Global Medical Device Podcast powered by Greenlight Guru

What’s the difference between design verification and validation, and why are these activities so important?Today’s guest is Niki Price. Niki is a Medical Device Guru with 15 years of experience in medical devices who worked in production, quality, product development, and project manager. Today she discusses questions like what is being tested by design verification and what is being tested by design validation.Listen to the episode to hear Niki discuss what’s involved in being a verification engineer, tests used for verification, and the biggest challenges she experiences in her role. Some of the highlights of this episode include:Niki’s background and experienceThe process involved in being a verification engineerThe Greenlight Guru differenceThe steps that a verification engineer has to go throughTests used for verificationDifficulties with the steps for verificationThe career path to design assurance professionalThe biggest challenges about this rolePitfalls of design verificationMemorable quotes from Niki Price:“I wanted to be drawing body parts in an OR somewhere. Or illustrations in books.”“The best time I ever had was sitting at my desk running through thousands of lines of data and trying to make charts out of it. I loved it.”“Requirements are a lot of times going to be your acceptance criteria for your testing.”“You have to think about verification is for design inputs, validation is for user needs.”Links:Niki Price LinkedInEtienne Nichols LinkedInBeginner's Guide to Design Verification & Design Validation for Medical DevicesGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What are the challenges in managing compliance and the difference between compliance and quality management positions? You’ll learn more by listening to today’s guest.In today’s episode, we spoke with Maryann Mitchell on the topic of Compliance Management. Maryann Mitchell is a Solutions Engineer at Greenlight Guru and is part of what we call our Guru Edge. She has more than 15 years of experience in Medical Devices and has worked in a variety of quality and regulatory roles.Listen to the episode to learn what Maryann has to share about the cultural barriers between engineering and quality management, the challenges she experienced as a compliance manager, and what aspects of implementing an eQMS stand out for Maryann. Some of the highlights of this episode include:What the compliance manager role was like for Maryann and what it meant to herThe relationship with compliance across departmentsAuditing across sitesPains companies go through when looking for quality management systemsCultural barriers between engineering and quality controlCompliance manager challengesHow the quality management system is like a design projectThe contrast in quality manager vs. compliance matterImplementing an eQMS and the difference between that and a paper systemThe relationship between compliance and quality departmentsAdvice for people filling multiple rolesAdvice for companies working toward compliance and developing a quality mindset. Memorable quotes from Maryann Mitchell:“Engineers love to iterate, they love to tinker, but you need to be able to document something, and that’s the importance of it so you can go back to it if you need to.”“We built better processes going forward so we wouldn’t recreate this problem.’“I love that you get to defend your quality system.”“A quality system doesn’t work in a silo, and what I was seeing was departments working in silos.”Links:Maryann Mitchell LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

DHF, DMR, and DHR are easy to mix up when you’re just using the abbreviations – they sound a lot alike! And they are connected. But it’s important to understand the differences between them as well as how they interact with each other.Medical Device Guru Laura Court joins the podcast today to discuss these three documents – what you need to know about them, what to do with them, and why it matters. Listen to the episode to learn how Laura thinks about best practices, what companies get wrong, and how to improve when dealing with these three different kinds of documentation.Some of the highlights of this episode include:DHF vs. DMR vs. DHRWhat’s involved with the design history fileRecommendations for retaining the design history fileThe difficulties of paper filesWhat device master records areMaking sense out of device history recordsWhat goes into the DHR per the FDAHow engineers can do a better job of the feedback processThe change control process to update the DMRLaura’s additional advice about documenting earlyMemorable quotes from Laura Court:“I am on the onboarding and implementation side of our team for the gurus here, so I help get our customers started in the software.”“Your design history file is truly the history of how your product was developed.” “Don’t assume that you know everything. Even if you’ve been reading your DHF, you’re not going to know everything.”