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.
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October 27, 2021Episode 23336 min
Project Management for Product Development of Medical Devices
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, including the Gantt chart. However, don’t blindly apply learned principles. The wrong time to use a Gantt chart is managing how people do their work. Be vulnerable, open, and trust the professionals to know what they are doing and get their work done. Project planning and management are not the same. Project planning does not equal project management. Follow the Keep It Simple Stupid (KISS) philosophy. Rather than build complex and sophisticated tools, acknowledge that you won’t do it right the first time and put time in to react to what you learn and optimize. Who’s running the show? There’s a lot of overlap and not enough room to redo, learn, and make a product better. Also, a lot of iteration happens between those steps. Give time and respect to making a product stronger. Good project management is perpetual because there is a flow to it. It’s cyclical. Prototype and conduct testing early and often if the schedule allows to define and refine product details. Memorable quotes from this episode: “Starting as an engineer and then moving into quality and approaching things with a 30,000-foot view, you kind of see the whole project and the impact of all the sub-tasks. It’s hard not to want to get involved and make sure that everything that needs to get done does.” Christie Johnson “It will ultimately deliver something. It might deliver it over budget. It might deliver it over time. It might deliver it with a bunch of disgruntled employees who hate going through product development because of the way that the project is being managed.” Devon Campbell “Potentially, too many bells and whistles that it makes it really easy for you to create something that looks really awesome, but it’s really hot garbage.” Devon Campbell “Critical path calculations and analyses through tools is generally meaningless. I don’t believe it whenever I see it because we build these really complex and sophisticated models.” Devon Campbell “There’s a lot of overlap and not enough...room to go back and redo and learn and make the product better. There’s a lot of iteration that happens between those steps.” Christie Johnson Links: Introduction to Project Management for Product Development of Medical Devices Medical Device HQ Devon Campbell with Prodct Christie Johnson with Kasota Engineering The Critical Chain Theory of Constraints What is a Gantt Chart? FDA - Design Control Guidance for Medical Device Manufacturers (Waterfall Diagram) FDA - Quality System Regulation, Part 820 Waterfall vs. Agile: Battle of the Product Development Methodologies X-teams: How to Build Teams That Lead, Innovate, and Succeed by Deborah Ancona Design Structure Matrix (DSM) Steven D. Eppinger Greenlight Guru Academy The Greenlight Guru True Quality Virtual Summit MedTech True Quality Stories Podcast Greenlight Guru YouTube Channel Greenlight Guru
May 16, 2024Episode 36739 min
#367: Interviewing the Interviewer
In this special episode of the Global Medical Device Podcast, Etienne Nichols switches roles from host to guest as Devon Campbell turns the tables to explore the invaluable lessons Etienne has learned from over 100 podcast episodes. Delve into key insights on product development, quality management, and the power of vulnerability and networking. Etienne shares practical tips and personal anecdotes that reveal the nuances of the MedTech industry, making this episode a treasure trove of knowledge for both new and seasoned professionals. Key Timestamps: [02:15] - Introduction and Etienne’s journey to becoming a podcast host [12:30] - The importance of vulnerability and honesty in product development [22:45] - Balancing quality for audits versus operational benefits [30:10] - Human factors and usability in MedTech product development [37:55] - Simplifying quality management systems [45:00] - The mantra of learn, lead, and love in networking [54:20] - Encouraging emerging entrepreneurs to own their expertise and impact regulations Quotes: "The heart of the problem is the seed of the solution." "Quality management documents should benefit your company first and be audit-ready second." "Be genuinely curious. Assume the person in front of you knows something worth listening to." Takeaways: Key Insights on the Latest MedTech Trends: Human factors and usability are often misunderstood but crucial in MedTech product development. Quality management systems should be practical and beneficial for the company, not just for audits. Networking is more than collecting business cards; it's about building meaningful connections. Practical Tips for MedTech Professionals: Be vulnerable and honest about the state of your projects. Focus on solving the right problems and avoid over-engineering. Create quality management documents that are easy to understand and useful for your team. Questions Predicting Future Developments: How will AI and machine learning shape the future of MedTech product development? What emerging trends in usability and human factors will impact regulatory changes? How can MedTech companies better prepare for cybersecurity challenges? References: Greenlight Guru - Quality management software for medical devices. Etienne Nichols - LinkedIn Devon Campbell - LinkedIn Prodct LLC - Devon's advisory firm Fred Crosby’s Quality is Free - A book on quality management principles. Beginner's Section: MedTech 101 Quality Management System (QMS): The system that outlines the processes and procedures to ensure product quality. Human Factors and Usability: The study of how people interact with products to improve design and user experience. Regulatory Strategy: The plan for complying with regulations to bring a medical device to market. Questions for the Audience: Poll: What do you think will be the most impactful MedTech advancement in the next five years? Email us your thoughts at podcast@greenlight.guru Feedback: We'd love to hear your feedback on this episode! Please leave us a review on iTunes and share your thoughts and suggestions for future topics. Email us at podcast@greenlight.guru with your ideas and comments. Sponsors: This episode is sponsored by Greenlight Guru. Their all-in-one platform is designed specifically for the unique needs of the medical device industry, helping you maintain compliance, reduce risk, and improve quality. Visit www.greenlight.guru today to learn how their platform can transform your medical device development process.
