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  • Advice You - How to Hire Industry Experts For Free

    If you follow the process for inventing outlined in my book, Inventing on a Budget and Cashing in on the American Dream, you will be hiring team members either en
    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
    tirely on contingency, or on a part-fee/part-contingency basis.

    Hiring on contingency means that instead of paying money upfront for services rendered, you pay y
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ur team members as a percentage of any net profits realized from the project. This payment structure has a number of important advantages over paying someone upf
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ont.

    1. You only pay out if you realize a profit. Most of your projects won’t realize a profit. Paying team members on contingency helps keep your upfront cost
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    s low and team members (including yourself) get paid only if the project is profitable.

    2. Ownership = Excellence. Paying team members on contingency gives them
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ownership of the project and incentive to perform at their highest levels. Fee-for-service providers are less motivated and usually shoot for the bare minimum to
    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
    justify their fee.

    3. You gain validation. If you cannot convince team members to sign onto a project on a contingency basis, perhaps your invention idea isn’t
    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
    as good as it needs to be. Each of your team members is an expert in their field and their signing onto your project is an implicit endorsement that they think i
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    will be successful. This validation gives the project momentum and further increases your chances of success.

    4. You can do more with less. Inventing is a num
    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
    ers game—the more inventions you can develop given your limited time and resources, the higher your likelihood for success. Hiring team members on contingency al
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ows you to stretch your resources and develop more inventions for less money.

    The obvious question is, “How much do you pay team members?” Of course there is no
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    one right answer but here are some guidelines that will help you get there.

    1. Consider hiring on a part-fee/part-contingency basis. Of course the higher the f
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e, the lower the contingency percentage and vice versa. I usually just offer to cover material costs, and translate their time into a contingency percentage.

    2
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    Shoot for what is fair. What is considered fair can, of course, be very subjective. Start by asking your prospective team member what they think would be fair.
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    If it sounds reasonable to you sign an agreement. If not, try to use objective criteria to arrive at something you can both agree on. For example, I estimate
    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
    he amount of money I expect to make from the project and base their contingency as some multiple of what their time would cost. Therefore, if a team member wante
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    to join a project that might pull in $100K by contributing $5K worth of work, I might offer them 15% (3x their work product) of the net profits.

    3. Tie percen
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    tage to net profit, timelines and deliverables. Use the Independent Contractor Agreement provided in the Appendix of my book to properly define net profit, and t
    .

    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
    e payment to proper execution of timelines and deliverables.

    4. Remember 100% of 0 is still 0. The correct percentage for team members is whatever the market w
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ll bear. Shop around and remember to not be greedy. You might think that 50% or more of your profits is high, but it still holds potential for you to make money


    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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