Global Medical Device Podcast powered by Greenlight Guru - podcast cover

Global Medical Device Podcast powered by Greenlight Guru

Greenlight Guru + Medical Device Entrepreneurswww.greenlight.guru
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Episodes

Meet a Guru: Brittani Smith

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, 202329 minEp. 315

Why Building Supplier Relationships Is So Important

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, 202336 minEp. 314

Systematic Literature Review for EU MDR

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...

Apr 05, 202338 minEp. 313

Building Your Design Controls (and Pitfalls to Avoid)

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, 202336 minEp. 312

Most Common Problems Found During FDA Inspections in 2022

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, 202345 minEp. 311

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

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, 202332 minEp. 310

Understanding the 'Compliance Manager' Role

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, 202321 minEp. 309

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

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, 202328 minEp. 308

How Communication Affects the Outcomes of Quality Activities

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, 202348 minEp. 307

Part 2: The Theranos Loophole & Lab Developed Tests

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, 202343 minEp. 306

Part 1: The Theranos Loophole & Lab Developed Tests

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, 202338 minEp. 305

Implementing an eQMS after Switching from Paper

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, 202331 minEp. 304

Essentials of Sterilization for Med Device Professionals

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, 202337 minEp. 303

UDI: 101

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, 202333 minEp. 302

Quality Myths and Lessons Learned

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, 202346 minEp. 301

Determining User Needs for Your Medical Device

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, 202342 minEp. 300

Fraud in the Healthcare Industry & the Role of Whistleblowers

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, 202353 minEp. 299

Auditing the Auditor

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, 202341 minEp. 298

What is MedTech Lifecycle Excellence?

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, 202345 minEp. 297

The Best of Jon & Mike Through the Years

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, 202251 minEp. 296

CDRH Proposed Guidance for FY 2023

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, 202243 minEp. 295

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

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, 202243 minEp. 294

The Future of Healthcare & How We Get There

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 e...

Dec 08, 202249 minEp. 293

What "Exempt" Means with Respect to Medical Devices & Regulatory

How should you be thinking about 510(k) exemptions for medical devices? Do you know when things do and don’t qualify for exemption and how that intersects with how a device is classed? This is the focus of today’s episode with recurring guest Mike Drues, in a conversation with host Jon Speer, founder of Greenlight Guru. Mike is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies. L...

Nov 30, 202252 minEp. 292

Developing a Regulatory Strategy

What is a regulatory strategy? And for that matter, what do people sometimes think is a regulatory strategy but isn’t? Those are the questions that today’s guest, Mike Drues, discusses as he begins his conversation with host John Speer, founder of Greenlight Guru. Mike 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 how Mike thinks about compe...

Nov 23, 202243 minEp. 291

We Achieved ISO Certification! Now What?

What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode. Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD America. Listen to the episode to hear what Mark has to say about how he uses a quality system as a competitive advantage, what companies should be doing...

Nov 17, 202244 minEp. 290

The Future of Reprocessed Used Medical Equipment

What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we spoke with Scott Carson on the future of buying and selling used medical devices. Scott has been in healthcare marketing, business development, sales, and management experience for more than 30 years. He was on the team that built the eBay Healthcare Marketplace structure and founded US Medical, Inc., the first Internet distributor of...

Nov 11, 202248 minEp. 289

The Importance of Cervical Cancer Screening in the U.S.

The importance of cervical cancer screening in the U.S.Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that screening?  Today’s episode features Chris Beddard, VP of US Marketing at BD. She joins the podcast today to discuss a product she and her team have been working on to improve the lives of women. Chris is passionate about bringing awareness about health options to women around the world.  Listen to the episode to hear what Chris ...

Nov 04, 202220 minEp. 288

Customer Discovery for Medical Device Companies

What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device companies. Kari Haab has been working in the medical device world for over 10 years. She’s a part-time mentor in residence at Western Michigan University and a Partner with Cantilever Business Partners, and an independent consultant for start-up organizations. Prior to this role, she was Vice President of Product Strategy, at Aquaro Histo...

Nov 02, 202239 minEp. 287

EUA and the Impending Transition

There’s a transition underway for devices that are currently under an EUA. People may not realize it, but this EUA, which was put into place under COVID, covers more than just COVID-related devices; many products are affected. Kyle Rose joins the podcast today to talk more about it. Kyle is the President of RookQS and works as a contract Quality Manager for multiple medical device companies, overseeing overall quality strategy and ensuring compliance through documentation and auditing services. ...

Oct 26, 202240 minEp. 286
For the best experience, listen in Metacast app for iOS or Android
Open in Metacast