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    In my world of working with companies to achieve their strategic plans through execution, we’re always developing goals and objectives to work on achieving during a calendar year. So in the prospecting side of my business I met many executives an
    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 business owners who tell me how well they have things covered, but still wonder why business is not doing as well as it should.

    Recently I was invited to spend sometime with a company and determine how what I do may be of use in improving the b
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    sinesses. Now this is a substantial business with a few divisions. The first meeting I attended was a typical example.

    My first thought was that these individuals were arrogant, pompous and full of hot air. I really wondered how they made any mon
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ey for the company! They had excuses for everything and reasons galore as to why nothing was really happening. They down graded sales numbers and operating info. Prices were too high, the competition were cutting prices, vendors were screwing them
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    the government wasn’t helping, the war in Iraq, and the price of gas really didn’t help. I wondered if they could have found any more?

    There was little to promote the conversation. No agenda, nothing positive, the customers weren’t mentioned onc
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    . No solutions or ideas. Nothing!

    After about 45 minutes of this they then turned to me and said “Hey, you’re the consultant what do you think?” I know they didn’t want to hear anything. So I said, “OK, let me understand what it is each of you do
    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
    ” “What do you do on a daily basis? Your job roles?”

    We listed the roles that each person was responsible for. I asked which role was determined to be the most critical to the process of developing their business?

    Then I asked them each to list
    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
    wo or there of the most important priorities that each role need to be achieving. We came up with about 25 items and then prioritized that down to a mere 10 for simplicity. They all agreed these were it. If these things were not being achieved bus
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    iness was in the toilet. Each of them had some involvement in one or more of the items.

    I then asked the Ops manager (COO), whose role was deemed to be the most important, how many hours he worked last week. 60hours. I asked how many of the hour
    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
    last week were devoted to the number one priority item on the list. He looked at me, lowered his eyes and said “None, last week.”

    We then went onto the second item and received the same response. The fourth and sixth and eighth had some time spe
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t on them which amounted to about 4.2 hours. That is 4.2 hours out of 60 hour week spent at work. That’s a whopping 7 percent of senior management time spent on the top ten most important objectives of this organization, in one week. It was, he a
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    greed, a fairly normal week.

    So 93 three percent of the COO’s time was spent on less important items. Some of the things he worked on were actually not even part of his job description. It makes a senior executive feel really important when put i
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    that perspective. A seven percenter! A few more questions revealed similar patterns with the rest of the team.

    The high cost of Seven percenters

    So if you figure that around that boardroom there was about a $2 million annual salary expen
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    se. Which with a simple bit of arithmetic meant they were costing this company $1,145 per hour. This was an expensive meeting in which nothing was resolved!

    Calculation
  • $2,000,000 ? 12 managers = $166,666 per manager

  • tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    2,080 annual working hours x 7% efficiency = 145.6 efficient working hours
  • $166,666 ? 145.6 effective hours = $1,145 cost to the company per hour


  • Here was a first indicator of the problems facing this company. People had become
    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
    over paid and were prepared to look busy to avoid performing. Managers worked on things they liked and could be seen to be doing something rather than working on the strategic priorities.

    Just by highlighting this caused enough of a stir to reali
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ze that the process probably occurred all the way through the organization. Yes it all flows down hill. I had a new client.

    How’s your organization doing? How many Seven percenters are you supporting? Are you one of them?

    The trick to resolving
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    his conundrum is fairly simple. Make sure the overall company knows the strategic goals and the actions required to achieve them. Cascade this across and down the company. Monitor this monthly, if it makes sense to do it weekly, do it. Take action
    .

    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
    to resolve variations.

    Many companies have Balanced Scorecards which help reduce this approach but often these become too large and complex to be of any value. A Balanced Scorecard is a great approach but it must be easy to use and understand. T
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    en it will lead a business to success. It’s really just short interval control on an expanded strategic basis. Simple management 101 stuff. Just not common practice in the corporate world.

    Maybe only 7 percent of the organizations are doing this


    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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