I say in my opinion, this is pretty valid. The FDA like every other government structure is going through massive changes and updates, and one example is Social Security looking at emerging from old Cobol systems for another example. This is what we have out there and needs for upgrades in technology are massive. In California our Governor slates the same issues, it’s all over.
Now combine this fact with all the new emerging technologies, software inquisitions, etc. and you can certainly seem some validity here with investors not knowing exactly which way to go at times. Sure the FDA is under pressure to do a better job regulating, but they too like us get that new left curve every day from technology so a balancing act of sorts here is the same thing we are all looking at. Devices with software questions is a big issue as we are seeing quite a few recalls now, relating back to the software. In essence they are having to examine and approve some combinations that have never been around before. The big item in the news of course is the radiation questions and how the “defaults” get set and the various warnings that need to be changed and implemented too.
It’s all about those algorithms working correctly and yes we are once again back to my favorite word here, it’s the decision making mathematical formulas that we use for decision making processes, all over the place, technology, budgets, you name it. This has also opened some doors for additional companies to try and help different areas of development, with matching software with medical hardware devices and in doing so new partners who have never worked together before are getting acquainted. No matter what we do, we all still “have to get acquainted” in one form or another. Here’s an example of one such company, e-Zassi where last year I conducted an interview with the President to find out more of what it is all about. The VC firms out there may certainly be having a look here when looking at their risk management models.
E-Zassi Introduces Online US FDA Regulatory Calculator – Medical Device Assessment
You can go straight to the interview at the link below and read up on how collaboration can take place with this web based product without exposing patients or intellectual property rights.
e-Zassi Marries Innovation and Collaboration in the Medical Device Industry – Interview with Peter Von Dyck
I’m sure there may be several other companies similar in nature out there, but this company asked to chat with me last year and I am somewhat familiar with what their algorithmic processes are. Last year I also spoke in depth with Microsoft Life Sciences and what directions they are headed and going, these are the heavy 
weight folks that think on their feet and in the interview we discussed what they are doing for Pfizer in the research/technology area to move things forward.
A Deep Dive into Microsoft Life Sciences Today and in the Future – Interview with Michael Naimoli
I might guess event the FDA at times as well as the rest of us is pondering too for direction at times since this is such a big moving target with having the weight of being the ultimate consume protection agency out there relative to healthcare. Back in September of 2008 under the former administration, the FDA had a report out that some of their researchers will still writing out studies in long hand and that all employees didn’t have a computer, so you can now see how values have changed rapidly with technology use and how the old “tech denial” folks hopefully have been forced back into some type of closet if you will so we can all learn and move forward. We have a lot of drug and device recalls that have to be handled correctly too. I have my own little suggestion campaign below for some of this.
Microsoft Tags on CBS Early Show – Wake Up FDA, Pharma and Medical Device Companies –Scan Those Drugs, Medical Devices and Synchronize with an FDA Tag Data Base – Recalls, Theft Tracking and More….
In summary, the investors and the FDA and all of use are somewhat in the same boat here with emerging technologies and trying to predict what direction some decision will go, and with investors putting some big dollars out there and expecting a return, it gets complicated. To bring Health IT into the FDA realm too, reliance on other departments and outside technologies is a must – this would be brand new regulatory territory for them and it is the way we are headed with one department relying on collaboration with other departments and outside developed technology. BD
A small survey of the New England Venture Network by MassDevice.com shows real concern among local investors over moves made by the Food & Drug Administration.
Concerns in the investment community over changes in the 510(k) clearance process and other uncertainty over new regulation at the Food & Drug Administration outweigh worries about the healthcare reform act, according to a MassDevice survey of local med-tech investors.
The survey, conducted with the help of the New England Venture Network, polled a dozen VC professionals in the life science community. The respondents said that, overall, the climate for medical technology investment was "mostly negative." The survey was kept small and anonymous to ensure open and honest responses.
The investors cited regulatory changes at the Food & Drug Administration as their primary concern.
"For now, we have stopped investing in any new med-tech companies with FDA exposure," wrote one investor.
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