References - Business

Following death and taxes, the third guaranteed ‘thing’ in life seems to be that you’ll *never* have enough time to put int

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

o action, all of your great ideas and plans for expanding your business and streams of income. That is why so many of the g

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

Examples of combination products may in

eat ideas we entrepreneurs have, seem to end up on the ‘back burners’ of our excessive compulsive, clickity clacking brains

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

. Sometimes never to be seen or remembered again…

The problem is that sometimes that back burner of ideas seems to get cro

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

ded to the point where you have to decide what really is a priority and what needs to be tossed out with the scraps.

Here

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

Combination pro

are a couple ways to help you sort these ideas and keep yourself from wasting valuable time you could be spending on more f

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

uitful ventures.

First, keep a written list of ideas. This can be very simple. In my case, I use a composition book that I

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

bought for a dollar at the grocery store. Every time I have a new idea, I write it in this book that I always keep next to

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

my keyboard. This way, I don’t end up getting distracted from what I’m working on and I don’t forget the crazy ideas that p

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

op into my head almost constantly. Once a week I go through the ideas I’ve written down and decide which ones are really wo

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

th pursuing and which ones to scrap.

Next, I decide what ideas I’ll put into action on my own and which ones I’ll outsourc

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

Following aspects would a

e to someone I trust. Hiring a third party to do your dirty work can be one of the most profitable things you can ever do i

dd to the challenges in developing combination products:

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

your business. The trick is learning to let go of the high level of control that you have when you are doing everything yo

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

urself. If you’re a control freak / perfectionist like me, this can be a true test of your will but the end almost always j

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

stifies the means.

Another great method of idea implementation and time management is to joint venture your golden ideas w

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

ith trusted partners. This method saves me time by splitting the work load between myself and a partner or even among three

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

Professional from academic institutions, pharmaceutical industries, health care indust

of us if the project is labor intensive. The only downside to this method is that you of course have to split the profits b

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

ut I’m sure you’ll agree that this is much better than having a great idea that goes nowhere because you simply didn't have

.

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

the time to implement it on your own.

Now take a look at your own ‘back burner’ of ideas…

Is it time for you to do a litt

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

Companies that provide selfless information through particip

le clean up? If so, try to apply the methods here to your own great plans. You’ll be surprised at the progress you can make

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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