Here's a look at how to make sure you're jumping through all the right regulatory hoops to bring your mobile medical app to market.

By David Amor, CQA, MS

mobile medical apps

Editor's note: This is the fourth installment in David Amor's Med-Dev from Scratch: Compliant Innovation column dedicated to helping entrepreneurs build their medical device companies in a compliant and streamlined way. You an also read the first, second, and third...

November 3rd, 2014


St. Jude Medical's Nanostim leadless pacemaker.

Leadless pacemakers and implantable cardioverter defibrillators (ICDs) are expected to deliver a welcome jolt to the cardiac rhythm management (CRM) market in the coming years owing to their small profile, potential to reduce complications, and shorter recovery times. The pace at which they live up to that potential may be slower than anticipated, however.

While transvenous devices have long been the standard of care, they’re not without significant drawbacks. Several high-profile recalls during the past decade, for example,...

October 28th, 2014

If last year was a good year for M&A activity, 2014 can safely be described as the year when mega merger mania overtook the medtech world.

On Monday, two other companies caved into the charms of scale and what heft can achieve in a new world of fee-for-value in healthcare.

Memphis, Tennessee-based Wright Medical Group said that it is merging with Amsterdam, Netherlands based Tornier N.V. in an all-stock deal worth $3.3 billion. The combined company named Wright Medical Group N.V. will be based in Amsterdam but led by Wright Medical's Robert Palmisano. David Mowry, Tornier’s president and chief executive officer, will become executive vice president and chief operating...

October 28th, 2014

If I hear of one more wearable device that tracks heart rate or sleep or respiration rate, I am going to have a meltdown.

Making products for the worried well as venture capitalist Wende Hutton so succinctly puts it, as opposed to people who are really ill, seems to be a gross misuse of powerful technology that the human race has developed.

But two companies are deciding that they want to tackle big problems in healthcare using wearables. The problem in this case is healthcare-associated infections.

According to the Committee to Reduce Infection Deaths, a nonprofit educational campaign, more than 100,000 people in the U.S. die each year...

October 27th, 2014


Why does something so simple become so difficult?

By David Amor, CQA, MS

Editor's note: This is the third installment in David Amor's Med-Dev from Scratch: Compliant Innovation column dedicated to helping entrepreneurs build their medical device companies in a compliant and streamlined way. You an also read the first and second installments in the series or hear him speak about improving existing methodologies in design, review, verification, and validation at the...

October 24th, 2014


Consolidation has been a hot topic in the medtech industry in 2014 as uncertainty over the move to a value-based healthcare system has led large companies to merge with others. 

One example of that is Medtronic wanting to buy Covidien for $42.9 billion. The hope is that by reaching out to other parts of a hospital system - such as general surgery - beyond the cath lab where Medtronic's core products are found, it can sell more products to providers. In other words, it can bundle products across...

October 22nd, 2014

The company’s chief medical officer and vice president of global clinical affairs shares his take on the trend of medtech megamergers.

St. Jude Medical has long been skeptical of rival Medtronic’s attempts to change the medtech industry’s business model.


Last year, after Medtronic began its foray into the hospital solutions realm with the purchase of remote monitoring firm Cardiocom,...

October 20th, 2014

Mark Carlson, St. Jude Medical’s chief medical officer, explains how the CardioMEMS HF System might evolve and shares his vision for the future of epidemic disease care.

Heart failure patients used to be stuck in the intensive care unit so physicians could manage their condition. But thanks to the CardioMEMS HF System, which uses an implantable wireless sensor and external transmitter to measure pulmonary artery pressure and send it to physicians remotely, they can now be effectively monitored in the comfort of their own homes.

October 15th, 2014


By John Pennett and Joseph DiFalco

2014 has seen a surge in medtech companies going public. EP Vantage has reported "a frenzy for device company IPOs" with seven firms going public in April 2014 alone - almost as many the 12 firms that went public in all of 2013.  
Once a small medtech company has determined that an IPO is the right strategy, the road ahead might seem uncertain and overwhelming. Up until now, internal efforts were most likely focused on developing a viable product, business strategy, etc. Developing...
October 14th, 2014

By Rich Quatrocchi

With organizations and bipartisan politicians lobbying for changes and improvements to HIPAA to accommodate mobile apps and technologies it's important to address just how much of an impact that HIPAA-compliant mobile apps can have, particularly in the role of patient engagement.

Now, more than ever, hospitals are under pressure to improve patient outcomes and reduce readmissions. With billions of dollars on the line, patient engagement plays a key role to lowering costs.
Medical contact centers combined with mobile applications are positioned to revolutionize post surgical follow up. HIPAA-...
October 13th, 2014