Our Thoughts

New Biology Fosters New Business Partnerships


November 6th, 2014
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You may have read the announcement this week of the joint venture between the preeminent medical genetics lab of Baylor College of Medicine and Japan-based Miraca, a holding company operating in the healthcare sector.

I am delighted to have had the opportunity to shape the strategy for this relationship and look forward to rolling up my sleeves and helping with the implementation.

Why do I think this is so exciting and interesting?

Through this venture, world-class academic science meets the commercialization capacity of a global multinational business organization.

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Johns Hopkins mHealth Report Shows Technology’s Impact in Developing Countries


October 20th, 2014
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My friend Alain Labrique, director of the Johns Hopkins University (JHU) Global mHealth Initiative, recently issued the initiative’s 2014 Annual Report, and I’m not at all embarrassed to share my initial response upon opening it:

Wow!

From its work with Maiti Nepal to use mobile technology to prevent human trafficking; to improving maternal health by providing remote education, advice and services; to collaborating with policy leaders in South Asia to enable evidence-based mhealth innovations – all 130 projects supported by the initiative are inspiring. The JHU report provides proof that digital and mobile technologies can indeed help resolve what had been seen as intractable health problems, in resource-constrained countries. For infectious disease, nutrition, and social issues that are enormous problems in the developing world, digital tools can enable fundamental epidemiology research, and begin to overcome persistent problems of unequal access to healthcare.

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Dodging Product Development Failures, Part 3 – Integrated Team Work


October 16th, 2014
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There are many elements that lead to a successfully developed product; we’ve already covered two important factors: 1) Assessing all risks and going beyond prototype development and 2) developing an uncanny customer insight. In this post, I’ll discuss a third key element, the importance of teamwork.

Pitfall: Team activities that are not integrated
Product development depends on many different disciplines, including engineering, regulatory, marketing, manufacturing, finance, sales, and quality control. While these specialists bring a depth of expertise, you’ll need to integrate all of them. While a specialist will certainly be able to identify a task and complete it, she or he may balk at attending team meetings where the discussion is far outside her or his specialty. But the best teams are made of people who know how every discipline connects to the product. Only with an integrated team will you know what a customer really wants, have a superior sense of priorities, and gain the ability to shift attributes like price, time to market, or specific product features. Unfortunately, many groups who call themselves teams don’t have this level of connectedness.

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EHRs Must Find Zebras Among the Horses


October 10th, 2014
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This post is originally published on InformationWeek Healthcare, October 8, 2014

 

EHRs should be adaptive, so that when something like the Ebola outbreak occurs, the overworked ER doc has help catching the one critical piece of information that wasn’t as relevant a year ago.

In my last article for InformationWeekWill Electronic Health Records Ever Be Usable?, I introduced the American Medical Association’s EHR usability priorities, published last month. This time let’s dig a little more deeply into some of these priorities.

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Dodging Healthcare Product Development Failures, Part 2 – Developing Uncanny Customer Insight


October 8th, 2014
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In product development, a lot of parts have to be working well for the whole project to succeed. In my last post, we talked about the need for a disciplined approach to developing a product, as well as the need to think beyond the prototype and its design. In this post, I’ll talk about another area of enormous importance to successful development—insight. Just as development isn’t just about product design, insight isn’t just about what your customers say.

Pitfall:  Insufficient customer insight
Truly disruptive innovations address a need that customers can barely articulate before being exposed to the product. Examples of this type of successful development abound; from smartphones to intermittent windshield wipers to single-use bioprocessing. None of these new products addressed a known, clearly expressed need, but in today’s world we couldn’t imagine living without them. While listening to customer ideas, complaints and expressed needs is necessary, product development can’t stop there. Many products that sound perfect during customer interviews end up unused (and unusable) in the real world. Developing something truly new and useful depends on an uncanny insight around what customers are trying to achieve, their environments and the capabilities of alternative technologies.

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Will Electronic Health Records Ever Be Usable?


October 2nd, 2014
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This post is originally published on InformationWeek Healthcare, September 26, 2014

 

AMA attempts to address the frustration EHRs create, especially for doctors and other healthcare workers.

 

“It’s easy to use, once you know where everything is,” the instructor said during an EHR training session I recently attended. Most EHR companies seem to believe this is an acceptable way to design software.

 

EHR usability has been greatly ignored by vendors, and last week the American Medical Association issued eight usability priorities in an attempt to address the issue. This directive comes as a result of a joint study by the RAND Corporation and the AMA highlighting EHRs as a significant detractor from physicians’ professional satisfaction.
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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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