How do you build a company that puts culture before function? Results before profit? Building a culture of quality to improve lives for a better world is more than just a slogan, it's a shared mission. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Dan Purvis, CEO and co-founder of Velentium, about building quality-centric, life-changing products for the medical device space. Velentium is a professional engineering firm that specializes in the design and manufactu...
May 20, 2022•45 min•Ep. 262
Are you passionate about human-centered design and how it relates to health care? Patients deserve a high quality experience when bringing medical devices into their home. They want a product that they can use and want to use, without sacrificing any elements that would otherwise exist in a clinical setting. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Dylan Horvath, Founder, President, and Chief Product Officer at Cortex Design. Dylan has a degree i...
May 18, 2022•47 min•Ep. 261
How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations? In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is pas...
May 12, 2022•38 min•Ep. 260
What are the regulatory pathways used in the United States versus the European Union (EU)? Dealing with regulators can be challenging and emotionally draining. Win in the U.S. and EU marketplace by delegating all things regulatory to a grief counselor. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Michelle Lott, Founder and Principal of leanRAQA. Also, she served a four-year term on the FDA’s Device Good Manufacturing Practice Advisory Committee (DGM...
May 06, 2022•40 min•Ep. 259
Have you ever played the game, Operation ? The patient’s nose would light up and buzz if your tweezers touched the side. Neurophysiology is a lot like that game. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Shawn Regan, CEO and Co-founder of Rhythmlink International, at the South Carolina Biosciences (SCBIO) Conference. From startup to industry leader, Rhythmlink is a company that designs, manufactures, and distributes medical devices that physically connect pat...
May 04, 2022•45 min•Ep. 258
What will the future be for software as a medical device (SaMD) and cybersecurity? Manufacturers need to identify cybersecurity issues with their medical devices because incidents have become more frequent, severe, and impactful. In this episode of the Global Medical Device Podcast, Etienne Nichols talks to Chris Gates, Director of Product Security at Velentium and author of Medical Device Cybersecurity for Engineers and Manufacturers . Chris has more than 30 years of experience developing and s...
Apr 30, 2022•40 min•Ep. 257
In this episode of the Global Medical Device Podcast Etienne Nichols talks to Patrick Hayes, Associate Director of Program and Project Management at Commissioning Agents (CAI), about how to achieve operational readiness in a manufacturing setting. CAI is a professional service provider that helps medical device companies get their quality products to market through operational readiness. The company provides expertise to get products out the door and qualified in a safe, effective, and cost-effi...
Apr 27, 2022•28 min•Ep. 256
Selling a medical device in the EU? Understanding the importance of clinical data and what's required will be crucial to your success. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Adam Steadman, Chief Commercial Officer for SMART-TRIAL, about best practices—not shortcuts—to bridge the gap between medical devices and clinical data. SMART-TRIAL is an Electronic Data Capture (EDC) company that provides software as a service (SaaS). The EDC software ge...
Apr 20, 2022•50 min•Ep. 255
Navigating the Medical Device Single Audit Program (MDSAP) may cover most of your regulatory requirements; however, it does not mean that your product will automatically be cleared or approved by FDA. Any medical device company considering MDSAP should be familiar with what the program is and is not. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Danny Kroo, a medical device consultant and sub-contract lead auditor for several registrars that provides ...
Apr 13, 2022•41 min•Ep. 254
Today’s innovative medical technology is more like a video game and makes a minimally invasive ablation so easy it could be done by a 12-year-old. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mina Fahim, CEO and President of MediView, about bringing augmented reality (AR) medical technology to market. MediView gives clinicians X-ray vision and leverages AR and artificial intelligence (AI) to simplify, democratize, and inform healthcare delivery. Pr...
Apr 07, 2022•32 min•Ep. 253
What are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech. Isabella discusses the necessity of informational meetings and answers some commonly asked ...
Mar 30, 2022•37 min•Ep. 252
For many new medical device professionals a bill of materials (BOM) may feel like a big black box. Who owns it? How does it function within a QMS? How is it used differently in design versus in manufacturing? In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols learn the answers to these common questions, and more, about a medical device bill of materials from guest Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device C...
Mar 23, 2022•28 min•Ep. 251
FDA has proposed a new rule to align its Quality System Regulation (QSR) with ISO 13485:2016, the international standard for medical device quality management systems. How will, what's being referred to as Quality Management System Regulation (QMSR), affect the medical device industry and regulatory bodies? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mike Drues of Vascular Sciences and George Zack of Two Harbors Consulting about the changes unfoldin...
Mar 16, 2022•49 min•Ep. 250
When developing a product in the medical device space, how does intellectual property (IP) protection work in the private sector versus at an academic institution, like a university? When is a patent needed and when is it not? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Neil Thompson, Kevin Buckley, and Stephanie Willerth about intellectual property and why it's important to understand the difference between inventorship and ownership. Some of the h...
