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Effective Delegation Requires Clear Communication

When you decide to delegate a task to someone, that person may se

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

e it as a welcome responsibility that shows your trust in him or her, or just another job to be added to an already

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

Examples of combination products may in

urdensome workload. Which it is can depend largely on how well you communicate with the person during the actual del

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

gation conversation.

Three aspects must be communicated and agreed upon right from the start in order to set up the

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

delegated task for success:

• WHAT the task is. Define the task clearly. While you may decide to leave the p

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

Combination pro

ocess open to their discretion, you must make clear precisely what you want the end result to be.

• WHY you

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

re delegating it to them. You should choose the person who will do the task based on their current competency or th

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

ir ability to quickly attain the necessary competency. Explain this reasoning in the initial discussion.

• WHERE

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

/b> the task fits in the 'big picture' of your department or the company as a whole. People resent feeling they are

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

ust being given meaningless, unimportant jobs, but even a seemingly small task CAN have impact on a larger desired r

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

sult --- it's your job to help them see that.

• WHEN it must be completed. Be clear not only about the final

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

Following aspects would a

deadline date, but any interim stage points that must be reached by specific dates. These can be tied in with inter

dd to the challenges in developing combination products:

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

m reporting to monitor the project in progress.

• WHAT resources are available. If expenditures will be nece

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

sary, tell them what the budget is and how they can access the money. If people are available for help or support, m

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

ke sure all parties are aware of this. If training is needed, explain how it can be obtained.

The first step in the

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

delegation process is to think it through clearly yourself to be sure you have all this information at your fingerti

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

Professional from academic institutions, pharmaceutical industries, health care indust

s before you meet with the person. Next, explain each of the above points clearly. Finally, through discussion, ensu

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

e that the other person has the same understanding of the process as you do.

Delegation has benefits for both parti

.

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

s. When managers pass on tasks they have been doing themselves, they save time. When subordinates are entrusted with

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

Companies that provide selfless information through particip

meaningful tasks and responsibilities, they are empowered.

It's a win for both, and for the organization as a whole

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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Digg It - Delegation and Empowerment: Communication is Key

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