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E-Folder - Why Don't We?
The other day a business client said to me, "Why don't I just do this stuff? I know how to do it. I know it 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 needs to be done, but I don't do it." What's it? It is the big rocks in your business that we avoid. It's w ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in orking in our business and not on it. It's lack of planning, lack of reviewing, lack of analysis. Why don't lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. we do it? For many of us, it's fear. What if I stop long enough to plan? Won't my business get away from me here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ? Won't my clients/customers leave because they see I'm not paying attention? If I don't get to that network d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ing meeting, people will forget me and then I won't get a new client. We're like the White Rabbit from Alice 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 in Wonderland, always rushing around saying we are late. From the time I took my first job at an A & P superm 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 rket in New Jersey, I've been told to "look busy" even if there was nothing to do. In the corporate world, si nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically tting around with your feet on the desk thinking just wasn't done (except by the big boys), particularly for 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 woman. And I carry that attitude into my own business most of the time. If I'm not sitting at the computer ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi typing, then I'm not really working, am I? Can you relate to this? Are you scurrying around and panicking wh ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a en there's nothing "TO Do," even though your todo list is long. If this is a slow season for you, seize the o dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod pportunity! If it's a crazy season for you, plan for a few weeks once the holiday rush is over. What should cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin you do? Business Plan: If you don't have a business plan, make one. Check your actual income and expenses a tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ainst an old one and update it. Marketing Plan and Budget: Plan out what you will spend your marketing plan 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 and budget on in the coming year. Also determine how you will learn about the effectiveness of your marketing ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust . Contact Management: Figure out how to manage the contacts you do make at networking meetings, and how to f y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products ollow up with clients and customers you do have in order to retain them. Finances: Get with a financial cons . 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 ultant and learn the reports you need to review on a regular basis to see how your business is doing. Read: elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip Read a business book or two. Take a class. Learn something new, even if its a new way to make meat loaf! ** 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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