Social Articles - Computers and Technology

I have been meaning to write this column since the day I first bought a home computer in 1993. It probably was getting online that first prompted the desire to write this. What has been keeping me from writing this column until now is that e

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

very time I made an attempt, I would dissolve into a pool of tears and end up on the bed uttering vile profanities.

But here I am. I am bucking up. I am finally going to write this column. Maybe I should call it, “Why I hate computers, the

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

Examples of combination products may in

Internet, and Bill ______!”

Let me first ask you something. If you spent a small fortune (and in 1993, computers cost a lot) to buy a high tech piece of equipment, wouldn’t you expect it to work? If you bought, let’s say, a brand-new Sony f

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

at-screen television set, wouldn’t you expect to see The Guiding Light (or whatever program was your pleasure) when you hit the power switch?

What would you think if you hit the “on” button and the television just sat there doing nothing ex

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

cept making clicking sounds and scary humming noises? What would you think if you tried changing channels but only got a nicely-written message saying that the channel you selected is no longer in existence (and furthermore never had existed

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

Combination pro

)? What would you think if you turned on the satellite only to get an error message telling you that you don’t have an account and if you ever had one, it has expired?

These are very legitimate questions. They get worse. What if you have be

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

n struggling with this wonderful, high-tech, never-before-has-the-world-seen-such-a-marvel television for years and years? What if you hit channel 4 but you get channel 4,450 instead? You call tech support and they tell you that your televi

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

sion isn’t programmed correctly. The geeks at Sony television lead you on a three-hour wild goose chase of fixes, after which they proudly announce that they have to be gods because they have miraculously cured your technical problem and you

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

r set will now work. Only, when you try it, it still does the same stupid thing.

Excuse me if I am wrong here, but when you pay a fortune for something that is supposed to do that for which it was designed, shouldn’t it do exactly that?

I

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

bout blew my flash memory when I read that Microsoft is releasing a new Windows Operating System.

But…but…Mr. Bill _____, why doesn’t the one I have work? Why not make the one that currently exists and tortures everyone all around planet Ea

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

rth work? Why not end my suffering with the one that presently sits on a desk in my house and works only when it wants to?

Here is a problem, one that is probably all too familiar to you readers. I have had this problem for years with all t

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

Following aspects would a

he computers I have owned. Upon occasion, but not always, when I attempt to download the Windows Updates (which should be called The Windows OS killer!), they download and install nicely. Then it gives me the fatal, murderous message, You no

dd to the challenges in developing combination products:

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

must restart your computer.

When I do this, it causes some kind of “feedback loop” that makes my computer recycle FOREVER in the start-up mode. It never does anything but make a lot of noise, then reboots forever and ever, Amen!

It sounds

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

, acts, and looks like what I can only imagine what a hard drive must go through when it is having cardiac arrest or a stroke.

If Sony television sold TVs that pulled this sort of nonsense that Mr. Bill ______ and his wunderkind geeks pull,

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

they would soon not be selling many TVs.

What are we, the consumers, to do? We keep buying and buying and buying PC’s with OS’s that consistently do not work!

I have owned many computers since my first one in 1993. I have friends, co-work

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

rs, and colleagues who have owned many PC’s since PC’s were first born to make human’s lives miserable. All, and I mean all, have conspired to torture me and my friends with what is touted as “The Mother of all Operating Systems—Windows!”

W

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

Professional from academic institutions, pharmaceutical industries, health care indust

hy do they want to release another Operating System when the one they’ve presently got does not work? Now, all of you reading this know that what I am writing is true. I am most certainly preaching to the Windows OS choir.

Windows OS works

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

when and if IT wants to.

Not only that, with every single new, off-the-shelf computer I have ever bought, I have had to spend an additional amount of money in software just to get the OS monster to work right. With the computer I bought in

.

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

exico, I had to buy software for virus protection, firewalls, registry cleaners, file deletion, error nuking and fixing, defragging, and more.

You know this is so because you have had to do the same thing!

So, there, I have said it and do

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

Companies that provide selfless information through particip

not feel one bit better. I do not know who to be madder at…Mr. Bill ____ of Microsoft or myself for my insistence in buying PC after PC.

I wonder if I can get a MAC in Mexico?

Now excuse me, please, while I start crying and fall on the bed

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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