Kwame Ulmer

Managing Partner

2017 - Current

MedTech Impact Partners is a medical device regulatory strategy consulting firm that partners with some of the most innovative medtech companies and investors to navigate the FDA.

Venture Partner

2018

Wavemaker Three-Sixty Health is the leading U.S. seed stage venture capital fund focused 100% on healthcare. The fund is backed almost exclusively by healthcare LPs - both leading organizations and prominent individual executives - across payers, providers (across the continuum of care), and pharma. This gives the fund a unique advantage with respect to identifying, evaluating, and, most importantly, supporting early-stage healthcare technology companies.

Lecturer and Researcher

2021

Board Member

2023

Board Observer

2022

Vice President Regulatory Affairs Quality Assurance

2015 - 2017

Our Department was engaged. We experienced an annual increase in department engagement, culminating in best-in-class scores. Product Launch - I led a cross-functional team as senior champion for product launch in China. We developed an integrated plan including Go-To-Market, Manufacturing, and Regulatory approvals. Change Management - I was the senior leader responsible for a team of 30 permanent and temporary associates in an accelerated 4-month compliance resolution project. I led an evaluation of over 10,000 records ahead of schedule mitigating significant business risk. Budget Development / Management - I instituted a regular budget development and review process in concert with finance partners. We realized on-time proposals and more accurate forecasts.

Director, Strategic Regulatory Affairs

2014 - 2015

Process Optimization - I led a platform-level FDA application improvement process resulting in a 50% reduction in additional information questions.

Deputy Director

2009 - 2014

I oversaw a nearly 2X growth in the Division. We maintained top performance in on time delivery of our main deliverable: 510(k) decisions.

Branch Chief

2006 - 2009

Technical Evaluation - I presented a complex case to an expert federal panel evaluating Lasik risks, resulting in enhanced safety measures, protecting 1M patients per year. I Initiated a comprehensive evaluation of ophthalmic in-vivo diagnostic devices and developed internal templates for review of complex clinical and engineering issues.

Biomedical Engineer

2002 - 2006

Technical Diligence - I have conducted over 1,000 reviews of technologies. Most of my time was spent evaluating cardiovascular pacemaker and defibrillator leads reviews for entire medical device industry, while maintaining workload 2.5 times organizational average. I Collaborated with large cardiovascular companies in developing preclinical techniques for major guidance on evaluation of cardiovascular devices.