) sales model. Customers now pay for the software they use, on a monthly, quarterly, or annual basis. They always had access to the latest version of the software. And with cloud delivery, there are no upfront hardware costs. In a nutshell, companies went from spending on Capex to just budgeting software use under operating expenditure. However, in the SaaS model, clients can terminate a software contract if they don’t get the value they expected. And that would mean a loss of revenue (unlike perpetual licensing, where almost all of the payment is upfront). The implication means that the software should solve the customers’ problems; it needs to deliver on the promises of the salespeople. And that’s where Customer Success came into play. Today, Customer Success plays a critical role in software adoption. It plays a vital role in the SaaS land-and-expand model. In this interview, 7investing Lead Advisor Anirban Mahanti chats with Customer Success Manager Kyle Holden. Kyle is a senior customer success manager at Okta (NASDAQ: OKTA), where he works with enterprise customers ranging from 5000 to 25,000 employees. In this chat, we cover various topics, including: The origin of customer success How customer success has evolved How customer success works with sales & marketing and product development teams The importance of Dollar-based net retention (DBNR) and how investors should think about DBNR for large vs. smaller enterprise software businesses This is a fascinating conversation that enterprise software investors shouldn’t miss. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us: ► https://www.facebook.com/7investing ► https://twitter.com/7investing ► https://instagram.com/7investing

Apple has spent billions of dollars on its streaming TV service but its goals for that product may not be the same as its rivals. For the technology giant, it’s not all about subscriber counts. In fact, it’s not entirely easy for people to judge whether Apple is on the right track with Apple TV+ or if the company has fallen behind its goals (partially because Apple does not share much information on its streaming service. Anirban Mahanti, however, knows what the company wants to achieve and he joins Dan Kline on “7investing Now” to explain what success looks like for the expensive, and relatively lightly-watched streaming service. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us on Social Media ► https://www.facebook.com/7investing/ ► https://twitter.com/7investing ► https://instagram.com/7investing

Danielle Ecuyer has decades of equities experience that spans the globe. She completed a Commerce degree at the UNSW in the early 1980’s and then trained in Australian equities. In the 1990s, Danielle moved to the UK and worked in senior positions at some of the world’s pre-eminent financial firms, where she specialized in emerging markets. She retired when she had her son and transitioned to becoming a private, full-time, investor.   Anirban Mahanti sat down with Danielle Ecuyer to chat about her career, her investing and how it has changed over the decades, the most important skills to investing successfully over the long-term, and her books. Yes, Danielle is the author of two wonderful books on investing: “Shareplicity: A simple approach to share investing” and “Shareplicity2: A guide to investing in US stock markets”. Both books are available via Amazon as well as other book stores. Welcome to 7investing. We are here to empower you to invest in your future! We publish our 7 best ideas in the stock market to our subscribers for just $49 per month or $399 per year. Start your journey toward's financial independence: https://www.7investing.com/subscribe Stop by our website to level-up your investing education:  https://www.7investing.com Follow us on Social Media ► https://www.facebook.com/7investing/ ► https://twitter.com/7investing ► https://instagram.com/7investing