Advice You - Business

When the recent Games of the XXVIII Olympiad came to a close in Athens, two events stood out in my mind as perfect examples of the importance of time management:

1. Teenage swimmer Michael Phelps, America’s most-celebra

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

ted Olympic athlete, matched Mark Spitz’s record of four individual gold medals with a stirring comeback in the 100m butterfly. Phelps pulled off an incredible feat in the final 50 meters, making up a half-body length to

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

Examples of combination products may in

nip teammate and world-record holder Ian Crocker by four-hundredths of a second.

2. In the men’s 100m track and field final, the United States took first, third and fourth. The time separating Justin Gatlin’s gold medal

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

performance from teammate Shawn Crawford’s fourth place finish was again four-hundredths of a second. That means after running more than the length of a football field, four men crossed the finish line separated by less

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

time than you can start and stop a stopwatch.

Fortunately, most small business owners don’t have to overcome such narrow time margins to achieve success in their endeavors. The key for you is to get the most out of your

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

Combination pro

entire working day. Once you identify your Genius Time – those high-impact activities that lead to your peak performance and bring the biggest return to your franchise business – your Olympic challenge becomes disciplin

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

ng yourself to focus on it regularly. To do this, you must become a gold medalist at delegation.

Success Handler Action: After you finish reading this e-newsletter, spend some time thinking about things you do in your s

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

mall business that could be given to others with a few minutes of instruction. These are “Delegation Tasks” that may require you to go over the “how to” with a person the first few times, yet could easily transition to s

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

meone else’s responsibility on a regular and ongoing basis. Here are some questions to help you get started:

~ What things did you do today that someone else could have handled?

~ Where are you spending time that your

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

instincts tell you someone else should be doing?

~ Why do the ‘smaller’ things keep getting in the way of accomplishing your ‘bigger’ goals?

~ When you are away for awhile, which employees ‘get things done’?

~ Who in

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

our small business best accepts new challenges?

Eliminating Delegation Tasks does not necessarily require increasing your payroll. It can be as simple as choosing a few of the less-important things you do frequently (ou

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

Following aspects would a

clients often mention answering the phone, making bank deposits, copying and filing), and transferring them to an existing employee.

The second step to maximizing your Genius Time is to identify your “I Wish Tasks.” Th

dd to the challenges in developing combination products:

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

ese are the two or three things you wish someone else would do, and they may take an hour or more of guidance on your part to get this person up to speed (invoicing and writing thank you notes are two examples that come

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

p during our coaching sessions). When you think about how much money your time is worth per hour, it probably makes sense to off-load these to someone else.

Success Handler Action: If you don’t have people on staff to h

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

andle Delegation and I Wish Tasks, it won’t cost a fortune to have someone take them over for you. Here are five places to look for the right person to give you four or five hours each week at less than $10 per hour:

1.

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

Friends and neighbors who left the workforce to become stay-at-home parents

2. Family members who could use some extra money

3. Full-time college students looking to create work experience for their resum?

4. Seniors

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

Professional from academic institutions, pharmaceutical industries, health care indust

who retired from successful business careers

5. The best volunteers in your local elementary school’s parent-teacher organization

Olympians train for years for the chance to have their moments of glory. Whether legends

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

like Jesse Owens or those who finish out of medal contention and fade from the spotlight, each takes on the enormous challenge of the Olympic motto – Swifter, Higher, Stronger.

Developing your Genius Time won’t occur ov

.

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

ernight. You’ll find yourself drifting off course and allowing Delegation and I Wish Tasks to interrupt your productivity. The goal – your gold medal – is to commit to changing how you approach your role in your small bu

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

Companies that provide selfless information through particip

iness. Delegate those things that aren’t of Olympic importance, and spend your time focusing on the areas that give you the best shot at celebrating victory.

Copyright © 2004 by Success Handler, LLC. All rights reserved

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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