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

Jesseca Lyons, a Mechanical Engineer, discusses challenges in determining user needs for medical devices. She highlights using Root Cause Analysis, guiding customers through defining user needs, and the importance of understanding the problem before solving it. Lyons emphasizes the significance of identifying core user needs early in the design process to avoid pitfalls and ensure successful outcomes.

What does the False Claims Act do, and when does it involve medical devices? In today’s episode, you’ll hear from Jonathon Tycko, an attorney who represents whistleblowers. Jonathan is a founding Partner with Tycko & Zavareei LLP, a law firm with offices in Washington, D.C., and California. His practice represents whistleblowers under the False Claims Act, along with similar statutes. Jonathon created and hosts his own podcast, The Garrulous Gavel.In today’s conversation, we cover the history of the False Claims Act and the lifecycle of the medical device. Listen to the episode to hear what Jonathon has to say about the process of the whistleblower’s claim, best practices for companies in relation to whistleblowers, and what kinds of penalties might result from a finding of fraud.Some of the highlights of this episode include:History of the False Claims ActThe process of filing a whistleblower claimWhat happens if the whistleblower’s claim isn’t investigatedThe flow of money in whistleblower casesHow many whistleblower cases are successful each yearBest practices for companies in relation to whistleblowersWhether whistleblowers can be reintegrated into the company when they don’t have a caseWhistleblower cases in the medical device fieldBoundaries and understanding when you’re on the hook for what you do within your companyWhat the penalty for potential fraud could look likeDefinitions of profiteering and price differentiations between the government or another entityAdvice for medical and medical device companiesMemorable quotes from Jonathon Tycko:“The vast, vast, vast majority of the cases that the government brings is because of whistleblowers, because of that 1986 amendment.”“This is where most companies get in trouble in the device field. It’s in the marketing of the product.”“You don’t want to do this and get caught by the Department of Justice. It will not be worth it to you.”“If your goal is to have a sustainable company that’s going to be around for a while, you have to accept the fact that you’re in a highly, highly, highly regulated business, and you can’t just put the blinders on when it comes to compliance.”Links:Jonathan Tycko LinkedInTycko & Zavareei LLPThe Garrulous Gavel podcastEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

For some people, audits are terrifying. But today’s guest says you need to learn to love the audit process, and she shares information that can help you do that.Sara Adams is a Medical Device Guru at Greenlight Guru. Medical Device Gurus are part of Greenlight Guru’s “Guru Edge.” Medical Device Guru’s help customers onboard to their new software and guide them through the various regulatory requirements and challenges unique to MedTech companies and Medical Device Professionals.Listen to the episode to hear Sara share some of her wisdom about audits. She talks about what happens when you don’t accept the finding of an audit, the different types of rules and approaches to different kinds of audits, and the kinds of problems she consistently sees from people when they’re learning to do audits. She also shares details about her own first audit!Some of the highlights of this episode include:Sara’s background and experience with auditsHow Sara trained other people to auditHow to build a culture of collaborationSara’s first audit experienceWhat the process of negotiating an audit finding looks likeWhat’s unique about each auditThe partnership in a supplier auditConsistent problems people face during audits and how to overcome themWhat’s important to know about getting ISO certificationMemorable quotes from Sara Adams:“In an internal audit, you need to avoid a conflict of interest. Like I don’t need to be auditing my own work.”“Quality is everyone’s responsibility and not just the quality department’s.”“We all have a first day. Everybody has a first day.”“Never look at something as just a checkbox.”Links:Sara Adams LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru

Why is the state of MedTech culture and tools the way it is? How should the industry be thinking about moving away from generic compliance and toward MedTech Lifecycle Excellence?Jon Bergsteinsson, co-founder of SMART-TRIAL by Greenlight Guru, is a MedTech professional and clinical affairs expert. Jon is also involved in educating and helping the MedTech industry get safe and effective devices to market faster and more efficiently.Listen to the episode to learn more about how MedTech is different from pharmaceuticals and other similar fields in the industry, why it’s important to look at the entire lifecycle of a medical device, and where the MedTech industry is going. Some of the highlights of this episode include:The gap that medical device technology companies experienceHow regulations are changing and how it could help the industryWhat could be accomplished by pursuing MedTech Lifecycle ExcellenceHow people in the industry feel about sharing informationWhere the MedTech industry should be goingKeeping talent in the MedTech industry and drawing more talent into the fieldMemorable quotes from Jon Ingi Bergsteinsson:“When you start working in MedTech, and you have experience from other parts of the life science industry, you start to realize how different it is from pharmaceuticals and other similar product developments like biotech, for example.“It’s easier to innovate medical device technology.”“Ease of use has a lot to do with the fact that you haven’t involved your end users well enough, or you haven’t involved the right end users.”“When it really comes down to it, you can’t really help or facilitate growth and development in the industry without experiences and insights from other industries.”Links:Jon Ingi BergsteinssonSMART-TRIALEtienne Nichols LinkedInGreenlight Guru AcademyMedTech Excellence CommunityGreenlight Guru