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Main Subject - Would You Make This Mistake, Too?
A storeowner told me a story recently that I think probably every storeowner has dealt with at one time or another. He has a very liberal return policy. If something is w
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
rong with an item, he will make it right, period. He is that kind of guy. His philosophy is if you keep the customer happy, he will return and purchase more from you in t
; 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
he long run. He realizes that the value of a customer is not a one-time sale. But having that customer return many times during his lifetime and them tell other people of
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the good experiences he has had in dealing with that store owner is what makes a business successful.
However in one particular instance, he made a mistake with a good cus
However in one particular instance, he made a mistake with a good cus
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
tomer over a two-dollar item. The family had been good customers over the years and had purchased lots of items from him. However, lately they had not been shopping with
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
im as much as usual. One of the big discount stores had opened nearby and his sales had decreased.
On this particular day, the family had came in and purchased several it
On this particular day, the family had came in and purchased several it
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
ems including a wooden paddle with the ball tied to it. Every kid has had at least one in his or her life. Even adults get into the act to see who is the best at bouncing
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
this ball on the paddle.
About two hours later, the little boy came back into the store with the wooden paddle and it was broken. The boy asked if he could get another o
About two hours later, the little boy came back into the store with the wooden paddle and it was broken. The boy asked if he could get another o
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ne because he broke this one. “How in the world did this kid break that wooden paddle?” the owner wondered. He told the little boy that he would not give him another one
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
free. The little boy left the store crying and his family has not returned to his store and it has been over a year now since that incident.
What would you do in that sit
What would you do in that sit
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ation? Was the store owner right not to give another one to the young boy. Obviously, the boy had broken the toy. The owner thought that the child should learn responsib
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
ility for his actions. Although, the toy only cost two dollars, the owner did not think that he should have given him another. He told me that he also thought that the pa
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
rents were not teaching their child anything about responsibility and that he should have taken care of his toys.
What really happened to the toy does not matter. Whose f
What really happened to the toy does not matter. Whose f
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
ault is not an issue. The issue is whether or not the owner should have replaced the broken toy. Although the owner was right because the boy had broken the paddle, he co
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
uld have handled the situation differently and perhaps not lost a good customer in the process.
The business owner had three options.
He could have replaced the item with
The business owner had three options.
He could have replaced the item with
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
ut question. This would have been the easiest option, however, the child would not learn anything about responsibility. But it would have kept him happy and his family pro
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
bably would have continued shopping there.
He could have talked to the parents and worked something out with them. Even if he finally replaced the toy, at least the paren
He could have talked to the parents and worked something out with them. Even if he finally replaced the toy, at least the paren
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ts would know that he thought they were taking advantage of his business.
And finally, as he did, he could have refused to replace the toy. However, in the long run, that
And finally, as he did, he could have refused to replace the toy. However, in the long run, that
.
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
decision may have cost him hundreds, if not thousands of dollars in sales.
The parents were wrong for sending a child into a business to replace a toy that he had broken.
The parents were wrong for sending a child into a business to replace a toy that he had broken.
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
And they are wrong for not shopping there anymore. But not all parents think things through and leave it to others to show children the real world.
So, what would you do
So, what would you do
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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