MedTech Impact Partners is a Medical Device Regulatory Strategy Consulting Firm that provides expert insights, develops regulatory strategies, and manages risks for medtech companies, law firms, and investors, facilitating compliance with FDA regulations.

MedTech Impact Partners

MedTech Impact Partners | 687 followers on LinkedIn. Talk to the FDA Before You Talk to the FDA. | Talk to the FDA Before You Talk to the FDA

MedTech Impact Partners is a global leader in regulatory strategy and solutions.
Our mission is to leverage our team’s deep expertise in regulatory strategy to help medtech companies in the US and abroad achieve critical milestones faster. We help companies accelerate growth and protect their bottom line.

Managing Partner at MedTech Impact Partners || Venture Partner at Wavemaker Three-Sixty Health

Kwame Ulmer

Founder, Principal Consultant | Medical Device Regulatory and Quality Strategy

Ery Anguiano

Operations Assistant

Althea Beatrix Ruiz

Cyrus Safavi

It's hard to believe that my time at MedTech World Malta was nearly two weeks ago. Now that I've had a little time to settle back in the US, I wanted to share a short recap. I had the opportunity to share insights from top global companies on navigating the US medtech market in 2024. We explored trends in digital health over the past decade and discussed the steady stream of venture capital activity. Key lessons centered around strategic partnerships, non-dilutive financing, and prioritizing critical milestones. It's particularly nice to see South Africa leading Africa's medtech growth, with projections estimating a surge in MedTech revenue from $11.02B in 2024 to $14.91B in 2029. The US and Israel continue to dominate De Novo device approvals, while South Korea, Israel, and Africa are experiencing consistent growth in 510K clearances. It was a pleasure connecting with industry leaders and discussing the future of medtech. You can view my full keynote "Cracking the Code" here: https://lnkd.in/d4kAJRui P.S.: If you're in Houston today for the Lifeblood Goodwin Experience during MedTech Houston or MedTech Strategist 's Innovation Summit in San Diego, let's connect. MedTech Impact Partners #medtech #medtechworld #malta #medtechtrends #venturecapital #africa #globaltrends #thoughtleadership

🚀 Embracing Change in MedTech 🚀 FDA is evolving with tech like #AI in cancer detection, AirPods as hearing aids, and brain chip innovations. Dr. Michelle Tarver will be leading the charge. 🔬 Startup Opportunities Apply for The National Institutes of Health 's Medtech Pathways program, aimed at budding innovators from HBCUs and MSIs in neurotechnology. 🌍 MedTech World Malta Recap Insights from global leaders, Africa's growth, and market trends. 📅 Upcoming Events - Lifeblood-Goodwin in Houston, Nov 18 - Innovation Summit San Diego, Nov 19 Connect with us to stay informed!

Join us for MedTechForum 's 6th episode on Nov 18, 12-1 PM PT. We're tackling the health of Black Women in the US, focusing on access to care. Moderated by Vernessa Pollard with expert panelists. Registration is $20, with 50% going to MedTech Color . 💫 Ways to show your support!💫 🎟️ Register to attend 👥Share with your network 💵 Donate if you can't attend but want to support the cause Don't miss this important event! Register: https://lnkd.in/gZC4yrRE #WomensHealth #HealthEquity #MedTechWomen #HealthinAmerica #SavetheDate

MedTech Color

MedTech World Keynote by Kwame Ulmer Cracking the Code: Lessons from the best international companies to enter the US medtech market in 2024 • Return to Pre-Pan Valuations • Seed+ Raises • Importance of De-Risking Pre-FDA Medtech revenue in Africa • 2024 $11.02 Billion | 2029 $14.91 Billion #medtechmalta24

Sandeep Pulim M.D.

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 whatHouston 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 hashtag #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

MedTech Malta is off to a great start! MedTech World Kwame Ulmer Dylan Attard MD, MRCSI, MEnt. Lifeblood #medtechworld #medtechmalta

👏 This clip never gets old. Get the most out of your efforts to take this path to market.

🌍 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

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MedTech Impact Partners