Contributor: Karen Gierszewski

Over the last few years, a slowdown in the growth rate of the US medtech industry has occurred—while 2004 yielded a growth rate of more than 15%, 2010 showed a much more modest 3.5% expansion. It’s easy to quickly blame this on the allegedly burdensome Food and Drug Administration (FDA) approval process or economic difficulties, but are there other factors at play here?

Contributor: Karen Gierszewski, Mashkur Reza, Kyle Verleyen

There have been a couple interesting and unexpected events in the orthopedic biomaterial market over the last few weeks. First, BioMimetic Therapeutics has not yet received Food and Drug Administration approval for its Augment Bone Graft , which was originally anticipated to enter the market in 2012 following a positive recommendation for approval in May 2011 .

Contributor: Karen Gierszewski

As Valentine’s day 2012 rolls around, we can barely go anywhere without being inundated with hearts—heart-shaped decorations, heart-shaped candies, teddy bears holding hearts. All great indications of a fun, happy holiday. But what about for those of us nursing a broken heart this year?

Contributor: Karen Gierszewski

Several instances of faulty implants have recently put pressure on regulatory bodies to examine if they need to better track devices postapproval. In the US, this pressure has occurred amid concerns over metal-on-metal hip implants.

Contributor: Karen Gierszewski

I think we can all agree that as we come out of a rough 2011 for medtech, a number of questions are weighing on everyone’s minds for 2012. On January 31, MRG COO Ken McLaren answered these questions with his presentation on the top 10 trends that medtech companies should look out for this year.

Contributor: Karen Gierszewski

Both Medtronic and Boston Scientific have been hit with multimillion dollar tax claims by the US Internal Revenue Service (IRS). Combined, the two companies could owe the IRS approximately $2 billion, although both companies plan to contest the allegations in US Tax Court.

Contributor: Karen Gierszewski

The first time I came across an article on hacking into digital medical devices, I dismissed it pretty quickly. After all, what could be the possible motivation for hacking an insulin pump or a pacemaker? But then I came across another one. And then another one. Maybe this topic does deserve some attention?

Contributors: Karen Gierszewski and Sara Scharf

The threat of pay cuts for doctors treating Medicare patients still looms. While the implication for medical device manufacturers will not be as obvious as for the reimbursement prepayment audits, discussed yesterday, it could potentially hinder the adoption of electronic medical records (EMRs) among physician practices due to lower incomes in general.

Contributors: Karen Gierszewski and Sara Scharf

Physicians have been reacting to the news that the CMS is rolling out a new pre-reimbursement review system across 11 states. This system would involve challenging doctors for proof that a procedure is necessary before granting reimbursement, which is a significant change from the status quo.

Contributors: Karen Gierszewski and Sara Scharf

With the economic turmoil affecting the European countries, it seems natural that the medtech industry would suffer the consequences. But how exactly are each of the big five European countries feeling the effects of economic instability? Are recent health care reforms substantially changing anything?