December 21, 2023Episode 3491 hr 10 min
#349: Climbing the MedTech Career Ladder - How to Get to the Top
In this episode of the Global Medical Device Podcast, we’re joined by Elena Kyria, a talent acquisition specialist and CEO of Elemed. Elena delves into what it takes to climb the career ladder in the medtech industry, whether you're early or late in your career journey. Our host, Etienne Nichols, engages in a rich discussion on career paths, leveraging personal strengths, and the importance of networking and personal branding. Quotes "If you're not talking about the value that you add, how is anybody going to know what impact you're having?" - Elena Kyria "Everything's uncertain really, isn't it? What you've got to have is a clear sense of forwards and just have a goal." - Elena Kyria "Nobody goes to the gym and looks at the weights and gets fit. You have to do the reps." - Elena Kyria Takeaways Networking is Key: It's not just what you know, but who knows you and what they know you're doing. Visibility of Achievements: Share your successes within your company; if you don't, others may not recognize your contributions. Defining Success: Success doesn't always mean reaching the VP level; it's about personal satisfaction and contribution. Strengths and Weaknesses: Focus on your strengths but be aware of your weaknesses and compensate with your team. Career Paths: Understand the different career paths (leadership, expert, generalist) and what they entail for growth. Communication Skills: Strong communication skills are paramount for leadership and for translating technical details to a broader audience. Continuous Learning: Always seek new knowledge and experiences, no matter where you are in your career. Adaptability: Be prepared to pivot and adapt to changes within the industry and your career. Take Action: Don't just reflect on advice; apply it to make actual changes in your career approach. Reference Links: Elena Kyria's LinkedIn Elemed Working Genius Greenlight Guru Etienne Nichols' LinkedIn Remember to engage with the hosts and guests on LinkedIn for feedback and further discussions. Don’t forget to leave a review on iTunes! *Interested in sponsoring an episode? Use this form and let us know!
December 29, 2025Episode 43942 min
#439: MedTech AI Trends 2025: Scaling Regulatory Intelligence with Michelle Wu
In this episode, Etienne Nichols sits down with Michelle Wu, Founder and CEO of Nyquist AI and one of the top 100 women in AI, to discuss the transformative state of artificial intelligence within the MedTech regulatory and quality space. Reflecting on her recent personal experience as a surgical patient, Michelle shares a unique perspective on the critical importance of the devices and quality systems that keep the industry running. The conversation dives deep into the "Great Rewiring" of the medical device industry. Michelle outlines how we have moved past the initial phase of AI skepticism and "AI fatigue" into a period of hyper-acceleration. With the introduction of the FDA’s ELSA and the implementation of the EU AI Act, the industry has reached a point where AI is no longer a side project but a fundamental requirement for operational longevity. Finally, the episode provides a roadmap for both organizations and individual contributors. Michelle introduces her "Holy Trinity" framework for AI implementation—Data, Workflow, and Agents—and explains why the next two years will be defined by the "Invisible Colleague" or AI copilot. For junior professionals, the message is clear: knowledge is now a commodity, and the real value lies in the ability to ask high-quality, strategic questions. Key Timestamps 00:00 – Introduction and Michelle Wu’s background in MedTech and AI. 03:45 – A founder’s perspective: Michelle’s personal experience in the OR seeing her clients' devices. 