MD+DI readers got a chance to rate FDA on several criteria. They were harsher on the agency than our regulatory experts, but you may be surprised by the issue for which they gave FDA high marks.

Marie Thibault

Our readers are tough critics! Last month, we gave readers a chance to weigh in on what they think of FDA. This followed our FDA Report Card 2015, where we asked regulatory experts to grade the agency on a number of criteria.

The five readers who participated in our reader poll included people working in R&D, engineering, and as regulatory consultants. All had firsthand interaction with FDA. Based on this, it seems industry is harder on FDA than the regulatory experts. Almost...

September 3rd, 2015
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Large and mid-sized medtech companies have had their eyes on emerging markets for a while now, but even the world's biggest medtech company is dealing with a difficult question. 

Arundhati Parmar

Back in 2012, management consulting firm McKinsey & Co. published a piece that advised medtech companies to follow lessons learned from other industries to be successful in emerging markets.

It advised medtech firms to adopt seven strategies to accelerate growth and capture the mid-tier market that including moving away from a distributor led model to build presence and local insight, enable local...

September 3rd, 2015
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Coming up with a breakthrough innovation isn't enough; you have to prove its worth, as one 19th century doctor tragically learned. 

Jamie Hartford

Ignaz Semmelweis was an early pioneer of antispetic procedures, but his contributions were not really appreciated during his lifetime.

 

Innovation isn’t always appreciated. Take, for example, the story of Ignaz Semmelweis, a 19th century Hungarian obstetrician.

At the Vienna hospital where Semmelweis practiced, the maternal death rate was about five out of every 1000 live births, although Semmelweis noticed that the rate quadrupled when physicians,...

September 3rd, 2015
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Mini-laparoscopic surgery is gaining favor among thought leaders in surgery. Find out why some experts believe "mini-lap" should be used more frequently.

Marie Thibault

 

Although mini-laparoscopy, a surgical technique that allows for even smaller incision sites than traditional laparoscopy, has been performed by some surgeons for years, the technique may finally be coming into its own. Surgeons who have been perfecting "mini-lap," as it is known, believe it is better not only for cosmesis, but is also better for surgeons and comes with fewer patient side effects. 

This flies in the face of what many believe. Some in the medical profession have dismissed mini-lap as allowing for smaller scars in easy cases but not good for...

September 3rd, 2015
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Continuous glucose monitors are evolving to better service people with diabetes, but those without diabetes could also benefit from CGM technology. What's needed to make CGM accessible to a wider patient population?

Samantha Katz

 

Dexcom's G5 CGM transmitter and a smartphone are tools that can be used to monitor blood glucose levels.

The recipe for a successful health wearable is still in the works. Many have gotten step one right (acquire lots of users) but step two (retain lots of users) has yet to be perfected. In fact, Rock Health, a leading digital health investment fund and accelerator, dug through Fitbit’...

September 3rd, 2015
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Two studies point to the need for a more efficient, informed medical device approval process at FDA.

Jim Dickinson

Their pedigrees and their scholarship couldn’t be faulted—two deeply researched studies emerged in the dog days of August when most Washington policymakers were away, each providing potent reasons for speeding up the FDA approval process for medical devices.

The first, with no fewer than 26 authors from diverse professional settings in academia, industry, clinical practice, informatics and government, came from FDA with far-reaching recommendations to integrate existing and developing data systems and registries to “promote continuous accrual of benefit/risk and safety knowledge from invention to obsolescence.”

Entitled Recommendations for a...

September 2nd, 2015
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Despite the technology’s potential to help with everything from reducing costs to customizing devices, 3-D printing has barely scratched the surface in medtech.

Jamie Hartford

 

Still not sold on 3-D printing for medical? Today at the MEDevice San Diego conference, Derek Mathers, business development manager at Minneapolis-based product design firm Worrell Design, presented a convincing argument to make doubters change their minds.

Sales of 3-D printing machines and materials have quadrupled since 2010, with the market currently valued at $4.1 billion, Mathers said. Consumer tech giants like...

September 1st, 2015
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Pay attention to these four best practices when developing a combination product.

Arundhati Parmar

Combination products are complex by the very fact that they involve the confluence of multiple elements - drug and device; device and biologic, or biologic and drug.

That is precisely why it's imperative to follow best practices when developing these products, says David Amor, managing partner and principal at MEDgineering Inc at the MEDevice San Diego Conference and Tech Showcase Tuesday.

Here are the four that all companies developing combination products should consider:

Figure out Your Primary Mode of...

September 1st, 2015
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Medical device makers that have facilities outside the United States and use foreign suppliers are still being scrutinized by FDA. An expert weighs in on the specific challenges device manufacturers face today.

Marie Thibault

The medical device industry is becoming increasingly global, with U.S. companies gaining foreign facilities and trial sites through outsourcing, acquisitions, and geographic expansions. Suppliers from outside the United States are providing the components for medical devices cleared and sold in the United States.

But even though these facilities and suppliers are physically located far beyond the U.S. borders, FDA still has responsibility to ensure U.S. devices are safe. This means FDA has had to expand its OUS presence as well. 

What is FDA doing to...

September 1st, 2015
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BioSig Technologies

Minneapolis-based BioSig Technologies wants to improve the success of ablation procedures to treat cardiac arrhythmias with its Pure EP System, which cuts out noise to improve electrophysiology recordings.

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August 31st, 2015
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