MedTech Impact Partners

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🌍 Ghana is making strides in the MedTech arena! 🔍 Companies outside the US can benefit from Ghana's regulatory process: 1️⃣ Align with US FDA SaMD regulations. 2️⃣ Compare classifications and optimize testing timelines. 3️⃣ Study recalls and warnings for risk insights. 4️⃣ Keep Ghana's staffing in mind for realistic timelines. 📚 Explore FDA Ghana: fdaghana.gov.gh #MedTech #Innovation #Regulation #Ghana

For those of you following news on the FDA’s Center for Devices and Radiological Health (CDRH), you may have seen Steve Silverman’s recent article on major changes in leadership. He shares an addendum to that opinion— “After the article published, FDA announced the selection of Dr. Michelle Tarver, MD, PhD as the new CDRH Director. The addendum highlights 3 results of this decision: current CDRH initiatives will continue; CDRH will focus on core regulatory responsibilities; and regulatory conversations will change.” #fda #medtechupdates #regulatory #industryinaights

*Complimentary* MedTech Event on Monday, November 18th in Houston, Texas in the world's largest medical center of the Texas Medical Center. Creatively, this event is called: Houston MedTech Join us on Monday, November 18th for Houston MedTech, an event that brings MedTech professionals to #Houston while highlighting what #Houston has to offer to those coming from out of town. Complimentary registration: https://lnkd.in/et6Y-Z8q The Basic Details... * Sponsor: Goodwin and Lifeblood * Registration Form: https://lnkd.in/et6Y-Z8q * Date: Monday, November 18th 2024 * Time: 12:00 – 8:00pm (CDT) * Location: Levit Green, Houston, Texas * Maximum Capacity: 250 * Nearby hotel accommodations: --> Home2 Suites by Hilton Houston Medical Center, TX --> Hilton Garden Inn Houston Medical Center, TX THE AGENDA...Oh, and we have live music, drinks, and food * 12:00 – 12:50pm: Doors open for mingling * 12:50 – 1:00pm: Opening remarks: Martin Gomez and Giovanni Lauricella * 1:00 – 2:00pm: How and Why Corporate Strategics Buy Startups?: Nick Benson, Jason Topolosky, David McDonough * 2:00 – 2:30pm: Crossing the Biotech-MedTech Chasm: David St. Denis * 2:30 – 2:45pm: Academindustry? Transitioning from Research to Business: Lindsey Cauthen, Ph.D. * 2:45 – 3:00pm: The 3B Model – From Bench to Business to Bedside: Maarten Rotman, Ph.D. * 3:00 – 3:15pm: Medical Device (MD) Anderson?: Jean K. Gilbert * 3:15 – 3:45PM: Freedom to Operate Isn’t Free…It’s Avoided? Martin Gomez * 3:45 – 4:00pm: Networking Break * 4:00 – 5:00pm: What is Going on in MedTech Right Now – A View on Fundamentals and Capital Markets: David Roman * 5:00 – 5:30pm: Networking Break * 5:30 – 6:45pm: MedTech Stakeholders…The Full-Spectrum Perspective (See below for details) * 6:45 – 7:00pm: 2025 Outlook for MedTech in #Houston: Emily Reiser * 7:00 – 8:00pm: Networking with Drinx, Live Music, and Fire Places The panel details: MedTech Stakeholders…The Full-Spectrum Perspective * Moderator: (Houston) Giovanni Lauricella * Strategic Acquirer: (Illinois) David McDonough * FDA: (California) Kwame Ulmer * Entrepreneur: (Houston) Meagan R. Pitcher, Ph.D. * Physician: (Houston) Mas Takashima, MD, FACS, FAAOA * Board Member: (Arizona) Michael Nagel * Investor: (Houston) John Nghiem * Hospital Venture Arm: (North Carolina) Evan Bernath * Academic Research Partner: (Houston) Homer Quintana * Industry Partner: (Minnesota) Nathan Piland, M.Eng, MBA * Patient: (Houston) Cody Jorgensen You haven't registered already? There is 250 maximum spots to attend and as of today we are more than half spoken for. Giddy up...Complimentary registration: https://lnkd.in/et6Y-Z8q

📰 Hot off the press! ♨️ We've released MedTech Impact Partners' October Newsletter where we discuss the latest updates from the FDA, share our recap of The MedTech Conference, and MedTech Color's Networking Breakfast. 💻 Plus, we don't want to miss an upcoming webinar celebrating Hispanic trailblazers who are leading innovators in medtech (TODAY at 11:30 PT). https://lnkd.in/gTJUjEaJ #medtech #newsletter #regulatoryinsights #fdaupdates #webinar #diversityinmedtech #industryinsights

Join us on Monday, November 18th where Kwame Ulmer, Ex-FDA, Managing Partner of MedTech Impact Partners, and Venture Partner for Wavemaker Three-Sixty Health, will be contributing to Houston MedTech, an event that brings MedTech professionals to #Houston while highlighting what #Houston has to offer to those coming from out of town. Complimentary registration: https://lnkd.in/eqEz-qP5 The Basic Details... * Sponsor: Goodwin and Lifeblood * Registration Form: https://lnkd.in/eqEz-qP5 * Date: Monday, November 18th 2024 * Time: 12:00 – 8:00pm (CDT) * Location: Levit Green, Houston, Texas * Maximum Capacity: 250 * Nearby hotel accommodations: --> Home2 Suites by Hilton Houston Medical Center, TX --> Hilton Garden Inn Houston Medical Center, TX THE AGENDA...Oh, and we have live music, drinks, and food * 12:00 – 12:50pm: Doors open for mingling * 12:50 – 1:00pm: Opening remarks: Martin Gomez and Giovanni Lauricella * 1:00 – 2:00pm: How and Why Corporate Strategics Buy Startups?: Nick Benson, Jason Topolosky, David McDonough * 2:00 – 2:30pm: Crossing the Biotech-MedTech Chasm: David St. Denis * 2:30 – 2:45pm: Academindustry? Transitioning from Research to Business: Lindsey Cauthen, Ph.D. * 2:45 – 3:00pm: The 3B Model – From Bench to Business to Bedside: Maarten Rotman, Ph.D. * 3:00 – 3:15pm: Medical Device (MD) Anderson?: Jean K. Gilbert * 3:15 – 3:45PM: Freedom to Operate Isn’t Free…It’s Avoided? Martin Gomez * 3:45 – 4:00pm: Networking Break * 4:00 – 5:00pm: What is Going on in MedTech Right Now – A View on Fundamentals and Capital Markets: David Roman * 5:00 – 5:30pm: Networking Break * 5:30 – 6:45pm: MedTech Stakeholders…The Full-Spectrum Perspective (See below for details) * 6:45 – 7:00pm: 2025 Outlook for MedTech in #Houston: Emily Reiser * 7:00 – 8:00pm: Networking with Drinx, Live Music, and Fire Places The panel details: MedTech Stakeholders…The Full-Spectrum Perspective * Moderator: (Houston) Giovanni Lauricella * Strategic Acquirer: (Illinois) David McDonough * FDA: (California) Kwame Ulmer * Entrepreneur: (Houston) Meagan R. Pitcher, Ph.D. * Physician: (Houston) Mas Takashima, MD, FACS, FAAOA * Board Member: (Arizona) Michael Nagel * Investor: (Houston) John Nghiem * Hospital Venture Arm: (North Carolina) Evan Bernath * Academic Research Partner: (Houston) Homer Quintana * Industry Partner: (Minnesota) Nathan Piland, M.Eng, MBA * Patient: (Houston) Cody Jorgensen You haven't registered already? There is 250 maximum spots to attend and as of today we are more than half spoken for. Giddy up...Complimentary registration: https://lnkd.in/eqEz-qP5

It’s #official! Congratulations are in order for Michelle Tarver, MD, PhD! She was named Director of FDA’s Center for Devices and Radiological Health today. Tarver replaces longtime leader Jeff Shuren who stepped down this summer. #medtechleadership #FDA #MTCmember #MedTechColor #femaleleaders #diversifyingmedtech

This week, I'm joining more than 200 colleagues for the 2024 Global CEO Summit hosted by JLABS at NYSE; an event designed to facilitate connections between leaders, entrepreneurs, and investors. Happy to be part of a great group of business and science leaders who share a common goal of leveraging deep expertise to bring early-stage innovations to commercialization in an effort to solve the world's toughest healthcare challenges. #johnsonandjohnson #jandjboardfellow #medtech #thoughtleadership #nyse #jlabs #ceo #ceosummit #healthcaresolutions MedTech Impact Partners

Join us on Monday, November 18th where Kwame Ulmer, Ex-FDA, Managing Partner of MedTech Impact Partners, and Venture Partner for Wavemaker Three-Sixty Health, will be contributing to Houston MedTech, an event that brings MedTech professionals to #Houston while highlighting what #Houston has to offer to those coming from out of town. Complimentary registration: https://lnkd.in/eqEz-qP5 The Basic Details... * Sponsor: Goodwin and Lifeblood * Registration Form: https://lnkd.in/eqEz-qP5 * Date: Monday, November 18th 2024 * Time: 12:00 – 8:00pm (CDT) * Location: Levit Green, Houston, Texas * Maximum Capacity: 250 * Nearby hotel accommodations: --> Home2 Suites by Hilton Houston Medical Center, TX --> Hilton Garden Inn Houston Medical Center, TX THE AGENDA...Oh, and we have live music, drinks, and food * 12:00 – 12:50pm: Doors open for mingling * 12:50 – 1:00pm: Opening remarks: Martin Gomez and Giovanni Lauricella * 1:00 – 2:00pm: How and Why Corporate Strategics Buy Startups?: Nick Benson, Jason Topolosky, David McDonough * 2:00 – 2:30pm: Crossing the Biotech-MedTech Chasm: David St. Denis * 2:30 – 2:45pm: Academindustry? Transitioning from Research to Business: Lindsey Cauthen, Ph.D. * 2:45 – 3:00pm: The 3B Model – From Bench to Business to Bedside: Maarten Rotman, Ph.D. * 3:00 – 3:15pm: Medical Device (MD) Anderson?: Jean K. Gilbert * 3:15 – 3:45PM: Freedom to Operate Isn’t Free…It’s Avoided? Martin Gomez * 3:45 – 4:00pm: Networking Break * 4:00 – 5:00pm: What is Going on in MedTech Right Now – A View on Fundamentals and Capital Markets: David Roman * 5:00 – 5:30pm: Networking Break * 5:30 – 6:45pm: MedTech Stakeholders…The Full-Spectrum Perspective (See below for details) * 6:45 – 7:00pm: 2025 Outlook for MedTech in #Houston: Emily Reiser * 7:00 – 8:00pm: Networking with Drinx, Live Music, and Fire Places The panel details: MedTech Stakeholders…The Full-Spectrum Perspective * Moderator: (Houston) Giovanni Lauricella * Strategic Acquirer: (Illinois) David McDonough * FDA: (California) Kwame Ulmer * Entrepreneur: (Houston) Meagan R. Pitcher, Ph.D. * Physician: (Houston) Mas Takashima, MD, FACS, FAAOA * Board Member: (Arizona) Michael Nagel * Investor: (Houston) John Nghiem * Hospital Venture Arm: (North Carolina) Evan Bernath * Academic Research Partner: (Houston) Homer Quintana * Industry Partner: (Minnesota) Nathan Piland, M.Eng, MBA * Patient: (Houston) Cody Jorgensen You haven't registered already? There is 250 maximum spots to attend and as of today we are more than half spoken for. Giddy up...Complimentary registration: https://lnkd.in/eqEz-qP5

While I am now living #LATechWeek and #BioscienceLAWeek vicariously from afar, I was delighted to be able to make it to The MedTech Conference #MTC24 to join AdvaMed and other friends and collaborators for the biggest medtech gathering in the US – so big, we had to move it to Canada this year! Highlights of the day, in no particular order: - joining Kwame Ulmer, Katrina Holland, Cheyne Stennis, Danielle Arellano, and the rest of the MedTech Color team for an incredible reception, just moments after MTC pitch alum Maria Artunduaga, MD, MPH, MTM won the MedTech Innovator pitch competition - did I mention that Maria of Samay won MedTech Innovator? I was glad I was able to get here in time to see all the pitches, catch a bit of last year’s winner Alex Ballatori, and say hi to Paul Grand, Kathryn Zavala, Brian Benson, Ayelet Marom , Ph.D., PPM, Daphne Radfar, and Jerry Ciolino, who make MTI the biggest and best healthtech accelerator in the world - catching up with my UCLA Anderson School of Management classmate Olivier Lauzeral, who is killing it with iNAP Sleep (also part of the MedTech Innovator program) - talking #MedTechCon, #HLTHUSA, #RPM, and more with Lisa Carmel and Joseph Ferrara - spending time comparing innovation, governance, and “things we wish we learned in b-school” with another #UCLAAndersonAlumni Derek Herrera and the ever-present Kwame Ulmer - strengthening my global connections with long-time collaborators like Stuart Dignam (MTPConnect, Australia) and Justin Leushner (Launchit Solutions, Canada) - managing a quick hello with fellow Angeleno and world traveler Tom A. - brainstorming new collaborations with Sarah Arth, CAE, Sara Maki, Erin Lee, and the AdvaMed team - getting a bit of a turbo exploration of Toronto, a city I will need to visit again - enjoying another conference concert from the front row with Angus McQuilken, this time featuring American Authors (aka The “Best Day of My Life” Band) - enjoying a traditional Tim Hortons donut (if only that were the only junk food I had on this trip…) More to come from Toronto, including just maybe some coffee with Big4Bio!