08:12 – The 2025 Inflection Point: FDA ELSA, EU AI Act, and global AI expectations. 11:50 – From billable hours to value-based output: How AI is disrupting the consulting business model. 15:35 – Micro-timestamp: 2026 Predictions. The shift toward universal AI Copilots and Agents for every MedTech role. 18:22 – The Holy Trinity of AI: Breaking down Data Layers, Workflow Automation, and AI Agents. 22:10 – Case Study: How a top-tier MedTech company automated 17,000 quality and regulatory tasks. 27:45 – The 56.8% Salary Premium: Why AI literacy is the most important skill for young RAQA professionals. 31:15 – Shifting from memorization to "Clarity of Mind" and high-quality inquiry. Quotes "Knowledge is a commodity now. Previously, regulatory consultants or professionals stood out by their knowledge. Now, with AI leveling the field, the capability lies in those who can ask high-quality questions." - Michelle Wu, Nyquist AI Takeaways AI Literacy is a Financial Multiplier: LinkedIn data shows that non-engineering knowledge workers with AI literacy can command a salary premium of up to 56.8%. The 80/20 Rule of Automation: Approximately 80% of current RAQA tasks are tedious, manual, or administrative. Successful teams are using AI to automate that 80%, allowing humans to focus on the 20% that is strategic and high-value. The Three-Layer AI Strategy: To effectively implement AI, companies should look at the Data Layer (intelligence), the Workflow Layer (automation of specific tasks), and the Agent Layer (autonomous "employees"). Value-Based Billing: As AI reduces the time required for regulatory submissions and gap analyses, the industry is moving away from the "billable hour" toward pricing based on the value and quality of the output. References Nyquist AI: Michelle Wu’s platform specializing in global regulatory intelligence and AI-driven workflow automation for MedTech. FDA ELSA: The FDA’s internal AI tool that marked a significant shift in the agency's embrace of the technology. IMDRF GMLP: Good Machine Learning Practice guidelines for AI-enabled medical devices. EU AI Act: The first comprehensive legal framework for AI, affecting MedTech compliance timelines. Etienne Nichols: Connect with Etienne on LinkedIn . MedTech 101: AI Agents vs. AI Chatbots While many people are familiar with AI Chatbots (like the early versions of ChatGPT), the industry is moving toward AI Agents . Think of a Chatbot like a very smart encyclopedia. You ask it a question about a 510(k) submission, and it gives you information. An AI Agent , however, is like an AI Intern . It doesn't just give you information; it performs a multi-step task. For example, you can tell an Agent to "find the three most relevant predicates for this new device, summarize their 510(k) summaries, and draft a gap analysis table." The Agent "thinks" through the steps and delivers a finished product, not just a response. Sponsors This episode is brought to you by Greenlight Guru . As Michelle and Etienne discussed, the future of MedTech is driven by data and efficiency. Whether you are navigating the complexities of the EU AI Act or scaling your R&D, Greenlight Guru’s QMS (Quality Management System) and EDC (Electronic Data Capture) solutions provide the structured data foundation necessary to leverage AI effectively. By integrating quality and clinical data, Greenlight Guru helps you move from "reactive" compliance to "proactive" innovation. Feedback Call-to-Action We want to hear from you! How is your team currently leveraging AI in your regulatory or quality workflows? Are you feeling the "AI fatigue," or are you seeing the "salary premium" Michelle mentioned? Send your thoughts, guest suggestions, or specific questions to podcast@greenlight.guru . Etienne personally reads and responds to listener feedback, and we would love to feature your insights in a future episode.
