Kwame Ulmer from MedTech Impact Partners to Deliver Keynote at MedTech Malta 2024

Each year, the world’s leading medtech and healthtech innovators, experts, and investors converge at MedTech Malta, setting new standards for the industry. MedTech Malta 2024 promises to be no exception, and among the distinguished keynote speakers is Kwame Ulmer, Managing Partner at MedTech Impact Partners, who will share his insights and expertise on the global stage. With a distinguished career spanning over two decades in digital health, cardiovascular care, and ophthalmology, Ulmer has played pivotal roles, including serving as Deputy Division Director at the FDA and Vice President of Regulatory Affairs/Quality Assurance at Fortune 150 company, Danaher. His extensive background in both the public and private sectors positions him as a leading voice in MedTech innovation. 

Key Insights into Global MedTech Trends 

Ulmer’s keynote builds on his 2023 address titled Future Proof Your Global Company, which explored crucial industry topics such as investment trends, regulatory shifts, and strategies for companies aiming to enter the U.S. market from Europe. His talk at MedTech Malta 2024 will dig deeper into these areas, offering attendees a comprehensive look at the evolving challenges and opportunities within the MedTech sector. 

Kwame Ulmer, said, “As the MedTech industry continues to innovate, one of the greatest challenges remains balancing rapid technological advancements with regulatory and reimbursement frameworks. Understanding both the U.S. and European systems is critical for companies looking to scale effectively across borders.” 

Parallels Between U.S. and EU Regulations 

Ulmer’s 2023 keynote highlighted the growing alignment between U.S. and European regulatory frameworks. He noted that while Europe has developed a robust system ensuring device safety and efficacy, the main obstacle lies in harmonizing reimbursement processes with the fast pace of digital health advancements. Recent developments at the FDA, including new guidelines for the 510(k) pathway, reflect ongoing efforts to streamline regulatory pathways. However, Ulmer emphasized that reimbursement remains the top challenge for MedTech companies navigating global markets. 

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Essenvia Releases 2024 State of US MedTech Regulation Report

Are you a medical device manufacturer? What are some of the biggest challenges you've faced? I'd bet they have a lot to do with regulatory changes and new technology advancements; just to name a few.

With its brand-new “2024 State of US MedTech Regulation” report, Essenvia has pinpointed eight specific hurdles that many medical device manufacturers will have to jump over in the coming years. Learn what they are and how you can position your product to have a successful path to market.
Access the report.

** Join Essenvia CEO Soumya Mahapatra and VP of Regulatory Affairs Dhriti Roy on May 16 at noon EST for a FREE, informative MedTech Intelligence webinar that will walk through key findings of the “2024 State of US MedTech Regulation” report. REGISTER FOR THIS FREE WEBINAR NOW! **

MedTech Color Announces the 4th Annual Pitch Competition Top Winners

MedTech Color’s 4th Annual MedTech Color Pitch Competition took place on March 15, 2024, at Covel Commons on the UCLA campus in Los Angeles, California. The highly anticipated event focused on identifying and supporting the next generation of founders aiming to diversify and bring innovation to the medical technology field, with a particular focus on African-American and Hispanic entrepreneurs.

The competition featured a new addition in 2024: a pediatric track. The Alliance for Pediatric Device Innovation partnered with MedTech Color for the “Make Your Medical Device Pitch For Kids!” ™ competition. This track offered up to $50,000 in additional funding for startups developing medical devices specifically for children.

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Medical Device Data and Evidence: An Integrated Approach

One of the most formidable challenges in bringing a medical device to market is generating clinical and commercial evidence for a diverse group of stakeholders, such as the FDA, insurance payers and healthcare providers. It’s a complicated process where any misstep can lead to costly delays and a loss of profits.

In this webinar with Orthogonal, distinguished MedTech leaders including MIP’s Kwame Ulmer share insights, case studies and best practices for developing effective evidence gathering strategies. These pioneers will speak to shifts in the regulatory and reimbursement landscape related to integrated data strategy, including Total Product Life Cycle (TPLC), Predetermined Change Protocol Plans (PCCP), CMS's TCET pathway and FDA/CMS Parallel Review. They also discuss a new industry collaborative from the Digital Medicine Society (DiME) working on an Integrated Evidence Plan for Digital Health Products. You’ll leave this webinar with actionable advice to achieve success in obtaining evidence needed to satisfy stakeholders and set you up to successfully bring a medical device to market.

If you’d like to learn more about strategies that will move innovative medical devices to market faster, visit our blog.

Future-Proofing Your Global Company and More with Kwame Ulmer

Kwame Ulmer gives keynote at Med-Tech World in October 2023.

What investment trends are currently dominating the American Healthcare industry? What are entrepreneurs to do in the wake of rapid regulatory advancements? These questions and more were discussed in Future proof your Global Company, an enlightening presentation given by Mr. Kwame Ulmer during MedTech Malta last October.

At the Mediterranean Conference Centre in Valletta, Kwame Ulmer took to the stage, drawing from over two decades of expertise evaluating medical technologies. 

As Managing Partner at MedTech Impact Partners and Venture Partner at Wavemaker Three-Sixty Health, his roles at the FDA and in the private sector enrich his insights.

Mr. Ulmer is also the Founder and a Board Member of MedTech Color, where he champions diversity in the sector, aiming to amplify marginalized voices. MedTech Color’s mission encompasses mentorship, community building, and thought leadership, reflecting Mr. Ulmer’s dedication to fostering inclusive innovation and leadership within the dynamic landscape of the medical device industry.

Med-Tech World recently reached out to Mr. Ulmer, who shared the following about the industry and the show: 

“Over the last two decades, we have seen increased clarity from regulatory bodies. At the same time, we know more opportunities exist for companies based throughout the world to launch in major markets if quality and testing standards were even more harmonised.”

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Panel Recap: Investment Perspective, Insights, & Increasing Representation | LSI Europe '23

This panel took place at LSI Europe ‘23 Emerging Medtech Summit in Barcelona, Spain and explores diverse investment perspectives and insights with regard to fostering increased representation and inclusivity within the Medtech ecosystem.

“Leverage the people who you know, who have those networks, because then we’re all stronger together.”

Meet the trailblazers who are redefining the VC landscape with fresh perspectives, insightful strategies, and a commitment to representation in our #LSIEurope23 panel, “Investment Perspectives, Insights, & Increasing Representation With Leaders Changing the Face of VC.”

In this panel we hear firsthand about the shifts in strategy, the success stories, and the challenges they've faced along the way, all while championing a more representative future for the industry.

Tune into the full panel to hear more from these incredible panelists: Kwame Ulmer, Tracy Dooley MD, Nicole J Walker, Esther Reynal de St Michel Richardot.

Unlocking Insights with Kwame Ulmer: A Journey Through MedTech, FDA, and Venture Capital

This interview with Kwame Ulmer is part of a larger series of interviews where we discuss the intersection of healthcare and technology with subject matter experts from Adhera Health’s Advisory Board.

Kwame Ulmer leads MedTech Impact Partners (MIP), bringing over twenty years of experience evaluating medical technologies from both government and private sectors. In addition, Mr. Ulmer is a venture partner at Wavemaker Three-Sixty Health, the leading Southern-California based, early-stage venture capital firm focused on the healthcare industry. His career highlights include a 12-year tenure at the FDA in roles such as Deputy Director and Branch Chief, as well as serving as Vice President of Regulatory Affairs and Quality Assurance at Implant Direct, a subsidiary of Danaher Corporation. In addition to Adhera Health, Mr. Ulmer is a board member for Essenvia Inc. and Strados Labs Inc. He is a lecturer and researcher at the University of California, Los Angeles, and the founder of MedTech Color, a nonprofit aimed at enhancing the representation of persons of color in the medical device industry.

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. 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.

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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

(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

(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. 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.

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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. 

About MDisrupt

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.

MIP Job Announcement | Regulatory Associate

We are looking for an experienced Regulatory Associate to work as a remote consultant with MedTech Impact Partners.

Responsibilities

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process

• Provide varying levels of support to the regulatory team

• FDA meeting preparation as needed

• Proposal writing

Qualifications

• Minimum of 2 to 5 years of Regulatory experience

• Relevant experience in proposal writing

• Proven successful track record of authoring/submitting FDA submissions (Pre-Submissions, 510(k), De Novo) and Draft Regulatory Strategies, CE experience a plus

• Previous experience working directly with the FDA

• Regulatory Affairs Credentials (RAC) a plus

• Strong organizational skills with attention to detail

MedTech Impact Partners is a medical device regulatory strategy consulting firm, leveraging deep executive-level experience from the USFDA, private sector and world-class research to deliver expert insights for companies, law firms and investors. MedTech Impact’s work results in improved compliance for medtech companies, expert interpretation of FDA laws, regulations and policies for law firms, and enhanced diligence for venture capital firms.