MEDC and MichBio partnered up on a brand new index of medical device and supporting firms in the State of Michigan! Join us on the show floor at MD&M West in Anaheim as Mark Ignash, Senior Sector Development Director for MEDC takes us on a tour and then discusses this new resource with Stephen Rapundalo, CEO of MichBio.

Chapters Intro Local and National Events How Do You Catch a 1200 Pound Medical Device? Updated News on Philips CPAP/BiPAP Recall Delaying MDR... It's "EU Official" Interview: Mark Ignash - MEDC and Stephen Rapundalo - MichBio

Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Listen at your leisure, or join us LIVE Fridays at 2-3 PM ET!

MTC Playlist on YouTube: https://youtube.com/playlist?list=PLlV9Zv0XJRlZAnOXVF70SERfATrpuaKFY MTC Playlist on Spotify: https://open.spotify.com/show/0I1MeKuWi2pZizCSWGsAjh?si=de5952b861ef4e6e

MTC Playlist on Apple Podcasts: https://podcasts.apple.com/us/podcast/medtech-crossroads/id1673797787

MTC Playlist on Google Play: https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkLnBvZGJlYW4uY29tL21lZHRlY2hjcm9zc3JvYWRzL2ZlZWQueG1s in2being: https://www.in2being.com MTC Landing Page: https://www.in2being.com/medtech-crossroads

Mark Ignash LinkedIn: https://www.linkedin.com/in/mignash/ Stephen Rapundalo LinkedIn: https://www.linkedin.com/in/rapundalo/

MEDC: https://www.michiganbusiness.org/ MichBio: https://www.michbio.org Motion Dynamics: https://motiondc.com/

FDA: https://www.fda.gov/medical-devices/medical-device-recalls/ge-healthcare-recalls-nuclear-medicine-600800-series-systems-risk-detector-fall-may-injure-patients https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due

RAPS: https://www.raps.org/news-and-articles/news-articles/2023/2/european-parliament-votes-to-extend-mdr-transition

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE

EPA says that ethylene oxide sterilization is bad and dangerous as we reported last week. But as we mentioned, the risks may not be well quantified - and the crackdown may be keeping needed medical devices out of doctors hands. This week Gene sat down with Kelli Jonas, VP of Quality and Regulatory for MediSurge to talk about the ethylene oxide dilemma from the perspective of a manufacturer working hard to provide needed medical devices to doctors.

Chapters Intro Local and National Events Here it comes: the industry pushback on FDA's Clinical Decision Support Software (CDSS) Guidance Big diagnostics firms are struggling FDA DO NOT USE: Skippack COVID Test Just the facts: 3rd party FDA clearance by the numbers Interview: Kelli Jonas - MediSurge Comparison of 3rd party times to FDA 510(k) times

Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Listen at your leisure, or join us LIVE Fridays at 2-3 PM ET!

MTC Playlist on YouTube: https://youtube.com/playlist?list=PLlV9Zv0XJRlZAnOXVF70SERfATrpuaKFY MTC Playlist on Spotify: https://open.spotify.com/show/0I1MeKuWi2pZizCSWGsAjh?si=de5952b861ef4e6e in2being: https://www.in2being.com MTC Landing Page: https://www.in2being.com/medtech-crossroads

MTC Prior Episode on EtO: https://www.youtube.com/watch?v=g_r66v2QnCM&t=1294s MTC Prior Episode on CDSS: https://youtube.com/live/lQNCxGomT0k

Kelli Jonas LinkedIn Profile: https://www.linkedin.com/in/kelli-jonas-b9697914 MediSurge: https://www.medisurge.com/ FDA: https://www.fda.gov/about-fda/cdrh-transparency/510k-third-party-performance-metrics-and-accreditation-status https://www.fda.gov/medical-devices/medical-device-recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not MedTech Dive: https://www.medtechdive.com/news/diagnostics-companies-restructure-GS-HLTH-NEO-NVTA-WGS-NTRA-LMDX-VCYT-GH-CDNA-MYGN-EXAS/642145/ https://www.medtechdive.com/news/pushback-fda-clinical-decision-support-guidance/642297/ Ontogen MedTech: https://www.ontogenmedtech.com/news-articles/how-long-does-510k-approval-take-2021

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE

We rely on medical sterilizers to prepare the products that we design and that so many doctors and patients rely on. But are these sterilization services creating health problems for their communities? EPA says yes, others say no. All this as well as our interview with Carl Sturm of PSPS Business Abroad at the MEDICA tradeshow in Dusseldorf Germany. Carl knows all about lead generation, so if you are thinking of attending a trade show and don't know about lead generation... tune in!

Chapters Intro Local and National Events "Like Theranos, but it works" The Bridge: A New West Michigan MedTech Incubator Are Medical Device Sterilizers Poisoning Local Communities? Too Good (Rx) to be True? Interview: Carl Sturm - PSPS Business Abroad

Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Listen at your leisure, or join us LIVE Fridays at 2-3 PM ET!

MTC Playlist on YouTube: https://youtube.com/playlist?list=PLlV9Zv0XJRlZAnOXVF70SERfATrpuaKFY MTC Playlist on Spotify: https://open.spotify.com/show/0I1MeKuWi2pZizCSWGsAjh?si=de5952b861ef4e6e in2being: https://www.in2being.com MTC Landing Page: https://www.in2being.com/medtech-crossroads

MEDC: https://www.michiganbusiness.org/ PSPS: https://psps-ba.nl/en/ TechCrunch: https://techcrunch.com/2023/02/01/ftc-slaps-online-pharmacy-goodrx-for-sharing-users-health-data-with-facebook-and-google/ AdvaMed: https://www.advamed.org/wp-content/uploads/2023/01/2023-01-18-letter-to-the-President-on-EtO-January-2023-final.pdf MedTech Dive: https://www.medtechdive.com/news/boston-scientific-sterigenics-start-tracking-ethylene-oxide-emissions-EPA/617485/ https://www.medtechdive.com/news/sterigenics-reaches-408m-ethylene-oxide-settlement-to-resolve-hundreds-of/640135/ Stanford Daily: https://stanforddaily.com/2023/01/20/stanford-researchers-theranos-that-works/ Michigan Business Network: https://www.michiganbusinessnetwork.com/blog/michigan-business-beat-spartan-innovations-and-health-innovation-partners-discuss-startup-office-incubator-the-bridge-on-medical-mile-in-grand-rapids

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE