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How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations?In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner. Some of the highlights of this episode include:In the medical device industry, De Novo refers to something new and innovative.  When you have an idea that has not been done before and is not substantially equivalent, then the De Novo pathway may be the right choice.The De Novo process is not as commonly used as the 510(k) pathway. The rate of innovation compared to incrementals tends to not be as often.Rob describes the pros and cons of the De Novo pathway. Some people think it requires extra work and higher submission fees, but it’s an opportunity to work with the FDA to create and regulate a new product category that may be copied.The De Novo pathway takes longer to review than 510(k) submissions due to risk management activities. It’s worth it to be the first innovative leader in the field.Think, prepare, and plan for different scenarios and conflicting messages when choosing a pathway to avoid pitfalls, such as analysis paralysis.Don’t compromise core technology and features when making a product/device. Focus on quality without sacrificing compliance to improve quality of life.Work together and collaborate to understand the client’s needs and amount of key information to give to the FDA to provide meaningful and quality feedback. Memorable quotes from Rob MacCuspie:“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.”“The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.”“The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.”“Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.”“Don’t be afraid of the De Novo process. It’s actually a really great tool.”Links:FDA - De Novo Classification RequestFDA - Medical Device OverviewFDA - Q-Submission Program GuidanceFDA - 510(k) SubmissionFDA - Premarket Approval (PMA)FDA - Case for QualityRob MacCuspie on LinkedInProxima CROTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGMPAC).Michelle is on a mission to help smaller companies with regulatory strategy, planning, submissions, audit preparation and remediation, due diligence, quality systems, and compliance.Some of the highlights of this episode include:Why new clients work with Michelle: It’s easy to find a competent regulatory person, but how many are you going to enjoy working with and able to make you laugh when you really feel like crying?Even with the adoption of EU MDR, people are still in denial when it comes to those with certificates that expire in May 2024 and think they still have time to get certificates reissued.Several small companies, as well as large corporations, are choosing to not go to market or withdraw products in the EU because of the lack of value and revenue.The cost, clinical data, and limited number of notified bodies are some of the biggest challenges for those in the EU versus U.S. market.Companies should perform a market analysis to determine if their revenue model will support year-over-year costs and third-party fees to stay in the EU market.The impact to quality in the European healthcare system could turn the U.S. into a destination for medical tourism. It could happen if an analysis is not done by the government or competent authority.A quality management system (QMS) has to have an ISO 13485 certification in the EU. The U.S. doesn’t require a QMS until a product is put into commercialization and meets performances, standards, and expectations.According to Michelle, the five stages of regulatory grief are denial, anger, bargaining, depression, and acceptance.Memorable quotes from Michelle Lott:“If you don’t have a relationship with a notified body yet, you’re already almost too late. You just can’t make any commitments to or marketing plans for the EU right now, in terms of timing.”“The first thing is to do that market analysis, and then, if they decide that Europe is still  something that they want to do, second, you need to get in line with a notified body.”“There’s no such thing as grandfathering underneath the EU.”“There were 18,000 certificates issued under MDD, and only one percent of those have made it all the way through MDR.”“To properly prepare technical documentation, it is truly a cross-functional effort and it’s going to require a lot of very in-depth expertise.”Links:Michelle Lott on LinkedInRegulatory + Quality Assurance (leanRAQA)leanRAQA - Free GuidesRAQA Today PodcastFDA - Device Good Manufacturing Practice Advisory Committee (DGMPAC)European Union - Medical Device Regulation (EU MDR)ISO 13485FDA - Quality Management System Regulation (QMSR)True Quality 2022The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

Have you ever played the game, Operation? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game.In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Shawn Regan, CEO and Co-founder of Rhythmlink International, at the South Carolina Biosciences (SCBIO) Conference.From startup to industry leader, Rhythmlink is a company that designs, manufactures, and distributes medical devices that physically connect patients to machines to elicit or record neurophysiologic information.  Rhythmlink’s products are used during risky surgeries to help prevent or reduce paralysis, identify tumors, map the nervous system, and monitor brain waves. Its devices were the first of their kind to be cleared by the FDA to work specifically in MRIs.Some of the highlights of this episode include:Shawn describes neurophysiology as electrodes put on or under a patient’s skin to monitor their nervous system in real-time to identify dangerous situations.As a startup, Rhythmlink recognized the need to change from reusable to disposable products. Although the company did not know when that was going to happen in the medical industry, they knew it would and why.Early on, Rhythmlink experienced several challenges as a medical device company. It didn’t have any money, patentable technology, or intellectual property (IP). Co-founders had an idea, figured out how to create it, and bootstrapped it. Collaborating with the FDA 20 years ago was easy and straightforward. Rhythmlink wanted to know how to submit a 510(k) to get FDA clearance.Rhythmlink’s electrodes can be put on and left on during an imaging study to allow the brain to be monitored more often, which results in much better clinical information quicker and consistently to find and treat dangerous situations.Rhythmlink decided to automate some of its products because shipping rates changed, led to higher quality products, and customers liked the products better.Rhythmlink makes its products in China and sells its products in the United States, European Union (EU), and nine other countries.Cost-Benefit Analysis: Rhythmlink’s regulatory strategy is to identify all the different regulatory requirements for all the different countries the company wants to be in and make sure there is enough of a market to be worthwhile.Memorable quotes from Shawn Regan:“If you remember the game operation when you touch the side and the nose buzzes and goes off, it really is a lot like that.” “With our electrodes, the ability to put the electrodes on once and keep them on and leave them on during an imaging study allows the brain to be monitored more often.” “You get much better clinical information quicker and consistently all the time. So, you’re able to find those dangerous situations and then treat them.” “For our products, not every country has made the switch from reusables to disposables. All of the products that we make are disposable products, none of them are reusable at this point.” Links:RhythmLinkShawn Regan EmailSouth Carolina Biosciences Organization (SCBio)South Carolina Research Authority (SCRA)FDA - Medical Device OverviewCenters for Medicare & Medicaid Services (CMS)Plan, Do, Check, Act (PDCA) CycleEuropean Union Medical Device Regulation (EU MDR)EU Medical Devices Directive (MDD)The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become more frequent, severe, and impactful. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, Director of Product Security at Velentium and author of Medical Device Cybersecurity for Engineers and Manufacturers.Chris has more than 30 years of experience developing and securing medical devices for device manufacturers and collaborates with regulatory and standardization agencies to present, clarify, and systemize tools, techniques, and processes that enable the creation of secure medical devices.Some of the highlights of this episode include:Although the FDA understands the importance of updating cybersecurity guidance, it should tie the documents to real standards from ISO and EU MDR, rather than only referencing consensus standards for global harmonization.To make secure medical devices, a standard cybersecurity requirement needs to be created for manufacturers to do it the same way based on research and tools.During the development portion of the product life cycle, manufacturers need to identify threats. However, if there is not a workable requirement and the developer does not know what to do or not do, then nothing is done but ignored.Manufacturers have to look for the vulnerabilities or end-root cause of all exploits and threats during development. Vulnerabilities occur during the design, implementation, and use of third-party software components.Software Bill of Materials (SBOMs) need to be readable and consumable. An asset management system needs to be built in to address risk mitigation.When buying medical devices, health delivery organizations (HDOs) want SBOMs, support, and other cybersecurity expectations included in contracts.Find out what you need to do to create secure medical devices. At the very least, look at it as a competitive advantage in the industry.Memorable quotes from Chris Gates:“I want something that’s workable, something that’s harmonized.” “What you have to look for are the vulnerabilities or the end-root cause of all exploits and threats.” “We want SBOMs. We want people to talk to. In case of a breach, we want some help.” “Take a look at what you need to do to be a good corporate citizen and create secure medical devices. At the very least, look at it as a competitive advantage in the industry.” Links:VelentiumMedical Device Cybersecurity for Engineers and ManufacturersFDA - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket SubmissionsFDA - Quality Management System Regulation (QMSR)International Organization for Standardization (ISO)European Union - Medical Device Regulation (EU MDR)Protecting and Transforming Cyber Healthcare (PATCH) ActSupply Chain - Cybersecurity and Infrastructure Security Agency (CISA)NIST Special Publication (SP) 800-161, Supply Chain Risk Management Practices for Federal Information Systems and OrganizationsSoftware Bill Of Materials - National Telecommunications and Information AdministrationSoftware Bill of Materials - CISAOWASP CycloneDX Software Bill of Materials (SBOM) StandardCycloneDX Tool CenterInternational Open Standard (ISO/IEC 5962:2021) - Software Package Data Exchange (SPDX)MedcryptCyber BOM (SBOM) Management - CybellumSBOM Use Case - RKVSTThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight GuruGlobal Medical Device Podcast Email

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting.CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-efficient manner.Some of the highlights of this episode include:CAI utilizes integrative services to identify clients’ needs to achieve operational readiness. Then, operational excellence is the end goal. Most CAI agents are Project Management Professional (PMP) qualified through Project Management Institute (PMI). Patrick encourages and recommends people to attain PMP certification to enhance their degree of success.Patrick describes the steps of a solid project management process. It includes planning, integration, and execution.The earned value calculation is where every action item is shown a direct correlation to the amount of money spent. Basically, you are getting more or equal to what you paid.If a small company with 2-5 employees is not ready to use or formalize a project management process, Patrick advises people to invest in education and training. The project manager is a hub of communication. Always keep everything accurate to create a sense of security for having everything that will be needed. Memorable quotes from Patrick Hayes:“Everybody strives for operational excellence, but yes, a strong package with operational readiness is the key.”“In a project, especially with startups, I’d say there’s no such thing as over communicating.”“Anything in the medical device industry directly affects, correlates, and supports the public. It’s a huge market and it’s a very important market.”“Never make any shortcuts to your quality.”Links:Patrick Hayes on LinkedInCAISouth Carolina Bio Conference (SCBio)FDA - Medical Device OverviewProject Management Institute (PMI)PMP CertificationPMI - Roles, Responsibilities, and Resources (Responsible, Accountable, Consulted, and Informed - RACI Chart)Earned Value CalculationLinkedIn LearningTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru AcademyGreenlight Guru

Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices⁠—not shortcuts⁠—to bridge the gap between medical devices and clinical data.SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software generates, collects, and manages data used in clinical studies.Some of the highlights of this episode include:EDC is a newer concept or discipline for the medical device industry. Compared to the pharmaceutical space, automation from the clinical trial perspective has been a bit slower because of smaller sample sizes.Post-market surveillance activities are driven by EU MDR. In Europe, medical device companies are now being forced to prove to the world that their device continues to be effective against its peers and new products getting to market.Pre- and post-market data is to get medical devices to market and continue to be adopted, reliable, effective, and not discontinued due to new products.Another type of data that SMART-TRIAL can capture is related to payors. Does your product show an economic benefit to get reimbursed? It’s difficult to get feedback from those in the field, during tests, and clinical trials. If something’s not working, expect more feedback. If it’s working, you get less.EU MDR has had two significant impacts: the number of notified bodies is still not where it needs to be and it has created rationalization of product SKUs.Decentralization or remote patient care can change data results in clinical trials by using medical devices and technology to work more efficiently. For example, what’s the difference between medical device vs. health/lifestyle product data?Rules are slightly different when developing algorithms and software for medical devices. They’re not written that differently and updated standards are not typically complete overhauls.Memorable quotes from Adam Steadman:“The device industry in terms of automating from a clinical trial perspective has been a little bit slower than the pharma side of things. One of the reasons is we have much smaller sample sizes.”“Technology has gotten to the point now where we can do it efficiently and inexpensively at the same time.”“What’s really happening in Europe now is that you’re being forced to prove to the world that your device continues to be effective against its peers and against other products that are coming out on the market as new products.” “There’s a good reason for regulation. There’s a good reason why we changed the regulations in Europe. We’ve got to have these standards for everyone’s benefit.”