Square-1 Engineering's managing director Travis N. Smith shares the details of how Southern California's medical device industry got its start and the history which led us to present day!
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In this episode of Medtech Snapshot we're joined by Quality Executive Robert Lahaderne to talk Root Cause Analysis (RCA)! Hear how Robert shares his perspective on the impact Root Cause makes to a medical device organization when it is done correct versus when it is done incorrectly and how rushing through FMEAs and hazard analysis creating unnecessary challenges down the road. Medtech Snapshot features Fastwave Medical's CEO Scott Nelson sharing insights on the impact of using the 'sales funnel' process for medical device fundraising purposes. Listen how Scott's approach to fundraising starts off by casting a wide net via branding and mission/ story telling efforts then intentionally narrows the funding field to a smaller audience of potential investors which are aligned with his company's mission. Medtech Snapshot returns with an enticing debate as RAQA medtech industry experts Stephanie Rallis-Daw, RAC, CQE, CMDA and Robert Lahaderne, MBA spar on the topic of "When starting a new job/ project, what is the most common medtech compliance shortfall you can expect to encounter at your new company?" Medtech Snapshot features Peman Montazemi, CTO - explaining how he's overcome some of the biggest software development challenges for medical device applications. In this Medtech Snapshot episode we feature Nidus Biomedical COO Glen Rabito talking through the five considerations to keep product development moving forward, especially in the early phases of development. Medtech Snapshot episode features Seth A. Kaufman, MSHCA as he shares his insights on the best way to land a great clinical research organization (CRO) partner - before you need their help! Hear how Seth outlines his engagement process, things to watch out for and ways to approach your trials with your new partnership. In this 2-part series of Medtech Snapshot we're joined by Square-1 Engineering Director of Delivery & Operations Trisha Aure as she walks us through the highlights of our article 'FDA Announcement: 21 CFR 820 and ISO 13485 Guidance' Hear the areas where 21 CFR 820 differs most from ISO 13485 and what this means for medical device OEMs. Part-2 of this series will cover the process to transition and key considerations when doing so. This 3-part series of Medtech Snapshot features Jeff Gable, medtech embedded software SME. In part-3 Jeff dives further into strategies for developing design requirements and how staying away from 'TBD requirement' data is advisable. Hear how flushing out requirements to their full level of detail is vital, while establishing appropriate traceability processes in tools like Matrix or Jama will keep you organized and moving your team and project forward. Medtech Snapshot - Agile and NPD episode part-2 of 3 features Jeff Gable, embedded software SME, diving in on Agile and NPD activities. Jeff walks us through his strategy for Agile development with FDA design controls, specifically within the design input phase. Hear the first two steps of his four step approach. This episode of Medtech Snapshot features our good friend Jeff Gable, medtech embedded software SME, diving in on Agile and NPD activities. Jeff walks us through his strategy for Agile development with FDA design controls, specifically within the design input phase. Hear Jeff's 4 step approach and how a tight feedback loop is critical between requirements and system design/ architecture. Medtech Snapshot presents Rodney Brenneman, medtech start-up exec, who shares his winning strategy on what is needed from a leadership perspective in order to propel a pre-clinical company forward. Hear how emotional intelligence, adaptability and long-term strategies make the difference! ABOUTThe Medtech Snapshot Podcast, hosted by Square-1 Engineering's managing director Travis Smith, is a 1 question, 1 answer podcast digest featuring medical device industry executives offering quick insights into a variety of medtech topics including running start-ups, funding, product development, finance, clinicals, manufacturing and much more. ArchivesCategories
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White Papers &PubsThe History of Southern California Medical Device
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