Global Medical Device Podcast powered by Greenlight Guru

Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies standardized and reproducible.In this episode of the Global Medical Device Podcast Jon Speer talks to Carlton Weatherby, Vice President and General Manager of Spine and Biologics at Medtronic. Listen to Carlton discuss recent developments in spine and biologics technology at Medtronic, a global healthcare technology leader tackling the most challenging health problems with innovative medical devices that transform patient lives.Some of the highlights of this episode include:The spine business is an untapped opportunity that can impact patients across the globe with technology solutions being developed by Medtronic.Would you rather live with back pain or have surgery? Basic spine surgery has advanced and improved, but there’s still a wide variability in the outcomes based on where patients live, training of the surgeons, and technologies used.Surgeons have more confidence and patients have more confidence in the surgeons as they identify a path to improve the patient’s condition, alleviate their pain, and perform a procedure to achieve greater outcomes.The golden age of medical devices due to innovation has made the regulatory environment more willing to collaborate. Regulators and the medical device industry try to help patients, but agree that there’s still room for improvement.Through partnership, acquisition, and organic development, Medtronic already has the assets and pieces to determine if surgery makes sense for patients.Medtronic has brought new products to the market to replace invasive spine surgery. An open procedure versus a minimally invasive surgery (MIS) takes more time and has more complications.Medtronic is bigger than most, and 80% of medical device companies have 50 or fewer employees. Startups dream about an acquisition. Carlton advises them to start with a clinical value proposition connected to a clinical need for customers.Memorable quotes from Carlton Weatherby:“Spine is very much an untapped opportunity in terms of the impact it can have on patients across the globe with technology solutions like the ones we’re developing.” “It’s still more of an art than a science and that’s where the opportunity lies.” “Areas of technology advancements that we’re making allow us to support our surgeons to instill the confidence that they have going into it and especially their patients.” “When you integrate new technologies, it’s not easy, especially if those technologies don’t talk together. That’s where an ecosystem truly becomes valuable.” Links:Carlton Weatherby on LinkedInMedtronicMedtronic Spine SurgeryMedtronic Minimally Invasive Spine Surgery (MIS+)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Medical device companies must comply with a list of strict requirements throughout the duration of their product's lifecycle. These compliance efforts will be put to the test once an FDA inspection or ISO audit rolls around. As it turns out, there are a few common culprits when it comes to compliance issues for manufacturers.In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rynkiewicz, Vice President of Life Sciences for RA/QA and ASQ Certified Quality Auditor, about the three most common compliance issues and offer answers to questions like, why are the same select areas continuing to cause issues and what’s beyond these recurring compliance issues?Some highlights of this episode include:Based on FDA data, the same issues are the top issues year after year. Are people simply not paying attention to the observations they receive? Are they intentionally not being compliant? Probably not, but then, what are the reasons?FDA does not require medical device companies to share internal audit results that address components of a quality system. Rather than being dishonest, hire an independent, third-party to conduct internal audits. Another issue with internal audits is that only individual components of the quality system are audited. However, when FDA performs an inspection, they inspect the entire quality system - all components combined.The corporate management mindset is to manage complaints and CAPAs. However, the entire process should be built upon having zero complaints. Improve the product, make it safer, make it better quality to not get complaints.The CAPA effectiveness measure is not always effective. Some elements may be good to know, but do not actually measure the effectiveness of CAPAs.FDA audits will find something. Nobody’s perfect, including inspectors. Their ultimate goal is to improve products and safety.Human Behavior: Be honest, transparent, and take a system approach to gain efficiency and true quality culture.Memorable quotes from Tom Rynkiewicz: “Out of just human behavior, they want to help each other. So, they are not brutally honest.”“The second issue about internal audits is they’re auditing individual components of the quality system. When the FDA comes in, they inspect the quality system.”“We all manage our complaints. We manage our CAPAs, and as long as they hit some acceptable threshold, we’re good.”