Stuart Karten Says Obamacare Will Innovate Medical Device Design

 In a recent radio interview with KCRW, Stuart Karten, principal of Marina Del Rey, CA-based Karten Design, said that the restrictions imposed by Obamacare are a blessing in disguise for medical device designers. While many bemoan the impact of the medical device tax, Karten told KCRW that anticipation of the tax is a good thing for new products entering the market.

MD&M West, Feb. 10-13, 2014. 
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“When you put constraints or barriers around anything it causes innovation and things to pop up,” Karten said. “With the Affordable Care Act and Obamacare there's a whole range of things that are driving really good things from a design perspective and an innovation perspective.”
While older products can't simply raise their price point, Karten argued, new products can build the tax in. Big business is taking a hit now he said, but in the long term will reap the benefits of the the up to 9% increase in people moving into healthcare. “It's short-term versus long-term thinking,” Karten said.
He credits a lot of this design innovation to “a move from sick care to healthcare.” Doctors who were previously paid for performing procedures will now be held accountable for outcomes under Obamacare. For Karten, this opens up a window for designers to focus on patient compliance and on designing products that foster and encourage behavior change. He cited a number of Karten Designs's work such as their development with AliveCor and it's still-developing Latitude Heart Coach mobile app, which will provide patients with access to data from their implantable cardiac defibrillators (ICDs). “Now you have to have patients engaged in their actual outcomes,” Karten said. “Now the hospitals are not just interested in what goes on in the hospital, they're interested in what happens when you leave the hospital.”
Listen to Stuart Karten's full interview with KCRW below:

-Chris Wiltz, Associate Editor, MD+DI


Regulations For Everything Except : "I've Fallen & Can't Get Up

It seems that all the talk around the Medical Device Tax has focused on the wrong area. No one has mentioned any focus on the quality of the device itself.
Why don't we want to discuss this area ? Why are we content with implant recalls on hip ,shoulder , knee and mesh implants. The public seems oblivious to the fact that there is no real guidance but "best practices" revolving around implant quality control. I'm very curious how the device tax scenario will play out but I fear it will be akin to accountents bayoneting the wounded during an audit.

Re: restrictions

Karten is referring to are the new rules imposed by the medical device tax itself with regards to the definition of a taxable device itself. Depending on their product companies may have to comply with certain provisions to make sure their device is taxed correctly (if at all). Retail devices for example such as contact lenses and hearing aids are subject to a retail exemption.

The IRS has some handy (albeit long) documents that clarify some of the restrictions and requirements of the tax.