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

Innovative, early-stage medtech startups should consider crowdfunding as a potential source of capital and a means of demonstrating market demand to future investors.                   


Crowdfunding, via the rise of such platforms as Kickstarter and Indiegogo, has become a cultural phenomenon in recent years. Entrepreneurs have leveraged the concept to finance ventures ranging from ridiculous pet projects such as The World Speed Project, which aims to collect every available VHS copy of the 1994 Keanu Reeves bus-based thriller Speed, to humanitarian efforts,...

October 1st, 2014

By Jim Dickinson

If your company is among the recipients of more than 100 letters from CDRH rescinding a marketing clearance under Sec. 510(k) of the Food Drug and Cosmetic Act, you’re now arguably free to resume marketing the affected device because FDA’s letters are illegal. That’s the bottom line of a September 26 decision by the Court of Appeals for the D.C. Circuit.

In a 2-1 decision with a whiff of politics about it, the George W. Bush–appointed majority overwhelmed its Obama-appointed colleague to rule in Ivy Sports Medicine v. Burwell that FDA cannot short-circuit the statutory medical device reclassification process by rescinding a 510(k) decision in what FDA...

September 30th, 2014

If the fanfare over the iPhone 6 has proven anything it's that Apple's customers are just as loyal and rabid as ever. Meanwhile, the last time people waited in line for hours for a Google product was...well, it hasn't ever happened.

However, in a piece for Forbes, writer Dan Munro argues that Apple's popularity won't necessarily give the company a leg up in the healthcare space—especially given how deeply Android phones have penetrated the market. While Apple may be a top selling brand, it's the only one with iOS phones. Phones that run on Google's Android OS outnumber iPhones 2-to-1 according to estimates.
Munro argues for three key reasons Google will win out over Apple in the healthcare space:
1.) Google is winning with software...
September 29th, 2014

Manufacturers of Class III medical devices are now required to submit unique device identification data to FDA’s Global Unique Device Identification Database. Here’s how to ensure the process goes smoothly.

By Denise Odenkirk

Starting September 24, 2014, manufacturers of Class III medical devices have been required to submit unique device identification (UDI) data for their products to FDA’s Global Unique Device Identification Database (GUDID). In the coming years, this requirement will extend to manufacturers of Class II and Class I devices as well.

To comply, many manufacturers are choosing to leverage UDI to achieve a more consolidated view of product data within their organizations. Having a holistic technology solution that generates the required Health Level 7...

September 25th, 2014

 By Melissa Masters

Cybersecurity is a growing concern in all aspects of our lives. From our home computers, servers that store our credit card information and identities, and now our medical information and medical devices that we rely on to keep us healthy (and even alive in some cases) are all at risk. But, with new FDA guidance and growing media awareness, the bar is being raised regarding the expectations for a secure device. At the same time, the opportunities for attacks by cyber criminals are increasing. Securing devices, systems, and infrastructure is a critical issue for all of our safety and the challenges here are great.


September 24th, 2014

If you're heading to Minneapolis October 29 and 30 for the show, here are four happenings you'll want to catch.

Minneapolis has long been the center of the medical device universe, serving as a home to industry giants and startups alike. And on October 29 and 30, 2014, thousands of other industry professionals will converge on this important medical device industry hub for MD&M Minneapolis, the Midwest’s largest medical design and manufacturing conference and exposition. If you’re heading to Minneapolis for the show, here are five happenings you won’t want to miss.

Conference Sessions

Stay on top of industry trends and developments by attending some of the educational sessions available at the...

September 23rd, 2014

FDA has announced its intention to issue draft guidances on the regulation of laboratory-developed tests—a controversial decision that could increase the burden of compliance and stifle innovation.

By Allyson B. Mullen

Allyson Mullen

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of LDTs, entitled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)” and “...

September 19th, 2014