Global Medical Device Podcast powered by Greenlight Guru

What can you still do to help in response to the COVID-19 pandemic? The National Institute of Biomedical Imaging and Bioengineering (NIBIB) announced that its Point-of-Care Technology Research Network (POCTRN) is soliciting proposals to further advance SARS-CoV-2 testing technologies to fill specific unmet national needs through RADx Tech II, a fast-track program that leverages POCTRN.In this episode of the Global Medical Device Podcast Jon Speer talks to Mark Marino, Vice President of Growth and Strategy Development at VentureWell. VentureWell has been involved with the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Program. Listen to this episode to learn more about the RADx Tech II program to fast-track eligible technologies to market in 2021.Some highlights of this episode include:Under this RADx Tech II solicitation, NIBIB is seeking proposals to accelerate validation, manufacturing scale up, and commercialization of innovative COVID-19 testing capabilities.Capabilities include the full range of COVID testing from antigen to labs and POC to over-the-counter (OTC).Mark is starting to see some rapid evolution with some exciting technologies that are starting to come up in the pipeline of the market.It’s unfortunate that it took COVID-19 to spark innovation and acceleration of bringing products and technologies to the market.Unmet needs still exist, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.How are tests holding up to variants? Adjust and modify tests to be as fast and responsive to address variant capabilities.RADx Tech I versus Tech II programs will follow a similar phased-based approach for funding, infrastructure, and other systems. Less data is needed, but the data still needs to hold up.Memorable Quotes from Mark Marino:“It’s labs, point of care, it’s antigen, it’s over-the-counter, really the full-range of COVID testing.”“Now, we’re really starting to see some really rapid evolution with some really exciting technologies that are starting to come up in the pipeline of the market.”“Everyone kind of knows, everyone has an expertise. Everyone has the same goal. People are letting go of both ego and showing up with tons of humility about what can I do to help? How can I add value?”“We still understand that there are some unmet needs, particularly when it comes to screening, surveillance, diagnostics, and prognosis related to at-home and point of care tests.”Links:Mark Marino - LinkedInRADx Tech II - POCTRN - CIMITVentureWell Home Page - Welcome to VentureWellNational Institutes of Health (NIH)National Institute of Biomedical Imaging and Bioengineering (NIBIB)FDA - Emergency Use Authorization (EUA)The Manhattan ProjectGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Hungry for medical device industry knowledge? Greenlight Guru has you covered — now, medical device professionals can enjoy additional, sought-after training courses in the already popular educational platform, Greenlight Guru Academy, through a new partnership with Medical Device HQ.In this episode of the Global Medical Device Podcast, Jon Speer talks to Peter Sebelius, the founder and CEO of Medical Device HQ.Together, Peter and Jon discuss the importance of online learning and providing access to relevant, role-based training for medical device professionals. Listen now to understand the true value-add of this partnership and the further learning opportunities it brings the medical device industry.Some highlights of this episode include:Peter finds the process of developing or creating something new is almost as exciting as doing the actual technical work.Also, Peter believes that blended courses are helpful because people get to learn at their own pace and validate their understanding of the content through formative assessments and evaluations.Why are we doing these things? The FDA requires regulations and standards to be met for good reasons. It’s motivation to be meaningful. Peter started his career in the defense industry, which is good at structured product development. However, he transitioned to the medical device industry to go from taking lives to giving life.The COVID-19 pandemic has put more emphasis on online learning, which is useful and remains a trend.Memorable Quotes from Peter Sebelius:“The process of developing something or creating something new is almost as exciting as doing the actual technical work.”“Being able to work in an industry where both those two things are important is such a privilege for me.”“Unfortunately, quite a lot of people that are instructors in this industry will forget all the good things. We’re doing the things that the requirements tell us to do.”Links:Peter Sebelius on LinkedInMedical Device HQMedical Device HQ on YouTubeFDA - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What did FDA report as the most-cited issues during medical device inspections for the fiscal year of 2020? Understanding the data can help you prepare against making these common, avoidable mistakes during your next quality system inspection.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences. Together, Mike and Jon discuss the FDA FY2020 data for medical device quality system inspections and evaluate the top three most cited QSR clauses that resulted in 483 observations.Some highlights of this episode include:The volume of inspections and number of findings, such as 483 observations and warning letters, were down - partially due to the COVID pandemic.Other reasons may include whether remote inspections are effective or even allowed. However, the number of 483s issued against medical device quality systems decreased by 50% in 2020.Top 3 Cited Claims: CAPAs, complaints, and design controls made up about 35% of all 483 observations issued by the FDA in 2020.Of the 197 times that CAPAs were issued last year, manufacturers either did not document or cite procedures. Medical device companies must have a quality management system (QMS) and follow a CAPA process to be compliant.CAPA should be changed to preventative and corrective actions (PACA). Put the emphasis on preventing problems, rather than correcting problems and complaints when they happen.Almost 200 complaints were cited because manufacturers didn’t document procedures for maintaining files.Also, 139 complaints were filed due to medical device failures not investigated, not containing required information, or lacking rationale to not conduct an investigation. Every complaint requires some level of investigation.Design validation of design controls gets most 483 observations for not having procedures, not performing or documenting risk analysis, not having software validations, or not using a production equivalent device in validation studies.Memorable quotes from this episode:“When the number of findings is down, is it because we in companies and we as an industry are doing a better job? Or, is it because of something else?” Mike Drues“Apparently, FDA doesn’t have a mandate or I’ll use the word, permission, or something of that nature, to do remote inspections for med device companies.” Jon Speer“Our job as medical device professionals is to make sure that the products that we design, develop, manufacture, sell, so on and so forth, they’re as safe and effective as they can possibly be.” Jon Speer “I have a responsibility, certainly to the patients, to do an investigation when I learn about something.” Jon Speer“Average regulatory professionals know the rules, but the best ones know the exceptions.” Mike DruesLinks:The Top 10 Most-Cited Issues in FDA FY2020 Medical Device InspectionsFDA - Inspection ObservationsFDA - Medical DevicesFDA - Corrective and Preventive Actions (CAPA)FDA - Form 483 Frequently Asked QuestionsFDA - Premarket Notification 510(k)Code of Federal Regulations (CFR) - Title 21 Part 820CFR Part 820:30 - Design ControlsThe Bleeding Edge Documentary on NetflixMike Drues on LinkedInGreenlight Guru AcademyMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training.In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies.Kevin is the mindset coach for Greenlight Guru and has worked with Jon and Greenlight Guru employees over the years by providing mindfulness tools and techniques that teams can use to improve overall mindset. Listen to what Jon has learned from this mindset training and how the medical device community, too, can benefit from engaging in mindset practices at work.Some highlights of this episode include:Being the CEO of a high-growth startup proved to take a whole other level of work that required mental strength and resilience. Kevin used mental models to reframe experiences and have a more positive attitude while leading people.CEO Cues: Feeling motivated or burnt out? How is the business doing? People follow their leaders and want to boost productivity and camaraderie.Working with Kevin from Dreamfuel has changed the world for Jon and his colleagues, as well as other companies trying to do great things, make a difference, and feel better.Mindset is an important practice for success in a company. About 95% of thoughts are subconscious and automatic, like a heartbeat. Also, 70-80% of those thoughts and actions are negative, disempowering, limiting beliefs.A measurable difference, consistency, and alignment of peak performance can be achieved by companies, executives, and staff via neuroscience principles.The stigma around meditation is stopping people who need it from doing it. What’s the goal? There’s no outcome you are going for in meditation.Acknowledge and let go of thoughts spinning in your mind because dopamine (pleasure) and serotonin (joy, happiness, and presence) create a balanced mind.Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, and what you do. If you can control your physiology, it’s easier to control your thinking and behaviors. Breathe rhythmically and smoothly.Memorable quotes by Kevin Bailey:“Mindset is such an important practice for success in a company.”“We’re trying to kind of take these practices that have been utilized for ions to help people be happier and perform better, wrap them with some neuroscience, so that people can accept and understand them, but there’s still that stigma.”“There’s no outcome you’re going for in meditation. You purely do meditation to do meditation.”“Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, what you do.”Links:Kevin Bailey on LinkedInDreamfuel CoachingDr. Diane PowellWhy Greenlight Guru Rewards Employees Who Get the Best SleepThe Beatles’ Meditation Coach - Maharishi Mahesh YogiBreath by James NestorGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators.Some highlights of this episode include:In January 2021, HHS declassified a number of medical devices without first consulting or notifying FDA. As a result, the reclassification initiative is on hold pending a review due to regulatory freeze.The HHS proposal affects seven (7) Class I devices (all gloves) and eighty-three (83) Class II devices, such personal protective equipment (PPE) and thermometers.It’s ironic that regulatory quality requirements apply to products but don’t seem to apply to processes that regulate those products. It’s another example of not practicing what you preach.Some companies want FDA to require feedback before down classifying and exempting changes. Reasons why? Safety, efficacy, and competitive advantage.Design controls, risk management, and quality management systems demonstrate that products are safe, effective, and meet indications for use.Proceduralizing and establishing processes is a way to describe how you operate and run your business. Why are they perceived as bad things and barriers?Recommended approach: begin with biology, engineering, then regulatory requirements.Memorable quotes from this episode:“Changing medical device classification, whether we’re going down or up, doesn’t matter, without notifying or consulting the folks that are responsible for evaluating these medical devices...politics aside, Jon, it’s hard to connect those dots. What sense does that make?” Mike Drues“You don’t have to have a Ph.D. in biomedical engineering...to appreciate that gloves and thermometers and other forms of PPE—these are not the most complicated kind of products in the world.” Mike Drues“It should not take a Ph.D. in biomedical engineering or an RAC after somebody’s name to appreciate that maybe it doesn’t make sense to lump gloves and thermometers into the same category as infusion pumps and ventilators.” Mike Drues“Isn’t evaluating changes or the potential for changes, in this case in a medical device, always a good thing?” Mike Drues“Things like design controls and risk management and establishing a quality management system is all about science. It’s all about demonstrating that the product is safe, that it’s effective, and that it meets the indications for use.” Jon SpeerLinks:Mike Drues on LinkedInVascular SciencesU.S. Department of Health and Human Services (HHS)HHS ProposalFDA - Medical DevicesHHS’ proposed 510(k) exemption proves the need for regulatory scienceDevice, digital health firms oppose HHS’ proposed 510(k) exemptionsFDA walks back Trump-era premarket notification exemptions21st Century Cures ActEmergency Use Authorization (EUA)Overview of the 510(k) ProcessPremarket Approval (PMA)De Novo Classification RequestGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination.In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Manager, and Jesseca Lyons, Operations and Enablement Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearning platform is helping users around the world advance their medical device careers.Some highlights of this episode include:Greenlight Guru Academy is a learning management system (LMS) path that allows medical device gurus, customers, and others to share knowledge and educational content and courses to encourage retention and effectiveness.About six years ago, whenever a new customer would come on board with Greenlight Guru, it was a manual process. Fast forward to a few years later, Greenlight Guru Academy has made that process automatic and evergreen.Feedback from some of the thousands of Greenlight Guru Academy users who have completed the various courses help gauge success and types of content.Learner’s Mindset: I want to do the right thing. I want to make it better. I want to help someone, but it’s next to impossible to do. Demystify the medical device space, especially as the industry changes.Greenlight Guru Academy is for anyone getting started to veterans wanting to hone their skills in the medical device industry. Expect to see a lot more audit and inspection courses and content. Also, expect basic regulatory learning.Memorable quotes from this episode:“In the academy, we have all sorts of awesome courses - go at your own pace courses - on topics like document management, design controls, risk management, training, audits, and the list is going to continue to grow and evolve.” Jon Speer“Ultimately, the academy looks to really be this educational kind of beacon in the medical device industry for anything anyone could ever need to know from just getting started to a veteran looking to hone their skills.” Aaron Lucas“There’s something about the medical device industry that breeds these folks who don’t just recognize that they have to learn this stuff but they actually kind of like it.” Aaron Lucas“Why am I making a medical device in the first place? I want to help someone.” Jesseca Lyons“This is an opportunity to get a chance to really impact more and more people.” Jesseca LyonsLinks:Aaron Lucas on LinkedInJesseca Lyons on LinkedInGreenlight Guru Academy - Enroll NowAbout Greenlight Guru AcademyFDA - Medical DevicesInternational Organization for Standardization (ISO)510(k) Premarket NotificationEuropean Union’s Medical Device Regulation (EU MDR)Risk Management True Quality Summit SeriesGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Have you ever had to “sell” your brand to someone? To do this effectively, you must master the art of networking and selling whatever it is that you bring to the table.In this episode of the Global Medical Device Podcast, Jon Speer talks to Chip Helm, a Dental School dropout turned National Sales Manager of a multi-billion-dollar medical device company. Also, Chip is a guest lecturer and bestselling author who is creating a sales revolution.Together, Chip and Jon chat about the importance of a person's brand, which consist of three main types, and how medical device professionals can create new opportunities for growth with intentional self awareness tactics.Some highlights of this episode include:Chip’s Books: It doesn’t matter what career you take and where you go, his books teach basic principles of business and lessons that fit into anybody’s career, any company.Importance of Branding: Whether it’s your personal or professional brand, you have got to have self awareness to build, develop, and write your personal brand.Google your name. What can you do if you don’t like the brand you have? Find five things about yourself and how others you trust perceive you and your brand.Compartmentalize: Perception is reality, it doesn’t matter if you didn’t do something. Your personal brand can take years to build, but it can take only seconds to lose it.Rules of Engagement: There’s three brands—personal, colleague/industry, and customer—observe and listen more, speak less to communicate.Your company must have a great product, but it’s still about networking and building relationships. Help people by offering solutions to solve their problems.Sales Component: If you’re just trying to sell someone something, they can tell if you care about them or not. Commission gets people too close to not doing the right thing for the right person.Memorable quotes by Chip Helm:“It doesn’t matter what career you take and where you go, it teaches five basic principles of business. It fits into anybody’s career, any company, it doesn’t matter.”“Everyone’s in sales.”“Most people say when they think of branding, they think of corporate branding. They really don’t think that there’s a thing called personal branding out there.”“It could take years to build up a personal brand, but it will take seconds to lose it.”“If you want to get promoted, if you want to get a better paycheck, if you want to make advancements...you need to be up on your personal brand. You’ve got to understand it.”Links:Chip Helm’s WebsiteEveryday Sales Wisdom for Your Wealth and Career by Chip HelmBigger Than Sales - How Humility and Relationships Build Career Success by Chip HelmTo Sell is Human by Daniel H. PinkMark Cuban on Shark TankGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Have you ever wondered, what does a medical device guru actually do? What role do they play within Greenlight Guru and what value do they bring medical device companies in the context of the QMS software?In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rish, a senior medical device guru and manager of the guru team at Greenlight Guru.Tom shares his unique insights into the life of a medical device guru at Greenlight Guru, how the guru team engages with customers beyond the software itself, and how the "Guru Edge" has come to be one of Greenlight Guru's most valuable offerings to medical device companies around the world.Some highlights of this episode include:Role of the Medical Device Guru: Collect as much feedback as possible from customers throughout the sales process to determine why they select Greenlight Guru’s QMS over other quality management systems.Medical Device Guru Team Philosophy: Give peace of mind to customers and help them meet their goals, whether it’s to launch a product or pass an audit. Gurus want their customers to succeed the first time.Do you want to be a medical device guru at Greenlight Guru? You are encouraged to be curious, inquisitive, and willing to learn and help because you are exposed to different medical device companies and technologies.The process of setting up a medical device quality system, getting your product to market is much more overwhelming than it actually is. First, focus on design controls and risk management. You can add more later.Build as You Go: Use phased approach to implement a QMS to make paperwork less of a burden and less tedious to add value and improve business efficiencies.Market Research: You need to know your industry and understand your users and their needs. Talk to as many people as possible - clinicians, patients, etc.Memorable quotes by Tom Rish:“Greenlight Guru is more of an experience and not just buying software. We feel like the gurus are a big part of that experience and we want to make sure that we hold up our end of the bargain to that.”