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  • E-Folder - Entrepreneurs - Giant Steps or Baby Steps?

    Many people plan to start their own business some day. Many of these people have a specific kind of business they'd like to start and spend many years think
    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
    ing about it. Others are looking simply to quit working for other people and will do almost anything that they feel they might succeed at.

    Assuming you do
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ish to start your entrepreneurial life then you may be lucky enough to know exactly what you want to do. This is great as such passion is important if you'r
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    going to persist until you achieve success.

    But that leaves the remainder of us who wish to start some kind of new venture but have no idea what it might
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    e.

    Something I learned recently when looking for a new venture to pursue is that it's worth trying out a number of ideas on a small scale and seeing what a
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    tually works and what doesn't.

    I chose a couple of ventures that fulfilled the following criteria:

    • They could be started with very little money
    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
    and effort
  • I could easily drop the ideas if they didn't show promise early on
  • They were scalable, so that I could grow them if I wished<
  • 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
    li>
  • I was passionate enough about them to put in more time and effort if they showed signs of potential


  • By doing this I was surprised to f
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nd that ideas I though would almost definitely be successful showed little signs of success. Conversely, some ideas which I had doubts about have actually p
    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
    oved early on to be immediately profitable.

    What I've ended up with now is some ideas which I know aren't worth pursuing further but which cost me very lit
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    le time and effort to find this out. I am really glad I didn't invest a large amount of time and money into these ideas.

    More importantly I have one or two
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ideas which I previously wouldn't have invested anything in but which have proven to be profitable from the beginning.

    Now, this next part is important...
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod

    If we also consider my original criteria above I can safely say that I now have a couple of ideas which fulfil the following criteria:

    • They have
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    proven to be immediately profitable on a small scale
  • I am passionate enough about them to put in more time and effort
  • They're scalable,
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    o I can grow the ventures almost limitlessly

    I do now intend to pursue these ideas further. Due to these small scale experiments I am also safe
    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
    in the knowledge that these ideas work. This is something that many people don't normally find out until many months of effort and many thousands of pounds
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    have been put into an idea which was probably never going to succeed anyway.

    I think the lesson to learn here is to start small, try out a few idea which a
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    e cheap and easy to try, which are scalable if they succeed and which you're passionate about. Then drop the ones which show little sign of success but run
    .

    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
    ith the ones which prove themselves worthy of further efforts.

    I appreciate that there are some ideas which can't be tried out on a small scale and to whic
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    these experiments don't apply. However, for many ideas a small scale test is possible and is highly recommended for the reasons stated above.

    Best Regards


    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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