Medical Device App - FDA Regulations

I've pretty much given up on blogging, replacing it with app development as a hobby.  One of the apps I created, FDA Regulations, is medical device related.  It simply displays FDA regulations in an app format so you don't have to carry around a book.  It can be downloaded for free from the Google Play Store (Android only).

Good Intentions

In The Road to Hell is paved with Good Intentions a playground expert talks starts with a discussion about requiring helmets at all times and ties it into updated standards for playground surface and what happens in real life.  Sometimes these things just don't work out like expected.  On children wearing helmets:

The question arises then, what is the impact of using a safety helmet? In talking with child development physiologists they suggest several issues. First they suspect, although there is little research on this, that such protective gear may disrupt the normal progression of reflex maturation. They also are concerned that the lack of consequences when falling may retard the child’s ability to form proper assessments of their skill, i.e. reduce their judgment. Finally they speculate that it reinforces a pattern of parenting that is over protective and ultimately harmful.

On playground surfaces:

There are many possible reasons for the accident rates to remain unchanged that have nothing to do with the resiliency of the landing surface. One possibility is that the recent trend to cover the entire playground with rubber is so expensive that the amount of play equipment has to be reduced significantly. This results in a lack of events, which in turn reduces the opportunities for graduated challenge that allow kids to gain skills incrementally. On the one hand little kids must use equipment that is beyond their skill level and on the other hand older kids find little to challenge them and so use the equipment in inappropriate ways.

This type of debate happens in medical devices, although working through ASTM to make appropriate changes is probably much easier than working through the FDA.  There are a lot of good intentions that don't necessarily lead to better outcomes.

New Links

I've added Ford & Associates to the links on the side.  He has a blog covering mostly medical device quality and regulatory news, but the feed isn't working right for me at this time.

I've also added a link to Knobbe Medical's Blog.  All of Knobbe Medical bloggers are very well dressed so you know they're not wrong (feel free to use that quote on  your website guys).  I can assure you that I don't clean up so nice.  For some reason their feed doesn't seem to work either, maybe its Blogger's issue.

Just FYI, I signed up as an Amazon associate, if you buy anything through one of the Amazonlinks on this site, I get a small percentage at no additional cost to you.

Start Up Blog

Blake Masters has an outstanding series of posts covering Peter Thiel's CS183, a class on start ups.  Class one is here, the index is here,  Class 7 or 8 are where it really gets into it with how to approach venture capitalists.  If you are interested in starting a start up, joining a start up, shutting a competitive start up down, or just like to read about business, you'll enjoy them.

On the Job Advice

A few non specific business links I thought were interesting to read, mostly about getting things done.  Not necessarily the safe approach.

Seth Godin asks: "Why am I here?"

This is a simple mantra that is going to change the way you attend every meeting and every conference for the rest of your life.

You probably don't have to be there. No gun held to your head, after all. So, why are you spending the time?

Boston Globe on: Why setting goals can backfire

IN THE EARLY years of this decade, General Motors had a goal, and it was 29. Determined to boost its flagging profits and reverse a long, steady fall from postwar dominance, the automotive giant did the natural thing: it set a goal. The company pledged to recapture 29 percent of the American market, the share it had ebbed past in 1999.

...industry analysts argue that one of the most damaging things the company did was to set that goal.

In clawing toward its number, GM offered deep discounts and no-interest car loans. The energy and time that might have been applied to the longer-term problem of designing better cars went instead toward selling more of its generally unloved vehicles. As a result, GM was less prepared for the future, and made less money on the cars it did sell.

And one I don't like from Best Life and Career:  5 Tips to Get Unstuck When You Hit a Plateau  I won't quote it, but Take a Class?  Really, this is the best we can do? 

I suggest re-evaluating what is actually value added work and focusing on those items and working to eliminate the rest.  I find that when I get bogged down and don't seem to be making any progress its usually due to overwork which doesn't allow me to focus on what I really feel needs to be done.  Drilling down I find that much of the overwork is due to various individuals' preferences that helps the individual, is marginally useful for myself, but overall bad for the company.  Yeah, you'll get that report reformatted from the database standard, that compliance memo drafted to supplement a non-conformance or corrective action, or that inspection annotated with extra details, but why do you want this from me?  No one else can write a memo?  Choose to do work that matters.  Engineers make more than $50 an hour and you want me to do this several times a week at the expense of work non engineers can't do.