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E-Folder - Thinking Outside The Box - Access Collective Genius
My wife had a pretty little turquoise and silver bracelet. After wearing it one day she discovered she couldn't get it off. It was stuck and the clasp wouldn't budge. Cal 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 ling on my vast experience as a fixer of broken things, she asked me to unstick it. I failed. She wore it to bed that night. She didn't sleep well - the bracelet was just ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in tight enough to be irritating. The next morning she declared it had to come off. We looked at it - we both tried to get the clasp to work - to no avail. It wasn't so val lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. uable that we should take it to a jeweler. That damned clasp just wouldn't move. We ended up cutting it off with a bolt cutters. And as soon as we did, the part of the br here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe acelet that we thought was the hinge fell off - and we discovered we had been trying to open the wrong end of the clasp! Have you ever zeroed in on something and just ha d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro d to act on what you saw - and later discovered that there were other - possibly better ways to deal with the issue? Is that thinking in the box. I think so. Another exa 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 mple. We use a picture in our seminars that illustrates how differently the same object can be viewed by two people. The picture is a black and white drawing of an old wo 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 an - or a young woman - or both an old and a young woman, depending on how you see it. In my experience, when first shown the picture, about half see the young woman, and nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically about half see the old woman. Very few see both women in the picture. (Send me a request with your E mail address and I will send you a copy of the picture). And once pe 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 ople have "locked in" on a particular view, it is very difficult for them to see the other woman, even after they are told she is in the picture. It is only after careful ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ly pointing out the different outlines that people begin to see the other picture - the one they did not see originally. Once again, we get so locked in on that first imp ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a ression that we find it hard to see any other view. How do we overcome that very human behavior? It's easy to say "Think outside the box" - but how do we do it? I sugge dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod st the very best way to think outside your box is to think inside some else's. How do you do that? Going back to the young lady/old lady exercise: when one person says th cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ey see an old lady, and another says they see a young lady, rather than insist on the rightness of their own personal observations, the effective people share information tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen struggle through their own first impression, and come to a broader interpretation of the picture. Effective people respect and depend on the Collective Genius of the gr 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 oup – they know the result of out of the box thinking results in solutions greater than the sum of the parts. The payoff - more possibilities, better information, persona ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust l growth and success. The essential attributes to think outside the box are: communication skills - particularly listening being open to expanding your own position ba y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products sed on the input of others developing relationships with others that allow an interchange of information a real respect for the values of others ability to suspend jud . 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 gment on others Collective Genius thinking takes the willingness to use the most feared words in many people's vocabulary - "What do you think?" Scary words for a lot elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip of managers – but absolutely essential to out of the box thinking. If you are looking for a powerful way to increase your personal effectiveness, this will do it. Try it 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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