Global Medical Device Podcast powered by Greenlight 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

FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.Some of the highlights of this episode include:The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made or are they a waste of time and money? Good regulation is agnostic of time and technology.Government bodies in different parts of the world want to protect their citizens. Will there ever be global harmonization for quality? Are the most important principles of quality a function of geography? No, quality is quality.The timeline to transition is one year, but companies and inspectors may need or want more time due to a limited number of resources and notified bodies.If a company does what it should do for the safety and efficacy of medical devices, it should really be a tiny or no leap at all to make changes. The only changes are in the paperwork and forms.Medical device professionals should know about ISO 13485. If they do not know about this standard, whether it is required or not, that could be a problem.For those adhering to ISO 13485, if there are new requirements that make sense from a biology and engineering perspective, that’s the way to do something.Memorable quotes from this episode:“They are not going to adopt ISO or any other standards across the board. They’ll take sort of a piecemeal approach, and I think that makes sense.” Mike Drues“When was the last time that the design control guidance was updated since it was created in 1997? The answer is, never. That guidance has remained exactly the same.” Mike Drues“Good regulation is timeless.” George Zack“While it might not be a huge shift, I think it is a step in a direction of many steps toward some sort of global harmonization.” George ZackLinks:ANSI/AAMI/ISO 13485:2016 HandbookNIST's "ABC's of Conformity Assessment"International Medical Device Regulators Forum (IMDRF)ISO 13485:201621 CFR Part 820 - Quality System RegulationFDA - Design Control Guidance for Medical Device ManufacturersFDA - Case for Quality ProgramFDA - Medical Device Single Audit Program (MDSAP)European Union Medical Device Regulation and In Vitro Diagnostic Regulation (EU MDR and IVDR)Mike Drues of Vascular Sciences on LinkedInGeorge Zack of Two Harbors Consulting on LinkedInTrue Quality 2022Greenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not?In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership.Some of the highlights of this episode include:At a university, Stephanie describes the process that professors and students follow when they have an idea. Before they publish it, if they think they have something novel and meets the definition for a patent, they file a disclosure.In the private sector, Kevin describes the publishing, patent, and funding process as being very different. To patent a trade secret, it must be incredibly robust and support a very valuable program. Funding for commercial entities or for-profit companies does not include grant monies.On the university side, there is no equivalent to a trade secret but the know-how  in the quest to do research and common sense in licensing agreements. There’s no protection for know-how and only royalties are paid related to patents and in countries where patents are enforced.Roles associated with an IP differ depending on the school and its policies and licensing terms. Restrictive conditions are put on IP and licenses because they know they will be negotiated, applied, and sold. Memorable quotes from this episode:“Do we keep this trade secret or do we patent it? If we’re going to patent it, this better be incredibly robust and it better support some commercial embodiment, some very valuable program. Otherwise, there is no publication.” Kevin Buckley“Some companies do not want their secret sauce—how they’re making a drug, what the drug is—eventually, drugs will be disclosed and basically hidden in a patent application until they go into clinical trials. When the drug is published.” Kevin Buckley“If all you have is trade secrets and you don’t have any patents, you’re not going to be seen as valuable.” Neil Thompson“There’s a big difference between inventorship and ownership.” Kevin Buckley“It’s a lot different if you make something in your garage or if you spend five years making it in your research lab.” Stephanie WillerthLinks:Patent Cooperation Treaty (PCT)Creative Destruction Lab (CDL)Stephanie Willerth on LinkedInNeil ThompsonKevin BuckleyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool to guide development, allowing you to improve your products by turning risk into a value-add type of activity.In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Shannon Hoste, President of Agilis Consulting Group and former lead for the FDA’s Human Factors Team.Shannon explains her philosophy and approach on how the pieces of human factors, risk management, and product development come together. It’s all about user-related risks and making the right design decisions early on during product development.Some of the highlights of this episode include:Human factors is a risk management activity that the FDA and International Organization for Standardization (ISO) requests. It’s all about use-related risk.Risk management helps make design decisions around safety and efficacy, and human factors provide a focused view on user- and use-related risks.The main contributor that companies come across are deficiencies and questions regarding the human factors process, including the use-related risk assessment.Probability and occurrence is challenging for most people. To understand product risk, understand risk is probability and disparity. To know what’s driving human factors, understand what could lead to high-disparity harm or kill someone.Based on user needs and human behavior, risk management helps companies understand users, how they interact with your product, and what can go wrong.Step-by-step process of risk assessment is to identify all tasks, identify what can go wrong, stay focused to build information, and then identify solutions.Product development engineers want their product to be safe and work. Embrace human factors to improve that as a likelihood. Do not resist it.Memorable quotes from Shannon Hoste:“Human factors at its core, at least the regulatory aspect of human factors, is a risk management activity. It’s all about use-related risk.”“All of it is a tool to guide development.”“I need to look at anything that could lead to high-disparity harm, regardless of if it doesn’t happen that often, if it’s going to kill someone, then I want to understand it.”“Engineers really like to solve problems. We’re going to jump in and look for solutions, and I think that the human factors, the user needs work, as well, is all about understanding the problem and not solving it.”Links:Shannon Hoste on LinkedInAgilis Consulting GroupPathway for Patient HealthFDA - Medical DevicesFDA - Human Factors ConsiderationsFDA - Human Factors and Medical DevicesISO 62366 - Medical Devices — Part 1: Application of usability engineering to medical devicesThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement.In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach!Jon and Mike share tips on what you can do to improve upon your medical device company’s quality philosophy to ensure that true quality becomes a part of your company’s culture.Some of the highlights of this episode include:Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.In the regulatory and FDA space, quality is not about good or bad, but about consistency. A company can make a consistently good or bad product.The difference between product and process quality depends on understanding acceptance criteria, levels, and specifications involved that need to be followed.Not whom but what is ultimately responsible for quality? Consistency. Appreciate what the word ‘quality’ means and whether what you’re doing is good or bad.Quality management systems (QMS) shouldn’t emphasize checking all boxes to be in compliance, but describe how business is done and how KPIs, objectives, and criteria are measured to demonstrate quality at process/product levels.Memorable quotes from this episode:“The problem I have with that simple explanation is there’s subjectivity involved to that, right? What you think is good or bad, might be completely different to what I think is good or bad.” Jon Speer“For quality to be meaningful, it’s something we have to define in as least subjective terms as we possibly can. We need to make it as objective as we can, but I think we need to measure it to determine whether or not we are actually meeting our definition of quality, whatever that might be.” Jon Speer“Quality is not about good or bad. Quality in the regulatory sense is about consistency.” Mike Drues“From the product perspective, does it work or not? Does it perform as expected? That may be a little bit outside the domain of the quality professional.” Jon Speer“You have culpability and responsibility for quality at some level. It sounds cliche, but I think everyone in the organization should have that opportunity to influence or be a part of quality and influence the decisions that are made.” Jon Speer Links:A Regulatory Gap Analysis of FDA's Systems & PoliciesUltimate Guide to 21 CFR Part 820ISO 13485FDA - Classify Your Medical DeviceFDA - Premarket Notification 510(k)FDA - De Novo Classification RequestFDA - Premarket Approval (PMA)Mike Drues on LinkedInThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal eye movement? In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Scott Anderson, Chief Clinical Officer (CCO) at SyncThink about the groundbreaking work the company is doing in advancing neurological assessments by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.You’ll hear how Scott went from his position as Head of Sports Medicine program at Stanford University, where he was part of a multidisciplinary research collaborative studying the natural history of head injuries. Though the technology was initially developed to aid in concussion protocol and the clinical care of athletes with head injuries, the potential of EYE-SYNC technology is now used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.Some of the highlights of this episode include:SyncThink specializes in neurological assessment by building and using a proprietary digital health platform based on tracking, capturing, recording, and objectively measuring eye movements.Besides concussions, EYE-SYNC technology is used to diagnose and manage neurodevelopment, neurological function/performance, and neurodegeneration.Verbal or motor actions are the result of real-time brain function using the eyes to orient yourself to what’s happening and respond in real-time. Neurological deficits in performance occur across one’s lifespan due to disease or impairment.SyncThink’s EYE-SYNC technology has the potential to proactively prevent health problems in the future. It could facilitate the migration of hospital-based care to consumer-based driven care to preserve brain health. If used as a surveillance or monitoring tool, EYE-SYNC can identify improvement in brain function based on medication deployment. It helps clinicians learn to better titrate medication to specific individuals, such as children with ADHD.Scott admits that he faced logistical challenges and obstacles when doing clinical trials to get the first FDA clearance for following concussion patients. Memorable quotes from Scott Anderson:“There’s a whole host of neurological disorders that have a high prevalence of abnormal eye movements associated with it.” “Your eyes actually serve as the window to the brain. It allows you to orient yourself to the things that are happening around you.” “Your brain uses your eyes to select content it wants to interact with.” “Our bread and butter is the software and analytics and the eye tracking measurement, and there’s a whole host of these cases for this.” “As technology evolves, too, as well, there will be, I think, several opportunities in order to accelerate the clinical utility of something like eye tracking for a whole host of neurological conditions.” Links:Scott Anderson on LinkedInSyncThinkFDA - Medical Device OverviewFDA - 510(k) ClearancesQ-CollarThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he wants to share with listeners of the show. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, founder of Consiliso LLC, and author of Medical Device Company In A Box.As a contract manufacturer himself, Mark brings a wealth of knowledge and insight to his discussion with Jon and Etienne, helping listeners understand how to navigate the selection process for medical device contract manufacturers.Some of the highlights of this episode include:Characteristics to consider when evaluating a contract manufacturer include cost, plant location, services provided, complexity of product, process validation, and available technology.Who’s doing what? Create a quality agreement because the overlap and what’s covered under the contract manufacturer’s and medical device company’s quality management system (QMS) should interact and intermix.There are four levels of risk and criticality when selecting suppliers for contract manufacturing: Zero (office supplies) to Level 3 - what you do is going to directly affect the patient experience.Some contract manufacturers have dedicated auditors to control information. MedAccred is an outsourced organization that conducts audits of medical devices and products.When outsourcing to contractor manufacturers, manual work may be cheaper, but automation provides consistent and better quality products.A master validation plan should set expectations of how to validate the product. Modify plan, release reports, and conduct risk assessment to make a product that meets a spec.Contract manufacturers need to communicate to share knowledge and understanding of what a medical device/product is used for as well as the scope and process controls.Memorable quotes from Mark Rutkiewicz:“You can outsource all these different aspects and that’s all part of contract manufacturing.”“The price of the part and what your volume is going to be is directly related.”“What you do is going to directly affect the patient experience. If you mess up, they might die.”“Contract manufacturers - we just take a little cut. We’re not making huge profits.”Links:Mark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoHow to Select a Contract Manufacturer for your Medical Device - White PaperFDA - Device Registration and ListingISO Standards - Sterilization and Validation ServicesMedAccredFailure Mode and Effects Analysis (FMEA) ToolGreenlight Guru AcademyTrue Quality 2022MedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.Some of the highlights of this episode include:Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.The biggest problem with 510(k) is predicate creep. There’s room for improvement because the 510(k) is the workhorse of the medical device industry.Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA. Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device."Change Creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons. Memorable quotes from Mike Drues:“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”“As we all know, the 510(k) is the workhorse of the medical device industry.”“I’m a huge advocate of communication with the FDA.”“We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”Links:FDA - Corrective Action/Preventative Action (CAPA)FDA - Overview of Device RegulationFDA - Premarket Notification 510(k)FDA - Premarket Approval (PMA)FDA - General WellnessFDA - Case for QualityFDA - Warning LettersFDA - Form 483 FAQFDA - De Novo Classification RequestFDA - Emergency Use Authorization (EUA)FDA - Breakthrough Devices Program (BDP)FDA - Safer Technologies Program (STeP) for Medical DevicesFDA - Custom Device Exemption (CDE)Centers for Medicare and Medicaid Services (CMS)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare?In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA.Some of the highlights of this episode include:EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo, or Premarket Approval (PMA) cleared.Quality versus Quantity: What is worse - not having enough ventilators, diagnostics or more ventilators, diagnostics that don’t work? Both the regulatory and quality burden is higher for companies in the medical device industry.Certain shortcuts are justified in the short-term but not in the long-term. What companies did before for COVID/EUA medical devices is not enough now. Don’t waste the FDA’s time. The EUA needs to be a part of a company’s overall regulatory strategy to determine how it fits into the bigger picture.Memorable quotes from this episode:“For those of you that have products that went through the EUA pathway to get to market, if you want to keep those products in the market post-EUA, there’s things that you should be doing and frankly you should have already been doing them.” Jon Speer “The emergency use authorization or the EUA is one of many pathways to market that medical device companies can use to bring devices onto the market here in the U.S.” Mike Drues “Basically, it’s a very, very special kind of pathway. It is not an approval. It is not a clearance. It’s an authorization.” Mike Drues “If you’re not building a plan, a strategy, and starting to execute that strategy, you’re going to be leaving the market with your products.” Jon SpeerLinks:FDA issues draft guidance for transitioning medical devices granted EUAs during pandemicTransition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyTransition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health EmergencyWebinar: How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?The End of EUA Is Coming SoonFDA - Medical Device OverviewMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.Some of the highlights of this episode include:The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.The UDI is stored in a worldwide central database. Different countries have different requirements. In the United States, medical device manufacturers can use three different types of identifiers (GS1, HIBC, and blood banking). For Bills of Materials (BOMs), it’s important to understand the rules of interchangeability to set medical device products apart and determine whether to assign different codes.A data matrix and quick resource (QR) code are intermixed and both are two-dimensional. Mark explains how to visually tell the difference between the two and the three components required.Integrating UDIs and codes into databases represents levels of complexity that are added to medical devices.The UDI is intended for the hospital user. So, a sellable product needs to have a UDI that can be scanned and validated. When parts are too tiny, the UDI will be placed elsewhere on the product packaging.Memorable quotes from Mark Rutkiewicz:“Every part that you use in the hospital room has a barcode on it.”“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.” “Nobody's really standardized." “You can scan it to make sure that you are using the right product with the right other products and with the right patient.” Links:Mark Rutkiewicz on LinkedInMark Rutkiewicz on TwitterInnovizeConsiliso LLCMedical Device Company In A Box: The Case For ConsilisoFDA - Unique Device Identification System (UDI System)European Union Medical Device Regulation (EU MDR)Medical Device Innovation Consortium (MDIC)ISO 13485 - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that matters.In this episode Jon is joined by Etienne Nichols, a medical device guru at Greenlight Guru and Jon’s new co-host of the Global Medical Device Podcast. This is a must-listen-to episode, offering details into this exciting news and other key thoughts and observations Jon and Etienne share about the medical device industry.Some of the highlights of this episode include:Etienne is passionate about the medical device industry and decided to join Greenlight Guru to help make things better, such as documentation. Guru Edge: Greenlight Guru is the only medical device system platform for the medical device industry built by actual medical device professionals.Greenlight Guru runs the gamut and covers everything from electrical and mechanical to packaging and production. There’s more medical device experience at Greenlight Guru than at most medical device companies.  In the future, Etienne predicts that data-driven decision making involving patients will be one of the biggest trends or themes in the medical device industry.Jon is anticipating the convergence or blending of technology with everyday devices (i.e., wellness wearables). The lines between what is and is not a medical device are blurry. The COVID pandemic has created opportunities for innovation in healthcare. Wellness, telehealth, and home-use products have become more common and make patients more comfortable.Etienne has experienced highs and lows with the FDA in the past. Now, he appreciates and is thankful for FDA regulations as guardrails, not limitations, that are flexible and open to interpretation. The FDA’s job is to protect and promote the health of U.S. citizens. It not only covers medical devices, but many other areas. It’s an awesome responsibility that encourages collaboration and communication.Memorable quotes from this episode:“When I came to Greenlight Guru, part of what kind of led me here, was the desire for things to be better.” Etienne Nichols“No one guru has all the answers on our team, self included." Jon Speer“I’m excited about all the different ways the medical device industry is going to be improving our lives in the future.” Etienne Nichols“The more data that can be behind a decision, I love that.” Etienne NicholsLinks:Meet a Guru: Etienne NicholsEtienne Nichols on LinkedIn21 CFR Part 820FDA - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary.In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI).Some of the highlights of this episode include:AR is a relatively new technology that some people don’t quite understand how it is or can be used in healthcare today and in the future. It’s important for people to try Magic Leap’s AR device and platform to expand their thinking of use cases.AR is not the same as VR and other technologies. VR is completely immersive and involves wearing a headset. You can’t see the real world. All you’re seeing is digital content. VR has advantages and limitations.Magic Leap’s AR headset device allows users to not only see the real world, but digital content can be overlayed on top of the real world while maintaining spatial awareness and sensibility.Magic Leap isn’t just about AR, but the convergence of other elements and capabilities, such as AI, 5G, and Internet of Things (IoT). AR is going to be the catalyst that generates additional new sources of data not currently captured.AR is not replacing healthcare providers, doctors, nurses, and others. It augments the clinical workforce to present/provide insights that advance and enhance the practice and expertise of medicine when delivering care.Memorable quotes from Jennifer Esposito:“There are places where the differences between those technologies is actually really important in terms of deciding which one you would use for a certain use case.”“What we’re doing isn’t really just about AR. It is this convergence of these other capabilities.”“Augmented reality is also going to be the catalyst to generate additional new sources of data that we don’t currently have.”Links:Jennifer Esposito on LinkedInMagic Leap: Augmented reality platform for EnterpriseMedical Device Innovation Consortium (MDIC)FDA - Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. Some of the highlights of this episode include:According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.There are a few reasons why the FDA is making CDS software important and its #1 priority. More companies and customers are or want to work and produce products in this space.For now, CDS software is not regulated by the FDA due to limited resources. However, that will change when companies’ products provide wrong or inaccurate information. Nobody or not too many people have been harmed, yet.According to Mike, CDS software provides clinicians as well as patients with information to enhance health and health care. Examples of CDS software include telehealth and AI platforms that ask patients questions about their health.FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person - not by a device or software.Make sure that CDS software properly provides accurate information because there can be major product liability implications if not regulatory ones.Regulated or not, usability testing is a must. What if your software tells patients they don’t have a problem, but actually do, and wait to take care of it? Memorable quotes from Mike Drues:“I’ve got a growing number of my customers and potential customers wanting to play in this space or asking me about the possibility of playing in this space.”“Right now, much of this is not being regulated by the FDA. The FDA - they’re using their enforcement discretion to not regulate.”“FDA does not regulate the practice of medicine as long as the practice of medicine is being practiced by a person.” “As soon as the practice of medicine is being practiced by a device or in this particular case, software, now all bets are off.”Links:Clinical decision support guidance tops FDA’s agenda for 2022 (Med City News) (Oct. 29, 2021)FDA's 2022 A-list guidance plan hits on software, post-pandemic futureCDRH Guidance: Clinical Decision Support Software (September 2019)FDA - Medical DevicesSoftware as a Medical Device (SaMD)Combination Products Webinarhttps://www.greenlight.guru/webinar/combination-productsGeneral Wellness Device and Wearable Exemption WebinarWebMDMike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices.In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices.Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in mind so they are easy to use, safe, and supportive for the end user.Some of the highlights of this episode include:Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by doing their work correctly.Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. They should not have to overcome barriers and adapt to the device. It should be easy to use, safe, and supportive.Determine if you are on track when developing a product by conducting formative evaluations of tasks that need to be done and how they should be done.When done with development, a summative evaluation shows the use of a medical device does not come with any unacceptable risks. It offers proof of use.Opportunities for Improvement: Some mistakes that Michaela has observed include not meeting or listening to users, starting too late, and not conducting formative before summative evaluations for feedback. Memorable quotes from Michaela Kauer-Franz:“It’s not about me being excited about it, but about the user being excited about it. Being able to understand it. I think this is a very valuable insight.”“You have so much impact on the quality of life of so many people. You can save life, you can improve life, you can prevent damage if you do your work right.”“Usability is the translation from the capacity that an expert or user has into a device that is being easily used and intuitive, understood, and safe.”“See usability as something that you have to do constantly. It’s not a one-time activity that you do.”Links:Michaela Kauer-FranzCustom MedicalGreenlight Guru AcademyMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight 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

Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message.In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Perriello, who previously cofounded MassDevice and now current founder and principal at Circle Hill Life Science Communications, about his unique line of work helping medical device companies learn how to effectively tell their story.Listen to this episode now to learn what your company can and can't say to different target audiences and how to effectively communicate your company’s core message and story so it positively resonates with the listener.Some of the highlights of this episode include:Brad Perriello, alongside fellow journalist Brian Johnson, founded the online medical device business journal MassDevice based on his belief that small businesses and startups drive everything that lead to the biggest outcomes.Although medical device companies know their story best, they do not always effectively tell people their story, what they do, and why they do what they do.Startups telling their story is applicable and important to raise funds, but engineers are not strong narrative writers or speakers. They tend to focus too much on details, which can derail the intended message.A medical device company’s core message and story is the same, but is communicated differently. For instance, investors want to know the ROI, patients want to know if it’s safe and effective, physicians want to know about safety, efficacy, and cost.When hiring outside help with communications, they should be familiar with the medical device industry because the regulatory environment is strictly unique. Be aware of quality systems, design controls, and reimbursement issues.Some things change over time, and some things never change. Find an unmet need and help patients and others by figuring out what they need to hear. Be able to effectively communicate with all audiences.Social media evolves quickly and provides powerful communications tools with massive reach. Companies succeed by having a dedicated team member who knows how to leverage each platform based on the audience.Memorable quotes from Brad Perriello:“These folks know their stories really, really well...but they don’t know how to tell them all the time.”“Through no fault of their own, they’re not really effectively telling people, this is our story, this is what we’re about, and this is why.”“The old adage is that engineers can’t write.”Links:Brad Perriello on LinkedInMassDeviceBrian Johnson of MassMEDIC on LinkedInMedtronicFDA - The Pre-submissionFDA - 510(k) Premarket NotificationGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet.In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device Designation (BDD). Learn what the BDD experience was like and how their team is currently navigating the FDA regulatory process and collecting the necessary clinical data with the hopes of soon placing OsteoBoost on the US market.Some of the highlights of this episode include:More than 50 million Americans are suffering from osteopenia and low bone density. Half of all women will have a fracture from osteopenia and osteoporosis - that’s more than heart attack, stroke, and breast cancer combined.As people get older, especially women, shrinking is a real issue that is usually due to a fracture that causes pain as well as breathing and digestive problems.People with hip fractures have a 20-plus percent mortality rate. Hip fractures are difficult to recover from and a high percentage of people lose their independence.Currently, there are no approved treatments for osteopenia. Basically, your only options are to get enough Calcium and Vitamin D and do high-impact exercise. Give your bones enough stimulation to lessen the decline.There are medications for osteoporosis. However, the side effects, the way they work, and indications for use are for people with osteoporosis.When vs. If: Most people will eventually get osteopenia. Heredity is a factor that influences less dense and smaller bones. Lifestyle matters, such as excessive drinking and smoking or steroid use can have an impact on bone density.Also, if you are an astronaut or go into space, bone loss is accelerated. Evidence from NASA shows that using whole body vibration improves bone density.People must use such a device regularly, it is expensive, and it requires doing nothing for a period of time. Bone Health Technologies is developing OsteoBoost, a more practical and easy-to-use product that leverages whole body vibration.Memorable quotes from Laura Yecies:“Osteopenia is an incredibly common problem, and we have over 50 million Americans suffering from low bone density.”“If you walk around a nursing home, people are there typically for one of two reasons - they have Alzheimer’s or they have a hip fracture.”“Most people will eventually get it.”“There’s a body of evidence from NASA about using whole body vibration essentially to improve bone density. Astronauts lose a lot of bone when they are in space. Their bone loss is accelerated.”Links:Laura Yecies on LinkedInBone Health TechnologiesOsteoBoostU.S. Food and Drug Administration (FDA)FDA: Breakthrough Devices ProgramGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations.In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling.Some of the highlights of this episode include:When Mike and Jon refer to labeling, they are talking about the content of the label - the words used and claims made.High-level labeling describes intended use, indications for use, and label claims. Low-level labeling includes directions for use and package inserts. A claim is a claim whether put in high- or low-level labeling.High- and low-level labeling can be leveraged as a strategic, competitive advantage to minimize or streamline regulatory burden, which means how much effort and evidence is needed to go through the FDA and put on the market.Intended use focuses on a device (what it does, how it works, and what is its mechanism of action). Indications for use focuses on the patient (what illness, injury, disease, or condition is the device intended to prevent, diagnose, or treat).Why do we need a new rule about intended use? The intended use rule is important for medical device manufacturers because labeling is not limited to what they say or print.The root cause for the rule relates to manufacturers’ saying or claiming one thing, but inferring and implying another thing. FDA does not regulate, at least not yet, the names of medical devices.Manufacturer's Objective Intent: If manufacturer knows or has knowledge of facts that product, device, or drug would be used for conditions or purposes other than what is advertised/claimed, manufacturer may need to provide adequate labeling.Manufacturers also need to consider product liability and reimbursement implications of a device being used for purposes other than what’s on the label.Memorable quotes from this episode:“When we refer to labeling, at least when I refer to it, I’m not talking about the sticky piece of paper that we stick on a package or in a box that a medical device comes in, nor am I talking about the graphics that go onto that label.” Mike Drues“There have been numerous and continues to be numerous warning letters, recalls, etc, etc, etc, that are strictly related to content or lack thereof or misinformation that’s on labeling.” Jon Speer“FDA does not regulate, at least not yet, the names of medical devices. So, you can embed a claim in the name of your device without it being subject, at least directly, to FDA regulation.” Mike Drues“Don’t just focus on what you say in your labeling, also consider what you don’t say and how you don’t say it.” Mike DruesLinks:FDA finalizes long-awaited intended use ruleFDA Delays Implementing Parts of 'Intended Use' RuleFederal Register’s Regulations Regarding “Intended Uses”FDA - Center for Devices and Radiological Health (CDRH)Mike Drues on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors.In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program. Jon, Renee, and Devin discuss their work together in the program and Renee and Devin share their experiences using the eQMS from Greenlight Guru in the classroom and how it's helping students engage and better understand medical device risk and quality management concepts and practices.Some of the highlights of this episode include:Introducing Greenlight Guru to students has helped them to understand eQMS and how they can take the things they learn in theory and apply them in practice.Biomedical engineers need to be taught design principles, technical writing, and how to conduct tests and case studies with a risk matrix.Students should have a working knowledge and understanding of quality and regulatory affairs to prepare them for real-world application. The traditional approach to teaching risk in an engineer setting is to focus on failure modes and effects analysis (FMEA) and design failure modes and effects analysis (DFMEA). However, this singular approach is not efficient and can leave some medical device risks undetected, resulting in harm.Case studies should include ways to be reasonable, realistic, and helpful in product design and quality systems to think about how other options could fail.It is challenging in capstone design to deal with risk. Capstone courses are overwhelming for students and difficult to teach. Tackle risk in manageable way.Students don’t like doing busy work associated with quality management and risk assessments, but there’s a reason for it: ensuring the safety of people using a device you designed.Memorable quotes from this episode:“Using Greenlight in particular, introducing that to our students has really opened a lot of eyes and doors for our students at understanding what quality management systems look like and how they can take the things they are learning in theory and then apply them in practice.” Renee Rogge“There’s things that our students are getting out of an eQMS platform like Greenlight that they wouldn’t get if we were trying to do a paper-based system. There’s just subtleties and nuances that are built in that we don’t really have to teach. They can learn by experience.” Devin Hubbard“It’s not just a bunch of checkbox things they have to do. It’s critical for the development of the product that they communicate their ideas because someone’s going to pick it up and run with it later.” Renee Rogge“Risk is bigger than just a thing that you do as part of your design. It is a thing that drives your design.” Devin Hubbard“I think it’s easy to make risk boring. I think it’s hard to make risk engaging in a way that is educational for the students.” Devin HubbardLinks:Renee RoggeRose-Hulman Institute of TechnologyDevin HubbardUniversity of North Carolina/NC State - Joint Biomedical Engineering ProgramGuideWire PodcastFDA - Medical DevicesFDA - Design ControlsFDA - 510(k) Premarket NotificationISO 14971: Medical Devices - Application of Risk ManagementGuideWire PodcastGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs.In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and executives make better decisions for teams to achieve greater outcomes.Some of the highlights of this episode include:Learn the must-haves of management reviews, such as inputs, feedback, complaints, reporting, and audits during planned intervals, by following ISO 13485 and FDA 21 CFR Part 820 - Quality System Regulation.How often should management reviews be performed? The industry standard is once a year, but a lot could happen in 12 months. Greenlight Guru recommends management reviews twice a year, especially in the early parts of your business.Internal audits and management reviews are two activities that offer a snapshot in time of the overall picture of the health of your QMS. Then, the management review is a platform to escalate issues.Best practices for a management review include where more research, time, and effort should go. Don’t mistake a management meeting for a review. Pulling off a management review last minute is a lot easier than an internal audit.Your company’s key performance indicators (KPIs) and goals should be put on the agenda as a checkbox activity for the management review. Yet the list of topics/objectives should be discussed to assess how you handle your business.Document any decisions and actions to maintain the suitability, adequacy, and effectiveness of your QMS. In meeting minutes, include an action plan and product improvements related to customer requirements and correct problems.You can share your management review meeting minutes with notified body auditors, but not the FDA.If you have to hurry up and hustle to get data, is it reality data that you need? Is it that important? Automate, divide, and conquer.Memorable quotes from this episode:“The standard is pretty general on how often you should be doing management reviews.” Taylor Brown“Management review is really a platform to escalate issues.” Taylor Brown“Pulling off a management review last minute is a lot easier than trying to pull off all of your internal audits last minute.” Jon Speer“Executive management needs to be aware of and involved with the health of the quality system.” Jon SpeerLinks:ISO 13485 - Medical DevicesFDA - 21 CFR Part 820 Quality System (QS) RegulationTaylor Brown on LinkedInGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight Guru

Guru Edge. It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey.In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru.Listen to this episode to learn about Ryan's professional journey which brought him to Greenlight Guru and how he's helping companies with design of experiments, design controls, contextual inquiry, FDA QSR and ISO 13485 compliance, protocol/report writing, protocol execution, and quality system implementation and maintenance.Some of the highlights of this episode include:Ryan studied biomedical engineering and eventually zoned and honed in on medical device entrepreneurship.After graduating from college, Ryan worked for a startup in Omaha that was a Greenlight Guru customer. Ryan was able to develop a device, get 510(k) clearance, and go to market using Greenlight Guru.Ryan’s first-hand experience with Greenlight Guru not only helped the development of the customer’s product, but boosted Ryan’s personal development as an engineer.To better prepare engineers, reduce the concepts to practice and teach design controls, quality, and regulatory curriculum.Ryan advises engineers to get the knowledge they need to be successful via a foundation of quality. Then, put into practice what you learn to be compliant.Risk Management/Design Controls: Always make sure you know why you are doing things. What’s the purpose? Find value in things and collect feedback.Ryan’s keys to customer success include using Greenlight Guru as a quality system and medical device platform to find early wins and deeper motivation.Memorable quotes by Ryan Behringer:“I love the entrepreneurship element in the medical device space.”“I had the pleasure of developing a device, getting  510(k) clearance, and getting to market utilizing Greenlight Guru. It was really instrumental in our development of the product and kind of my personal development as an engineer - gave me loads of confidence.”“I really enjoy the technical element of things.”“I always make sure that the things I’m doing, I know why I’m doing them. They have a purpose, and I can find value in those things.”Links:Ryan Behringer on LinkedIn21 CFR Part 820 (Quality System Regulation/Medical Device)ISO 13485 - Medical DevicesFDA - 510(k) ClearancesMedical Device HQGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the US, for manufacturers and regulators alike.In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about the opportunities and challenges associated with medical device cybersecurity. Listen as Mike and Jon share their thoughts on the potential ways to eliminate or reduce cyber threats and encourage better cybersecurity practices for medical devices.Some highlights of this episode include:Cybersecurity is an important topic, but why is the FDA concerned about it? It’s important not to over-generalize.For example, identity theft may involve a physical medical device or Software as a Medical Device (SaMD). With that, a person’s personal information such as their credit card number could be stolen. Should not be the FDA’s concern.What about patient privacy? Personal health information or confidential electronic health records are a HIPAA matter - not the FDA’s concern.Cybersecurity related to the safety and efficacy of a medical device, however, is the FDA’s concern.  Safety and efficacy of medical devices is part of FDA’s Center for Devices and Radiological Health (CDRH) mission.Some have seen in the popular press or been told the urban legend around cybersecurity concerns for implantable devices, such as insulin pumps, pacemakers, catheters, and angioplasty (a.k.a. the Johnny Carson Procedure).NIST’s call for position papers/statements covered five areas:Criteria for designating critical software.Initial list of secure software development lifecycle standards, best practices, and other acceptable guidelines.Guidelines outlining security measures that will be applied to the federal government’s use of critical software.Initial minimum requirements for testing software source code.Guidelines for software integrity chains and provenance.The categories above are not new and don’t really relate to cybersecurity. These should be standard operating procedures for companies developing products where cybersecurity and software is applicable.How to minimize or avoid cybersecurity concerns? Join boards/committees to create standards, and determine if there’s a legitimate reason to connect to the internet and communicate with the outside world.Memorable Quotes from this episode:“Safety and efficacy of medical devices is at least a paraphrase of part of the FDA - CDRH mission.” Jon Speer“If there’s a cybersecurity concern that could affect the safety of the device, that is something that FDA could and should be, quite frankly, concerned about.” Mike Drues“I’m a big fan of using regulatory logic.” Mike Drues“None of this is new. These should be standard operating procedures for companies that are developing products where cybersecurity and software is applicable.” Jon SpeerLinks:FDA lays out device cybersecurity efforts as feds look to implement Biden executive orderWorkshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain SecurityResponse to NIST Workshop and Call for Position Papers on Standards and Guidelines to Enhance Software Supply Chain SecurityHealth Insurance Portability and Accountability Act (HIPAA)FDA - Center for Devices and Radiological Health (CDRH)U.S. Department of Health and Human Services (HHS)The Terrorist Hack that Shocked America – and Why it Matters (Homeland Episode)Johnny Carson Procedure (Angioplasty)Al GoreInternational Organization for Standardization (IOS)ASTM International - Standards WorldwideUnderwriters Laboratories (UL)Mike Drues of Vascular Sciences on LinkedInGlobal Medical Device Podcast, Episode 164: What is a multiple function device?Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitMedTech True Quality Stories PodcastGreenlight Guru YouTube ChannelGreenlight 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

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

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.Some highlights of this episode include:New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.FDA managers are trying to make sure that their teams get the training and mentorship that they need, but it is difficult and challenging.Deficiencies: What is four-part harmony? How are they written? List what was provided, what’s missing, what needs to be provided, and why is it needed?It’s not only the lead reviewer looking at a regulatory submission, but a team of people. Review the deficiencies and manage the additional information (AI) letter to ask relevant questions.To improve the speed of review and the time it takes for files, it’s important to support the reviewers and resources during that process.There’s just not enough time for FDA reviewers to read through and understand all the guidance documents put out by the FDA. Include guidance documents in files to help the reviewers and express how regulations are being followed.Recommendations for new reviewers: There’s what the regulation states, the legal definition, and then people's interpretation of the regulation, what does it mean and how does it apply?There are different risks to different devices. For most questions, there are multiple correct answers that are acceptable by FDA. As a reviewer, you feel a huge burden of wanting to make sure nothing bad happens.Memorable Quotes from Allison Komiyama:“We’re kind of dealing with a lot of new reviewers who are trying to navigate being a new reviewer and what’s actually important. We can see that reflected in some of the questions that we’re getting.” “I think the managers at FDA are doing an amazing job trying to make sure that their teams get the training and the mentorship that they need while they are there. But it’s hard.” “Sometimes that knowledge doesn’t get passed on as seamlessly as we all would want. From the industry perspective, one of the most beneficial things that we can do to improve the speed of review and improve the time that our files take to go through that process is really to support the reviewers.”“One of the things she didn’t realize when she was a new reviewer was how diligent a lot of us in industry are at keeping up on guidance and the changes in regulations because that’s my job. That’s what we do.”Links:Allison Komiyama on LinkedInAcknowledge Regulatory StrategiesRegulatory Science ForumFDA - Medical DevicesFDA - Guidance DocumentsBreakthrough Devices Program (BDP)Safer Technologies Program (STeP)510(k) Submission ProcessPremarket Approval (PMA)Emergency Use Authorization (EUA)David Pudwill (a.k.a. Mr. Regulatory) Code of Federal Regulations (CFR) Title 21Medical Device User Fee Amendments (MDUFA)Use of ISO 10993-1 Biological Evaluation of Medical DevicesGreenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Great uncertainty brings great opportunities for growth...career growth. Currently, regulatory roles are one of the highest in demand in the medical device industry. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mitch Robbins, founder and managing director at The Anthony Michael Group. Listen as Mitch shares his unique insights and perspectives into why there's such a high demand right now for regulatory and quality roles and how you can find your next career opportunity with the help of a regulatory affairs recruitment solution for employers and candidates.Some highlights of this episode include:The COVID-19 pandemic affected everything, including hiring practices. Companies started to shut down progressively and put hiring people on hold. Since April-May 2020, Mitch’s firm has worked non-stop with organizations that need help placing regulatory and quality talent.COVID has caused leaders to look at things differently, if they want to continue their business. Some are uncomfortable, others view it as an opportunity to move forward, adapt, and innovate. Flexibility and autonomy are key reasons why people are interested or not. Necessity is the mother of invention: Being forced to do things in a different way, how many businesses will continue the remote workforce model or go back to a brick-and-mortar office setting?  The high demand for regulatory staff is based on several reasons, including the eventual rollout of EU MDR, unbelievable innovation and hypergrowth in digital health, population continues to age, and more medical technology startups.Career Hunters is an online, step-by-step program for professionals interested in moving their career forward. MedTech Talent Lab is a show that talks about all things talent related to medical technology and features a variety of guests.Recruiting has to change. The employer value proposition differentiates hiring opportunities. Top talent cares about organizations that help save lives or improve quality of life, rewards their talent, and offers meaningful value.     Memorable quotes from Mitch Robbins:“When this pandemic started to happen, as rapidly as it did, in March, I, as the owner of our business, like everybody else was pretty freaked out because I saw things start to shut down and shut down more and more progressively.”“We had some searches going on that a couple had just finished up and a couple that were in the final stages went on hold—just pretty much overnight.” “We have just been non-stop with organizations that need our help to place regulatory and quality talent. So, I would say that the market is on fire and demand is...greater than it’s ever been.”“Be okay being uncomfortable—meaning, especially with hiring practices, so many organizations, never in their wildest dreams thought they would hire on a remote basis, let alone build a remote workforce.”“People that are moving and adapting to what is reality are the ones that are winning. It’s okay to be uncomfortable, especially if you see a way forward to continue to innovate.”Links:Mitch Robbins on LinkedInMitch Robbins EmailThe Anthony Michael GroupThe Career HuntersEuropean Union - Medical Device Regulation (EU MDR)FDA - Classify Your Medical DevicesTony RobbinsRisk Management True Quality Virtual Summit SeriesGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program.Some highlights of this episode include:BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.STeP is for medical devices and device-led combination products that improve the safety of currently available treatments or diagnostics that target an underlying disease or condition less serious than those eligible for BDP.FDA hones in on the indication statement for breakthrough devices. A general indication statement of intended use that is not indication specific is more likely along the lines of STeP, then it is a breakthrough device.BDP designation and STeP need to be their own usually distinct q-submissions. It’s a 60-day period between submission and final designation or denial. At day 30, most get a request for more information.Some of the drawbacks of the BDP and STeP process include engagement and interactions with the FDA that do not go as expected. Consider reimbursement early on because it’s important. The Centers for Medicare and Medicaid Services (CMS) has paused the Medicare Coverage of Innovative Technology (MCIT) reimbursement for BDP designation. Memorable quotes from Isabella Schmitt:“When you have more of a general indication statement, it’s more of an intended use and not really indication specific, that’s probably more along the lines of STeP than it is a breakthrough device.”“FDA really hones in on the indication statement for a lot of breakthrough devices.”“Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.”“The FDA’s bar can get a little bit higher for your clearance or approval because you’re focusing on specific language...and you’re basically making claims that need to be proven.”Links:Isabella SchmittProxima CROBreakthrough Device Designation ReimbursementFDA - BDPFDA - STePSTeP Guidance Document510(k) Premarket NotificationPremarket Approval (PMA)De Novo Classification RequestQ-Submission GuidanceEuropean Union Medical Device Regulation (EU MDR)Emergency Use Authorization (EUA)Centers for Medicare and Medicaid Services (CMS)Medicare Coverage of Innovative Technology (MCIT)Medical Device User Fee and Modernization Act (MDUFMA)Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.Some highlights of this episode include:Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.Even if you don’t have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.Memorable quotes from Joanne LeBrun:“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we’re supposed to go live. They have a year to get more notified bodies.”“I think that notified bodies are very overwhelmed.”“While the MDR has more constituents involved, I think that it’s going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” “That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”Links:Joanne LeBrun on LinkedInMDC AssociatesFDA - Medical DevicesEU IVDREU MDRNotified BodiesNew Approach Notified and Designated Organizations (NANDO)ISO 13485:2016ISO 14971:2019 ISO/TR 24971:2020Medical Device Single Audit Program (MDSAP)Overview of the 510(k) ProcessAllison Komiyama from AcKnowledge Regulatory StrategiesGlobal Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun Greenlight Guru AcademyGreenlight Guru AcademyGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru

It's easy to get so wrapped up in the risk management of your medical device that you forget about managing your business risk with the same level of diligence and ongoing attention.In this episode of the Global Medical Device Podcast, Jon Speer talks to Michael Cremeans, Life Sciences Industry Practice Leader at Hylant. Together, Mike and Jon talk about how medical device companies should approach and manage business risk, which systems and tools can help, and advice on how to review contracts and terms and conditions.Some highlights of this episode include:Are you ready to grow your company? Is it the right time for a business owner to think about the business, liability, and intellectual property? Time to engage Mike.There are consequences to a company’s distribution model and selling strategy.  Each has a different set of contracts and risks that need to be assessed and receive recommendations.Insurance is there for when you need it, even if you don’t understand it. Contractual liability is usually the biggest risk for entrepreneurs and startups.Mike often says that there are three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.Jon defines risk management as a platform with intentionally built workflows related to ISO 14971. Greenlight Guru mitigates risk for companies as they operate quality systems to manage information and handle audits.What you do and don’t do influences and represents your risk profile. Don’t make insurance an afterthought to achieve better outcomes and goals. Do everything you can to be the best company. Don’t just do the minimum, but go above and beyond to change the quality of life.Memorable quotes from Michael Cremeans:“What I’m going to do is help people map out where they’re headed. What could go wrong? Who’s going to be upset at them? What are they going to be upset about? What are the financial damages? What things should you be focused on?”“How can you figure out what they need if you haven’t asked them about their company?”“There’s three truths in the insurance business: We have our own language, we like to confuse, and we’re really good at it.”“Do not sign a contract until you’ve talked to me.”Links:HylantMike Cremeans on LinkedInMike Cremeans: Risk and Insurance ConsultingFDA - Device Approvals, Denials, and ClearancesFDA - GuidancesISO 14971ISO 13485:2016Greenlight Guru AcademyThe Greenlight Guru True Quality Virtual SummitGreenlight Guru YouTube ChannelMedTech True Quality Stories PodcastGreenlight Guru