By Scott Sheaf

 
 
This is a pretty exciting time for mHealth and personalized medicine. We are on the brink of major changes in the way we manage our own health and wellness. Apple and Samsung’s recent entrance into the health and wellness arena with their respective HealthKit and Simband platforms are the latest, albeit high profile, addition to the wealth of work going on in the quantified self and personalized health space. Both companies are taking the approach of developing a platform and...
June 9th, 2014
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There is a term for the seismic changes occurring in medtech and the broader healthcare marketplace today: I call it the "Atlas Shrugged" moment.

Atlas of course is the Greek mythological figure charged with carrying the planet on his shoulders. Imagine him shrugging: If he does, the old world together with all its comfortable assumptions comes crashing down.

That analogy seemed even more apt after an interview with Shaye Mandle, the new president and CEO of LifeScience Alley, a respected industry association in Minnesota that is attempting to reinvent itself just as its customers - medtech firms - adapt to the changes wrought by the Affordable Care Act. 

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June 6th, 2014
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The Proteus Ingestible Sensing Solution

Proteus Digital Health is redefining what remote patient monitoring means with the introduction of a pill that taken alongside a medication can tell physicians whether the patient has been adhering to the medication regimen at home or elsewhere. Earlier this week the company raised a whopping $120 million from new investors.

Improving clinical outcomes by making sure that physicians know remotely when patients haven't taken their medication and alerting...

June 6th, 2014
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From the humble stethoscope invented back in 1816 to the hybrid commercial MRI/PET scanner produced in 2008, medical technology has wrought big changes in the medical industry.

The infographic below, created by OBizMedia.com and presented by SmallCellLungCancer.net, captures all the major technological milestones of the medtech industry including the above, making the case for how the industry has made life better by allowing faster diagnosis, less invasive treatments and shorter hospital stays.

 

[Featured Photo: iSotckophoto.com user ...

June 4th, 2014
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You hear of phrases like the new healthcare paradigm. You hear of a fundamental shift in how healthcare is consumed and paid for in the U.S. You hear how fee-for-service is going to one day collapse under the infinitely more practical, but perhaps a little bit hard to quantify, fee-for-value.

And yet these are not pie-in-the sky schemes, nor the latest buzzword doing the rounds.

To borrow a VC's phrase - a tectonic shift is underway. Medtech companies are being asked by their hospital customers to help solve their problems, sell their devices even more cheaply, and do more to keep patients healthy. As medtech companies try to reinvent their business models, what attitudes that would cause companies to fail need to be identified and then require a full 180-degree pivot?

Here are five:

We are not focused on...

June 3rd, 2014
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Predictable and repeated returns on investments in medical devices have been elusive during the past five years. 

That has led entrepreneurs who are still active in medtech, where many have withdrawn or failed, to search for the most effective models to finance a successful startup.

Of course, there have been some exceptions where above average exits have been driven by investments in ground-breaking technologies such as TAVI, refractive surgical devices and surgical oncology tools. In large part, however, too much capital has been buried in companies hindered by lengthy regulatory and reimbursement processes and expensive distribution efforts.

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May 30th, 2014
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Europe has long been considered an ideal market for the first commercial launch of innovative products, thanks to its size and a regulatory system that is perceived as more predictable, consistent, transparent, and speedy than that of the United States. But with potentially more stringent regulations on the horizon in the EU, will medtech companies reevaluate their launch strategies?

Launching innovative products in Europe first has allowed medtech companies to gain market and patient access three to five years quicker than they would in the United States, ...

May 29th, 2014
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It seems like it wasn’t just President Barack Obama who took inspiration from Doris Kearns Goodwin’s book about Abraham Lincoln entitled, “A Team of Rivals,” and brought on archrival Hillary Clinton as secretary of state after the 2008 elections

Current trends in the orthopedics industry seem to indicate that executives are adopting a similar approach. Zimmer, for example, hopes to have a green light from the Federal Trade Commission on its plan to acquire close competitor Biomet in a deal worth $13.35 billion.

And then just this week after rumors surfaced, Stryker CEO...

May 29th, 2014
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By Keith Barritt

 

Should you submit your app for FDA clearance? Keith Barritt of Fish and Richardson, a law firm specializing in medical device-related litigation, offers some quick tips to guide you.

The Food & Drug Administration’s 2013 guidance on mobile medical apps limits the agency’s regulation to apps that both (1) fit the definition of “medical devices” and (2) whose functionality could pose a risk to a patient’s safety if they do not function as intended....
May 29th, 2014
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By Megan Kuhn

The medical device development cycle can be a continuous iteration of progress and setbacks, but the competition for releasing the product to market puts the pressure on medical device companies to expedite a quality delivery and minimize delay. Pushing the project at breakneck speed results in cutting corners in the name of expediency and can have the consequence of forcing the team to compromise on quality if not properly managed. But, the good news is that the fast-track does not need to mean compromising quality for time. When applied artfully, fast-tracking your product development ensures product quality while maximizing the time and efforts of the team. The next time you want to effectively fast-track your product development, consider these few tips:

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May 28th, 2014
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