Advice You - Business

Ask yourself the following questions to glean some insight into what might be keeping you

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

from generating the clients (and the cash) you desire!

I am wasting billiable t

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

Examples of combination products may in

ime doing tasks that I hate doing, I'm not very good at, and that other people could easil

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

y do. True/False

I'd like to hire someone to help me, but financially it's just

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

not possible right now! True/False

I'm not using any sort of marketing plan to k

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

Combination pro

eep me focused and on course toward my bigger business goals. True/False

I have

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

a few client-generating ideas I'd like to implement, but I just don't seem to find the tim

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

or energy to get them into action. True/False

I don't have solid client-generat

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

ing systems in place for much of what I do. True/False

Basically, my ideal clien

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

t or target market is ANYONE and everyone! True/False

The way my business is cur

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

rently set up, I can't take any time off without my cash flow taking a huge hit. True/Fals

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

Following aspects would a

I market, but I don't ever seem to get any results. True/False

I'm s

dd to the challenges in developing combination products:

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

tarting to feel like I'm working way too hard. I have very little time for anything fun in

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

my life. True/False

I feel the passion and excitement I once had for my busines

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

starting to slip away. True/False

Truth be told, things have not been going so

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

well in my business for well over a year now. True/False

How'd you do? Did you

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

Professional from academic institutions, pharmaceutical industries, health care indust

answer "False" to all of them? If so, congrats! There's nothing standing in your way of ge

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

nerating all the clients you need.

If you answered all (or mostly all) "Trues" -- then it

.

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

's time to take a close look at these areas, and begin making changes immediately. These o

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

Companies that provide selfless information through particip

bstacles are preventing you from effectively growing your business!

(c) Connie Scholl 200

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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