Medical device inventors, engineers, and executives know the importance of inspiration. Design and innovation experts weigh in on how to encourage ingenuity.

Marie Thibault


How do some medical device companies churn out hit products consistently? Perhaps they've perfected the art (and science!) of cultivating flashes of genius or "lightbulb moments" among their employees. 

At the June 2015 MD&M East Conference in New York City, a panel of experts talked about how to achieve such moments within a medical device organization. Panelists included Tom KraMer, president of Kablooe Design; Jeffrey Reynolds, director of Technology Innovation at Bayer Healthcare; Craig Scherer, senior partner and cofounder at Insight Product Development; and Joseph Gulfo, MD...

July 22nd, 2015
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Senators have introduced a bill to streamline current FDA regulations for combination products. What does it entail?

Marie Thibault

Legislators this Congressional session have had no shortage of proposals intended to improve medical device innovation. See—among others—the "21st Century Cures Act," the "FDA Device Accountability Act,"  the "Protect Medical Innovation Act," and the "Innovation Act." 

Now...

July 22nd, 2015
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One company is attempting to usher in a new era of retail clinics by leveraging digital medical devices and the cloud to connect patients to providers in a convenient setting.

Arundhati Parmar

Retail healthcare has largely meant the ability of consumers suffering a minor ailment to walk into the likes of Target, CVS and Walgreen and get a diagnosis and prescription by experienced nurse practitioners.

One company that has been attempting to turn that model on its head is HealthSpot, a telehealth startup that is seeking to bring the expertise of board certified providers into the retail...

July 21st, 2015
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Positive exposure from key opinion leaders is an important part of medical device marketing. How can device companies make the most of their KOL relationships?

Julie Wegman

Medical device companies invest heavily in training subject-matter experts (SMEs) and building relationships with key opinion leaders (KOLs) in order to establish themselves as thought leaders and provide peer-to-peer perspective on key topics pertaining to their specialties, therapeutic areas, and/or products. They are contracted to give talks, create content, assist with trials, get involved with grant funding, sit on advisory boards, and more. And they can be paid handsomely to do so.

Companies that manage KOLs are not doing it out of the kindness of their hearts. They’re likely doing it to drive...

July 20th, 2015
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Despite strong interest, bids to overhaul the 510(k) regulatory process have hit a wall. The chances for reform seem to be waning—at least near term. 

Jim Dickinson

As another 510(k) safety issue emerged in July and an injured-patients’ legislative 510(k) reform effort took an unexpected hit on Capitol Hill, the prospects for significant change in the status quo seemed to be wobbling on a high-wire act.

The pivot-point is a basic question first presented by a controversial and widely ignored 2011 Institute of Medicine committee report that concluded that FDA’s 510(k) process “cannot be transformed into a premarket...

July 20th, 2015
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About 30% of medical device patents awarded in the United States go to international applicants, and these countries are leading the pack.

Jamie Hartford

The vast majority of medical device patents granted by the U.S. Patent and Trade Office go to applicants from the United States. From 1994 through 2013, around 70% of medical device patents awarded by the office went to U.S. applicants. But what about the other 30%? Here's a look at which countries are seeing the most applicants staking a claim to their intellectual property in the United States.

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July 17th, 2015
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Read expert advice on how to implement FDA’s rule on current Good Manufacturing Practices for combination products.

Mary C. Getz, PhD, Olivia Wong, D. Michelle Garrett, and W. Ben Shand

In January 2013, the FDA’s Office of Combination Products (OCP) released the final rule for 21 CFR Part 4 to address current Good Manufacturing Practices (cGMPs) for combination products. This regulation was followed up by a companion draft guidance published in January 2015 to further clarify the final rule and to provide additional recommendations on the application of cGMPs to combination products.

However...

July 16th, 2015
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There are three key factors to consider when creating a device that enhances a patient’s abilities and senses.

Nigel Syrotuck

Many animals in the world can sense an amazing variety of things. So why can’t we?

If you’ve seen The Sixth Sense, you may believe more than five senses exist—and you’d be right. However, unlike the thrilling conclusion to the movie, these extra senses aren’t supernatural. They just aren't human—yet. Scientists, body modification experts, and biomedical device manufacturers have come up with ways to break the limits of our “regular” human bodies and let us feel things that no humans ever have before....

July 15th, 2015
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The Patient Will See You Now

Influential physician Eric Topol follows up his 2013 book, The Creative Destruction of Medicine, with The Patient Will See You Now, which explains how the doctor-knows-best mantra in medicine is giving way to patient empowerment.
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July 15th, 2015
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Enchanted Objects

David Rose, an MIT Media Lab scientist, explores the future of the Internet of Things in Enchanted Objects, his prediction of how omnipresent technology will transform our lives.
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July 15th, 2015
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