Archive for September, 2014

What FDA’s MDDT Pilot Program May Mean for Diagnostics Business Leaders

September 30th, 2014
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Recently, FDA announced a pilot program to solicit proposals from companies interested in participating in its voluntary Medical Device Development Tool (MDDT) initiative. This FDA pilot initiative will allow the development of certain standardized tools (e.g., biomarker detection test, methods of measuring clinical endpoints or outcomes, or in vitro animal, human or computer models) to help FDA and device manufacturers assess the safety, performance and effectiveness of devices. In FDA’s view, a validated development tool that has been reviewed by FDA and made broadly available could potentially be used to reduce time and resources needed to develop products, and possibly reduce the number of rejections by the agency.


One of the proposed requirements of the MDDT initiative is that the tools be made freely available to the public, an element that has caused industry to balk. Both AdvaMed and Boston Scientific have offered suggestions to make the program more palatable to industry, one of which includes having the tool(s) still reside in the hands of the companies that develop them, but made available to other entities via licensing. In this way, the developing companies can protect their IP while sharing FDA’s interest in seeing the tools disseminated. It remains to be seen if FDA will incorporate these suggestions into the final guidance, which will be issued while the pilot program is underway. This MDDT initiative is yet another of FDA’s well-intentioned efforts to be seen as a collaborative partner in advancing innovation in the healthcare space, and the agency is to be commended for doing this.

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Dodging Healthcare Product Development Failures, Part 1—Risk Assessment Trumps Design Devotion

September 25th, 2014
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A new healthcare product is an exciting thing. It could alter people’s lives, perhaps change the world, and maybe even earn some money. But what comes as a surprise to most people is how few of the many new product ideas actually make it to market.


There are a number of reasons why most products don’t survive; the development process is complicated and often counter-intuitive. However, in my experience, there are a few pitfalls that commonly trap product developers, but also ways to sidestep those pitfalls. This is by no means a comprehensive list, because every product is different and many things can trip up development. Often a project can be clicking on five cylinders and you need just one more to make it work. In this three-part post, we’ll look at common ways to kick start that extra cylinder.

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Next-Gen Sequencing Could Unlock Ebola’s Secrets, Yield Outbreak-Halting Clues

September 23rd, 2014
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The Ebola outbreak in West Africa has dominated recent newscasts and shocked many people with the speed and ferocity of its spread. Any such outbreak raises questions about its origin, its rate of transmission, and measures that can be taken to control its propagation. Thus far more than 2,600 people have died and the numbers are rising. There currently is no cure or treatment, notwithstanding recent high profile reports of experimental drugs and vaccines that are under development. In the absence of treatment, the main goal of healthcare workers is to care for the sick and to limit the spread of the virus. And fortunately, researchers are now also applying the latest technologies to search for new ways to halt Ebola.


In an effort to better understand both the virus and the current outbreak, Pardis Sabeti and colleagues at the Broad Institute/Harvard University, and the Sierra Leone Ministry of Health and Sanitation recently reported in Science the genomic sequence of 99 Ebola isolates that were collected from 78 patients in Sierra Leone during the first 24 days of the outbreak. Reviewing this information will ultimately help in the development of both diagnostic tests and drugs to better manage the virus. The Ebola genome is just under 20,000 nucleotides in length, encoding just seven genes. The apparent simplicity of the virus belies the havoc that is wreaked upon infection based upon an assault on the immune system and disruption of the blood clotting process, leading often to fatal internal bleeding.

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What the Ebola Outbreak Shows Us About Modern Health Technology

September 15th, 2014
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Unfortunately, emerging disease outbreaks are nothing new. However, the current Ebola virus outbreak in Africa is showing us more than just the cracks in international public health response effectiveness. The unfolding situation is also showing how modern healthcare technology can help defeat the virus and could be applied to other emerging diseases.


Since its first identified outbreak in Zaire in 1976, Ebola had been known for its deadliness (with mortality rates reaching 90 percent), as well as for its clearly identified transmittal. This year’s outbreak, while maintaining a very high death rate, was not as easily traced back to its original reservoir and is resisting efforts, for containment. So far, about 5,000 people in six countries have been infected, with no sign of letting up.
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Apple Watch: Not a Digital Health Breakthrough – Yet

September 10th, 2014
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As a surprise to no one, Apple announced a smartwatch at the company’s event yesterday in San Francisco. Apple has been under mild pressure to introduce such a device to keep pace with competitors and to demonstrate that new CEO Tim Cook is an able successor to the product development genius, Steve Jobs.


Though the announcement of the device was expected, the features of the watch had been the subject of much speculation, greatly centered around health and wellness. Rumors were bolstered by Apple’s recent hiring of a number of senior executives from the medical device industry and the announcement of partnerships with Mayo Clinic and Epic. Many were hoping that the Apple juggernaut would provide the push needed to drive adoption of digital health into the mainstream consumer market.


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