On September 2nd, 2021 Dr. Matthew Colman presented AVATAR MEDICAL at the 2021 Annual Meeting of the American Academy of Orthopaedic Surgeons(AAOS) held in San Diego, California. Paris-based, AVATAR MEDICAL has developed a Medical Image VR platform that aims at facilitating the preparation of complex surgeries. As part of his presentation to the AAOS, Dr. Colman presented AVATAR MEDICAL as …
Tag: U.S. Healthcare
XClinical to Merge with Carenity and Fortress Medical Systems Forming a New Data Science Company Serving Life Science Markets Worldwide
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 …
#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: …
#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 …
#3 How to improve patient outcomes, while decreasing the cost of healthcare?
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 Improve outcomes The changes in the U.S. healthcare ecosystem to serve more patients and the cost/benefit of introduction of …