Greenlight Guru

#325 The Role of dFMEAs in Risk Management for Medical Devices

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 paragraph
Who the management representative is and what they are supposed to do
Why you need management review even if you’re not selling products
Getting executive management on board with a culture of quality
Making management review meaningful



Management Responsibility: The most important part of a QMS

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.<h3>Some of the highlights of this episode include:</h3><ul><li>Susan’s past experiences in the industry</li><li>How Susan got into the combination products space</li><li>Specific examples of the multilingual approach Susan had to take</li><li>How the different chapters in Susan’s books evolved and who collaborated with her</li><li>What it was like to work with so many different professionals on the book</li><li>Thoughts about challenges that may be addressed in the future</li><li>How to harmonize language differences in the glossary</li><li>Overcoming the challenge of being a niche within a niche and juggling multiple fields</li><li>How industry knowledge interacted with FDA knowledge</li></ul><h3>Memorable quotes from Susan Neadle:</h3>“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.”<h3>Links:</h3><a href="https://www.linkedin.com/in/susan-neadle-088b462/" rel="noopener noreferrer" target="_blank">Susan Neadle on LinkedIn</a>20% Discount for<a href="https://www.routledge.com/The-Combination-Products-Handbook-A-Practical-Guide-for-Combination-Products/Neadle/p/book/9781032291628" rel="noopener noreferrer" target="_blank"> The Combination Products Handbook</a><a href="http://www.combinationproductsconsulting.com/" rel="noopener noreferrer" target="_blank">Combination Products Consulting</a><a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer" target="_blank">Etienne Nichols LinkedIn</a><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a>

The Combination Products Handbook

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.<h3>Some of the highlights of this episode include:</h3><ul><li>What it means to have lean documentation, and what the norm is in the MedTech community</li><li>How to write for employees while meeting auditor requirements</li><li>Building a template for a standard operating procedure</li><li>Collaboration between the production of a document and ownership of that document</li><li>Making repairs on documentation vs. starting over</li><li>Proving the ROI on a good or bad QMS</li><li>Taking care not to be overly prescriptive</li><li>The importance of root cause analysis over treating symptoms</li><li>Mapping instead of including every SOP and repeating yourself</li><li>What management responsibility looks like</li><li>Making documentation work better in terms of root causes</li></ul><h3>Memorable quotes from Steve Gompertz:</h3>“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.”&nbsp;“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.”<h3>Links:</h3><a href="https://www.linkedin.com/in/stevegompertz/" rel="noopener noreferrer" target="_blank">Steve Gompertz LinkedIn</a><a href="https://www.qrxpartners.com/" rel="noopener noreferrer" target="_blank">QRX Partners</a><a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer" target="_blank">Etienne Nichols LinkedIn</a><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a>

Leaning into Lean Documentation

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.<h3>Some of the highlights of this episode include:</h3><ul><li>How the FDA tried to clear a path for routine patches and updates</li><li>The minimum that the omnibus bill is talking about</li><li>No longer needing to make the link between cybersecurity and safety and effectiveness</li><li>When they have the legal authority to enforce cybersecurity</li><li>Why the document took so long to go through</li><li>Security architecture analysis</li><li>Why you should be referencing the April 2022 draft</li><li>Unpatched vulnerabilities at the time of submission</li><li>The effort needed to understand the FDA’s intentions</li></ul><h3>Memorable quotes from this episode:</h3>“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.”<h3>Links:</h3><a href="https://www.linkedin.com/in/christopher-gates-8912a81a/" rel="noopener noreferrer" target="_blank">Christopher Gates</a><a href="https://www.linkedin.com/in/chrreed/" rel="noopener noreferrer" target="_blank">Chris Reed</a><a href="https://www.linkedin.com/in/kenhoyme/" rel="noopener noreferrer" target="_blank">Ken Hoyme</a><a href="https://www.velentium.com/" rel="noopener noreferrer" target="_blank">Velentium</a><a href="https://www.medtronic.com/us-en/index.html" rel="noopener noreferrer" target="_blank">Medtronic</a><a href="http://www.darkstar-consulting.com/" rel="noopener noreferrer" target="_blank">DarkStar Consulting</a><a href="https://blog.greenlight.guru/hubfs/Medical%20Device%20Cybersecurity%20in%202023%20(1).pptx.pdf" rel="noopener noreferrer" target="_blank">Medical Device Cybersecurity in 2023 and Beyond Slides</a><a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer" target="_blank">Etienne Nichols LinkedIn</a><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a>

Cybersecurity and the Future of MedTech

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 &amp; 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.<h3>Some of the highlights of this episode include:</h3><ul><li>The difference in perspectives between a regulatory affairs professional and a regulatory affairs attorney</li><li>Best recommendations for regulatory affairs professionals when approaching off-label</li><li>Examples of when the dissemination or communication of on and off-label information comes into play</li><li>General and specific use, and being specific with your indication for use</li><li>Whether a case study could be built around a physician’s off-label use</li><li>How compliance monitors sales for off-label promotion</li><li>Ad promo enforcement action</li></ul><h3>Memorable quotes from Mark DuVal:</h3>“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!”<h3>Links:</h3><a href="https://www.linkedin.com/in/mark-duval-j-d-fraps-1133564/" rel="noopener noreferrer" target="_blank">Mark DuVal</a><a href="http://www.duvalfdalaw.com/" rel="noopener noreferrer" target="_blank">DuVal &amp; Associates</a><a href="https://www.amazon.com/Cardiac-Arrest-Heart-Stopping-Years-Hit-List/dp/1483588386" rel="noopener noreferrer" target="_blank">Cardiac Arrest: 5 Years as a CEO on the Feds Hit List (book)</a><a href="https://www.fda.gov/media/88031/download" rel="noopener noreferrer" target="_blank">Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices</a><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-product-communications-are-consistent-fda-required-labeling-questions-and-answers" rel="noopener noreferrer" target="_blank">Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers</a><a href="https://casetext.com/case/washington-legal-foundation-v-henney" rel="noopener noreferrer" target="_blank">Washington legal foundation case</a><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/generalspecific-intended-use-guidance-industry" rel="noopener noreferrer" target="_blank">General/Specific Intended Use - Guidance for Industry</a><a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer" target="_blank">Etienne Nichols LinkedIn</a><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a>

Ad Promo and The Difference in Regulatory & Legal

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.&nbsp;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.<h3>Some of the highlights of this episode include:</h3><ul><li>When can we reach a point where we know the data is accurate</li><li>The future of risk assessment for MedTech</li><li>Why use a model for predicting risk</li><li>How this model impacts a company</li><li>The change in trajectory for the medical device industry</li></ul><h3>Memorable quotes from Tyler Foxworthy:</h3>“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.”<h3>Links:</h3>Tyler Foxworthy LinkedIn<a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer" target="_blank">Etienne Nichols LinkedIn</a><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a>

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#325 The Role of dFMEAs in Risk Management for Medical Devices

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