Saturday, August 25, 2007

What difference does a $1.65 make to you?

[Click on Post Title for Link to External Article]

To some, it could mean getting the year's largest investment deal, or not..

In somewhat of a funny way the series E round of $110 mn USD that Globus Medical raised, leads the amount raised by CardioNet, another medical device company by just $1.65.

It does seem like a coincidence, but I would say someone, somewhere has a sense of humor after all.

Sense of humor aside, one would wonder are we at the front end of a bubble that is just forming, or is there really a lot of money to be invested in medical devices?

Before shooting off, remember neither Globus Medical nor CardioNet are new companies flittering around with a bunch of prototypes. They are both well-established companies, that have been around for a while, have been selling products and are not doing too bad themselves.

So these companies might not even be good examples of venture funding. However, it does seem encouraging that at many levels, Venture Capital firms trust medical device companies quiet a bit.

For more, do take a look at the comment posted in the linked blog article.

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Thursday, August 23, 2007

Radiant Medical: a blimp in medical device history but a grave leasson to learn and re-learn about the industry

I heard this on the Medical Device Network newsletter today:
"Radiant Medical of Redwood City has ceased operations as of today when further venture funding was not available. Nearly all of the 25 employees were laid off. Radiant was a private medical technology company focused on the research and development of endovascular therapeutic hypothermia. This news was relayed to me by an employee who is leaving today."

For those in Wall Street, medical device companies are just another avenue to praise or complain about the economy. Whenever there is a small movement at Medtronic, J&J or Boston Scientific, there is a lot of noise. But the difficulties persist for smaller companies too.

Medical Device companies have to wade through a whole array of problems leading from safety and efficacy to quality, regulation, competition among hundreds of other factors. Having a great idea and a great team might also not be enough for an industry riddled with several problems.

Radiant had a lot going for them. From what I have known historically, therapeutic cooling did seem like a good idea. Radiant's team also was supposed to be good. (A friend of mine used to work there in the past and only had good things to say about the place). Still, it took too long and while we may or may not find out the actual reasons behind why the device never took off, they simply ran out of funding.

The moral of the story: even if you have good things going for you, it may not be enough in medical devices!

The takeaway: If there are geniuses in your company wasting time with paper work, unnecessary plant closures, too much pow-wow about innovation without actually producing anything, and creating a hostile enough working environment that the company looks like one big revolving door...fire 'em! You already have too much to worry about as a medical device company!

This is also a warning. In the medical devices industry there cannot be and should not be a bubble! So don't be taken in by all the funding that is driving the industry right now. When the correction happens, and it will, things can get painful...

The point is not to make a gloomy post, but to make sure that people have their feet planted on the ground when looking at the industry.

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Wednesday, August 22, 2007

New FDA rules to benefit everyone by reduced fee structure for PMA applications

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So the FDA went ahead and generously reduced the fee structure, even for international companies. They realized a lot of companies are not in a position to pay. I agree. We are all happy with this news.

I am also glad that the EU lobbied with the US to reduce fees.

However, the FDA has me looking at them in admiration! Here's why:

Guess this is their way of making sure that not one of us goes back and asks, "So why in heaven where they charging companies (inside or outside, shouldn't matter - we are talking of people's health) with such exorbitant fees to start with?"

But wait, I just did....oh well. Enjoy submitting your innovations for approval!
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Tuesday, August 21, 2007

The USPTO: Killing innovation, 5 claims at a time...

[Click on Post Title for Link to External Article]

So, too many patents are being filed. Yes, maybe there are not too many people innovating, but just folks trying to protect everything under and above the sun...

It is becoming harder to review patents...

Too many companies are fighting over them...

And, of late, the work has started becoming strenous...

Voila! The new rules of USPTO ensure that not only will all these problems go away but they will also ensure that ALL logic will be defied!!! After all, isn't it the first duty of the government to ensure that over time its services become limited, confounded, expensive and anti - public?

Why would I only have five independent claims to a patent? Why is 5 the magic number? Why cannot I have more than 2 reviews to extend my patent? And why did this just become more expensive for me ? (In case you didn't notice, the person(s) filing the patent now have to do some of the USPTO's work...)

If there is any glimmer of hope to save us from deliverance by the USPTO, it would be the public comment period ending October 9. Hopefully, this doesn't promote other branches of the government to adopt the USPTO philosophy. After all, there has been all this talk about free speech and how everybody wants it.....

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