#7-Designing your medical device to address the pain points of the U.S. Healthcare system: The home-stretch

In conclusion to the Medtech series, to prepare for US Market Entry, early product concept documents, and most business plans for MedTech start-ups must include a clear-cut definition of the product “Intent of Use” and related FDA pathway, and CMS reimbursement pathways.  The selected intent of use and underlying technology platform must address all the new pain points of the …

#6-Plan a reimbursement strategy from the start

“Designing for CMS” becomes an essential part of any new product development process, which needs to be implemented 16 to 24 months before drafting specific U.S. Market Entry plans. Medicare patients will now get reimbursed for medical devices that the FDA designates as a breakthrough technology. A medical device is a breakthrough technology if it fulfills the following criteria Coding: …

#Medtech Webinar

While the US market for medical technologies is the largest in the world, it is probably the most complex when it comes to the practical monetization of novel technologies. Even before: clinical validation plans are made, FDA trajectories are explored, or KOL recruited, the board (and in particular the CEO) of any entrepreneurial healthcare company must be able to answer …

#5- Designing your product for FDA approval The example of 510k Premarket Notification Process

“Designing for FDA” is an essential part of any new product development process, which needs to be implemented 10 to 18 months before specific U.S. Market Entry and FDA submission plans are drafted. The Center for Devices and Radiological Health (CDRH) department of the Food and Drug Administration (FDA) has released Guidance for Industry on the 510(k) Premarket Notification Process …

Synapsys acquired by Inventis

Inventis Srl (www.inventis.it) announced in January that it has acquired 100% share capital of Synapsys SAS (www.synapsys.fr), the French leader in balance diagnostic systems.With this first acquisition, Inventis, an Italian company founded in 2005 with headquarters in Padua, which designs and manufactures advanced audiological diagnostics equipment, is launching its announced strategy that aims to complete its product range, at the same time extending its international …

How to improve the readiness of your medical technologies for the U.S. market?

Series of blog post written by Mathieu Petitjean, CEO, Mednest and Susan Z. Paquette MBA, MS, Executive Consultant, MedNest Part 1: Why you need to adapt your strategy for the $156 billion US market. Garnering the attention of U.S. policy makers, investors and innovators, the U.S. Medical Device market reached $156 billion in 2017 (40% of the global market!) and …