October 20, 2025Episode 42922 min
#429: MedTech Regulatory Risk: Navigating the FDA During a Government Shutdown
This episode, hosted by Etienne Nichols, delves into the critical impact of a U.S. government shutdown on the medical device industry, specifically focusing on the Food and Drug Administration ( FDA ). Guest Michael Nilo, President and Principal Consultant of Nilo Medical Consulting Group and a former FDA Scientific Reviewer, offers an insider's perspective on which FDA functions halt and which remain active during a funding lapse. He clarifies that while the processing of new, user-fee-supported marketing applications like PMAs and 510(k)s typically stops, essential activities like active review of already-filed submissions, post-market safety surveillance, enforcement of recalls, and Investigational Device Exemption (IDE) reviews continue, drawing on existing user fee reserves. The discussion pivots to the significant slowdowns that occur, notably the suspension of non-MDUFA-goal-tied interactions, such as Q-submissions (Pre-Submissions) and most interactive reviews. For startups and small manufacturers, the halting of the crucial small business designation processing can be particularly detrimental, leading to astronomically higher user fees once the government reopens. Michael emphasizes that the industry should anticipate this political risk and plan submission timelines strategically, positioning a government shutdown as an "uncontrollable natural disaster" that requires proactive risk mitigation. Michael provides actionable advice for MedTech leaders to pivot during a shutdown. He recommends using the enforced delay to significantly improve the quality of submissions —making them easier to navigate and review once the FDA is fully operational—to gain a crucial advantage over the backlog of queued submissions. Furthermore, companies should utilize the time to focus on parallel activities such as process validation , refining quality systems, and strengthening commercial and reimbursement strategies. Michael stresses the importance of remembering the core mission: getting life-improving technologies to patients, and using any delay as an opportunity to emerge stronger and more prepared for commercial launch. Key Timestamps 1:45 - The initial effects of a shutdown: What truly stops at the FDA (new submissions) versus what keeps running (existing reviews, IDEs, post-market surveillance). 3:50 - Why active review of filed submissions continues—the role of the user fee "reserve." 5:58 - Critical functions that stop or slow down: Pre-submissions (Q-subs), interactive reviews, new policy guidance, and routine inspections. 7:25 - The major impact of halting the small business designation process on user fees for new manufacturers. 8:36 - MDUFA (Medical Device User Fee Amendments) explained: How user fees fund the FDA and maintain operations during a lapse. 11:51 - Direct effects on a MedTech company's runway and the loss of interactive review. 13:17 - Actionable advice: Improving submission quality for easier review to mitigate the post-shutdown backlog. 15:00 - Strategic pivot: Focusing on parallel work like process validation and quality system refinement. 16:03 - Communicating with investors and partners: Positioning the shutdown as an uncontrollable event and shortening the commercial launch gap. 18:50 - Looking ahead: Planning submissions around budget resolution deadlines to anticipate shutdown risk. 20:53 - Final advice: Keeping the patient-focused mission in mind and maximizing internal efforts. Quotes "Active review of device submissions, if you already had something in or you were smart enough, you saw the writing on the wall, you got it in on September 30, you’re good to go. Those will still keep going on schedule with and the FDA is going to try to meet their MDUFA goals..." - Michael Nilo "If yours stands out as being something that is easier to handle, makes it easier to process, they can navigate through it better, you have a better chance of getting a quicker, faster, better review process once it’s opened up." Takeaways Regulatory Strategy & Submission Quality: Use any government shutdown delay to drastically improve the navigability and clarity of your marketing submission (PMA, 510(k)). A well-organized, hyperlinked, and clear application will likely be processed faster by reviewers facing a post-shutdown submission backlog. Financial Risk & Small Business Designation: Small medical device manufacturers should anticipate potential government shutdowns and file their small business designation application well in advance. Failure to process this designation during a lapse can result in paying the full, significantly higher user fee, which dramatically impacts startup runway. Operations & Quality Focus: While regulatory submissions are stalled, pivot R&D and Quality teams to focus on parallel work streams. This includes advancing process validation , completing outstanding quality system activities (e.g., risk management file updates), and solidifying commercialization and reimbursement strategies. IDE Reviews Continue: Companies initiating clinical trials should note that Investigational Device Exemption (IDE) submissions are generally considered essential and will still be reviewed within the MDUFA 30-day timeline. This is one of the few submission types that allows for continued progress during a shutdown. Leverage User Fee Systems: Understand that the FDA's user fee structure ( MDUFA ) ensures that key pre- and post-market safety functions, as well as active review of existing applications, can be maintained for a period, acting as a crucial shock absorber for the industry. References Michael Nilo's LinkedIn Etienne Nichols' LinkedIn: Connect with Etienne MDUFA (Medical Device User Fee Amendments): The legislation that authorizes the FDA to collect fees from companies that submit