Subjects - Business

Delegating or assigning tasks and projects to someone else, can be very difficult to do. You may not want to ask for help or be anxious to prove that you can do

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

it all. However, delegating can be one of the most liberating things you do for yourself and help with your career. Delegating can be seen as training and offe

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

Examples of combination products may in

r value to your company and accomplishments to your resume.

In today’s business environment, learning to delegate projects is especially important because we a

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

re all challenged daily to do more. If you are a manager or a small business owner, delegating can make the difference between profit and loss on your bottom l

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

ine. Avoid the trap of believing the old axiom “If you want it done right, do it yourself.” Do not listen to that little voice in you that says, “it will take

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

Combination pro

extra time to train and I can not be sure of the results or that the person will complete the task”.

Think of delegation as allowing others on your team to lea

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

rn from your expertise, you're giving them an opportunity to grow towards their potential and reach their career goals.

Even if you are busy right now, before

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

you begin, take a little time to sketch out a basic project time line.

Doing the research helps you to implement the training plan. It may seem like a lot of w

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

ork in the beginning but once this outline is developed you can use it over and over. A good way to set the stage with your team is to sit down and find out wh

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

at they want from their career and plan a course to help them get there! Create win win right up front!

Delegate tasks that provide your team 'along the way' o

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

pportunities to use as learning steps towards their career goals. If you do not delegate and take the time to train your team, you may be keeping all the growth

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

Following aspects would a

opportunities for yourself!

Here are some steps to consider as you prepare to delegate:
• To maintain responsibility for the output of the project you'l

dd to the challenges in developing combination products:

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

l need to plan ahead.

Prepare a timeline outlining all the tasks/projects on the left and the dates they need to be completed to the right. Also schedule in re

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

gular follow up dates to make a progress check. Later, you can fill in the person's name to whom the task has been assigned.
• When you meet for the first

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

time with the person you have chosen, outline your project simply and ask for feedback on the project and the timeline. If you can, adjust your timeline to acc

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

ommodate their input - this opens the door and moves you into the mode of collaboration and gains buy in from your helper.
• Build trust and strengthen yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur role as a manager by letting your helper know you will be following up on these dates ahead. Use positive language to support your team and let them know you

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

are in this together. If appropriate, praise past accomplishments and link them to the present task.
• Plan to celebrate. Plan an opportunity for everyone

.

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

to get together to share the stories of their personal success and tie it into the team’s success.

Last but not least, always have thank you/success note card

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

Companies that provide selfless information through particip

s ready to let people know you appreciate their contributions.

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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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