#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: …

Progress USA : Comment aborder le marché américain en période de COVID-19 ?

 Beneficiez de du programme risingSUD et faites-vous accompagner par des professionnels ! Vous souhaitez progresser sur des aspects stratégiques avec une approche structurée afin de préparer votre lancement commercial américain ? Faites partie des 6 entreprises sélectionnées pour participer au programme Progress USA 2020 !  Un consultant chevronné de big bang factory (multi entrepreneur, expert en ventes, marketing ou levée de fonds) …

#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 …