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As a business grows, the more moving parts it has. And the more difficult it is to keep an eye on everything that is happening. Then the balls start to drop. Does your business have as many moving parts as a Jumb

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

o Jet? How do 747 pilots manage?

When a business starts-up, because of the risk of failure, the owner has to watch everything. Fortunately, when you start-up, there is not a lot to watch! But it is hard to get o

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

Examples of combination products may in

t of the habit, which is why so many business owners continue to micromanage the business as it gets larger. Now if you could keep your eye on every ball in the air that might be ok. But at some point it becomes

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

impossible to maintain, with owners focussing on where they feel most comfortable, rather than on what is most important.

Studies have shown that there are limits to how many different things a human being can m

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

nitor and react to. This of course, varies from person to person, but everyone has their limit. For example, only the most skilled jugglers can keep more than six balls in the air. The world record is 12. So when

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

Combination pro

we try to keep our eye on everything, we will start dropping balls.

So how does a Jumbo Jet pilot keep an eye on everything? Funnily enough, they have six gauges in the cockpit, representing the key areas of 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

plane’s performance. Or in business speak, the plane’s Key Performance Indicators. These are the most vital to keeping the plane in the air. So if the seat 57D does not fully recline, or the airline logo paint i

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

starting to flake on the body of the plane, they do not know about it. They have the flight attendants and the maintenance engineers to worry about such problems. However, these personnel are highly trained to n

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

otify the pilots if there is something they should worry about. The pilot trusts these personnel to do their job and follow their procedures, and only let him or her know about things that affect the plane’s safe

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

y. So the pilots can concentrate on flying the plane.

But what if there is an engine problem. The plane’s flight management system is set up so that any problem with a key part in the flight system will be evide

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

t on the high level gauges. So if there is a drop in airspeed, the pilot will query the system to determine which of the many causes may be responsible. They are able to drill down from the high level gauge which

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

Following aspects would a

has moved from the safe area to investigate which of the plane’s subsystems may be a fault. In almost all cases, the pilot is able to identify and either correct the problem or take action that will enable the p

dd to the challenges in developing combination products:

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

ane to land safety. If they worried about every little non-critical problem on the plane, the chances are they might only notice the big ones when it is too late to do anything about them.

In business, the owner

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

might identify that their cash reserves are declining. (Cash at Hand is one of the biggest Key Performance Indicators for any business.) Having seen this, the owner might ask the accountant to look at their deta

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

led reports to identify the cause. Is it due to slow sales, overdue payments by debtors, cost blow-outs or overinvestment in inventory.

Having identified cost blowouts as the cause, the accountant might ask the

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

perations manager why costs have gone up. She might advise that a maintenance problem has caused the over-run. When the operations manager speaks to the maintenance superintendent, she may discover the problem wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

s caused by poor quality feedstock. In other words, a cash problem was caused by supplier quality control problem. Further analysis is of course, possible. The owner has therefore uncovered a critical supplier pr

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

blem by interrogating staff after a key performance indicator has moved from the safe zone.

By having a small number of Key Performance Indicators which define the health of a business, and which are linked to o

.

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

ther more detailed reports, the owner can fly their business using just few gauges. So, if there is a deeper problem in the business it will become visible. Because an owner with an excellent Business Management

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

Companies that provide selfless information through particip

ystem is confident that they will identify problems in a timely fashion, they can focus on flying their business towards their ultimate objective which is their real job.

Copyright 2005 Empower Business Solution

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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