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  • Digg It - Notes for Newbies - Part Thirteen - Commissioning Software

    Hello again



    Today we want to talk about commissioning software. This is a topic we probably should leave until you have been in the business for a while. But there are times when you wis
    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
    h you could do something in a certain way and you can’t find the software to do it.



    Commissioning software
    Sometimes your Internet search fails to help you find a s
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    lution to your problem. When this happens, you can look for somebody to create software for you. We are talking about two very different needs:


    • You have looked closely at your market
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    and decided there is a need for a brand new product – an ambitious software system that will solve a problem for people on your list
  • You regularly are frustrated by a silly little problem
  • here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    and your life would be happier – and your income greater :-) – if you could find a bit of software to solve it


    You probably will want to leave the first until you have some experi
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    nce in the business and some money in the bank. It’s not unusual for somebody to pay ?10,000 to ?20,000 for a software system that over time will return him or her ?2,000,000 in sales. :-)
    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


    Realize when you have commissioned a system this way, you own it. You may do anything with it you choose. You may sell copies of it to people on your list, you may license your customers to sel
    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
    l it to others, or you may license your customers to license people on their lists to sell it to others.



    In a later article we shall talk about joint ventures. These are situations where
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    somebody with a product joins up with somebody with a list. They sell the product to people on the list and agree split the profits – a typical split is 50%-50%.

    Suppose you have a produ
    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
    t and you are going looking for somebody with a list. Naturally you are going to try to join up with the person with the most impressive list available. People with impressive lists (remember I t
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ld you in Part Three about the importance of your list) realize they are sitting on gold mines. They are usually only interested in products that you own or for which you hold exclusive licence.<
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    br>


    But you need to be a bit careful with a project like this. On one hand, you stand to win big, but on the other you stand to lose a bundle you probably can’t afford as a Newbie if you get
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    it wrong. Leave this one for now.



    The second is different. As you go about your business, as you fine-tune your operation, there are many times when you say to yourself, ‘Wouldn’t it be
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ice if I could…?’ and you can’t find a way to do it. Help is a hand.



    Check out these two websites: www.rentacoder.com and
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ="_new" href="http://www.elance.com/">www.elance.com. Here is where freelance software developers and programmers go when they are looking for work. When you are looking for a software soluti
    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
    n, put your project up on these sites and watch the offers roll in.



    Recently I needed a snippet of HTML code to solve a little, troublesome problem with a webpage. I put my project up on
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    RentaCoder and specified a maximum price of $75. Within two days I had quotations, literally from around the world, at prices from $60 down to $15. Amazing, this Internet thing!



    (The big
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    players also find resources here to solve their ?20,000 problems.)



    This can work the other way, too. If you are a programmer or software developer, you can register with these two sites
    .

    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
    and generate some income for yourself.



    That’s all for this time. See you soon.



    Next time we shall talk about testing. This is the process you use to try to figure out which head
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    ine or which price is the best for a product you are offering for sale.

    Thanks for listening :-)



    Copyright © 2006 Mary Rice-Johnston & Golden Goose Direct. All rights reserved


    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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