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Just Other Articles - Revealed - Why Your Computer System Is A Mess
Ever wondered why it takes you so long to find the information you need on your corporate computer system? That's if you can find it at all. Did y
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
ou know that the tooth fairy could be partly to blame?
The tooth fairy visited our house just last week. Nothing particularly new in that: it mus
The tooth fairy visited our house just last week. Nothing particularly new in that: it mus
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
t have been about her twentieth visit. The interesting thing is that the famous fairy is still trading our daughters' off-cast teeth even though s
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e is no longer believed in. It's a classic case of suspended disbelief.
You see, our daughters have never confessed that they don't believe in th
You see, our daughters have never confessed that they don't believe in th
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ese small people with big wallets.
They're smart enough to know that if they were to admit any real doubt, the fairy's financier (i.e. me) would
They're smart enough to know that if they were to admit any real doubt, the fairy's financier (i.e. me) would
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ave a reason to cease payments. And with half a dozen teeth to go, well, you can do the maths.
So suspending their disbelief is essentially an ec
So suspending their disbelief is essentially an ec
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
onomic decision. It wouldn't be the first time that economic sensibilities have distorted a belief system.
Since the 1960s, vendors of management
Since the 1960s, vendors of management
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
information systems (MIS) have been promising organizations centralized information and simplified planning. As the years have gone on, these sys
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ems have become more expensive while the promises associated with them have become more expansive.
These days you will be promised detailed table
These days you will be promised detailed table
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
s and charts showing you exactly how well your business or unit is running. Instantly - and all at the click of a button.
The reality tends to be
The reality tends to be
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
less magical. In 2007, the truly effective MIS is still about as rare as Tinkerbell and her fang finding friends.
Consider these insights sampled
Consider these insights sampled
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
from a recent survey by Accenture of over 1,000 managers in the US and UK:
* Middle managers spend up to two hours a day searching for informati
* Middle managers spend up to two hours a day searching for informati
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
on;
* More than half of what they find is of no use to them;
* 59% of managers miss seeing valuable internal information because they can't easi
* More than half of what they find is of no use to them;
* 59% of managers miss seeing valuable internal information because they can't easi
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
y find or retrieve it; and
* 42% accidentally use incorrect information at least once a week.
Statistics like this will come as no surprise to a
* 42% accidentally use incorrect information at least once a week.
Statistics like this will come as no surprise to a
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
great many managers.
Yet businesses continue to sink billions of dollars into software implementations and upgrades. At each turn, disbelief is
Yet businesses continue to sink billions of dollars into software implementations and upgrades. At each turn, disbelief is
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
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
uspended as decision makers convince themselves that this time it will all come together. And just as it was when they were children, this suspend
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ed disbelief is driven by economics.
The promise of newfound profitability motivates these software adoptions in the first place - whether or not
The promise of newfound profitability motivates these software adoptions in the first place - whether or not
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
they are really needed. And the threat of blowing the budget leads to chronic under-investment in the critical supporting phases of business anal
.
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
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
sis, user training and documentation.
After over 40 years, statistics like those above are a damning indictment on the MIS industry. A reality ch
After over 40 years, statistics like those above are a damning indictment on the MIS industry. A reality ch
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
eck is long overdue. It's time the industry stopped behaving like the tooth fairy and started behaving like Bob the Builder. (He's real, isn't he?
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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