Global Medical Device Podcast powered by Greenlight 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