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The old maxim “if you want something done right, do it yourself,” does not address the busy manager with assignments and deadlines facing them everyday. Many managers find themselves limited simply by the hours in a day to meet the many dema

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

nds confronting them. Giving up control and authority is a challenge that many managers fear more than working twelve hours a day six days a week. But the effective manager is one who understands his or her limitations and has confidence in

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

Examples of combination products may in

both their ability to delegate and their subordinates. There are five steps that insure that the delegation process will yield the best results for the manager and the recipient of delegated tasks.

1. Clarify the assignment. Look

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

carefully at the task and what is required to complete it. What steps are involved in the assignment? What knowledge is needed? Who in your organization is best qualified to assume this task? If you are not clear in your assignment the r

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

esults will definitely be in jeopardy. Finding the employee with the necessary skills and experience to do the job is only half the challenge. Once that employee is designated you have to be clear about what you want done. For best results

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

Combination pro

, delegate the outcome of the assignment. Let your subordinate choose methods and strategies that they feel will best allow them to complete the assignment. Also long as you’ve made your goals clear, your chosen employee is the best person

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

to determine the way to reach a positive outcome.

2. Specify the range of authority. Every time you delegate a project you also delegate authority. But every assignment and the authority required have inherited constraints. It is

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

ruitless to give an assignment and not delegate the authority needed to gather information, enlist others help, and utilize company resources. When you clarify the assignment, examine how much authority is required and inform your designee o

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

f the range of discretion you are giving them. Be clear about constraints and limits that you are granting and the boundaries involved.

3. Inform all affected parties that delegation has occurred. Your designee is going to need coo

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

peration to complete the given project. Also, they are acting in your place and to avoid misunderstandings and confusion, let everyone know that you’ve delegated this task and to whom the task has been given. Failure to communicate with oth

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

ers will sabotage your employee’s efforts. Also, in all organizations where established lines of authority are clearly drawn, changes can cause uncertainty and concern about other members of your team. Avoid “water cooler gossip” by being up

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

Following aspects would a

front with your employees and communicate your trust that they will cooperate with your designee as they would cooperate with you.

4. Allow your subordinate to participate. Employees that are encouraged to participate in the require

dd to the challenges in developing combination products:

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

ments, methods, degree of authority, and time frames of a given project are more motivated and enthusiastic in assuming tasks. When you give an assignment, draw on the thoughts and opinions of your subordinate to map out the assignment and y

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

our expectations. This illustrates a manager’s confidence in the recipient and their abilities. A cooperative spirit goes a long way to ensuring success. When employees feel they have a voice in a given project there is a higher degree of

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

atisfaction, motivation, and accountability for performance.

5. Establish an open line of communication for feedback and monitoring progress. As you set time tables and reporting guidelines, also make sure that your employee has a r

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

oute for questions, advice, and concerns that may arise. Delegation is an ongoing process and communication is essential to its success. This communication should involve not only concerns of your subordinate but the managers concerns as th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e project progresses. Periodic monitoring insures that problems along the way are dealt with in a timely and efficient manner. Each step involved in an assignment should have a corresponding time frame and specific reporting requirement. M

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

utual understanding and acceptance of these reporting requirements is vital to a smooth transition from your actions to the actions of your designee.

Delegation is an issue facing managers more and more as personnel budgets are tightened but

.

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

demands on mangers time and expertise are growing. Delegating is not a sign of limitation or failure to meet expectations but a sign of a confident and secure manager who can draw upon the talent within their organization. Indeed, delegati

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

Companies that provide selfless information through particip

on is the truest test of a manager’s confidence. The mission of every manager must be trust in themselves and trusting the team they have assembled. After all, why build a great team if you don’t use its talents to the fullest degree?

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 with Confidence - Five Essential Steps

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