“When you’re developing algorithms, when you’re developing software for medical devices, the rules are slightly different and they’re not written that differently.”Links:SMART-TRIALAdam Steadman on LinkedInISO 14155:2020ISO 20916:2019European Union Medical Device Regulation (EU MDR)FDA - Medical Device OverviewFDA - 510(k) ProcessFDA - Premarket Approval (PMA)Quality is Free by Philip B. CrosbyTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved by FDA. Any medical device company considering MDSAP should be familiar with what the program is and is not.In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides quality management system (QMS) and regulatory affairs services.Listen to Jon, Etienne, and Danny as they help to align expectations about the MDSAP journey so manufacturers can understand both how program works and how it should be leveraged from a regulatory strategy standpoint.Some of the highlights of this episode include:The reaction to requiring MDSAP certification to access and sell medical devices in Canada created price increases and smaller companies were unable to justify changing the notified body or auditing organization.MDSAP provided opportunities and benefitted some distributors by getting and using technical files and documents provided by the original manufacturers.MDSAP satisfies the need for some countries, including the United States and Canada, but some companies in other countries think the approach takes too much time, money, and resources for a single audit.MDSAP involves assigned tasks, questions, and interpretations for seven processes during the single audit. For ISO 13485 certification, there is variability and jurisdictions are not always asked the same questions by all auditors.There should not be any surprises during an audit if companies conform to requirements outlined in regulatory resources, such as guidance documents, FAQs, procedures and forms.The FDA’s MDSAP model and approach should be an easy process, but it depends on your company and the level of maturity of your quality system.Easily find and retrieve tribal knowledge by capturing and organizing it in your company’s quality system in the event of an audit. Memorable quotes from Danny Kroo:“If you do want to sell into a country, especially Canada, you need to have an MDSAP certificate.” “It made things more expensive and it made the barriers for entry much higher.”“What is the purpose of an audit? It’s to see if you conform to the requirements.” “It should be an easy process. It isn’t so easy because some companies’ systems are mature and they go through it quite easily and others are not. It depends on your company, it depends on the level of maturity of your quality system.” “A certain level of tribal knowledge is still there because you have the system.” Links:FDA - Medical Device Single Audit Program (MDSAP)FDA - MDSAP Audit ApproachFDA - MDSAP Audit Procedures and FormsISO 9001ISO 13485:2016European Union Medical Device Regulation (EU MDR)Health CanadaDOCUSYSDanny Kroo on LinkedInDanny Kroo’s EmailTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old.In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, ​CEO and President of MediView, about bringing augmented reality (AR) medical technology to market.MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Previously, Mina worked at Medtronic, Abbott, Beckman Coulter, and Excelen.Mina is a serial entrepreneur in the medtech and fintech spaces. He approaches his life with a foundation of trust, team, transparency, and track record to encourage collaboration and innovation focused on advancing people’s everyday lives. Some of the highlights of this episode include:MediView solved the problem of how to place a 3-D representation of a patient’s specific anatomy underneath the skin to millimeter accuracy.MediView’s solution enables opportunities for digital health care for minimally invasive procedural guidance and data analytics.MediView’s imaging technology and data feed its platform through a pre-operative or intraoperative scan, such as a CT or MRI, taken of the patient.The scan is communicated to a headset and an algorithm combines/lines up digital AR and physical coordinates to create a 3-D reconstruction that’s put directly into and onto the patient.In the U.S., between physical therapy, loss of productivity, and time off, there’s $120-billion of economic impact due to ergonomic injury of medical imaging.The first therapeutic area and clinical unmet need MediView is targeting is liver and kidney cancer. Only 1 or 2 patients receive a minimally invasive procedure, while the others have to go through chemotherapy or resection.Mina describes the differences of virtual reality (VR) versus AR. VR puts you in a fully digital world, while AR superimposes digital content onto the physical world.MediView’s work culture materializes into the company’s business strategy and model across four functions—trust, transparency, team, and track record. Memorable quotes from Mina Fahim:“We are hardware agnostic. So, we don’t depend, actually, on any one specific headset because of the unique algorithms that we built in.”