Presenters from most sectors of our industry – manufacturers, healthcare providers and government – were pressing on the core theme — the need for a centralized system to act as a dynamic repository for capturing the economic value of therapies and diagnostic modalities, as well as their procedures, throughout the life-course of patient’s care to assess the true economic value to our healthcare system.

In the U.S. they call this “Comparative Effectiveness Research” (“CER”); in the EU they call it “Health Technology Effectiveness” (“HTE”). No matter what it is called, this grassroots movement is slowly evolving us to a new breed of clinical trial protocols capturing not only safety and efficacy/effectiveness but also economic value and comparing that value with that of the “gold standards” of care at any point in time.

What was not presented was what agency or group that would take the responsibility to fund and create the central data repository. There was a large minority agreeing that in the U.S. it will need to be a centralized service, similar to ClinicalTrials.gov…and it would likely cost billions of dollars to develop, commercialize and manage.

But where does that leave the developer and manufacturers of our new medical innovations? I am convinced that manufacturers need to act now and on a smaller scale. Each company will need to establish its own data management system (DMS) that is easy to use and compatible with the newly evolving central system, allowing as seamless uploads to this planned national central repository as possible.

Your comments?

Next week…likely solutions for practical DMS.

Stay alert, be intelligent -

Victoria Hunsicker Sanko – Senior Editor

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Jordan Zornes – Editor & Senior Analyst

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Current News “Top Picks” by MIB Editors…

Sebelius: Health care repeal would put insurers in charge
McClatchy, 2011-01-05
“Repealing the new federal health care law will put power back in the hands of insurance…”

Department heads urge against repeal, outline reform’s benefits
The Hill, 2011-01-05
“Federal agency leaders outlined the progress of the new healthcare reform law in a letter…”

Amendments to health reform repeal filed by Dems to force vote
The Hill, 2011-01-05
“House Democrats on Wednesday filed four amendments to Republicans’ healthcare reform…”

Puget Sound Health Alliance Launches Nationwide Project to Improve Healthcare Using Health IT
Hospital Review, 2011-01-05
“Puget Sound Health Alliance, a non-profit organization aimed at improving healthcare quality…”

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The increasingly urgent need to manage the growing number of petabytes of diagnostic data is driving development of a new breed of personalized medicine.

Consider for example the recent WeirdMedical post from June 4 ["Weird New Advances in Ancient Device Material"]. The article gives you a glimpse into the future of how medical practitioners and industry may be able to gather and report on personal medical intelligence about a patient. According to Technology Review’s “10 Emerging Technologies 2010” or “TR10″ published by MIT in the article “Implantable Electronics,”

“Tufts University biomedical engineer Fiorenzo Omenetto is using silk as the basis for implantable optical and electronic devices that will act like a combination vital-sign monitor, blood test, imaging center, and pharmacy–and will safely break down when no longer needed.”

Further consider, this additional diagnostic data needs to be managed. We need to ask who will keep up with capturing and storing additional streams of data from this and other new sources in addition to those from current sources. We can barely manage now. As updated patient progress reports are produced, patient records transcribers, data entry techs, auto bar code readers, etc., will not be able to keep up. Data flow will be too rapid and voluminous.

We need intelligent capturing, recording and storing solutions for accurate retrieval   To be discussed next posting…is “intelligent cloud computing” the solution?

Let us help you master your business and competitor intelligence content management.

Stay alert, be intelligent -

Victoria Hunsicker Sanko
Senior Editor

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Applying the technology to the problem is typically the job of senior applications and design engineers. Extending its application to making it manufacturable is the responsibility of the senior manufacturing engineers.

But managing the technology can be assigned to any number of functional managers from engineering to marketing to business development to senior management.

No matter who assumes the role, your management team needs to be well-informed with intelligence. And not just commercial or industry intelligence but technology application intelligence. In our life sciences industry, this technology as applied to the problem is considered a clinical or medical application.

So whose responsibility is it to track clinical competitive intelligence to make strategic business decisions? Clinical research? Marketing communications? Business development? Competitive intelligence? Let’s propose a hybrid between clinical research and marketing to create “Clinical Marketing.”

Clinical marketing does not manage the daily marketing communications, marketing messaging or sales support roles.  Clinical marketing (CM) guides the clinical research team and reports to senior management, closely tracking competitor activity, clinical research results,  new physician practice patterns, off label uses, and more to understand the market and strategically layout the course organization will follow. CM also keeps a close eye on clinical research results, medical findings and technology developments to interpret and broadcast their potential impact to prevent your company from being caught by surprise enabling it to surpass the competition.

Assign a new function, that of clinical marketing to keep your management team alert, knowledgeable and insightful, giving your company the market advantage.

Stay alert, be intelligent -

Victoria Hunsicker Sanko

Senior Editor

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