All articles by Thomas C Novelli

The need for speed: the US race to improve device regulation

On 23 June 2010, the Food and Drug Administration (FDA) and Centers for Medicare and Medicaid Services (CMS), the federal…
Save the Innovation Ecosystem

As the global leader in the development and commercialisation of medical devices, the US is at a crossroads. A new…
Foreign Affairs: Marketing Medical Devices Overseas

One of the greatest challenges for any medical device company is to gain access into new markets. Such challenges are…
FDA Under Pressure

Any company that has recently applied for a Premarket Application or 510(k) clearance for their medical device may have noticed…
Stormy Outlook for US Healthcare Industry

The recent healthcare reform debate in the US positioned the medical device industry for a period of anxiety unlike anything…

Innovation Under Siege from Potential Taxes

It was only a few months ago that the US device industry's primary concerns with healthcare reform were focused on…
Change of Face

The promotion of medical technologies in the US can be generalised in targeting two broad audiences. The first audience is…
Patents: A New Direction

The intricacies and ever-changing dynamics of patent law in emerging medical devices markets have been discussed at length. As device…
Change on the Horizon

The 2008 elections in the US marked a significant divergence in public opinion in the policy direction of the United…
A Costly Global Challenge

The worldwide financial crisis has caused many industries to adjust their financial projections and outlook for the next several years.…