“Shouldn’t the entire process be built upon having zero complaints? The reason we’re doing this is to improve the product, make it safer, make it better quality, so we don’t have to manage complaints.”Links:FDA - Medical DevicesISO 13485 - Medical DevicesFDA - Corrective and Preventive Actions (CAPA)FDA - Case for Quality ProgramFDA - Current Good Manufacturing Practices (CGMP) RegulationsTom Rynkiewicz on LinkedInRaland Compliance PartnersThe Five Behaviors by Patrick LencioniGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very important in virtually all medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about human factors and usability—two terms used synonymously despite subtle differences—to help you better understand how each function and should be applied.Some of the highlights of this episode include:Mike defines usability or human factors as the user’s ability to use the device in a way that it is intended to be used to get the result it’s intended to get.Jon understands how product development engineers forget that they designed a product based on how they think it should operate, function, and be used.Unfortunately, there are few opportunities for engineers to actually test, use, or implant a product that they developed and designed on actual end users, like cadavers or live animals.The user population has expanded beyond a trained healthcare professional. From a human factors perspective, it doesn’t always make sense or make it easier or complicated for some people to use medical devices.Current FDA guidances that focus on general usability/human factors for medical devices are inadequate. FDA does not differentiate devices that should be used by a trained healthcare professional versus a patient or lay person. Usability is important in virtually all medical devices, but there are some exceptions. However, usability is even more important when medical devices are being used by non-trained medical professionals.FDA now requires usability testing for medical devices because of issues with infusion pumps. However, usability testing should be considered based on risk. Is usability testing needed to put on a BAND-AID® or spit into a tube?There are two types of usability testing: Formative is testing that happens prior to design freeze during the development process. Summative testing occurs after the point of design freeze to ensure that the product can be used as intended.Memorable quotes from this episode:“Usability or human factors is the user’s ability to use the device in a way that it’s intended to be used to get the result that it’s intended to get.” Mike Drues“Those who are designing the product are stuck and convinced that they know the way the product should be used.” Jon Speer“The user population has expanded beyond a trained healthcare professional.” Jon Speer“Usability is important in virtually all medical devices across the board. Not all, there are some exceptions, but virtually all.” Mike DruesLinks:FDA - Applying Human Factors and Usability Engineering to Medical DevicesFDA - List of Highest Priority Medical Devices for Human Factors ReviewFDA - Premarket Notification 510(k)FDA - In Vitro Diagnostics Regulation (IVDR)The Global Medical Device Podcast, Episode 223: Understanding FDA's New Intended Use Rule and its ImplicationsMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell with Prodct and Christie Johnson with Kasota Engineering and Prodct partner about Greenlight Guru Academy’s new course offering, Introduction to Project Management for Product Development of Medical Devices.Some of the highlights of this episode include:It’s assumed that engineers good at managing projects, getting things done, and working with different resources/team members make good project managers.The gold standard is Gantt charts and waterfall methodologies. They have their place and have done a lot of good, but developers do not have to follow the waterfall method - it’s simply a project management practice and example.There’s an appropriate time and place for PM practices and tools, including the Gantt chart. However, don’t blindly apply learned principles.The wrong time to use a Gantt chart is managing how people do their work. Be vulnerable, open, and trust the professionals to know what they are doing and get their work done.Project planning and management are not the same. Project planning does not equal project management.Follow the Keep It Simple Stupid (KISS) philosophy. Rather than build complex and sophisticated tools, acknowledge that you won’t do it right the first time and put time in to react to what you learn and optimize.Who’s running the show? There’s a lot of overlap and not enough room to redo, learn, and make a product better. Also, a lot of iteration happens between those steps. Give time and respect to making a product stronger.Good project management is perpetual because there is a flow to it. It’s cyclical. Prototype and conduct testing early and often if the schedule allows to define and refine product details.Memorable quotes from this episode:“Starting as an engineer and then moving into quality and approaching things with a 30,000-foot view, you kind of see the whole project and the impact of all the sub-tasks. It’s hard not to want to get involved and make sure that everything that needs to get done does.” Christie Johnson“It will ultimately deliver something. It might deliver it over budget. It might deliver it over time. It might deliver it with a bunch of disgruntled employees who hate going through product development because of the way that the project is being managed.” Devon Campbell“Potentially, too many bells and whistles that it makes it really easy for you to create something that looks really awesome, but it’s really hot garbage.” Devon Campbell“Critical path calculations and analyses through tools is generally meaningless. I don’t believe it whenever I see it because we build these really complex and sophisticated models.” Devon Campbell“There’s a lot of overlap and not enough...room to go back and redo and learn and make the product better. There’s a lot of iteration that happens between those