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Good leaders are always building and maintaining the self-esteem of their team members. In fact, this skill may very we

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

ll be the cornerstone of effective leadership. However, leaders often move too quickly to take the care needed to do th

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

Examples of combination products may in

is effectively when providing feedback. The result can be both the loss of loyalty and talent. Both come with a high

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

price tag to the organization.

To illustrate the fragile nature of self-esteem, consider for a moment one of the world

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

s finest musicians: Beethoven. The film, “Immortal Beloved,” is about the life of Beethoven and while it has a fictiona

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

Combination pro

l story line, it also offers many true scenes from this great masters life.

In one such scene, Beethoven is conducting

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

his own composition (imagine that for a moment) but he is completely deaf. This fact, however, has not yet been discov

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

red by his audience or the community at large. Shortly into the piece, the orchestra becomes completely frustrated wi

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

th Beethoven and literally stops playing. The audience is quite entertained and begins laughing due to their perception

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

of his lack of competence. Beethoven is devistated by their response and leaves the concert hall immediately. It is

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

a painful example of the fragility of self-esteem, and how easy it is for us to jump to conclusions about someone’s be

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

Following aspects would a

havior and be totally off the mark.

When confronted with performance that falls short of an expectation:

dd to the challenges in developing combination products:

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

e time to gather facts and observe the employee before having a conversation.

Ask the team member for their opinio

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

n first and try to understand the situation from their perspective before providing your own observations.

Find o

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

t if the expectations are clearly understood, or if there are other factors you may not know behind this performance.

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

Should the employee admit to a lack of performance they are in essence inviting you to do some coaching. They know

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

Professional from academic institutions, pharmaceutical industries, health care indust

they are off track. They need and want you to hold them accountable. Make a contract together for the expected improvem

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

ents and follow up to see that these promises are kept.

By not jumping to conclusions you give your team member t

.

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

he benefit of the doubt. You are saying, look I do not know all there is to know about you and your job, tell me; I

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

Companies that provide selfless information through particip

trust you. You'll gain perspective that builds both the relationship and the performance of your employee and your team

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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