Global Medical Device Podcast powered by Greenlight 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