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  • Main Subject - Two Lean Tools You Can Use to Improve Processes at Your Site

    In quality improvement engineering there are many tools. I would like to illustrate a few and show how they can apply to healthcare. I will be using tools taken from Lean Manufacturing, an approach used at Toyota Motor Compan
    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
    y for many years now. These tools are easily adaptable with a bit of imagination to healthcare. I am not proposing that all healthcare should blindly adopt Lean as the new “flavor of the month,” but if some of the tools fit 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 site well, then use them. From my experience, the best progress in quality at a site is in the identification and use of quality improvement tools that can be mastered by the employees of the site. There is no use in being
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    a Jack-of-all-trades and master of none.

    Two tools that seem to go hand in hand are 5S and Point of Use Storage. 5S is sort, set in order, shine, standardize and sustain. In the most recent issue of Quality Progress (Americ
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    n Society of Quality’s magazine) these tools were applied to storage areas. A storage area should only contain items that are useful to tasks that are performed nearby. For instance in an examination room there should be a go
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    od assortment of bandages, but it probably doesn’t make sense to store printer ink in the exam room. This is an example of point of use storage. Further, any storage area no matter the size should be well ordered. You don’t
    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
    ant to have too many of any one item; it is better to have in stock what is needed for a day or two and restock as needed. That way, you can have a wider variety of items in the storage area and will waste less time going to l
    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
    ook for a supply when it is needed and it isn’t nearby.

    Besides having the right amount of items in a storage area, you should have it arranged so that the most frequently used items are easiest to access. A way to make sure
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    hat this order is maintained is to have a diagram in the storage area showing where things are located. That way, whenever restocking occurs, items will be placed in the right place so anyone who uses the supplies can easily f
    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
    ind them. With a diagram of the work area a person using it for the first time will be easily able to locate an item. A good rule is that anyone should be able to find any item in 30 seconds or less.

    Finally, in arranging a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    torage area, be sure to get rid of any outdated items. If an item is rarely used in activities near that storage area be sure to transfer it to the point where it would be most useful or if no one uses it, dispose of it. Of c
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ourse, this arrangement of stored items will only be successful if most everyone will work at maintaining it.

    Another useful tool in lean is to eliminate wasted effort. One glaring example that I have seen is the amount of ti
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    e nurses have to expend in getting prescriptions refilled for patients at primary care sites. The nurses and other representatives from the staff should examine the process of refilling patient prescriptions by drawing a diagr
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    am of the process (value stream mapping) and measure how much time each step takes and which are really needed in the process. I bet that some steps can be eliminated and thus time saved. One suggestion that I have is for pre
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    criptions that are used over a long period of time, such as hormone replacement medications. Why not move the patient into ordering 3 months of the prescription at a time through a mail order pharmacy? It may take a bit of ef
    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
    fort to move a patient into this habit, but is will save a lot of time in the long run for an office and will free nurses to do much other needed tasks. The patient will also be happier as they can usually save money by orderi
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    g in this fashion. My wife and I order all our recurring prescriptions this way and easily save over $200 per year.

    Many in healthcare think that these tools are not useful to them. Recently I was talking to someone about us
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ing Lean principles in their office. This person thought that because health plans had so many rules applying to such things as coding and billing and other documentation that there was little room for improvement. To me this
    .

    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
    is an illustration of lack of communication among the various people on staff. If a team was formed of representatives from the staff and the above tools examined I know that the team could find many ways to find savings in ti
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    me, money and effort similar to the ones that I chose to illustrate. Once the processes are identified and standardized, then the site can continue seeking ways to further improve in a process of continuous quality improvement


    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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