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    I can’t remember who’s idea it was. It may have been Glenn my business partner, or maybe me. If I had to lay a bet, I’d say it was our manager at the time, Gary.

    The doors to our business had been open for about three
    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
    years and we thought that we need a spruce up at the front of the building. First up was painting. A nice bright colour to make the building stand out. Vibrant purple! We choose that colour because it was in our logo. So the
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    painting went ahead and it certainly made the building stand out, especially at night under the lights. But the original sign had to change. It was looking a bit tired. So, through who’s ever idea it was, we employed a chap to
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    onstruct a BIG sign. He was actually a friend of our manager. He came and met with us and showed us his work. He had indeed done some BIG signs. 3D signs!

    Since we were in the music business, we decided on using a gui
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    tar. A BIG guitar. We thought that we’d get some press as well as create a landmark for musicians.

    So the sign man made some plans and began work. Now you’d figure that a thirty foot long 3D guitar would cost a bundle
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    right? Wrong. He had no idea how to charge. The total bill was only $1300.00 which included two ‘word’ signs in 3D as well. That price included delivery and installation.

    It took the sign man about six weeks to make
    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
    this thing. Then the fateful day came, a Saturday, when it would go up on to the front of the building. The sign man had driven from the central coast with this guitar. He had pieces inside his van and strapped on top. How he
    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
    ade it to us, I’ll never know.

    First thing was to unload. Since he was by himself, we had to help him. How he planned to install the thing without any help is a mystery. So just to make sure he put the guitar on the r
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    ight building, we suddenly became his associates! Once it was out of the van, we checked that it would go together OK. It all seemed to work.

    Now to the magic moment, putting up the first piece. At this point I though
    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
    it may be wise to ask him how he intended to secure the guitar to the building. That was the moment I knew we’d made a bigger mistake than I originally thought. He pulled out a packet of 50mm self-tappers from his pocket. His
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    idea was to screw through the wall sheeting and into the wooden frame of the building. He had put on a few right angle brackets to do this. About six. Yes, that’s right, he intended to hold up a thirty foot guitar with six sc
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    rews!

    Now, this guitar was made of five ply, and would have weighed at least 180Kilos. To say we were staggered at his securing method was an understatement. We flatly refused to let him do it. After a heated debate,
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e called it a day after dragging the guitar inside.

    Now we had a thirty-foot guitar clogging up our load in area and we took control over the securing method. So much for the bargain. With some family help we made s
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ome metal straps that would be attached to the guitar, then fold over the top of the roof line. They could also be secured with coach bolts. This meant the main weight was essentially hanging from the building frame and the bolt
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    just held it close to the wall. It seemed like a good idea and it did work. We only intended to have it up there for about three years.

    The next big day came when we lifted the guitar piece by piece into position. It
    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
    was very, very hard work. Not only did we have sign man, but three of our employees and a friend of mine. Even with all this muscle, it was a devil of a job.

    After some touch up paintwork, we stood back to take in
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    he new sensation. It was quite impressive. It did get us some press and it did become a landmark for musicians. So from that aspect, I guess we got it right. But, it had caused us a huge headache and a mountain of time. After
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    it was done, we gladly gave the sign man his $1300.00 just to see the last of him.

    That guitar was put up about eleven years ago. Today is does not look anything like it used to. The business has been sold four times
    .

    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
    ince we sold it and the place is in ruin. Most of the guitar has fallen down. Only part of the body and part of the headstock remain. It is a reflection of the current owners feeling towards their business. They obviously coul
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    d not care less.

    So the moral of the story is to find a good sign man, make sure he understands exactly what is required (and get it in writing!) and make sure you get everything for your money, even if it’s a bargain


    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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