Global Medical Device Podcast powered by Greenlight Guru

DescriptionIn today’s episode, Shawnnah Monterrey discusses the 3P510k - which is short for the 510k 3rd Party Review Program. This is a lesser known program, but there can be significant benefits from using it, which we talk about during the episode. Some of the issues we discussed include:How utilizing this program can accelerate the submission process, or at least remove some uncertainty around the timelineWho this program is for - not just for small startups, but rather how even experienced Regulatory Affairs specialists working at large corporations can benefit from this program.Lastly, we don’t usually get into the specifics of cost and expenses, but we even discuss some of the differences in how much you’ll pay using the 3P510k route vs. the traditional submission route.Shawnnah Monterrey is the founder of BeanStock Ventures after nearly a 20-year career as a technical leader. Shawnnah was responsible for developing strategies and leading complex global product development programs and functional management of software and software quality assurance departments for both startup and mature organization with emphasis on the development of medical instruments, life science, diagnostics, clinical applications.Reference Links:Shawnnah Monterrey on LinkedInBeanStock Ventures – 3P510kEtienne Nichols on LinkedInGreenlight Guru softwareFDAs 3P510k page

DescriptionMost people in the world of Medical Devices know that they need a Quality Management System, but what is the best way to go about building that QMS, when should you start, and how do you know when you've built it to the point it can stand on this own?In this episode, Rob MacCuspie, PhD, Manager of Regulatory and Quality Affairs at Proxima Clinical Research, Inc., discusses the best practices of companies he has worked with to help implement their Quality Management System in a manageable way.Takeaways:What is the difference in your QMS and a Document Management System?What is the most important aspect of a QMS?Who really needs a QMS, and when?What are the phases of a QMS?How to start building a QMS.Quote:""If my SOPs and training process can bring in somebody that has no experience and they can hit the ground running, I'm not worried if the auditor has any experience now in my space, right. Because I now have everything in place to show somebody how they can teach themselves and learn and get up to speed and walk through the process."Reference Links:Rob MacCuspie on LinkedInEtienne Nichols on LinkedInProxima Clinical ResearchGreenlight Guru software

DescriptionIn April of 2023, FDA released a draft guidance entitled, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning (AI/ML) - Enabled Device Software Functions." In today's episode, we speak with Mike Drues, PhD, President of Vascular Sciences, about artificial intelligence in medical devices, the history of this type of technology in the medical device field, and what this guidance means and doesn't mean. We hope you enjoy this episode of the Global Medical Device Podcast!Questions AskedWhat does artificial intelligence mean in software as a medical deviceWhy is this new draft guidance needed?What recommendation for medical device companies does the draft guidance provide?What are the challenges with validating the modifications for an ML-DSF? (Or are there other, greater challenges?)What are some of the specific items a PCCP should include?Does a PCCP negate a future need of a Letter to File or new 510k? What would necessitate an additional market submission?Quotes"I really try to stress what I call 'regulatory logic,' because if you understand the regulatory logic, really, all of this should be common sense." - Mike DruesReference LinksDraft FDA GuidanceEtienne NicholsGreenlight Guru

In this episode with Fran Cruz, Chief Customer Officer at Greenlight Guru, we explore the investment of a purpose-built electronic Quality Management System (eQMS). Some of the topics we explore are:3rd- party study by Hobson & CO that reveals significant reductions in setup time, full-time employee requirements, time spent on development and documentation, training time, and audit preparation time.The recent ROI Calculator developed by Greenlight Guru to help customers customize the study's findings to their specific inputs and demonstrate the value of the software for their business.The current economic climate, with budget cuts and limited investments, and the importance of efficiency and cost savings provided by a quality management system.Prioritizing success metrics, measuring outcomes, and holding ourselves accountable lead to better decision-making and improved effectiveness in the long run.Success criteria for customers implementing a quality management system include time to implement (time to value) and achieving specific outcomes.How Greenlight Guru aims to balance efficient setup and time to value for customers, focusing on milestones like entering documents and processing changes.The way different customer profiles require different approaches, such as providing guidance and templates for early-stage companies or assisting with migration for existing quality systems.The different functions Greenlight Guru offers, such as services like Guru Assist and GG Academy to support customers in their implementation and learning process."I think ultimately this whole study was really illuminating because it was able to give executive teams, buying teams the numbers that they needed to make a smart decision." ~Fran CruzReference Links:Etienne Nichols LinkedInIndependent Study on ROI of eQMSROI CalculatorGreenlight GurupKtQjeyoDImuAoc2OjH5

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