5. Putting a Price For Positive Outcomes

Providers and insurers are all reluctant to pay for high drug prices unless the drugmakers can actually prove that they are improving clinical outcomes for patients and/or lowering costs. While the PwC report focuses on drugs, device makers are also faced with the same challenging market. Gone are the days when device vendors could simply tweak an existing product, add a bell or a whistle, and then charge a premium and have no one blink.

Now drugmakers and device makers alike need to prove to payors and providers that their products improve clinical outcomes and also lowers overall costs, a tall order.

Even new advances are often not guaranteed success. Genomics has made remarkable progress in the past couple of years bringing the promise of personalized medicine a little...

December 4th, 2014
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 3. Balancing Privacy And Convenience

The report states that in 2015, the "tension" between data security/privacy and convenience in terms of accessing healthcare data will only grow. In the survey, privacy concerns won out over access to most kinds of data. 

However, people are less concerned about privacy if they can be convinced that sharing data will have a healthcare benefit. More than half of survey respondents said they would be open to sharing data if it improves care coordination. And nearly half were willing to share data to support real-time decision-making.

...

December 4th, 2014
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 2. Making The Leap From App to Medical Device

The Food and Drug Administration has been regulating mhealth apps if they function as a medical device and so far 100 products have been approved, the report states. While all mhealth apps do not need to be regulated and some should stay in the consumer realm, there are others that might benefit from an FDA stamp of approval. 

Even among consumers, 20% of respondents to an HRI consumer survey said FDA approval was very important in their decisions to use a mobile app. Not surprisingly, a greater share of clinicians - 26% - responded that FDA approval was most important when deciding to prescribe apps.

"We believe it's helpful to think of apps like drugs. Just like in a local drug store, we need an "Apps Pharmacy" with tiered levels of certification/regulation and process for physicians to recommend or even prescribe apps," said William Falk, North & South...

December 4th, 2014
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2014 was the year that one of the Affordable Care Act's main provisions - the healthcare exchanges - went into effect. That, along with the Sunshine Act that requires companies to disclose how they physicians and other changes has heralded a shift into a new healthcare paradigm.  

What will 2015 bring? PricewaterhouseCoopers' Health Research Institute (HRI) published a report Thursday that identifies the top 10 health industry issues that will emerge next year. The report is based on an annual fall survey of 1,000 consumers and interviews with health industry experts. 

Here is a slideshow of 10 charts to explain the key issues further:

1. Do-it-Yourself Healthcare

Patients are...

December 4th, 2014
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When it comes to getting the word out about your medtech company, stick with tried and true methods.

By Sarah Sherwood

I talk a lot about how communicating publically has changed. But what the new guard is doing to speak on your behalf is not necessarily better. The old ideas of working with a handful of reporters to help tell a story has worked for years, and the practice, as a result, has helped clients access their customers in an exciting way. The secret to a successful program that yields the results medtech companies want today involves a combination of exercising old and new habits in communications, keeping in mind that some of the new methods aren’t working at all.

Don’t Abandon Traditional Media Relations

Social...

December 2nd, 2014
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A recent report from PricewaterhouseCoopers provides evidence that China is a market that medtech multinationals just cannot ignore.

As growth has stymied in mature markets like the U.S. and Japan, executives need to look eastward in emerging economies for growth, the report urges. And while the prospect of navigating an emerging market with different culture, language and regulatory regimes is daunting, the data that PwC presents makes the market very attractive.

For instance, PwC estimates that between 2013 and 2017, China'e medtech market is expected to grow at an compound annual growth rate of 20% reaching nearly $50 billion by 2017. In 2013, the Chinese medtech market was valued at $23.7...

December 2nd, 2014
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The healthcare industry is one of the fastest-growing - that is not news. However, the infographic below created by NowSourcing takes data from the Bureau of Labor Statistics to present the top seven positions that will need to be filled by the year 2020.

The need for more healthcare workers is in part being fueled by the sheer volume of baby boomers retiring every year.  

 

Healthcare Jobs are Booming

by ...
November 25th, 2014
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During design verification, how many samples should you use for testing? A consultant answers the question.

In the “MyQuickConsult Question Grab Bag," a new series, David Amor, cofounder of medical device consultant marketplace www.myquickconsult.com, will answer one question submitted by clients for the MD+DI readership.

Today’s question comes from a start-up in Minneapolis, MN:

Q: We are planning to launch a second generation of a currently existing product in our portfolio for plaque excision. The product is currently undergoing design verification, but we do not have a standard operating procedure (SOP) or work instructions that specify sample sizes. During design verification...

November 21st, 2014
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Could Republicans' triumph in the midterm elections be the kiss of death to the 2.3% medical device tax?

By Jim Dickinson

One thing the new Republican majority in the U.S. Senate has made certain is the early end of Obamacare’s 2.3% medical device excise tax at the hands of both Democrats and Republicans, despite its negligible impact on anybody.

More a convenient source of political hyperbole than actual economic detriment, the tax became a poster-child of broad unhappiness with President Barack Obama’s management style in general and the reputed ills of Obamacare in particular.

The day before the midterm elections gave Republicans full control of Congress on November 3, the nonpartisan Congressional Research Service provided lawmakers solid backing to repeal the device tax, even if they...

November 17th, 2014
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Boston Scientific has had a great year with strong financial results, but from a legal perspective, it seems that someone has put a pox on the house of the the Natick, Massachusetts company.

On Thursday, a federal jury ordered Boston Scientific to pay a total of $26.7 million to four plaintiffs for making faulty transvaginal mesh products. And then a lawsuit filed by Johnson & Johnson over the Guidant acquisition that has been languishing in court for two years is now...

November 14th, 2014
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