Advice You - Business

What?

There is a time when chaos comes in handy. How many times have you struggled to get started o

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

n something and when you finally got started, everything was easy from then on? Consider getting off to a chaotic sta

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

Examples of combination products may in

rt. You can go back to your more methodical and sane ways after you have the project rolling forward.

So Wha

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

?

Many people procrastinate or fail to start something because they try to “get it right” on the front end.

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

It’s much easier to get started on something, and revise it or improve it, than to get it right the first time.

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

Combination pro

ong>Now What?

Here’s a good way to get things going when you are stuck.

Get a few people (preferably some

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

out-of-the-box thinkers) in a room with a stack of index cards. Write the topic you want to explore or the project yo

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

u want to start on a flipchart or grease board. Pause and give everybody a minute or two to think about the topic and

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

ask them to write each idea they have on a separate index card. Then debrief the group by asking them to read their i

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

deas out loud and toss their index card in the middle of the table. As one person reads their idea out loud, instruct

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

the others to try to come up with other ideas that are triggered by the reader’s idea. Keep doing this until you have

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

Following aspects would a

a lot of ideas on cards in the middle of the table.

Then categorize the ideas and group cards with similar or relat

dd to the challenges in developing combination products:

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

ed ideas together. Ask the group to point to the best idea and turn the index card explaining the idea facedown. Then

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

determine the next best idea and turn the card explaining that idea facedown on top of the first one. Keep doing this

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

until all the cards are facedown. Then turn the stack of cards over. You now have plenty of ideas to help you get st

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

rted, and they are organized in priority order. Assign the cards to people who will follow up on the ideas and get st

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

Professional from academic institutions, pharmaceutical industries, health care indust

arted on your project. The meeting will seem a little chaotic at first, but you will end up with a highly organized p

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

lan of action.

Other Applications

Use this technique in the following situations:

Making

.

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

iring decisions

Solving problems

Preparing speeches or presentations

Preparing proposals

Designin

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

Companies that provide selfless information through particip

g products

Designing processes

The first steps and the last steps are usually the hardest.

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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Advice You - Project Management - Getting Started!

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