big bang factory is happy to share the great news! We have been lucky enough to work with Carenity to support their rapid international expansion. XClinical, a leading vendor of eClinical software has announced a merger with France-based Carenity, a social platform supporting patients and caregivers worldwide, and Fortress Medical Systems, the US-based vendor of Clindex®, an integrated CTMS and …
Tag: US development
Boost your US Development with Alpha RLH and big bang factory
After a tumultuous year that was 2020, it is time to get business back in order- more so the conquest of the American market. By organizing a webinar in association with big bang factory, Alpha RLH thus took this opportunity to upskill their members with tactics to boost their US development. The main aim of this webinar was to discuss …
To Outsource or to not Outsource your US development?
Starting your US development can feel as if you were a quarterback who has to score a touchdown to win. Winning clients is hard. Winning clients in the most competitive market in the world is even harder. Innovative companies are aware that US development is the key to becoming a global player. But defining the right strategy, reaching out to …
#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 …
#4- No clinical or marketing claim without evidence
Let’s say your solution increases access to care, decreases the cost of care and improves outcomes…but can you prove it? In our previous articles we discussed the huge Cost of healthcare in the US and the latter seeking solutions that will Increase Access to Care, decrease the cost of care and improve outcomes. Let’s focus on the importance of evidence …
#2 pain point your medtech technology can solve
Decreasing the cost of care As a result of its huge cost, the U.S. Healthcare ecosystem is now seeking solutions that will (i) Increase Access to Care, (ii) decrease the cost of care and (iii) improve outcomes. In this post, we are going to focus on (ii) decrease the cost of care. The growing burden of healthcare costs has been …
When should I launch my product in the U.S.?
Timing is probably one of the most complicated parameters for a US expansion, as I stated in my previous article about “Why do startups fail in the US?” If you come too soon, you might burn your cash before finding your product market-fit. If you come too late, competition will be too fierce for you to get a chance to …