Complaints that FDA’s busiest pathway to market for medical devices is anything but straight piled up in 2014.

By Jim Dickinson

Looking back, 2014 will be remembered as the year when FDA’s busiest medical device route to market, the 510(k) “substantially equivalent” process, came under unprecedented challenge amid calls for structural change and even general abandonment.

There is dissatisfaction with the 510(k) status quo both within FDA (if unexpressed) and throughout industry and patient activist communities.

Industry Complaints

Kicking off the argument in January was a petition from the Minneapolis-based DuVal & Associates law firm on behalf of the Minnesota Medical Device Alliance and the medical device industry generally asking FDA to...

December 17th, 2014
 Biomerics microcatheter

Significant technological progress, favorable reimbursement conditions, and the medical device industry's windfall—the massive army of aging baby boomers—will spur the U.S. neurovascular market to exceed $600 million by 2020, according to market research firm iData Research

 And a critical driver of growth in this sector has been the various advancements in microcatheter design and development. "Almost every device placement or therapy taking place in or above the neck will require a microcatheter to support the intervention,"...

December 12th, 2014

To realize the benefits of big data in healthcare, technical, regulatory, and financial hurdles must be overcome.  

By Bill Betten

Today we hear a lot about big data and how it will revolutionize our lives in variety of ways. In healthcare, big data offers breakthrough possibilities from increased efficiencies and better outcomes to lower costs and more personalized care. But as connected applications provide us with more data than ever before, many organizations are struggling with what to do with that data to take full advantage of its potential.

This article explores some common pitfalls of big data in the medical industry and discusses strategies to leverage this data to affect change and improve healthcare.

The amount of information being generated in the healthcare...

December 10th, 2014

Large Consolidators

It was the year of the megamerger. In an effort to better compete in the new healthcare landscape, several major players sought to gain scale, complement their product portfolios, and extend their reach into the hospital.

In a $42.9-billion deal that rocked the industry, tax inversion and the resulting access to overseas cash became the focal point of Medtronic’s intent to acquire Covidien. But the synergies between the two companies and long-term business strategy proved to be a primary driver.

Prior to Medtronic’s big news, Zimmer set off the wave of megamergers when it announced plans to acquire cross-town rival Biomet for $13.35 billion. The deal is expected to secure the orthopedic giant’s stronghold in the large joint market and better position itself to compete with...

December 8th, 2014

 Companies that Fought FDA and Won

Medtech companies that have ever gone toe-to-toe with regulators let out a cheer this year when two from their ranks won significant battles versus FDA.

In June, Electromedical Products International Inc., a maker of cranial electrotherapy stimulation (CES) devices, prevailed in its nearly quarter-century campaign to convince FDA to down-classify CES devices from Class III to Class II.

Then, in September, the Washington DC Court of Appeals ruled in favor of the plaintiff in Ivy Sports v. Burwell. Ivy Sports had been fighting a decision by the agency to rescind market clearance for the Collagen Scaffold surgical mesh that forced its predecessor company, ReGen Biologics, into bankruptcy in 2011.

These David-versus-Goliath victories provided a welcome dose of...

December 8th, 2014

Proteus Digital Health

Proteus is leveraging medtech to help pharma.

Proteus Digital Health is leveraging medtech, pharma, wireless technology, wearable technology, cloud computing, and mobile health to solve one of the biggest problems in healthcare: how to get patients to comply with their medication regimen.

The company’s FDA-cleared ingestible sensor, coupled with a wireless patch, can track when patients take their pills or if they miss a dose, as well as collect information on heart rate, respiration rate, and activity. That data can be shared with family members, caregivers, and physicians via the cloud.

Investors are noticing, too. This year, they...

December 8th, 2014


Google's smart contact lense technology has been licensed by Novartis.

While tech players like Apple and Microsoft danced around the medtech market this year, Google, the sector’s 800-pound gorilla, entered it in earnest.

The Web search giant grabbed industry headlines in January with the announcement that its secretive Google[x] lab was working on smart contact lenses that can monitor blood glucose levels. By July it had inked a deal with Novartis’s Alcon eye division to develop and commercialize the technology.

And the company isn’t stopping there. In October, Andrew Conrad, who leads the life sciences team at Google[x], revealed an ambitious...

December 8th, 2014


FDA commissioner Margaret Hamburg

The traditionally cool relationship between U.S. regulators and the medical device industry seemed to warm somewhat this year.

Nowhere was the shift more apparent than at AdvaMed 2014, the annual conference held by the industry’s biggest trade group. In session after session, panelists praised FDA for making progress in terms of transparency, predictability, and cooperation with industry.

Even Edwards Lifesciences CEO Mike Mussallem admitted the “FDA climate has dramatically improved.”

A town hall meeting with CDRH representatives including director Jeffrey Shuren was positively congenial, with Shuren cracking jokes and members of the audience actually laughing.

So what’s behind the industry’s change...

December 8th, 2014

Clinical Wearables


 Medtronic's Seeq is a 30-day wearable, continuous cardiac monitor. 

Wearables landed on MD+DI’s 2013 loser’s list largely because of the overwhelming focus of wearables makers to create health and fitness-type consumer devices with scant regard for moving the needle on chronic disease management or in using wearables in a regulated, clinical environment. This year, however, major strides were made to incorporate wearable devices in clinical environments both by startups and established companies, while providers began to adopt them, too.

Chrono Therapeutics, based in Hayward, California raised $32 million to develop its SmartStop programmable transdermal drug delivery system to help...

December 8th, 2014

Edwards Lifesciences

Edwards' Sapien XT has been a boon for the company in 2014.

Last year, Edwards Lifesciences landed on our list of medtech losers for an overly cautious U.S. launch of the Sapien transcatheter heart valve that threatened its first-mover advantage in the lucrative transcathether aortic valve replacement (TAVR) space. Yet despite Medtronic’s earlier-than-expected U.S. launch of the CoreValve, Edwards has maintained its market-leading position.

The company’s continued dominance in the sector has been attributed to the European launch of the Sapien 3 coupled with the U.S. launch of the next-generation, lower-profile...

December 8th, 2014