MedTech Impact Partners Grows Regulatory Support Expertise
MedTech Impact Partners is pleased to announce that Marie Rigley has joined our regulatory support team as a Senior Regulatory Associate. Marie Rigley has more than a decade of experience as a regulatory professional supporting and advising medical device companies.
MedTech Impact Partners is pleased to announce that Marie Rigley has joined our regulatory support team as a Senior Regulatory Associate. Marie Rigley has more than a decade of experience as a regulatory professional supporting and advising medical device companies. She has led successful FDA engagements and interactions by leveraging her scientific background to quickly grasp a wide variety of therapeutic areas and technologies with the goal of developing and implementing strategic regulatory objectives while simultaneously meeting evolving business needs. Marie specializes in cardiovascular, respiratory, surgical implants, face masks and more. She will work with MIP clients to craft strategy for pre-submissions and 510(k) submissions for various medical devices.
Marie Rigley, Senior Regulatory Associate
"I am thrilled about joining the MIP team. The prospect of working alongside Kwame Ulmer and learning from his industry-leading expertise is such an excellent opportunity. I look forward to engaging in ongoing initiatives that contribute to a positive impact on the future of our MedTech clients."
Marie’s expertise complements the wide range of FDA and industry experience across MedTech Impact Partners’ team. Our regulatory consulting services can be found here. In addition, our online Insights offers a comprehensive collection of publications and perspectives from our experts on current issues in FDA regulation and policy.
About Medtech Impact Partners “Talk to the FDA before you talk to the FDA.”
MedTech Impact Partners is a leader in regulatory strategy and support. Built on decades of government and private sector experience, our services position clients to get innovative health technologies to market faster.
Our team of consultants guide MedTech companies over regulatory hurdles at the FDA, helping them deliver on key milestones and protect their bottom line. MIP’s customized approach and suite of services focus on developing sound regulatory strategy, diligent review, and managing risks for clients.
CellKey Partnership Poised to Reshape Bioanalytical Research
This dynamic collaboration propels us into an exciting journey to revolutionize protein and glycoprotein analysis, a critical domain for diagnosing and treating diseases, including cancer.
(Source: Cellkey)
On August 29th, Cellkey marked a momentous occasion with the official Memorandum of Understanding (MOU) ceremony alongside Emerald Cloud Lab (ECL) – a true trailblazer in cloud-based laboratory facilities. The event brought together Je Min Yoo from CellKey, Jennifer Henry-Smith, Louis Sintasath, Jake Hostetler from ECL, and Kwame Ulmer, CellKey’s mentor, through BioHealth Innovation, Inc.’s US market entry program.
This dynamic collaboration propels us into an exciting journey to revolutionize protein and glycoprotein analysis, a critical domain for diagnosing and treating diseases, including cancer.
The synergy of CellKey and ECL, fueled by ECL's advanced lab tech, opens new horizons. Our SpAC9 Data Foundry, the proprietary glycoprotein analysis platform, now empowers global researchers. This shift enables cutting-edge remote glycoprotein and protein analysis, breaking barriers and fostering collaborative innovation.
Beyond tech, it is also about researcher support. Our partnership with ECL exemplifies our dedication to global access to advanced facilities, propelling us toward innovation without borders.
I’m excited to be partnering with an outstanding group of innovators who are taking steps to create medtech and research support that will make great strides in the fight against cancer and treating diseases. - Kwame Ulmer
From Student to Board Member: Crafting a Lasting Lincoln Legacy
Kwame Ulmer, Lincoln University Class of ’96, is one of Lincoln University’s most prominent advocates. With an unwavering commitment to education and healthcare, this successful entrepreneur has channeled his resources and dedication into supporting Lincoln University, leaving a historical mark on our legacy.
(Source: Lincoln University)
Kwame Ulmer, Lincoln University Class of ’96, is one of Lincoln University’s most prominent advocates. With an unwavering commitment to education and healthcare, this successful entrepreneur has channeled his resources and dedication into supporting Lincoln University, leaving a historical mark on our legacy.
FROM ENTREPRENEURSHIP TO PHILANTHROPY
Kwame Ulmer wears many hats, but perhaps the most notable is that of the founder and Managing Partner of MedTech Impact Partners, a regulatory strategy consulting firm with a passion for providing services and capital to healthcare companies. Yet, beyond the business world, Ulmer has a heart dedicated to philanthropy, particularly education and healthcare.
A PROUD ALUMNUS
Ulmer's journey with Lincoln University began in 1996 when he proudly walked the hallowed halls of our historic institution, graduating with a degree in Physics. During his time at Lincoln, he distinguished himself in the LASER program, a pioneering STEM initiative at the university. This early exposure to science and technology laid the foundation for his future endeavors.
After his undergraduate studies, Ulmer's desire for knowledge led him to earn two Master's degrees from the University of Virginia, specializing in Materials Engineering and Business Administration. After experiencing the community on our campus, Ulmer decided to continue his Lincoln story and began to help us further our mission.
MDisrupt + MedTech Impact Partners | A Partnership to Provide More Regulatory Support to Digital Health Companies
Medtech Impact Partners is partnering with MDisrupt to meet the growing need for regulatory support and strategy. Through this collaboration, MedTech Impact Partners and MDisrupt are providing streamlined access to industry leading regulatory experts on demand, providing crucial support for minimizing risks, avoiding delays, and ultimately bringing innovative healthcare solutions to patients efficiently and safely.
Medtech Impact Partners is partnering with MDisrupt to meet the growing need for regulatory support and strategy. There is a constant evolution of regulations with increasing significance in the field of health technology. Having access to experts with specialized knowledge and experience in regulatory affairs can significantly streamline the process of gaining necessary approvals and certifications. It enables companies to ensure compliance with regulatory requirements, expedite product development timelines, and ultimately bring innovative health technologies to market more efficiently, benefiting patients and healthcare providers alike.
Kwame Ulmer, Managing Partner of MedTech Impact Partners
“Medtech companies have done the hard work of creating life-changing innovations. Our team at Medtech Impact Partners leverages decades of insights and expertise to remove hurdles that will slow their path to market. We focus our work in regulatory strategy to keep pace with evolving needs. We make it our mission to be an effective regulatory partner for digital health companies and our partnership with MDisrupt enables us to offer more support globally,” said Kwame Ulmer, Managing Partner of Medtech Impact Partners.
MDisrupt, the healthtech industry’s leading marketplace for health experts on demand, is actively creating new opportunities for their health technology clients to access a wider range of best in class experts related to regulatory strategy and submissions.
“Establishing a robust regulatory process is arguably one of the most critical steps in successfully building a product that scales into the healthcare system.” said Ruby Gadelrab, CEO of MDisrupt. “Due to the ever-changing regulatory landscape and the number of companies building products that need to be implemented by health systems and reimbursed by payors, we are seeing increasing demand for regulatory expertise. We are so proud to be partnering with MedTech Impact Partners to expand our services.”
Ruby Gadelbrab, CEO of MDisrupt
Through this collaboration, MedTech Impact Partners and MDisrupt are providing streamlined access to industry leading regulatory experts on demand, providing crucial support for minimizing risks, avoiding delays, and ultimately bringing innovative healthcare solutions to patients efficiently and safely.
In addition, MDisrupt's expert network extends to more than 1,200 professionals encompassing clinicians, payors, health economists, scientists, as well as product and commercialization experts. This vast network can be leveraged to provide comprehensive support to both our existing and prospective clients at Medtech Impact Partners.
About Medtech Impact Partners “Talk to the FDA before you talk to the FDA.”
MedTech Impact Partners is a leader in regulatory strategy and support. Built on decades of government and private sector experience, our services position clients to get innovative health technologies to market faster.
Our team of consultants guide MedTech companies over regulatory hurdles at the FDA, helping them deliver on key milestones and protect their bottom line. MIP’s customized approach and suite of services focus on developing sound regulatory strategy, diligent review, and managing risks for clients.
MDisrupt is the health technology industry’s leading expert marketplace, connecting innovators with vetted and curated health expert operators to help them build, commercialize and scale their products quickly and responsibly.
With its tech-enabled platform, MDisrupt simplifies and democratizes access to the most experienced experts in healthcare, including clinicians, regulatory experts, payors, health economists, and product and commercialization leaders.
Earning the trust of a growing network of startups, investors, and healthcare companies, MDisrupt has solidified its position as the industry’s go-to talent marketplace for fractional health expertise.