Today, Information Week listed its top 10 Health IT predictions for 2012. Sure, there are tons of predictions to sift through this time of year, but, at first glance, three of these ten seem particularly significant. They are:

  1. By the end of 2012, the bulk of U.S. providers will be using electronic medical records (EMR).
  2. Successful accountable care organizations (ACOs) will be established.
  3. Payment for healthcare costs will be increasingly tied to successful outcomes.

electronicsIf those three predictions turn out to be accurate, they would represent a sea change for how healthcare is delivered in this country. (The remaining seven predictions are worth checking out, too.)

The first is tied to the...

December 28th, 2011

The da Vinci robot from Intuitive Surgical is a fascinating device. The robot, which enables physicians to perform surgery from a remote console, transformed the standard of care and created a new market segment when it debuted a decade ago. It has since played a significant role in bolstering the adoption of minimally invasive surgical procedures. Hospitals that own a da Vinci robot or two often promote the fact that they do because it makes good sense from a PR standpoint; owning a da Vinci robot helps hospitals look high tech. The manufacturer has played a role in this, of course, and has supported robust media relations efforts.

The maker of the device has essentially a monopoly in the market segment and was thus able to have a compound annual growth...

December 27th, 2011

Medtronic and the University of Minnesota's Medical Industry Leadership Institute Student Association (MILIsa) recently sponsored an interdisciplinary competition at the university’s Carlson School of Business. The event, which has been held for four consecutive years, attracts students from a variety of studies to solve problems in the medical device industry.

Medtronic also has a similar-minded initiative known as Medtronic Eureka that attempts to bring physicians and inventors together to come up with ideas for new medical technologies.
A reader wrote in to share his perspective on the news. “I know Medtronic well enough to know that they have their own agenda, but I applaud them for thinking outside the box and tapping as many minds as possible,...
December 20th, 2011

Steven NiedelmanI recently spoke with Steve Niedelman, lead quality system and compliance consultant King & Spalding LLP (Washington, DC) who is speaking on the topic of supplier controls at the upcoming MD&M West trade show held in Anaheim, CA in February 2012. Before his tenure at King & Spalding, Niedelman was the deputy associate commissioner for regulatory operations for FDA.

Niedelman gave me a preview of his talk (more information is available on the MD&M website) and shared some advice for medtech companies that outsource to destinations such as China and India. 

Many companies don't really know the companies they...

December 20th, 2011

The MD+D team is gearing up for 2012, and we need your help.

Have a design question you can't answer? Maybe confusion over a quality or regulatory practice is slowing down your development process. Have you heard about a new technology that might improve your job performance? Perhaps your cross-functional teams aren't all that functional. Let us know and we can help.

We'll tap into our experts and create practical articles to help you meet your goals, answer your burning questions, or provide tools to help your team.

Send us a note or leave a comment below.

The MD+DI editorial team

December 20th, 2011
By Joe Pustka
Staying one step ahead of the market by coming out with new design iterations consumers want proves to be a winning strategy for most.
Change the color to one that market research shows has more appeal? Why not!
Use a newer composite material that will significantly lower the device weight? Why not!
However, based on my experience developing leak detection systems for medical devices, considerable fat can be trimmed from new product development if more upfront consideration of every detail of full-scale production is made even at the earliest stages of prototype development. This could be that added lean manufacturing boost that so many seek in these economic times.


December 19th, 2011

FDA logoWhile FDA (CDRH) and the medical device industry have a long history of antagonism, the relationship seemed to become especially sour in 2011. The agency has acknowledged it is facing real problems with staff turnover and tight funding. Both of these issues are leading to inconsistent reviews in the CDRH Office of Device Evaulations and, yes, some degree of incompetency—because many of its new reviewers are recent college grads with no relevant work experience.

But many of the decisions the agency makes are fair and rational. Sure, it doesn't help when, for instance, Jeffrey Shuren, MD, blames most of 510(k) clearance delays on the industry, when high CDRH staff turnover is at least part...

December 18th, 2011

Last week, at the Biomedevice conference in San Jose, at a presentation titled "Speed to Market for Medical Devices," panel member Stacey Chang, healthcare director of design firm IDEO had an interesting perspective on how many companies fool themselves with unrealistic expectations during product planning. 

"A conversation we commonly have with our clients is one we call project anchors. It’s the consulting version of the good, fast, or cheap—which two do you want?" he said. In this method of viewing a project, there are four anchors, Chang explained: the product cost, product features, project cost, and project timeline. "You don’t get all four," he explained. Instead, companies should identify which...

December 16th, 2011

A colleague and I visited with a startup company last week, one that was designing a product that can detect certain ailments through your breath. Named Menssana Research, the company is housed across the street from the New Jersey Institute of Technology, in a building owned by the college (which just happens to be my alma mater).

One test that company claims to have perfected is a non-invasive breath test for markers which can predict the probability of a Grade 3 rejection in heart transplant recipients who received their transplants in the preceding year. Called the Heartsbreath, it consists of a breath collection apparatus (BCA) that resembles a small telescope.


The BCA collects volatile organic compounds found in a person’s breath using a sorbent trap. You can see it in action in this...

December 16th, 2011
Robert Perry, MD, a resident at University of Oklahoma Medical Center, has developed a simple device to help clinicians locate vasculature. The EZ Vein device, which  works similar to a blood pressure cuff, redirects blood flow from deep tissue to a selected vein near the surface in order to simplify injection. Unlike tourniquets, the device works in the absence of a pulse. FDA approved the device in only 17 days, reports the Daily Oklahoman.
Perry, a practicing physician develops devices in his spare time. He explained that his product ideas are born out of his practice, where he identifies product needs. “I have a machine shop at house,” Perry told the Daily Oklahoman. “I would see a need and think about, build a prototype...
December 15th, 2011