Main Subject - Business

As one of the (apparently) few fans of Martha Stewart's Apprentice show, I liked to pick apart what happened on the show.

Some o

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

f Martha's apprentice candidates, including a few who were fired before the end of the show, deserved acknowledgement for their ex

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

Examples of combination products may in

cellence in keeping the goal in mind. Usually, their only goal was making the most money in sales. It was not to net the mo

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

st money; just to make the most in sales.

During the flower shop week, it was interesting to see how creative the corporate tea

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

m could be. It reminded me of when I owned a retail store years ago and some customers asked me what I used to do for a living

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

Combination pro

When I told them I was an accountant, I enjoyed seeing the freaked-out expressions on their faces. You'd think I was going 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

be lining the store shelves with adding machines and columnar paper.

One of the corporate team members on Martha's apprentice 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

ow mentioned how they handled an area that was their weakness. She said, "The corporate team members know that when we're aske

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

d to do something that we don't know much about, we outsource it." They called in a celebrity florist in New York City to hel

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

p them figure out a strategy. As a back-up, they also had their "plan B," which they implemented mid-day on their one-day sale

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

in order to increase sales. They ended the day selling more than the other team.

Through the second and third week, it was inte

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

Following aspects would a

resting to see how one team constantly kept the goal in mind (make the most money from the project), while the other te

dd to the challenges in developing combination products:

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

am would lose that perspective and seemed to find a new goal (such as, make something really cool and different). The c

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

reative team put so much work, effort, and concentration on the activities of the task that they just could not beat the sales f

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

igures of the opposing team.

It made me think about the business world at large. Do you have responsibility for directing a te

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

am of people? How well do you keep the goals in mind? How well do you help your team members keep the goals in mind? (It's a lo

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

Professional from academic institutions, pharmaceutical industries, health care indust

easier to do that for yourself than to help other people do the same.) Do your team members get so buried in the tasks at hand t

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

hat they can no longer envision the goals?

As the leader of a team, it is your job to make certain that the goals can be 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

een (which is the first step to ensuring that the goals can be attained). If people cannot envision the goal, they ca

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

Companies that provide selfless information through particip

nnot reach those goals very easily! Make certain the goals are within your team's line of vision.

© 2006 Borgeson Consulting, Inc

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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The U.S. workforce is very tight and finding good employees is extremely difficult. Are your managers contributing to higher turnover because of poor ethics?

It certainly could not be more obvious the incestuous relationship between big business and government than when the FTC made a special exemption of the Franchise Law for Large Corporate Franchisors. There is practically no fraud at all to be heard of in the franchising industry. Now there is quite a bit in the business opportunities sector, but in franchising there is very little something like 0.1%.

With everyone hiding behind voice mail and email, how do you properly follow up with prospects and customers. You need unique ideas. Ideas none of your competitors are using.

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