Global Medical Device Podcast powered by Greenlight Guru

Many medical device companies experience challenges with managing clinical trials even in the most ideal settings, so what happens when big changes occur, like COVID-19 and new regulations, that compound those challenges? If only there was a solution...In this episode of the Global Medical Device Podcast, Jon Speer talks to Pall Johannesson, CEO and co-founder of Smart-Trial – a digital platform that helps medical device companies manage many, if not all, clinical data activities.Listen to Pall’s story about his solution for managing clinical trials, which has many similarities to that of Greenlight Guru, as he discusses his vision and the problem they're attempting to solve to help manufacturers, as well as patients, save time and money with clinical trial management.Some highlights of this episode include:Pall started Smart-Trial as a solution to solve the problem of the medical device industry being underserved. The technology being used to generate clinical evidence and collecting clinical data in clinical studies was outdated.Smart-Trial empowers medical device manufacturers to be in control of their own clinical evidence. Data is becoming more valuable, so companies need to control and access their own data. EU MDR has increased the need for clinical evidence and ongoing clinical data for products. Pall discusses how some companies adopt and adapt to it by taking advantage of collecting data and clinical evidence early on and doing it well.Pall describes similar challenges in the United States and EU. The MDR has pushed companies toward the United States as far as where to start with your market access and different directions to develop clinical evidence.  Smart-Trial’s products and services streamline the clinical side of things. Pall works with startups to well-established corporate medical device companies. However, the complexity of the device comes with complexity of the studies. Pall agrees that the medical device industry is moving toward integration of AI, machine learning, and other intelligent technology. It’s better to find experienced partners to make smart decisions that benefit manufacturers and patients.A big mistake made by medical device companies is collecting too much data. Start small and be specific. One of the best practices is to involve analysis of clinical evidence by a statistician.  Memorable quotes from Pall Johannesson:“The technology that they were using for generating clinical evidence or basically collecting clinical data in clinical studies was outdated by far.”“We empower medical device manufacturers to be in control of their own clinical evidence. Data is becoming more and more valuable.”“Medical device companies, today and in the future, will have to rely much more on having control and access to their own data.”“The biggest impact is definitely companies that wait too long.”Links:Pall Johannesson - LinkedInSmart TrialEuropean Union - Medical Device Regulation (EU MDR)U.S. Food and Drug Administration (FDA)FDA - 510(k) Premarket NotificationHalo by Greenlight GuruGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes.In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming what's known today as EMERGO by UL.Listen to this episode as Jon and René discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.Some highlights of this episode include:Only two economic operators can be held responsible for placing a device on the market - a legal manufacturer that resides in the European Union or an importer.EU MDR does not clearly define who is who in the supply chain when it comes to economic operators. Articles 11, 13, and 14 overlap activities, obligations, and responsibilities for authorized representatives, importers, and distributors.According to René, there are three kinds of distributors: 1. Takes on the role of importer, as well; 2. Capable of taking on the importer role; and 3. Refuses to take on extra liability as the importer.Conduct proper due diligence when selecting an importer. First, map out who is who within your supply chain. Are there multiple distributors with quality agreements in place? Are obligations properly addressed to be met?Importers and/or distributors should have a quality management system (QMS) that complies with ISO 13485 and MDR to fulfill obligations.Person Responsible for Regulatory Compliance (PRRC) and importers are definitely different. PRRC is within an organization, and importers are outside representatives hired to provide services.Memorable Quotes from René Van De Zande:“It’s here, and it’s here to stay. There are no delays - at least not for the MDR. Since May 26, it’s alive and kicking.”“The role of the importer is a critical one because there are only two of the economic operators that can be held responsible for placing a device on the market.”“The MDR has not clearly defined who is who in the supply chain when it comes to economic operators.”“You need to do proper due diligence. First, you need to map out as a company, who is who within your supply chain.”Links:René Van De Zande on LinkedInMedEnvoy GlobalEmergoUnderwriters Laboratories (UL)European Union - Medical Device Regulation (EU MDR)Economic Operators Guidance DocumentMedical Devices Directive (MDD)EU In-Vitro Diagnostics Regulation (IVDR)ISO 13485Mutual Recognition Agreement (MRA) for Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

A Pre-submission can add tremendous value with the feedback given by FDA, which manufacturers can use to guide product development and marketing submission planning. There is an art to preparing a Pre-submission, though, so it's important to include the necessary contents (and avoid common pitfalls) that will yield the best possible results.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about Pre-submissions. Listen as the two share recommendations about what content to include in a Pre-sub request to FDA as well as costly pitfalls to avoid with this particular Q-submission type.Some highlights of this episode include:A Pre-submission meeting is an opportunity to communicate with FDA prior to a marketing submission.About 3,306 medical device-related Pre-submission requests were made to FDA in 2020. In 2021, more than 1,500 Pre-submission requests have been made so far.Not all Pre-submission requests are made for meetings with FDA. About two-thirds of Pre-subs requested a meeting and one-third requested written email communication only.On average, FDA takes two months to give a written response of approval or denial for a Pre-submission request.A Pre-submission is completely optional and never required, but highly recommended.The only time that Mike does not recommend a Pre-sub is when the marketing submission is a ‘slam dunk’ in terms of the agency's decision. That rarely seems to occur, especially because 75% of 510(k)s and 89% of PMAs are rejected the first time.Unlike 510(k) and PMA submissions, as well as 513(g) requests for information, there is no user fee associated with Pre-submissions.When crafting a Pre-submission, justify reasons for why certain approaches are being taken over others.Memorable Quotes from Mike Drues:“A Pre-submission meeting is an opportunity to talk to the FDA before you actually make your submission.”“Clearly, the popularity of the program is increasing.”“A Pre-sub is purely optional. It is never required. A company can choose to do a Pre-sub or not.” “Unlike 510(k) and PMA submissions, unlike 513(g) requests, and so on, there is no user fee associated with the Pre-sub—although at least not yet.”Links:FDA - Q-Submission Guidance - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission ProgramFDA - Premarket Notification 510(k)FDA - Premarket Approval (PMA)FDA - De Novo ProgramFDA - 513(g) Requests for InformationFDA - Medical Device User Fee Amendments (MDUFA) ReportsFDA - Center for Devices and Radiological Health (CDRH)FDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight 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