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For many people, both in and out of business, one of the hardest things to do is listening to experts. Why? Because experts generally g

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

ive advice that runs contrary to what people want to hear. Experts are not always right, but their opinions are worth consideration, es

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

Examples of combination products may in

ecially if all you have to go on is a gut feeling.

There are two television shows where people generally ignore the experts to their o

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

n detriment. On Cops, as police officers try to sort out circumstances, they continually tell people, “Sit down and be quiet.” B

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

t as Blue Collar comic Ron White says about his own arrest, “I had the right to remain silent . . . I just didn’t have the abili

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

Combination pro

y.” On Cops, people ignore police advice, even after several warnings and are finally hauled off to jail.

On the antique show <

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

>Bargain Hunt, David “Cheap as Chips” Dickinson provides two separate teams with two hundred pounds and an expert. The teams then h

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

ve an hour to roam around a flea market and purchase two or three items, which are sold at auction a week later. The team that makes th

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

most money gets to keep the profit. However, there usually isn’t very much profit because the teams don’t listen to their experts all

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

hat much.

On a recent episode the two women of the Blue Team came up with a child’s chair. The expert suggested a different child’s ch

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

ir for about the same price of 20 pounds. The expert’s chair was from the previous century, had “turned” rather than “straight” support

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

Following aspects would a

, and had some worn spots that gave the chair character. The Blue Team chose the one they found rather than the expert’s find, because

dd to the challenges in developing combination products:

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

hey liked it.

Next the team came back with a metronome, which wasn’t that old and made odd sounds. The expert voiced disapproval and g

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

ve his reasons. His opinion was ignored. Finally, the Blue Team approved the purchase of a wooden collection box the expert suggested f

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

r only 11 pounds. I think the Blue Team approved it because they felt guilty. The expert seemed relieved.

The Red Team didn’t take all

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

of their expert advice either, but they listened enough to make a 24 pound profit. The Blue Team made a profit of 14 pounds, which most

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

Professional from academic institutions, pharmaceutical industries, health care indust

y came from the expert’s collection box. The box sold of 28 pounds, making a whopping profit of 17 pounds, but that wasn’t enough to of

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

set the Blue Team’s combined loses with the child’s chair and the metronome.

When given expert advice, the first thing we need to do i

.

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

listen. The second thing to do is evaluate. If an expert’s opinion runs completely against what we want to do, then we should consider

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

Companies that provide selfless information through particip

changing our opinions. We should remain silent and make our final decisions based on facts and reasoning, not on our hopes and feelings

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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Potential customers unfamiliar with a business will be affected by and respond to its Corporate Identity. Existing customers will likewise be affected by Identity but not necessarily in the same manner or in a similar timeframe. Nonetheless the reactions of both groups can be a make or break situation for an enterprise.

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