Advice You - Business

Seems as though there are a lot of business closings goin

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

g around lately. Everywhere I look small businesses -- on

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

Examples of combination products may in

on top of another -- are closing their doors.

On small

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

arquee signs, empty storefronts, and in the newspaper it'

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

common to see the message, "ABC Company Closes It's Door

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

Combination pro

After 35 Years."

Is that what you want the newspaper to

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

print about your business?

Somewhat deflating, isn't it

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

Like a balloon leaking air. So where will your business

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

e in 35 years? Have you decided what "the end" looks like

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

for your small business yet?

Decide -- now -- whether yo

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

r business will end with an explosive headline such as, "

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

Following aspects would a

QTD Company sold to YXZ Company for 10 Billion Dollars!"

dd to the challenges in developing combination products:

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

r fizzle out like ABC Company and fade quietly into the s

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

nset.

Define your small business "end" now and work towa

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

d it. Dream big. Create a visual that shows exactly what

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 want your business to look like when you're done.

Def

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

Professional from academic institutions, pharmaceutical industries, health care indust

ine the steps necessary to make that visual you created a

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

reality. Turn it into your plan for success by identifyin

.

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

how and when you will make each step happen. Take those

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

Companies that provide selfless information through particip

teps and create a road map to follow so you can get there

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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There are a lot of great and thoughtful things you can do to build a business. But we both know it's not the things you can do, it's the things you should do that matter most. Better yet, it's the things you should do that you can accomplish with the least amount of effort. Thankfully, there are four things that meet this criterion.

Offer proof to your prospects. Testimonials are one of the most powerful and cost effective selling tools you can implement in your arsenal of marketing. Why? Because you are offering social proof to your prospects from their peers attesting that your services/products actually work.

Scripture teaches us that when we are asked to go one mile, go another one. Every self-help author I have ever known or read has in some way espoused this critical philosophy. Let me take an excerpt from one of the books by one of my mentors, the late Og Mandino. (A Better Way to Live.)

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Advice You - The End -- Fireworks or Fizzle?

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