In order to understand how machines and products come to market, I found this talk at my meeting interesting. I didn’t understand the vast difference between a PMA and a 510K… And in looking at the routes, and which route each product has taken, I think there is a big difference in what comes out.
Blah blah blah. I know your eyes are glazing over, just like they do when I tell you to wear sunscreen and don’t smoke. But I have been on a tirade for years now about the marketing of medicine. What is real? What works? What claims can you trust?
Brief overview (I know you Bay Area people have to get out and enjoy the sunshine, now that summer has finally arrived),
- PMA. Pre market approval. Tends to be a 2-3 year process. Costs $300K – $2 million. Has nonclinical and clinical data. On average in the US takes 54 months. (examples: Vaser, Ultrashape, Endermolgie)
- 510K. 3-6 month process. Costs $3K- $2 million. Only 10% have any clinical data. (examples: Zeltiq, Zerona, Velasmooth, Smoothshape)
- New Drug Approval. 6+ years. Costs $100-150 million. Phased trials. need to have 800-1500 patients. Require a lot of evidence in animal models for at least 6 months, including effects on reproductive, cardio, and gene toxicity.
I was really struck by the difference in these paths. A new fledgling company has a totally different cost and time to market depending which path it needs to take. The amount of hard, good science is also different. It is amazing to see for some products the “scientific studies” of support being of a group of 10 patients, without histology, only followed for 3 months. The drug clearance is much more vigorous.
Also there was a big difference between the FDA clearance and clearance overseas, with Europe being much clearer in what they want from the companies and faster in helping them get to market when they cleared their goals. You will find a lot of products available in Europe and not in the US for this reason.
I feel sorry for the new companies out there. There is a lot of competition. One company doing great research and coming to market after years of development (like botox) used to have years of being the “only kid on the block” to recoup the money used for research and development. Now, there are many companies, all vying for the same space. One speaker said there is a 24 month window to be the hot new thing… Then poof. Your window is gone.
For you, the patient and consumer of these products, how do you wade through it all? It is tough. The usual gatekeepers to filter through this were the doctors. Now with how the world is run and the speed of it all, companies are bypassing the doctors and scientific studies to go straight to you.