Podcasts about class iii

Halei Heinzel is getting ready to learn who the next Alice in Dairyland will be. The final phases of interviews begin today in Crawford County. Jill Welke talks with Heinzel about her year-long experience and what memories she'll be taking away when she departs officially in July. Severe weather is on the way for a good chunk of Wisconsin today. Stu Muck draws the lines where heavy weather's expected.Stephanie Hoff introduces us to another one of the six finalists for the Alice position. Natalie Roe from Monticello first found out about the Alice program when the selection process came to Green County. She says her love of agriculture's been apparent since she was a little girl. Ben Jarboe gets in a quick conversation with the incoming executive director of the Wisconsin Farmers Union in Chippewa Falls. Danielle Endvick grew up in agriculture and previously served as communications coordinator for WFU. She shares some of the priorities she's bringing to the post. Keep an eye on the cheese market. Beginning next week, barrel cheese essentially "goes away" in Chicago and the Class III pricing formula. That's according to Matt Tranel, dairy analyst with EverAg. He joins Pam Jahnke for the discussion.See omnystudio.com/listener for privacy information.

In Part 1 of this two-part series, Etienne Nichols sits down with regulatory strategist Dr. Mike Drues to explore the nuanced differences between prescription (Rx) and over-the-counter (OTC) medical devices. They demystify key terms, regulatory classifications, and the growing trend of label expansions from Rx to OTC—highlighting real-world examples like CPAP machines and continuous glucose monitors (CGMs). This episode unpacks how intended users, environments, and risk tolerances shape device categorization, and why usability testing is far more complex than many realize. Whether you're developing a consumer health product or preparing a label expansion strategy, this is a must-listen for your regulatory roadmap.Key Timestamps[03:05] – What defines an OTC vs. prescription medical device?[06:45] – Market size of OTC devices and major product categories10:00 – Label expansion: moving from Rx to OTC status13:22 – The role of intended use environment in OTC classifications20:40 – Examples of devices in each FDA class that are OTC26:30 – Prescription devices used in home settings vs. true OTC31:15 – Characteristics that qualify devices for OTC status37:55 – Self-diagnosis, self-selection, and patient usability challenges43:00 – “Reasonably foreseeable misuse” and how to interpret guidance49:05 – Do you design for the lowest common denominator?56:10 – Representing diverse user populations in usability testing1:01:45 – Can a device launch OTC first? The case for wellness-to-Rx strategies1:08:15 – FDA's perspective on device safety: OTC vs. RxQuotes“The best regulatory professionals don't just know the rules—they know the exceptions.”Dr. Mike Drues reminds us that exceptional regulatory strategy lies in understanding nuance, especially in OTC classifications where edge cases can redefine categories.“Just because a device is used at home doesn't mean it's over the counter.”This insight challenges a common industry assumption, underscoring the importance of carefully defining intended use and environment early in development.Key TakeawaysOTC ≠ Low Risk by Default – Many Class II and even rare Class III devices can be OTC; it's more about intended user, use environment, and risk mitigation than class alone.Label Expansion Requires Strategy – Transitioning a device from prescription to OTC isn't just about removing a doctor's role—it may involve new usability studies, labeling changes, and potentially a 510(k) or de novo submission.Understand the "Intended Use Environment" – FDA doesn't just care about where the device is used, but how those environmental parameters (like light, humidity, and user training) affect safe operation.Usability Testing Must Reflect Real Users – For OTC devices, human factors validation must account for diverse educational backgrounds, not just ideal users.Don't Rely on Labels Alone – Whether or not users read (or understand) instructions must be tested, not assumed. Intuitive design is critical for OTC success.References & ResourcesEtienne Nichols on LinkedInGreenlight Guru Medical Device Classification Webinar with Mike Drues (for explanation on device classes)FDA Guidance: “Factors to Consider When Making Benefit-Risk Determinations in Medical Device...

Are you new to the medical device industry—or mentoring someone who is? In this foundational episode of the Global Medical Device Podcast, host Etienne Nichols sits down with Sara Adams and Chris Rush from Greenlight Guru to deliver a MedTech 101 masterclass. They unpack the roles, regulations, and realities of medical device development in a heavily regulated space. From defining what actually counts as a medical device to navigating FDA classifications and global regulations, the trio offers practical insights, industry analogies, and personal war stories that make this episode as entertaining as it is educational. Whether you're in R&D, marketing, clinical, or quality, this is the episode to bookmark and share with every new hire.Key Timestamps02:20 – What counts as a medical device? Intended use and labeling06:48 – Differentiating roles: Quality, Regulatory, Clinical, R&D, and Marketing15:40 – Understanding regulatory bodies: FDA, EU MDR, Health Canada, and more20:15 – FDA Classifications: Class I, II, III, and what determines risk26:00 – Standards to know: ISO 13485, 14971, 14155, 21 CFR Part 82033:05 – FDA pathways: 510(k), De Novo, PMA – when and why they apply41:55 – The design control matrix explained (User Needs through Validation)49:00 – Reverse engineering design controls: pitfalls and best practices55:30 – Clinical trials vs. preclinical studies: When each is required1:00:45 – Manufacturing & supplier controls: operations meets compliance1:04:15 – Final advice for MedTech newcomers: Read the regs and know the problemQuotes“Just because you don't call it a medical device doesn't mean the FDA agrees with you.” – Sarah AdamsThis quote highlights a key regulatory pitfall: your marketing claims, not just your label, determine if the FDA considers your product a medical device.“A 510(k) is like someone checking your wristband at the door—you're cleared to go in. A PMA? That's a locked door and you need full approval to enter.” – Chris RushA memorable analogy that demystifies the difference between FDA clearance and approval pathways.Top TakeawaysLabeling + Intended Use = Regulatory TriggerWhether it's software or a simple tool, if your product makes medical claims or supports medical decision-making, it may fall under FDA or other international regulatory oversight.Regulatory Pathways Are Tied to Risk and NoveltyKnow the difference between a 510(k), De Novo, and PMA. Class II “me-too” devices may avoid clinical trials, while Class III and novel devices usually require significant evidence.Understand Design Controls EarlyReverse-engineering documentation late in development is risky and inefficient. Start early with user needs and build forward through the five pillars: inputs, outputs, verification, and validation.Cross-functional Understanding Prevents Compliance GapsMarketing, clinical, and R&D all influence regulatory standing. Even social media likes can trigger off-label scrutiny—every department needs to understand their regulatory impact.Reading Regulations Is Not OptionalA strong regulatory foundation is key to faster development, better audits, and smoother market access. Resources like 21 CFR Part 820 and ISO 13485 are surprisingly readable and essential.References & ResourcesEtienne Nichols on LinkedInChris Rush on LinkedIn

As we hit the quarter-century mark in agriculture and ag lending, there’s a tale of two economies unfolding. According to Dr. David Kohl from Virginia Tech’s Department of Agriculture and Applied Economics, the U.S. economy is holding strong, but the global economy is facing headwinds. Stu Muck tells us what rainfall could look like around the state this evening and into the Easter weekend. Spring is the time for bunnies and baby chicks. It's fur and feather swap season at a town near you. In Walworth County, they're gearing up for a swap to help fund the Fur & Feather Sale at the county fair and several scholarships for youth exhibitors. Dr. Temple Grandin tells Ben Jarboe that if you get down and see what an animal sees, then you can better understand their behaviors. At a UW-Madison event, she tells Mid-West Farm Report about key moments in her career that have led her to new animal welfare research today. Ever.Ag dairy analyst and broker Cody Koster joins Mid-West Farm Report with an explanation for the Class III rally. He says, despite the tariff scare, countries can't argue that U.S. dairy products are the cheapest in town, spurring an increase in export numbers, aided by a weaker U.S. dollar. Exports are critical to eating up the domestic supply.See omnystudio.com/listener for privacy information.

In this episode of The Milk Check, find out why some dairy producers may be eyeing the exit. Sarina Sharp, risk manager at Ag Business Solutions and the writer behind TC Jacoby's Weekly Market Report joins the Jacoby team this week. Sarina brings invaluable insights as we dig into critical topics like: Milk prices and financial stability: How long can dairy farmers survive with Class III prices dipping below $17? Supply chain shifts: How whiplash tariffs, changing federal orders, and fluctuating demand are affecting the U.S. dairy market. Bird flu and milk production: How the bird flu has changed U.S. milk production, and where it may strike next. Tune in to The Milk Check episode 75: Exit stage left: Why some producers are selling out while they can. If you like milk (and we know you do), then pour yourself a mug and tune in for insights on how to navigate this uncertain landscape and stay ahead in the coming months. Special Guest: Sarina Sharp, risk manager, Ag Business Solutions, and market analyst for the Daily Dairy Report The Jacoby Team: Josh White, vice president, dairy ingredients Ted Jacoby III, CEO & president, cheese, butter & dry ingredients Mike Brown, vice president, dairy market intelligence Gus Jacoby, president, fluid dairy ingredients & dairy support Intro (with music): Welcome to The Milk Check, a podcast from T.C. Jacoby & Company, where we share market insights and analysis with dairy farmers in mind. Ted Jacoby III: Welcome everyone to the March 28th, 2025, edition of The Milk Check, a T.C. Jacoby & Company podcast. It is my pleasure to welcome a couple of special guests to the podcast this week, first, Sarina Sharp of Ag Business Solutions and the Daily Dairy report. Welcome to the podcast, Sarina. Most of you know that Sarina is also the writer of the T.C. Jacoby Weekly Market Report, which we publish every Friday. Sarina, we're honored to have you join us today. More importantly, thank you for the partnership. I can't tell you how often I get compliments on the weekly report that you write for us, so thank you very much. Sarina Sharp: Thanks for having me. Thrilled to hear it. Ted Jacoby III: In addition, we have a few of our usual suspects: my brother Gus, head of our fluid group; Josh White, head of our dairy ingredients team, and I am excited to announce that Mike Brown, formerly of IDFA and Kroger fame, is joining the Jacoby team as our new vice president of Dairy Market Intelligence. Mike, I am excited to have you on the team, and I look forward to having you on this podcast as a regular presence. Mike Brown: Well, thank you, Ted. I'm delighted to be here. It's good to be back in markets and away from government regulation. I'm very excited about the opportunity. And Sarina, I am really looking forward to working with you. I've been a fan for decades now. Appreciate that opportunity to work with you as well. Sarina Sharp: Time flies. Ted Jacoby III: It sure does. So my first question is this. We've been talking for probably a couple of years now about the heifer replacements and the issue that's been evolving because many dairy farmers are breeding to beef simply because it's really hard to pass up $700 for a black cow rather than spending $3,000 to raise that calf into a heifer. But we're getting to the point where right now, for example, our traders that sell into the retail space, they're telling us demand's not that great. Those who are selling into the food service space are saying demand's not that great. Even our traders who export are telling us that Trump's rhetoric about tariffs is having an effect and making it difficult for us to export. In other words, demand is not that great on the horizon. Milk prices have come down. Class III price is probably going to be in the low 17s, maybe even into the high 16s in April. Are we getting to the point that we're starting to reach that line where dairy fa...

Cargill Kitchen Solutions is recalling nearly 215,000 pounds of its liquid egg products that were sold in Texas and other places because the food could possibly contain a cleaning solution made with sodium hypochlorite. The U.S. Department of Agriculture's Food Safety and Inspection Service said the recalled liquid egg items were produced on March 12 and 13, and have the establishment number “G1804” printed on the carton. The recall on the liquid egg products is considered Class III, which means FSIS scientists concluded that use of the item should not cause adverse health consequences – or the risk is negligible. However, consumers and foodservice locations are urged to not consume or serve these products; In other news, North Texas food providers are scrambling to find a way to fill a $9.2 million funding gap following cuts in March to two U.S. Department of Agriculture programs that bought food from local farmers; Dallas HERO threatened Monday to file a lawsuit if the city did not adhere to a November voter mandate to hire 900 more police officers and meet with the nonprofit to review the budget. It's the second time the nonprofit has said it would sue the city since voters approved two controversial changes to the city charter; and Texas House budget writers on Monday endorsed a $337.4 billion state spending plan for the next two years, sending it to the floor for a vote expected next week. Passing a balanced spending plan for the 2026-27 cycle, which starts in September Learn more about your ad choices. Visit podcastchoices.com/adchoices

Ever.Ag Principal Mike North says one of the reasons the Class III milk price is hindered is due to unknowns regarding retaliatory tariffs, notably with Canada and Mexico. In addition, milk production is rising. North emphasizes the need for producers to sign up for the Dairy Margin Coverage program. The deadline is March 31.See omnystudio.com/listener for privacy information.

