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It is often said that medical regulations are for a reason. There is no room for mistakes in the medical industry. What if a minor error could have dire consequences, and in extreme cases, it can cost human lives? Therefore, every medical device startup before releasing a product to the market, must face a series of requirements.
For most people (especially when you build your product for the first time), understanding the complexities of the law or keeping up with changes feel like navigating an endless maze. Non-compliance with regulations means that startups’ medical devices will not be allowed on the market, and they may also face fines. Fortunately, there are individuals who know how to navigate this maze and are capable of guiding companies through the complex regulatory processes.
Most people associate smart wearables only with smartwatches or fitness trackers, but this is only a tip of an iceberg in possibilities where this technology can be used. These advanced electrical gadgets are designed to be worn on the user’s body. They are equipped with sensors and processors of various kinds which enables them to be connected with other devices as well as with the internet. It allows them to gather, analyze and exchange data in real time. In medicine it has found its use for monitoring health and condition, communication and for personal requirements.
Launching a medical device startup involves dealing with many variables influencing success. One critical factor is speed to market. Successful startups often move swiftly and gain momentum during commercialization. However, minor setbacks can slow development, significantly impacting time to market and financial outcomes.
There’s a dynamic duo that’s been quietly saving the day: engineers and their knack for MedTech innovation. Medical technology has been turning heads with its life-saving devices and game-changing solutions. It’s the engineers who are pulling the strings, making magic happen from scratch. This article is all about shining a light on the engineers role in shaping the future of MedTech.
Kickstart your medical startup: The 3rd edition of the Mother and Child Startup Challenge is here!
Are you a visionary entrepreneur with groundbreaking ideas in MedTech or Digital Health field? The Mother and Child Institute invites you to join the 3rd Edition of the Mother and Child Startup Challenge!
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?