In this episode, Sandra Rodriguez, an analyst at Axendia, dives deep into the complexities of Computer Systems Validation (CSV) versus Computer Software Assurance (CSA) in the MedTech sector. She discusses the FDA's draft guidance from September 2022, the industry's response, and the practical applications of it all. The conversation also covers the evolution of software validation processes, the cost of system implementation, and the importance of critical thinking in Quality System Regulations. The impact of AI on Quality Assurance, the changing dynamics of the CSA Modern Validation, and the role of Software Assurance in the life sciences industry are also discussed.Some of the highlights of today’s show include:The evolution of software validation processes, the cost of implementing a system in the life sciences industry, and the role of critical thinking in Quality System Regulations.FDA's draft guidance from September 2022, the industry's response, and its practical implementationsThe cultural shift and challenges that accompany the transition to CSA Modern Validation.The evolving relationship between life science companies and their technology vendors and how it can bring value to the organizationThe pivotal role of Computer Software Assurance (CSA) in the life sciences industry, including the unintended consequences Cybersecurity and how the FDA is looking to adopt this approach across multiple agenciesHow companies can stop spending resources on testing every feature and functionThe industry's shift towards automation and data-driven processesThe use of the word “validation” vs. “assurance”Links:Medical Device International ConsortiumCase for Quality Working GroupsFDA CSA Draft GuidanceEtienne Nichols LinkedInGG AcademyOmnibus BillGreenlight GuruQuotes: “Keep in mind if you talk software validation to anyone outside of life sciences, they're going to glaze over. Validation is not used. Software validation is not used outside of this industry.”“You could tell a lot about potential changes to a draft guidance based on the number of times you see certain things show up as a comment.”“Now look, if everything is high risk, then you didn't do a risk assessment, just like if everything's a high priority, you haven't prioritized anything.”

How can dFMEA and ISO14971 work together? This topic is controversial but essential, and today’s guest is more than capable of tackling it. Risk management is one of the top 3 reasons why the FDA issues 483s, so it’s important to understand.In today’s episode, Wade Schroeder, a medical device guru with a master's degree from the University of Dayton, shares his insights on risk management in medical device design. Wade discusses the importance of a top-down approach, the collaboration between dFMEA and ISO4971, and how Greenlight Guru software aligns with ISO14971. The conversation covers the value of considering the patient perspective, the complexities of regulatory, ethical, and business obligations, and the benefits of tools like dFMEA and fault tree analysis.Some of the highlights of today’s show include:Understanding risk management in medical device designImportance of collaboration between dFMEA and ISO4971Exploring ISO14971 and FDA consensus standardsA top-down approach to risk management in medical device designConsidering the patient perspective in the risk management processThe complexity of regulatory, ethical, and business obligationsISO14971 as a regulatory burden ensuring patient safetyHow Greenlight Guru is designed to align with ISO14971Benefits of tools like dFMEA and fault tree analysisMapping dFMEA and ISO14971 for FDA reviewLinks:Wade SchroederEtienne Nichols LinkedInetienne.nichols@greenlight.guruMedTech NationGG AcademyGreenlight GuruQuotes: “Put simply, it's all about telling the story of what could go wrong with your device and what harms could that lead to." -- Wade Schroeder "Before you even start your design, you’ve identified, ok, here’s the serious harms we need to avoid." -- Wade Schroeder

Management responsibility is crucial to the success of a QMS… but what is it? What’s covered by the topic of management responsibility and who’s the responsible party? In today’s episode, you’ll hear from Sara Adams, Lead Auditor, Quality Engineer, and now Medical Device guru, on the subject of management responsibility and all that entails. Listen to the episode to learn what Sara is thinking about when she thinks about the topic of management responsibility. She shares her thoughts on quality policy, organizational structure, management review, and quality systems procedures. Some of the highlights of today’s show include:Whether a summary statement is enough, or whether the policy needs to be a paragraphWho the management representative is and what they are supposed to doWhy you need management review even if you’re not selling productsGetting executive management on board with a culture of qualityMaking management review meaningfulLinks:Sara AdamsEtienne Nichols LinkedInGG AcademyGreenlight GuruQuotes: “The quality policy should be the battle cry, the rally cry, the thing that pumps us up that we remember, not just words on a page.”“It is really important to have enough resources in the right roles to be able to meet the requirements of this regulation.”“Don’t just gloss over it. It is something that you have to do, but make it meaningful.”

Combination products are a difficult niche because they combine so many different elements. However, today’s guest literally wrote the book on the topic, and she’s joining the podcast to share her insights. In today’s episode, Susan Neadle and I spoke on the topic of Combination Products, and specifically how she recently wrote the Handbook on this topic, with many co-authors from FDA.Susan is a recognized international Combination Products and Medical Device expert with over 30 years of industry experience. Her FDA peer-reviewed book, “The Combination Products Handbook: A Practical Guide” is available for purchase through CRC Press. Listen to the episode to hear about her past experience and how she ended up in products, how the different chapters of her book came to be, and how her collaborators were involved.Some of the highlights of this episode include:Susan’s past experiences in the industryHow Susan got into the combination products spaceSpecific examples of the multilingual approach Susan had to takeHow the different chapters in Susan’s books evolved and who collaborated with herWhat it was like to work with so many different professionals on the bookThoughts about challenges that may be addressed in the futureHow to harmonize language differences in the glossaryOvercoming the challenge of being a niche within a niche and juggling multiple fieldsHow industry knowledge interacted with FDA knowledgeMemorable quotes from Susan Neadle:“It was really a great adventure, being there right at the ground level when it all started.”“If people aren’t able to use the product effectively, they’re not going to take their drug, which means all sorts of other ramifications.”“It’s important to understand what are the combination inspection product criteria.”“It was great, although it would have been much easier if I was trying to write the book by myself, because I have control of my own timelines.”Links:Susan Neadle on LinkedIn20% Discount for The Combination Products HandbookCombination Products ConsultingEtienne Nichols LinkedInGreenlight Guru

What is lean documentation and how can you achieve it? Our guest on today’s live podcast is an expert on quality management systems, audits, and most importantly for today’s conversation, documentation. Steve Gompertz is a partner at QRX Partners and has led initiatives in project management, engineering automation, configuration management, audit, and software development.During today’s episode, we’ll talk about the most important parts of a QMS, what differentiates a good QMS from a bad one, and how to prove ROI on a QMS. Steve will also discuss what he would do if he were starting a medical device company today. Listen to the episode to learn more about lean documentation and how you can learn to write for your actual audience – the workers – while still pleasing the auditors.Some of the highlights of this episode include:What it means to have lean documentation, and what the norm is in the MedTech communityHow to write for employees while meeting auditor requirementsBuilding a template for a standard operating procedureCollaboration between the production of a document and ownership of that documentMaking repairs on documentation vs. starting overProving the ROI on a good or bad QMSTaking care not to be overly prescriptiveThe importance of root cause analysis over treating symptomsMapping instead of including every SOP and repeating yourselfWhat management responsibility looks likeMaking documentation work better in terms of root causesMemorable quotes from Steve Gompertz:“I’m fond of telling people, ‘The auditors don’t work here. That’s not who these documents are for.’”“Done correctly, efficiency and effectiveness are not enemies.” “Everybody has a customer internally; everyone produces a product.”“On the quality systems pyramid, the smallest piece is the quality manual. So why is it the biggest document.”Links:Steve Gompertz LinkedInQRX PartnersEtienne Nichols LinkedInGreenlight Guru

The "Consolidated Appropriations Act of 2023" (more commonly referred to as the Omnibus Act) was passed and signed into law on December 29th, 2022. This amendment to the Food and Drug Cosmetic Act has expanded the scope of the FDA beyond just "safety and efficacy" to include the cybersecurity of medical devices. This amendment resembles a watered-down version of the PATCH Act, which failed to pass in late 2022.As a result, on March 29, 2023, the FDA gained the legal authority to define and enforce medical device cybersecurity. So for today’s episode, we got THE leading minds in MedTech cybersecurity together to discuss what we need to do next. Chris Gates, Director of Product Security at Velentium, Chris Reed, Vice President of Product Security at Medtronic, and Ken Hoyme, CEO of Dark Star Consulting, join the podcast today to discuss the new guidelines, what the FDA can and can’t say about it, and what kinds of deficiencies you’ll be seeing in the future because of the new legislation.Some of the highlights of this episode include:How the FDA tried to clear a path for routine patches and updatesThe minimum that the omnibus bill is talking aboutNo longer needing to make the link between cybersecurity and safety and effectivenessWhen they have the legal authority to enforce cybersecurityWhy the document took so long to go throughSecurity architecture analysisWhy you should be referencing the April 2022 draftUnpatched vulnerabilities at the time of submissionThe effort needed to understand the FDA’s intentionsMemorable quotes from this episode:“Literally, if you’re not aware of this already, you’re already behind the 8-ball right now and there’s things you’ve got to do.”“Basically, if you think it might be a cyber device, it is a cyber device.”“Don’t sit there and try to be pedantic about this and say “I don’t need to do this because there’s a comma here.” It ain’t gonna work for you.”“A synonym for threat modeling really is security architecture analysis.”Links:Christopher GatesChris ReedKen HoymeVelentiumMedtronicDarkStar ConsultingMedical Device Cybersecurity in 2023 and Beyond SlidesEtienne Nichols LinkedInGreenlight Guru