A new organization is working to ensure rural Wisconsin thrives. The Rural Policy Institute is a coalition of agricultural and rural organizations. Executive Director Bob Welch says it's not an advocacy group, but a research organization. It starts with defining rural. A warm-up is coming your way along with showers. Stu Muck relies on weather observers through the National Weather Service. You could be one, too. Visit WisconsinWeatherWatchers.org. Wisconsin Farm Bureau's Jason Mugnaini says Ag Day at the Capitol was a success, welcoming 400 farmers and advocates. The celebration also got the public's attention with equipment, calves, and cheese on the Square. WFBF met with urban lawmakers in addition to rural policymakers. Conversations included ARIP funding and expanding Wisconsin product market opportunities. Brian Reisinger was a guest speaker at Ag Day with his book, Land Rich, Cash Poor. The book, which explores the history of disappearing farms, has resonated with policy and mental health groups across the state. "Naturally Wisconsin" is boosting the market for Wisconsin's all-natural products, explains Executive Director Jamie Valenti-Jordan. Ever.Ag Principal Mike North says one of the reasons the Class III milk price is hindered is due to unknowns regarding retaliatory tariffs, notably with Canada and Mexico. The deadline is April 2. See omnystudio.com/listener for privacy information.

In this episode, Hatem Rabeh will explain to us what are Clinical Data and also if there is a chance for you to avoid Clinical Investigations. There are also some confusion between Clinical Evaluation and Clinical Investigation. Let's clarify all this and give you the right strategies for your Medical Devices. So stay tuned.  Who is Hatem Rabeh?  Hatem Rabeh is a Medical Doctor with an MSc in Medical Engineering, specializing in clinical evaluation for medical devices.   With over 8 years of experience, he supports manufacturers in MDR compliance by preparing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) for Class I to Class III devices, including software, implants, and robotic systems.  His expertise covers literature reviews, clinical strategy, and regulatory compliance.   Hatem also shares his knowledge through online training, consulting, and LinkedIn content.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Hatem Rabeh LinkedIn: https://www.linkedin.com/in/hatem-rabeh/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

This podcast is the audio version of the Gear Garage Live Show, where we answer submitted questions and talk all things whitewater. Topics and links that Zach talked about this episode Ecuador Rowing School Answer Questions Some of the Questions that Zach covered in the Q&A section of this episode Topic: PFD Review Request Hey Zach, I love your channel! I have a quick question. Could you do a review on the Kokatat Maximus Centurion PFD? My apologies if you already have one in your library. Topic: Chetco How far does the Chetco go up from its mouth at the ocean before one hits a Class III? Topic: Sleeping Pad Hey Zach, love the show. I operate a small outfitting business and always appreciate your information and analysis. I'm repairing and replacing gear for the coming season and wondering what your favorite client sleeping pad is? Our trips all involve some bush flying so big pads like paco's are out of the question. I've been trying to find something a little more plush than the old standard therm-a-rest (Basecamp model) but have been plagued with leaky materials and valves. Love to know what you use. Topic: Maravia Glue Up Several years ago I bought a used 2009 Maraiva glue up boat. One of my seams has developed a leak and I am having trouble finding the right information on the proper repair of such a unique boat. If you have any info about this I would appreciate it. I love your YouTube Channel and what you guys do for the whitewater community. Topic: John Day SUP I stumbled upon your content about SUP adventure on the John Day. I am motivated to do something very similar and found your advice and tips helpful. I am reaching out to you regarding my plans and if you have insight as to the stretch of river I plan to paddle. John Day, 50 miles from Service Creek to Clarno (before the rapids I think). If you know what type of waters these are in June I would be grateful and very appreciative for any input you have. I feel pretty confident in my ability to handle class 2, but not sure about class 3.

Charitee Seebecker sits down with Chuck Connor, president and CEO of the National Council of Farmer Cooperatives. As we kick off 2025, he says farmers across the country are facing a mix of big challenges and new opportunities. For example, this year, $4 trillion in tax deductions will expire unless Congress intervenes. These include provisions crucial to farmers, such as estate tax relief.Ag meteorologist Stu Muck says a thaw is coming this weekend when temps get above freezing. Snow continues to fall in Southeast Wisconsin.Thousands of dollars, hardworking people, and good weather - that's what it takes to make a successful county fair concert. Talent buyer Variety Attractions works with county fairs in the Upper Midwest to line up musical artists. They tell Mid-West Farm Report what the hot music bands are for 2025.Katie Burgess, Ever.Ag, says volatility is back in the Class III market with large swings up or down day by day. Post-inauguration, she says the talk of a possible trade war with Mexico would not bode well for dairy. Regardless of the risk coming your way, she advises looking into the Dairy Margin Coverage program. Enrollment opens Jan. 29.See omnystudio.com/listener for privacy information.

Send us a textLast month, the FAA announced changes in screening for color vision deficiency.  On this episode we discuss what pilots will be directly affected and address some of the common questions being asked right now by our patients and aviation medical examiners across the country. What tests will be allowed? What happens if my AME doesn't have one of the new approved computer-based color vision screening tests? What happens if I have a color vision waiver now with a Class III medical and want to move up to a Class I or Class II certificate?

Today's dairy market is global. In our latest episode of The Milk Check, we dive into the New Zealand and Oceania markets to understand how they may impact the U.S. dairy market. Join Jacoby and our two special guests Jo Bills, ag market analyst and director of global Insights at Ever.Ag, and Steve Spencer, managing Director at Ever.Ag as we dive into dairy. Tight global supplies of skim milk powder and strong demand will likely keep prices high through 2025 New cheese plants in the U.S. market increase Class III supply and may drive cheese prices down and limit powder output, tightening global powder supply New Zealand enjoys tariff-free access to the Chinese market, but China's economic woes have reduced dairy demand Lower Chinese demand pushed New Zealand to focus on skim milk powder, butterfat, and cheese And lots more information on the global dairy market and our predictions 2025. We have a positive outlook for dairy in 2025, but cheese may be our wild card. Get the market scoop from the Jacoby team, including Ted Jacoby, III, CEO & President, Cheese, Butter & Dry Ingredients; Josh White, Vice President, Dairy Ingredients; and Diego Carvallo, Director of Dry Dairy Ingredient Trading. Intro (with music): Welcome to The Milk Check, a T.C. Jacoby & Company podcast where we share market insights and analysis with dairy farmers in mind. Ted Jacoby, III (T3) Hello, everybody, and welcome to The Milk Check. This month, we are excited to welcome special guests Joanne Bills and Steve Spencer from Freshagenda to share their thoughts on milk production and dairy demand in Asia, Oceania, and internationally for 2025. Joining us from the Jacoby team are Josh White and Diego Carvallo from our dairy ingredients team. Welcome, everybody, and thank you for joining us today. Steve Spencer: Thank you, Ted. It's great to be here. We enjoy these. We've done a few of these, so it's always good fun. T3: We're about to enter year two of China's tariff changes regarding New Zealand dairy products and how they are imported into China. For our audience, many of whom are dairy farmers here in the U.S., why don't you give us a quick overview of those changes? Then, we can discuss what that has meant for dairy markets in that region and how it affects dairy prices. Steve: In basic terms, New Zealand has tariff-free access to the Chinese market. That was preset for an extended period. They were on a slow rundown of tariffs over a long haul. A few years before that was due, they had a review, and it seemed to be that that was just a little period to push it out a bit longer, and that's in the rearview now. So, we're in a very tariff-free environment for New Zealand exports, which you'd think has freed them up to go wild. The only trouble is China's not a market that is allowing many people to go wild right now because that's come at the same time as China hitting a phase of the second wave after Covid; the second wave lockdowns were much harsher, much longer, much more damaging to the economy and so that's crippled demand for dairy in many parts of the market because spending, consumer spending has been depressed and many things are contributing to that right now and that's still a happening thing. So, that has freed New Zealand up to grow its share of the market in skim milk, powder, cheese, and butterfat and they've certainly done that at a time when the import volumes are a lot lower. So, we've got to sit back and look at the overall trends in China. We think they're just off the bottom regarding those import trends, but New Zealand has certainly picked up share, and their exports to China are falling. You could take the story of product by product because the products that China isn't producing or doesn't produce, skim milk, powder, butterfat, cheese, a small production of those, really the trade is probably following the pattern of demand we're seeing in that market.

Today's dairy market is global. In our latest episode of The Milk Check, we dive into the New Zealand and Oceania markets to understand how they may impact the U.S. dairy market. Join Jacoby and our two special guests Jo Bills, ag market analyst and director of global Insights at Ever.Ag, and Steve Spencer, managing Director at Ever.Ag as we dive into dairy. Tight global supplies of skim milk powder and strong demand will likely keep prices high through 2025 New cheese plants in the U.S. market increase Class III supply and may drive cheese prices down and limit powder output, tightening global powder supply New Zealand enjoys tariff-free access to the Chinese market, but China's economic woes have reduced dairy demand Lower Chinese demand pushed New Zealand to focus on skim milk powder, butterfat, and cheese And lots more information on the global dairy market and our predictions 2025. We have a positive outlook for dairy in 2025, but cheese may be our wild card. Get the market scoop from the Jacoby team, including Ted Jacoby, III, CEO & President, Cheese, Butter & Dry Ingredients; Josh White, Vice President, Dairy Ingredients; and Diego Carvallo, Director of Dry Dairy Ingredient Trading. Intro (with music): Welcome to The Milk Check, a T.C. Jacoby & Company podcast where we share market insights and analysis with dairy farmers in mind. Ted Jacoby, III (T3) Hello, everybody, and welcome to The Milk Check. This month, we are excited to welcome special guests Joanne Bills and Steve Spencer from Freshagenda to share their thoughts on milk production and dairy demand in Asia, Oceania, and internationally for 2025. Joining us from the Jacoby team are Josh White and Diego Carvallo from our dairy ingredients team. Welcome, everybody, and thank you for joining us today. Steve Spencer: Thank you, Ted. It's great to be here. We enjoy these. We've done a few of these, so it's always good fun. T3: We're about to enter year two of China's tariff changes regarding New Zealand dairy products and how they are imported into China. For our audience, many of whom are dairy farmers here in the U.S., why don't you give us a quick overview of those changes? Then, we can discuss what that has meant for dairy markets in that region and how it affects dairy prices. Steve: In basic terms, New Zealand has tariff-free access to the Chinese market. That was preset for an extended period. They were on a slow rundown of tariffs over a long haul. A few years before that was due, they had a review, and it seemed to be that that was just a little period to push it out a bit longer, and that's in the rearview now. So, we're in a very tariff-free environment for New Zealand exports, which you'd think has freed them up to go wild. The only trouble is China's not a market that is allowing many people to go wild right now because that's come at the same time as China hitting a phase of the second wave after Covid; the second wave lockdowns were much harsher, much longer, much more damaging to the economy and so that's crippled demand for dairy in many parts of the market because spending, consumer spending has been depressed and many things are contributing to that right now and that's still a happening thing. So, that has freed New Zealand up to grow its share of the market in skim milk, powder, cheese, and butterfat and they've certainly done that at a time when the import volumes are a lot lower. So, we've got to sit back and look at the overall trends in China. We think they're just off the bottom regarding those import trends, but New Zealand has certainly picked up share, and their exports to China are falling. You could take the story of product by product because the products that China isn't producing or doesn't produce, skim milk, powder, butterfat, cheese, a small production of those, really the trade is probably following the pattern of demand we're seeing in that market.

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities.Key Timestamps:00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message03:15 – Introduction to Dr. Mike Drues and his background in PMAs05:45 – Overview of PMAs and when they should be used11:30 – Are PMAs the only pathway for Class 3 devices?16:20 – Types of PMAs: Traditional, Modular, and Streamlined22:40 – Advantages of PMAs compared to 510(k)s and de novos27:50 – The strategic use of predicates in the PMA process33:00 – Clinical data requirements and misconceptions for PMAs41:10 – Post-market requirements and differences for PMA devices47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals54:30 – Final thoughts on overcoming industry resistance to PMAsStandout Quotes:"Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues"Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues3 Key Takeaways:PMA Isn't the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden.Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market.Clinical Data Isn't Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies.References:Previous Greenlight Guru Webinars by Dr. Mike DruesGreenlight Guru's QMS SoftwareEtienne Nichols' LinkedInMedTech 101:PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements.Audience Engagement:Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you...

In this episode of the Uplevel Dairy Podcast, host Peggy Coffeen dives into the current landscape of dairy markets with Curtis Bosma from HighGround Dairy. The episode starts by giving listeners an overview of recent trends in dairy futures, including notable gains in Class III and Class IV prices and the implications for dairy producers. Curtis shares insights on the influence of managed money in the commodity markets and what this indicates about future market movements.Throughout the episode, Curtis discusses the critical impact of diseases such as the Blue Tongue virus in Europe and the H5N1 avian influenza in California. He highlights how these events affect global and local dairy production and what dairy farmers need to watch for regarding their milk supply and pricing. Curtis also offers advice on how dairy producers can navigate these tumultuous times by leveraging risk management strategies.The episode wraps up with an in-depth conversation about valuing corn silage, especially during the current harvest season. Curtis breaks down the various factors that should be considered, from managing shrinkage to understanding the financial implications of either growing or purchasing corn silage. This timely discussion is aimed at helping dairy farmers make informed decisions about their feed strategy to ensure financial stability and operational efficiency. Grab your September Market Report Here:  https://marketing.highgrounddairy.com/producer-market-update-september-2024. Information shared in this podcast is for educational purposes and is not a solicitation to buy or sell commodities.  Opinions expressed are current opinions as of September 18, 2024 at 10 a.m. CST and only represent the views of the speaker and not those of HighGround Trading, unless otherwise expressly noted.

