Articles By Jim Pomager
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Graphene Biosensors — The Next Frontier In Medical Diagnostics?
9/18/2014
Graphene — the übermaterial that is 1 million times thinner than paper, 100 times stronger than steel, and the world’s best conductor of both electricity and heat — has become one of the hottest areas of materials science R&D over the past decade. Much of the graphene research has focused on two main objectives: 1) finding a way to better manufacture the substance, and 2) identifying the best applications for it. Recently, I was introduced to a company that claims to be close to achieving both goals, and its work could have considerable influence on how graphene is used in healthcare, particularly in the area of in vitro diagnostics.
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Window Through The Skin: The Development Of A Pocket-Sized Imaging Device
9/3/2014
I have a confession to make: I am more than a little afraid of needles. When it comes to getting blood drawn, an IV inserted, or pretty much any other procedure that involves shoving one of those pointy little devils through my skin and into my blood vessels, I am an abject coward. So you can imagine my enthusiasm when the folks at Analogic introduced me to their new Sonic Window ultrasound device, which was recently cleared by FDA for use in peripheral IV access procedures. Read on to learn how this novel approach to handheld ultrasound imaging made its way from the university to the clinic.
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Could Your Next Device Be Exempt From FDA Premarket Requirements?
8/25/2014
CDRH has been busy in August, issuing more than 10 new guidances and draft guidances — with a week left to go. The first new guidance of the month basically amounted to a list of some 170 medical devices that the FDA proposes exempting from 510(k) premarket notification requirements. If your device doesn't appear on the list, it would be tempting to simply disregard it. But by doing so, you could be missing out on an important opportunity.
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7 Unconventional Ways To Fund A Medtech Startup
8/5/2014
Bringing innovative new medical technology to market today is as challenging, complex, and competitive an endeavor as it’s ever been for entrepreneurs. Making matters worse, venture capital — the fuel that fledgling companies once depended on to drive product development — has dwindled in recent years. Hear what industry experts from Cleveland Clinic, UnitedHealthcare, and other organizations have to say about nontraditional sources of funding that just might fit the bill for your medtech startup.
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Cutting Through The Remote Patient Monitoring Hype
7/21/2014
There is so much hype surrounding remote patient monitoring (RPM) — and related buzzterms like wearables, mobile apps, big data, the Internet of Things (IoT), and mHealth — that sometimes it is difficult to separate hyperbole from reality. What opportunities does RPM really afford medical device makers? What should they do to take advantage? How do wearables fit into the equation? Should the medtech industry fear or embrace the involvement of tech titans like Google and Apple? Read on for answers to these and other important RPM-related questions.
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Reverse Engineering A Human Heart Valve
7/8/2014
The man who literally wrote the book (two books, in fact) on the aortic valve has devised a new artificial valve design that that he says will revolutionize transcatheter aortic valve implementation (TAVI). And if everything goes according to plan, his heart valve could reach European patients in 2015 and U.S. patients soon after. Find out how he and his startup company developed this technology — by using the natural aortic valve for their design output.
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Do You Make These 5 Usability Mistakes In Your Medtech Development Process?
6/27/2014
Major healthcare systems are starting to pay much closer attention to usability during the medical device procurement process. They are establishing internal human factors teams, having usability experts evaluate technologies prior to purchase, and sharing their learnings with other healthcare systems. If you fall prey to these five usability design pitfalls, your device won’t stand a chance in this new user-centric procurement environment.
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5 Tips For Successfully Outsourcing A Medical Device Clinical Trial
6/22/2014
Medical device manufacturers are under increased pressure — from regulators, payers, healthcare providers, and even patients — to amass more clinical data on their products than ever before. As a result, there has been a rise in medical device clinical trial activity, and a corresponding increase in the outsourcing of clinical trial services. This article explores five best practices for working with clinical research organizations, based on my experience at the inaugural Partnerships in Medical Device Trials Conference this month.
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4 Important Medtech Policy Takeaways From The MDMA Annual Meeting
5/22/2014
During his opening remarks at the Medical Device Manufacturers Association (MDMA) Annual Meeting, MDMA chairman Dan Moore pointed out that we were sitting in a meeting room called the “Hall of Battles,” a fitting location for a besieged U.S. medical device industry to draw up its plan of attack. The enemies at the gates are legion: a “punitive, misguided device tax” (as Moore put it), inefficient regulatory and reimbursement pathways, a dysfunctional patent system, and many others. Here are the four main observations I took away from the event.
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State Of Innovation: The Next U.S. Medtech Hotspot
5/6/2014
Minnesota. California. Massachusetts. Ask someone to list the top U.S. states for medtech activity, and these are the names you will usually hear (in some order). But another state has quietly positioned itself to join the ranks of the medtech elite. Find out which state it is, along with 7 reasons why medical device and diagnostics companies are flourishing there.