certain marketing applications for medical devices, which funds a significant portion of the agency's device-related activities and performance goals. IDE (Investigational Device Exemption): An FDA process that allows a device that is not yet legally marketed to be used in a clinical study to collect safety and effectiveness data. IDE reviews are generally protected during a shutdown. MedTech 101 Section: User Fees and the MDUFA Buffer When the U.S. government shuts down, it means Congress hasn't passed a budget, and non-essential federal agencies must pause most operations because their taxpayer funding stops. However, the FDA has a financial safety net for its medical device work: User Fees , authorized by the Medical Device User Fee Amendments (MDUFA) . Think of MDUFA as a dedicated savings account funded by MedTech companies. When a company submits a major application like a 510(k) or PMA, they pay a fee. This money goes into a separate reserve. When a government shutdown happens, the FDA can tap into this reserve to keep essential, MDUFA-related work going. This includes the salaries of reviewers who are already working on your application, ongoing post-market surveillance, and crucial safety functions. The money acts as a buffer , allowing the FDA to continue its core mission for a limited time, which is why existing reviews aren't immediately halted. New submissions, however, often can't be processed because that intake and processing function is deemed non-essential and is not typically covered by the emergency user fee funding. Feedback Call-to-Action We thrive on your input! If this discussion about government shutdowns and MedTech strategy sparked any thoughts, or if you have a topic you'd like us to cover, we want to hear from you. Email us directly at podcast@greenlight.guru . We personally read every email and are committed to providing you with the most relevant and actionable MedTech insights. Sponsors This episode is brought to you by Greenlight Guru , the only MedTech-specific platform providing end-to-end solutions. Don't let a government shutdown pause your internal quality momentum. Leverage Greenlight Guru's eQMS and EDC solutions to keep your product development, design controls, and clinical data management moving forward, ensuring your systems are inspection-ready and helping you build a submission so flawless it cuts through the FDA's post-shutdown backlog. Visit www.greenlight.guru to learn more.
June 2, 2021Episode 21031 min
Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead
If you love learning and want to level up your medical device industry knowledge on topics such as audits, document management, design controls, risk management, and more, Greenlight Guru Academy is your education destination. In this episode of the Global Medical Device Podcast, Jon Speer invites colleagues Aaron Lucas, Training and Education Manager, and Jesseca Lyons, Operations and Enablement Guru, to join the show and explain to listeners what Greenlight Guru Academy is and how the eLearning platform is helping users around the world advance their medical device careers. Some highlights of this episode include: Greenlight Guru Academy is a learning management system (LMS) path that allows medical device gurus, customers, and others to share knowledge and educational content and courses to encourage retention and effectiveness. About six years ago, whenever a new customer would come on board with Greenlight Guru, it was a manual process. Fast forward to a few years later, Greenlight Guru Academy has made that process automatic and evergreen. Feedback from some of the thousands of Greenlight Guru Academy users who have completed the various courses help gauge success and types of content. Learner’s Mindset: I want to do the right thing. I want to make it better. I want to help someone, but it’s next to impossible to do. Demystify the medical device space, especially as the industry changes. Greenlight Guru Academy is for anyone getting started to veterans wanting to hone their skills in the medical device industry. Expect to see a lot more audit and inspection courses and content. Also, expect basic regulatory learning. Memorable quotes from this episode: “In the academy, we have all sorts of awesome courses - go at your own pace courses - on topics like document management, design controls, risk management, training, audits, and the list is going to continue to grow and evolve.” Jon Speer “Ultimately, the academy looks to really be this educational kind of beacon in the medical device industry for anything anyone could ever need to know from just getting started to a veteran looking to hone their skills.” Aaron Lucas “There’s something about the medical device industry that breeds these folks who don’t just recognize that they have to learn this stuff but they actually kind of like it.” Aaron Lucas “Why am I making a medical device in the first place? I want to help someone.” Jesseca Lyons “This is an opportunity to get a chance to really impact more and more people.” Jesseca Lyons Links: Aaron Lucas on LinkedIn Jesseca Lyons on LinkedIn Greenlight Guru Academy - Enroll Now About Greenlight Guru Academy FDA - Medical Devices International Organization for Standardization (ISO) 510(k) Premarket Notification European Union’s Medical Device Regulation (EU MDR) Risk Management True Quality Summit Series Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru
September 30, 2020Episode 16441 min
What is a Multiple Function Device?
What is a multiple function device? From a high level, it’s a product with at least one portion that meets FDA’s Code of Regulations’ (CFR) definition of a medical device and at least one other portion that does not. In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about multiple function devices to help listeners gain a clear understanding of this increasingly popular device type.
