Woozles and Data Transparency
Transparency of data is an important topic in any field, but in healthcare it is paramount to ensuring that we get the very best outcomes for patients - because at the end of the day, why else do we all work in the healthcare setting? I've been an advocate of data transparency in medical communications for as long as I can remember and I continue to shout about the need to publish more real world/market research data to further our understanding of patient pathways - the emotive side as well as the bare bones facts. But does the rise of social media, especially in the current COVID-19 environment, threaten some of the work the medical publications sector has done? We have after all come a really long way in promoting data publication and transparency. 
View Aug 6, 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world.
View Jul 1, 2020