steps.” Christie JohnsonLinks:Introduction to Project Management for Product Development of Medical DevicesMedical Device HQDevon Campbell with ProdctChristie Johnson with Kasota EngineeringThe Critical ChainTheory of ConstraintsWhat is a Gantt Chart?FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram)FDA - Quality System Regulation, Part 820Waterfall vs. Agile: Battle of the Product Development MethodologiesX-teams: How to Build Teams That Lead, Innovate, and Succeed by Deborah AnconaDesign Structure Matrix (DSM)Steven D. EppingerGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product.In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.Some of the highlights of this episode include:Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.EU MDR was supposed to go into effect in May 2020, but due to COVID-19 and other reasons, it was pushed off for a year. Guidance drafts were available in 2014-2015, but only a few hundred companies have made that full transition.According to a survey conducted by RWS, 53% of organizations are impacted by both EU MDR and IVDR, yet only 4% of those organizations admit that the regulations are a top priority.Companies with a medical device should proceed to effectively implement EU MDR or it may cost them their business. Also, refer to the definition of medical device that includes monitoring, prediction, and prognosis.Adnan encourages companies to not underestimate the cost of quality and regulatory. Build it in and know your market. With labeling and packaging, don’t forget about Brexit and associated symbols/marks.Regulations happened to catch up with technological advancements and public safety to become more transparent because patients were traumatized or died due to failure of efficacy in medical devices not being tested appropriately.Memorable quotes from Adnan Ashfaq:“They’ve really had to rethink their entire commercial strategy - whether they want to keep their devices within the European market, whether it’s financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are.”“I think it really boils down to what is the priority, and a lot of businesses don’t actually realize to keep themselves in business that they need to see this as a high priority.”“Regulations are mandatory, they are not optional.”“Don’t underestimate the cost of quality and regulatory and very often, that is done. You have to build it in. You have to know your market.”Links:Adnan Ashfaq on LinkedInWelcome to Simplimedica - Simplifying Device RegulationGuidance - MDCG endorsed documents and other guidance - Public Health - European CommissionEuropean Union Medical Device Regulation (EU MDR)European Union In Vitro Diagnostic Regulation (EU IVDR)RWS - Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulationsEUDAMEDFDA - Software as a Medical Device (SaMD)BrexitGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.Some of the highlights of this episode include:You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.Despite some trite responses, FDA cannot ask you to do whatever it wants. The FDA must give a specific reason, and then you decide whether to accept or fight against it and wave the least burdensome flag.Informal and formal options include understanding concerns of the agencies and working with review team to come up with a compromise or amicable solution.Escalating the issue is another option with an email or phone call to move things along and voice your concerns. If a compromise cannot be made, document the final product.The goal of the Least Burdensome Flag is to quickly address the FDA’s requests that submitters do not believe are least burdensome or held to a different standard than the legally marketed predicate device.Before throwing the Least Burdensome Flag, you need to meet specific criteria: Try to address concerns with the lead reviewer, limit it to two topic areas, and submit it within 60 calendar days of FDA issuing the request or deficiency letter.The last resort option is taking the issue to court. Tread cautiously because you can win the battle, but lose the war.Memorable quotes from Mike Drues:“Why is FDA asking us to do this additional testing, collect this additional data, whatever? FDA should be able to give you a legitimate reason as to why they’re looking for this information.”“We should respect the FDA, but at the same time, they should respect us.”“The goal of the Least Burdensome Flag is to quickly address FDA requests.” “Whatever we do, that needs to be justified. There needs to be a reason for doing it...needs to be justified based on the biology and engineering.”Links:Developing and Responding to Deficiencies in Accordance with the Least Burdensome ProvisionsFDA/CDRH Webinar - The Least Burdensome Provisions: Concept and Principles510(k) Submission ProcessInvestigational Device Exemption (IDE)ISO 10993 - Biological Evaluation of Medical DevicesCode of Federal Regulations (CFR)Medical Device User Fee Amendments (MDUFA)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.Some of the highlights of this episode include:Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.It takes time, often several years, for companies to transition to new or revised regulations and standards. Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.Mark describes a do versus don’t do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.Memorable quotes from this episode:“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer“It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert“Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert“A lot of companies, I think their quest is towards compliance.” Jon SpeerLinks:ISO 13485ISO 9001FDA - Medical DevicesFDA - Quality System RegulationEuropean Union Medical Device Regulation (EU MDR)European Union In Vitro Diagnostics Regulation (EU IVDR)Mark Alpert on LinkedInThe Global Medical Device Podcast: Quality - Who, What, When with Christie Johnson from Kasota EngineeringGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.Some of the highlights of this episode include:What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.Memorable quotes from this episode:“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike DruesLinks:FDA UDI Homepage: Unique Device Identification SystemCDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturersCode of Federal Regulations (CFR)FDA - 510(k) Submission ProcessFDA - Software as a Medical Device (SaMD)FDA - Premarket Approval (PMA)ABILIFYMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices.Some of the highlights of this episode include:Who manages quality? Most startups first hire someone with years of experience, but Christie encourages early firms to embrace the teach mentality. Christie enjoys training teams to build an understanding of quality from scratch.What is quality? Those with a willingness and capability to learn can be coached to know what a quality management system is and needs to include initially.Two Schools of Thought: Companies either view quality as, do it later when the time is right or that’s not my job. Quality is a way for companies to ensure safety and efficacy. Put your products and services at the center of your universe.Christie’s philosophy is to never do what traditional consultants in the industry do. She never just shows up, throws some documents down, and walks away.Which QMS to implement? The system that you should implement is the one that your team will use. Make it simple and fast. If your team cannot understand and readily use the tool, they’re not going to do it or follow the procedure/process.Delivering a QMS without providing step-by-step training can lose functionality. Start with baby steps into processes, especially for those without experience.What to include? You don’t need to comply with regulations right away. Put things in place - early data, suppliers - document/record what you’re doing during the research and discovery phase. Tell your story and take credit for your hard work.Why are you struggling? The reality is it takes longer than six months to one year to get your idea or product on the market. Trial knowledge can reduce risk.Memorable quotes from Christie Johnson:“If you can read and understand the regulation and if you can sit and work with me and help me understand your background and I can coach you, we can start putting in place your early quality system.”“Our philosophy is very much to never do what traditional consultants in the industry do, which is show up, throw some documents down, and walk away.”“The system that you should implement is the one that your team will use and make it easy.”“It’s really easy to get lost or just ignore the quality system that’s in place, especially if you come into an organization that already has way more than they need.”Links:Christie Johnson on LinkedInKasota EngineeringNational Institutes of Health (NIH) - Rapid Acceleration of Diagnostics (RADx)Devon Campbell with ProdctFDA - Medical DevicesISO 13485Meet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge⁠—a team of medical device professionals with a ton of industry experience.In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team.Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success.Some of the highlights of this episode include:Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems.While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that there’s a whole different level of terror when it comes to the FDA.Maryann was attracted to joining the Greenlight Guru team because of her interest in quality system software. She wanted to help the company sell its software and connect with customers and medical device companies.Maryann shares some of her favorite stories working with companies trying to evaluate their options for quality systems. The best part is customers’ positive reactions during design control matrix and risk matrix demonstrations.The benefits of Greenlight’s QMS include the ability to quickly and easily find and access visually appealing information and data. Ultimately, it helps people get through audits faster and be in compliance.However, Maryann explains how and why EU MDR continues to be a challenge for medical device companies. Compiling records and evidence for submission as well as interconnectivity are just some of the bigger quality issues.If the FDA transitions to the 13485 standard, Maryann believes the medical device industry shouldn’t panic but anticipate it. It would be better to have a harmonized way of auditing and inspecting companies.Memorable quotes from Maryann Mitchell:“I’ve lived and breathed the 13485, 820, all those fun standards, which I love. It’s really exciting and I love being in audits.”“There’s a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully, I wasn’t in the hot seat for those, but I was in the front room to participate.”“Not just during an audit, but for your own internal quality, it’s just so much easier when your systems are connected, and that’s exactly what Greenlight offers to our customers.”“You should always be audit ready.”Links:Maryann Mitchell on LinkedInISO 13485 - Medical DevicesFDA InspectionsEuropean Union’s Medical Device Regulation (EU MDR)Meet a Guru - Sara AdamsMeet a Guru - Taylor BrownGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru