Global Medical Device Podcast powered by Greenlight 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