“We found early that our customers are coming to us with a lot of different questions.”“It’s very humbling and also encouraging to see how many people out there are just really passionate about their ideas.”“You can do a lot of work to get your product ready to launch knowing that you can add stuff on later.”Links:Tom RishFDA - Medical DevicesFDA - Guidance Documents510(k) Submission ProcessFDA Inspections and ISO Audits: What is the difference?Software as a Medical Device (SaMD)European Union Medical Device Regulation (EU MDR)In Vitro Diagnostics Regulation (IVDR)Global Medical Device Podcast, Episode 177: 5 Actionable Lessons Learned from the RADx Initiative by NIH Global Medical Device Podcast, Episode 205: Global Medical - Things I wish I knew as FDA reviewerGlobal  Medical Device Podcast, Episode 158: Meet a Guru - Tom RishGlobal Medical Device Podcast, Episode 155: Meet a Guru - Jesseca LyonsGlobal Medical Device Podcast, Episode 153: Meet a Guru - Taylor BrownGlobal Medical Device Podcast, Episode 160: Meet a Guru - Wade SchroederGlobal Medical Device Podcast, Episode 188: Meet a Guru - Sara AdamsGlobal Medical Device Podcast, Episode 206: Meet a Guru - Laura CourtGlobal Medical Device Podcast, Episode 207: Meet a Guru - Etienne NicholsGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

The Guru edge: it's what makes Greenlight Guru so unique and valuable to the medical device companies it serves. The Guru team is comprised of industry experts with a knack for helping companies succeed; each of whom have a specific skillset and knowledge base that companies can tap into and leverage throughout their medical device journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Etienne Nichols, a Medical Device Guru at Greenlight Guru, to learn more about his expansive industry knowledge, experience, and passion, of which he uses in his approach to help customers work through the design and development process to bring safe, high quality products to market.

What makes Greenlight Guru unique? It’s the 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 Laura Court, a medical device Guru at Greenlight Guru, about her journey in the medical device industry, which ultimately brought her to Greenlight Guru, and Laura shares tips for success she's learned along the way.Some of the highlights of this episode include:Laura gained hands-on manufacturing experience because she believes medical device professionals can’t design a product well if they don’t know how it’s made or what is gone through to get a product made and put on the market.What made Laura move towards Greenlight? Ultimately, it was her love of helping people and getting out on the floor to help people who make products.Laura sought advice and looked to manufacturers for knowledge to validate products because they knew the systems and processes better than anyone and she wanted to help fix problems.Also, Laura learned that people using products can drastically alter what medical device professionals do.Laura likes being a Guru because she has the opportunity to meet companies and customers, as well as collaborate and interact with people doing and coming out with amazing work and new technology.Greenlight Guru Academy offers courses on risk management, design controls, and document management. Laura believes the educational resource features well-written content that makes the transition to a medical device career easier.Most interactions at Greenlight have been virtual and remote. It takes a desire to learn, surround yourself with smart people, and gain experience.Keys to Success: Use and rely on resources that you can find. You don’t need to know everything right now or be an expert on everything you touch and see.Memorable quotes by Laura Court:“I’m a true believer that you can’t design a product well if you don’t know how it’s being made or what you go through to make a product.”“Ultimately, I just loved helping people. I loved getting out on the floor and helping people who are helping us make the products and things like that. That’s what ultimately drew me towards coming towards Greenlight.”“I’ve already met so many different companies and just learned about some amazing technology that people are coming out with.”“I just love the collaborative side of all of it.”Links:Laura Court on LinkedInFDA - Medical DevicesEuropean Union Medical Device Regulation (EU MDR)ISO 13485 - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru