Meet Our Founder
Managing Partner
Kwame Ulmer is a MedTech executive, lecturer, and researcher with decades of industry experience.
Kwame Ulmer has more than 20 years of government and private sector experience. He partners with companies to help them set a clear regulatory strategy and deliver on key milestones. He also serves as an expert witness and advises venture capital firms. Kwame established an efficient regulatory process during his time working as an operating company executive and evaluated over 1,000 technologies during his tenure at the FDA. Kwame Ulmer leads MedTech Impact Partners (MIP). He works with a team of regulatory professionals that help clients around the world get medical innovations to patients faster.
Career Overview
Expertise: Digital Health, Cardiovascular, Ophthalmology, General Hospital, Infection Control, Dental, Anesthesia, Respiratory
Past Roles: Over a decade at FDA (Former Deputy Division Director) and Vice President Regulatory Affairs / Quality Assurance at Danaher (Fortune 150 Company)
Education
He earned his B.S. in Physics from Lincoln University, and has two Masters degrees from the University of Virginia, in Materials Engineering and Business Administration.
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MBA, MS Materials Engineering
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BS Physics
Activities & Affiliations
NIH & ARPA-H, Advisor
Wavemaker Three-Sixty Health, Venture Partner
California Life Sciences, Board Member
University of Virginia Licensing & Ventures Group, Board Member
ScaleHealth, Steering Committee Member
University of California Los Angeles, Lecturer and Researcher
MedTech Color, Founder
Regulatory Strategist. Investor. Researcher. Servant Leader.
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Kwame brings over twenty years of experience evaluating medical technologies in the government and private sector, and serving in senior operating roles at medical device companies. He has personally evaluated more than 1,000 medical technologies in his career. Kwame spent 12 years at the U.S. Food and Drug Administration (FDA) in progressive leadership roles, including Deputy Director and Branch Chief. He also served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation operating company.
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Kwame Ulmer is a venture partner at Wavemaker Three-Sixty Health - the leading Southern-California based, early stage venture capital firm (Seed and Series A) focused on the healthcare industry. He leads the medtech practice and participates in all aspects of fund management (e.g. deal sourcing, diligence, negotiation and advising portfolio company management teams). Kwame serves on the boards of Essenvia Inc. and Strados Labs Inc.
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Kwame is a lecturer and researcher in MedTech Innovation at the University of California, Los Angeles. His work focuses on the intersection of medtech regulatory, investing and innovation. Kwame regularly speaks at industry conferences and is cited in industry trade publications on regulatory topics.
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Kwame serves on boards of the University of Virginia Licensing and Ventures Group and Lincoln University Foundation. Kwame founded MedTech Color, a nonprofit with a mission to advance the representation of persons of color in the medical device industry.
Writings & Research
The State of U.S. MedTech Regulation, April 2024
The State of MedTech & Digital Health Innovation: A New Decade, First Quarter 2022
“FDA Veteran Outlines Bold Plans to Increase Diversity in Medtech Industry”, Medical Device and Diagnostic Industry, October 2020
“Predicting Future Device Problems Because Of COVID-19”, MedTech Insight, April 2020
Kwame Ulmer. “How to Thrive Through Any FDA Change”, MedTech Strategist Market Pathways, September 2019
Kwame Ulmer. “Is MedTech Too White?”, MedTech Strategist, September 2018
“Adverse Events Stack Up At FDA; 2016 Warning Letter Data Show Troubles With MDRs, Complaints”. MedTech Insight, October 2016
Public Speaking
MedTech World Keynote Speaker “Future-Proof Your Global Company: Investment Climate, Technology, Mega-Trends and Regulatory Landscape”, October 2023
AdvaMed The MedTech Conference Speaker “Investing in 100% of the Future: Our Children”, October 2023
LSI Europe Panel Moderator - Investment perspectives with leaders from historically underrepresented communities, and moving the needle on diversity and inclusion in investment in our industry, September 2023
Startup Starter (2022 Equity Crowdfunding Week) Speaker “The Future of Healthcare: Investors Perspective”, November 2022
2022 Bloomage Spring Biomaterial Forum Speaker “US Regulations on Dermal Filler Related Product Development”, April 2022
Medmarc Annual Meeting Keynote Speaker "Key Trends in the Medical Device Industry", November 2021
AdvaMed The MedTech Conference Annual Meeting "Innovating to Meet Patient Needs”, September 2021
A Matter of Innovation Interview, May 2021
Emerging MedTech Conference Panel Moderator - Medtech VC & Corporate Investing Trends, May 2021
California Institute of Technology “FDA 101: The Insider's Guide to Getting Regulatory Approval”, September 2020
University of California Los Angeles Biodesign Program “Regulatory Strategy 101”, September 2020
University of Southern California Health, Technology & Engineering Program “Regulatory Strategy Workshop”, October 2019
University of California Los Angeles Biodesign Program “Regulatory Strategy 101”, September 2019
University of Southern California Biotech Speaker Series “Early Stage Healthcare, Investing in LA”, April 2019
MedTech World Keynote
In this enlightening presentation, Kwame Ulmer explores strategies to navigate the dynamic landscape of global business, providing insights into future challenges and opportunities.
