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E-Folder - Small Business Success Secret: Focus on Your Genius Work?
Do you know what your genius work is? It's the highest and best use of your time. It's the best leverage your busi 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 ness has in the marketplace. You're doing your genius work when your activities are producing the greatest resu ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in ts in the shortest period of time. You know you're doing your genius work when you enter the state of flow - that lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. state when time is altered for you. When you are so engaged in what you are doing that hours can pass without you here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe noticing. When you are not spending as much time as possible doing your genius work, your business is a struggle. d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro It's difficult and frustrating. And it is not going to be a place that makes your heart sing or your feet want to 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 jump out of bed in the morning. To identify your genius work, ask yourself these questions:
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 of all the tasks that must be done in my business, which ones can only be done by me? nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically business that has the biggest impact on the bottom line? 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 , or special about my business? ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi n my today's "To-Do List" only things I do
magnificiently? As a business owner your genius work ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a might include activities such as:
dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ing a potential referral or alliance partner tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen w draft of your service offerings for the coming year 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 r to delivery to the client ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust When you begin to focus your time and energy on your genius work, and learn to delegate those tasks a y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products d activities that are a struggle for you to your subcontractors, your business is positioned for growth. As a bon . 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 us, you'll find you have more time for a personal life. In fact, it is not uncommon for you to be able to reclaim elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip etween 10 and 20 hours each week by learning to use your subcontractors more effectively. Copyright 2003 Rose Hil 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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