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  • Main Subject - Understanding the Mind of a Venture Capitalist

    So you have a new and wonderful idea, possibly to save the planet, to solve the mystery of life, create an object, make a better cookie or just simply to make things better for humankind. Great!

    These, of course, are t
    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
    hings that you want, but not what a Venture Capitalist or VC wants to hear. They want to hear about your market and who you will be selling to, how much will it cost and if there really are buyers. Most VC's do not care
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    about your dreams, they care about getting the highest return (ROI) they can on the investment.

    Do they consider you in this picture? Well sort of. They consider whether or not you are the best company representative t
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    assure their success. If not, you will be replaced because success must be reasonably assured. If you are opening a restaurant, for example, and your appearance is disheveled and your behavior is erratic or non-approac
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    able, then you can assume a big NO! If you are considering a high-tech company and you think everyone truly wants a head-mounted computer system, assume NO, do not go to the meeting, and you will remain a much happier
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    erson.

    The reason I bring all this up, if you are an American Idol watcher you should understand now, is very simple. You see 10,000 would be singers arrive and less than 25 make the cut because they have not been revi
    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
    ewed for a successful audition and most of the ideas or singers, simply can not sing. I have been up against many VC's in my career and the more I meet and talk to them the smarter one becomes.

    They are simple folk. Th
    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
    y either immediately see dollar signs all over you and your idea or they do not. There is no middle ground, which I find comforting. Meaning, that I rather receive a hard NO with reasons that I can ponder, than a Maybe
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    nd never really know either way. While Simon, on AI, is deeply cutting when he tells one of the contestants that "you simply can not sing!" He is telling them that their chosen path is not only foolish and wasteful but
    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
    ot easily achieved within their knowledge and talent base, just like a VC would. It's cruel, but I have been in rooms where 25 groups with incredibly poor ideas, no research, no evidence, and no true differentiation, bu
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    have a dream, and just threw away all the money they had in hope of an immediate gold ring.

    The mind tricks us terribly sometimes.

    You have to think clearly. You have to obtain honest opinions from people that have t
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rue experiences in the field you are entering and they will tell you the truth. I have told many people considering VC's that "Hope is Not a Plan!". However, the following is:

  • You must sit down and put your thought
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    on paper.
  • You must have someone else read and argue your position to see if it holds water.
  • You must read and research what you are up against to enter a market, industry or support an idea.
  • You must g
  • cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t the help you need to cover the areas you are weak in, this takes being self-aware.
  • You must come up with a budget that has details to see if you are missing anything.
  • You must read up on your idea or plan.
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    li>You must quietly test it out on others for reactions.
  • You must patent or trademark early including preliminary patents for protection.
  • You must prepare yourself like an athlete for a VC.
  • You must be re
  • 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
    ted, extremely confident and well rehearsed - you only have one chance to impress.
  • You must present yourself as respectable and you will be respected - plan the complete success.
  • You must know who might be you
  • ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    r competition.
  • You must describe what makes you so different, so think about this early.
  • You must understand what a "barrier to entry" means in your planning
  • You must understand what advantages you have o
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    er others- remember it's their money right now.
  • Your presented plan must have a logical flow so they quickly get it.
  • You must write an elevator pitch to see if you can explain your entire plan in the time of a
  • .

    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
    ride up.
  • You must prepare a more detailed version of the elevator pitch for a group to understand as well.


  • Finally and most important...if you truly have something (verified by others as stated) do not waiv
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    r, do not run away, do not give up. Stand your ground because your stamina alone will win over anyone else's weakness! Learn from your failures and quickly adjust your plans.

    Now go out there and make the world better


    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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