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  • Main Subject - Communicating with Case Studies:Provide Value

    A few weeks ago, a couple of colleagues and I discussed a new business idea. But, we had trouble expressing how this new business would provide value.

    And, out of our discussions came the
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    idea of writing a case study. If you're not familiar with them, case studies are histories of business initiatives.

    They're like articles, but they put the reader into the shoes of a per
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    on making a difficult decision. Other professions also use case studies; you've probably heard of medical case studies, for example. Medical students get a set of facts about a patient
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    and perhaps some background or context, and then must diagnose the patient's condition or disease.

    Business case studies have proven popular at many university business schools (with t
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    he profs, at least). In some senses, the case study is the next best thing to being involved in a real case.

    Now, how is this relevant for you? Well, if you have to persuade others to ado
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    t your point of view, or buy your products, or vote for you, then you might find a case study useful.

    In fact, you may be doing something like that already. Whenever you tell a story
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    hat's designed to make a certain point, you're using a form of case study. During my brief foray into life insurance sales, for example, I learned that emotion sells policies, and not log
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    ic. That's why people in the business have a raft of stories about people who did or did not have protection when they died.

    The moral, of course, is that you should not only have life in
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    urance, but you should have the right kind, and in the right amount. Now, if you sold life insurance, you would quickly find that no one listens when you explain the logic, but they will
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    listen -- and act -- if you have your case studies (your anecdotes).

    So, having gone through all that, is a case study just a fancy name for an anecdote or story? Yes, to a certain exte
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t it is.

    But, when you think of a case study, think of it as a more elaborate and more logically constructed story. And, it's usually a real-life story. To illustrate the idea further,
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    let's go through the steps involved in creating one.

    Your case study starts by identifying a person and an organization, along with relevant information that provides context to the issue
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    addressed in the case.

    It also introduces the decision or dilemma. In many cases, the writer sets out two or more possible options. One of those options may be to do nothing, to maintain
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    he status quo. Another option may demand significant changes, and yet a third option would require more modest changes. However you set the options, they should offer distinct choices
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    to the reader. Don't allow a muddling-through solution that involves easy compromises.

    Now that you've set out the choices, provide the basic facts and opinions the reader will need to
    t?

    As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
    ake a logical choice. Like the writer of a mystery novel, you need to provide all the critical information without giving away the solution. And like a mystery writer, you may introduce
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    few false trails.

    As you develop the case study, keep in mind that you're trying to convey that the person or company in the case had to make a difficult decision. And the more the rea
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    der feels that difficulty, the more effective the case.

    Finally, provide an outcome if possible. Let the reader know which option the person or company chose, and how that decision worked
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    out. After all, you've been telling a story, and your audience will want to know how it ended. Ideally, you would not give the reader access to the outcome until after he or she makes th
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    t decision.

    In summary, you can make your point more powerfully by creating a case study, a specially constructed story that puts the reader or listener in the shoes of a decision maker


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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