Global Medical Device Podcast Powered By Greenlight Guru podcast

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with regulatory expert Dr. Mike Drues to demystify the pre-market approval (PMA) process for medical devices. They delve into the key differences between PMAs, 510(k)s, and de novos, bust common myths, and explore strategic advantages for companies willing to pursue the rigorous PMA pathway. Mike explains the nuances of the “six-year rule,” alternatives like the humanitarian device exemption (HDE), and the evolving role of clinical data. With insights on using PMAs as a competitive strategy and overcoming internal resistance to high-risk device development, this discussion is essential for MedTech innovators looking to turn regulatory challenges into opportunities. Key Timestamps: 00:00 – Intro and Greenlight Guru's Quality Management System software sponsor message 03:15 – Introduction to Dr. Mike Drues and his background in PMAs 05:45 – Overview of PMAs and when they should be used 11:30 – Are PMAs the only pathway for Class 3 devices? 16:20 – Types of PMAs: Traditional, Modular, and Streamlined 22:40 – Advantages of PMAs compared to 510(k)s and de novos 27:50 – The strategic use of predicates in the PMA process 33:00 – Clinical data requirements and misconceptions for PMAs 41:10 – Post-market requirements and differences for PMA devices 47:25 – Innovation and the future of PMAs: Six-year rule and potential EU approvals 54:30 – Final thoughts on overcoming industry resistance to PMAs Standout Quotes: "Don't be afraid of the big bad PMA—often, the regulatory burden is justified for complex devices tackling high-risk conditions." – Dr. Mike Drues "Regulatory professionals know the rules; the best ones know the exceptions. When it comes to PMAs, there are more options than many realize." – Dr. Mike Drues 3 Key Takeaways: PMA Isn’t the Only Path for Class 3 Devices: Companies can consider alternatives like the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP) to reduce the regulatory burden. Strategic Use of PMAs Can Provide a Competitive Edge: By choosing the PMA route, companies can create barriers for competitors, potentially driving smaller rivals out of the market. Clinical Data Isn’t Always Mandatory for PMAs: While most PMAs involve clinical trials, there is flexibility in requirements, offering an opportunity to minimize the scope and cost of clinical studies. References: Previous Greenlight Guru Webinars by Dr. Mike Drues Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 101: PMA Pathway Explained – Pre-market approval (PMA) is the FDA's strictest regulatory pathway, typically reserved for Class 3 medical devices with higher risks. Unlike the 510(k) pathway, PMA requires evidence of safety and efficacy, often through clinical trials, but the scope can vary. There are traditional, modular, and streamlined PMA types, each with unique requirements. Audience Engagement: Poll Question: "Have you considered using a PMA as a strategic advantage for your MedTech device? What challenges do you anticipate?" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

Global Medical Device Podcast powered by Greenlight Guru

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#393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko 33:48

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In this episode of the Global Medical Device Podcast, Etienne Nichols talks with Justin Bushko, president of Concise Engineering and founder of MedTech Man. Justin shares his extensive experience in MedTech, guiding startups and major players alike through complex engineering challenges. From simplifying prototypes to pivoting product strategies, Justin emphasizes the importance of clear user needs, iterative testing, and knowing when to focus or adapt. Whether you’re an early-stage founder or an industry veteran, this conversation is filled with insights on navigating design, reducing costs, and succeeding in MedTech’s complex regulatory landscape. Key Timestamps: 00:00 – Introduction and Greenlight Guru sponsor message 02:45 – Welcoming Justin Bushko; background in MedTech and engineering 07:20 – Overcoming early-stage engineering challenges, like autoclave and sterility testing 10:45 – Prototyping with a purpose: Ensuring design iterations target risks 16:00 – Balancing innovation, user needs, and cost-effectiveness 20:30 – Defining essential versus “nice-to-have” features in MedTech 26:45 – Strategic pivots in MedTech: When and why to change course 32:50 – The critical role of design freeze and usability studies 39:10 – Lessons from competitive benchmarking and reverse engineering 46:25 – Handling unique challenges in regulated industries like MedTech 52:15 – Opportunities for MedTech innovation and faster regulatory approvals 58:45 – Advice for founders and importance of building the right team Standout Quotes: "Prototype with purpose: Focus on the biggest risks and test early to eliminate costly mistakes down the road." – Justin Bushko "MedTech is a complex dance of regulation, innovation, and simplicity—knowing when to add and when to strip away is key to success." – Justin Bushko 3 Key Takeaways: Test Prototypes with a Purpose: Focus on high-risk areas and essential features early to prevent costly mistakes in later stages. Simplicity is Often the Key: Resist the urge to over-engineer; clarify core features and eliminate unnecessary ones to save on costs and improve usability. MedTech Requires Unique Knowledge: Navigating regulations, usability studies, and design iterations requires industry-specific experience and collaboration. References: Connect with Justin Bushko on LinkedIn Greenlight Guru’s QMS Software Etienne Nichols’ LinkedIn MedTech 101: Formative vs. Summative Usability Testing – Formative testing occurs early in the design process to gather feedback and iterate quickly, while summative testing is conducted later to validate that the design meets user needs and regulatory requirements. Audience Engagement: Poll Question: "Have you ever had to pivot your MedTech product development strategy due to user feedback or regulatory hurdles? Share your story below!" Feedback: We’d love to hear from you! Share your thoughts on this episode, or suggest topics you’d like covered. Email us at podcast@greenlight.guru and don’t forget to leave a review to help others find us.…

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