“We have an algorithm that combines the digital world in AR with the physical world.”“The interventionists are not comfortable taking a needle, sticking it into the abdomen, trying to hit a grape inside of a watermelon blindly to get that tumor ablated.”“We give clinicians imaging modalities they trust and are comfortable with today to validate the new way we’re providing them to practice and exercise medicine.”“If a company’s exit strategy is acquisition, having a robust QMS that someone can look at effectively, efficiently, and simply…that has a mental impact, an emotional impact, a burden impact."Links:Mina Fahim on LinkedInMediViewMedtronicMark GriswoldFDA - Medical Device OverviewCode of Federal Regulations (CFR)The Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you don’t have the information needed to support questions. Some of the highlights of this episode include:Informational meetings are valuable and important for helping medical device professionals and manufacturers build a relationship with the FDA.Informational meetings tend to focus on the early stages of a specific product, technology, or suite of products.Being prepared for informational meetings is beneficial. Rehearse ahead of time and identify pain points according to the FDA.During the informational meeting, pay close attention to what questions the FDA asks as well as address its feedback and suggestions.Some companies do not have or make time and resources available for anything not required, such as informational meetings. However, time and money can be saved in the future by addressing FDA concerns/issues.The FDA is more inclined to attend informational meetings than other meetings because they like learning about new products and technologies.Memorable quotes from Isabella Schmitt:“With FDA, the relationship building from informational meetings is a huge component, and anything relational done with FDA is valuable and important.” “It’s never too early for a pre-sub, but sometimes it is if you don’t actually have the information that you need to support the questions that you’re asking.”“To find them valuable, you need to conduct them in a way that creates the value.”“They like to attend informational meetings because we’re not really asking anything of them and they just get to be nerds again and geek out over the technology.”“If you have a complex product, I would plan to do an informational meeting before pre-subs, just to talk about the product and get FDA to understand it foundationally.”Links:FDA - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramIsabella SchmittIsabella Schmitt on LinkedInProxima CROM1 MedTechInventing Tomorrow PodcastTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing?In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box.Mark has more than 30 years of experience in the medical device industry and takes organizations to the next level of quality system, product development, and operational excellence. His vision, experience, and hands-on leadership drive best practices in quality system processes and project management.Some of the highlights of this episode include:The FDA and ISO quality system requirements include design controls, which have a direct correlation to BOMs.The Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR) are parts associated with design controls. Mark explains the difference between the three to build a product.For BOMs, there needs to be one source of the truth and everything else needs to match it. A master document needs to be defined, then other files and records copy and configure the same data.Based on configuration management, BOMs should include several components, such as a unique identifier/part number, description of part, quantity, unit of measure, operations step, assemblies, and reference designators.When building a BOM, define attributes or metadata that accommodate manufacturing and design points of view to avoid confusion.Design a flexible system. If you design for flexibility, then you’ll never have to worry about changing your quality system because it can’t handle a new product.Determine the rules of interchangeability. As products change, remember to change the part number and update the version on the BOM.Who owns the BOM? The medical device manufacturer owns the BOM because they are the approver and own the DMR and DHF.Memorable quotes from Mark Rutkiewicz:“The Bill of Materials, you can also grow it to be a Bill of Documents and a Bill of Operations. All that is sort of what’s required to build a product.”“That’s why there’s multiple documents today. The manufacturing people want to see it this way. The design people want to see it this way. They’re not talking to each other.” “If you design for flexibility, then you’re never going to have to worry about, ‘Oh, I ve got to change my quality system because I got this new product because my quality system can’t handle it.’” “Every digit in the part number means something.” Links:FDA - Quality System (QS) RegulationISO - Quality Management Systems RequirementMark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoBill of Materials (BOMs)Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What’s the difference?Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru