Advice You - Business

I was having a discussion with a banker friend of mine who suggested that businesses that wer

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 successful were good at identifying and hiring high quality people. I disagreed. Ouch! 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

at is totally against the grain of conventional wisdom, right? Not really.

More important t

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

an hiring high quality people is establishing solid and proven processes that make your busin

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

ss work. Take a look at McDonalds. This business is successful, not because of the quality

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

Combination pro

of the people, but because of the quality of the processes that the people follow. This is w

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

hy over 75% of franchise businesses succeed while 90% of start-ups fail.

So what is the less

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

n here? As a small business owner, you should focus your attention on defining what works an

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

what doesn't in your business. Measure your activities to a point, so when asked, you will

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

now exactly how long it takes for the fries to cook, when to flip the burger and exactly how

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

uch secret sauce to put on the bun. If you have defined your business processes to this leve

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

Following aspects would a

l, all you need are employees willing to follow your rules. The rest will be automatic.

Tha

dd to the challenges in developing combination products:

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

's not to say that you should hire just anybody. On the contrary, as you grow you will want

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

o hire people that are loyal, trustworthy, innovative, and talented. These people will becom

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

the backbone of your company. In the beginning, however, what you need are technicians, wor

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

ers who can free up your time so you can work on growing the business.

In the early days, th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e secret is loyalty. Employees that are willing to follow your rules are more valuable than

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

xperts that think their experiences will contribute to your success. If you have done your h

.

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

mework, you already know what works and what doesn't. Hire those who are willing to follow a

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

Companies that provide selfless information through particip

d your profits will be better than those who pay a premium for the experts.

To Your Success

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 - Do People Really Make a Difference?

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