Main Subject - Business

From the moment he putted with Bob Hope on the Mike Douglas Show at age two, Tiger Woods appeared destined for fame. After an unprecedented junior and amateur career, his ent

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

ry into the professional ranks in 1996 received tremendous publicity – and one of the largest sponsorship contracts in history. At age 28, having claimed 40 PGA Tour titles a

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

Examples of combination products may in

d with eight majors in his trophy case including the Tiger Slam, he has exceeded the loftiest expectations. Even more impressive, he is one of the most recognizable faces on

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

he planet and is bringing thousands of new fans and players to the game.

Those of us who have regular jobs often feel pressure to perform. Imagine for a moment what it would

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

be like to work with 50,000 people standing nearby and a worldwide television audience watching your every move, and you will briefly experience what it feels like to be Tige

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

Combination pro

. His disciplined approach to becoming the world’s dominant player is well documented. From his father teaching him concentration by employing distracting tricks, to learning

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

a new swing despite winning The Masters by a record 12 strokes in 1997, Tiger dedicated himself to perfecting his “A” game.

Success Handler Action: With your team, discuss

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

our “A” game. Talk about the things you do best in your small business. Here are some questions to help you get started:

~ What are the strongest areas in your company?

~ W

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

ere do you consistently beat your competition?

~ In what ways are you improving every day?

~ How do you maintain playing at the highest level?

~ Which things can you chang

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

to make you and your team even better?

In 2000-2001, when Tiger became the first player to hold all four modern majors simultaneously, he took the game to an unimaginable l

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

vel. Drives boomed 310 yards dead solid perfect. Long irons nestled close to the hole. Twenty-foot putts disappeared center cut. Playing in the final group on Sunday with Tig

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

Following aspects would a

er became an unbearable burden for otherwise great players.

More than anything during his incredible run, it was Tiger’s attitude that allowed him to devour fellow competito

dd to the challenges in developing combination products:

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

s. He believed no one could beat him, and proved it on golf’s biggest stages. As a small business owner, it’s essential to take the same approach. You and your employees must

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

have a vision of greatness for your company – your perfect swing – and set about practicing every day whatever it takes to get you there.

Success Handler Action: Gather your

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

team and talk about what it would look like if you were the number one operation in the world, the best of the best – a Tiger. To set out on your path, follow these five step

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

:

1. Conduct a SWOT, identifying your Strengths, Weaknesses, Opportunities and Threats

2. Have each team member define which areas they most impact

3. Outline specific act

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

Professional from academic institutions, pharmaceutical industries, health care indust

ion steps for capitalizing on Strengths and Opportunities

4. Create a plan for changing Weaknesses and responding to Threats

5. Set specific timetables for completing initi

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

tives, and hold individuals accountable

If Earl Woods had not imagined what Tiger could become, his career might have peaked at age two and he would simply be Eldrick to a s

.

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

all circle of friends and coworkers. Add Earl’s vision to Tiger’s incredible passion and you have a combination for greatness. Create vision and passion in your franchise bus

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

Companies that provide selfless information through particip

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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This is largely a fictional story, but do not allow that to detract you. It is true to the Imagination and, if that is the case, it is or can be for you true to the Meaning you represent and are. Do not be afraid. As long as you have on the Helmet of your Imagination, you should be safe....

If you're a small business owners, you know just how tough it can be to get yourself and your products or services out there. No matter what size your business is , you should know how to sell it.

No one can effectively work alone and no one ever does. Often, an idea may spark from a single person's mind but this would develop through the accumulation of ideas as contributed by those who have knowledge on a specific topic or simply have the innate quality to explore an idea from its simplistic point of view towards a more profound perspective.

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Main Subject - Go On, Be A Tiger

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