In this episode, Nick and Don catch-up with Bluberi's Chief Product Officer, Mike Brennan, and Chief Commercial Officer, Casey Whalen. Learn how an insurgent supplier with roots in Quebec is parlaying a string of surprise hits into some of the most exciting product offerings for the Class III slot space. Hear about their design philosophies, banking strategies, release plans, cultural imperatives, and (music to our ears) obsession with fair share performance. Also in this episode, G2E 2024.  © 2015 -2024 RM Holdings B.V. and ReelMetrics B.V. All rights reserved.For transcripts of ReelCast episodes, please see https://www.reelmetrics.com/reelcast.For legal statements apropos of this and other ReelMetrics content / "Materials", please see https://www.reelmetrics.com/legal

Just last week, the legislative session for the year ended in Sacramento meaning a batch of legislation was passed that, if signed into law by Governor Gavin Newsom, would change the way the state conducts its transportation business. In this episode of SGV Connect, co-host Damien Newton goes it alone, interviewing Streetsblog California editor Melanie Curry. As an aside, both Newton and Curry will be at the Streetsblog San Francisco/Streetsblog California anniversary party next week at Manny's in the Mission on Thursday, September 12, at 6:00 p.m. along with a bevy of transportation reform superstars including mayors, transit board chairs and Senator Scott Wiener. If you happen to be in the area, drop by and join us. Reserve your ticket, here. But for now, buckle in and enjoy today's podcast. A full transcript can be found beneath the audio player below. Damien   Before we get into the podcast, let me remind everyone that SGV Connect is supported by Foothill Transit, offering car-free travel throughout the San Gabriel Valley with connections to the new Gold Line Stations across the Foothills and Commuter Express lines traveling into the heart of downtown L.A. To plan your trip, visit Foothill Transit. “Foothill Transit. Going Good Places.”   Hello, welcome to SGV Connect episode 127. My name's Damien Newton. We have a bit of a throwback episode here in that I am doing it on my own - or well, I'm not on my own, I have a guest: Melanie Curry, the editor of Streetsblog California, who's going to give us an update on legislation that has been passed and is awaiting the signature of the governor…hopefully.   We timed this episode to coincide with our Streetsblog San Francisco/California anniversary dinner next Thursday. If you'd like to join us on September 12, click here for more details.   And a link with all the information is in the email, excuse me, in the text of the story that accompanies this podcast. Boy, I'm struggling today, Melanie. I hope you're on your A game.    …and she gave a thumbs up. You guys can't see that because we're not recording the video.   All right. So it just so happens that the first couple pieces of legislation we want to talk about were authored and introduced by Senator Scott Wiener, who happens to be one of our guests of honor next week.   Isn't that an amazing coincidence? So why don't you start off by telling us a little bit about these two pieces of legislation? And again, these are passed by the legislature, but awaiting signature or possibly something worse from the governor.   Melanie Oh, we don't want it to be worse.    This is one of the reasons that we are giving a Streetsie to Senator Scott Wiener - because he got SB 960, a complete streets bill, passed… again. He's tried three times with this bill and last time it was vetoed by the governor. So we're crossing our fingers that that doesn't happen again.   It's a little bit different this time around. Caltrans pushed just as hard against it as it had in the past. They keep saying, “we're already making complete streets a priority.”   Damien …um…are they already making complete streets a priority?   Melanie It's hard to say. At the headquarters level, their talk is good, but how it comes out on the ground is a different story. CalBike is working on a report about that very issue, which they're not quite ready to release, but we'll find out soon what they have to say.    At any rate, Caltrans says they have a complete streets policy. But they're not really doing it. So what happened with SB 960 is Caltrans pushed back. They got language that they are more comfortable with, which is kind of similar to what they already have: they'll make complete streets when they are working on maintenance projects where feasible, which still gives them kind of a lot of outs.    However, the bill is a lot stronger than last time around. It specifically includes a requirement to create a transit priority policy at Caltrans - which is a huge difference. It requires better transparency, so Caltrans has to report on their complete streets and how much money they're putting into it.    It also requires them to come up with a shorter encroachment permit process - which sounds really wonky and kind of is - but it makes it easier for cities to make their own changes on their streets if they want to build a bike lane or something like that without having to go through  the onerous process that Caltrans makes them do..    Anyway, it's been passed. We've got our fingers crossed. It's not the solution, but it's a really good step in the right direction for making Caltrans make complete streets on all of their facilities when they are repairing them..Not freeways, but all the other ones.   Damien If this is a stronger piece of legislation than last time, doesn't it seem less likely that Governor Newsom will sign it?   Melanie Well, it's interesting. It's stronger in ways that are outside of the when and where. It's stronger because it has transit priority, which it didn't before. It's stronger because it calls for better transparency and a shorter permit process. But in terms of requiring when and where complete streets are to be incorporated into Caltrans projects, it's really similar to what the current Caltrans policy is.    It's kind of an interesting argument. [Newsom] said “give Caltrans a chance” when he vetoed a similar bill in the past. But at that time, there was a new Caltrans director. So they got a chance. That was four years ago. They had their chance. We haven't seen any results. So we're back with this bill.   I think it will take something to get the governor to sign it, but it might not be as onerous as it would have been four years ago. I mean, weigh in, call the governor! I don't know. It definitely needed support to get passed by the legislature, but I think it has a better chance than the last one did.   Damien But that's not the only thing that Senator Wiener's done that has him on our list of “legislation to talk about today.” He's also done something with passive speed enforcement. You might need to explain this one a little bit.   I know you just did a story on it, and I read the story. I could totally talk about this if I had to, but, you know, people would rather hear you talk about it than me.   Melanie Are you sure?   Damien I assume.   Melanie I don't know. My voice can get a little whiny. No, it's not enforcement. It's assist. So it's in-car technology that tells people, hey, you've gone over the speed limit. And it does that with, like, a beep.    So this one was going to be a great bill. We were excited about it when Wiener first [introduced it] because he was looking for something more active - which is also a, technology that exists where … it prevents you from going over the speed limit. But that was just too crazy. So - not too crazy, it's a known and used technology. European cars have it. But there was too much pushback. So he said, “OK, passive speed limit assist technology in all new cars starting in 2030.”   And that passed. And you know it's better than nothing. A lot of new cars already have this technology…   Damien …almost every rental car too   Melanie It would be very surprising if it didn't get passed. It's a help. There's actually surveys that show that drivers like it.   And what's really strange to me is that about six or seven Republican legislators in California wrote this strongly worded letter to Governor Newsom telling him to veto it because enforcement is a better way to [handle this issue]. And they said it puts an “undue burden on the majority of responsible drivers,” which, uh, wait a minute.   Damien Wait, but they're speeding, right?   Melanie Yeah. Yet it's an “undue burden.” Like it's going to beep at you. Like one beep. It's only a one-time notification. So I don't know where they get any of that, “Undue burden on responsible drivers?”    If you're going over the speed limit, wouldn't you want [your car] to tell you? I don't know. I really don't know where this comes from. I imagine all of them just want to speed like crazy for as long as they want to.   Damien These are the people that obviously rent rental cars and then speed in them.   Melanie And they don't like that one beep.   Damien They don't like that beep…Not that I know from my recent road trip what that sounds like.   Melanie Does it continue or is it just one [sound]?   Damien I think it depends. The car that we had, it beeped every time you went 10 miles over the speed limit. So, we obviously heard it once and then adjusted our driving for the rest of the drive across the country because, yeah.   Melanie Yeah. Right. Which is what people want. You know, like what if you're in a place that you don't know? What if you're driving in Oregon and there might be a cop that's going to pull you over?   Damien Or what if the speed limit drops and you miss the sign?   Melanie Exactly.   Damien If we drove through a county and you know at the speed limit dropped 10 miles an hour, and then all of a sudden we went from driving roughly the speed limit to driving 10 miles over the speed limit…that's where we were.   Melanie And that's where you're likely to get a ticket, too. So it's really helpful to be told by your car.   Damien Was it the ticket lobby that was against this?   Melanie You know, I don't know who those people are. I don't know if they're a lobby. They're just Republicans. I could find the letter and read you their names if you want, but they're Republican legislators who just hated it.   Damien I'm just flashing back, as I always do, to the efforts to set the speed limit…legislation that we fought for for so long and finally got passed by Laura Friedman a couple of years ago, and the dumb arguments we would hear about it.   Melanie Yeah, it's weird to me…. I'm looking at some of the names of the people that signed it, and I have to say some of them say some really dumb things in the hearings.   So I don't want to say they're dumb, but they're not very well informed.   Damien We can say that if you want to.   Melanie And this letter proves that…And they have an agenda that doesn't make a lot of sense.    Just the idea there, they are law-and-order Republicans and for some reason they really love the idea of giving people tickets to enforce this [issue]. I don't understand their thinking. I have the feeling that's not going to have much sway with Governor Newsom. Who knows?   Damien I mean, you never know these days. And he's been… he's been more conservative in the past year than I would have thought.   Melanie Yeah.  I'm not a politician for a reason. I don't understand the way you think about things when you're a politician. It's not always logical.   Damien Speaking of not always logical, let's talk about a bill that had to do with when you can and can't paint sharrows that was passed, but without the support of its initial sponsor, Streets for All…So what happened there?   Melanie Gosh, who knows. So, this is SB 1216 from Catherine Blakespear.   This was also a[similar]  provision in another bill from Laura Friedman, AB 2290, but that one was just held back. It didn't go anywhere.    So what this was trying to do was limit the use of Class III bike routes, which are, you know, they are signs and sharrows painted in the street, at most. They might just be signs, but they were really trying to get away from calling those even bike routes. People like Caltrans will put them down and say, “look, we made you a bike route.” But they don't really have any kind of good standards for when they use them, so the legislature tried to limit their use..    Plus, [the sponsors] wanted to eliminate funding for those projects. And actually, they sort of succeeded. When it was in the Assembly [Transportation} Committee, the bill was amended to restrict sharrows to roads that are 30 miles an hour or slower.    Imagine riding your bike at, what, 10 miles an hour on a 30 mile an hour road, and there's a sharrow there telling you to go ahead and use it. So whoever decided that 30 miles an hour or slower made sense is not a bike rider. And [the committee] would not remove any limitation on using bike route signs, so they can mark a bike route wherever they want, which doesn't also doesn't make sense.    Thinking of fast streets in the San Fernando Valley, for example, they could just call those bike routes. So when you look on Google Maps, it's going to tell you to go that way…and you get out there and you're like, “ah, I don't want to ride this road.”    It was so bad that the sponsor, Streets for All, just gave up. But! One good thing about that bill is it does have a provision that says that … Active Transportation Program projects can no longer use [ATP funds] for Class III bike routes, after January 2026.    I have a feeling that it doesn't really do that much anymore because the people who run the program are pretty aware of what makes a good bike route or a good bike project, and Class III doesn't really count. However, Caltrans is still going to use class III bike routes and claim credit for creating bike facilities. We have to keep our eye on that.   Damien One piece of legislation that we covered in our Santa Monica publication is Malibu would now be able to put speed cameras on the PCH as part of the pilot program.   There's a lot of reasons this is interesting.    A) that so many communities want to get in on a pilot program. There were three cities in Senator Ben Allen's district, but only Malibu made it on this piece of legislation.  B) is the need for this extremely complicated pilot program that a year after the legislation was passed, no cities actually have speed cameras up. Yet they're allowing other cities - and yet we [already] know from the entire rest of the world that speed cameras work - to join this complicated pilot program.   Do you want to talk at all about this legislation, what it actually does, and if maybe I took all of the thunder away on the interesting things, tell me to be a better interviewer. But if I did not, then fill in some other interesting things about this.   Melanie SB 1297 from Senator Ben Allen adds the city of Malibu to the speed camera pilot program that was created by AB 645 last year. That was from assemblymember Laura Friedman that allowed Glendale, LA, Long Beach, San Jose, Oakland, and San Francisco to do pilot programs with a limited number of cameras under all these really tight restrictions about where they could be, how they could be deployed, how they collected information from them, how they gave tickets, and they had to keep the the tickets out of the court system, and the fines had to be low and all kinds of really really tight restrictions.   None of those cities, as far as I can tell, have put up any cameras yet.   San Francisco, Oakland, and San Jose have chosen locations for them, but they're not going to install them until next year. I can't find out about the other cities. At any rate, the city of Malibu will be able to add five cameras along the Pacific Coast Highway in Malibu [under this bill].   So what do we do about all the other cities like Santa Monica that might also want to put up speed cameras? They're all gonna have to wait. There's so much pushback from privacy groups and law enforcement, all these people who object to these programs. For law enforcement, this will make their life easier, but okay, whatever.   Damien The whole thing baffles me. Allen introduced this after there was a high profile crash that killed a bunch of Pepperdine students standing on the side of the road late last year. The PCH in Malibu has always been a safety disaster for bicyclists, for pedestrians, for car drivers, for everyone. Allen tried to address this - there are several different project programs that are going on, educational programs, enforcement programs…this effort was sort of added on to those.   But as soon as he announced it, all the other cities in his district were like, “ooh, us too, us too.”   Because cities want these. It just feels weird to me that the state is making it so hard, with a cumbersome pilot program and only certain cities.   This feels like an effort to keep them out, not an effort to promote them.   Melanie Yeah. What's fascinating to me about it is one of the arguments - which is a valid argument - against this was that street design is a more [effective] way to slow people down.   Yes, it's true. So one of the provisions in the original bill is that other street design changes had to be made. And especially if they put up a camera and it didn't slow speeds, then they had to make those street design changes.    Well, PCH really needs some design changes. And the ones – the responses that they have [had] to that crash are just pathetic. I'm sorry, they put up speed feedback signs and they put up signs. Education, enforcement, those are fine, but those are not the kinds of things that make people slow down or actually change the street so that people have to drive slow.   We just have so much resistance to creating calm streets. And because the PCH is such a heavily used thruway, people want to zoom on it. It doesn't make sense for people to be zooming on it. But it's just part of our speed culture that we just can't change [yet]. It's a bummer.   Damien I say romantic, I don't necessarily mean romance; but how many pop culture references over the years feature the hero or heroine in their convertible speeding up the PCH?   Melanie Absolutely. It's glamorized for sure.   I say people who want to go fast and feel the wind in their hair should roll their windows down and stick their heads out the window while they drive and feel the wind that way because it feels like you're going fast even if you're going like 20 miles an hour.   Damien Is it a little weird to hear the argument that it's road design that really slows streets down so we can't…we shouldn't do speed cameras 10 minutes after we were just discussing how Caltrans doesn't want to be mandated to do safe road design.   Melanie Yeah, we're in a very strange tangle trying to make sense out of all of this.   I mean, we can see it, advocates can see it. But the arguments can be complicated. I maintain hope that we will prevail sooner or later. And it's partly because we have super smart people working on these issues. But man, it's not easy. It's not easy.   Damien There was one more piece of major legislation we wanted to talk about before we might run down some of the other pieces, and that was what's been going on with e-bikes. It doesn't appear like there's much of an effort to make statewide e-bike policy. Instead, it's an effort to define what different communities can and can't do.   Melanie Yeah, and I wouldn't even call these major legislation.   Both of the authors of these two e-bike bills, [Assemblymembers] Tasha Boerner and Damon Connolly, had started off with bills that were going to require a license to ride e-bikes, at least class 2 or class 3 e-bikes. I'll go over the classifications in a minute. They're all about speed and throttle and stuff like that. But it became pretty clear those bills were not going anywhere. So both of them changed them.    In Boerners case San Diego and in Donnelly's case Marin County - they allow local jurisdictions to create e-bike restrictions.    Borners would allow San Diego to pass an ordinance banning children under 12 and from riding class 1 or 2 e-bikes. You have to be 18 to ride a class three e-bike [already]. What is a class 3 e-bike? Let's see, [it's] a little complicated: You have to use the pedals. You can't use just the motor, but it can go up to like 28 miles per hour using pedals.   You have to be 18 to ride that kind of bike. So Boerner wants it to change it so no one under 12 can ride a class 1 e-bike, which has a little bit of pedal assist up to 20 miles an hour at the most, or class 2, which has a throttle assist up to 20 miles per hour. And then after that, you would have to use your pedals, but [a class 2] could go 28 miles per hour.   Connelly has a similar bill, but he doesn't want anyone under 16 [to ride]. So [his bill would] allow Marin to pass an ordinance to require people to be at least 16 to ride a class 2 e-bike. And they could, if they wanted to, [also] pass an ordinance requiring any e-bike rider to wear a helmet. Even adults.    So it's a problem because they're inconsistent. They're local ordinances. Local helmet ordinances from the get-go are a bad idea. There's a lot of people from Berkeley who ride into Marin. So like, what are they going to do suddenly? There's a different law for them over there?   Damien I remember down here when one city was talking about banning scooters and others weren't, and it was like, well, what's gonna happen to someone riding on a scooter when they cross a border…Is it just gonna, like, stop?   Melanie Yeah. Well, yeah, actually they can. They do put speed limiters on scooters! Not cars…not cars where they could really do some good.    Those [bills] are like mostly annoying. They both passed, though. They're on the governor's desk. He may well sign them. Whether San Diego and Marin County passed those ordinances is a different question.   Another e-bike bill was from Senator Dave Min, which is kind of [an] interesting [one]. First it says that any e-bike sold in California has to have an e-bike battery that is certified to be safe, either the UL or the EU certification [or the like]. People are worried about battery fires and that would prevent that.   It's not without its controversy because when they were talking battery standards for the e-bike incentive program, there were a lot of bike sellers who were mad about that. They were selling bikes that didn't have that certification. And they were like, “they're fine!    But anyway, that passed. So if he signs it, they'd have to be certified.   And then the other thing that [the bill] did was clarify the definition of e-bikes. The reason that was an issue was because there is at least one manufacturer that makes these bikes that they sell as class 2 ebikes.    So class 2 has a throttle assist and you can go with the throttle up to 20. With pedaling you can go up to 28 miles an hour. So they were selling these as class 2 e-bikes, but they had a switch on them that would allow them to go “off-road.” [That would allow them to] go way faster with just the throttle, which means they're basically mopeds. Min's bill made those illegal. If  you sell something that's switchable, it's not an e-bike.   Wait, it's not illegal. It's a moped, which means, you know, age restriction and helmet restriction, etc. Because if you can go over 28 with a throttle, it…Yeah, that's not an e-bike.   And the thing is, like, how do you enforce that?   Can a cop tell from looking at it whether a bike is an actual class 2 e-bike or is it something else?   Damien So let's try and run down the rest of the legislation we had that we were going to at least touch on today.   Melanie Just a few things…One thing that passed that I think is really important because it makes me nervous is Assemblymember Aguiar-Curry worked really hard to get a bill passed that said you could not have any autonomous vehicle big rigs being tested on California roads unless there was a human operator present.   It was amazing how hard she had to argue for this.   Newsom had vetoed a similar bill last year, so he may veto this again. But meanwhile, the DMV is already … starting to put out draft regulations… for autonomous big rigs.   Isn't that fun to think about: driving on a road like Highway 5 and knowing the truck next to you has nobody in it?   If he signs this, there will have to at least be a person in the vehicle.   Damien Yeah, he's not, he's not signing that, I bet.   Melanie Maybe I can just like curl up in a ball and stay home for the rest of my life. Or they hurry up with that train so I don't ever have to get on a highway again.   Damien You saw the video? I mean, it looks like it's just about finished.   Melanie Uh no… but okay it's happening.   I would say one more more [bill] that's kind of cool is AB 2503 which gives a CEQA exemption for zero emission trains. There's a problem with that, of course, as it's another way that they're poking holes in CEQA instead of just reforming CEQA, and also it specifically says zero emission trains and people are still calling hydrogen trains zero-emission trains, and they don't understand why I refuse to do that. So, okay…a CEQA exemption for clean energy trains.   We need that, but still it's not great.   Senator Blakespear had got passed SB 689 so that you would not need to conduct a study to convert a vehicle lane into a bike or a transit lane in coastal areas. That was specifically to overcome problems with the Coastal Commission process.    And then there's another one, AB 3177. Streets for All sponsored it, and it's a little wonky. It says that you cannot require a new housing project to pay a mitigation fee to be used towiden a road. So that's big. And then there's one more, AB 2086, which calls for more transparency from Caltrans -  they have to create a dashboard that shows their funding which is very complicated   None of these have been signed, however.   Damien Right. None of these have been signed. Based on previous years, some of them might not be slam dunks, but if people have heard anything today that they want to weigh in on - again, you can contact your governor. Sorry. It's a little play of words off the, you know, contact your representative today. Contact your governor. It's the same governor I have. I think he's in state right now. So it's a good time to get him   So again, if you want to talk to us about this in person, we will be in San Francisco next week at Manny's in the Mission at 6 PM on Thursday. Feel free to stop by. Feel free to buy a ticket. Feel free to say hello. More information on that event is on Streetsblog California and Streetsblog  San Francisco, and of course, links to all of that are included with the text that accompanies this podcast.    Thank you for your time today, Melanie, and we will talk to you again probably at the end of the year. We'll talk about which of these bills have been signed and not signed and what we're looking forward to in 2025, which is getting closer.

The Class III milk and cheese prices have seen fireworks in the past few weeks. Ryan Yonkman, the vice president of producer services for Ever.Ag, says it's due to bullish buying events and reports stacking up on each other.See omnystudio.com/listener for privacy information.

Ryan Yonkman, the vice president of producer services for Ever.Ag, says it's due to bullish buying events and reports stacking up on each other.

The Class III milk and cheese prices have seen fireworks in the past few weeks. Ryan Yonkman, the vice president of producer services for Ever.Ag, says it's due to bullish buying events and reports stacking up on each other.

We kick off our Ian Marter retrospective with a look at his time at Oxford University. Thanks to back issues of St. Edmund Hall Magazine, we uncover new information that places Marter at Oxford three years earlier than is widely and incorrectly reported in other published sources. From our research, we found that Marter was at St. Edmund Hall, aka Teddy Hall, from 1963-1966 and was heavily involved with drama in the college's John Oldham Society and the Oxford's drama cuppers.Before Oxford, Marter went to school at the Beckenham and Penge Grammar School in Greater London and went to Oxford on a scholarship to study English language and literature. Among other highlights, Marter directed a well received production of John Osbourne's Luther in 1964 during the Trinity Term of his freshman year at the Oxford Playhouse. He also acted in productions of Fire in Heaven, The Sport of My Mad Mother, and Anton Checkov's The Cherry Orchard. In his final year at St. Edmund Hall, Marter co-starred in Samuel Beckett's play, Waiting for Gadot and was in Richard Burton's production of Doctor Faustus, by Christopher Marlowe which was also released as a film in 1967, giving Marter his first screen credit. Marter was awarded a Class III degree from St. Edmund Hall, which may help explain why he never corrected the record about his time at Oxford.After leaving Oxford in 1966, he landed an assistant stage manager job at the Bristol Old Vic and by the following year, he was acting once again. We briefly talk about his small role in the Vincent Price horror film, The Abominable Dr. Phibes, and his reoccurring role in ITV's Crown Court where he played a police constable and then barrister, Quentin Ingrams, QC. Finally, we discuss being cast as Lt. John Andrews in "Carnival of Monsters" and how Doctor Who may have been different if he landed the role of Capt. Mike Yates a few years earlier. The opening and closing music is "Sinfonietta: IV. Allegrteto," composed by Leoš Janáček and performed by the Pro Arte Orchestra, which was the opening theme for ITV's Crown Court. We recorded this episode on 12-13 August 2024.

In this episode, Nick and Don speak with Derik Mooberry, CEO of Zitro USA. Learn about Zitro's rise from niche electronic bingo provider to a global supply-side powerhouse, its plans for the North American market, and the company's increasingly compelling Class III slot portfolio. Also in this episode, leveraging superstar inventory to dial-back free play. © 2015 -2024 RM Holdings B.V. and ReelMetrics B.V. All rights reserved.For transcripts of ReelCast episodes, please see https://www.reelmetrics.com/reelcast.For legal statements apropos of this and other ReelMetrics content / "Materials", please see https://www.reelmetrics.com/legal

This quarter two seismic shifts occurred in the United States and Germany with a common denominator: the DEA advanced the rescheduling of cannabis from a narcotic to a Class III drug in the USA, and Germany completed the rescheduling with passage of the Cannabis Reform Law April 1. However, the implications are different for the two largest cannabis markets. Join us for a fireside chat with Arthur de Cordova, a former Country Manager for AstraZeneca in Europe, and CEO of Ziel.

Andy discusses his background growing up on a farm and how it shaped his work ethic. He talks about his experience founding Engineering Consultants and working with medical device startups. Key topics include challenges in commercializing devices, balancing an inventor's vision with engineering feasibility, and advice for engineers entering the field.Main Topics: Medical device regulationsChallenges in commercializationBalancing an inventor's visionStem cell and gene therapy advances in ophthalmologyAdvice for young engineers About the guest: Andy Schieber is a seasoned medical device engineer and entrepreneur with extensive experience in research and development. He is the Founder and President of Ingenarious Consultants, a firm that specializes in early-stage medical device development, offering services from concept to clinical trials. Andy has a remarkable track record in designing and developing Class III implantable medical devices, and he holds over 40 patents including the Hydrus Microstent, which is a significant innovation in ophthalmology.He also serves as the Head of Engineering at Rivermark Medical, where he contributes to the development of novel medical technologies. Andy's educational background includes a Master's degree in Mechanical Engineering from the University of Minnesota and a Bachelor's in Engineering from the University of Wisconsin-Stout​.Links:Andy Schieber - LinkedInIngenarious Consultants WebsiteAbout Being An Engineer The Being An Engineer podcast is a repository for industry knowledge and a tool through which engineers learn about and connect with relevant companies, technologies, people resources, and opportunities. We feature successful mechanical engineers and interview engineers who are passionate about their work and who made a great impact on the engineering community. The Being An Engineer podcast is brought to you by Pipeline Design & Engineering. Pipeline partners with medical & other device engineering teams who need turnkey equipment such as cycle test machines, custom test fixtures, automation equipment, assembly jigs, inspection stations and more. You can find us on the web at www.teampipeline.us

The Class III milk market has experienced significant volatility recently, with prices fluctuating and market participants seeking clear direction.  NAFB News ServiceSee omnystudio.com/listener for privacy information.

