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Advice You - Technical Staff: Protect Your Business
If you're not really careful with how you hire the expert technical staff on your pa 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 yroll, you could end up training and nurturing a future competitor. In this article, ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in you'll learn how to minimize your risk. Consider this example: Your firm (ABC Con lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. ulting) hires a technical person and pays for their Microsoft, Cisco, or Citrix trai here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe ning. This person gets really skilled and get lots of great field experience. Now, d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro ne day the employee wakes up says, “You know what? I don't think I want to work for 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 ABC Consulting anymore. I'm going to start my own consulting company out of my spa 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 e bedroom. And take 'my' clients with me.” Be Prepared for Potential Disasters Tha nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically t's one reason you shouldn't rely on just one salesperson or just one technical pers 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 n to carry the entire weight of your company. Figure out a way to be more actively i ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi nvolved in the sales process and service delivery process. Even if you're not the ma ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a in person who does the work all the time and even if you don't have the strongest sk dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod lls, having some finger in the pie will be very important for keeping your prized cl cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin ient accounts loyal and healthy. Don't Forget To Have Technical Staff Sign Contract tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen Make sure that you've covered your bases by having technical staff sign documents 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 such as non-compete clauses and non-disclosure agreements (NDAs) when you hire peopl ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust (talk with your attorney about these). Keep your eyes open and have a plan so that y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products you can deal with these issues before they become business crises. Copyright Notice . 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 Copyright MMI-MMVI, Small Biz Tech Talk. All Worldwide Rights Reserved. {Attention elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip Publishers: Live hyperlink in author resource box required for copyright compliance 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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