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Why is regulation going to get worse? In what sense?

Worse in the sense that there are various complexities. How do we discern safety and efficacy? How much efficacy do we need to show against cost benefits? For safety, of course, everyone realizes — absolutely: We do not want to put anything out there that is not safe. The complexity of understanding efficacy and cost benefit, however, won’t come from a double-blind trial as we do in pharmaceuticals. What are the benchmarks that we are setting as our regulatory hurdle? This is where we need to begin communicating with the government, otherwise we will be regulating the cell phone as well as the potential tool that we are putting out there. That will only increase the cost burden and defeat the purpose of efficiency.

Any closing thoughts?

Yes, I think another purpose for our event is to increase awareness and clarity of the potential investment in wireless healthcare from several groups — the venture capital, institutional investors, corporate investors and government private equity. The pools of capital that really going to fuel innovation here have yet to get clarity on the model. I really want people to explain the model in terms of how these are revenue generating and sustainable opportunities. Some of that explanation only comes from creation, but there are many companies experimenting with this and we’d like to know how they are doing it. Explaining that there are various ways that this is going to work will help both entrepreneurs and investors understand that appropriately. Start-ups don’t all have to be as capital intensive as a CardioNet, for example.

And all of this will be covered at the event you are producing at Duke University?

Yes, we were very fortunate to get such a stellar line-up. Attendees will speak highly of all of our speakers because they are all thought leaders and successful operators of various private and public entities. The commentary that comes out of it will be very meaningful. We will present to both policy makers and investors something that is both extremely important and exciting.

We thought it was high time to produce an event related to the medical device sector, and so we are starting with Wireless & Consumer. This event is more of an industry institutional investor-facing event that includes speakers who are setting the stage for the next stage of healthcare. This is really going to be a platform for leaders in wireless and consumer healthcare to discuss the issues and successes they have had in maneuvering around particular hurdles.

This will be the inaugural event and we hope that Wireless & Consumer will be an annual event.

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This entry was posted on Thursday, September 10th, 2009 at 6:45 am and is filed under Slideshow. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.