Every time I go home to visit my parents, one thing that comes up more often than not, is the fact that our local Blockbuster closed. It’s been about two years now, and they still can’t get over it. Me? I’m happy to rent from a RedBox, or even better, kick my feet back on the coffee table and click the OnDemand button. Video rental stores have been completely overtaken by something much simpler and cheaper. THAT is what a disruptive technology is.

Now would be a good time to introduce you to my good friend, Clayton Christensen. While I have never actually met him before, he frequently appeared in slideshows in my business classes at grad school. Christensen was the first to coin the term “disruptive technology”. I highly recommend reading his books The Innovator’s Dilemma and The Innovator’s Prescription if you are interested in innovation.

Rather than bore you with definitions, I’ll jump into an example of what disruptive technology looks like in the medical device industry. Back in the old days, people used to eat bacon, eggs, and toast soaked with butter everyday for breakfast, before we knew that cholesterol clogged your arteries. The only option for folks with clogged arteries was to undergo open heart surgery. Open heart surgery is no small matter. They make a large incision, crack your rib cage open, operate on your heart, and then sew you back up. That is assuming, of course, that you were well enough for surgery in the first place.

Then, along came stents. This was a completely new way of unclogging the arteries. This allowed surgeons to make a small incision, guide a catheter to the heart through the blood vessels, unclog the arteries with a balloon, and leave a stent in place to keep them open. There is no rib cage cracking, no 12” incisions, and minimal recovery time as compared with open heart surgery. The improvements in morbidity and mortality were huge.

Stents shook up the cardiovascular industry in a big way. The standard of care completely changed, and a whole new field of medicine was generated. The rate of open heart surgeries decreased dramatically, while the rate of stenting soared. This is a disruptive technology that really reinvented cardiovascular care.

Today, stents are regulated as part of the product code MAF – Coronary Stent. They are a Class 3 device, and require a PMA. Anything in the cardiovascular space is usually a risky type of device, so it is not that surprising that the FDA requires PMA’s on stents. However, I would venture to guess that many disruptive medical technologies would need to go through the PMA or de novo pathway. By nature, a disruptive technology is usually one that has completely new technological characteristics or applications. It would not be so easy to show safety and efficacy of a product if there is nothing else out there that works like yours does.

Is the benefit of the disruptive technology worth the possibly higher regulatory burden? As long as the technology has a strong value proposition, and it really works as you expect it to, I would say yes. If you can overcome the regulatory challenges and get your product on the market, your company, customers, and investors will reap long term benefits.

In one of my previous posts, I hit on how sometimes adoption of disruptive technologies can be slow at first. However, once they hit, they usually hit big. Just drive around, how many Blockbuster’s do you see compared with 5 years ago?

- Sherri

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