• “Economic Issues in U.S. Healthcare” Breaking News Free – March 9, 2011

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    Is healthcare industry economic intelligence tough to track?

    Keep up to date with “Economic Issues in U.S. Healthcare” Breaking News Free:

    MedIntelliBase(R) Breaking News
    Current News “Top Picks” by MIB Editors…
    Streamlined FDA process could aid biotech device makers
    …for additional Current News click on “Full Breaking News Listing.”

    Most Read News from Last Week…

    Patent plethora in 2010 breaks record for Biocitech technology park residents
    PharmaLive, 2011-03-02
    Don’t Fear the Future of Healthcare – It’s Working
    HealthLeaders Media, 2011-03-02
    Healthcare Sector Faces Greater FDA Scrutiny
    MarketWire, 2011-03-02
    Fresh signs of a biotech buyout blast in 2011
    FierceBiotech, 2011-03-02

    Stay alert, be intelligent -

    Jordan Zornes – Editor & Senior Analyst

    Victoria Hunsicker Sanko – Senior Editor

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  • Economic “Comparative Effectiveness Research” Data Management

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    At the annual Life Sciences Alley meeting held in Minneapolis (December 8, 2010), presenters dissected the economic benefit of new medical innovations to our global society. It was an eye-opening discussion trained on the theoretical best methods to capture new innovations’ relative and absolute economic value.

    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

  • Personal Medicine in the Clouds?

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    No man is an island. Neither is his medical record file.

    To practice intelligent medicine and advance medical technology discovery and development, the power of consolidated medical data needs to be harnessed.

    Clinical trials are not the only source of scientific discovery. Retrospective analysis of site-specific procedural and product use and consumption metrics reveal essential medical professional decision and use insights without violating the individual’s personal medical records, satisfying HIPPA and other regulations. And the later source of data can do so in a much more cost effective manner using current bar coding technologies and data entry, securely and selectively accessing remote hospital databanks. Since medical records for patient cohorts would be pulled as consolidated groups, no one person’s medical records would be inappropriately revealed.

    But all has to operate in a virtual space to be fully accessible and must be fully compatible to be most effective. And what better way than through cloud computing where content management meets essential applications?

    Ask yourself, “In this extremely tough economy, how will my company cost effectively manage its own content-rich databases of retrospective data to improve our decision-making capabilities?

    Stay alert, be intelligent -

    Victoria Hunsicker Sanko
    Senior Editor

    And what better way than through cloud computing?
  • Intelligence – The Responsibility of Clinical Marketing

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    As with our life sciences industry, any industry that relies on technology to diagnose, mitigate or solve a problem, needs to take a strategic view of how that technology is applied and managed.

    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

  • Keep It Simple…Intelligence for All

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    Just a simple thought this week…share your company’s competitive intelligence across your organization. DO NOT restrict it to a few senior management team members or within a specific department. If you do not share it, your company (and YOU) are more likely doomed to an inevitable blunder.

    Case in point, a few days ago an associate and I were talking about a recent peripheral vascular clinical trial…(the name of the companies and trial are withheld to protect confidences. But to make it real, insert one of your past company’s names and a pivotal trial that was critical at the time. The salient point is the lesson learned.)…Each week the clinical research team tracked medical conference proceedings, The Gray Sheets, press releases, any source that had hints of what the outcome of the competing sponsor’s trial would mean for its own stent. But the marketing team was confident that trial results would prove in favor of stenting. The team was preoccupied with executing its marketing strategy – developing collateral materials, demo kits, communications for its customers, patients and sales team. The list went on. However, no one in the marketing department, not even the senior managers bothered to meet with the clinical research team until the trial results were within weeks of release. The results did not favor stenting. It caught managers in marketing and up the line flat-footed. Heads rolled and many were demoted or fired.

    There is major lesson to be learned here – enlighten all the members on your project team. Give them access to the same intelligence that you subscribe to. Your companies have enterprise subscriptions, so use them to keep your teams informed.

    And don’t be cheap. If there is a per-user subscription fee, pay it for each of the key folks on your team. Everyone has to be informed and up-to-speed to do his/her job well. The few extra dollars spent are inconsequential compared to the expense of an entire 5-10 year development program derailed and jobs lost.

    Next week, we’ll explore a new breed, a hybrid between clinical research and traditional marketing…”clinical marketing.”

    Stay alert, be intelligent -

    Victoria Hunsicker Sanko

    Senior Editor