“Everything should go through document control.”Links:Laura Court LinkedInDesign History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?Etienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why do quality professionals struggle with clear communication in writing? What’s the problem with jargon? These are some of the questions explored in today’s podcast.Joining the show this episode is Lesley Worthington. Lesley has 20 years of quality and regulatory experience in medical devices, and she uses that experience to work with individuals and teams to fine-tune their quality conversations, initiatives, and internal communications with the goal of creating more and better understanding of the role and concepts of quality assurance in organizations.Listen to the episode to hear Lesley’s take on how communication affects the outcome of audits, impacts the lives of quality professionals, and the common communication pitfalls Lesley sees in organizations. Some of the highlights of this episode include:Why writing to be understood is difficult for quality professionalsWhether it’s possible to get completely away from jargonCommon pitfalls that Lesley has seenThe length of attention spans and how reading and writing have changedThe importance of reading, including fictionWhat audits mean for communication and writingFear of writing differently from the way it’s always been doneLesley’s LinkedIn game and how she keeps up with all the writingOther important points that Lesley covers when teachingEmbracing the hatersMaking sure that everyone has the same visionLetting down your guardMemorable quotes from Lesley Worthington:“It’s not just about sounding different; it’s about the science of how we sound and how we read.”“The clearer your writing is, the more likely the reader will be to think that you know what you’re doing.”“Sometimes when things get really technical and really complex and really high-level, people lose the thread.”“The purpose of regulations are completely different from the purpose of procedures in your organization.”Links:Lesley Worthington's LinkedInLesley Worthington ConsultingEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

In a continuation of the previous episode, Mike Drues joins the podcast to further discuss LDTs, IVDs, and how those related to the ongoing Theranos situation.Mike is the president of Vascular Sciences, has a Ph.D. in biomedical engineering, and has extensive experience with Regulatory Strategy. In today’s episode, he begins by reviewing some of the information in Part 1 of this discussion. He discusses how the current regulations and language around LDTs relate to the Theranos situation and what companies should be doing to ensure they’re ready when the VALID act goes through. Listen to this episode to hear what Mike has to say about the risks of LDTs, the engineering work that should go into LDTs, and how the regulations could be changed to close the Theranos loophole. Some of the highlights of this episode include:The risk behind LDTs vs IVDsWhether LDTs belong in the IVD categoryThe relationship between the LDT situation and TheranosPrinciples to use with LDTsWhat companies should be doing now in anticipation of the VALID actThe importance of a contingency planThe criteria for a legitimate LDTSpecific parameters to define an LDTLabelingTechnologyRiskRequiring hospitals to put LDTs through institutional review boardsBetter oversightCreating a EUA-like pathwayMemorable quotes from Mike Drues:“Even from a technology perspective, the technology of these LDTs is becoming much much more complicated.”“Long story short, I think Theranos took a fairly liberal interpretation of the words surrounding the LDT.”“I’m a biomedical engineer first and a regulatory consultant second. And that’s the order we should think about these things.”“Even though I’m a regulatory consultant, I’m not a fan of creating new regulation.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’s the difference between an LDT and an IVD and what does that have to do with the Theranos case? In this episode, we dig deep into this topic.Mike Drues, a frequent returning guest to the Global Medical Device podcast is the president of Vascular Sciences. He has a Ph.D. in biomedical engineering and extensive experience with Regulatory Strategy, the FDA, and the history behind most of the regulations. In today’s episode, Mike Drues and I spoke about the topic of Lab Developed Tests (LDTs), the ongoing Theranos case, and the state of LDTs & IVDs.Listen to the episode to learn more about Lab Developed Tests and what some examples of them are, what testing and regulations are required for LDTs, and how Theranos was able to market a test without the typical testing rigor. Some of the highlights of this episode include:Why Lab Developed Tests fit in with medical devicesWhat the difference is in LDTs and IVDsHow LDTs are regulatedExamples of LDTsWhy labs develop their own testsThe risk when it comes to LDTsWhy non-invasive LDTs can be listed as class 3Memorable quotes from Mike Drues:“A lot of people like to talk about what FDA regulates. I like to talk about what FDA doesn’t regulate.”“Remember, regulation is about the interpretation of words.”“There is no difference in terms of the technology between an IVD and an LVT. The difference primarily is who uses it and where it’s developed.”“If the hospital does one thing, they’re treated one way; if a company does exactly the same thing, they’re treated another way. Something’s not quite kosher about that logic.”Links:Mike Drues LinkedInVascular Sciences webpageVALID ActEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What’s involved in switching from a paper-based QMS to an eQMS? What kinds of difficulties do companies experience when making that change? Today’s guest will explain her experiences with making that switch.In today’s episode, you’ll hear a conversation with Kendyl Williams on the topic of Implementing an eQMS. Kendyl is a Medical Device Guru at Greenlight Guru. When it comes to implementing an eQMS - Kendyl has experienced the sales process and has also implemented it for her company, and now she works with companies to help them implement the new software as well.Listen to the episode to hear what Kendyl has to say about the pain points of a paper QMS that can prompt making a switch to eQMS, challenges at the beginning of the switch, and a realistic timeline for implementing the new system. Some of the highlights of this episode include:The pain points of a paper-based QMSThe effectiveness of document-signing partiesWhat the implementation of the eQMS was likeWhat isn’t validated out of the boxComplaints or challenges in the beginningHow to ensure traceability between risk and design controlsWhat to do with the physical documents after switching to eQMSA realistic timeline from purchase to implementationMemorable quotes from Kendyl Williams:“I know Greenlight has definitely changed a lot since we used it last, and I love all the new features that have come out because I think they really help to set people up for success when getting into Greenlight.”“I think my team struggled initially with the nomenclature of documents.”“The sandbox is also just a fun place to poke around.”“What I usually tell people building an eQMS is to be intentional in your setup.”Links:Kendyl Williams LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be talking about in today’s conversation.Laura Maher previously appeared on the podcast to talk about UDI, and now she’s here to talk more about sterilization. Laura is a Medical Device Guru at Greenlight Guru and is a self-proclaimed sterilization enthusiast. Listen to the episode to learn what Laura has to say about Gamma vs. EO, new modalities recognized by the FDA, and the sterility pitfalls Laura has experienced or heard of.Some of the highlights of this episode include:Different types of sterilizationDifferent sterilization modalitiesChoosing gas vs. radiationTools of the sterilization tradeWhat to do when you have dose audit failureWhat “too numerous to count” meansSterility pitfallsMemorable quotes from Laura Maher:“Biology is my main passion with chemistry kind of like behind it.”“People will talk your ear off about sterility all day, which is super fun.”“Packaging is a huge component of sterility because it IS your sterile barrier.”“If you have a chance to see a Gamma source, take it. It is really cool.”Links:Laura Maher’s LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode, you’ll hear from two guests with UDI experience. You’ll learn a lot about UDI and learn where to find some fantastic resources that can increase your knowledge.Laura Maher and Brittani Smith are both Medical Device Gurus and Greenlight Gurus. Their jobs involve guiding companies through regulations and quality requirements and challenges unique to MedTech companies and medical device professionals, and UDI is among those challenges. Both Brittani and Laura bring a wealth of experience and knowledge to the topic.Listen to the episode to learn the difference between device identifiers and product identifiers, the process of getting a UDI and applying it, then going on with the registration process, and how to think about the UDI requirements that are coming into effect. Some of the highlights of this episode include:What UDI is and the difference between the device identifier and the product identifierPhysical applications of UDIThe leading zeros and what they mean for packagingThe process flow of getting the UDI, applying the UDI, and registering the deviceChallenges with bar code verificationTips for manufacturers going through UDI implementationUploading to GUDIDWhy the UDI requirement is in placeThe different acronyms involved in UDIThe importance of finding and using the resources available to youMemorable quotes from this episode:FDA doesn’t set a specification for what your bar code quality should be, but depending on who you’re using, your GS1 specifically, they have standards for what the quality of their bar code should be.” –Laura Maher“Just like Laura, I became a little bit of a UDI expert at the company, just because I got to learn the ins and the outs of it.” –Brittani Smith“You’ve got to be careful about contrast and the color that you’re using for your bar code.” –Laura Maher“For your surgeons and your patients, the end users, the biggest thing is safety.” -Brittani SmithLinks:Brittani Smith LinkedInLaura Maher LinkedInGS1UDI with Gary SanerGreenlight Guru Ultimate Guide to UDIEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in his book and will be talking more about them in today’s interview.Kevin Becker has a bachelor’s degree in Mechanical Engineering from the University of Minnesota and a Master's degree in Reliability Engineering from the University of Maryland. Kevin is an ASQ Certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt with experience as a Quality/Reliability Engineer, Quality Manager, Director of Engineering, and Director of Quality in the medical device field. Kevin has authored and co-authored published papers in the areas of reliability, probabilistic risk assessment, and measurement correlation and has written a book titled Quality Myths and Lessons Learned.Listen to the episode to hear what Kevin has to say about ethical considerations in Quality, Quality’s PR problem, and why having a principle-based decision-making process matters. Some of the highlights of this episode include:What prompted Kevin to start a consulting businessExamples of things few engineers realizeHow you grow the muscle of realizing what you’re incentivizingWhat a quality engineer might specifically be interested in with regard to ethicsGray areas in ethicsHow to use flow chartsHaving a principle-based decision-making processHow a competitive culture can lead to pushing the rulesOvercoming peer pressure in the industryThe most important part of a quality management systemMemorable quotes from Kevin Becker:“Communication is another issue that is really difficult for engineers. They should be good at it, but they’re not.”“The worst possible answer is wrong but believable.”“I’ve seen some flow charts that have a lot of circular loops, and I don’t think they help make things clearer.”“The goal of any company should be: recognize (ethical deterioration) long before it gets to an ethical or, even worse, legal consideration, and then take action to correct it in a timely fashion.Links:Kevin Beckers LinkedInQuality Myths & Lessons Learned BookEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru