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Just Other Articles - Carved in Granite
In the Black Hills of South Dakota, carved in granite, the six-story faces of George Washington, Thomas Jefferson, Abraham Lincoln and Theodore R 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 oosevelt create a grand impression viewed from a distant, or standing on the national monument's viewing terrace. Visiting Mount Rushmore on vaca ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ion, I found the documentary of its making fascinating. Weeks later, one story stayed with me. It turns out the sculptor, Gutzon Borglum, planne lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. to have the figure of Thomas Jefferson on George Washington's right. But after painstakingly carving a portion of the massive face, Borglum reac here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ed such poor quality granite that he could not complete the stone portrait the way he desired. So, he decided to blast away the carved face he ha d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro worked months to create, starting again in a new location. But unlike Borglum, many of us aren't willing to do major revisions to our work. We 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 treat our endeavors, ideas and projects as if they were carved in granite. We cling to an original vision or stay the course even when results ar 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 lacking. We resist revision, redirection and starting over. We see our completed work as unchangeable, often resisting input, feedback, critique nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically or suggestions that would cause us to rethink our approach. And because we do, our results are often mediocre at best. I learned that lesson whe 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 asked to write speeches for a company president as part of my other job responsibilities. I found myself entrenched in holding-on behavior. Inst ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi ad of tearing up a finished draft I wasn't pleased with and starting over, I treated my words with a permanence, working to preserve their essenc ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a e no matter, only to realize I'd wasted enormous effort producing something inherently flawed. Only when I realized I had an abundance of approac dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod es and words did I changed my behavior. I learned in twenty years in management, it's better to let go of the attachment to completed work. It's cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin better to start over, dramatically cut, enhance or revise projects, businesses, and work endeavors as needed. It's better to think of your work a tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen if sculpted in sand, not stone; as a fluid and ongoing process, not a finished piece. People who are winning at working have that mind-set. The 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 practice non-attachment. They're comfortable with change, improvement, input and new ideas. They understand they can create a better work, come ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust up with a better idea or develop a better result if they let go of what's not working. They treat their work like renewable putty, confident ther y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products are plenty of ideas inside them. If you want to be winning at working then you'll need to make changes, correct errors, fix mistakes and enhanc . 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 ideas along the way. Sometimes that requires the workplace equivalent of blasting granite. As Tom Peters puts it, "You can't live life without a elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip eraser." And I would add, you can't achieve results and be winning at working without one either. (c) 2006 Nan S. Russell. All rights reserved 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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