2009 RAPS Horizons Conference & Exhibition

The 2009 RAPS Horizons Conference & Exhibition is April 1-3, I discussed last year's RAPS conference here. Unfortunately I will be unable to attend, we're moving some manufacturing to a contract manufacturer and keeping on top of it is taking a huge amount of time.

Medical Device Grants Available

The 2009 Recovery Act includes $200 million in grant funding for medical device ideas, see the RFA.

Hat tip: Medical Devices Blog.

Pictured: IV bag with a neck strap, is your idea better?

Misconceptions on medical device costs

The Happy Hospitalist has a post on a vacuum assisted wound closure device, Wound VAC, his post and the Wound Vac site have videos and everything. Anyway, Happy complains about the cost:

"I checked with Happy's Hospital wound care nurse. Guess how much these cost retail, should you wish to purchase them outright?

...

Nope. She tells me to buy them outright is thirty thousand dollars. Thirty grand for a LCD screen and some surgical steel, surrounded by a power supply.

I suspect parts and manufacturing would run you about $300. Legal costs about $29,700."

No one pays retail anyway! I think those numbers are a bit off, since you can't buy a lab vacuum pump for less than $1000, let alone an easily portable one with a color touch screen, battery, alarm system, controller and medical grade power supply, I would guess the cost of goods is more likely around $4000. It is tough to say since I don't know what exactly is included in a system. Medical device assembly is not as cheap as you think it is, traceability requirements tend to drive up costs, plus it is difficult to outsource. This isn't consumer electronics where you can just throw it together and hope it works.

There are some legal costs, but I bet they're not more than $100 per device. Although I'm obviously not an expert. What you're mostly paying for is meeting regulations and the design and validation of the next wound care device. Those alarms don't write and validate themselves.

Medical Device Premarket Approval (PMA)

Advanced Medical Technologies (AMT) has an interesting post about the number of Premarket Approvals (PMAs) and Medtronic's dominance of the market. AMT created the graphic on the left using FDA data. Interesting that with health care approaching 20% of GDP, AMT notes that only one of the PMAs is original, the rest are supplemental information for PMAs filed in the past.