The MedTech landscape is constantly evolving. Staying ahead of the curve requires continuous learning, networking, and exposure to the latest innovations. To help you maximize your professional development, MedTech Impact Partners has curated a list of top industry conferences to attend in 2025. These events offer valuable opportunities to connect with industry leaders, explore cutting-edge technologies, and gain valuable insights into the future of MedTech.

Explore how the recent federal mandate limiting DEI initiatives impacts FDA medical device regulations. Learn about the implications for clinical trials, rule changes, and your organization's compliance.

The recent US presidential election has significant implications for the medical device industry. By proactively addressing these areas, MedTech companies can navigate the evolving regulatory landscape and ensure the success of their products.

Ghana's medical technology (medtech) industry is booming! This presents a golden opportunity for companies worldwide, but navigating the regulatory landscape can feel daunting.

The FDA has finalized its Accreditation Scheme for Conformity Assessment (ASCA) Program, marking a significant advancement in regulatory compliance for medical device manufacturers. With four new guidance documents, the FDA provides clear direction for both testing laboratories seeking ASCA accreditation and medtech companies navigating device testing and submission complexities.

The FDA's recent ruling on Clinical Laboratory Improvement Amendments (CLIA) Laboratory Developed Tests (LDTs) marks a large shift in regulatory oversight that will have both short and long-term implications for CLIA labs. This decision will impact laboratory operations, from regulatory compliance to operational practices. Here’s a look at how this ruling will affect CLIA labs.

In June, MedTech Impact Partners’ Kwame Ulmer joined industry colleagues to tackle the controversial topic of deciding which regulatory path to take when getting a medical device through the FDA’s rigorous approval process. In their enlightening session, medtech innovators, investors, and former regulators provided guidance on whether the Breakthrough Device Program will bring value to your device or portfolio investment based on their experience in the program, industry research, and novel insights from the 95 devices that have obtained FDA market authorization to date.

In this blog, we share key takeaways from their discussion–insights that we hope will help you in your journey to market. 

Getting a medical device through the FDA's approval process and to the patients who need them is no small feat. Join Kwame Ulmer for relevant and timely regulatory insights that provide important information to help medical device manufacturers make strategic decisions that helps them get their products over regulatory hurdles and to market faster.

In FDA in a Minute's first episode, Kwame Ulmer shares implications of the FDA's updated Breakthrough Device Designation Program and what it means for medical device companies looking to expedite their submission and path to market.

The FDA issued three draft guidances to further modernize the most common regulatory application pathway-the 510(k). Here are key actions for the guidances regarding selecting the best predicate.

Having a Quality Management System (QMS) in place is key for early-stage companies looking to reach regulatory milestones and increase their value.

Moving innovative technologies from inception to market is a marathon full of hurdles. We believe that raising capital to develop a product is important and enabled by meeting regulatory and maintaining compliance. Having a solid regulatory strategy adds value for medtech companies. Knowing when, how and what topics to engage the U.S. Food and Drug Administration (FDA) is the first step in getting your regulatory plan in place. Here are a few recommended actions and our top 10 reasons to talk to the FDA.

Making it through the FDA’s rigorous approval process is a big accomplishment. Getting your medtech device or software to market and in the hands of patients who need it most is even bigger. But, that’s not the end of the journey. Have you planned for your technology’s future?

Team, technology and understanding the regulatory landscape all impact how efficiently your early stage company gets to the finish line. The better you can navigate the FDA submission process, the faster you can get your product in the hands of people who need it most. Check out MedTech Impact Partners' latest insight on how to best position your company for a successful submission.

Starting a medtech company isn't easy and getting a novel device through the FDA's approval process is challenging. Get off to the right start with MedTech Impact Partners by adding our pres-submission package to your strategy of getting your device to market faster.

Milestones are important and that’s why we are thrilled to celebrate five years at MedTech Impact Partners! We couldn’t have grown to this point without the wonderful support of our global network of partners and outstanding clients.