Summer is here, and the high-water season for recreational paddlers has reached Colorado's iconic rivers. While Colorado manages 43 state parks, the Arkansas Headwaters Recreation Area is among the most unique in that it spans across a 152-mile corridor that follows the Arkansas River from the high mountains near Leadville to Lake Pueblo.AHRA isn't only a whitewater destination, though. It also boasts eight developed campgrounds and 19 dispersed camping areas while also offering gold-medal fishing, incredible wildlife viewing and hiking and climbing opportunities.Still, it's the whitewater that many think of first when it comes to AHRA. It's one of the nation's most popular rafting and kayaking destinations and is the most commercially rafted river in the United States.Along with that many boaters and stretches of Class III to Class V rapids comes challenges for CPW staff. AHRA rangers have already responded to multiple rescue calls this year, and there has already been one kayaking fatality in early June.In this episode, hear from AHRA Manager Tom Waters and River Ranger Supervisor Jeffrey Hammond on what it takes to manage AHRA, the diversity of the rescue and recovery situations they find themselves in and the ever-present danger that comes with whitewater recreation

Episode 1: CME spot cheese prices have rallied 50 cents and nearby Class III milk futures are up $4 to $5 per hundredweight while SMP and butter prices in Europe have rallied. Dave Kurzawski and Fearghal McCabe talk about the markets and what they are seeing.

Tisotumab vedotin garners a regular FDA approval for metastatic cervical cancer with OS benefit data. A lingering question that demands a focused RCT: What is the optimal dose of methotrexate in primary CNS lymphoma? I'm glad I'm not the only one with this question: https://doi.org/10.1177/10781552231176754 What, some BRAF mutations in colorectal cancer might respond to EGFR-mab therapy? https://doi.org/10.1200/OP.21.00160

The Mauston School District picked up one of Wisconsin's Farm-to-School grants, and it's moving their locally grown food effort forward.  Charitee Seebecker finds out what's happening with school coordinator, Jacqui Peyer.Craig Trnka is the CEO of the World Championship Blacksmiths, LLC. He explains how blacksmithing has evolved and gives us perspective into the life of a blacksmith. USDA is implementing new testing requirements for dairy cattle crossing state lines.  It's all about monitoring HPAI in the dairy population. Stephanie Hoff gets the details from Alan Bjerga, from the National Milk Producers Federation.Meet Cierra Essock, one of the six finalists for the Alice in Dairyland position.  Essock is currently an agriculture instructor at Hustisford.  Pam Jahnke visits with her. Bryce Windecker, broker analyst with EverAg, gives Pam Jahnke perspective on how the market's reacting to the USDA announcement, and where the appetite is for cheese and butter.  He says the volatility in the Class III milk market has gotten some attention for cheese.See omnystudio.com/listener for privacy information.

Sponsor: Medboard: https://www.medboard.com/ EU MDR and IVDR national languages update - France accepts English MDR: https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/document/download/1e312d8f-8b34-45da-a5fa-1918ba618aca_en?filename=md_sector_lang-req-table-ivdr.pdf   Which devices for Expert Panel - Active Implantable Device on Top: https://health.ec.europa.eu/document/download/4c43abea-b989-434b-9ac1-94134bf1a538_en?filename=md_annual-overview-cecp-2022-2023_en.pdf 94.4% for Class III implantable and 5.6% for Class Iib Administer or remove medicinal products On Class III implantable - Top is with Active Implantable Devices Exempt devices are mainly within 3 categories (Main reason: Modification of a device already marketed): Vascular and cardiac prostheses Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligaments synthesis Implantable prosthetic and osteosynthesis devices     Annex XVI: Is Brain Stimulation device risk? -  SCHEER should evaluate by End 2025: https://health.ec.europa.eu/document/download/e6de1e88-2821-48f6-98f9-a56ea61cbfad_en?filename=scheer_q_031.pdf SCHEER = Scientific Committee on Health, Environmental and Emerging Risks   SCHEER on Phtalate - Update of the guidelines: https://health.ec.europa.eu/consultations/scheer-public-consultation-preliminary-update-scheer-guidelines-benefit-risk-assessment-presence_en Consultation until April 28th, 2024   MDCG subgroup Agenda - What is coming?: https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf MDCG 2024-3 on CIP - Clinical Investigation: https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en.pdf New Notified Body RISE Sweden - Welcome to the team 3033: https://api.tech.ec.europa.eu/nando-prod/files?repo=nando&id=d37c034bc695d2e143b5145b4cb7cd73caf8983c&group=NOTIFICATION&download=true 44 MDR NB 12 IVDR NB   UK MHRA: Electrical Devices in Clinical Trials - Advice on application with separate document: https://assets.publishing.service.gov.uk/media/65fb0d66aa9b76001dfbdc28/MHRA_Electrical_Guidance_for_Clinical_Investigations_Modified_12_Feb.pdf Ireland HPRA Newsletter- IVD, Eudamed, Custom-made, Clinical trials: https://www.hpra.ie/docs/default-source/publications-forms/newsletters/hpra-medical-devices-newsletter-issue-57-february-2024.pdf Turkey Reminder on MDR transition period - May 26th, 2024: https://titck.gov.tr/storage/Archive/2024/announcement/duyurumetni_67231ed0-2553-4708-8231-7951c767e066.pdf Turkey strongly inform the different parties regarding MDR transition   Events RAPS Euro Convergence - May 6-8 in Berlin-Germany: https://www.raps.org/europe-2024/home Medtech Conf Map: https://medtechconf.com/event/connect-with-european-andinternational-regulatoryaffairs-peers-in-berlin-2/ Services Packaging for Medical and Pharmaceutical - Design, Manufacturing and delivery: https://easymedicaldevice.com/packaging-for-medical-devices/ ROW USA Ban devices - Electrical Stimulation Devices for Self-injurious or Aggressive Behavior: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans CNN article: https://edition.cnn.com/2024/03/25/health/fda-ban-electrical-stimulation-devices/index.html Comments open until May 28, 2024: https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-proposes-new-ban-electrical-stimulation-devices-self-injurious-or-aggressive-behavior Bans Prosthetic Hair Fibers since 1983 Powdered Surgeon's Gloves since 2017 Electrical Stimulation Devices for Self-injurious or Aggressive Behavior since March 2024     Animal Studie for Dental Bone Grafting devices - Choose the right animal Model: https://www.fda.gov/media/177340/download Minimum of 3 animals Animal Model: Canine and Porcine model instead of rodents   FDA: Deviations on Neuralink lab - Animal Study good practices: https://www.reuters.com/business/healthcare-pharmaceuticals/fda-finds-problems-animal-lab-run-by-musks-brain-implant-company-2024-02-29/ Calibration of equipment's are not done Quality officials not signing documents   Australia Vigilance Reporting in Australia - For Recall and non-Recall: https://www.tga.gov.au/sites/default/files/2024-03/uniform-recall-procedure-therapeutic-goods-urptg.pdf Recall action Template: https://www.tga.gov.au/resources/resource/forms/recall-action-templates   Saudi Arabia Guidance on Surgical Sutures - This contains some cheat code: https://www.sfda.gov.sa/sites/default/files/2024-03/%28MDS-G021%29En.pdf Endpoints that should be addressed Laboratories should be ISO/IEC 17025 Shelf life should follow ASTM F1980   Brazil MOU between Brazil and Paraguay - Memorandum of Understanding: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-e-agencia-reguladora-do-paraguai-assinam-primeiro-memorando-de-entendimento Bilateral cooperation on health surveillance Strenghtening regulatory capacity   GMP validity from two to four years - If certified through MDSAP: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-amplia-para-quatro-anos-prazo-de-validade-do-certificado-de-boas-praticas-de-fabricacao Prioritize registration of Dengue Diagnosis Devices - Submit Now: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2024/anvisa-prioriza-registro-de-dispositivos-para-diagnostico-da-dengue Combat dengue epidemic as a matter of urgency   India CDSCO: PSUR through online portal - From April 1st, 2024: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTEwMTI= Online portal: https://www.cdscomdonline.gov.in/NewMedDev/Homepage   Malaysia Malaysia Faster approval - Establishment license application: https://www.mda.gov.my/index.php/announcement/1377-faster-approval-for-establishment-license-application-complete-applications-processed-within-14-21-working-days 14 to 21 Working days from date of application List of documents within the link   China China Guidelines on registration - Specific products: https://www.cmde.org.cn/xwdt/zxyw/20240318133300123.html Corneal Topograph Laparoscopic surgery system Optical Radiation Safety device Monkeypox virus nucleid acid detections agent: https://www.cmde.org.cn/xwdt/zxyw/20240318111545184.html   Podcast Podcast Nostalgia Episode 275 - FDA aligns QMSR with ISO 13485 (Naveen Agarwal): https://podcast.easymedicaldevice.com/275-2/Episode 276 - How to do Postmarketing Surveillance to right way? (Steve Curran): https://podcast.easymedicaldevice.com/276-2/ Episode 277 - How to benefit from Survey to build Clinical Evidence? (Cesare Magri): https://podcast.easymedicaldevice.com/277-2/   Easy Medical Device info@easymedicaldevice.com Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode, Tim Boire and Geoff Lucks at VenoStent and Duane Mancini discuss their background in the Medtech space, how they founded VenoStent, their clinical trial, fundraising strategy, and its correlation to achieving milestones and so much more.

There's a lot of different discussions happening in Wisconsin about affordable health care options for farm families. Our state's largest general farm organizations are bringing it up as a top priority in this legislative session and have brought different strategies to the table. Wisconsin Farmers Union, for example, is asking the state to expand BadgerCare by accepting federal Medicaid expansion dollars. With the expansion, they hope to reach more farmers. Stephanie Hoff gives us some perspective.Potato and vegetable growers are gathered together in Stevens Point through today for their annual winter conference.  Blair Richardson leads Potatoes USA, a trade group looking for new opportunities for U.S. potatoes.  He says that they also have to be concerned about misinformation about potatoes that filters not only to consumers, but also health care providers.  He speaks with Stephanie Hoff in Stevens Point.Fundraising is the primary goal right now for WI FFA Foundation board members.  Past president, Tom Bressler, says WI FFA is experiencing tremendous growth that requires more financial resources to be really effective. It looks like U.S. cheese prices have finally hit bottom and are starting to come back up - a little.  That's the observation Andy Faulman with EverAg shared with Pam Jahnke this morning.  He also reminded dairy producers to keep an eye on dry whey prices.  He explains the correlation on whey prices to Class III milk prices which drive Wisconsin dairies.See omnystudio.com/listener for privacy information.

EU Transition to the IVDR and EUDAMED Roll Out -An extension? Never !!!!!: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-proposal.PDF Measures: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/ip_24_346/IP_24_346_EN.pdf Question and Answers: https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_24_347/QANDA_24_347_EN.pdf Factsheet: https://health.ec.europa.eu/system/files/2024-01/mdr_in-vitro-factsheet_1.pdf   MDCG 2024-1 Vigilance System for CE - Guidance and Template: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf MDCG 2024-1-1 Device for Cardiac Ablation: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf MDCG 2024-1-2 Coronary Stents and associated delivery systems: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf MDCG 2024-1-3 Cardiac Implantable Electronic Devices (CIEDs): https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf MDCG 2024-1-4 Breast Implants: https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf   Language requirements for Manufacturers (MDR & IVDR) - Check where English is not applicable: MDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf IVDR: https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-ivdr.pdf eQMS your eQMS SmartEye - The best eQMS ever:  https://eqms-smarteye.com UK Future Regulation roadmap - We still have to wait: https://assets.publishing.service.gov.uk/media/659d3539aaae22001356dc3c/Roadmap_towards_the_future_regulatory_framework_for_medical_devices__Jan_24.pdf Course Training EU MDR Green Belt - February and March 2024 : https://school.easymedicaldevice.com/gb/ Notified Bodies and Approved Bodies UK Approved bodies - They are 9 now: https://www.gov.uk/government/news/mhra-announces-two-new-uk-approved-bodies-to-certify-medical-devices LNE-GMED: https://assets.publishing.service.gov.uk/media/65b799f2a0ae1b000d52616e/LNE-GMED_Scope_Medical_Devices.pdf Scarlet NB UK: https://assets.publishing.service.gov.uk/media/65b79a11a0ae1b000d52616f/AB_Scarlet_Scope_Jan_2024.pdf   GDP video Good Documentation Practices - Check how to be sure to have good documents: https://www.youtube.com/watch?v=nkBpef5AstI ROW USA US FDA Quality Management System Regulation - Alignment to ISO 13485: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked US FDA IVD Reclassification - Move from Class III to Class II: https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrh-announces-intent-initiate-reclassification-process-most-high-risk-ivds FDA Remote Regulatory Assessment (RRA) - Question and Answers: https://www.fda.gov/media/160173/download Estar 5.1 version -: IVD and non-IVD: https://www.fda.gov/medical-devices/how-study-and-market-your-device/estar-program Non-IVD: https://www.fda.gov/media/174458/download?attachment IVD: https://www.fda.gov/media/174459/download?attachment eStar 5.0 video with Rob Packard: https://www.youtube.com/watch?v=KDkKnRnBfgc   Saudi Arabia Webinar: Artificial Intelligence and Software -:February 13th, 2024 at 10 AM Middle East time : https://www.sfda.gov.sa/en/workshop/93262   Manufacturing Devices at Point of Care (PoC) - uidance on how to manufacture them: https://www.sfda.gov.sa/sites/default/files/2024-01/MDS%20–%20G009E.pdf   Events Medtech Conf - RAPS Workshop - Feb 27th until March 1st: https://medtechconf.com/event/raps-events/ Podcast Nostalgia - Relisten again and again Episode 267 - Warning! Apply to your Notified Body Now! with Pritam Mekala: https://podcast.easymedicaldevice.com/267-2/ Episode 268 - You are not the Physical Manufacturer, can you be MDR certified: https://podcast.easymedicaldevice.com/268-2/ Episode 269 - Why you should use Pre-Submission or Q-Sub with FDA: https://podcast.easymedicaldevice.com/269-2/ Whatsapp Community: Whatsapp community - Register even if it says no: https://chat.whatsapp.com/DvpnuGLihD98zGXsiYicQq

