Latest Commentary

Go big or go home: A call for 2015 Fierce 15 nominations

We need your help to ferret out the best, most timely examples of med tech innovation. Who has ambition and the potential to make a real leap forward, while being wildly appealing to physicians, patients and payers across a global healthcare environment that is increasingly value-based?

U.S. to vie with India for top bioabsorbable stent market after FDA approval

Bioabsorbable stents are projected to account for 17% of global procedure volume by 2021, up from less than 2% in 2014, said GlobalData analyst Amen Sanghera during a recent webinar. He's a bull on the emerging technology, and estimates a compounded annual growth rate of 56.7% over that time period.

Advice for med tech entrepreneurs: Identify your customer and consider stakeholders' incentives carefully

The med tech ecosystem is diverse and teeming with myriad stakeholders, to the point that identifying the customer of a company or device can be challenging. Successfully creating a new company in med tech means identifying the customer and then finding a way to meet that group's needs.

Outgoing FDA commissioner highlights record, outlines industry future in farewell remarks

Margaret Hamburg gave a forceful recounting of her tenure at the agency in her final formal remarks as outgoing FDA commissioner. The March 27 speech at the National Press Club in Washington, DC, seemed designed to hand the baton off smoothly to FDA Chief Scientist Stephen Ostroff, who has been widely cited as her presumptive replacement.

DOJ cracks down on devicemakers in 2014 with $100M+ in fines

In a show of force, the Department of Justice just announced two fines against providers for healthcare fraud under the False Claims Act totaling more than $10 million. The news coincided with release of an annual report on healthcare fraud, which claims that the feds recovered $3.3 billion in fiscal year 2014.

FDA will discuss challenges and opportunities of robotic surgery at public meeting this summer

The FDA is putting robot assisted surgery in the spotlight this summer. 

Medtronic prioritizes product development post-Covidien deal close

A little more than a month after Medtronic closed its $49.9 billion purchase of Covidien, the combined company is forging ahead with ambitious plans for growth. And as Medtronic's chief integration officer, Geoff Martha, told FierceMedicalDevices, the company's "first and foremost strategy" involves developing new devices to support innovative therapies, ultimately cutting costs and making healthcare more efficient.

Remote patient monitoring taking off as hospitals look to empower patients, cut costs

Remote monitoring can empower patients and lead to more fine-tuning of care while saving hospitals money and helping hospitals meet their Affordable Care Act goals. Sales of remote-monitoring devices are expected to top $32 billion this year, according to Market Research Group, and will grow at a compounded annual growth rate of 9.2% between 2014 and 2019.

Feds set reimbursement targets, increasing government payments' impact on device world, M&A

Secretary of Health and Human Services Sylvia Burwell, incoming head of the federal Centers for Medicare & Medicaid Services, last week set explicit goals toward paying providers based on quality and not quantity, as the agency aims to put the fee-for-service model to sleep--permanently.

U.S. pushing for provision on fair medical device, drug reimbursement in free trade agreement with Asia

Negotiators are debating a section of the planned Trans-Pacific Partnership free trade agreement that would commit the 12 member countries to transparent procedures and fairness in federal medical device and drug reimbursement decisions, AdvaMed Senior Vice President Philip Agress told FierceMedicalDevices.