August 15, 2024Episode 37936 min
#379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer
In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Vernon Baker, a medical device guru, about key strategies for early-stage MedTech companies, particularly around implementing Quality Management Systems (QMS), supplier management, and compliance. Vernon shares his experience of transitioning from engineering to quality and regulatory roles, emphasizing the importance of being a "jack of all trades" when hiring early quality managers. They discuss how small companies can navigate the complexities of ISO 13485, supplier audits, and regulatory intelligence. This episode is a must-listen for startup founders and quality professionals seeking to establish a strong foundation in MedTech. Key Timestamps : [00:02] – Introduction: Etienne Nichols introduces the topic of early-stage MedTech QMS implementation and guest Vernon Baker. [04:30] – Vernon’s Background: From mechanical engineer to quality expert in MedTech. [13:00] – Wearing Many Hats: How early hires in quality roles manage multiple responsibilities in small companies. [22:10] – Supplier Management: The importance of supplier audits and choosing the right partners. [35:45] – Management Reviews & Communication: Aligning quality efforts with company goals. [47:00] – Regulatory Intelligence: Staying updated with regulatory changes and standards. [59:20] – Final Advice: Qualities to look for in an early-stage quality manager. Notable Quotes : “You don’t have to be an expert in everything, but you do need to know where to find the answers.” – Vernon Baker on managing quality systems. “A good management review should feel like a real conversation about the direction of the company, not just a checkbox exercise.” – Vernon Baker on management reviews. “Supplier management is critical in small organizations. You’re outsourcing a lot, and you need to vet and audit your suppliers well.” – Vernon Baker on supplier controls. Key Takeaways : MedTech Trends : Focus on Flexibility : Early hires in MedTech quality roles need to be adaptable, covering everything from product development to regulatory compliance. Supplier Audits Are Essential : Strong supplier management, including on-site audits, is vital to mitigate risks and ensure high-quality materials and components. Regulatory Intelligence : Regularly updating your team on changing regulations and standards is crucial for maintaining compliance and avoiding costly mistakes. Practical Tips : Leverage Consultants : For niche areas like biocompatibility and regulatory changes, hiring external consultants can provide critical insights. Invest in Training : Encourage your team to undergo formal training in ISO 13485, risk management, and process validation to build internal competency. Use Document Templates : Start with pre-existing QMS templates and refine them according to your company’s specific needs. References : ISO 13485 : The international standard for medical device quality management systems, which is essential for compliance in various jurisdictions. FDA Recognized Standards : Lists that guide device manufacturing and safety, critical for ensuring that products meet U.S. regulatory requirements. EU MDR : A sweeping update to European medical device regulations, requiring stricter quality and reporting standards. Connect with Etienne Nichols on LinkedIn for more insights into quality management in the MedTech industry: Etienne Nichols on LinkedIn MedTech 101 : QMS (Quality Management System) : A structured system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. For MedTech, this typically involves compliance with ISO 13485. Supplier Management : The process of vetting, auditing, and maintaining relationships with external suppliers to ensure they meet your quality and regulatory standards. Management Review : A formal meeting where top management reviews the performance of the QMS to ensure its effectiveness and alignment with business objectives. Questions for the Audience : How do you manage regulatory changes in your MedTech company? What tools or resources do you rely on most? What are your predictions for how supplier management will evolve with advancing technologies in MedTech? Let us know by emailing your thoughts to podcast@greenlight.guru ! Feedback : We’d love your feedback on this episode! Please leave us a review on iTunes, or send your thoughts and suggestions for future topics to podcast@greenlight.guru . Sponsor Message : This episode is brought to you by Rook Quality Systems , specializing in custom QMS solutions for MedTech startups. Rook helps streamline processes and ensure regulatory compliance. Visit rookqs.com to learn more and start building your ideal QMS today!
