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
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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
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Google

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
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FDA

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
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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
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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
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A look at the medtech players that came out on top this year.

Medtech can be a volatile business—one year you're up, the next, you're somebody's punching bag. But in 2014, these players and technologies fared better than the rest. 

 

[main image courtesy of DIGITALART/FREEDIGITALPHOTOS.NET]

December 8th, 2014
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Medtech experts are increasingly advising companies to look for revenue beyond U.S. shores. The idea is that overseas markets while challenging are ripe for the picking and can help to increase top line revenue given slower markets domestically.

Large companies like Medtronic, Stryker and Covidien have set up manufacturing and R&D facilities in places like China to take advantage of the emerging nation's appetite for healthcare. Companies are also doing business in Brazil, not to mention Japan and Europe. Yet 2015 will bring a new reality for companies operating overseas and in emerging markets - especially for those whose foreign revenue makes up a big chunk of their overall revenue.

The culprit: the strong American dollar, which essentially means that it's more expensive to conduct business overseas.

In a research...

December 8th, 2014
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A new nongovernmental organization is seeking to leverage mobile and connected health technologies to improve healthcare access for the poor in the United States. 

By Bradley Merrill Thompson

I mentioned to a friend that a group I am involved with is launching an NGO called Aventor, the mission of which is to encourage the use of connected health—technologies like mobile apps and telemedicine—to increase access to healthcare for the poor in America.

He looked at me like I was daft, then asked me three questions:

  1. Anatomically speaking, aren’t the poor somewhat similar to the rich? (According to research, it turns out they are!) So how can...
December 5th, 2014
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wearables, mhealth, digital health device, mhealth device

On Thursday, PricewaterhouseCoopers published a report on the top 10 health issues of 2015, which found that 90% of MDs in a survey done by its Health Research Institute said mhealth apps and devices will be important to their practices over the next five years.

And nearly half pf physicians polled said they would use data from an urinalysis device/app for example to prescribe medication or decide whether a patient should be seen. 

As the importanec of wearables and mhealth in the clinical environment is growing, one healthcare provider is actually making a wearable device...

December 5th, 2014
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