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

By David P. Mierswa 


The healthcare Industry is facing many legal issues that not only affect healthcare workers, but patients as well. “Obamacare,” also known as the Patient Protection and Affordable Care Act (PPACA), has been the central topic within the healthcare industry for many years now. The constitutional and implementation issues are among some of the most challenging. In the wake of the PPACA, healthcare providers are facing major compliance issues and cost in the millions. However, putting aside the PPACA, there are many other legal issues facing the healthcare industry that are just as important.

The issue of data breaches is another hot button topic facing the healthcare industry. As providers switch from paper to complete electronic systems, they...
October 13th, 2014
Attendees at AdvaMed's 2014 Conference

One of the top medical device conferences - AdvaMed 2014 - concluded in Chicago, Wednesday and a few themes emerged around an industry that is witnessing seismic changes in what the marketplace is demanding.

Reimbursement Is The New Challenge
An executive from health insurance company Cigna succinctly encapsulated the mood of the medtech industry when it comes to reimbursement.

"The enemy used to be the FDA and now I hear it's us," said Scott Josephs, MD and VP, National Medical Officer, Cigna to the audience, only half joking.

In fact at AdvaMed officials kicked off the conference with the...

October 8th, 2014

Stuart Karten thinks the world needs to look more like the movie Her, especially with regards to health. “Today it seems like we're obsessed with screen size, resolution, thickness, new gestures, and bendablity,” the principal of Marina del Rey, CA-based Karten Design told the audience at the 2014 USC Body Computing Conference. “Serious issues to be considered, but certainly not going to lead us to the solutions of the future.” 

In the film Her the technology behind Samantha (voiced by Scarlett Johansson)– the artificially intelligent operating system – never draws attention to itself. It simply exists, allowing Joaquin Phoenix's character to work, manage his schedule, play video games, and even fall in love without...
October 7th, 2014

 By Tom KraMer

Brainstorming is taking lots of heat lately.
Some suggest that “out loud” brainstorming favors the bold or other personalities who tend to dominate every meeting. Alternatives include brain-writing or brain-swarming, which focuses more on writing out your ideas so that extroverts cannot dominant introverts and hamper idea generation. Still others suggest that the brain doesn’t make connections in a rigid atmosphere, because there is too much pressure or politics for people to freely respond.
Most people are not really knocking brainstorming. What they are criticizing is the results you can pull out of brainstorming.
October 1st, 2014