September 2, 2021Episode 22615 min
Meet a Guru: Maryann Mitchell
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 Medical Device Success Platform (MDSP) to better understand their product and business needs and how Greenlight Guru's MDSP solution can help them achieve ultimate success. Some of the highlights of this episode include: Maryann’s background is in quality systems initiatives, and she has extensive experience with ISO 13485. She loves being a part of audits and truly enjoys defending quality systems. While Maryann has been through numerous ISO 13485 audits, she has experienced only a few FDA inspections. She explains that there’s a whole different level of terror when it comes to the FDA. Maryann was attracted to joining the Greenlight Guru team because of her interest in quality system software. She wanted to help the company sell its software and connect with customers and medical device companies. Maryann shares some of her favorite stories working with companies trying to evaluate their options for quality systems. The best part is customers’ positive reactions during design control matrix and risk matrix demonstrations. The benefits of Greenlight’s QMS include the ability to quickly and easily find and access visually appealing information and data. Ultimately, it helps people get through audits faster and be in compliance. However, Maryann explains how and why EU MDR continues to be a challenge for medical device companies. Compiling records and evidence for submission as well as interconnectivity are just some of the bigger quality issues. If the FDA transitions to the 13485 standard, Maryann believes the medical device industry shouldn’t panic but anticipate it. It would be better to have a harmonized way of auditing and inspecting companies. Memorable quotes from Maryann Mitchell: “I’ve lived and breathed the 13485, 820, all those fun standards, which I love. It’s really exciting and I love being in audits.” “There’s a whole different level of terror when it comes to the FDA, but it was really exciting to be there. Thankfully, I wasn’t in the hot seat for those, but I was in the front room to participate.” “Not just during an audit, but for your own internal quality, it’s just so much easier when your systems are connected, and that’s exactly what Greenlight offers to our customers.” “You should always be audit ready.” Links: Maryann Mitchell on LinkedIn ISO 13485 - Medical Devices FDA Inspections European Union’s Medical Device Regulation (EU MDR) Meet a Guru - Sara Adams Meet a Guru - Taylor Brown Greenlight Guru Academy The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru
June 9, 2021Episode 21228 min
How Mindset Training Can Help Your Team Operate at Peak Performance
Close your eyes, take a deep breath in, and imagine your team operating at peak performance, exceeding goals and each member feeling and working at their best. Now, breathe out, letting out a sigh of relief knowing that's fully within the realm of possibility — through mindset training. In this episode of the Global Medical Device Podcast, Jon Speer talks to Kevin Bailey, mindset coach and founder of Dreamfuel, a mindset coaching solution for high growth companies. Kevin is the mindset coach for Greenlight Guru and has worked with Jon and Greenlight Guru employees over the years by providing mindfulness tools and techniques that teams can use to improve overall mindset . Listen to what Jon has learned from this mindset training and how the medical device community , too, can benefit from engaging in mindset practices at work. Some highlights of this episode include: Being the CEO of a high-growth startup proved to take a whole other level of work that required mental strength and resilience. Kevin used mental models to reframe experiences and have a more positive attitude while leading people. CEO Cues: Feeling motivated or burnt out? How is the business doing? People follow their leaders and want to boost productivity and camaraderie. Working with Kevin from Dreamfuel has changed the world for Jon and his colleagues, as well as other companies trying to do great things, make a difference, and feel better. Mindset is an important practice for success in a company. About 95% of thoughts are subconscious and automatic, like a heartbeat. Also, 70-80% of those thoughts and actions are negative, disempowering, limiting beliefs. A measurable difference, consistency, and alignment of peak performance can be achieved by companies, executives, and staff via neuroscience principles. The stigma around meditation is stopping people who need it from doing it. What’s the goal? There’s no outcome you are going for in meditation. Acknowledge and let go of thoughts spinning in your mind because dopamine (pleasure) and serotonin (joy, happiness, and presence) create a balanced mind. Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, and what you do. If you can control your physiology, it’s easier to control your thinking and behaviors. Breathe rhythmically and smoothly. Memorable quotes by Kevin Bailey: “Mindset is such an important practice for success in a company.” “We’re trying to kind of take these practices that have been utilized for ions to help people be happier and perform better, wrap them with some neuroscience, so that people can accept and understand them, but there’s still that stigma.” “There’s no outcome you’re going for in meditation. You purely do meditation to do meditation.” “Your breath controls your physiology, and your physiology heavily influences how you feel, how you think, what you do.” Links: Kevin Bailey on LinkedIn Dreamfuel Coaching Dr. Diane Powell Why Greenlight Guru Rewards Employees Who Get the Best Sleep The Beatles’ Meditation Coach - Maharishi Mahesh Yogi Breath by James Nestor Greenlight Guru Academy The Greenlight Guru True Quality Virtual Summit Greenlight Guru YouTube Channel MedTech True Quality Stories Podcast Greenlight Guru
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