Main Subject - Business

A team is formed to achieve a goal, and for that all the team members have to combine

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

and pool their abilities to achieve different tasks and achieve that single goal. Many

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

times it is seen that a team with high performance individuals fails to achieve the g

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

iven targets. There may be many reasons for failure of the team. One of them may be th

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

e ego of the individual team members.

Ego generally means the sense of self-importanc

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

e. Ego gets defined in different ways by psychiatrists and plays many roles in shaping

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

our life. Ego clashes are well known. Even small children have egos. How does ego aff

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

ect our performance as a team? Let us quiz on that.

Quiz your goals - what are the go

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

als of the team, who is playing which role, who is being given what importance and who

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

will be given how much amount of credit, these questions must be clearly answered oth

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

erwise the result will be conflict at some point of time. Every team member has be cle

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

arly told about expectations from him/her and made to feel important. These are person

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ality goals that have to be defined and achieved.

Quiz the ego levels - The team lead

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

er should talk to individual team members and find out the ego level of each member. O

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

nce the team member understands the sensitivities of all the members, he/she can treat

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

the member accordingly. It does not mean that if a team member has high ego then that

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

that has to be pampered. In that case the member has to be given that input and asked

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

to keep his /her ego expectations low and matching with the team goals.

Ego can cont

.

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

ribute to great success and also play havoc. Control the ego of the team members and y

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ou will get fabulous results. Quiz your team about all these aspects and you will win.

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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