Personally from doing this blog it doesn’t appear to me that we have a shortage in the development area, but where the issues lie is in standards and bringing some imageof this to a better collaborative effort.  You do NOT want to rush the programmers of the software for the sake of having a product to sell that will jeopardize safety, but yet it happens all the time.  The development of new tools is software for evaluation and decision making.  On the drug side of the formula here, I’m not sure how this would work as I am not a chemist or scientist.   Earlier I posted this about Provenge, which is relying heavily on software, just due to the type of treatment plan it is. 

Dendreon “Intellivenge” Algorithmic Software Supporting Administration of Provenge – Seeking FDA Approval by May 1st

We also have the other side of the coin called “compliance” and there’s a lot going on in that area too with devices reporting data, which brings along security and privacy that we have to work with as well, and sometimes all those implications are not known up front, so I see this as “interesting” and secondary to healthcare reform.  We certainly need the research and development, but are we pricing ourselves out of the market in doing so?  BD 

The Food & Drug Administration and the National Institutes of Health are collaborating on an initiative to accelerate the development of innovative medical technologies.

and the National Institutes of Health launched a new program aimed at speeding innovative medical technologies to market.

The joint program involves translational science, "the shaping of basic scientific discoveries into treatments," and regulatory science, or "the development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality," according to a press release.

FDA, NIH to fast-track med-tech innovation | MassDevice - Medical Device Industry News


Post a Comment

Google Analytics Alternative