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, ...
Jun 07, 2023•56 min•Ep. 322
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 enfo...
Jun 02, 2023•1 hr 13 min•Ep. 321
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...
May 26, 2023•34 min•Ep. 319
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 prom...
May 24, 2023•1 hr 27 min•Ep. 320
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...
May 13, 2023•38 min•Ep. 318
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....
May 03, 2023•39 min•Ep. 317
When bringing a medical device to the market, it’s important to be aware of the fatal 510(k) flaw. In today’s episode, Mike Drues joins the podcast to discuss the potential issues the 510(k) program presents and how companies are dealing with it. Mike holds a Ph.D. in biomedical engineering, has served as an expert witness, and is one of the foremost regulatory minds, currently serving as the president of Vascular Sciences. Listen to today’s conversation to learn how to approach a 510(k) submiss...
Apr 27, 2023•45 min•Ep. 316
What’s it like to become a Medical Device Guru? In today’s episode, you’ll meet one of our newer Gurus, Brittani Smith, and find out more about her role and journey working through UDI implementation, EU MDR preparation, and finding her place in a MedTech company. Brittani is a Medical Device Guru at Greenlight Guru. Our Medical Device Gurus are part of what we call the Guru Edge here at Greenlight Guru. As a Medical Device Guru, Brittney helps guide companies through the various Quality and reg...
Apr 20, 2023•29 min•Ep. 315
How do human relationships impact supplier management in the medical device field? Today you’ll hear from Taylor Brown, a Medical Device Guru and Manager of Onboarding and Implementation for Greenlight Guru, and Maxime Rochon, the Director of Quality Assurance and Clinical Affairs for Puzzle Medical. In this episode you’ll hear about why building supplier relationships is so important and some of the best practices for those relationships. Listen to the episode to hear how Taylor and Maxime are ...
Apr 12, 2023•36 min•Ep. 314
What’s involved in a systematic literature review for the EU MDR, and how should companies handle those steps? In today’s episode, you’ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting. In today’s conversation, we covered topics like where information for the literature review comes from, the types of tools used to make evaluations, and more. Listen to the episode to hear what Ethan has t...
Apr 05, 2023•38 min•Ep. 313
What do engineers need to understand about manufacturing? How can you apply that knowledge to design controls? On today’s episode, our guest Tom Rish covers the topic of Design Controls. Tom is the Director of Guru Services at Greenlight Guru and a Product Development Engineer in Orthopedics. Listen as we talk about the differences between user needs and design inputs and the pitfalls companies get into when building design controls. Tom also shares what he thinks people should understand about ...
Mar 29, 2023•36 min•Ep. 312
Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Mike Drues joins the podcast to talk about the FDA's Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections. Recurring guest Mike Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Mike is a medical device profess...
Mar 23, 2023•45 min•Ep. 311
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...
Mar 15, 2023•32 min•Ep. 310
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 epis...
Mar 09, 2023•21 min•Ep. 309
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, a...
Mar 02, 2023•28 min•Ep. 308
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...
Feb 23, 2023•48 min•Ep. 307
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 wh...
Feb 16, 2023•43 min•Ep. 306
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)...
Feb 10, 2023•38 min•Ep. 305
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 ...
Feb 02, 2023•31 min•Ep. 304
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 mod...
Jan 26, 2023•37 min•Ep. 303
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 challe...
Jan 21, 2023•33 min•Ep. 302
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...
Jan 19, 2023•46 min•Ep. 301
What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These are some of the topics you’ll hear about in today’s episode. Jesseca Lyons joins the podcast today to share more information about user needs. Jesseca is a Mechanical Engineer who’s spent most of her career gathering and defining requirements for new product design and development in the medical device industry. During today’s conve...
Jan 14, 2023•42 min•Ep. 300
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 histo...
Jan 12, 2023•53 min•Ep. 299
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 e...
Jan 07, 2023•41 min•Ep. 298
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 differ...
Jan 05, 2023•45 min•Ep. 297
Today’s episode is a little different than usual. This will be Jon Speer’s last podcast for Greenlight Guru, as he’ll be moving on to future ventures as of December 31st. In honor of many podcast episodes featuring Jon and Mike Drues, this episode is a tribute to some of the best episode topics that the two of them have tackled. They review some of their favorite episodes and throughlines of their discussions throughout the time they’ve been podcasting together. Listen to Jon and Mike discuss ho...
Dec 29, 2022•51 min•Ep. 296
What are the proposed CRDH guidelines for the 2023 fiscal year, and why do they matter? How should you be thinking about them? Today’s episode covers the newly-released guidelines and addresses important questions about these guidelines specifically and about the practice of releasing these guidelines in general. Today’s conversation is with regular guest Mike Drues. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device...
Dec 22, 2022•43 min•Ep. 295
EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today’s discussion with guest, Mike Drues. Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. Listen to the episode to learn what Mike has to say about what EUAs are, what COVI...
Dec 15, 2022•43 min•Ep. 294
What kinds of possibilities exist in the future for healthcare? How can medical devices reach across different fields of medicine and provide a holistic patient experience in collaboration with each other? These are some of the ideas you’ll hear about in today’s conversation with Daniel Kraft about the future of healthcare. Daniel Kraft is a Stanford and Harvard-trained Physician-Scientist innovator and investor with over 25 years of clinical, research, biotechnology, and entrepreneurial experie...
Dec 08, 2022•49 min•Ep. 293
