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BioWorld - Saturday, September 23, 2023
Home » Blogs » BioWorld MedTech Perspectives » A whole new world

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BioWorld MedTech / FDA / Medicare

A whole new world

Oct. 28, 2011
By Amanda Pedersen
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Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me.

I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway to commercialization via a 510(k) clearance and a pre-market application approval, and I knew that Johnson & Johnson had recently lost a fierce bidding war with rival Boston Scientific over stent maker Guidant – a deal J&J must, to this day, be thanking its lucky stars that it lost.

Without a doubt, reporting on the medical device industry has broadened my horizons as both a journalist and a healthcare consumer. Being a part of the med-tech universe over the past five years has changed me for the better, I believe. The world also has changed considerably in that time frame – for better or for worse, I’m not sure. Healthcare reform, comparative effectiveness, the device tax, CMS reimbursement, and a possible overhaul of the FDA's 510(k) process are just a few of the hot-button topics that have soaked up much of our attention in recent years.

To illustrate some of the ways med-tech has changed during my time at MDD, here’s a look at the top MDD headlines of each October since 2006.

October 2006 – “Editorial adds to new questions about safety, overuse of DES” and “FDA backs blockbuster tech, but its evaluation continues”

October 2007 – “ICD market gets ‘kick in the shins’ from recall of Medtronic ICD leads”

October 2008 – “Panel eyes election’s impact on future medical innovation”

October 2009 – “Innovation is missing from the healthcare reform debate”

October 2010 – “Medtronic to pay $268M to settle Sprint Fidelis suits” and “New challenges could strain long-standing business model”

October 2011 – “Abbott reports plan to split into two separate companies,” and “HIT seen as hottest investment in healthcare,” “Survey says over 40% of VCs plan to pull back,” and “Can FDA be fixed?”

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