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 he...
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...
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
What if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises. In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in ...
Oct 06, 2021•35 min•Ep. 230
Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify! In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality. Some of the highlights of this episode include: Mark and Jon a...
Sep 22, 2021•27 min•Ep. 229
When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA. Listen as Jon and Mike provide clarity for...
Sep 16, 2021•38 min•Ep. 228
There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices. In this episode of the Global Medical Device Podcast Jon Speer talks to Christie Johnson with Kasota Engineering, a consulting firm focused on quality in the medical device industry. Listen to this episode as Jon and Christie offer their insights and guidance on medical device quality management best practices. Some of the highlights of this episode include: Who manages quality...
Sep 08, 2021•28 min•Ep. 227
What makes Greenlight Guru unique and sets it apart from other medical device solutions? It’s Guru edge—a team of medical device professionals with a ton of industry experience. In this episode of the Global Medical Device Podcast Jon Speer talks to Maryann Mitchell, a Medical Device Guru and Solutions Engineer who has recently joined the Greenlight Guru team. Listen as Maryann shares fascinating details about her day-to-day working with device companies who are evaluating the Greenlight Guru M...
Sep 02, 2021•16 min•Ep. 226
Medical device companies need to tell slightly different versions of their stories depending on the intended audience—investors, suppliers, regulators, clinicians, and patients—and each version must be strategically crafted and told in order to convey the right message. In this episode of the Global Medical Device Podcast Jon Speer talks to Brad Perriello, who previously cofounded MassDevice and now current founder and principal at Circle Hill Life Science Communications, about his unique line o...
Aug 25, 2021•26 min•Ep. 225
Is your body becoming more frail? Are you worried about fractures? Do you want to improve your bone health? Osteopenia and osteoporosis are very common problems that don’t have completely effective solutions, yet. In this episode of the Global Medical Device Podcast, Jon Speer talks to Laura Yecies, CEO of Bone Health Technologies, about the product journey of OsteoBoost, a vibration belt that aims to prevent osteopenia and osteoporosis that has recently received the FDA’s Breakthrough Device De...
Aug 19, 2021•25 min•Ep. 224
FDA published a final rule, which goes into effect the first of September, to amend its “intended use” regulations. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the implications of FDA’s final rule on intended use, manufacturer’s objective intent, and the role that it has with labeling. Some of the highlights of this episode include: When Mike and Jon refer to labeling, they are talking about the content of the label - the words...
Aug 11, 2021•35 min•Ep. 223
Have you ever thought about the versatility of an eQMS? As it turns out, the use of one medical device eQMS solution in particular is extending across multiple sectors. In this episode of the Global Medical Device Podcast, Jon Speer talks to Renee Rogge and Devin Hubbard, two academic professors/faculty members of biomedical engineering programs which are involved with the Greenlight Guru Academic Partner Program. Jon, Renee, and Devin discuss their work together in the program and Renee and Dev...
Jul 28, 2021•36 min•Ep. 222
How efficient are your management reviews? Could improvements be made? It might be time to reevaluate and reconfigure your system processes to eliminate burdens and extract utmost value from these critical checkpoints while still satisfying compliance needs. In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, senior medical device guru at Greenlight Guru. Together, Taylor and Jon discuss the nuances of management reviews to help medical device managers and exec...
Jul 19, 2021•25 min•Ep. 221
Guru Edge . It's what makes Greenlight Guru so unique and particularly valuable to medical device companies. These Gurus form an elite team of medical device experts who serve Greenlight Guru customers in a variety of ways to ensure success throughout their product journey. In this episode of the Global Medical Device Podcast, Jon Speer talks to Ryan Behringer, a Training and Onboarding Medical Device Guru at Greenlight Guru. Listen to this episode to learn about Ryan's professional journey whic...
Jul 14, 2021•28 min•Ep. 220
Cybersecurity continues to be a crucial concern for medical device safety and effectiveness in the US, for manufacturers and regulators alike. In this episode of the Global Medical Device Podcast Jon Speer talks to Mike Drues from Vascular Sciences about the opportunities and challenges associated with medical device cybersecurity. Listen as Mike and Jon share their thoughts on the potential ways to eliminate or reduce cyber threats and encourage better cybersecurity practices for medical device...
Jul 13, 2021•31 min•Ep. 219
