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    Many couples first met on the job, are involved in family businesses, or find themselves considering working together on something they both love. One of the basics behind success in such ventures is whether they can make it past the hurdle of compet
    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
    ing with each other.

    First, some personal history. Probably due to very similar personalities, my wife, Pam, and I have almost always been involved in some such joint venture. After marriage we became the volunteer caretakers at a church camp. Then
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    we jointly enrolled in seminary. We were co-pastors for four years. I always like to say that our marriage "survived" those years.

    Back then we didn't have the maturity to know what true cooperation and intimacy was. Whatever she could do I felt I h
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    ad to do just as well or better. Whatever decision she made I would need to add my critique to. The "shop-talk" at home rarely was put aside. You can imagine what happened to the romance in our marriage!

    We got smart at that point and took separate
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    obs and began separate training in our clinical disciplines. Then the opportunity to work together came around again. For the last ten years we've co-directed the Samaritan Counseling & Education Center in Colorado Springs, CO.

    At first, I was worri
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ed the same old competition would occur. What a pleasant surprise to find that some level of maturity had set in! It was now clear to me that my wife is the perfect "out front" person with true qualities for group organization and leadership.

    I was
    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
    just fine being the "behind-the-scenes" clinician that sat in my office hour after hour seeing clients. She provided the flash and dazzle, while I was the steady presence cranking out therapy and caring for the staff. In other words, we each knew our
    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
    respective strengths and were emotionally adjusted to being who we were. A few years had made a lot of difference!

    And what about now, ten years later? We're still running the Center, but we also have our own developing businesses on the side. I, o
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    course, have this newsletter, and Pam always proof reads it for me (along with editorial comment!), and she has an equine therapy and education business that I support with many hands-on hours of harnessing horses, moving them from place to place, a
    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
    long with feeding and watering duties.

    Competition Vs. Emotional Intimacy

    Business together can be a wonderfully unifying couple activity. This is why multi-level-marketing companies always want to make the business a family affair. However, the wh
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ole enterprise can founder on the rock of competition.

    Competition is fine in its place, such as with business competitors or on the sporting field. But it will kill the emotional intimacy between two lovers. Competition sets up a "win-lose" paradig
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    m. Someone must lose in order for someone to win.

    Emotional Intimacy requires vulnerability. If we are vulnerable, it is safe to share ourselves with the other. It is safe to be open with feelings, thoughts, dreams and asperations. Once we start to
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    ompete (any kind of argument or heated disagreement), it is no longer safe and our emotional life will shut down.

    Most of us first came together because we wanted to be wanted. We wanted another person to want to know us deeply and to appreciate wha
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    t they found. Unless we are careful, being in business together can kill the very thing that brought us together.

    What I have found in my work with couples, is that making decisions by consensus is what almost always works. Competition doesn't, cons
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    ensus does. This means making decisions only when both partners can agree. It is inefficient and time consuming, but it is what works.

    If you find yourself in ongoing competitive struggles, resolve to get help and to work it through. My experience w
    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
    ith my wife suggests it is well worth it. Plus, I find that my work as a counselor with couples in business is some of the most rewarding time I put in.

    Are You And Your Honey Going To Be Good Business Partners?

    Probably not right away. It takes pr
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    ctice and experience. But this is no reason not to try it. Anything worth doing requires a significant learning curve. How will you ever know if you don't try it?

    One place to try it out with a low entrance fee is to start an online business togethe
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    r. Try an online newsletter, a web site that sells one or many items, or perhaps buying and selling on ebay. See what can interest you both, and see what you can learn about working together on it.

    Conclusion

    Your project together doesn't have to b
    .

    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
    e a business. Pam and I spent three years hiking the Colorado Trail together. That's 470 miles from Denver to Durango! How many people can say they've walked from Denver to Durango? Not many. But we have, and it was a great couple building time for t
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    he two of us.

    So, your project may be business, and it may not be. But the value of an endeavor together, with the personal growth that comes from it, can and probably will, catapult your relationship to new levels of energy, closeness, and maturity


    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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