Mar 09, 2022•36 min•Ep. 249
Don’t give up on risk management. It’s the backbone of the product development lifecycle and human factors is one of its most important activities. It serves as a tool to guide development, allowing you to improve your products by turning risk into a value-add type of activity. In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Shannon Hoste, President of Agilis Consulting Group and former lead for the FDA’s Human Factors Team. Shannon explains her philos...
Mar 02, 2022•41 min•Ep. 248
What are the shortcomings, obstacles, and challenges when it comes to quality? Are there opportunities for improvement (OFIs) for quality? The regulatory and quality landscapes within the medical device industry can always do better through continuous improvement. In this episode of the Global Medical Device Podcast host Jon Speer talks to Mike Drues with Vascular Sciences about quality. Practice what they preach! Jon and Mike share tips on what you can do to improve upon your medical device com...
Feb 23, 2022•42 min•Ep. 247
They say eyes are windows to the soul; that studying someone’s gaze can reveal their innermost emotions. But what can the eyes reveal in a neurological sense, particularly when tracking abnormal eye movement? In this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Scott Anderson, Chief Clinical Officer (CCO) at SyncThink about the groundbreaking work the company is doing in advancing neurological assessments by building and using a proprietary digital health p...
Feb 17, 2022•34 min•Ep. 246
What is the best way for medical device professionals, early-stage, and established companies to select and engage with contract manufacturers? One medtech expert has a winning formula that he wants to share with listeners of the show. In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, founder of Consiliso LLC, and author of Medical Device Company In A Box . As a contract manufacturer himself, Mark brings a wealt...
Feb 02, 2022•43 min•Ep. 245
What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement? In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach. Some of the highlights of this episode include: Mike ex...
Jan 26, 2022•53 min•Ep. 244
Does your company have products that were granted emergency use authorization to get to market? Assuming you want to keep those products on the market post-EUA, do you know what you need to do now to prepare? In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues with Vascular Sciences about the recently released FDA draft guidance that describes transition plans for EUAs and how medical device companies should be preparing before EUAs are terminated by FDA. Some of t...
Jan 12, 2022•42 min•Ep. 242
Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists. TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should kn...
Jan 06, 2022•34 min•Ep. 241
Global Medical Device Podcast host and founder of Greenlight Guru, Jon Speer, always says he has the best job in the world. He gets to talk to amazing medical device professionals and hear about amazing products and technology improving the quality of life. Now, there’s an opportunity to take the most listened to podcast in the medical device industry in a new direction by introducing a second voice to the show to share a variety of contexts and perspectives around the why behind what we do that...
Dec 16, 2021•34 min•Ep. 240
Technology can accelerate the transformation of healthcare to improve health, quality of life, safety, and security. Augmented reality (AR) is finding its way into the healthcare ecosystem and there’s greater potential for it to be revolutionary, not just evolutionary. In this episode of the Global Medical Device Podcast Jon Speer talks to Jennifer Esposito, Vice President and Managing Director of Magic Leap's Health business unit, about AR in healthcare, explaining what it is and is not, as wel...
Dec 09, 2021•25 min•Ep. 239
At the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it? In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software. The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to ...
Dec 02, 2021•31 min•Ep. 238
Usability is essential. If you design something, anything used by humans, it needs to be designed for the users. This is especially true for medical devices. In this episode of the Global Medical Device Podcast Jon Speer talks to Michaela Kauer-Franz, CEO of Custom Medical, which offers usability engineering and testing for medical devices. Listen as the two medical device industry veterans discuss the topic of usability and how companies should be designing medical devices with usability in min...
Nov 24, 2021•25 min•Ep. 237
Do you want to alleviate pain, restore health, and extend patients’ lifespan? Accelerate the transformation of the spine industry by making outcomes and technologies standardized and reproducible. In this episode of the Global Medical Device Podcast Jon Speer talks to Carlton Weatherby, Vice President and General Manager of Spine and Biologics at Medtronic. Listen to Carlton discuss recent developments in spine and biologics technology at Medtronic, a global healthcare technology leader tackling...
Nov 17, 2021•18 min•Ep. 236
Medical device companies must comply with a list of strict requirements throughout the duration of their product's lifecycle. These compliance efforts will be put to the test once an FDA inspection or ISO audit rolls around. As it turns out, there are a few common culprits when it comes to compliance issues for manufacturers. In this episode of the Global Medical Device Podcast, Jon Speer talks to Tom Rynkiewicz, Vice President of Life Sciences for RA/QA and ASQ Certified Quality Auditor, about ...
Nov 10, 2021•31 min•Ep. 235
What is usability? Human factors? Are they one and the same or different in the medical device industry? When do each apply? Whatever you call it, both are very important in virtually all medical devices. In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about human factors and usability—two terms used synonymously despite subtle differences—to help you better understand how each function and should be applied. Some of the highlights of thi...
Nov 03, 2021•36 min•Ep. 234
What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project. In this episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell with Prodct and Christie Johnson with Kasota Engineering and Prodct partner about Greenlight Guru Academy’s new course offering, Introduction to Project Management for Product ...
Oct 27, 2021•36 min•Ep. 233
With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product. In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes ...
Oct 21, 2021•24 min•Ep. 232