In this episode, Dave Tinker discusses the importance of accessibility in fundraising. He shares his personal connection to the disability community and explains why making the world more inclusive is a passion of his. Dave provides practical tips for interacting with constituents with disabilities and highlights the curb cut effect in fundraising. He also discusses the importance of incorporating accessibility features on websites and social media platforms. Dave emphasizes the ethical and strategic importance of accessibility and encourages organizations to stand out by prioritizing accessibility in their communications. He concludes by providing his contact information for further discussion.TakeawaysIncorporating accessibility in fundraising is important to ensure inclusivity for all potential donors.Interacting with constituents with disabilities should be done in a way that is accessible and accommodating.Websites and donation pages should include accessibility features such as alt tags and high contrast colors.Direct mail should also consider accessibility through large fonts and clear layouts.Tracking data on donors with accessibility needs can help organizations better understand and serve this audience.Building websites and communications with accessibility in mind is both ethical and strategic.There are various tools and resources available to help organizations improve website accessibility.Guest BioDave is Vice President of Advancement at Achieva and a consultant with GoalBusters Consulting. In these roles he raises funds and helps nonprofits with their communications. He was also an adjunct professor of informatics at Muskingum University for over a decade. A certified Association of Fundraising Professionals (AFP) Master Trainer, he received the Outstanding Fund Raising Executive Award from the AFP Western PA chapter in 2013. In October 2016 he was honored by AFP International as one of six in the inaugural class of Distinguished Fellows. Dave has published numerous articles in professional journals and has written fundraising curriculum for The Fund Raising School® at the Lilly Family School of Philanthropy at Indiana University and the Alliance for Strong Families and Communities.Dave is a past president of the AFP Western PA chapter and has served in many volunteer roles for AFP International and his own chapter. In addition to AFP, Dave has served as a member of the Ethics Committee for the Grant Professionals Association where is also an approved trainer. Dave received a Master of Public Affairs with a concentration in Nonprofit Management from the Lilly Family School of Philanthropy at Indiana University. He received a Bachelor of Arts in Chemistry and English and a Master of Information Strategy, Systems and Technology from Muskingum University. He is also a graduate of Leadership Works - Indianapolis, Class III and the National Leadership Consortium on Developmental Disabilities at the University of Delaware, Class 44.Chapters02:03 Dave's Passion for Accessibility in Fundraising03:26 Incorporating Accessibility in Daily Interactions04:53 The Curb Cut Effect in Fundraising05:56 Interacting with Constituents with Disabilities06:04 Technological Considerations for Website Donation Pages07:36 Using Alt Tags on Social Media Platforms08:32 The Future of Accessibility in Fundraising10:45 Tips for Creating Accessible Websites and Donation Pages12:56 Considerations for Direct Mail Accessibility17:37 Tracking Data on Donors with Accessibility...

We always have a problem to contact regulators to ask them if our strategy is correct. In Europe, you cannot do that with a Notified Body unless you apply with one first and they cannot provide you with advice but just agree or disagree on your plan. Is it the same with the FDA. They have a specific pathway called Q-sub or Pre-Submission and you'll see that this may be your Superpower to accelerate your success with your FDA application. Let's listen to Saad Attiyah who will explain what is Q-SUB.  Who is Saad Attiyah?  Experienced Regulatory Affairs and Quality Assurance professional with 20+ years of experience in medical devices, in-vitro diagnostics, human/cell tissue products, and combination device/drug products. Proven experience with U.S., Canadian, and E.U. Regulators, submissions, and Global Strategy Development. Extensive experience authoring U.S. 510(k)'s, E.U. MDR Technical Documentation, HDE Supplement, HDE/PMA Change Assessments for Supplements, Letters to File, Q-Submission, and Canadian New Submission/Amendments. Certified Lead Auditor, QMS Expert, and Warning Letter Remediation.    Areas of specialty: New Product Development Strategy for Global Markets, Maintenance and remediation of existing devices, clinical evaluation reports/trials, and compliance activities, QA/QC, SOP development.   Device Types: Capital equipment and consumables such as blood analyzers and reagents, sterilizers and sterilant, ventilators, aspirators, centrifuges, implantable devices, single use medical devices, reusable instruments, and thermometry devices. Device Classifications: US I through III, Canada Class II through IV, E.U. Class I through Class III, Compassionate Use   510(k): K072866-Spinal Fixation System, K080281- Interbody Fusion Device, K090566- Novel Interbody Fusion Device, K091134- Anterior Cervical Plating, K092904 -Vertebral Body Replacement Device, K111009- Spinal Fixation System, K111774- Interbody Fusion Device, K153379- Orthopedic Plating, K161863- Shoulder Arthroplasty Devices w/expanded indications, K181091- Orthopedic Plating w/ Pediatric Indications.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Saad Attiyah  LinkedIn:  https://www.linkedin.com/in/saadattiyah  US FDA QSUB guidance :  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Episode 156: Obesity, Fertility, and PregnancyFuture Dr. Hamilton defines obesity and explains the pathophysiology of obesity and its effects on fertility and pregnancy. Dr. Arreaza adds some input about the impact of epigenetics on newborn babies.  Written by Shelby Hamilton, MS3, American University of the Caribbean School of Medicine. Editing by Hector Arreaza, MD.You are listening to Rio Bravo qWeek Podcast, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California, a UCLA-affiliated program sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. This podcast was created for educational purposes only. Visit your primary care provider for additional medical advice.Definition of obesityObesity is a multifactorial chronic disease that is increasing in prevalence across the globe. It can be defined as a body mass index (or BMI) greater than 30 kg/m2. According to the CDC from 2017-March 2020, the prevalence of obesity in United States adults was 41.9%.Classification of obesity by BMI.Obesity can further be divided into three classes: class I which is a BMI between 30-34.9; class II which is a BMI between 35-39.5; and class III which is a BMI greater than 40. We recommend avoiding the term “morbid obesity” because of the negative connotation of the word “morbid.” Class III or severe are better terms in those cases. This classification is based on the individual risk of cardiovascular disease. One of the greatest health consequences affecting individuals with obesity is the cardiovascular effects including hypertension, dyslipidemia, and coronary artery disease. Other effects include insulin resistance and diabetes, cholelithiasis, non-alcoholic fatty liver disease, osteoarthritis, and even depression.How Does Obesity Affect Fertility?Obesity can have an extensive effect on the overall health of an individual. In addition to these commonly discussed effects, obesity can also influence a person's fertility. This is especially observed in women with polycystic Ovary Syndrome (PCOS) who have a greater BMI and also have symptoms of anovulation. Excess adipose tissue plays a role in the effects that obesity has on fertility. White adipose tissue can secrete a specific group of cytokines known as ‘adipokines'. These adipokines include leptin, ghrelin, resistin, visfatin, chemerin, omentin, and adiponectin. With a greater percentage of adipose tissue, there are higher rates of hypothalamic gonadotropin hormonal dysregulation, which can be combined with insulin-related disorders, low sex hormone binding proteins, and high levels of androgens. The combination of these factors can result in decreased ovarian follicle development and decreased progesterone levels.Hormonal changesObesity is an endocrine disorder. One specific adipokine that affects the hypothalamic-gonadotropin axis is chemerin. Chemerin impairs the release of follicle-stimulating hormone (FSH) from the pituitary gland. This reduction in FSH release consequently leads to anovulation, meaning that no egg will be released from an ovarian follicle, contributing to infertility. Shelby: Another adipokine affecting fertility is adiponectin. The receptors of adiponectin are predominantly expressed in reproductive tissues, including the ovaries and endometrium. In individuals with a greater BMI, a decrease in adiponectin secretion has been observed, resulting in decreased stimulation of its receptors, especially in the endometrium, which has been linked to recurrent implantation failure. Adiponectin has also been shown to affect glucose uptake in the liver. With reduced adiponectin levels, there is reduced hepatic glucose uptake, leading to insulin resistance. As tissues become less sensitive to insulin, the body compensates by secreting higher amounts of insulin, leading to hyperinsulinemia. Higher levels of circulating insulin have also been proven to cause hyperandrogenemia in women by blocking the hepatic production of sex hormone-binding globulin. Insulin can also act on the IGF-1 receptors in the theca cells, increasing steroidogenesis, and thus, increasing androgens. With hyperandrogenemia, there is also increased granulosa cell apoptosis as well as increased peripheral conversion of androgens into estrogen. This creates negative feedback to the hypothalamic-pituitary axis to decrease the release of gonadotropins such as FSH which are critical in ovulation.Leptin is another adipokine that is shown to be increased in obesity. Studies on mice have shown that leptin impairs the development of ovarian follicles, resulting in a decrease in ovulation. In these studies, it was also observed that leptin reduces the production of estriol by the granulosa cells in the ovarian follicles as well as increases the rate of apoptosis in granulosa cells, both of which affect ovulation. Leptin decreases hunger, but persons with obesity may be resistant to its effects and that's why they have higher levels than a person with normal weight. They have high levels of leptin but are still hungry because they have leptin resistance.Studies have also shown that the fatty acid composition of follicular fluid found in ovarian follicles also plays a role in fertility. In individuals with a high BMI, this fluid contains high levels of oleic acid, which can cause embryo fragmentation after fertilization occurs. Stearic acid is another fatty acid found in elevated levels in the follicular fluid of women with a greater BMI, which can also affect the quality of the embryo while in the blastomere stage.The bottom line is obesity decreases fertility. It does not mean that patients with obesity will not get pregnant, but it can make it harder to get pregnant. Female patients who are losing weight must be warned about their improved fertility once they start to lose weight.What effect does obesity have on pregnancy?While obesity may make it more difficult for a woman to get pregnant, it is not impossible. However, there are potential risks both to the mother's health as well as the baby's health. Therefore, it is very important to monitor these patients even more carefully.Women who have a greater BMI pre-pregnancy are at a greater risk of developing gestational hypertension. Gestational hypertension is defined as blood pressure greater than 140/90 on more than one reading in the second half of pregnancy. Hypertension during pregnancy can also have serious complications such as kidney failure, stroke, myocardial infarction, or even heart failure. Gestational hypertension can also result in preterm birth or low birth weight.Treatment of mild hypertension in pregnancyRecent studies published in the AFP Journal support the treatment of mild hypertension in pregnancy. It states that “evidence and expert opinion support treating mild chronic hypertension in pregnancy with approved antihypertensives, with a strength of recommendation: B”. There was a randomized control trial with about 2,000 women who were randomized to receive antihypertensive treatment vs no treatment. The treatment group had a lower incidence of preeclampsia with severe features, preterm birth, placental abruption, and neonatal or fetal death. There was not an increase in fetal growth restriction or maternal or neonatal complications. So, it is advisable to treat chronic, mild hypertension in pregnancy, according to the AFP Journal.PreeclampsiaPreeclampsia is another condition that is at a higher risk in women with obesity, which is a more serious manifestation of hypertension in the second half of pregnancy. Along with high blood pressure, there are also effects on the kidneys and liver. Hypertension accompanied by proteinuria is indicative of preeclampsia and should be taken seriously. Preeclampsia can become eclampsia, where the patient also experiences seizures. There is also the risk for stroke, HELLP syndrome, placenta abruption, preterm birth, and fetal growth restriction.Gestational diabetesAnother risk is gestational diabetes. Elevated blood glucose during pregnancy can result in a larger baby and delivery by cesarean. There may also be a greater risk of the mother and child developing diabetes mellitus later on in life.OSAWomen with a greater BMI may also be at risk of developing obstructive sleep apnea during pregnancy. Not only can this result in fatigue but can also contribute to the development of gestational hypertension and preeclampsia.Effect of obesity on the fetusAs mentioned, there are some risks to the fetus in women with a greater pre-pregnancy BMI. There is a greater risk for these babies to be born with birth defects such as congenital heart defects and neural tube defects. Another risk previously discussed is macrosomia, or large for gestational age. Larger babies are also at increased risk for shoulder dystocia during delivery as well as resulting clavicle fractures, brachial plexus injuries, and nerve palsies. Preterm birth is another risk, which also increases the risk of short-term and long-term health complications. Lastly, a higher BMI is directly correlated with the risk of spontaneous abortion or stillbirth.SummaryAs the prevalence of obesity increases, it is important to discuss the health risks that are associated with this disease. In our patients of childbearing age and who may be hoping to conceive, it is even more important to discuss how a higher BMI may affect fertility and pregnancy. While discussing these topics with patients, it is important to try our best to build rapport with the patient so that the discussion is seen more as one of concern and support rather than one of criticism regarding their weight. We may want to help by not only telling patients to “lose weight” or “diet”, but we can also provide them with resources regarding dietary adjustments and ways they can incorporate physical activity into their lives without just telling them to eat less and move more. Stay tuned for our episode on the management of obesity in pregnancy.ConclusionNow we conclude episode number 156, “Obesity, fertility, and pregnancy.” Future Dr. Hamilton explained how obesity affects the hormonal regulation of fertility. She also explained the obstetrical risks associated with obesity. Primary care professionals need to educate our patients about the benefits of preconception weight control. Dr. Arreaza explained that hypertension is a common condition in pregnant patients with obesity and mentioned the benefits of treating mild hypertension in pregnancy. We hope to bring you an episode on the management of obesity in pregnancy soon, so stay tuned! This week we thank Hector Arreaza and Shelby Hamilton. Audio editing by Adrianne Silva.Even without trying, every night you go to bed a little wiser. Thanks for listening to Rio Bravo qWeek Podcast. We want to hear from you, send us an email at RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. See you next week! _____________________References:Gautam, D., Purandare, N., Maxwell, C., Rosser, M., O'Brien, P., Mocanu, E., McKeown, C., Malhotra, J., & McAuliffe, F. (2023) The challenges of obesity for fertility: A FIGO literature review. International Journal of Gynecology & Obstetrics, 160(S1), 50-55. https://doi.org/10.1002/ijgo.14538Pandey, S., Pandey, S., Maheshwari, A., & Bhattacharya, S. (2010). The impact of female obesity on the outcome of fertility treatment. Journal of Human Reproductive Science, 3(2), 62-67. https://doi.org/10.4103/0974-1208.69332.Perreault L. Obesity in adults: Prevalence, screening, and evaluation. In: UpToDate, Pi Sunyer FX (Ed) Wolters Kluwer. https://www.uptodate.com (Accessed on October 6, 2023).Obesity and Pregnancy FAQ, The American College of Obstetricians and Gynecologists (ACOG), https://www.acog.org/womens-health/faqs/obesity-and-pregnancy, Accessed on October 10, 2023.Adult Obesity Facts, Centers for Disease Control and Prevention (CDC), https://www.cdc.gov/obesity/data/adult.html, Accessed on October 7, 2023. Dresang L, Vellardita L. Should Medication Be Prescribed for Mild Chronic Hypertension in Pregnancy?. Am Fam Physician. 2023;108(4):411-412. Royalty-free music used for this episode: "I Think We Have a Chance."  downloaded on November 11, 2023,  from https://www.videvo.net/.

