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Main Subject - Don’t Let Your Systems Drive Your Customers Crazy!
Does your company run like clockwork? Are your accountants pleased with how everything moves smoothly? Are your managers content with how customers a
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
re managed by your system?
If so, watch out! Your present methods, regulations, policies and procedures may be convenient for the company but utterl
If so, watch out! Your present methods, regulations, policies and procedures may be convenient for the company but utterl
; 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
frustrating for your customers.
Customers discover these landmines of dissatisfaction almost by accident, stumbling upon them in the normal course
Customers discover these landmines of dissatisfaction almost by accident, stumbling upon them in the normal course
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
f business. Dedicated customers will speak up and complain. Others will just go away.
I am a customer who makes a point of letting companies know wh
I am a customer who makes a point of letting companies know wh
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
n their policies are frustrating, preposterous or just plain customer-unfriendly.
Unfortunately, many organizations have built up a thick layer of r
Unfortunately, many organizations have built up a thick layer of r
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sistance and defensiveness towards such feedback. They have stopped listening to the voice of the customer…especially the customer with a complaint.
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
Sometimes I wonder whether anyone is listening at all.
The stories in this book are all true, and many are entertaining. But they are only valuable
The stories in this book are all true, and many are entertaining. But they are only valuable
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
f they inspire you to listen more closely to your customers and to more carefully examine your policies and procedures.
Key Learning Point
Key Learning Point
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
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Customers are often frustrated by standardized and inflexible
Customers are often frustrated by standardized and inflexible
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
policies. This may cause your customers to fume in frustration, but the rest of your staff and system may quietly conspire to silence the voice of co
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
plaining customers. You have to make an effort to really listen.
Action Steps
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Action Steps
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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
---------------------
Ask your customers: `How can we serve you better? What frustrates you most about the way we provide our service? Is ther
Ask your customers: `How can we serve you better? What frustrates you most about the way we provide our service? Is ther
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
anything you would like us to do more of? less of? start doing? stop doing? What do other companies do for you that we don't do here?'
Ask your sta
Ask your sta
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
f:
`What do our customers ask for that frustrates you the most? Are there any special customer requests that drive you crazy? Is there anything they
`What do our customers ask for that frustrates you the most? Are there any special customer requests that drive you crazy? Is there anything they
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
ask for that is against our company policy?'
Ask your managers:
`Is it the customers that make our staff so mad, or are they driven to distress by
Ask your managers:
`Is it the customers that make our staff so mad, or are they driven to distress by
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
imitations in our systems, policies and procedures?'
Ask other service providers:
Whenever you dine, travel, shop, purchase or rent, make special r
Ask other service providers:
Whenever you dine, travel, shop, purchase or rent, make special r
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
quests. Ask for things that are `not on the menu', slightly different from the routine.
Watch carefully how each establishment responds. Are they fa
Watch carefully how each establishment responds. Are they fa
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t, flexible and friendly? What is it about their policy and systems that allows them to respond that way?
Learn to improve your own systems by testi
Learn to improve your own systems by testi
.
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
g the flexibility of others.
Finally, ask yourself:
Are you willing to make the changes your customers require?
Your accountant and your managers
Finally, ask yourself:
Are you willing to make the changes your customers require?
Your accountant and your managers
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
ay be comfortable. But who are you in business for?
Your Accounting Department will still be with you tomorrow. Will your customers be with you, too
Your Accounting Department will still be with you tomorrow. Will your customers be with you, too
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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