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Compliance In Focus


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Posted by John Lehmann on Wed, Mar 04, 2015

Taking Medical Device Opposition Directly to Employees

We have written many blogs on the medical device tax and thought we have covered almost angle on this issue.  However, we thought this article in FierceMedicalDevices brought a new strategic twist to the discussion. There has been a concerted effort by the industry to repeal the 2.3% medical device revenue since it was introduced in the Affordable Care Act.

Topics: AdvaMed, Medical Device Tax, Affordable Care Act

Posted by John Lehmann on Wed, Mar 04, 2015

A Call to Eliminate Tax on Certain Medical Devices

Earlier this month Congressman Mike Turner of Ohio reintroduced the First Responder Medical Device Tax Relief Act. According to the press release on the Congressman’s website, this legislation is to repeal the2.3% excise tax on the sale of medical devices by manufactures, providers, and importers.

Topics: BioOhio, Medical Device Tax, Congressman Mike Turner

Posted by John Lehmann on Wed, Mar 04, 2015

3 Costly Traps on the Road to Device Innovation

No matter the therapeutic area, device companies agree: Creating cutting-edge products is expensive. From the R&D costs to the pricy FDA fees, the expense for innovation adds up quickly. As products become more technologically advanced, the cost for designing new devices has increased. At the same time, device companies are being hit with fees that are wiping out their R&D budgets, such as the new 2.3% medical device tax, which reportedly requires companies to collectively pay an estimated $194 million per month. How do the companies overcome this expense?

Topics: Medical Device Tax, Device Innovation, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Just Who is Paying for the Medical Device Tax?

As of this month, the US Medical Device Sales tax has become a reality. Many device companies have braced for the impacts of the tax, and we’ve covered the topic at length in anticipation for the changes ahead. An early observation that has been buzzing around the industry is that hospitals are bearing the brunt of the tax burden from the raising rates.

Topics: Medical Device Tax, Fierce Medical, Medical Device Industry

Posted by John Lehmann on Wed, Mar 04, 2015

5 Questions Regarding the Medical Device Tax

As the medical device industry braces for the impacts of the Medical Device Tax, we’ve covered the topic at length as we try to understand all the effects the new tax will have on the medical device industry. Stone Carlie is a firm that focuses on business consulting and wealth advising.  Recently a blog was posted on their website that brings understanding to a new facet of the tax in an easy to follow question and answer format.

Topics: Medical Device Tax, Stone Carlie Blog, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Top 3 Challenges for the Medical Device Market

The US market for medical devices has faced numerous obstacles and changes over the last several years. While some are easily resolved, many challenges facing our industry continue to linger. A recent article on Becker’s Orthopedic and Spine’s website featured an article which focuses on the pressing challenges currently facing the medical device industry.

Topics: Medical Device Tax, Top 3 Challenges, Medical Device Market

Posted by John Lehmann on Wed, Mar 04, 2015

The Great Debate: Medical Device Tax

Even though the election has been settled, the debate over the medical device tax continues.  We have covered this debate in earnest, but thought you might enjoy seeing a recent opinion column in Politico.   The column was written by industry leaders who argue that medical device tax will thwart industry innovation and needs to be repealed by Congress.

Topics: Medical Device Tax, Affordable Care Act, Debate

Posted by John Lehmann on Wed, Mar 04, 2015

Affordable Care Act: Impacting America’s Leadership?

Affordable Care Act: Impacting America’s Leadership? At the Medical Device Conference 2012 (MedCon), held at Xavier University, in Cincinnati, Ohio, Kem Hawkins, President and CEO of Cook Incorporated and Cook Medical, delivered a powerful keynote address. In his speech, Hawkins proposed that FDA has not demonstrated the leadership necessary for the United States to maintain its position as global forerunner in the healthcare arena. Hawkins also touched on his opposition to the medical device tax included in the Patient Protection and Affordable Care Act (ACA).

Topics: Medical Device Tax, Kem Hawins, Cook Medical, Affordable Care Act

Posted by John Lehmann on Wed, Mar 04, 2015

The Affordable Care Act: The Implications for Med Tech Companies

The Affordable Care Act (ACA) (colloquially known to many as Obamacare) was signed into law last year. However, many Americans are still trying to grasp what this reform means to them.

Topics: Medical Device Tax, The Affordable Care Act, Med Tech Companies, Amy Siegel

Posted by John Lehmann on Wed, Mar 04, 2015

Finding the Hidden Costs in the Medical Device Tax

There continues to be rumblings about the medical device tax from the industry.  This article in MassDevice talks about concerns over the hidden cost associated with the legislation.  With less than 9 months until the 2.3% sales tax becomes a reality many in the industry are coming to realize that the levy may, in fact, be even more expensive than initial projections indicated.

Topics: Medical Device Tax, Impact Profits

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