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Can you imagine a pediatric healthcare today without MedTech solutions? Without a support of technology, both hardware and software? Why do they play a crucial role in disseminating and personalizing patient care, especially for the youngest ones? Children require a dedicated approach and specialized medical solutions that not only address their unique physical needs but also consider psychosocial aspects.
One crucial decision startups face is whether to pursue certification from the United States Food and Drug Administration (FDA) or the European Union’s Medical Device Regulation (MDR). Both regulatory bodies offer pathways for market approval, but understanding the advantages and suitability of each is essential for startup success. In this article, we explore the notable advantages of FDA or MDR and discuss which option may be better for MedTech startups.
In 2024, innovative MedTech startups stand at the forefront of a transformative journey, poised to redefine our healthcare experience. These young companies aren’t merely players in the field. Armed with fresh perspectives and groundbreaking technologies, they’re introducing novel ideas, developing cutting-edge medical devices, and challenging traditional approaches to healthcare. From ingenious gadgets to intelligent diagnostic tools, they’re reshaping the very fabric of healthcare delivery.
The synergy between MedTech startups and Low-Volume CDMOs is increasingly becoming a pivotal force driving innovation and growth. Often likened to a love-at-first-sight scenario, this partnership holds immense potential to revolutionize the industry and bring groundbreaking medical devices and solutions to the market.
Despite astonishing advances in medical treatment and substantial investments that have been made in healthcare innovation, MedTech Startups have one of the highest failure rates. To find out why, it is important to break down underlying challenges and examine the driving forces. How does the nature of product development in MedTech differ from other fields? What mindset and expertise are essential to navigate the uncertainty? What are the best questions to ask that can help MedTech startups reflect on their journey and improve themselves?
Should MedTech startups or academic spin-outs partner with Contract Development and Manufacturing Organizations (CDMOs)? It’s tempting to push the project alone and consume the glory, yet these organizations play a pivotal role in driving innovation, streamlining production processes, and ensuring the delivery of high-quality medical devices and technologies.
The Mother and Child Startup Challenge is a unique European project that brings together state medical entities in the pursuit of harnessing the potential of innovative solutions related to comprehensive healthcare. This year’s edition attracted 51 startups and companies from various countries, competing for the opportunity to introduce their innovative ideas to six public hospitals in Warsaw, Łódź, Białystok, Gdańsk, and Olsztyn.
As innovative technologies continue to reshape the landscape of healthcare, conducting a comprehensive State of Knowledge Analysis emerges as a crucial step in the development of any MedTech project. This strategic examination involves assessing the current state of scientific understanding, technological advancements, regulatory landscape, and market trends relevant to the specific medical technology under consideration.
We proudly announce our recent accolade as a recipient of the esteemed 2023 Global Award for excellence in four categories on Clutch, the preeminent global B2B service provider marketplace. This distinguished honor is a reflection of our unwavering commitment to MedTech industry expertise and exceptional service delivery, as evidenced by the commendations derived from thousands of client reviews on the Clutch platform.
