We generally encounter five main phases when working with OEMs to launch a new medical device. Getting a product to market can be notoriously difficult; it’s a long process with plenty of potential obstacles. (Read about the consumer product development process here and here. Facebook. The following is an overview of what your The path to bringing a medical device to market is usually winding, but working with an experienced partner that will guide you through the process can make it much more navigable and efficient. It's a lot like bringing any other device to market, but with 4 massive hurdles. “Anyone can be an innovator” was the guiding phrase of Pathways to Market: Focus on Medical Devices, a panel held at Boston Children’s Hospital on January 6, 2014. These include an ever-changing landscape of regulatory processes, new compliance and documentation requirements and cyber security issues for connected devices. Published 16 August 2013 Last updated 26 February 2019 + show all updates Expertise in Bringing Medical Devices to Market Go-To-Market Regulatory Strategy From intended use and design all the way through regulatory approval and product launch, we create playbooks rooted in trusted practices that will serve as the guide for success in securing market approvals.

Twitter. EMMA International has the regulatory expertise to build you a tailor-made regulatory strategy and walk you … Bringing Medical Devices to Market Faster With Early Supplier Involvement Thursday, June 27, 2019 by Parker Global Team Market globalization, increased regulatory requirements, more educated consumers, and today’s cultural demand for immediate results and satisfaction are fueling the whirlwind pace of breakthrough innovation in the medical device manufacturing industry. )And if you’re in the medical device industry, the process is even a little more difficult and involved. by Julie Tibbets February 17, 2016. bringing a medical device to market is a daunting challenge Medical device companies face an increasingly complex set of variables in bringing their devices to market. See how to report a non-compliant medical device if you notice any issue with a medical device placed in the UK market. The process of bringing a medical device to market through the FDA can be extremely complicated and time-consuming if you don’t have a proper plan in place. Bringing a Medical Device to Market.