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Useful Advices - It's Human to Expect Perfection
How many times have you been criticized for making an honest mistake? Perhaps you left laundry in the dryer, forgot to put
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
the milk away, or neglected to set your alarm for work? Hey…these things happen. After all, we’re only human right?
; 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
> Then why, at times, do we forget this universal truth and excessively criticize others for their mistakes?
The answer i
The answer i
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
simple and something I believe everyone, including myself, can improve upon; always assume positive intent. In oth
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r words, when you witness someone else’s mistake, assume they didn’t do it intentionally and they were trying their best to
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
prevent making the mistake in the first place.
As an example, I’ll share with you a pretty big “boo boo” I made in 2004
As an example, I’ll share with you a pretty big “boo boo” I made in 2004
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
/b>. I was coding the first draft of our company's monthly billing script, which bills every subscriber we had for their u
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
coming month of service. As you can imagine, I was pretty nervous. With so many clients, what if something went wrong?
I
I
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
tested the script over and over to make sure I was charging each client the correct amount. Each time I ran the test, it a
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
peared to be working. Confident that everything was in order, I executed the script for the first time in our history, whi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
h quickly led to my first biggest mistake in its history.
Instead of billing each client correctly, I billed them anywh
Instead of billing each client correctly, I billed them anywh
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
re from $50 to $9,000! My fatal error? Not testing my script with more than one account at a time. If I had, I would
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
have noticed that I wasn’t resetting the value for each subscriber’s account total.
So instead of this:
Joe Smith: $50
So instead of this:
Joe Smith: $50
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
Allen Wood: $75
Bob Stanley: $50
It looked like:
Joe Smith: $50
Allen Wood: $125
Bob Stanley: $175
Bob Stanley: $50
It looked like:
Joe Smith: $50
Allen Wood: $125
Bob Stanley: $175
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
>
Multiply that by a few hundred clients and you can quickly see how I made it to the $9,000+ mark.
Oops.
I, of course,
Multiply that by a few hundred clients and you can quickly see how I made it to the $9,000+ mark.
Oops.
I, of course,
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
ad a number of reasons for the mistake, but if I was never given the opportunity to share them, my time there would have sh
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
rtened dramatically. It was the assumption of positive intent given to me that didn’t allow this one mistake, to be my
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ast.
So the next time you or someone you know makes a mistake… remember...
So the next time you or someone you know makes a mistake… remember...
- Hindsight is always 20/20
.
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
li>It’s easier to criticize a job than complete it
It’s not the mistake that’s important, but what you learned fr
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
m it
But most importantly, remember that success comes from having the courage to make one more mistake.
But most importantly, remember that success comes from having the courage to make one more mistake.
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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