Digg It - Business

I bet your just aching to know what the one, big bang, knock it out of the park secret is to uncorking profits in your business is.

Everything els

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

e comes in second to this...

Nope, it isn't marketing your business, although that is the close second.

It's not an enormous cas

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

Examples of combination products may in

windfall either...I have seen enough business owners fiddle one of those away faster than you can make a peanut butter and jelly sandwich.

Wanna

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

now what it is?

Get out of your own way. Yep, that's it. Before you fire up that email program to say "Joe, t

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

at is so stupid"...allow me to explain. The explanation might hurt the ego a little. Don't worry, I have been here too though.

It starts with a qu

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

Combination pro

stion...

"Mr. Business Owner, how many times have you felt that you 'just had' to involve yourself in a meeting, discipline an employee, or da

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

bble in some operational part of your business etc...?"

I understand why you feel this way. You don't want whatever your over-analyzing to go

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

wrong (notice I said over-analyzing). You are striving for perfection.

While it is ok to have high standards for your business an

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

the product or service your business offers to the community...you are probably doing more harm than good to the end result. What if you actually

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

strong>trusted the person to perform the task, conduct the meeting, etc...?

What would happen if you got out of the way and "let

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

things happen" in your business?

I am not suggesting you play golf all day, every day here. What I am suggesting is you start to do two things in

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

Following aspects would a

your business starting today:

1) Create systems that people (even freelancers) can work in your business. For example, an auto sh

dd to the challenges in developing combination products:

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

p owner might have a step by step customer interaction process that she trains her staff on...so that each customer is handled pretty close to the

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

ame way. Then, the owner does not have to monitor that part of her business unless that person does something wrong (which actually happens a lot l

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

ss than you think).

2) They are humans, trust them. The point here is to have confidence in your hiring abilities (or the person

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

ou trained/outsourced to hire for you, which should be the case). Then, trust the people you hire to do the job you have

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

Professional from academic institutions, pharmaceutical industries, health care indust

shown them to do. Don't hover, or micromanage a project to death. You lose your valuable time that you can better invest in $300 an hour tasks.

Be

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

ides, why did you hire someone if you are going to monitor them 24-7 anyhow?

Quit it. Relax.

Now the advanced lesson for business owners that act

.

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

ally hire a General Manager/CEO/President to "run things for them." Get out of the way...you have built your business to the point where it's time

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

Companies that provide selfless information through particip

o "let go" and watch it grow. Or, keep pulling your hair out trying to run things around the "shop."

Get out of your own way. You know who you are

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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