A recent report describes new business models disrupting healthcare while also providing clues to where opportunities lie for medtech companies.

Arundhati Parmar 

Business model innovation is a buzzword underscoring the current need for large and small medtech companies to find new ways to be relevant and add value in a rapidly changing healthcare paradigm.

A recent report on the state of the medtech industry globally provides a visual clue as to efforts at business model innovation that is addressing the overall concept of "quality healthcare." The "Thinking Ahead, 2nd LIMEDex Index Report" from Swiss consultancy Concep+ shows how different strategies are being put to work on...

June 30th, 2015
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Academic research points to FDA as the regulator with the appropriate amount of oversight for medical devices.

Marie Thibault

There's a surprising finding in a recent academic paper on medical device regulation and its impacts on innovation—FDA strikes the right balance as a regulator. It's a novel conclusion regarding the agency, since stakeholders often claim FDA is either too strict or too lenient.

The paper, "Regulating Innovation with Uncertain Quality: Information, Risk, and Access in Medical Devices," was authored by Matthew Grennan, PhD, assistant professor of Health Care Management at The Wharton School...

June 30th, 2015
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Thinking about bringing your medical device to Canada? Get familiar with the basics of Health Canada regulations.

Don Boyer

In the almost 25 years I spent regulating medical devices within Health Canada, one thing remained a constant trend in my conversations with foreign manufacturers, particularly the small to medium size companies: the general lack of understanding of the Canadian medical devices regulatory framework and requirements. To a certain extent, this was not surprising given Canada’s population and market size in comparison to the United States or the European Union, or given Canada’s largely “public” healthcare system where budgets for healthcare are constantly under pressure. The Canadian market was likely not the first choice for many companies. However...

June 29th, 2015
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A new MD+DI ebook sponsored by Cirtec lays out best practices for medical device design.

Jamie Hartford

Before Apple legend Steve Jobs brought beautiful, elegant consumer tech devices to the masses, design was thought of as little more than the art of choosing a color scheme.

“Most people make the mistake of thinking design is what it looks like,” Jobs was famously quoted as saying. “People think it’s this veneer—that the designers are handed this box and told, ‘Make it look good!’ That’s not what we think design is. It’s not just what it looks like and feels like. Design is how it works.”

That philosophy is especially relevant...

June 29th, 2015
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Materials failures account for a significant percentage of medical device recalls and performance problems but are often overlooked as a potential source of risk. 

Amy Heintz, PhD

Will the materials in your medical device perform as expected when it counts? Materials failures account for a significant percentage of medical device recalls and performance problems but are often overlooked as a potential source of risk.

An Undercounted Cause of Product Failures

Medical device product recalls have been rising steadily over the past 15 years. According to a...

June 29th, 2015
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Healthcare enterprise systems can be especially hard to secure against cyberattacks. An expert offers tips on how to get started.

Adam Hesse

Anyone following today’s headlines is aware that cyberattacks represent a very serious threat to virtually every business sector. Even the largest enterprises are susceptible to cyberattacks that result in not only data breaches, but also data corruption and the introduction of destructive viruses. Still, the numbers may surprise you. According to IBM, companies are attacked an average of 16,856 times per year, with many resulting in a quantifiable data breach....

June 26th, 2015
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Healthcare buzzwords are too often misused and abused. It's up to companies to give them meaning.

Jack Plotkin

It is not surprising that an industry as complex as healthcare is rife with buzzwords that are commonly misused or misunderstood—sometimes by accident, other times by design. In the face of sweeping change from forces as diverse as the Affordable Care Act and cloud computing, healthcare provides particularly fertile ground for befuddling buzzwords. With healthcare organizations struggling to keep pace, opportunistic vendors have coopted emerging terminology to put a new sheen on legacy products while industry administrators have been peer-pressured into misusing the terms before fully processing their meanings.

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June 25th, 2015
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In an analysis of FDA approvals for medical device PMAs, one state is the obvious winner, with the shortest time to approval. Which state is home to the quickest PMA approvals?

Marie Thibault

Minnesota wins again as the state with the fastest regulatory approvals. After being crowned a few weeks ago as the state with the shortest average time for 510(k) clearances—115 days—a new analysis shows that Minnesota also has the fastest average time for first PMA approvals, at 376 days.

Both analyses were conducted by Minnesota trade association LifeScience Alley using data...

June 25th, 2015
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Electrical, Electronics, and Electromechanical Assemblers

Electrical, Electronics, and Electromechanical Assemblers

2014 Industry Employment: 5620

Percent Change Since 2012: 36.74%

Salary: $34,210

             ...
June 24th, 2015
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Chemists and Materials Scientists

...

Chemists and Materials Scientists

2014 Industry Employment: 460

Percent Change Since 2012: 31.43%

Salary: $87,860

             
June 24th, 2015
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