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Just Other Articles - To Team or Not to Team?
Everyone thinks teams are a good thing. Leaders like to form teams. People, for the most part believe in the value and purpose of teams . . . All of us are smarter than each of us. 1 + 1 = 3 . . . are just two common p 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 hrases that reinforce and prove how pervasive our belief in teams is. And that belief is justified. Sometimes. There are many times in our civic or church groups, and in our businesses and professional associations that ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug. Examples of combination products may in we need teams of people to work on an issue or a project. And sometimes we would be better off without a team - with individuals contributing as individuals. What? No team? You got it. At least not the type of team you lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together. probably think of, when you think of a team. Two Basic Types of Teams To keep things simple, I believe there are two basic types of teams. There are basketball teams and there are track and field teams. Baske here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe tball Teams Basketball teams (or soccer or hockey) are teams that require, by the nature of their task, that everyone play as one unit. On teams in these sports the players are interdependent. At any moment of any ga d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations. Combination pro me, in order to be successful, the entire team needs to be working in harmony. The role of each player is designated by their position (which takes into account their innate strengths and acquired skills). However, the situ 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 ation at any moment during the flow of the game, may require any player to take any role. And on good teams of this sort, all players are willing to be flexible, to assist, to change roles, to “do what it takes”. Because 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 they know that without working together, they can’t achieve their team goals of victory. The nature of the game forces interdependency among the team members. Track and Field Teams Players on track and field teams nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically on the other hand (except in a few relay events) are not interdependent, they are independent. Shot putters have a skill set that is largely unrelated to the sprinters. And the high jumpers can be personally skilled and 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 successful without any tangible help or support from the distance runners. At the end of the day (or meet), the team can win if enough of the individuals do well. In other words if enough individuals win, the team will wi ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi n. The most successful of these teams will have highly talented individual contributors, supporting each other to reach their common goal of winning. In this way they are definitely a team. They may feel allegiance to th ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it. Following aspects would a e group. They certainly can have pride in being a part of the group. They want each other to be successful. They know that they can all be more successful when each individual is more successful. They can have a common dd to the challenges in developing combination products: Which markets to tap where the combination products can do fairly well? Which combination prod goal (to win the meet or championship). But the fundamental relationship between the players isn’t the same as it is on a basketball team. What This Means to Us In our organizations we most likely have both sorts cts are meaningful and rational? Which therapeutic categories to select? Which Combinations can address unmet needs of the patients? Do combin of teams. We have teams that work in a process flow or project where the outputs of one person directly affect the work of the next – where the work and the people are highly interdependent. We also have teams that look m tions increase the patient compliance? What would be the developing cost? How to tackle the risks encountered during combination product developmen ore like the track and field team. In these situations people are working toward a common mission and goal, but their work doesn’t intersect in nearly the same ways as for the highly interdependent teams. Fair enough you 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 say. But in my experience, we tend to want all teams to think they are basketball teams. If the work or project dictates that focus, great. But if you have a track and field (independent) team, you don’t need the same fo ping new procedures for reviewing their safety, efficacy and quality. Professional from academic institutions, pharmaceutical industries, health care indust cus on interdependence and traditional “team building” activities. What Do We Do Now? If you lead a team or form teams or are just a member of a team, you need to think about and talk about this distinction. Deter y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products mine across the team (or future team) what type of team you are. Once there is agreement on the type of team you are, you can begin to set the right kinds of expectations for each other and for yourself. You can build mor . 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 e appropriate plans for training, development and team building. Knowing which type of team your work or project dictates is the first step towards helping that group of people be more successful and the work being done su elopment. They need to be wiser in analyzing the market trends and the regulatory requirements. Companies that provide selfless information through particip ccessfully. So maybe it isn’t really, “to team or not to team?”, but “which type of team?” . . . that is the question. Answer that one first. And, using the answer as a guide, watch all of your teams be more successful. 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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