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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 unfolding and the pros and cons of harmonization between QSR and ISO 13485:2016—a standard not governed by FDA.Some of the highlights of this episode include:The FDA is not expected to adopt ISO 13485 or any other standards across the board. Instead, it will take a piecemeal approach. Any future revisions to the 2016 version of the standard would need to be evaluated before becoming part of U.S. regulations.How often are periodic changes and updates made to QSR, ISO standards, and FDA guidances? Do changes even need to be made

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 highlights of this episode include:At a university, Stephanie describes the process that professors and students follow when they have an idea. Before they publish it, if they think they have something novel and meets the definition for a patent, they file a disclosure.In the private sector, Kevin describes the publishing, patent, and funding process as being very different. To patent a trade secret, it must be incredibly robust and support a very valuable program. Funding for commercial entities or for-profit companies d

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 philosophy and approach on how the pieces of human factors, risk management, and product development come together. It’s all about user-related risks and making the right design decisions early on during product development.Some of the highlights of this episode include:Human factors is a risk management activity that the FDA and International Organization for Standardization (ISO) requests. It’s all about use-related risk.Risk management helps make design decisions around safety and efficacy, and human factors provide a focus

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 company’s quality philosophy to ensure that true quality becomes a part of your company’s culture.Some of the highlights of this episode include:Quality is an ambiguous and esoteric word. To most, it means how good or bad something is, which leads to oversimplification and subjectivity.If you cannot measure quality, then you cannot improve it. For quality to be meaningful, it must be defined in less subjective terms, made to be objective, and needs to be measured.In the regulatory and FDA space, quality is not about good or

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 platform based on tracking, capturing, recording, and objectively measuring eye movements.You’ll hear how Scott went from his position as Head of Sports Medicine program at Stanford University, where he was part of a multidisciplinary research collaborative studying the natural history of head injuries. Though the technology was initially developed to aid in concussion protocol and the clinical care of athletes with head injuries, the potential of EYE-SYNC technology is now used to diagnose and manage neurodevelopm

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 wealth of knowledge and insight to his discussion with Jon and Etienne, helping listeners understand how to navigate the selection process for medical device contract manufacturers.Some of the highlights of this episode include:Characteristics to consider when evaluating a contract manufacturer include cost, plant location, services provided, complexity of product, process validation, and available technology.Who’s doing what? Create a quality agreement because the overlap and what’s covered under the contract manufactur

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 expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.The biggest problem with 510(k) is predicate cr

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 the highlights of this episode include:EUA is one of many pathways that medical device companies can use to bring devices onto the market in the United States. EUA is a temporary authorization—not approval or clearance.The FDA has authorized more than 800 EUAs for medical devices for COVID-specific indications. The regulatory burden is lower for an EUA than a traditional approval.The FDA is reasonably expected to give companies a six-month notice for terminating EUAs. However, it takes much longer to get a 510(k), De Novo

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 know about the UDI system.Some of the highlights of this episode include:The FDA requires the UDI to adequately identify medical devices that are manufactured, distributed, sold, and used by patients.According to the FDA, labels on most medical devices will include a UDI in readable forms to improve patient safety, modernize postmarket surveillance, and facilitate innovation.UDI eliminates mistakes. If a patient is prescribed something, you scan everything that they do. If somebody makes a mistake, they know right away.Th

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 matters.In this episode Jon is joined by Etienne Nichols, a medical device guru at Greenlight Guru and Jon’s new co-host of the Global Medical Device Podcast. This is a must-listen-to episode, offering details into this exciting news and other key thoughts and observations Jon and Etienne share about the medical device industry.Some of the highlights of this episode include:Etienne is passionate about the medical device industry and decided to join Greenlight Guru to help make things better, such as documentation.&nbs

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 well as how it compares and contrasts to virtual reality (VR), machine learning (ML), and artificial intelligence (AI).Some of the highlights of this episode include:AR is a relatively new technology that some people don’t quite understand how it is or can be used in healthcare today and in the future. It’s important for people to try Magic Leap’s AR device and platform to expand their thinking of use cases.AR is not the same as VR and other technologies. VR is completely immersive and involves wearing a headset. You can’t

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 be finalized in 2022. Some of the highlights of this episode include:According to the FDA, CDS software “provides healthcare professionals (HCPs) and patients with knowledge and person-specific information, intelligently filtered or presented at appropriate times, to enhance health and health care.”As with most regulations and guidances, the verbiage used for CDS software is ambiguous and makes room for interpretation or manipulation.There are a few reasons why the FDA is making CDS software important and its #1 pri

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 mind so they are easy to use, safe, and supportive for the end user.Some of the highlights of this episode include:Medical device professionals may develop something that they view as perfect, but what matters is what the person or patient using the product thinks of it. Medical devices/software should support people with health issues/problems.Those in the medical device industry and at Custom Medical have a major impact on the quality of life for many people. They can save and improve lives as well as prevent damage by do

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 the most challenging health problems with innovative medical devices that transform patient lives.Some of the highlights of this episode include:The spine business is an untapped opportunity that can impact patients across the globe with technology solutions being developed by Medtronic.Would you rather live with back pain or have surgery? Basic spine surgery has advanced and improved, but there’s still a wide variability in the outcomes based on where patients live, training of the surgeons, and technologies used.Surg

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 the three most common compliance issues and offer answers to questions like, why are the same select areas continuing to cause issues and what’s beyond these recurring compliance issues?Some highlights of this episode include:Based on FDA data, the same issues are the top issues year after year. Are people simply not paying attention to the observations they receive? Are they intentionally not being compliant? Probably not, but then, what are the reasons?FDA does not require medical device companies to share internal au

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 this episode include:Mike defines usability or human factors as the user’s ability to use the device in a way that it is intended to be used to get the result it’s intended to get.Jon understands how product development engineers forget that they designed a product based on how they think it should operate, function, and be used.Unfortunately, there are few opportunities for engineers to actually test, use, or implant a product that they developed and designed on actual end users, like cadavers or live animals.The user popu

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 Development of Medical Devices.Some of the highlights of this episode include:It’s assumed that engineers good at managing projects, getting things done, and working with different resources/team members make good project managers.The gold standard is Gantt charts and waterfall methodologies. They have their place and have done a lot of good, but developers do not have to follow the waterfall method - it’s simply a project management practice and example.There’s an appropriate time and place for PM practices and tools,

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 accordingly.Some of the highlights of this episode include:Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.EU MDR was supposed to go into effect in May 202

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 which manufacturers should approach responding to AI requests via the Least Burdensome Flag program from FDA CDRH.Some of the highlights of this episode include:You do have options to push back if you think the FDA’s response or request for more information, data, or testing is overly burdensome or unnecessary.Understand why the FDA is asking you for additional testing or to collect additional data. The FDA should be able to give you a legitimate reason.Despite some trite responses, FDA cannot ask you to do whatever it

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 agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.It takes time, often several years, for companies to transition to new or revised regulations and standards. Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.Some medical dev