Business Articles - Internet and Businesses Online

Recently, I received an e-mail asking how I know which direction to take my business and how I've lasted so long in an arena of here today and gone tomorrows. What was the secret to my success? My initial

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

reaction was that there really is no "secret."

Then I thought for a moment... "I am a chameleon!"

I've lost count of the number of times I've evolved my technology consulting business in the last decade.

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

Examples of combination products may in

he moment I get a sniff of a trend, I move. Taking risks or trying new things never really has been a problem for me. Actually, I don't see them as a "risk" at the time - just a good idea!

Besides the obvi

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

us of always being ultra sensitive to how I am perceived by virtue of my e-mail habits, Web site and technology use, there are a handful of issues I think about almost constantly that I believe have kept my

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

usiness healthy and ahead of the curve. I make a point of reviewing these issues at least once each week to ensure I am addressing the topics that are most important at that point in time.

So, how do I pla

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

Combination pro

n for the future? How do I make business decisions in an online environment that is always in flux? Just ask anyone who has been in my office and has asked me these questions - they were then promptly han

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

ed my Fortune Telling 8 Ball! For one thing I have never predicted - this gig never existed previously so how could I possibly make any sort of presumptions? There simply is no predictability ability. (Say

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

that fast 3 times!)

So when asked to explain how I've gotten to where I am today, here is a list of things I am constantly thinking about when it comes to my business:

What hasn't been done yet th

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

t is still a ripe "opportunity." Folks, there are still a ton of them out there! What products, services or opportunities do available information and data indicate may hold potential for my business?

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

What has been done that can be done better? What ideas have been implemented by others but with tweaking, changes or improvement can be used as a tool for my business? Unlimited opportunities here as

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

any online are still not doing it right!

Business as we know it has changed dramatically, permanently. The old corporate culture or old school business methodology many times will hold you back w

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

Following aspects would a

en getting involved in the online environment. Now, that is not to say business staples do not apply, just that they may apply differently and more creatively. You've seen that IBM commercial? Executivus ex

dd to the challenges in developing combination products:

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

inctus? Try something new - on a regular basis. Don't just think "outside the box"; think under it, over it and to all four sides.

Profitability ratios. Where you have cash flow and where your p

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

rofit is can be two different areas or they can overlap. Continually reviewing this information allows you to tweak your program positively. We are all in business to make a profit, right? You need to iden

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

ify where these areas are and cater to them while at the same time addressing and minimizing any drains on your profitability. Without profit, you don't have a business.

Efficiency. What can be d

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

ne, changed, modified, added to ensure that time is used most efficiently. What areas can be improved upon? What tools can you put in place to make more time available? Find them, learn how to use them and p

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

Professional from academic institutions, pharmaceutical industries, health care indust

t them to work for you.

Many times it is difficult to step away from the day to day business of running your business to take the time to look from the outside in. And, sometimes we have to look

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

at our business models and make the right decisions for all the right reasons not just what we are comfortable with. Put your ego on the shelf, look at the facts, available opportunities and do your due dil

.

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

gence.

My standard reply when asked how I've run my technology business successfully for the past decade? "Have a plan. Then, if necessary, be prepared to toss it out the window and create a new one tomorro

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

Companies that provide selfless information through particip

"We are chameleons, and our partialities and prejudices change place with an easy and blessed facility, and we are soon wonted to the change and happy in it."~ Mark Twain

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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