Industry discussion surrounds a docket's worth of changes to the Federal Milk Marketing Orders (FMMO), and we feel like it's high time that we weighed in. The USDA hearing on pricing formulas reconvened November 27, and the Jacoby team can't help but feel that much of the hearings will amount to wasted or misplaced effort. On this episode of The Milk Check, recorded in mid-November, a group from throughout the company discusses the potential changes that might help dairies with ongoing profitability problems. Then, they share their thoughts on the contents of the hearing so far. T3: Hello everybody, and welcome to The Milk Check podcast. Today, we are going to tackle the famous, or maybe rather infamous, subject of federal order reform. I think you'll find listening to our discussion, that you'll find us a little bit more ambivalent about the process than maybe you'd expect from a group that is experts in marketing milk and the federal order system. But I'll let the conversation speak for itself, as we talk about the different things that the federal order hearing is trying to tackle and what we think should be done. And hopefully, it'll be helpful to everybody. I look forward to discussing it further, when they finally come out with their recommendations for how the federal order needs to be changed. Dad, obviously, the federal order hearing is going on. And my suggestion is the reality is the path we're going down really isn't going to change a lot, and maybe that's what we should discuss is how some of these changes aren't going to have a big effect because the market is going to change to that. Things like, okay, they're going to change the make allowances. How much of an effect are changing the make allowances really going to have on the farmer's milk price? Ted Jr: Zero. T3: That's my point. Ted Jr: The real issue is qualification and not the classified pricing system. Instead of having bottling plant A, for example, responsible for balancing, you now kick milk back to somebody else, usually a co-op who has a butter powder plant and you give them the responsibilities for balancing and then of course you pay for that with an overrated premium. And the alternative would be, in my view at least, to weaken the minimum price requirements and do it in such a way, and I'm not sure you're going to get out of the box with something like this, but do it in such a way that you can transfer some of the balancing requirements back to the bottling plant so that they can run sales on milk so we can get some of our customers back. Something that promotes marketing and allows at least a portion of the balancing to be transferred to the plant, I think would be beneficial. Is that going to happen? No, they're not going to touch that With a 10-foot pole, the minimum price requirements are the key to qualification, and so that's where the thing meets the wall. In the meantime, our Class I sales continue to decline. Anna: I think the biggest issue for me is that Class I is completely hamstrung by how everything is based off of their sales, their qualification, their everything else. It means that we've talked about them not being able to be innovative before, just how much it really sticks them in a certain spot where they can't do anything new. I don't really have a major problem with qualification. I think when you change those provisions, you end up devaluing the whole pool, which is kind of against the point, right? But my biggest issue is that we're basing all of this on Class I and quite frankly, they're not the most difficult customer anymore. Class III is in many cases way more difficult. Gus: How is Class III more difficult? And I look at this knowingly from the standpoint that cheese plants tend to take a more consistent volume of milk and therefore they're an easier customer to serve. But why do you say that? Anna: I don't think they're as easy as they used to be.

Industry discussion surrounds a docket's worth of changes to the Federal Milk Marketing Orders (FMMO), and we feel like it's high time that we weighed in. The USDA hearing on pricing formulas reconvened November 27, and the Jacoby team can't help but feel that much of the hearings will amount to wasted or misplaced effort. On this episode of The Milk Check, recorded in mid-November, a group from throughout the company discusses the potential changes that might help dairies with ongoing profitability problems. Then, they share their thoughts on the contents of the hearing so far. T3: Hello everybody, and welcome to The Milk Check podcast. Today, we are going to tackle the famous, or maybe rather infamous, subject of federal order reform. I think you'll find listening to our discussion, that you'll find us a little bit more ambivalent about the process than maybe you'd expect from a group that is experts in marketing milk and the federal order system. But I'll let the conversation speak for itself, as we talk about the different things that the federal order hearing is trying to tackle and what we think should be done. And hopefully, it'll be helpful to everybody. I look forward to discussing it further, when they finally come out with their recommendations for how the federal order needs to be changed. Dad, obviously, the federal order hearing is going on. And my suggestion is the reality is the path we're going down really isn't going to change a lot, and maybe that's what we should discuss is how some of these changes aren't going to have a big effect because the market is going to change to that. Things like, okay, they're going to change the make allowances. How much of an effect are changing the make allowances really going to have on the farmer's milk price? Ted Jr: Zero. T3: That's my point. Ted Jr: The real issue is qualification and not the classified pricing system. Instead of having bottling plant A, for example, responsible for balancing, you now kick milk back to somebody else, usually a co-op who has a butter powder plant and you give them the responsibilities for balancing and then of course you pay for that with an overrated premium. And the alternative would be, in my view at least, to weaken the minimum price requirements and do it in such a way, and I'm not sure you're going to get out of the box with something like this, but do it in such a way that you can transfer some of the balancing requirements back to the bottling plant so that they can run sales on milk so we can get some of our customers back. Something that promotes marketing and allows at least a portion of the balancing to be transferred to the plant, I think would be beneficial. Is that going to happen? No, they're not going to touch that With a 10-foot pole, the minimum price requirements are the key to qualification, and so that's where the thing meets the wall. In the meantime, our Class I sales continue to decline. Anna: I think the biggest issue for me is that Class I is completely hamstrung by how everything is based off of their sales, their qualification, their everything else. It means that we've talked about them not being able to be innovative before, just how much it really sticks them in a certain spot where they can't do anything new. I don't really have a major problem with qualification. I think when you change those provisions, you end up devaluing the whole pool, which is kind of against the point, right? But my biggest issue is that we're basing all of this on Class I and quite frankly, they're not the most difficult customer anymore. Class III is in many cases way more difficult. Gus: How is Class III more difficult? And I look at this knowingly from the standpoint that cheese plants tend to take a more consistent volume of milk and therefore they're an easier customer to serve. But why do you say that? Anna: I don't think they're as easy as they used to be.

Jason T. Jacobson, MD, FHRS, of Westchester Med Center-New York Med College, discusses the CAST trial with David J. Callans, MD, FHRS, CCDS of Hospital of the University of Pennsylvania, and Gerald V Naccarelli, MD, FHRS of Pennsylvania State University Milton S. Hershey Medical Center. Class IC antiarrhythmic drugs have been generally avoided in patients with any degree of coronary disease and any type of cardiomyopathy, whether or not they fit the inclusion criteria of the trial. For the past 3+ decades, the CAST trial results have been extrapolated to a broader population despite a lack of evidence. In this study, the authors retrospectively look at the safety of these agents compared with Class III drugs in patients with atrial fibrillation and varying degrees of CAD.  https://www.hrsonline.org/education/TheLead https://www.jacc.org/doi/10.1016/j.jacep.2022.12.021 Host Disclosure(s): J. Jacobson: Honoraria/Speaking/Consulting Fee: American College of Cardiology, Zoll Medical Corporation; Research (Contracted Grants for PIs Named Investigators Only): Abbott, Phillips; Stocks (Privately Held): Atlas 5D Contributor Disclosure(s): D. Callans: Honoraria/Speaking/Consulting: Heart Rhythm Society, Thermedical, AtriCure, Inc., Abbott Medical, Biosense Webster, Volta Medical, Mediasphere Medical, Coherex, American College of Cardiology, Best Doctors, Bayliss Medical, Biotronik, Boston Scientific, Impulse Dynamics USA: Fellowship Support: Biosense Webster, Biotronik, Boston Scientific, Medtronic, Abbott; Other Financial Relationships: Wolters Kluver G. Naccarelli: Honoraria/Speaking/Consulting: Acesion, Sanofi, GlaxoSmithKline, Milestone, InCarda Therapeutics

The following question refers to Section 4.9 of the 2021 ESC CV Prevention Guidelines. The question is asked by Dr. Christian Faaborg-Andersen, answered first by UCSD fellow Dr. Patrick Azcarate, and then by expert faculty Dr. Melissa Tracy. Dr. Tracy is a preventive cardiologist, former Director of the Echocardiography Lab, Director of Cardiac Rehabilitation, and solid organ transplant cardiologist at Rush University. The CardioNerds Decipher The Guidelines Series for the 2021 ESC CV Prevention Guidelines represents a collaboration with the ACC Prevention of CVD Section, the National Lipid Association, and Preventive Cardiovascular Nurses Association. Enjoy this Circulation 2022 Paths to Discovery article to learn about the CardioNerds story, mission, and values. Question #35 In patients with a low risk of cardiovascular disease, which of the following is true?AAspirin does not affect the risk of ischemic strokeBAspirin increases the risk of fatal bleeding.CAspirin reduces the risk of non-fatal MI.DAspirin reduces cardiovascular mortality Answer #35 ExplanationIn 2019, an updated meta-analysis of aspirin for primary prevention of cardiovascular events found that patients with a low risk of CVD taking aspirin did not have a reduction in all-cause or cardiovascular mortality. There was a lower risk of non-fatal MI (RR 0.82) and ischemic stroke (RR 0.87). However, aspirin was also associated with a  higher risk of major bleeding (RR 1.50), intracranial bleeding (RR 1.32), and major GI bleeding (RR 1.52). There was no difference in the risk of fatal bleeding (RR 1.09).Accordingly, the ESC does not recommend antiplatelet therapy in individuals with low/moderate CV risk due to the increased risk of major bleeding (Class III, LOE A).Although aspirin should not be given routinely to patients without established ASCVD, we cannot exclude that in some patients at high or very high CVD risk, the benefits may outweigh the risks.Main TakeawayIn patients with low/moderate risk of CVD, aspirin for primary prevention is not recommended due to the higher risk of bleeding. For those at higher risk of CVD, low-dose aspirin may be considered for prevention in the absence of contraindications.Guideline Loc.Section 4.9.1, Page 3291 CardioNerds Decipher the Guidelines - 2021 ESC Prevention SeriesCardioNerds Episode PageCardioNerds AcademyCardionerds Healy Honor RollCardioNerds Journal ClubSubscribe to The Heartbeat Newsletter!Check out CardioNerds SWAG!Become a CardioNerds Patron!

Today on the Life Science Success Podcast, we have a very special guest with us—David Hibbard, the Vice President of Engineering at Sunrise Labs. With over 25 years of experience in medical device development, David has been at the forefront of innovation in areas ranging from Stress Echocardiography to Robotics.   The interview features David Hibbard, VP of Engineering at Sunrise Labs, who has over 25 years of experience in medical device development. He holds a biomedical engineering degree from Boston University. Sunrise Labs specializes in Class II and Class III medical devices and focuses on end-to-end service, from software to hardware. The team size is just under 100 people, with approximately 70 to 80 engineers. David discusses the importance of strong project management, emphasizing the need to understand regulatory strategy and timelines, and advises that good client relationships are formed through transparency and integration, even in daily scrums. On the topic of leadership, David mentions the importance of good integrity and communication for long-term partnerships. He emphasizes that understanding the end user's needs is crucial for successful medical device development. Hibbard also talks about the use of AI to improve code robustness and mentions some of the challenges they are facing with remote work and maintaining a work-life balance in the current environment.

In orthodontics, the name Dr. Luis Carriere is synonymous with innovation, clinical expertise, and a commitment to advancing the field.While many may associate his name with the Carriere Motion Class II and Class III corrector, Dr. Carriere is much more than an inventor. He is a master clinician, a gentleman of the highest order, and a second-generation orthodontist following in the footsteps of his renowned father.In this Greatest Hits Series, we revisit a popular episode where he graciously shared his insights into different clinical aspects of orthodontics.Among these clinical aspects we talk about is the crucial role of the tongue in malocclusions and overall oral health.The improper positioning of the tongue during functions like swallowing, chewing, and speaking can contribute to malocclusions and open bites.Dr. Carriere stresses the importance of training patients to reposition their tongues correctly. Understanding and addressing the tongue's role in orthodontics is essential for achieving long-term stability and preventing relapse.Tune in to learn from one of the leading experts in our profession.Key Takeaways- Meet the world-renowned Dr. Luis Carriere (01:19)- Difference between practicing in Spain and the USA (06:58)- What we must do as a profession to educate our patients (10:08)- The Motion Appliance (17:39)- The 5 components of Class II correction (19:39)- TMJ disorders and mandible position (25:58)- Orthodontic treatment and tongue positioning (34:26)Additional Resources

Sara's solo episode comes on her return from her climb on the Sierra High Route. A rugged 195-mile hike of which she did part last year and another part this year, with over 100 miles of off-trail travel, through both idyllic sub-alpine forest and tedious talus (rock) fields. It is a rugged alternate to the John Muir Trail (JMT)– it boasts about 100 miles of cross-country travel, numerous Class III scrambles, and endless miles of boulder hopping.  Sara uses this solo episode to talk about her experiences on the trails and how they proved to be symbolic for life and reminders for us all to know we are Limitless. She talks of 3 specific times on her week long trek that proved life's lessons. When she was at the Frozen Lake Pass, the second most dangerous Pass and she realized she was feeling fear,not her normal excitement. She stated to her hiking partners “I am afraid”. She relays how they supported her and reminded her she had done a scary Pass last year and got through it. She did. She also talks about how she is usually the last in line of fellow hikers. And to remember it's ok to be last. She was alone at a very snowy/icy part and no one was around. She froze up and had to really talk to herself to push through without her spikes on.  She made it. And her takeaway for herself and all of you, listeners is We go to what could happen, but instead we should pay attention to what goes right. When we proceed with Bravery, we are LIMITLESS. Listen to this episode for a diary of her climb, and some reminders of how we've Got this!!! Go Forward and grab your LIFE! Website: www.saraschultingkranz.com Social media: IG: https://www.instagram.com/saraschultingkranz/ YouTube: https://www.youtube.com/@saraschultingkranz./about Do the Difficult Tuesdays: Remember Sara's campaign on IG: Do the Difficult Tuesdays!  Sponsor: Go to www.saraschultingkranz.com and use the code Live Boldly at checkout to get the special price of $39 for programs offered. Learn more about your ad choices. Visit megaphone.fm/adchoices

Naomi Blohm of Total Farm Marketing by Stewart-Peterson joins to talk about post-harvest marketing strategies plus markets ranging from corn and beans to Class III milk. Price action perspective from Oliver Sloup of Blue Line Futures.See omnystudio.com/listener for privacy information.

Our team is (mostly) bearish right now. We're seeing signs that recent Class III price rises aren't supported by demand, and the lack of Asian demand for powders continues. In the August episode of The Milk Check, we discuss a recent LinkedIn post Ted made and whether there's any strong case against bearishness when looking at dairy prices. Butter continues to feel like an exception, and Joe Maixner wants to go “on the record” with a bullish outlook for the rest of the year but also into 2024. The international outlook, according to Diego Carvallo, couldn't get much more bearish. Ted: Welcome everybody to the August version of the Milk Check. Today we're going to have an old fashioned market discussion. We have with us, Josh White, Diego Carvallo, Joe Maxster, Jacob Menge, and I. So guys, I thought I'd start this conversation simply by mentioning the post that I just put on LinkedIn and you guys can tell me what you think of the post and if you think you agree with me or maybe where I'm wrong. So it's the middle of August, it's hot outside, you're seeing 100 degree temperatures all over the country. The milk supply is tightening as a result, schools will start up soon. So demand has picked up a little bit. The cheese market has popped, improving class three prices. And most of our other markets are starting to look like the bottoms are in. Does that mean the remainder of the year will be positive for dairy farmers? My hunch is that domestic demand will not be good enough to sustain decent milk prices. I see subtle signs everywhere. Very few of our domestic customers are giving us glowing sales reports. Most are using descriptions like average at best or slightly under budget. And while Mexico continues to be optimistic, our Asian customers are using words like depressing and even horrific to describe their sales. So even though milk production may turn negative year over year in the coming months, I just don't see enough positive demand to be bullish milk prices between now and the first half of 2024. Guys, am I being too bearish? Josh, what do you think? Josh: Just talking to different people I would echo what you mentioned. I had a few calls where people have said to date their overall demand has been lackluster. Their coverage going forward is taking into consideration some of that uncertainty about their demand, but we're starting to notice a few more transactional type, a little bit more transactional type business happening in the recent weeks that leads me to believe that the forward coverage isn't as strong as everyone thought from these type of companies. Ted: So what you mean by that is maybe the spot purchasing needs of some of the big buyers out there domestically between now and the end of the year may actually be a little bit stronger than it has been so far? Josh: I don't know that I'm predicting it, but I think there's a real opportunity for that. Jacob: The thing that I think is a bit of a black box still to this conversation is US demand, and I think you mentioned it in your LinkedIn post, Ted, but I think that's really the key here is that US demand piece. Because if you look at equity markets, for example, the US seems to be the favored child in the world right now where our markets are humming along, we're having the soft landing. Meanwhile, Europe specifically the UK, seemed to be on the brink or in a recession. And so again, will this kind of fiscal strength we've seen on the equity sides carry over into our household purchasing and as such mean we have good demand in the US. I think it remains to be seen. We've seen a number of arguments be made that the decent demand we've had so far this year is going to kind of falter in Q4. I think I might be in that camp. But if it doesn't, you pair decent demand along with a contracting supply, and especially if what Josh alluded to comes true, you have multi nets come in and do some buying on products here or there,

The following question refers to Sections 3.3 and 3.4 of the 2021 ESC CV Prevention Guidelines. The question is asked by CardioNerds Academy Intern student Dr. Adriana Mares, answered first by Brigham & Women's medicine resident & Director of CardioNerds Internship Dr. Gurleen Kaur, and then by expert faculty Dr. Allison Bailey. Dr. Bailey is an advanced heart failure and transplant cardiologist at Centennial Heart. She is the editor-in-chief of the American College of Cardiology's Extended Learning (ACCEL) editorial board and was a member of the writing group for the 2018 American Lipid Guidelines.  The CardioNerds Decipher The Guidelines Series for the 2021 ESC CV Prevention Guidelines represents a collaboration with the ACC Prevention of CVD Section, the National Lipid Association, and Preventive Cardiovascular Nurses Association. Enjoy this Circulation 2022 Paths to Discovery article to learn about the CardioNerds story, mission, and values. Question #26 Ms. Priya Clampsia is a 58-year-old never-smoker with a history of hypertension. Her BMI is 29 kg/m2. She also mentions having pre-eclampsia during her pregnancy many years ago. She describes a predominately sedentary lifestyle and works as a receptionist. You see her in the clinic to discuss routine preventive care. Her most recent lipid panel results were LDL of 101 mg/dL, HDL of 45 mg/dL, and triglycerides of 190 mg/dL. What additional step will provide valuable information regarding her CVD risk profile? A Send additional lab workup including C-reactive protein and lipoprotein (a) B Measure her waist circumference C Assess her work stress D Ask her about history of preterm birth E B, C, and D Answer #26 Explanation The correct answer is E – measuring her waist circumference, assessing her occupational stress, and obtaining history about adverse pregnancy outcomes including preterm birth all add valuable information for CVD risk stratification. BMI is easily measured and can be used to define categories of body weight. However, body fat stores in visceral tissue carry higher risk than subcutaneous fat and therefore, waist circumference can be a simple way to measure global and abdominal fat. When waist circumference is ≥102 cm in men and ≥88 cm in women, weight reduction is advised. While these WHO thresholds are widely accepted in Europe, it is important to note that different cut-offs may be appropriate in different ethnic groups. Work stress is important to ascertain as well because there is preliminary evidence of the detrimental impact of worse stress on ASCVD health, independent of conventional risk factors and their treatment. Work stress is determined by job strain (i.e., the combination of high demands and low control at work) and effort-reward imbalance. Pre-eclampsia is associated with increase in CVD risk by factor of 1.5-2.7 compared with all women. Both preterm (RR 1.6) and still birth (RR 1.5) are also associated with a moderate increase in CVD risk. Taking a thorough pregnancy history is important in determining future cardiovascular risk in women. The ESC guidelines give a Class IIb (LOE B) recommendation that in women with history of premature or stillbirth, periodic screening for hypertension and DM may be considered. Of note, the 2018 ACC/AHA guidelines include preeclampsia and premature menopause (occurring at age

This show was recorded 27 April 2023 and can be viewed on our website ⁠here⁠. The website recording has clickable chapters allowing you to instantly jump to different questions/topics. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in our ⁠⁠Knowledge Center⁠⁠. What type of evidence is considered sufficient to comply with the MDR? While we've spoken about this extensively in the past, we'll explore more ways to arrive at the answer and address many more questions this RQM+ Live! show. Perhaps in certain situations you're asking yourself, "What kind of clinical evidence do I need for my device?" Our seasoned panelists will share ways to determine exactly that by sharing recent thought processes and examples. We'll set the tone upfront with a list of factors that affect the 'definition' of sufficient clinical data, generally speaking: intended purpose, novelty, benefit-risk profiles, number of indications, users, where it's used in the world and supportive non-clinical data... just to name a few. What we'll cover: Less burdensome, yet effective ways to comply with clinical requirements, using examples from a variety of device types How do you collect clinical data for standard of care devices? How and when can you use Article 61(10) and what is an indirect benefit? Does it make sense for software devices? Is equivalence really no longer useable for Class III and implantable devices? Why monitoring the SOTA could potentially save your company from wasting resources and is much more than just another regulatory requirement Evidence for Annex XVI products (products with no intended medical purpose) This will truly be a loaded session that our team is incredibly excited about! There's much to discuss and our goal, as always, is to provide as much actionable value as possible for you. Panelists: Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation Jon Gimbel, Ph.D. – Vice President, Technical Sally Sennitt – Medical Director, Intelligence and Innovation Bethany Chung, Ph.D., RAC – Principal --- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message

The players, the schemes, the motivations and the treason. It's all richly evident in the dark swamp operation called J6. Stone, Ali and AJ always in the thick of it. The worst in people made obvious. The Gilead scripts, stolen servers and who knew what when. Is the FBI the most corrupt of all? J6 was always about UkraineGate, where they were all making bank. Ali got started in the Georgia statehouse. The Serbia guy and where he leads. Stealing data for the $$$. Influence ops are never OK. There's a Federal Antifa? Another big evidence stash are bank records and payment transfers. It's all about perception. Some hint at NATO involvement in all this. Someone is keeping both good and bad lists. Deception and lies to stroke egos. Proximity to targets is the real goal. When we shatter illusions, more real citizens will join the fight. Truth is always our most powerful weapon. Learn more about your ad choices. Visit podcastchoices.com/adchoices