Global Medical Device Podcast powered by Greenlight Guru

Description: In this episode, we discuss how to select a site for a Clinical Trial. Joining us for the conversation is Isabella Schmitt, MBA, RAC, the Vice President of Life Science Solutions at Proxima Clinical Research. Isabella brings a wealth of knowledge and experience in the intricacies of clinical study site selection, shedding light on the critical role it plays in MedTech product developm...

Description: In this riveting episode of the Global Medical Device Podcast, Etienne Nichols brings together the dynamic leaders from Greenlight Guru: David DeRam (internally known as DD) and Pall Johannesson. Together, they embark on a journey through the chronicles of Greenlight Guru and SMART-TRIAL, exploring its growth, trials, and moments that defined its course. The conversation is sprinkled...

Description: In this episode recorded in front of a live audience in Boston, MA, we speak with Christy Sheehy-Bensinger, the CEO & Founder of C-Light Technologies, Inc. about their recently cleared eye movement monitor. Listen as we unpack her journey from academia to startup life, explore the complexities of medtech communication, and delve into the intricate dance of securing FDA clearance....

Description: In this episode, we explore the impact of software development methodologies in the medical device industry. With industry experts from HTD Health, we dissect the Agile approach to compliance, the intricacies of Quality Management Systems (such as Greenlight Guru), and go-to-market challenges for innovative medical devices. Zach, CEO of HTD Health, is a self-taught software engineer t...

Description: Join Devon Campbell in MedTech funding. He unveils startup red flags, from data integrity to product maturity. His message? Know your weaknesses, fill the gaps. Considering cold-calling other Founders? It works. Understand your their investment landscape first. Recognize that VCs and Angels have different risk profiles. Devon says know your funding options and their strings. It’s abou...

Description: In this episode, Etienne Nichols and Ellie Reynolds explore FDA's Breakthrough Device designation. They discuss pursuing breakthrough status, aligning marketing strategies with FDA review, and navigating the medical device industry. This episode provides a roadmap for this complex regulatory terrain. Learn about the benefits and scrutiny of the breakthrough designation, hear examples...

Description: In this episode of the Global Medical Device podcast, we discuss the intricate world of medical device regulations, design, and innovation. Hosted live in San Jose, the podcast features the esteemed Nada Hanafi, SVP - Regulatory Strategy at Veranex, who brings her rich experience of 12 years at the the FDA and Regulatory Strategy to discuss pressing issues and notable developments in...

Description: During the Houston leg of our True Quality Roadshow series, we had the opportunity to sit down with Dan Purvis, CEO of Velentium and author of "28 Days to Save The World." Dan tells the story of how his company weathered the early days of startup life, and how the pandemic - which took so many companies down - turned out to be the springboard that tested the culture that Dan and his c...

Description In 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 arou...

Description Most 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 pr...

Description In 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 o...

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 preparatio...

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...

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 medi...

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 thinki...

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...

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,...

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...

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...

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 h...

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-TRIA...

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 Sci...

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 pre...

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 Greenligh...

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...