Advice You - Business

Well, folks, as luck and ratings would have it, it’s time for yet another season of that train wreck of reality TV, American Idol; the show that attempts to separate the talented from the terrible and brings them all

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

into your living room each week for you to enjoy. Get ready to call in and cast your vote for who should be applauded and who should be muzzled. How fortunate we are to be living in a time when we can judge our fell

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

Examples of combination products may in

w man via text message.

And don’t forget your judges, ladies and gentlemen, the flaky Paula Abdul, the canine-obsessed Randy Jackson (somebody get this guy a dog), and the perpetually nasty, Simon Cowell; who gives n

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

w meaning to the term, "I don’t mean this bad, but..."

To be honest, I’m not a fan of the show (too much negativity for my blood). The only time I watch it is when my wife screams, "Come here, you’ve got to see this!

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

And every viewing leads me to ask the obvious question: why would people without one scintilla of talent - I call them "the anti-talented" - willingly make complete fools of themselves on national TV, knowing that

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

Combination pro

the ridicule of a nation and the wrath of Simon awaits?

I guess it’s all about getting their fabled fifteen minutes of fame. You don’t have to win American Idol to profit from it. Look at William Hung; arguably the

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

worst singer in the history of the show (if not the planet). He was so bad his lack of talent became his shtick and he parlayed his fifteen seconds in the limelight into a record deal that made him a wealthy man.

Sh

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

rp entrepreneur, that William. His performing abilities (or lack thereof) became his unique selling proposition (USP) and he struck while the iron was hot. While the market was hungry for his product he gladly sold

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

t to them. What other valuable lessons might we learn about business from American Idol?

Don’t be afraid to follow your dream. You have to give credit to even the most horrible of singers who seriously have f

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

aith in their abilities: they have a dream and they are chasing it like a hound chasing a rabbit. They are not letting a lack of talent and an abundance of tone-deafness rain on their parade. In business if you don’

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

have a dream you don’t have anything to work toward. That’s why we entrepreneurs do what we do: to make our dreams come true.

Always be prepared. I’m amazed at how many people show up to audition for Idol w

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

Following aspects would a

thout knowing the words or melody of the song they are trying to sing. Many of those who get passed on to the next round are not necessarily those with the best voices, but the ones who are the most practiced and pol

dd to the challenges in developing combination products:

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

shed. In business you get one chance at making a great first impression with your customers, your vendors, your banker, etc. Don’t screw it up by forgetting the words to your elevator pitch. How do you make it to th

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

e Forbes 100? Practice, my son, practice.

Know your strengths and weaknesses. Many of the contestants bomb because they chose to sing a song that highlighted their weaknesses instead of showing off their st

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

engths. In business you must know your strengths and weaknesses so you can play to your strengths and take action to compensate for your weaknesses. Never get so big for your britches that you think your business do

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

sn’t have weaknesses. Every business has chinks in its armor. The key is to never let the public hear you sing about them.

Sometimes you just have to go for it. Sometimes you just have to damn the torpedoes

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

Professional from academic institutions, pharmaceutical industries, health care indust

nd the opinions of others and forge full steam ahead. If you have an idea for a business and you’ve done all the research to prove that your idea is viable (even if it’s a little off-key), you have to put faith in yo

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

urself and your abilities and just go for it.

Never, ever give up. Some Idol wannabes audition every year and never make it past the first round. Despite their lack of talent, you have to admire their tenacit

.

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

. They brush Simon’s teeth marks off their backsides and come back year after year; hoping that the result will be different, although knowing it will probably be the same. Business is tough and unpredictable. You

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

Companies that provide selfless information through particip

can be at the top of the charts one day and booed off stage the next.

As an entrepreneur you must have the ability to pick yourself up, dust yourself off, and get back on that stage. At least till the fat lady sings

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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