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    When I first started my business, a colleague suggested to me that I bill my clients based on the results I created for them. It was an appealing idea at the time - after all, who wouldn't take me up on that offer, and so long as I performed, I
    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
    'd get paid. Sounds too good to be true? It probably is. Here's an article that discusses charging models and why being paid on results, popular as this is becoming, may not be your best option.

    I'm currently reading Alan Weiss's book - "Mill
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ion Dollar Consulting", in which he has a section dedicated to payment models. (Highly recommended book, by the way, although I don't agree with everything he says).

    This is my interpretation of what he says: The ways to get paid are on a spec
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    rum from 100% up front, paid before beginning work at the extreme left hand side to contingency fees based on performance at the extreme right hand side i.e. you only get paid on results and over a timeframe beyond the end of the project. In be
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tween are situations like 50% deposit, then scheduled payments all due before completion of the project, and 100% payable on completion etc.

    He points out that your cashflow situation deteriorates as you move from left to right. In the worst c
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    se scenario, you may not see any return on your investment in the project until many months after it has been completed. If you incurred expenses or hired subcontractors, then not only would you not have any personal income, but you'd be out of
    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
    pocket as well. Most small businesses don't have the cash reserves to fund someone else's project, and if they have to borrow, then obviously their profit margins are eroded by interest payments. In the case of a "one-man-band" this might be O
    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
    K, if you have other income to live on in the meantime and do not incur any costs other than your time. However, in the UK, the major reason small businesses go under is cashflow problems, so for most of us, positive cashflow is a necessity.
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    What I would add (and I don't think Alan explicitly stated this) is that the level of risk increases as you move from left to right. For example, if there is any kind of disagreement during or after the project, and you haven't been paid, or ha
    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
    ve only received partial payment, then you risk losing some or all of your fee.

    If you work on a performance/results basis then you also risk:

    1. the client dragging their heels and not creating a situation where you can get started

    2. disag
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    eements or ambiguity over what constitutes results or performance

    3. the client being unethical or downright dishonest and not providing full disclosure of results

    4. the client not using your work in the way it was intended thus diminishing
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    the probability of success

    5. the client not being fully committed to the project or not valuing what you do because they're not committed to paying anything yet

    6. creating an image of yourself or your company as being "desperate" for work

    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    On the flip side of this is the risk to the client. Clearly, paying nothing until tangible results are delivered is the client's lowest risk (and probably most desirable) position, and paying the full fee up front is their highest risk position
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    If the client perceives a high degree of risk in employing you for their project, then they may take their business elsewhere or just abandon the project. Therefore many marketers advocate reducing the client's risk in order to win business by
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    working on contingency fees i.e. paid on results. In this scenario, the consultant or independent professional should negotiate so that the rewards outweigh the risks - so that they will be paid in excess of their standard fee by the cumulativ
    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
    payments based on results.

    Therefore the maxim for the consultant/professionals is to negotiate as much upfront fee as possible, in order to minimise the risk and prevent cashflow problems. But you need to be able to do this in a way that als
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    o reduces or eliminates the client's perceived risk (or else you make yourself vulnerable to another risk - that of not winning the business). Other ways of reducing the client's perceived risk include having a good reputation, building credibi
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    lity and being known as the expert, plus adding satisfaction or money back guarantees.

    You should only engage in results-based fees if:

    * the reward outweighs the risks and hit to your cashflow

    * contingency based fees are normal in your ind
    .

    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
    stry

    * you have spare capacity and something is better than nothing

    * you need the project to help build your credibility and reputation

    * you have agreed metrics upon which your performance can be measured and the client is legally obligate
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d to provide the corresponding information

    Other than that, try to stay over to the left-hand side of the spectrum as much as possible if you want positive cashflow and to stay in business for some time to come!

    Copyright 2005 Attractioneerin


    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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