MedTech Crossroads – Details, episodes & analysis

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

Local and National Events: / MedTech Innovator application deadline / FDA Electromagnetic Compatability (EMC) for IVD Webinar / A2 BioSocial / MD&M West / FDA Application of AI and Machine Learning for Precision Medicine Webinar / UM's Biomedical Innovation 101 / MichBio IP and Legal Expert Virtual Coffee Break / RAPS SaMD webinar / RAPS Cybersecurity conference / MichBio Legislative Fly-In / RAPS MDR by the Numbers webcast / MedTech Strategist Innovation Summit / AdvaMed 510(k), IDE, and PMA Submissions Workshops / Project MedTech Midwest Showcase / AdvaMed The MedTech Conference / Project MedTech Startup Symposium / RAPS AI Summit  / HFHS The Eye, The Chip, and the Auto

FDA and Industry News:

/ You did what? FDA reports on 2022 medical device numbers We recap CDRH's 2022 year end report and discuss some of the implications for our MedTech community.

/ Getting high on the priority list... changing cannabinoid regulations Turns out citizen petitions to FDA can get things moving. But is the direction a good one or a bad one? This remains to be seen. We discuss the process that FDA is going through on CBD products with wider implications for the whole MedTech and food ecosystem.

Interview:

/ Maci Gilmore - Senior Project Specialist - MEDC What does it take to present at a tradeshow? MEDC took a trade delegation to the MEDICA tradeshow in Dusseldorf Germany in November 2022 and we got a chance to participate. Join us for the 3rd installment of our coverage of one of the largest medtech tradeshows in the world. Maci was responsible for the booth, and takes us on a tour.

FDA and Industry News:

/ GUDID by the Numbers! The UDI system is ramping up and shows no signs of letting up. This long-time-coming system is well underway.

----- 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!

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE

Photobiomodulation, also call LLLT, is a thing now, and FDA has issued draft guidance to deal with it. Not a lot of surprises here on the basic asks, but get ready for detailed expectations surrounding clearance. All this and our interview with Stephen Rapundalo of MichBio on the tradeshow floor of MEDICA in Dusseldorf Germany!

Chapters: Intro Local and National Events Seeing Red (Light)? FDA and Photobiomodulation Interview: Stephen Rapundalo - CEO - 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 in2being: https://www.in2being.com MTC Landing Page: https://www.in2being.com/medtech-crossroads

MichBio: https://michbio.org/ MEDC: https://www.michiganbusiness.org/ FDA LLLT Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/photobiomodulation-pbm-devices-premarket-notification-510k-submissions

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE

Just when you think things have become static... the FDA landscape just might change. And when FDA reclassifies devices, opportunities emerge. All this as well as our interviews with Brendan Cherry, international trade manager for MEDC, and the companies of #teammichigan at the MEDICA tradeshow in Dusseldorf Germany.

PLEASE NOTE: With our apologies, the audio for this episode was inadvertently dropped for the first few minutes. We pick up where the audio begins.

Chapters Local and National Events Opening new doors: 8 new FDA reclassifications create opportunities Interviews: Michigan Companies Attending MEDICA Interview: Brendan Cherry - International Trade Manager - MEDC

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/

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE

Molly McCarthy - US Industry Leader for Health Providers and Plans - Microsoft interview from the MedHealth Summit at Ford Field. Also, we test drive the FDA's digital health policy navigator! All this and a refresher on FDA’s CDRH Learn and new risk modules.

Chapters

Intro

Local and National Events

"How do I...?" A refresher on CDRH Learn and new Risk Modules!

Gene's LIVE test drive of the FDA Digital Health Policy Navigator!

Interview: Molly McCarthy - US Industry Leader for Health Providers and Plans - Microsoft

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

Molly McCarthy LinkedIn Profile: https://www.linkedin.com/in/mollykmccarthy/

MedHealth: https://medhealthinnovation.org/

MEDC: https://www.michiganbusiness.org/

FDA:

https://www.fda.gov/training-and-continuing-education/cdrh-learn

https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-policy-navigator

CONTAINS NEITHER LEGAL NOR MEDICAL ADVICE