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    Company in General
    • Which targets – referring to the turnover and the profit resp. the personnel needed and the production means – do you intend to reach with your company within 3 years from today ?
    • Broken-down into s
    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
    ales region/country as well as product group and sales route – and in which steps – e. g. massive marketing investment and then switching to a permanent business or step-by-step-increase ?



    Present resp. Last years’ turnove
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    structure
    • Which turnover is generated by each sales region/country/sales route – with reference to the individual products ?
    • Which contribution margin/profit is generated for each sales region/ country/sales route refer
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ring to each product ?
  • Which sales routes should be envisaged/are necessary to reach the targets as per 1. above ?




  • Client structure
    • Which client groups/market segments do you supply today ?
    • here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
      > Do you have an analysis of the existing/potential clients per field of activity/product ?
    • Which client groups/marketsegments (for each sales region/country) are missing then (e. g. compared to your presently ‚strongest/most success
    • d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

      Combination pro
      ul’ market ?
    • Are you aware of the total number of potential clients for each sales region/country/market segment ?
    • Is/Would ‘key-accounting’ be important for you and which information is available about such potential clien
    • 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
      ts ?
    • Which is your market portion/coverage (as percentage of all clients available in the respective sales region/country/market segment ?




    Competition
    • Who is your competition – listed from ‚most im
    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
    ortant’ to ‚nearly negligible’ ?
  • Where are they better/worse compared to you (with reference to products and sales routes) – and why ?
  • Would it be advisable to adapt possibly any of the procedures of the competition for you
  • nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    without becoming untrustworthy to your clients ?



    Products
    • Which are the most successful products – as well in your own portfolio as compared to the competition - and why ?
    • Which new products are re
    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
    quested by the clients already today, respectively which tendencies are shown in the market with regard to HIS new developments, i. e. is known which market segment is going to develop how and do you think you will remain the suppliers to this m
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    rket (even if the final products are changed) ?
  • Is there any kind of replacement/substitution of your products already available and – if so – would it be advisable to produce these yourself or cooperate with others ?
  • With
  • ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    hom and would possibily some kind of exclusivity be available – especially e. g. for foreign markets … or any other … ?
  • Which new products do you intend to produce and why ?
  • Which products are so small in turnover/quantity
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    that they could possibly be eliminated from your range – or are there any good reasons to go on to produce tem ?



    Pricing/profit
    • Which contribution margins/product per client group/market segment are reached b
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    you and could they/how possibly be increased ?
  • Which contribution margin/profit generates each of the products checked on which sales route - Internet, direct sales, project orders, via representatives, … ?
  • Could possibly
  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    he ‚most successful’ sales route/product be adapted for other sales regions or how could this be solved ‘at the lowest possible cost’ ?



    Sales department
    • Do you know which cost per sales region/representative
    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
    are spent in total and have you elaborated a comparison regarding the profitabiltiy of the sales regions/sales routes with reference to the total profit, the products sold there and the total cost spent ?
  • Which new sales regions/count
  • ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ies - with reference to the client groups/markets segments should be developed in addition umtil when – based on which sales projections ?
  • How have the necessary sales regions to be structured – and why this way ?
  • Sales thr
  • y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ugh own personnel, subsidiaries, representatives, synergy-partners/alliances, Internet ?
  • Which additional contribution margin/profit can be expected by them and which investment would be necessary to develop such new sales regions/mar
  • .

    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
    ket segments ?
  • Which sales areas have to be re-structured due to the potential available in order to reach a better/optimum coverage of the market ?
  • Are all representatives well informed regarding their present clientele, i
  • elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    e. not only to know the decisive people of the client but also their future plans - with regard to products, sales regions, etc. ?
  • How is their success in winning new clients and who is responsible for the respective data ?


  • 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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