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When you delegate tasks or processes, you transfer a certain level of freedom in how the task

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

s are to be handled. These levels range from simply giving instructions to be followed right

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

Examples of combination products may in

through to handing over a complete project that then becomes part of the person's job descrip

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

tion.

But how do you decide? Here are three measures you can use:

1. The level of experienc

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

of the person to whom you are delegating. How much experience does this person have with the

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

Combination pro

company? With the department? How familiar are they with the work involved? Have they had a

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

chance to see you, or someone else, carry the task through so that they have some idea of wha

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

t will be involved? Someone who is totally inexperienced in the area may still be able to do

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

t, but they will need more supervision and the level of delegation will be at the lower end o

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

f the scale.

2. Proven reliability. Some people always come through. If they promise somethi

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

ng by 4 p.m. on Tuesday, you can set your watch by its arrival. This is a very desirable trai

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

Following aspects would a

t in an employee, and one you should encourage and develop. With this person, you will still

dd to the challenges in developing combination products:

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

ollow the delegation process including timelines and benchmark reporting dates, but you'll ha

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

ve more confidence in them being met.

3. How critical is the task? If a lot is riding on the

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

success of the task, you should weigh the first two points carefully because your choice of

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

person may well be the difference between success and failure. Test people with less critical

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

Professional from academic institutions, pharmaceutical industries, health care indust

tasks at first, and as they prove themselves worthy of your trust, move them up the delegatio

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

n levels.

One of the great benefits of effective delegation is the empowerment of employees,

.

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

but success or failure can depend on handing over just the right amount of freedom with the

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

Companies that provide selfless information through particip

task. Use these three guidelines to help you delegate each task at the most appropriate level

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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