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  • Subjects - Beware the Syndromes-Heading Off Workplace Injuries

    Working on a computer for a large part of each day can be challenging, not just with reference to mental aspects but in dealing with physical ramifications as well. You can find yourself stuck in awkward positions for e
    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
    xtended periods of time, often without realizing it until one of the dreaded “syndromes” surfaces.

    When facing the resulting injuries, there is more involved than personal discomfort. Productivity suffers as employees
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    struggle through pain. Eventually sick time can be taken, and workers’ compensation claims may arise. The cost, both in time and dollars, affects the bottom line, so it is worth a look around your office to determine a
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    reas that need to be adjusted.

    Even making one change can have significant positive results. For each of the following syndromes, start by focusing on just one area that can provide significant impact as you evaluate y
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    our current habits and determine if changes could keep the syndromes at bay.

    Syndrome #1: Carpal Tunnel

    Over the past years this has been spotlighted as one of the fastest growing injuries in
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    the workplace. While it can occur from any type of repetitive-motion activity, the development of the computer keyboard led to a steep rise in its incidence.

    Symptoms:

    • constant pain or swelling in h
    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
    and or wrist

  • numbness or tingling in hands or fingers

  • difficulty with even small manual tasks

  • problems sleeping



  • Prescription focus: Keyboard

    • keybo
    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
    ard tray under desk

  • keyboard tilted away from you so space bar is higher than letters

  • wrist and hand extend straight from your elbow, parallel to the floor

  • palms not resting on keyboard pa
  • nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    d while typing, just between stints



    Syndrome #2: Postural

    This is now overtaking carpal tunnel as the most common workplace complaint. Back pain is so widespread that it has spa
    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
    wned an entire industry of specialists, from surgeons to chiropractors, yoga instructors and massage therapists.

    Symptoms:

    • tension in neck

    • shoulders slumping or rounded

    • head thrus
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    t forward

  • back pain



  • Prescription focus: Chair

    • sturdy, five-legged base

    • casters to roll easily

    • adjustable armrests to keep forearms horizontal while u
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    sing keyboard

  • adjustable height so line of vision is at approximately the top of the monitor

  • adjustable backrest, lumbar support & seat pan to match the natural curve of the spine

  • feet fla
  • dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    t on the floor or on a footrest

  • ability to recline slightly



  • Syndrome #3: Computer Vision

    Just two hours a day in front of a computer monitor can lead to development of
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ocular problems.

    Symptoms:

    • eyestrain

    • blurred vision

    • headaches

    • dry and irritated eyes



    Prescription focus: Monitor

    • glasses designe
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    d for computer use to sharpen type

  • resting eyes and remembering to blink

  • glare control with dim lights, blinds, visor or anti-glare screen

  • monitor at right angle to window

  • no ex
  • 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
    otic screen colors (black letters on white background is easiest)



    Often your workday is full of pressure. When under stress, you are less likely to pay attention to your posture and other minor irritations
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    . It takes awareness to vary your pace and change habits. The problem is that these injuries occur over weeks and months, and by the time they have hold of you, the habits are entrenched.

    The more fit you are, the le
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    ss likely you are to suffer from ergonomic syndromes. Take frequent mini-breaks to stretch or close your eyes. Get up to get a drink of water. Instead of spending your evenings surfing the Web after a day sitting at y
    .

    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
    our office desk, take a walk or stretch out on a balance ball.

    If you are too busy now to take the time for breaks and exercise, you are definitely too busy to have to take time off to recover from chronic injuries. Be
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    aware of the syndromes lurking close by and take measures now to block their incursion into your life.

    © Key Organization Systems, Inc., 2006


    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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