With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming more so due to increased risk measures, and it’s important to understand what’s happening in the industry. To that end, today’s guest, Tyler Foxworthy, will share his expertise on the subject. Tyler Foxworthy was the Chief Data Scientist at Resultant, then the Chief Scientist at Demand Jump. Before founding his own company, he applied statistics and machine learning to help the medical device industry make informed decisions about changes to their devices. The company that he founded, Vertex was acquired by Greenlight Guru, where Tyler is now the Chief Scientist.Listen to the episode to hear Tyler explain more about data quality, the future of risk assessment, and how Bayesian statistics and analysis come into play.Some of the highlights of this episode include:When can we reach a point where we know the data is accurateThe future of risk assessment for MedTechWhy use a model for predicting riskHow this model impacts a companyThe change in trajectory for the medical device industryMemorable quotes from Tyler Foxworthy:“There is no such thing as absolutely perfect data, there’s only degrees of quality.”“I would like to see it as more rigor, in general, brought to the industry.”“This whole field of probabilistic risk assessment is firmly rooted in Bayesian analysis.”“This idea of using, bringing out tools and techniques and knowledge from other domains and fork lifting it into our industry, and making it valuable, to me there’s just something really intellectually appealing about that.”Links:Tyler Foxworthy LinkedInEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to regulatory affairs professionals and regulatory affairs attorneys? Those are just a few of the items covered in today’s live discussion with Mark DuVal.Mark is the founder and president of Duval & Associates. He’s been in healthcare marketing and advertising for over 20 years and is a leading expert in medical device promotion. In today’s episode, you’ll learn his tips for creating “appropriately aggressive, yet compliant” ad campaigns. Learn from Mark’s expertise as he discusses the four buckets of knowledge for information sharing, the different perspectives between regulatory and legal, and how to think about the information provided with a medical device.Some of the highlights of this episode include:The difference in perspectives between a regulatory affairs professional and a regulatory affairs attorneyBest recommendations for regulatory affairs professionals when approaching off-labelExamples of when the dissemination or communication of on and off-label information comes into playGeneral and specific use, and being specific with your indication for useWhether a case study could be built around a physician’s off-label useHow compliance monitors sales for off-label promotionAd promo enforcement actionMemorable quotes from Mark DuVal:“The regulatory affairs professionals are, a lot of times, they’re biomedical engineers and scientists, and they are much more steeped in the medicine and the science as we would be as lawyers.”“It’s kind of a mantra I make everyone repeat when I do a training exercise – I make them repeat after me, truthful, not misleading, fairly balanced.”“You have every right to participate in social media. But again, you’re still regulated.”“We don’t feel people should unnecessarily leave money on the table, nor should they foolishly aggravate FDA and receive a warning letter and get told to cease and desist.”“When you’re in the trenches day-to-day, trying to convince them to use something that’s real-world data is work. It can be done, though!”Links:Mark DuValDuVal & AssociatesCardiac Arrest: 5 Years as a CEO on the Feds Hit List (book)Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended PracticesMedical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and AnswersWashington legal foundation caseGeneral/Specific Intended Use - Guidance for IndustryEtienne Nichols LinkedInGreenlight Guru

What makes a clinical investigation run smoothly? In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical investigations. Jon has a master’s degree in biomedical engineering and is the founder of SMART-TRIAL by Greenlight Guru, which helps MedTech companies close the gap between their devices and clinical data. He was the CTO of SMART-TRIAL from 2013 to 2017, and since then has been leading SMART-TRIAL’s clinical operations. His valuable insights come from 10 years of experience in the MedTech clinical space plus a strong technical background.Listen to today’s episode to hear what Jon has to say about using Electronic Data Capture (EDC) systems in clinical investigations, the importance of data quality and what that really means, the tools available for clinical investigations, and educating leadership about clinical investigations.Some of the highlights of this episode include:The biggest challenges companies face during clinical investigationsWhat kinds of tools are available for clinical InvestigationsThe relationship between data quality and formattingThe impact a purpose-built tool has on a companyThe costs associated with clinical investigationsEducating leadership about clinical operationsWhat makes the best stand outMemorable quotes from Jón I. Bergsteinsson:“Data quality has everything to do with how you format your data.”“The leadership just doesn’t have that much of an understanding of what clinical operations do, so they need to be educated.”“When you have a person who’s very efficient, you can get 100 attributes in a couple of minutes.”“Digital first is what sets the best from the rest.”Links:Jón BergsteinssonSMART-TRIAL by Greenlight GuruEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru

What would you think about dealing with complaints all day? Today’s guest has some ideas. Brittney McIver is a Medical Device Guru at Greenlight Guru where she helps guide companies through the various quality and regulatory requirements and challenges that are unique to MedTech companies and Medical Device Professionals - like QMS implementation. Brittney has a bachelor’s degree in Biological Science, a master’s degree in Bioengineering from Clemson University, and is an ISO 13485 Lead Auditor.Listen to the episode to learn about Brittney’s experience shadowing doctors and watching surgery, the part of her job that involves handling complaints, and how complaints are related to post-market surveillance.Some of the highlights of this episode include:What effect does shadowing doctors and seeing surgeries haveThe difficulties of a complaint handling role and how Brittney would structure the role in the companyRegulations around the complaint-handling processDifferent streams that come into play as far as complaints goManufacturer employee complaints on social mediaHow complaints are related to post-market surveillanceAdvice and recommendations for companies about complaintsMemorable quotes from Brittney McIver:“One of the things I wasn’t prepared for was the sheer volume of complaints sometimes.”“You always look at a complaint and try to determine whether it is a complaint or not.”“Any decision you’re making, you want to make sure that it’s informed and you have a rationale behind it.”“One of the things that you don’t want to happen is your customer not report the complaint to you, but they report it to the FDA.”Links:Brittney McIverEtienne Nichols LinkedInGreenlight Guru AcademyGreenlight Guru